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نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
  SFDA PIL (Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)

Mesporin is an antibiotic for adults and children (including newborn babies). This medicine works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins. 
 
Mesporin is used to treat infections of:  the brain (meningitis),  the lungs,  the middle ear,  the abdomen and abdominal wall (peritonitis),  the urinary tract and kidneys,  the bones and joints,  the skin and soft tissues,  the blood,  the heart. 
 
It can be given to:  treat specific sexually transmitted infections (gonorrhoea and syphilis),  treat patients with a low white blood cell count (neutropenia) who have fever due to bacterial infection,  treat chest infections in adults with chronic bronchitis,  treat Lyme disease (caused by tick bites) in adults and children including newborn babies from 15 days of age,  prevent infections during surgery. 
 


 
a. Don't use Mesporin if:  you are allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6).  you have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems or monobactams). The signs include sudden swelling of the throat or face which may make it difficult to breathe or swallow, sudden swelling of the hands, feet and heels, and a severe skin rash that develops quickly.  you are allergic to lidocaine and if Mesporin is to be given as an injection into a muscle. 
 
Mesporin cannot be given to babies if:  the baby is premature.  the baby is newborn (up to 28 days of age) and has certain blood problems or jaundice (yellowing of the skin or whites of the eyes) or if the baby is to be given a product that contains calcium into a vein. 
 
b. Take special care with Mesporin Talk to your doctor, pharmacist or nurse before you are given Mesporin if:  you have recently received or are about to receive products that contain calcium.  you have recently had diarrhoea after taking an antibiotic, or if you have ever had problems with your intestine, in particular colitis (inflammation of the intestine).  you have liver or kidney problems.  you have gallstones or kidney stones.  you have other illnesses, such as haemolytic anaemia (a reduction in the red blood cells that may make your skin pale yellow and cause weakness or difficulty breathing).  you are on a low sodium diet. 
 
If you need a blood or urine test If you are given Mesporin for a long time, you may need to have regular blood tests. Mesporin may affect the results of urine tests for sugar and a blood test known as the Coombs test. If you are having tests:  tell the person taking the blood sample that you have been given Mesporin. 
 
Children Talk to your doctor, pharmacist or nurse before Mesporin is given to your child if:  he/she has recently received or is to be given a product that contains calcium into a vein. 

 c. Taking other medicines, herbal or dietary supplements  Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:  A type of antibiotic called an aminoglycoside.  An antibiotic called chloramphenicol (used to treat infections, especially eye infections). 
 
d. Pregnancy, breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will consider the benefit of treatment with Mesporin in relation to the risk to your baby. 
 
e. Driving and using machines Mesporin can cause dizziness. If you feel dizzy, do not drive or use tools or machines. Talk to your doctor if you get these symptoms. 


Mesporin is normally given by a doctor or nurse. It can be given by a drip (intravenous infusion) system or as an injection directly into a vein or muscle. Mesporin is prepared by the doctor, pharmacist or nurse and will not be mixed with or given at the same time as injections that contain calcium. 
 
Usual dose 
 
Your doctor will decide the correct dose of Mesporin for you. The dose will depend on the severity and type of infection, on whether you are taking other antibiotics, on your weight and age, and on your kidney and liver function. The number of days or weeks that you are given Mesporin depends on the type of infection that you have. 
 
Adults, the elderly and children over 12 years of age with a body weight  50 kilograms (kg):  1 to 2 g once a day, depending on the severity and type of infection. If you have a severe infection, your doctor will give you a higher dose (up to 4 g once a day). If your daily dose is higher than 2 g, you may receive it as a single dose once a day or as two separate doses. 
 
Newborn babies, infants and children between 15 days and 12 years of age with a body weight < 50 kg:  50-80 mg of Mesporin per kg of body weight once a day, depending on the severity and type of infection. If you have a severe infection, your doctor will give you a daily dose of up to 100 mg per kg of body weight up to a maximum of 4 g once a day. If your daily dose is higher than 2 g, you may receive it as a single dose once a day or as two separate doses.  Children with a body weight of 50 kg or more should receive the usual adult dose. 
 
 
Newborn babies (0-14 days)  20-50 mg of Mesporin per kg of body weight once a day, depending on the severity and type of infection.  The maximum daily dose should not exceed 50 . 
 
People with liver and kidney problems You may receive a different dose from the usual dose. Your doctor will decide how much Mesporin you will need and will monitor your condition closely, depending on the severity of the liver or kidney disease. 
 
a. If you use more Mesporin than you should If you accidentally receive a dose higher than your prescribed dose, contact your doctor or the nearest hospital immediately. 
 
b. If you forget to use Mesporin If you miss an injection, it should be given to you as quickly as possible. However, if it is nearly time to receive your next injection, skip the injection that you missed. Do not take a double dose (two injections at the same time) to make up for a missed dose. 
 
c. If you stop using Mesporin Do not stop using Mesporin unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or nurse. 
 


Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
The following side effects may occur with this medicine: 
 
Severe allergic reactions (not known, frequency cannot be estimated from the available data) If you have a severe allergic reaction, tell a doctor immediately. The signs may include:  Sudden swelling of the face, throat, lips and mouth. This may make it difficult to breathe or swallow.  Sudden swelling of the hands, feet and heels. 
 
Severe skin rashes (not known, frequency cannot be estimated from the available data) If you have a severe skin rash, tell a doctor immediately.  The signs may include a severe skin rash that develops quickly, with blisters or peeling of the skin and possibly blisters in the mouth. 
 
Other possible side effects: 
Common (may affect up to 1 in 10 people)  Abnormalities in blood levels of white blood cells (such as a decrease in leucocytes and an increase in eosinophils) and platelets (decrease in thrombocytes). 
 Loose stools or diarrhoea.  Changes in the results of blood tests for liver function.  Skin rash. 
 
Uncommon (may affect up to 1 in 100 people)  Fungal infections (e.g. candidiasis).  A decrease in the number of white blood cells (granulocytopenia).  A reduction in the number of red blood cells (anaemia).  Problems with blood clotting. The signs may include easy bruising, and pain and swelling of the joints.  Headache.  Dizziness.  Feeling sick or being sick.  Pruritus (itching).  Pain or a burning sensation along the vein where Mesporin has been given. Pain at the injection site.  A high temperature (fever).  Abnormal kidney function test (increase in blood creatinine). 
 
Rare (may affect up to 1 in 1,000 people)  Inflammation of the large intestine (colon). The signs include diarrhoea, usually with blood and mucus, stomach pain and fever.  Difficulty breathing (bronchospasm).  A lumpy skin rash (urticaria) that may cover a lot of your body, an itching sensation and swelling.  Blood or sugar in the urine.  Oedema (accumulation of fluid).  Shivers. 
 
Not known (frequency cannot be estimated from the available data)  A secondary infection that may not respond to the antibiotics previously prescribed.  A form of anaemia where red blood cells are destroyed (haemolytic anaemia).  Severe decrease in white blood cells (agranulocytosis).  Convulsions.  Vertigo (spinning sensation).  Inflammation of the pancreas (pancreatitis). The signs include severe stomach pain which spreads to your back.  Inflammation of the mucous lining of the mouth (stomatitis).  Inflammation of the tongue (glossitis). The signs include a swollen, red and sore tongue.  Problems with the bladder, which may cause pain, feeling sick and being sick.  A neurological condition that may occur in newborn babies with severe jaundice (kernicterus).  Kidney problems caused by deposits of ceftriaxone-calcium. There may be pain when urinating or low output of urine.    A false positive result for galactosaemia (abnormal accumulation of galactose in the blood). 
 Mesporin may interfere with some types of blood glucose tests  please check with your doctor.


Keep this medicine out of the sight & reach of children. 
 
Do not use Mesporin after the expiry date which is stated on the carton and bottle. The expiry date refers to the last day of that month. 
 
Do not store above 30 C. Store in the original package in order to protect from moisture and light. 
 
It is recommended to use each reconstituted solution freshly.

Its effectiveness remains for up to 6 hours at room temperature (15-25 C) and up to 24 hours under refrigeration (2- 8 C)
 
Any unused solutions for infusion should be discarded. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer require. These measures will help protect the environment.

 


The active substance is ceftriaxone in the form of sodium salt. Each bottle contains 250 mg, 500 mg or 1000 mg of ceftriaxone. 
 
The other ingredients are 1% lidocaine hydrochloride and water for injections.


Mesporin is a white or almost white crystalline powder with a characteristic odour. The ready-to-use solutions are colourless. Packs of 1, 2 and 4 units are available. Not all pack sizes may be marketed.

Marketing Authorization Holder: Acino AG Am Windfeld 35, D-83714 Miesbach Germany 
 
 
Manufacturer: Labesfal -  Zona Industrial do Lagedo 3465-157 Santiago de Besteiros Portugal 


This leaflet was last revised in June 2018
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

ميسبورين عبارة عن مضاد حيوي للبالغين والأطفال (بما في ذلك الأطفال حديثو الولادة). يعمل هذا الدَّ واء عن طريق قتل البكتيريا التي تسبب العدوى. ينتمي هذا الدَّ واء إلى مجموعة من الأدوية تسمى السيفالوسبورينات.

 

يسُتخدم ميسبورين لعلاج عدوى:

•                    المخ (الْتِهاب السّحَايَا).

•                    الرئتين.

•                    الأذن الوسطى.

•                    البطن وجدار البطن (الْتِهاب الصِّفاق).

•                    الجهاز البولي والكُلى.

•                    العظام والمفاصل.

•                    الجلد والأنسجة الرخوة.

•                    الدم.

•                    القلب.

من الممكن إعطاء العقار للأسباب الآتية:

•                    علاج أنواع محددة من العدوى المنقولة جنسيا (السيلان والزهري.)

•                    علاج المرضى الذين يعانون من انخفاض تعداد خلايا الدَّ م البيضاء (قلة خلايا العَدِلات) ممن يعانون من الحمى بسبب العدوى البكتيرية.

•                    علاج عدوى الصدر في البالغين الذين يعانون من التهاب الشعب الهوائية المزمن.

•                    علاج مرض لايم (النّاجم عن لدغات القراد) في البالغين والأطفال، بما في ذلك الأطفال حديثي الولادة  من عمر

١٥ يومًا.

•                    الوقاية من العدوى أثناء الجراحة.

 

أ.       لا تستخدم ميسبورين في الحالات الآتية:

•                    إذا كانت لديك حساسية تجاه سيفترياكسون أو أي من المكونات الأخرى بهذا الدَّ واء (المدرجة في القسم: ٦).

•                    إذا كنت قد أصبت بإحدى تفاعلات الحساسية المفاجئة أو الشديدة تجاه البنسيلين أو المضادات الحيوية المشابهة

(مثل: السيفالوسبورينات، الكاربابينيمات، أو المونوباكتامات). تشمل العلامات: تورم الحلق أو الوجه المفاجئ مما قد يجعل التَّ نفس أو البلع أمرًا صعبًا، تورمًا مفاجئًا في اليدين والقدمين والكعبين، وطفحًا جلديا شديداً يتطور بسرعة.

•                    إذا كنت تعاني من حساسية تجاه ليدوكائين وإذا كان يجب إعطاء ميسبورين في هيئة حقن داخل العضلة.

 

لا يمكن إعطاء ميسبورين للأطفال الرضع في الحالات الآتية:

•                    إذا كان الطفل الرضيع مبتسرًا.

•                    إذا كان الطفل حديث الولادة (حتى ٢٨ يومًا من العمر) ويعاني من مشاكل معينة بالدَّ م أو من اليرقان (اصفرار الجلد أو اصفرار بياض العينين) أو إذا كان يجب إعطاء الطفل الرضيع منتجًا يحتوي على الكالسيوم في الوريد.

 

ب. توخ حذرًا خاصا مع ميسبورين

تحدَّ ث إلى طبيبك، أو الصيدلي، أو الممرض(ة) الخاص(ة) بك قبل أن يتم إعطاؤك ميسبورين في الحالات الآتية:

•                    إذا كنت قد تلقيت مؤخرًا أو على وشك أن تتلقى منتجات تحتوي على الكالسيوم.

•                    إذا كنت قد أصبت بالإسهال في الآونة الأخيرة بعد تناول أحد المضادات الحيوية، أو إذا كنت قد عانيت من قبل من مشاكل بالأمعاء لديك، وعلى وجه الخصوص التهاب القولون (التهاب الأمعاء.)

•                    إذا كانت لديك مشاكل بالكبد أو الكلى.

•                    إذا كان لديك حصوات بالمرارة أو بالكُلى.

•                    إذا كنت تعاني من أمراض أخرى، مثل: فقر الدَّ م الانحلالي (انخفاض في خلايا الدَّ م الحمراء الأمر الذي قد يجعل لون الجلد لديك أصفرًا شاحبًا ويسبب ضعفًا أو صعوبة في التَّنفس).

•                    إذا كنت تتبع نظامًا غذائيا منخفض الصوديوم.

 

إذا كنت بحاجة إلى إجراء اختبار بالدم أو البول

إذا تم إعطاؤك ميسبورين لفترة طويلة، فقد تكون بحاجة إلى إجراء اختبارات الدَّ م بانتظام. قد يُؤثر ميسبورين على نتائج اختبارات البول للسكر، وعلى اختبارٍ الدَّ م المعروف باسم اختبار كومبس. إذا كنت تخضع لإجراء الاختبارات:

•                    أخبر الشخص الذي يقوم بسحب عينة الدَّ م بأنه تم إعطاؤك ميسبورين.

 الأطفال

تحدَّ ث إلى طبيبك، أو الصيدلي، أو الممرض(ة) الخاص(ة) بك قبل أن يتم إعطاء ميسبورين لطفلك/ طفلتك في الحالات الآتية:

•                    إذا تلقى/ تلقت مؤخرًا أو سوف يتم إعطاؤه/ إعطاؤها منتجًا يحتوي على الكالسيوم عن طريق الوريد.

 

ج. تناوُل أدوية أخرى، أو مكملات عشبية أو مكملات غذائية 

يرُجى إبلاغ طبيبك أو الصيدلي الخاص بك إذا كنت تتناول أو تناولت مؤخرًا أو قد تتناول أ َّ ية أدوية أخرى.

وعلى وجه الخصوص، أخبر طبيبك أو الصيدلي الخاص بك إذا كنت تتناول أيا من الأدوية التَّ الية:

•                    أحد أنواع المضادات الحيوية المعروف باسم أمينوُجْليكُوزيد.

•                    أحد المضادات الحيوية المعروف باسم كلورامفينيكول ( يسُتخدم لعلاج العدوى، خاصةً عدوى العين).

 

‌د.           الحمل والرضاعة الطبيعية 

إذا كنتِ حاملًا أو مرضعًا، أو تعتقدين أنكِ حامل، أو تخططين لذلك، فاستشيري طبيبك قبل تلقي هذا الدَّ واء.

سيضع طبيبكِ في الاعتبار فوائد العلاج بميسبورين بالنسبة إلى مخاطره على طفلك.

 

‌ه.           ممارسة القيادة واستخدام الآلات

من الممكن أن يسبب ميسبورين دوخة. إذا شعرت بدوخة، فتجنب ممارسة القيادة أو استخدام الأدوات أو الآلات. إذا أصِبت بهذه الأعراض، فتحدَّ ث إلى طبيبك.

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عادة ما يتم إعطاء ميسبورين بواسطة طبيبٍ أو ممرض(ة). من الممكن إعطاؤه عن طريق نظام التقطير (التسريب الوريدي) أو في هيئة حَقْن مباشر في الوريد أو العضل. يتم إعداد ميسبورين بواسطة الطبيب أو الصيدلي أو الممرض(ة) ،ولن يتم مزجه مع أو إعطاؤه في نفس الوقت مع الحقن التي تحتوي على الكالسيوم.

 

الجرعة المعتادة

 

سيحدد طبيبك جرعة ميسبورين الصحيحة لك .ستعتمد الجرعة على شدة العدوى ونوعها، وتعتمد على ما إذا كنت تتناول مضادات حيوية أخرى، وعلى وزنك وعمرك، وعلى وظائف الكلى والكبد لديك. يعتمد عدد الأيام أو الأسابيع التي يتم فيها إعطاؤك ميسبورين على نوع العدوى التي تعاني منها.

 

البالغون وكبار السن والأطفال ممن تزيد أعمارهم عن ١٢ عامًا وتبلغ أوزان أجسامهم ≥ ٥٠ كجم:

        ١ إلى ٢ جرام مرة واحدة يوميا، اعتماداً على شدة العدوى ونوعها. إذا كنت تعاني من عدوى شديدة، فسيعطيك طبيبك جرعة أعلى (حتى ٤ جرامات مرة واحدة يوميا). إذا كانت جرعتك اليومية أعلى من ٢ جرام، فقد تتلقاها في هيئة جرعة واحدة مرة واحدة في اليوم أو في هيئة جرعتين منفصلتين.

 

الأطفال حديثو الولادة، والرضع والأطفال الذين تتراوح أعمارهم بين ١٥ يومًا و١٢ عامًا وتبلغ أوزان أجسامهم > ٥٠ كجم:

•                    ٥٠-٨٠ مجم ميسبورين لكل كجم من وزن الجسم مرة واحدة يوميا، اعتماداً على شدة العدوى ونوعها. إذا كنت تعاني من عدوى شديدة، سيعطيك طبيبك جرعة يومية تصل إلى ١٠٠ مجم لكل كجم من وزن الجسم تصل حتى ٤ جرامات كحد أقصى مرة واحدة في اليوم. إذا كانت جرعتك اليومية أعلى من ٢ جرام، فقد تتلقاها في هيئة جرعة واحدة مرة واحدة في اليوم أو في هيئة جرعتين منفصلتين.

•                    يجب أن يتلقى الأطفال الذين تبلغ أوزان أجسامهم ٥٠ كجم أو أكثر الجرعة المُعتادة للبالغين.

 

الأطفال حديثو الولادة ( ٠-١٤ يومًا)

•                    ٢٠-٥٠ مجم ميسبورين لكل كجم من وزن الجسم مرة واحدة يوميا، اعتماداً على شدة العدوى ونوعها.

•                    يجب ألَا تتجاوز الجرعة اليومية القصوى ٥٠ مجم لكل كجم من وزن جسم الطفل الرضيع.

 

الأشخاص المصابون بمشاكل في الكبد والكُلى

قد تتلقى جرعة مختلفة عن الجرعة المعتادة. سيحدد طبيبك مقدار ما ستحتاجه من ميسبورين وسيراقب حالتك عن كثب ،اعتماداً على شدة المرض بالكبد أو الكلى.

 

‌أ.            إذا استخدمت كمية أكثر مما يجب من ميسبورين

إذا تلقيت جرعة أكبر من الجرعة الموصوفة لك بطريق الخطأ، فاتصل بطبيبك أو بأقرب مستشفى فورًا.

 

‌ب.        إذا أغفلت استخدام ميسبورين

إذا أغفلت تلقي إحدى عمليات الحقن، فيجب إعطاؤها لك بأسرع ما يمكن. مع ذلك، إذا كان وقت عملية الحَقْن التَّ الية الخاصة بك قد اقترب، فتخطى عملية الحَقْن التي أغفلتها. لا تتلقى جرعة مضاعفة (عمليتي حَقْن في نفس الوقت) لتعويض جرعة أغفلتها.

 

‌ج.         إذا توقفت عن استخدام ميسبورين

لا تتوقف عن استخدام ميسبورين ما لم يخبرك طبيبك بذلك. إذا كانت لديك أية أسئلة إضافية حول استخدام هذا الدَّ واء، فاستشر طبيبك أو الممرض(ة) الخاص(ة) بك.

مثله مثل كافة الأدوية، قد يسُبب هذا الدَّ واء آثارًا جانبية، على الرغم من عدم حدوثها لدى الجميع.

 

قد تحدث إصابة بالآثار الجانبية التَّالية مع هذا الدَّ واء:

 

تفاعلات حساسية شديدة (غير معروفة، لا يمكن تقدير معدل التكرار من واقع البيانات المتاحة) إذا كنت تعاني من أحد تفاعلات الحساسية الشديدة، فأخبر الطبيب فورًا.

قد تشمل العلامات الآتي:

•                    تورمًا مفاجئاً بالوجه، والحلق، والشفتين، والفم. قد يؤدي هذا إلى صعوبة في التنفس أو البلع.

•                    تورمًا مفاجئاً باليدين، والقدمين، والكعبين.

 

حالات من الطفح الجلدي الشديد (غير معروفة، لا يمكن تقدير معدل التكرار من واقع البيانات المتاحة) إذا عانيت من طفح جلدي شديد، أخبر الطبيب فورًا.

•                    قد تشمل العلامات: طفحًا جلديا شديداً يتطور بسرعة، مع بثور، أو تقشر الجلد، ومن المحتمل وجود بثور في الفم.

 

الآثار الجانبية المحتملة الأخرى:

شائعة (قد تؤُثر على ما يصل إلى شخص واحد من بين كل ١٠ أشخاص)

•                    اضطرابات في مستويات خلايا الدم البيضاء بالدَّ م (مثل: انخفاض في خلايا الدَّ م البيضاء وزيادة في الحمضات) والصفائح الدموية (انخفاض في الصفائح الدَّ موية).

•                    براز رخو أو إسهال.

•                    تغيرات في نتائج اختبارات الدَّ م لوظائف الكبد.

•                    طفح جلدي.

 

غير شائعة (قد تؤثر على ما يصل إلى شخص واحد من كل ١٠٠ شخص)

•                    العدوى الفطرية (على سبيل المثال: داء المبيضات.)

•                    انخفاض في عدد خلايا الدَّ م البيضاء (قلة خلايا المحببات.)

•                    انخفاض في تعداد خلايا الدَّ م الحمراء (فقر الدَّ م).

•                    مشاكل في تجلط الدَّ م. قد تشمل العلامات سهولة الإصابة بكدمات، وألمًا وتورمًا بالمفاصل.

•                    صداعًا.

•                    دوخة.

•                    شعورًا بالإعياء أو إعياء.

•                    حكة.

•                    ألمًا أو إحساسًا بالحرقة على طول الوريد حيث تم إعطاء ميسبورين. ألمًا بموضع الحقن.

•                    ارتفاع درجة الحرارة (حمى.)

•                    نتائج غير طبيعية لاختبارات وظائف الكلى (ارتفاع مستوى الكرياتينين بالدم.)

 

نادرة (قد تؤثر على ما يصل إلى شخص واحد من بين كل ١٠٠٠ شخص)

•                    التهاب الأمعاء الغليظة( التهاب القولون). تشمل العلامات: إسهالًا، عادة ما يكون مصحوبًا بدم ومخاط، وألمًا بالمعدة، وحمى.

•                    صعوبة في التَّ نفس (التشنج القصبي).

•                    طفحًا جلديا متكتلًا (شَرَى (أرتكاريا))، والذي قد يغطي مساحة كبيرة من جسمك، إحساسًا بالحكة والتورم.

•                    وجود دم أو سكر بالبول.

•                    وذمة (تراكُم السوائل).

•                    رعشات.

 

غير معروفة (لا يمكن تقدير معدل التكرار من واقع البيانات المتاحة)

•                    عدوى ثانوية قد لا تستجيب للمضادات الحيوية التي تم وصفها سابقًا.

•                    أحد أشكال فقر الدَّ م؛ حيث يتم تدمير خلايا الدَّ م الحمراء (فقر الدَّ م الانحلالي).

•                    انخفاض شديد في خلايا الدَّ م البيضاء (ندرة خلايا المحببات).

•                    تشنجات.

•                    دوار (شعور بالدوران.)

•                    التهاب البنكرياس. تشمل العلامات: ألمًا شديداً بالمعدة والذي يمتد إلى الظهر لديك.

•                    التهاب الغشاء المخاطي المبطن للفم (التهاب الفم.)

•                    التهاب اللسان. تشمل العلامات: تورمًا واحمرارًا وقرحًا باللسان.

•                    مشاكل بالمثانة ،والتي قد تسبب الألم، والشعور بالإعياء والإعياء.

•                    حالة عصبية من الممكن أن تحدث في الأطفال حديثي الولادة الذين يعانون من اليرقان الشديد (اليرقان النووي).

•                    مشاكل بالكُلى ناجمة عن ترسبات مكونة من السيفترياكسون مع الكالسيوم. قد يكون هناك ألم عند التَّ بول أو إخراج كمية قليلة من البول.

•                    نتيجة إيجابية كاذبة في اختبار كومبس (اختبار لبعض مشاكل الدَّ م).

•                    نتيجة إيجابية كاذبة للجالاكتوزيميا (التراكُم غير الطبيعي للجالاكتوز في الدَّ م).

•                    قد يتداخل ميسبورين مع بعض أنواع اختبارات جلوكوز الدَّ م - يرُجى التَّحقق من ذلك مع طبيبك.

يحُفظ هذا الدَّواء بعيداً عن رؤية ومتناول الأطفال.

 

لا تستخدم ميسبورين بعد تاريخ انتهاء الصلاحية الم دون على العبوة الكرتونية وعلى الزجاجة. يشُير تاريخ انتهاء الصلاحية إلى اليوم الأخير من ذلك الشهر.

 

يحُفَظ في درجة حرارة لا تزيد عن ٣٠ درجة مئوية ، يخزن في العبوة الأصلية للحماية من الرطوبة والضوء.

 

ينصح بإستخدام المحلول بعد إعداده مباشرة.

 

يظل المحلول المعد للاستخدام ثابتاً لمدة ٦ ساعات على الأقل في درجة حرارة الغرفة( ١٥-٢٥  درجة مئوية) ولمدة ٢٤ ساعة في الثلاجة( ٢ - ٨ درجة مئوية.)

 

يجب التَّخلص من أية محاليل معدة للتسريب لم يتم استخدامها.

 

يجب عدم التَّخلص من الأدوية عن طريق مياه الصرف أو مع المخلفات المنزلية. اسأل الصيدلي الخاص بك عن كيفية التَّخلص من الأدوية التي لم تعد بحاجة إليها. ستسُاعد هذه الإجراءات في الحفاظ على البيئة. 

 

المادة الفعالة هي سيفترياكسون في شكل ملح الصوديوم. تحتوي كل زجاجة على ٢٥٠ مجم أو ٥٠٠ مجم، أو ١٠٠٠ مجم سيفترياكسون.

المكونات اﻷخرى هي:  1%هيدروكلوريد الليدوكائين وماء للحقن.

 

 

ميسبورين هو عبارة عن مسحوق بلوري أبيض أو قريب للأبيض وله رائحة مميزة .تكون المحاليل المُعدة للاستخدام عديمة اللون.

تتوافر عبوات بحجم ١ و٢ و٤ وحدات.

 

قد لا يتم تسويق جميع أحجام العبوات.

مالك حق التَّسويق:

شركة أسينو أيه جي

أم ويندفيلد ٣٥، ٨٣٧١٤D-  ميسباخ ألمانيا

 

جهة التَّصنيع:

مختبرات لابيسفيل ألميرو ،المحدودة المنطقة الصناعية في لاجيدو

٣٤٦٥-١٥٧ سانتياجو دي بيستيروس البرتغال

 

تمت آخر مراجعة لهذه النَّشرة في يونيو ٢٠١٨
 Read this leaflet carefully before you start using this product as it contains important information for you

Mesporin 250 mg Powder and solvent for solution for IM injection 250 mg/2 ml powder and solvent for solution for injection Mesporin 500 mg Powder and solvent for solution for IM injection 500 mg/2 ml powder and solvent for solution for injection Mesporin 1000 mg Powder and solvent for solution for IM injection 1000 mg/3.5 ml powder and solvent for solution for injection

The active substance is ceftriaxone as the sodium salt. Mesporin 250 mg Powder and solvent for solution for IM injection Each vial contains 250 mg of ceftriaxone as ceftriaxone sodium. Mesporin 500 mg Powder and solvent for solution for IM injection Each vial contains 500 mg of ceftriaxone as ceftriaxone sodium. Mesporin 1000 mg Powder and solvent for solution for IM injection Each vial contains 1000 mg of ceftriaxone as ceftriaxone sodium. Excipient with known effect: Mesporin contains approximately 83 mg (3.6 mmol) of sodium per gram of ceftriaxone. For a full list of excipients, see section 6.1.

250 mg, 500 mg, 1 g powder and solvent for solution for injection. Powder and solvent for solution for injection. White or off-white crystalline powder.

Mesporin is indicated for the treatment of the following infections in adults and children, including full-term neonates (from birth):  
 
Bacterial meningitis  Community-acquired pneumonia  Hospital-acquired pneumonia  Acute otitis media  
Intra-abdominal infections  Complicated urinary tract infections (including pyelonephritis)  Bone and joint infections  Complicated skin and soft tissue infections  Gonorrhoea  Syphilis Bacterial endocarditis 
 
Mesporin may be used:  For treatment of acute exacerbation of chronic obstructive pulmonary disease in adults  For treatment of disseminated Lyme disease (early [stage II] and late [stage III]) in adults and children, including neonates from 15 days of age  For preoperative prophylaxis of surgical site infections  In the management of neutropenic patients with fever that is suspected to be due to a bacterial infection  In the treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above 
 
Mesporin should be co-administered with other antibacterial agents whenever the possible range of causative bacteria does not fall within its spectrum (see section 4.4). 
 
Consideration should be given to the guidelines on the appropriate use of antibacterial agents. 


Posology

The dose depends on the severity, susceptibility, site and type of infection and on the age and hepatic and renal function of the patient.

The recommended doses in the tables below are the generally recommended doses in these indications. In particularly severe cases, the dose at the higher end of the recommended range should be considered.

Adults and children aged over 12 years of age (≥ 50 kg)

Ceftriaxone dosage*: 1-2 g.

Treatment frequency**: Once daily.

Indications: Community-acquired pneumonia, Acute exacerbation of chronic obstructive pulmonary disease, Intra-abdominal infections, Complicated urinary tract infections (including pyelonephritis).

 

Ceftriaxone dosage*: 2 g.

Treatment frequency**: Once daily.

Indications: Once daily Nosocomial (hospital-acquired) pneumonia, Complicated skin and soft tissue infection, Bone and joint infections,

 

Ceftriaxone dosage*: 2-4 g

Treatment frequency**: Once daily

Indications: Management of neutropenic patients with fever that is suspected to be due to a bacterial infection, Bacterial endocarditis, Bacterial meningitis.

* In documented bacteraemia, the higher end of the recommended dose range should be considered. ** Twice daily administration (12 hourly) may be considered when doses greater than 2 g daily are administered.

 

Indications for adults and children over 12 years of age (≥ 50 kg) requiring specific dosage schedules:

Acute otitis media: A single intramuscular dose of Mesporin 1-2 g can be given. Limited data suggest that in cases where the patient is seriously ill or previous therapy has failed, Mesporin may be effective when given as an intramuscular dose of 1-2 g daily for 3 days.

Preoperative prophylaxis of surgical site infections: 2 g as a single preoperative dose.

Gonorrhoea: 500 mg as a single intramuscular dose.

Syphilis: The generally recommended doses are 500 mg - 1 g once daily, increased to 2 g once daily for 10 - 14 days. The dose recommendations in syphilis, including neurosyphilis, are based on limited data. National or local guidelines should be taken into consideration.

Disseminated Lyme disease (early [stage II] and late [stage III]): 2 g once daily for 14 - 21 days. The recommended treatment durations vary and national or local guidelines should be taken into consideration.

Pediatric population:

Neonates, infants and children from 15 days to 12 years of age (< 50 kg), For children with a body weight of 50 kg or more, the usual adult dosage should be given.

Ceftriaxone dosage*: 50-80 mg/kg

Treatment frequency**:  Once daily

Indications: Intra-abdominal infections, Complicated urinary tract infections (including pyelonephritis).

 

Ceftriaxone dosage*: 50-80 mg/kg

Treatment frequency**:  Once daily

Indications: Community-acquired pneumonia, Hospital-acquired pneumonia.

 

Ceftriaxone dosage*: 50-100 mg/kg (max. 4 g)

Treatment frequency**:  Once daily

Indications: Complicated skin and soft tissue infections, Bone and joint infections, Management of neutropenic patients with fever that is suspected to be due to a bacterial infection.

 

Ceftriaxone dosage*: 80-100 mg/kg (max. 4 g).

Treatment frequency**:  Once daily.

Indications: Bacterial meningitis.

 

Ceftriaxone dosage*: 100 mg/kg (max. 4 g).

Treatment frequency**:  Once daily.

Indications: Bacterial endocarditis.

 

* In documented bacteraemia, the higher end of the recommended dose range should be considered. ** Twice daily administration (12 hourly) may be considered when doses greater than 2 g daily are administered.

Indications for neonates, infants and children from 15 days to 12 years (< 50 kg) requiring specific dosage schedules:

Acute otitis media: For initial treatment of acute otitis media, a single intramuscular dose of Mesporin of 50 mg/kg can be given. Limited data suggest that in cases where the child is severely ill or the initial treatment has failed, Mesporin may be effective when given as an intramuscular dose of 50 mg/kg daily for 3 days.

Preoperative prophylaxis of surgical site infections: 50-80 mg/kg as a single preoperative dose.

Syphilis: The generally recommended doses are 75-100 mg/kg (max. 4 g) once daily for 10 – 14 days. The dose recommendations in syphilis, including neurosyphilis, are based on limited data. National or local guidelines should be taken into consideration.

Disseminated Lyme disease (early [stage II] and late [stage III]): 50-80 mg/kg once daily for 14 - 21 days. The recommended treatment durations vary and national or local guidelines should be taken into consideration.

 

Neonates from 0 to 14 days of age Mesporin is contraindicated in premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age).

 

Ceftriaxone dosage* 20-50 mg/kg

Frequency of treatment: Once daily

Indications: Intra-abdominal infections, Complicated skin and soft tissue infections, Complicated urinary tract infections (including pyelonephritis), Community-acquired pneumonia, Hospital-acquired pneumonia, Bone and joint infections, Management of neutropenic patients with fever that is suspected to be due to a bacterial infection.

 

Ceftriaxone dosage* 50 mg/kg

Frequency of treatment: Once daily. 

Indications: Bacterial meningitis, Bacterial endocarditis.

* In documented bacteraemia, the higher end of the recommended dose range should be considered. A maximum daily dose of 50 mg/kg should not be exceeded.

Indications for neonates from 0 to 14 days of age requiring specific dosage schedules:

Acute otitis media: For initial treatment of acute otitis media, a single intramuscular dose of Mesporin of 50 mg/kg can be given.

Preoperative prophylaxis of surgical site infections: 20-50 mg/kg as a single preoperative dose.

Syphilis: The generally recommended doses are 50 mg/kg once daily for 10 – 14 days. The dose recommendations in syphilis, including neurosyphilis, are based on limited data. National or local guidelines should be taken into consideration.

Duration of therapy 
 
The duration of therapy varies according to the course of the disease. As with antibiotic therapy in general, the administration of ceftriaxone should be continued for a period of 48-72 hours after the disappearance of the fever or evidence of bacterial eradication has been achieved. 
 
Elderly subjects 
 
The dosages recommended for adults require no modification in the elderly provided that hepatic and renal function is satisfactory. 
 
Patients with liver disease 
 
Available data do not indicate the need for dose adjustment in mild or moderate hepatic function impairment provided renal function is not impaired. 
 
There are no study data in patients with severe hepatic impairment (see section 5.2). 
 
Patients with renal impairment 
 
In patients with impaired renal function, there is no need to reduce the dosage of ceftriaxone provided hepatic function is not impaired. Only in cases of preterminal renal impairment (creatinine clearance < 10 ml/min) should the ceftriaxone dosage not exceed 2 g daily.  In patients undergoing dialysis, no additional dose is required following dialysis. Ceftriaxone is not removed by peritoneal dialysis or haemodialysis. Close clinical monitoring of safety and efficacy is advised. 

Duration of therapy 
 
The duration of therapy varies according to the course of the disease. As with antibiotic therapy in general, the administration of ceftriaxone should be continued for a period of 48-72 hours after the disappearance of the fever or evidence of bacterial eradication has been achieved. 
 
Elderly subjects 
 
The dosages recommended for adults require no modification in the elderly provided that hepatic and renal function is satisfactory. 

Patients with liver disease 
 
Available data do not indicate the need for dose adjustment in mild or moderate hepatic function impairment provided renal function is not impaired. 
 
There are no study data in patients with severe hepatic impairment (see section 5.2).  

Patients with renal impairment 
 
In patients with impaired renal function, there is no need to reduce the dosage of ceftriaxone provided hepatic function is not impaired. Only in cases of preterminal renal impairment (creatinine clearance < 10 ml/min) should the ceftriaxone dosage not exceed 2 g daily.  In patients undergoing dialysis, no additional dose is required following dialysis. Ceftriaxone is not removed by peritoneal dialysis or haemodialysis. Close clinical monitoring of safety and efficacy is advised. 
 
Patients with severe hepatic impairment and renal disease 
 
In patients with severe hepatic impairment and renal disease, close clinical monitoring of safety and efficacy is advised. 
 
Method of administration 
 
Intramuscular administration  Mesporin can be administered by deep intramuscular injection. Intramuscular injections should be injected well within the bulk of a relatively large muscle and not more than 1 g should be injected at one site.  As the solvent used is lidocaine, the resulting solution should never be administered intravenously (see section 4.3). The information in the Summary of Product Characteristics of lidocaine should be considered. 
 
For instructions on reconstitution of the medicinal product before administration, see section 6.6. 


Hypersensitivity to ceftriaxone, to any other cephalosporin or to any of the excipients listed in section 6.1. Known history of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of betalactam antibiotics (penicillins, monobactams and carbapenems). Ceftriaxone is contraindicated in: Premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age)* Full-term neonates (up to 28 days of age): - with hyperbilirubinaemia, jaundice, hypoalbuminaemia or acidosis because these are conditions in which bilirubin binding is likely to be impaired* - if they require (or are expected to require) intravenous calcium treatment or calciumcontaining infusions, due to the risk of precipitation of a ceftriaxone-calcium salt (see sections 4.4, 4.8 and 6.2). *In vitro studies have shown that ceftriaxone can displace bilirubin from its plasma protein binding sites, leading to a possible risk of bilirubin encephalopathy in these patients. Contraindications to lidocaine must be excluded before intramuscular injection of ceftriaxone when lidocaine solution is used as a solvent (see section 4.4). See information in the Summary of Product Characteristics of lidocaine, especially contraindications. Ceftriaxone solutions containing lidocaine should never be administered intravenously.

Hypersensitivity reactions 
 
As with all beta-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported (see section 4.8). In the event of serious hypersensitivity reactions, treatment with 
ceftriaxone must be discontinued immediately and appropriate emergency measures must be initiated. Before beginning treatment, it should be established whether the patient has a history of serious hypersensitivity reactions to ceftriaxone, to other cephalosporins or to any other type of beta-lactam antibiotic. Caution should be used if ceftriaxone is given to patients with a history of non-serious hypersensitivity to other beta-lactam antibiotics. 
 
Serious cutaneous adverse reactions (Stevens Johnson syndrome or Lyell's syndrome/toxic epidermal necrolysis) have been reported; however, the frequency of these events is not known (see section 4.8). 
 
Interactions with calcium-containing products 
 
Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and full-term neonates aged less than 1 month have been described. At least one of them had received ceftriaxone and calcium at different times and through different intravenous lines. In the available scientific data there are no reports of confirmed intravascular precipitation in patients, other than neonates, treated with ceftriaxone and calcium-containing solutions or any other calcium-containing products. In vitro studies have shown that neonates have an increased risk of precipitation of ceftriaxone-calcium compared with other age groups. 
 
In patients of any age, ceftriaxone may not be mixed or administered simultaneously with any calcium-containing intravenous solutions, even via different infusion lines or at different infusion sites. However, in patients older than 28 days, ceftriaxone and calcium-containing solutions may be administered sequentially, one after another, if infusion lines are used at different sites or if the infusion lines are replaced or carefully flushed with normal saline solution between infusions to prevent precipitation. In patients requiring continuous infusion of calcium-containing total parenteral nutrition (TPN) solutions, healthcare professionals may consider the use of alternative antibacterial treatments that do not have a similar risk of precipitation. If the use of ceftriaxone is considered necessary in patients requiring continuous nutrition, the TPN and ceftriaxone solutions may be administered simultaneously, although via different infusion lines and at different sites. Alternatively, infusion of the TPN solution can be stopped for the period of ceftriaxone infusion and the infusion lines flushed carefully between solutions (see sections 4.3, 4.8, 5.2 and 6.2). 
 
Paediatric population 
 
Safety and effectiveness of Mesporin in neonates, infants and children have been established for the dosages described in Posology and method of administration (see section 4.2). Studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin from serum albumin. 
 
Mesporin is contraindicated in premature and full-term neonates at risk of developing bilirubin encephalopathy (see section 4.3). 
 
 
 
 
 
Immune-mediated haemolytic anaemia 
 
Immune-mediated haemolytic anaemia has been observed in patients treated with cephalosporinclass antibiotics, including Mesporin (see section 4.8). Serious cases of haemolytic anaemia, including fatalities, have been reported during treatment with Mesporin in adults and children. 
 
If a patient develops anaemia during treatment with ceftriaxone, the diagnosis of cephalosporininduced anaemia should be considered and ceftriaxone should be discontinued until the aetiology is determined. 
 
Long-term treatment 
 
During prolonged treatment, full blood counts should be carried out at regular intervals. 
 
Colitis/Overgrowth of non-susceptible micro-organisms 
 
Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial agents, including ceftriaxone, and may range in severity from mild to lifethreatening. Therefore, it is important to consider this diagnosis in patients who have diarrhoea during or subsequent to administration of ceftriaxone (see section 4.8). Discontinuation of therapy with ceftriaxone and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given. Superinfections with non-susceptible micro-organisms may occur, as with other antibacterial agents. 
 
Severe renal and hepatic impairment 
 
In severe renal and hepatic impairment, close clinical monitoring of safety and efficacy is advised (see section 4.2). 
 
Interference with serological testing 
 
Interference with the Coombs test may occur as Mesporin mad lead to false-positive test results. Mesporin can lead to false-positive results in the galactosaemia test (see section 4.8). Non-enzymatic methods for urinary glucose determination may give false-positive results. During treatment with Mesporin, glucose determination should be performed enzymatically (see section 4.8). 
 
Sodium 
 
Each gram of Mesporin contains 3.6 mmol of sodium. To be taken into consideration by patients on a controlled sodium diet. 
 
Antibacterial spectrum 
 
Ceftriaxone has a limited spectrum of antibacterial activity and may not be suitable for use as a single agent for the treatment of some types of infections, unless the pathogen has already been confirmed (see section 4.2). In polymicrobial infections where suspected pathogens include 
organisms resistant to ceftriaxone, administration of an additional antibiotic should be considered. 
 
Use of lidocaine 
 
If a lidocaine solution is used as the solvent, ceftriaxone solutions should be used for intramuscular injection only. Contraindications to lidocaine, precautions and other relevant information as detailed in the Summary of Product Characteristics of lidocaine must be considered before use (see section 4.3). The lidocaine solution should never be administered intravenously. 
 
Biliary lithiasis 
 
If abdominal ultrasound scans reveal signs of biliary lithiasis, the possibility of calciumceftriaxone precipitates should be considered. Shadows that have been mistaken for gallstones have been detected on ultrasound scans of the gallbladder, most frequently at daily ceftriaxone doses of 1 g or above. Special care should be taken in the paediatric population. Such precipitates disappear after discontinuation of ceftriaxone treatment. Rarely, calcium-ceftriaxone precipitates have been associated with symptoms. In symptomatic cases, conservative non-surgical management is recommended and discontinuation of treatment with ceftriaxone should be considered by the physician based on a specific risk-benefit assessment (see section 4.8). 
 
Biliary stasis 
 
Cases of pancreatitis, possibly due to biliary obstruction, have been reported in patients treated with Mesporin (see section 4.8). Most patients presented with risk factors for biliary stasis and biliary sludge, e.g. preceding major treatment, serious illness and total parenteral nutrition. A trigger or cofactor role of biliary precipitation related to Mesporin cannot be ruled out. 
 
Renal lithiasis 
 
There have been reports of cases of renal lithiasis, which is reversible after discontinuation of ceftriaxone (see section 4.8). In symptomatic cases, an ultrasound scan should be performed. Use in patients with a history of renal lithiasis or with hypercalciuria should be considered by the physician based on a specific risk-benefit assessment. 


Calcium-containing solvents, such as Ringer's solution or Hartmann's solution, should not be used to reconstitute Mesporin vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form. Ceftriaxone-calcium precipitation can also occur when ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration line. Ceftriaxone should not be administered concomitantly with calciumcontaining intravenous solutions, including calcium-containing continuous infusions such as parenteral nutrition, via a Y connector. However, in non-neonatal patients, ceftriaxone and calcium-containing solutions may be administered sequentially if infusion lines are carefully flushed with a compatible liquid between infusions. In vitro studies using adult plasma and 
umbilical cord blood from neonates have shown that neonates have an increased risk of ceftriaxone-calcium precipitation (see sections 4.2, 4.3, 4.4, 4.8 and 6.2). 
 
Concomitant use with oral anticoagulants may increase the anti-vitamin K effect and the risk of haemorrhage. It is recommended that the International Normalised Ratio (INR) is monitored frequently and the dosage of the anti-vitamin K drug adjusted accordingly during and after treatment with ceftriaxone (see section 4.8). 
 
There is conflicting evidence regarding a potential increase in renal toxicity of aminoglycosides when used with cephalosporins. Monitoring of aminoglycoside levels (and renal function) in clinical practice is recommended. 
 
In an in vitro study, antagonistic effects were observed with the combination of chloramphenicol and ceftriaxone. The clinical relevance of this finding is not known. 
 
There have been no reports of an interaction between ceftriaxone and oral calcium-containing products or an interaction between intramuscular ceftriaxone and calcium-containing products (intravenous or oral). 
 
In patients treated with ceftriaxone, the Coombs' test may lead to false-positive results. 
 
Ceftriaxone, like other antibiotics, may yield false-positive results in tests for galactosaemia. 
 
Likewise, non-enzymatic methods for urinary glucose determination may yield false-positive results. For this reason, urinary glucose levels should be determined enzymatically during treatment with ceftriaxone. 
 
No impairment of renal function has been observed after concurrent administration of large doses of ceftriaxone and potent diuretics (e.g. furosemide). 
 
Simultaneous administration of probenecid does not reduce the elimination of ceftriaxone. 


Pregnancy 
 
Ceftriaxone crosses the placental barrier. There are limited data from the use of ceftriaxone in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/foetal, perinatal and postnatal development (see section 5.3). Ceftriaxone should be administered during pregnancy, and in particular in the first trimester of pregnancy, only if the benefit outweighs the risk. 
 
Breastfeeding 
 
Ceftriaxone is excreted into human milk in low concentrations but at therapeutic doses of ceftriaxone no effects on the breastfed infants are anticipated. However, the risk of diarrhoea and fungal infection of the mucous membranes cannot be excluded. The possibility of sensitisation should be taken into account. A decision must be made whether to discontinue breastfeeding or to 
discontinue/abstain from ceftriaxone therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman. 
 
Fertility 
 
Reproductive studies have shown no evidence of adverse effects on male or female fertility. 


During treatment with ceftriaxone, there may be undesirable effects (e.g. dizziness), which may influence the ability to drive and use machines (see section 4.8). Patients should be cautious when driving or operating machines. 
 


The adverse reactions most frequently reported with ceftriaxone are eosinophilia, leucopenia, thrombocytopenia, diarrhoea, rash and increased hepatic enzymes.

The data for determining the frequency of ceftriaxone adverse drug reactions were derived from clinical trials.

The following convention has been used for the classification of frequency: Very common ( 1/10) Common ( 100 to < 1/10) Uncommon (> 1/1000 to < 1/100) Rare (> 1/10000 to < 1/1000) Not known (cannot be estimated from the available data)

-          System organ classes:

 

1-      Infections and infestations:

Genital fungal infection (Uncommon)

Pseudomembra nous colitis (Rare)

Superinfection (b) (Not known )

 

2-      Blood and lymphatic system disorders

Eosinophilia Leucopenia Thrombocytopenia (common)

Granulocytope nia Anaemia Coagulopathy (Uncommon)

Haemolytic anaemia (b), Agranulocytosis (Not known)

 

3-      Immune system disorders:

Anaphylactic shock, Anaphylactic reaction, Anaphylactoid reaction Hypersensitivity (b) (Not known).

 

4-      Nervous system disorders:

Headache Dizziness (Uncommon)

Convulsion (Not known).

 

5-      Ear and labyrinth disorders:

Vertigo (Not known).

 

6-      Respiratory, thoracic and mediastinal disorders:

Bronchospasm (Rare).

 

7-      Gastrointestina 1 disorders:

Diarrhoea (b), Loose stools (Common)

Nausea, Vomiting (Uncommon)

Pancreatitis (b), Stomatitis, Glossitis (Not known)

 

8-      Hepatobiliary disorders:

Hepatic enzymes increased (Common)

Gallbladder calculi (b), Kernicterus (Not known)

 

9-      Skin and subcutaneous tissue disorders:

Rash (Common)

Pruritus (Uncommon)

Urticaria (Rare)

Stevens Johnson syndrome (b), Toxic epidermal necrolysis (b), Erythema multiforme, Acute generalized exanthematous pustulosis (Not known)

 

10-   Renal and urinary disorders:

Haematuria Glycosuria (Rare)

Oliguria Renal precipitation – reversible (Not known)

 

11-   General disorders and administration site conditions:  

Phlebitis Injection site pain, Pyrexia (Uncommon)

Oedema, Chills (Rare)

 

12-   Investigations:

Blood creatinine increased (Uncommon)

False-positive Coombs test (b), False-positive galactosaemia test (b), False-positive nonenzymatic glucose determination methods (Not known)

 

(a) Based on post-marketing reports. Since these reactions are reported voluntarily from a population of uncertain size, a precise estimate of frequency is not possible, and this is therefore categorised as not known.

(b) See section 4.4

Infections and infestations: Reports of diarrhoea following the use of ceftriaxone may be associated with Clostridium difficile. Appropriate fluid and electrolyte monitoring should be instituted (see section 4.4).

Ceftriaxone-calcium salt precipitation:  Serious and in some cases fatal adverse reactions have been reported rarely in pre-term and fullterm neonates (aged <28 days) who had been treated with intravenous ceftriaxone and calcium. Ceftriaxone-calcium salt precipitates have been observed post-mortem in lungs and kidneys. The increased risk of precipitation in neonates is due to their reduced blood volume and the longer half-life of ceftriaxone compared with adults (see sections 4.3, 4.4 and 5.2).

Cases of renal precipitation have been reported, primarily in children older than 3 years of age who were treated with either high daily doses (e.g. > 80 mg/kg/day) or total doses exceeding 10 g and who presented with other risk factors (e.g. fluid restriction or confinement to bed). The risk of precipitate formation is increased in immobilised or dehydrated patients. This event may be symptomatic or asymptomatic, may lead to renal impairment and anuria, and is reversible on discontinuation of treatment with ceftriaxone (see section 4.4).

Precipitation of ceftriaxone-calcium salt in the gallbladder has been observed, primarily in patients treated with doses higher than the recommended standard dose. Prospective studies in children revealed a variable incidence of precipitation with intravenous injection, in some studies above 30%. The incidence appears to be lower with slower infusions (20-30 minutes). This effect is generally asymptomatic, but in rare cases precipitation was accompanied by clinical symptoms such as pain, nausea and vomiting. In these cases, symptomatic treatment is recommended. Precipitation is usually reversible upon discontinuation of ceftriaxone (see section 4.4).


n the case of overdose, symptoms of nausea, vomiting and diarrhoea can occur. Ceftriaxone concentrations cannot be reduced by haemodialysis or peritoneal dialysis. There is no specific antidote. Treatment of overdose should be symptomatic. 


Pharmacotherapeutic group: Antibacterials for systemic use. Third-generation cephalosporins, ATC code: JOIDD04.

Mechanism of action:

Ceftriaxone inhibits bacterial cell wall synthesis following binding to penicillin-binding proteins. This results in the interruption of cell wall (peptidoglycan) biosynthesis, which leads to bacterial cell lysis and death.

Mechanism of resistance:

Bacterial resistance to ceftriaxone may be due to one or more of the following mechanisms:

-          hydrolysis by beta-lactamases, including extended-spectrum beta-lactamases (ESBLs), carbapenemases and Amp C enzymes that may be induced or stably derepressed in certain aerobic Gram-negative bacterial species.

-          reduced affinity of penicillin-binding proteins for ceftriaxone.

-          outer membrane impermeability in Gram-negative organisms.

-          bacterial efflux pumps.

Susceptibility testing breakpoints:

The minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:

Pathogen:

1-      Enterobacteriaceae, Dilution test (MIC, mg/L): Susceptible ≤ 1, Resistant > 2

2-       Staphylococcus spp, Dilution test (MIC, mg/L): Susceptible (a), Resistant (a)

3-      Streptococcus spp. (Groups A, B,C and G) Dilution test (MIC, mg/L): Susceptible (b), Resistant (b)

4-      Streptococcus pneumoniae, Dilution test (MIC, mg/L): Susceptible ≤ 0.5 (c), Resistant > 2

5-      Viridans group Streptococci, Dilution test (MIC, mg/L): Susceptible ≤ 0.5, Resistant > 0.5

6-      Haemophilus influenzae, Dilution test (MIC, mg/L): Susceptible ≤ 0.12 (c), Resistant > 0.12

7-       Moraxella catarrhalis, Dilution test (MIC, mg/L): Susceptible ≤ 1, Resistant > 2

8-      Neisseria gonorrhoeae, Dilution test (MIC, mg/L): Susceptible ≤ 0.12, Resistant > 0.12

9-      Neisseria meningitidis, Dilution test (MIC, mg/L): Susceptible ≤ 0.12 (c), Resistant > 0.12

10-   Non-species-related, Dilution test (MIC, mg/L): Susceptible ≤ 1 (d), Resistant > 2

a. Susceptibility inferred from cefoxitin susceptibility.

b. Susceptibility inferred from penicillin susceptibility.

c. Isolates with a ceftriaxone MIC above the susceptible breakpoint are rare and, if found,should be tested afresh and, if confirmed, should be sent to a reference laboratory.

d. Breakpoints apply to a daily intravenous dose of 1 gx 1 and a high dose of at least 2 gx 1.

 

Clinical efficacy against specific pathogens

The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of ceftriaxone in at least some types of infections is questionable.

Commonly susceptible species

Gram-positive aerobes: Staphylococcus aureus (methicillin-susceptible) £, Coagulase-negative Staphylococci (methicillin-susceptible) £, Streptococcus pyogenes (Group A), Streptococcus agalactiae (Group B), Streptococcus pneumoniae, Viridans group Streptococci.

Gram-negative aerobes: Borrelia burgdorferi, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Neisseria gonorrhea, Neisseria meningitidis, Proteus mirabilis, Providentia spp., Treponema pallidum.

Species for which acquired resistance may be a problem

Gram-positive aerobes: Staphylococcus epidermidis +, Staphylococcus haemolyticus +, Staphylococcus hominis +.

Gram-negative aerobes: Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli %, Klebsiella pneumoniae %, Klebsiella oxytoca %, Morganella morganii, Proteus vulgaris, Serratia marcescens.

Anaerobes: Bacteroides spp., Fusobacterium spp., Peptostreptococcus spp., Clostridium perfringens.

Inherently resistant organisms

Gram-positive aerobes: Enterococcus spp., Listeria monocytogenes.

Gram-negative aerobes: Acinetobacter baumannii, Pseudomonas aeruginosa, Stenotrophomonas maltophilia,

Anaerobes: Clostridium difficile.

Others: Chlamydia spp., Chlamydophila spp., Mycoplasma spp., Legionella spp., Ureaplasma urealyticum.

£ All methicillin-resistant staphylococci are resistant to ceftriaxone.

+ Resistance rates >50% in at least one region

% Beta-lactamase-producing strains are always resistant


Absorption 
 
After intravenous bolus administration of ceftriaxone 500 mg and 1 g, mean peak plasma ceftriaxone levels are approximately 120 mg/l and 200 mg/l, respectively. After intravenous infusion of 500 mg, 1 g and 2 g of ceftriaxone, plasma ceftriaxone levels are approximately 80 mg/l, 150 mg/l and 250 mg/l, respectively. After intramuscular injection, mean peak plasma ceftriaxone levels are approximately half those observed after intravenous administration of an equivalent dose. The maximum plasma concentration after a single intramuscular dose of 1 g is about 81 mg/l and is reached 2-3 hours after administration. The area under the plasma concentration-time curve after intramuscular administration is equivalent to that obtained after intravenous administration of an equivalent dose. 
 
Distribution 
 
The volume of distribution of ceftriaxone is 7-12 litres. Concentrations well above the minimum inhibitory concentrations of most relevant pathogens are detectable in tissues including the lungs, heart, biliary tract/liver, tonsils, middle ear and nasal mucosa, bone, and in cerebrospinal, pleural, prostatic and synovial fluids. An increase of 8-15% in the mean peak plasma concentration (Cmax) is seen on repeated administration; steady state is reached in most cases within 4872 hours, depending on the route of administration. 
 
Penetration of specific tissues 
 
Ceftriaxone penetrates the meninges. Penetration is higher when the meninges are inflamed. Mean peak CSF ceftriaxone concentrations up to 25% of plasma levels have been reported in 
patients with bacterial meningitis, compared with 2% of plasma levels in patients with noninflamed meninges. Peak CSF ceftriaxone concentrations are reached approximately 4-6 hours after intravenous injection. Ceftriaxone crosses the placental barrier and is excreted in human milk in low concentrations (see section 4.6). 
 
Plasma protein binding 
 
Ceftriaxone is reversibly bound to albumin. Plasma protein binding is 95% at plasma concentrations below 100 mg/l. Binding is saturable and the bound fraction decreases with increasing concentration (to 85% at a plasma concentration of 300 mg/l). 
 
Biotransformation 
 
Ceftriaxone is not metabolised systemically; however, it is converted into inactive metabolites by the intestinal flora. 
 
Elimination 
 
Plasma clearance of total ceftriaxone (bound and unbound) is 10-22 ml/min. Renal clearance is 512 ml/min. 50-60% of ceftriaxone is excreted unchanged in the urine, primarily by glomerular filtration, while 40-50% is excreted unchanged in the bile. The elimination half-life of total ceftriaxone in adults is about 8 hours. 
 
Patients with renal impairment or hepatic disease 
 
In patients with renal or hepatic dysfunction, the pharmacokinetics of ceftriaxone is only minimally altered, with the half-life slightly increased (less than twofold), even in patients with severely impaired renal function. 
 
The relatively modest increase in half-life in renal impairment is explained by a compensatory increase in non-renal clearance, resulting from a decrease in protein binding and corresponding increase in non-renal clearance of total ceftriaxone. 
 
In patients with hepatic impairment, the elimination half-life of ceftriaxone is not increased, due to a compensatory increase in renal clearance. This is also due to an increase in the plasma free fraction of ceftriaxone, contributing to the observed paradoxical increase in total drug clearance, with an increase in the volume of distribution comparable to that of total clearance. 
 
Elderly subjects 
 
In elderly persons over 75 years of age, the mean elimination half-life is normally 2 to 3 times greater than that in young adults. 
 
Paediatric population 
 
The half-life of ceftriaxone is prolonged in neonates. From birth to 14 days of age, the levels of free ceftriaxone may be further increased by factors such as reduced glomerular filtration and altered protein binding. During childhood, the half-life is lower than in neonates or adults. 
The plasma elimination and volume of distribution of total ceftriaxone are greater in neonates, infants and children than in adults. 
 
Linearity/non-linearity 
 
The pharmacokinetics of ceftriaxone is non-linear and all basic pharmacokinetic parameters, except the elimination half-life, are dose-dependent if based on total drug concentrations, increasing less than proportionally with the dose. Non-linearity is due to saturation of plasma protein binding and is therefore observed for total plasma ceftriaxone, but not for free (unbound) ceftriaxone. 
 
Pharmacokinetic/pharmacodynamic relationship 
 
As with other beta-lactams, the pharmacokinetic/pharmacodynamic index demonstrating the best correlation with in vivo efficacy is the percentage of the dosing interval that the free concentration remains above the minimum inhibitory concentration (MIC) of ceftriaxone for individual target species (i.e. %T > MIC).


There is evidence from animal studies that high doses of ceftriaxone-calcium salts led to the formation of concrements and precipitates in the gallbladder of dogs and monkeys that proved to be reversible. Animal studies produced no evidence of toxicity to reproduction or of genotoxicity. Carcinogenicity studies have not been conducted on ceftriaxone. 


Lidocaine hydrochloride

Water for injections. 
 


Based on the literature, ceftriaxone is not compatible with amsacrine, vancomycin, fluconazole and aminoglycosides. 
 
Solutions containing ceftriaxone must not be mixed with or added to other agents, except those mentioned in section 6.6. In particular, calcium-containing solvents (e.g. Hartmann's solution or Ringer's solution) must not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form. Ceftriaxone may not be mixed or administered simultaneously with calcium-containing solutions, including total parenteral nutrition (see sections 4.2, 4.3, 4.4 and 4.8). 
 


Closed container: 36 months. After reconstitution: the reconstituted solution remains stable for at least: - 6 hours - Store at room temperature (15-25 °C) and - 24 hours - Store in a refrigerator (2°C – 8°C).

Do not store above 30 °C. Store in the original package in order to protect from moisture and light.

For storage conditions after reconstitution of the medicinal product, see section 6.3.


Glass vial containing powder for solution for injection and IM solvent ampoule containing solvent for solution for injection, packaged in a carton. 
 
Mesporin 250 mg Powder and solvent for solution for IM injection and Mesporin 500 mg Powder and solvent for solution for IM injection. Each ampoule of IM solvent contains 20 mg of lidocaine hydrochloride and water for injections q.s. 2 ml. Mesporin 1000 mg Powder and solvent for solution for IM injection Each IM solvent ampoule contains 35 mg of lidocaine hydrochloride and water for injections q.s. 3.5 ml. 
 
There are packs of 1, 2 and 4 units.  
 
Not all pack sizes may be marketed.  
 


Ceftriaxone is usually administered by deep IM injection. 
 
Instructions for use and handling  
 
Mesporin must be dissolved in 2 ml (Mesporin dosed at 250 mg or 500 mg) or 3.5 ml (Mesporin dosed at 1000 mg) of 1% w/v lidocaine hydrochloride injection solvent.  
 
The resulting solution must be administered by deep intramuscular injection.  Doses greater than 1 g must be divided and injected at more than one site. 
 
Not more than 1 g of ceftriaxone may be administered at the same site of the body (see section 4.2).  
 
Lidocaine solutions must not be administered intravenously (see section 4.4).  
 
Ceftriaxone should not be mixed in the same syringe with any drug other than 1% w/v lidocaine hydrochloride solution (for intramuscular injection only).  

 The reconstituted solution must be shaken for about 60 seconds to ensure the complete dissolution of ceftriaxone. 
 
Please refer to section 4.2 for further information. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


Acino AG Am Windfeld 35, D-83714 Miesbach Germany

June 2018
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