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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)

Cloracef® suspension is made from granules of the active ingredient cefaclor, which is an antibiotic. You or your pharmacist will add fresh clean drinking water to the bottle containing the granules, to make up the suspension, before you take it. Cloracef® suspension is used to treat the following infections caused by bacteria that can be killed by cefaclor:

-        Bronchitis

-        Infection of lung tissue (pneumonia)

-        Bladder (cystitis) and kidney infections

-        Throat infections including tonsillitis and pharyngitis

-        Middle ear infections (otitis media)

-        Skin and soft tissue (e.g. muscle) infections

-        Infection of the sinuses (sinusitis).


Do not take Cloracef® suspension:

·         If you are allergic (hypersensitive) to cefaclor, any cephalosporin (other similar antibiotics) or any of the other ingredients of this medicine (listed in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

 

Warnings and precautions

Talk to your doctor or pharmacist before taking Cloracef® suspension if you

·         Have had an allergic reaction to penicillins or other drugs in the past

·         Have a history of gastrointestinal disease, especially inflammation of the colon (colitis)

·         Have severe kidney problems

 

Tell your doctor if you are having blood or urine tests. Cloracef® suspension may interfere with these tests.

 

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, including medicines obtained without a prescription.

This is especially important of the following, as they may interact with your Cloracef® suspension:

·         warfarin (a blood thinner)

·         probenecid (a treatment for gout).

It may still be all right for you to be given Cloracef® suspension and your doctor will be able to decide what is suitable for you.

 

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist before taking this medicine.

 

Driving and using machines

 Cloracef® suspension should not affect your ability to drive or use machines.

 

Important information about some of the ingredients of Cloracef® suspension

Cloracef® suspension contains ≈ 3g sucrose per 5ml:

-          If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

-          It may be harmful to the teeth.

-          This should be taken into account in patients with diabetes mellites.


Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

 

Dosage

For adults and the elderly, the usual dose is 250 mg three times daily. For more severe infections the dose may be doubled. The maximum daily dose is 4 g.

Patients with a severe kidney disorder or patients receiving dialysis may need a different dose.

 

Use in children

For children, and babies over the age of one month, the usual total daily dosage is 20 mg/kg (body weight). This total daily dose is usually divided into three and given eight hours apart. For throat and middle ear infections the total daily dose can be divided into two and given twelve hours apart. For more severe infections the dose may be doubled. The maximum daily dose is 1 g.

 

For reconstitution of Cloracef® 125 mg and Cloracef® Forte 250 mg suspensions:

Add 44 ml of purified water in two portions to the dry mixture in the bottle and shake well after each addition.

 

For reconstitution of Cloracef® 375 mg suspension:

Add 43 ml of purified water in two portions to the dry mixture in the bottle and shake well after each addition.

 

 

If you take more Cloracef® suspension than you should

Go to the nearest accident and emergency department or tell your doctor straight away.

 

If you forget to take Cloracef® suspension

If you miss a dose, take one as soon as you can. If you have missed several doses, tell your doctor.

 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


Like all medicines, this medicine can cause side effects, although not everybody gets them. All medicines can cause allergic reactions, although serious allergic reactions are very rare.

Tell your doctor immediately if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face, lips or limbs, rash or itching (especially affecting your whole body).

 

Serious side effects

The following side effects are serious. You should stop taking this medicine and contact your doctor immediately if you experience them:

·         serious peeling or blistering of the skin

·         severe diarrhoea, possibly with blood or mucus.

 

The following side effects have been reported

·         diarrhoea

·         feeling sick (nausea)

·         vomiting

·         measles-like rash, (alone)

·         itching

·         red wheals on the skin (urticaria) (alone)

·         rash with widespread joint pain and / or stiffness, swollen lymph glands, fever and, possibly, cloudy urine

·         swollen arms or legs

·         breathlessness

·         changes in blood counts, which may show up as bruising or a very tired feeling. You will need a blood test to confirm this.

·         damage to your liver or kidneys which can only be detected by a blood and / or urine test

·         jaundice (yellow skin and eyes)

·         weakness

·         pins and needles in the hands or feet

·         fainting

·         abnormally excitable behaviour

·         agitation

·         nervousness

·         sleeplessness

·         confusion

·         tight muscles

·         dizziness

·         seeing or hearing things (hallucinations)

·         itching of the vagina caused by thrush (candidiasis).


·         Keep out of the reach and sight of children.

·         Do not use Cloracef® after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

·         Keep tightly closed. Protect from light. Do not store above 30°C. After reconstitution store in the refrigerator between 2-8 °C. Discard unused portion 14 days after reconstitution.

·         Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

 


Cloracef® 125 mg suspension: Each 5 ml of reconstituted suspension contains 125 mg of cefaclor (as cefaclor monohydrate).

Cloracef® Forte 250 mg suspension: Each 5 ml of reconstituted suspension contains 250 mg of cefaclor (as cefaclor monohydrate).

Cloracef® 375 mg suspension: Each 5 ml of reconstituted suspension contains 375 mg of cefaclor (as cefaclor monohydrate).

The other ingredients are: Xanthan gum, hypromellose, povidone, glycamil, citric acid monohydrate, strawberry flavor, sodium lauryl sulphate, simethicone and sucrose.


Cloracef® suspension bottles contain off white to yellowish granules. After reconstitution, the suspension is homogenous white to yellowish-white suspension. The granules in each bottle are sufficient to prepare 75 ml suspension. Cloracef® granules for suspension are filled in amber glass bottles with child resistant polyethylene cap.

Dar Al Dawa Development & Investment Co. Ltd.

Prince Hashem Bin Al-Hussein Street.

Na'ur – Amman – Jordan

Tel. (+962 6) 57 27 132

Fax. (+962 6) 57 27 776

 


01/2020
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

تحتوي حبيبات معلق كلوراسيف على المادة الفعالة سيفاكلور، وهو مضاد حيوي. قم بإضافة الماء النقي للحبيبات في القارورة لتحضير المعلق قبل تناوله. يستخدم معلق كلوراسيف في علاج أنواع العدوى التالية التي تسببها بكتيريا يستطيع سيفاكلور القضاء عليها:

-          التهاب القصبات الهوائية

-          عدوى أنسجة الرئة (الإلتهاب الرئوي)

-          المثانة (التهاب المثانة) وإلتهابات الكلى

-          عدوى الحلق بما في ذلك التهاب اللوزتين والبلعوم

-          عدوى الأذن الوسطى (التهاب الأذن الوسطى)

-          عدوى الجلد والأنسجة اللينة (مثل العضلات)

-          عدوى الجيوب الأنفية (التهاب الجيوب الأنفية).

 

موانع استعمال معلق كلوراسيف:

·           لا تتناول كلوراسيف إذا كنت تعاني من فرط في الحساسية تجاه سيفاكلور او اي سيفالوسبورين (مضادات حيوية أخرى مشابهة) او اي من المكونات الاخرى (المذكورة في القسم 6).

قد تشمل بعض اعراض فرط الحساسية  طفح، حكة، صعوبة في التنفس او انتفاخ الوجه او الشفاه او الحلق او اللسان.

 

المحاذير والاحتياطات

أخبر الطبيب أو الصيدلي قبل تناول معلق كلوراسيف في حال:

·           سبق و أصبت برد فعل تحسسي تجاه أي من ادوية البنسلين أو أي أدوية أخرى

·           لديك تاريخ بالإصابة بمرض في الجهاز الهضمي، خاصة التهاب القولون (تهيج القولون)

·           كنت مصاب بمشاكل شديدة في الكلى

 

أخبر الطبيب إذا كنت تنوي إجراء فحوصات مخبرية للدم أو البول. من الممكن أن يسبب معلق كلوراسيف نتائج خاطئة في هذه الفحوصات.

 

التداخلات الدوائية من أخذ هذا المستحضر مع أي أدوية أخرى أو أعشاب أو مكملات غذائية

أخبر طبيبك أو الصيدلي في حال كنت تتناول أو تناولت مؤخرا أو قد تتناول أي أدوية أخرى، بما في ذلك الأدوية التي تم الحصول عليها دون وصفة طبية.

يعد ذلك مهماً في الأدوية التالية على وجه الخصوص، لأنها قد تتفاعل مع معلق كلوراسيف:

·           وارفارين (مميع للدم).

·           بروبنسيد (لعلاج النقرس).

قد يكون من المقبول أن تتناول معلق كلوراسيف، سيقوم الطبيب بتحديد المناسب لك.

 

الحمل والرضاعة

أخبري طبيبك أو الصيدلي قبل تناول هذا الدواء في حال كنتِ حاملا أو مرضع، تعتقدين بأنك حامل أو تخططين للحمل.

 

القيادة وإستخدام الآلات

لا يؤثر معلق كلوراسيف على قدرتك على القيادة واستخدام الآلات.

 

معلومات هامة حول بعض مكونات معلق كلوراسيف

تحتوي كل 5 مل من معلق كلوراسيف على ≈ 3 غم سكر:

-          إذا أخبرك طبيبك بأنك غير قادر على تحمل بعض أنواع السكر، إستشر طبيبك قبل تناول هذا الدواء.

-          من الممكن أن يكون له تأثير ضارا بالأسنان.

يجب أخذ ذلك بعين الاعتبار لدى مرضى السكري

https://localhost:44358/Dashboard

تناول الدواء تماما كما ارشدك الطبيب أو الصيدلي. تحقق من الطبيب أو الصيدلي إذا لم تكن متأكدا.

 

الجرعة

الجرعة الإعتيادية للبالغين وكبار السن هي 250 ملغم ثلاث مرات يومياً. قد يلزم مضاعفة الجرعة في حالات العدوى الاكثر شدة. الجرعة اليومية القصوى هي 4 غرام.

قد يحتاج مرضى الاعتلال الكلوي الشديد أو الذين يخضعون للديلزة الدموية إلى جرعة مختلفة.

 

الاستخدام في الأطفال

الجرعة اليومية الإعتيادية للأطفال والرضع الذين تزيد أعمارهم عن شهر واحد هي 20 ملغم/كغم (وزن الطفل). عادة تقسم الجرعة الكلية اليومية إلى ثلاث جرعات وتعطى كل 8 ساعات. لعلاج عدوى الحلق أو عدوى الأذن الوسطى من الممكن تقسيم الجرعة اليومية إلى جرعتين بحيث تعطى كل 12 ساعة. أما في حالات العدوى الأكثر شدة قد تحتاج إلى مضاعفة الجرعة. الجرعة اليومية القصوى هي 1 غم.

 

لتجهيز معلق كلوراسيف 125 ملغم ومعلق كلوراسيف فورت 250 ملغم:

أضف 44 مل من الماء النقي لمحتويات القارورة على دفعتين ورجها جيدا بعد كل اضافة.

 

لجهيز معلق كلوراسيف 375 ملغم :

أضف 43 مل من الماء النقي لمحتويات القارورة على دفعتين ورجها جيدا بعد كل اضافة.

 

الجرعة الزائدة من معلق كلوراسيف

قم بمراجعة قسم الطوارئ لدى اقرب مستشفى أو أخبر الطبيب على الفور.

 

نسيان تناول جرعة معلق كلوراسيف

إذا نسيت تناول الجرعة، تناولها في أقرب وقت ممكن. استشر الطبيب في حال نسيت تناول أكثر من جرعة.

 

في كان لديك أي تساؤلات أخرى حول استخدام هذا الدواء، اسأل الطبيب أو الصيدلي.

شأنه شأن الأدوية الأخرى، قد يسبب هذا الدواء تأثيرات جانبية، الا أنها لا تحدث عند كل المرضى. جميع الأدوية لها القدرة على احداث تفاعلات حساسية، لكن التفاعلات الخطيرة منها تحدث بشكل نادر جدا.

أخبر الطبيب على الفور في حال أصابتك بصورة مفاجئة أزيز، صعوبة في التنفس، تورم في جفن العين، الوجه، الشفاه أو الأطراف، طفح أو حكة (خاصة في حال ظهورها على كامل الجسم).

 

الأعراض الجانبية الخطيرة

تعد الأعراض الجانبية التالية خطيرة. عليك التوقف عن تناول الدواء واخبار الطبيب على الفور في حال أصبت بأي منها:

·         تقشير أو تقرح شديد في الجلد

·         اسهال شديد، من الممكن احتوائه على دم أو مخاط.

 

تم الإبلاغ عن الأعراض الجانبية التالية

·         اسهال

·         غثيان

·         تقيؤ

·         طفح يشبه الحصبة (دون أعراض أخرى)

·         حكة

·         بثور حمراء على الجلد - شرى- (دون أعراض أخرى)

·         طفح مع ألم في المفاصل واسع الانتشار و / أو تصلب، انتفاخ في الغدد اللمفاوية، حمى ومن الممكن ظهور بول عكر.

·         تورم في الأيدي والساقين

·         انقطاع النفس

·         تغيرات في نتائج فحوص الدم، والتي تظهر على شكل كدمات أو الشعور بتعب. عليك القيام بفحوصات مخبرية للدم للتحقق من ذلك.

·         تلف في الكبد او الكلى و الذي يمكن تحديده فقط عن طريق فحوصات مخبرية للدم و / أو البول.

·         يرقان (اصفرار الجلد والعينين)

·         ضعف

·         الشعور بوخز دبابيس وإبر في اليدين أو القدمين

·         إغماء

·         سلوك هائج بصورة غير طبيعية

·         اهتياج

·         عصبية

·         أرق

·         ارتباك

·         شد في العضلات

·         دوار

·         رؤية أو سماع أشياء (هلوسة)

·         حكة في المهبل تحدث بسبب القلاع (سلاق).

 

·         يحفظ بعيدا عن متناول ايدي الاطفال ونظرهم.

·         لا تستخدم كلوراسيف بعد تاريخ الانتهاء المذكور على العبوة الخارجية. يدل تاريخ الانتهاء على اخر يوم في الشهر المذكور.

·         إبق القارورة محكمة الاغلاق بعيدا عن الضوء.  يحفظ على درجة حرارة لا تزيد عن 30 درجة مئوية. بعد التجهيز يحفظ في الثلاجة بين 2-8 درجة مئوية . لا تستعمل المتبقي بعد 14 يوم من تجهيز المعلق.

·         يمنع التخلص من الأدوية في المياه العادمة أو النفايات المنزلية. إسأل الصيدلي حول الطريقة السليمة للتخلص من الأدوية التي لم تعد بحاجة إليها. سيساعد هذا في حماية البيئة.

كلوراسيف 125 ملغم معلق: تحتوي كل 5 مل بعد التجهيز على 125 ملغم سيفاكلور (على هيئة سيفاكلور احادي الماء).

كلوراسيف فورت 250 ملغم معلق: تحتوي كل 5 مل بعد التجهيز على 250 ملغم سيفاكلور (على هيئة سيفاكلور احادي الماء).

كلوراسيف 375 ملغم معلق: تحتوي كل 5 مل بعد التجهيز على 375 ملغم سيفاكلور (على هيئة سيفاكلور احادي الماء).

المواد غير الفعالة الأخرى هي: صمغ الزانثان، هيبروميلوز, بوفيدون, جلايكاميل، حمض السيتريك احادي الماء، نكهة الفراولة، ملح الصوديوم للوريل السلفات، سيميثيكون وسكر.

 

تحتوي قوارير معلق كلوراسيف على حبيبات لونها مائل للبياض إلى أصفر. بعد التجهيز يكون المعلق متجانس ولونه أبيض إلى أبيض مائل للصفار. تحتوي كل قارورة على الحبيبات اللازمة لتحضير 75 مل من المعلق.

يعبأ معلق كلوراسيف في قوارير عنبرية زجاجية محكمة الاغلاق بغطاء مقاوم لعبث الأطفال.  

شركة دار الدواء للتنمية والإستثمار المساهمة المحدودة.

شارع الأمير هاشم بن الحسين.

 ناعور – عمان –  الأردن

هاتف. 132 27 57 (6 962 +)

فاكس.776 27 57 (6 962 +)

01/2020
 Read this leaflet carefully before you start using this product as it contains important information for you

Cloracef® Forte 250mg/5ml granules for oral suspension. Cloracef® 375mg/5ml granules for oral suspension.

Cloracef® Forte 250mg suspension: Each 5 ml contains 250 mg Cefaclor (as cefaclor monohydrate). Cloracef® 375mg suspension: Each 5 ml contains 375 mg Cefaclor (as cefaclor monohydrate). For a full list of excipients, see section 6.1

Granules for oral suspension. Cloracef® granules for oral suspensions are off white to yellowish granules. After reconstitution the suspensions are homogenous white to yellowish-white.

Cefaclor is indicated for the treatment of the following infections due to susceptible micro-organisms: Respiratory tract infections, including pneumonia, bronchitis, exacerbations of chronic bronchitis, pharyngitis and tonsillitis, and as part of the management of
sinusitis
Otitis media
Skin and soft tissue infections
Urinary tract infections, including pyelonephritis and cystitis.
Cefaclor has been found to be effective in both acute and chronic urinary tract infections.Cefaclor is generally effective in the eradication of streptococci from the nasopharynx, however, data establishing efficacy in the subsequent prevention of either rheumatic fever or bacterial endocarditis are not available.


Paediatric population:
The usual recommended daily dosage for children is 20mg/kg/day in divided doses every eight hours, as indicated. For bronchitis and pneumonia, the dosage is 20mg/kg/day in divided doses administered 3 times daily. For otitis media and pharyngitis, the total daily dosage may be divided and administered every 12 hours. Safety and efficacy have not been established for use in infants aged less than one month.
Cloracef® Suspension

 125mg/5ml250mg/5ml375ml/5ml
<1 year (9kg)2.5ml tid  
1-5 years (9-18kg)5.0ml tid  
Over 5 years 5.0ml tid3.3ml tid


In more serious infections, otitis media, sinusitis and infections caused by less susceptible organisms, 40mg/kg/day in divided doses is recommended, up to a daily maximum of 1g. In the treatment of beta-haemolytic streptococcal infections, therapy should be continued for at least 10 days. For instructions on dilution of the medicinal product before administration, see section 6.6.

Adults: The usual adult dosage is 250mg every eight hours. For more severe infections or those caused by less susceptible organisms, doses may be doubled.Doses of 4g per day have been administered safely to normal subjects for 28 days, but the total daily dosage should not exceed this amount.

Cefaclor may be administered in the presence of impaired renal function. Under such conditions dosage is usually unchanged (see section 4.4. ‘Special warnings and precautions for use’).

Patients undergoing haemodialysis. Haemodialysis shortens serum half-life by 25- 30%. In patients undergoing regular haemodialysis, a loading dose of 250mg-lg administered prior to dialysis and a therapeutic dose of 250-500mg every six to eight hours maintained during interdialytic periods is recommended. The elderly: As for adults.

Method of administration
Cefaclor is administered orally


Hypersensitivity to the active substance, any cephalosporins or to any of the excipients listed in section 6.1.

Warnings
Before instituting therapy with cefaclor, every effort should be made to determine whether the patient has had previous hypersensitivity reactions to cefaclor, cephalosporins, penicillins or other drugs. Cefaclor should be given cautiously to penicillin-sensitive patients, because cross-hypersensitivity, including anaphylaxis, among beta-lactam antibiotics has been clearly documented. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose – isomaltase insufficiency should not take this medicine. If an allergic reaction to cefaclor occurs, the drug should be discontinued and the patient treated with the appropriate agents.

Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics, including macrolides, semi-synthetic penicillins and cephalosporins. It is important, therefore, to consider its diagnosis in patients who develop diarrhoea in association with the use of antibiotics. Such colitis may range in severity from mild to life-threatening. Mild cases usually respond to drug discontinuance alone. In moderate to severe cases, appropriate measures should be taken.

Precautions
Cefaclor should be administered with caution in the presence of markedly impaired renal function. Since the half-life of cefaclor in anuric patients is 2.3 to 2.8 hours (compared to 0.6-0.9 hours in normal subjects), dosage adjustments for patients with moderate or severe renal impairment are not usually required. Clinical experience with cefaclor under such conditions is limited; therefore, careful clinical observation and laboratory studies should be made. Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of gastro-intestinal disease, particularly colitis. Prolonged use of cefaclor may result in the overgrowth of non-susceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken. Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibiotics. In haematological studies or in transfusion cross-matching procedures, when anti-globulin tests are performed on the minor side, or in Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a positive Coombs' test may be due to the drug. A false-positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets.


There have been rare reports of increased prothrombin time, with or without clinical bleeding, in patients receiving cefaclor and warfarin concomitantly. It is recommended that in such patients, regular monitoring of prothrombin time should be considered, with adjustment of dosage if necessary.

The renal excretion of cefaclor is inhibited by probenecid.


Pregnancy: Animal studies have shown no evidence of impaired fertility or teratogenicity.
However, since there are no adequate or well-controlled studies in pregnant women, caution should be exercised when prescribing for the pregnant patient.

Breastfeeding: Small amounts of cefaclor have been detected in breast milk following administration of single 500mg doses. Average levels of about 0.2 micrograms/ml or less were detected up to 5 hours later. Trace amounts were detected at one hour. As the effect on nursing infants is not known, caution should be exercised when cefaclor is administered to a nursing woman.


Not relevant


Gastro-intestinal: The most frequent side-effect has been diarrhoea. It is rarely severe enough to warrant cessation of therapy. Colitis, including rare instances of pseudomembranous colitis, has been reported. Nausea and vomiting have also occurred.

Hypersensitivity: Allergic reactions such as morbilliform eruptions, pruritus and urticaria have been observed. These reactions usually subside upon discontinuation of therapy. Serum sickness-like reactions (erythema multiforme minor, rashes or other skin manifestations accompanied by arthritis/arthralgia, with or without fever) have been reported.

Lymphadenopathy and proteinuria are infrequent; there are no circulating immune complexes and no evidence of sequelae. Occasionally, solitary symptoms may occur, but do not represent a serum sickness-like reaction. Serum sickness-like reactions are apparently due to hypersensitivity and have usually occurred during or following a second (or subsequent) course of therapy with cefaclor. Such reactions have been reported more frequently in children than in adults. Signs and symptoms usually occur a few days after initiation of therapy and usually subside within a few days of cessation of therapy. Antihistamines and corticosteroids appear to enhance resolution of the syndrome. No serious sequelae have been reported.

There are rare reports of erythema multiforme major (Stevens-Johnson syndrome), toxic epidermal necrolysis, and anaphylaxis. Anaphylaxis may be more common in patients with a history of penicillin allergy. Anaphylactoid events may present as solitary symptoms, including angioedema, asthenia, oedema (including face and limbs), dyspnoea, paraesthesias, syncope, or vasodilatation.

Rarely, hypersensitivity symptoms may persist for several months. Haematological: Eosinophilia, positive Coombs' tests and, rarely, thrombocytopenia. Transient lymphocytosis, leucopenia and,

rarely, haemolytic anaemia, aplastic anaemia, agranulocytosis and reversible neutropenia of possible clinical significance. See section 4.5 ‘Interactions with other medicinal products and other forms of interaction’.

Hepatic: Transient hepatitis and cholestatic jaundice have been reported rarely, slight elevations in AST, ALT or alkaline phosphatase values.

Renal: Reversible interstitial nephritis has occurred rarely, also slight elevations in blood urea or serum creatinine or abnormal urinalysis

. Central nervous system: Reversible hyperactivity, agitation, nervousness, insomnia, confusion, hypertonia, dizziness, hallucinations and somnolence have been reported rarely.

Miscellaneous: Genital pruritus, vaginitis and vaginal moniliasis.

To report any side effects:
National Pharmacovigilance and Drug Safety Centre (NPC)
o Fax: + 966-11-205-7662 o
Call NPC at +966-11-2038222,Exts: 2317-2356-2353-2354-2334- 2340
o Toll free phone: 8002490000
o Email: npc.drug@sfda.gov.sa
o Website: www.sfda.gov.sa/npc


Symptoms of nausea, vomiting, epigastric distress and diarrhoea would be anticipated.Treatment. Unless 5 times the normal total daily dose has been ingested, gastrointestinal decontamination will not be necessary. General management may consist of supportive therapy.


Pharmacotherapeutic group: Second-generation cephalosporins, ATC code: J01DC04 Cefaclor is active against the following organisms in vitro:
Alpha- and beta-haemolytic streptococci
Staphylococci; including coagulase-positive, coagulase-negative and penicillinaseproducing strains
Streptococcus pneumoniae
Streptococcus pyogenes (group A beta-haemolytic streptococci)
Branhamella catarrhalis
Escherichia coli
Proteus mirabilis
Klebsiella species
Haemophilus influenzae, including ampicillin-resistant strains.

Cefaclor has no activity against Pseudomonas species or Acinetobacter species. Methicillin-resistant staphylococci and most strains of enterococci (eg, Str. faecalis) are resistant to cefaclor. Cefaclor is not active against most strains of Enterobacter spp, Serratia spp, Morganella morganii, Proteus vulgaris and Providencia rettgeri.


Cefaclor is well absorbed after oral administration to fasting subjects. Total absorption is the same whether the drug is given with or without food; however, when it is taken with food, the peak concentration achieved is 50-75% of that observed when the drug is administered to fasting subjects and generally appears from ¾ to one hour later. Following administration of 250mg, 500mg and 1G doses to fasting subjects, average peak serum levels of approximately 7, 13 and 23 mg/L respectively were obtained within 30 - 60 minutes. Approximately 60 - 85% of the drug is excreted unchanged in the urine within eight hours, the greater portion being excreted within the first two hours. During the eight-hour period, peak urine concentrations following the 250mg, 500mg and 1G doses were approximately 600, 900 and 1,900 mg/L respectively. The serum half-life in normal subjects is 0.6 - 0.9 hours. In patients with reduced renal function, the serum half-life of cefaclor is slightly prolonged. In those with complete absence of renal function, the plasma half-life of the intact molecule is 2.3 - 2.8 hours. Excretion pathways in patients with markedly impaired renal function have not been determined. Haemodialysis shortens the halflife by 25 - 30%.


There are no pre-clinical

data of relevance to the prescriber which are additional to that already included in other sections of the SPC.


Xanthan gum, hypromellose, povidone, glycamil, citric acid monohydrate, strawberry powder, sodium lauryl sulphate, simethicone, and sucrose.


Non known.


36 Months

Keep tightly closed. Protect from light. Do not store above 30 °C. After reconstitution store in the refrigerator between 2-8 °C. Discard unused portion after 14 days.


Cloracef® suspension is available in amber glass bottle that contains dry granules sufficient to prepare 75 ml suspension and a measuring cup.

 

Immediate packaging

glass bottle amber Child resistant cap

Immediate packagingOuter packaging
glass bottle amber
Child resistant cap
Carton
Leaflet
Label

 


Any unused product or waste material should be disposed of in accordance with local requirements.


Dar Al Dawa Development & Investment Co. Ltd. Prince Hashem Bin Al-Hussein Street. P.O. Box 9364 Na’ur - Amman - Jordan

02/02/2020
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