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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)

Clindamycin is an antibiotic, a medicine for fighting against certain pathogens. It belongs to the group of the lincosamides.

 

Dalacin C is used in cases of infection by bacteria in the nose, throat, ears, respiratory tract, skin, bones, joints, heart, teeth, sex organs or digestive system. Dalacin C can also be used in cases of infection of the lungs and brain in patients with AIDS.


Do not take Dalacin C:

-        If you are allergic to clindamycin, lincomycin or any of the other ingredients of this medicine (listed in section 6)

-        Clindamycin phosphate solution for injection must not be given to premature babies or neonates because of the benzyl alcohol content.

 

Warnings and precautions

Talk to your doctor or pharmacist before using Dalacin C.

 

-          This medicine has been prescribed to you as part of a medicinal treatment. It must not be used by others. Consult your doctor first before using this medicine for other conditions.

-          Tell your doctor if you have bowel problems, severe kidney function disorders, severe liver function disorders or if you are hypersensitive. This may be important for you.

-          Tell your doctor if you experience signs of hypersensitivity, such as irritation, itching, inflammation or skin reactions. It may be necessary to stop the treatment.

-          Also tell your doctor if you experience diarrhoea, especially if it is severe, persistent or bloody, during or after the treatment. This may be a sign of severe inflammation of the colon due to infection by a bacterium called Clostridium difficile. It may be necessary to stop the treatment.

-          Undiluted Dalacin C must never be administered intravenously. Therefore, intravenous administration is by infusion over 10 to 60 minutes.

-          Dalacin C solution for injection must not be used in new-borns, whether or not premature, unless absolutely necessary, due to the risk of serious toxic reactions, including abnormal breathing (“gasping syndrome”). See “Dalacin C solution for injection contains 9.45 mg of benzyl alcohol per ml” below.

-          As with any antibiotic preparation, it is important to remain alert to potential signs of infection by non-susceptible organisms, including fungi.

-          If you are already taking other medicines, please also read the section “Other medicines and Dalacin C”.

-          If you have a kidney or liver disorder (also see “Dalacin C solution for injection contains 9.45 mg of benzyl alcohol per ml”).

-          Acute kidney disorders may occur. Please inform your doctor about any medication you currently take and if you have any existing problems with your kidneys. If you experience decreased urine output, fluid retention causing swelling in your legs, ankles or feet, shortness of breath, or nausea you should contact your doctor immediately.

 

Talk to your doctor if any of the warnings above applies to you or has applied to you in the past.

 

In cases of long-term treatment with this medicine, your doctor may carry out further tests on your liver or kidney function.

 

Other medicines and Dalacin C

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.

 

Taking multiple medicines can influence the reciprocal activities and/or side effects of these medicines, for example, when other medicines against infections (specifically rifampicin or erythromycin and similar medicines) or medicines used in general anaesthesia during surgery are administered at the same time as Dalacin C.

 

If you are using warfarin or similar medicines (used to thin the blood), you might be more susceptible to bleeding. Your doctor may prescribe blood tests in order to check that your blood is clotting properly.

 

Dalacin C may increase the effect of muscle relaxants. Therefore, take Dalacin C with caution and with the advice of a doctor when taking it at the same time as muscle relaxants.

 

Talk to your doctor or pharmacist about using other medicines at the same time as this medicine.

 

Dalacin C with food, drink and alcohol

Talk to your doctor or pharmacist about consuming alcohol at the same time as this medicine.

 

Pregnancy and breast-feeding

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

 

This medicine and the benzyl alcohol contained in the solution for injection both cross the placenta.

This medicine is not recommended during the first trimester of pregnancy. Dalacin C should only be used during the second and third trimesters of pregnancy under the advice of your doctor (also see: “Dalacin C solution for injection contains 9.45 mg of benzyl alcohol per ml”).

 

Small amounts of this medicine are excreted in breast milk. As serious side effects can occur to the gastrointestinal flora in breast-fed infants, such as diarrhoea or blood in the stools, or rash (skin rash). a decision must be  When you use Dalacin C while breast-feeding, the risks and benefits should be carefully weighed against each other, taking into account the importance of the treatment for the mother and the potential side effects for the breastfed infant from this medicine.

 

Ask your doctor about using this medicine while breast-feeding.

 

Driving and using machines

Dalacin C has little of no influence on the ability to drive and use machines.

 

Dalacin C solution for injection contains 9.45 mg of benzyl alcohol per ml

Dalacin C solution must not be used in new-borns (up to 4 weeks) except if recommended otherwise by your doctor.

Do not use for more than one week in young children (under 3 years), unless advised to do so by your doctor or pharmacist.

Benzyl alcohol is associated with a risk of serious side effects, including breathing issues (known as “gasping syndrome”. Dalacin C solution for injection must not be used in new-borns (up to 4 weeks) except if recommended otherwise by your doctor.

Benzyl alcohol can cause allergic reactions.

Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding or if you have liver or kidney problems. Large amounts of benzyl alcohol can accumulate in your body and cause side effects (known as “metabolic acidosis”).

 

Dalacin C solution for injection contains less than 1 mmol (23 mg) of sodium per dose, meaning it is essentially “sodium-free”.


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

 

The dose of solution for injection is determined by your doctor according to the nature and severity of the condition.

 

Use in children

Dalacin C should be dosed based on total body weight regardless of obesity.

 

Intramuscular (IM) Dalacin C must not be diluted. Intravenous (IV) Dalacin C must be diluted (see Summary of Product Characteristics).

If Dalacin is given too fast it could uncommonly cause a heart attack

 

Your doctor will tell you how long you need to use Dalacin C. Do not stop treatment early because your infection may not be cured.

 

If you use more Dalacin C than you should

There are no specific symptoms of overdose.

If you have used or taken too much Dalacin C, contact your doctor, pharmacist immediately.

 

If you forget to take Dalacin C

 

As you receive the Dalacin C solution for injection under close medical supervision, it is unlikely that you will forget to take a dose. However, if you think this is the case, tell your doctor, pharmacist or nurse.

 

If you stop taking Dalacin C

Do not stop your treatment early. If all the bacteria have not been killed, the symptoms may return.

 

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

 


Like all medicines, this medicine can cause side effects, although not everybody gets them.

 

The side effects of Dalacin C may include:

 

Common side effects (may affect up to 1 in 10 people)

  • Inflammation with obstruction of a vein (thrombophlebitis) (after intravenous administration)
  • Diarrhoea, abdominal pain (see section 2, “Warnings and Precautions”)
  • Large intestine disorders (pseudomembranous colitis and C. difficile colitis)
  • Abnormal liver function tests
  • Spotty skin rash (maculopapular rash)
  • Increase in the level of one type of white blood cells (eosinophilia)

 

Uncommon side effects (may affect up to 1 in 100 people)

  • Taste disorders (dysgeusia)
  • Heart problems such as heart failure and low blood pressure (after intravenous administration)
  • Decrease in blood pressure (after intravenous administration)
  • Vomiting, nausea
  • Skin irritation, acute skin and mucous membrane disorder (erythema multiforme), itching
  • Pain and abscess formation at the injection site (after intramuscular injection)

                                                                                                      

Very rare side effects (may affect up to 1 in 10,000 people)

  • Serious, potentially life-threatening allergic reaction (anaphylactic shock) (after intravenous administration)
  • Inflammation of the colon caused by a bacterium (colitis)

 

Side effects of unknown frequency (cannot be estimated from the available data)

  • Vaginal infection (onset of another infection)
  • Disturbance in blood count
  • Serious allergic reactions, hypersensitivity
  • Jaundice
  • Exfoliative skin disease (with scaling) (toxic epidermal necrolysis), Stevens-Johnson Syndrome, serious reactions to medicines such as drug hypersensitivity syndrome with eosinophilia (increased number of a type of white blood cells) and systemic symptoms (DRESS syndrome) and acute generalised exanthematous pustulosis (AGEP), oedema, inflammation of the skin in the form of shreds or blisters
  • Irritation at the injection site (after intravenous administration)
  • Fluid retention causing swelling in your legs, ankles or feet, shortness of breath or nausea.
  • Musculoskeletal: Cases of polyarthritis have been reported.

 

If diarrhoea occurs during treatment, stop the treatment. Specific treatment is sometimes necessary.

 

During treatment, superimposed yeast infection can occur.

 

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

By reporting side effects, you can help provide more information on the safety of this medicine.

 

To Report side effects:

 

·       Saudi Arabia

 

National Pharmacovigilance Center (NPC)

-   Call center: 19999

-   E-mail: npc.drug@sfda.gov.sa

-   Website: https://ade.sfda.gov.sa/    

 

·       Other GCC States

 

-   Please contact the relevant competent authority.


Keep this medicine out of the sight and reach of children.

 

Dalacin C solution for injection

Store between (2°C – 8°C).

Do not freeze.

 

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

 

Shelf life: 24 months.

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


-        The active substance in Dalacin C 300 mg/2 ml and 600 mg/4 ml  solution for injection is clindamycin, in the form of clindamycin phosphate (178.23 mg), which corresponds to 150 mg of clindamycin per ml.

 

-        The other ingredients are:

 

-          Dalacin C, solution for injection:

Benzyl alcohol, edetate disodium, Sodium Hydroxide, water for injection


Solution for injection: Clear, colourless solution. Dalacin C 300 mg/2 ml: pack of 1 × 2 ml ampoule. Dalacin C 600 mg/4 ml: pack of 1 × 4 ml ampoule.

Marketing Authorisation Holder

Pfizer SA, 17 Boulevard de la Plaine, 1050 Brussels, Belgium

 

Manufactured Packed and Released by:

Pfizer Manufacturing Belgium N.V., Rijksweg 12, 2870 Puurs, Belgium

 


March 2022
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

كليندامايسين هو مضاد حيوي، أي دواء يستخدم لمكافحة أنواع معينة من مسببات الأمراض. وهو ينتمي إلى مجموعة اللينكوساميدات.

 

يستخدم دالاسين سي في حالات العدوى التي تسببها البكتيريا في الأنف، أو الحلق، أو الأذن، أو الجهاز التنفسي، أو الجلد، أو العظام، أو المفاصل، أو القلب، أو الأسنان، أو أعضاء الجهاز التناسلي، أو الجهاز الهضمي. ويمكن أيضًا استخدام دالاسين سي في حالات العدوى التي تصيب الرئتين والمخ لدى المرضى المصابين بفيروس نقص المناعة المكتسبة البشري (الإيدز).

موانع استعمال دالاسين سي

-        إذا كنت مصابًا بالحساسية تجاه كليندامايسين أو لينكومايسين أو أي مكون آخر من مكونات هذا الدواء (المدرجة في القسم ٦)

-        يجب عدم إعطاء محلول فوسفات كليندامايسين المخصص للحقن إلى الأطفال المبتسرين أو حديثي الولادة لاحتوائه على الكحول البنزيلي.

 

 ‌الاحتياطات عند استعمال دالاسين سي تحدث إلى طبيبك أو الصيدلي قبل استخدام دالاسين سي.

 

-        تم وصف هذا الدواء لك كجزء من علاج دوائي. ويجب عدم استخدامه من قبل آخرين. استشر طبيبك أولًا قبل استخدام هذا الدواء لعلاج حالات أخرى.

-        أخبر طبيبك إذا كنت تعاني من مشكلات في الأمعاء، أو اضطرابات شديدة في وظائف الكلى، أو اضطرابات شديدة في وظائف الكبد، أو إذا كنت مصابًا بحساسية مفرطة. فقد يكون هذا مهمًا بالنسبة لك.

-        أخبر طبيبك إذا أصبت بعلامات فرط الحساسية، مثل التهيج، أو الحكة، أو الالتهاب، أو التفاعلات الجلدية. فقد يلزم إيقاف العلاج.

-        أخبر طبيبك أيضًا إذا أصبت بإسهال، خاصة إذا كان شديدًا أو مستمرًا أو مختلطًا بدم، أثناء العلاج أو بعده. فقد يشير ذلك إلى وجود التهاب شديد في القولون بسبب عدوى ببكتيريا تسمى المطثية العسيرة (كلوستريديوم ديفيسيل)، وقد يلزم إيقاف العلاج.

-        يجب عدم استعمال دالاسين سي غير المخفف أبدًا عن طريق الوريد. لذلك يتم الاستعمال عن طريق الوريد بواسطة التسريب على مدار فترة تتراوح بين ١٠ دقائق إلى ٦٠ دقيقة.

-        يجب عدم استخدام محلول دالاسين سي المخصص للحقن مع حديثي الولادة، سواء كانوا مبتسرين أم لا، ما لم تكن هناك ضرورة قصوى لذلك، بسبب خطر الإصابة بتفاعلات سامة خطيرة، بما في ذلك التنفس غير الطبيعي ("متلازمة اللهاث"). انظر قسم "يحتوي محلول دالاسين سي المخصص للحقن على ٩.٤٥ ملجم من الكحول البنزيلي لكل مل" أدناه.

-        كما هو الحال مع أي مستحضر من مستحضرات المضادات الحيوية، من المهم أن تظل منتبهًا لرصد العلامات المحتملة للإصابة بعدوى بكائنات غير حساسة تجاه المضاد الحيوي، بما في ذلك الفطريات.

-        إذا كنت تتناول بالفعل أدوية أخرى، يرجى قراءة قسم "الأدوية الأخرى ودالاسين سي" أيضًا.

-        إذا كنت تعاني من أحد اضطرابات الكلى أو الكبد (انظر أيضًا قسم "يحتوي محلول دالاسين سي المخصص للحقن على ٩.٤٥ ملجم من الكحول البنزيلي لكل مل").

-        قد تحدث اضطرابات كلوية حادة. يُرجى إبلاغ طبيبك عن أي دواء تتناوله حاليًا وإذا كنت تعاني من أي مشكلات في كليتيك. إذا كنت تعاني من انخفاض في كمية البول، أو احتباس السوائل الذي يسبب تورمًا في ساقيك، أو كاحليك أو قدميك، أو ضيق في التنفس، أو غثيان، ينبغي لك الاتصال بطبيبك على الفور.

 

تحدث إلى طبيبك إذا كان أي من التحذيرات الواردة أعلاه ينطبق عليك أو انطبق عليك فيما مضى.

 

في حالات العلاج طويل الأمد بهذا الدواء، قد يجري طبيبك المزيد من الاختبارات لوظائف الكبد أو الكلى لديك.

 

 التداخلات الدوائية مع أخذ هذا المستحضر مع أي أدوية أخرى أو أعشاب أو مكملات غذائيةأخبر طبيبك أو الصيدلي إذا كنت تتناول/تستخدم أو تناولت/استخدمت مؤخرًا أو قد تتناول/تستخدم أي أدوية أخرى.

 

إن تناول أدوية متعددة يمكن أن يؤثر على الأنشطة المتبادلة و/أو الآثار الجانبية لهذه الأدوية، على سبيل المثال، عندما يتم استعمال أدوية أخرى مكافِحة لحالات العدوى (وتحديدًا ريفامبيسين أو إريثرومايسين والأدوية المشابهة لهما) أو الأدوية المستخدمة في التخدير العام أثناء الجراحة في نفس الوقت مع دالاسين سي.

 

إذا كنت تستخدم وارفارين أو أدوية مشابهة له (تُستخدم لزيادة سيولة الدم)، فقد تكون أكثر عرضة للإصابة بنزيف. قد يصف لك طبيبك فحوصات دم من أجل التحقق من أن دمك يتخثر كما ينبغي.

 

قد يزيد دالاسين سي من تأثير الأدوية المرخية للعضلات. لذلك، ينبغي توخي الحذر عند أخذ دالاسين سي وينبغي استشارة طبيب عند أخذه في نفس الوقت مع الأدوية المرخية للعضلات.

 

تحدث إلى طبيبك أو الصيدلي بشأن استخدام أدوية أخرى في نفس الوقت مع هذا الدواء.

 

 تناول دالاسين سي مع الطعام والشرابتحدث إلى طبيبك أو الصيدلي بشأن تناول الكحول في نفس الوقت مع هذا الدواء.

 

الحمل والرضاعة

إذا كنتِ حاملًا أو ترضعين رضاعة طبيعية، أو تعتقدين أنكِ ربما تكونين حاملًا أو تخططين للحمل، فاستشيري طبيبكِ أو الصيدلي قبل تناول محلول دالاسين سي .

 

إن هذا الدواء والكحول البنزيلي الذي يحتوي عليه المحلول المخصص للحقن يمران عبر المشيمة. يوصى بعدم استخدام هذا الدواء أثناء الثلث الأول من الحمل. ينبغي عدم استخدام دالاسين سي أثناء الثلثين الثاني والثالث من الحمل إلا بناءً على مشورة طبيبكِ (انظري أيضًا قسم "يحتوي محلول دالاسين سي المخصص للحقن على ٩.٤٥ ملجم من الكحول البنزيلي لكل مل").

 

تُفرز كميات صغيرة من هذا الدواء في لبن الثدي. ونظرًا لإمكانية حدوث آثار جانبية خطيرة على النبيت المعدي المعوي في الرضع الذين يرضعون رضاعة طبيعية، مثل الإسهال، أو وجود دم في البراز، أو الطفح الجلدي. يجب اتخاذ قرار عند استخدام دالاسين سي أثناء الرضاعة الطبيعية، إذ ينبغي الموازنة بين مخاطر الدواء وفوائده بعناية، مع الأخذ في الاعتبار أهمية العلاج بالنسبة للأم والآثار الجانبية المحتملة لهذا الدواء على الرضع الذين يرضعون رضاعة طبيعية.

 

اسألي طبيبك عن استخدام هذا الدواء أثناء الرضاعة الطبيعية.

 

 تأثير دالاسين سي على القيادة واستخدام الآلاتدالاسين سي له تأثير ضئيل  على القدرة على القيادة واستخدام الآلات.

 

يحتوي محلول دالاسين سي المخصص للحقن على ٩.٤٥ ملجم من الكحول البنزيلي لكل مل

يجب عدم استخدام محلول دالاسين سي مع حديثي الولادة (حتى ٤ أسابيع) إلا إذا أوصى طبيبك بغير ذلك.

لا تستخدم الدواء لأكثر من أسبوع واحد مع الأطفال الصغار (أصغر من ٣  أعوام)، إلا إذا نصح طبيبك أو الصيدلي بذلك.

يرتبط الكحول البنزيلي بخطر الإصابة بآثار جانبية خطيرة، بما في ذلك مشكلات التنفس (المعروفة باسم "متلازمة اللهاث"). يجب عدم استخدام محلول دالاسين سي المخصص للحقن مع حديثي الولادة (حتى ٤ أسابيع) إلا إذا أوصى طبيبك بغير ذلك.

يمكن أن يسبب الكحول البنزيلي تفاعلات حساسية.

استشيري طبيبك أو الصيدلي إذا كنتِ حاملًا أو ترضعين رضاعة طبيعية، أو إذا كانت لديك مشكلات في الكبد أو الكلى. يمكن أن تتراكم كميات كبيرة من الكحول البنزيلي في جسمك وتسبب آثارًا جانبية (تُعرف باسم "الحماض الأيضي").

 

يحتوي محلول دالاسين سي المخصص للحقن على أقل من ١ مليمول (٢٣ ملجم) من الصوديوم لكل جرعة، مما يعني أنه "خال من الصوديوم" بشكل أساسي.

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احرص دومًا على استخدام هذا الدواء تمامًا كما أخبرك طبيبك أو الصيدلي. استشر طبيبك أو الصيدلي إذا لم تكن متأكدًا مما يجب عليك فعله.

 

الاستخدام مع الأطفال

ينبغي تحديد جرعات دالاسين سي على أساس وزن الجسم الكلي بغض النظر عن السمنة.

 

يتم تحديد جرعة المحلول المخصص للحقن بواسطة طبيبك بناء على طبيعة الحالة وشدتها. يجب عدم تخفيف دالاسين سي الذي يؤخذ عن طريق العضل (IM). ويجب تخفيف دالاسين سي الذي يؤخذ عن طريق الوريد (IV) (انظر ملخص خصائص المنتج).

 

إذا تم إعطاء دالاسين  بسرعة أكبر من اللازم، فقد يتسبب بشكل غير شائع في حدوث أزمة قلبية

 

سوف يخبرك طبيبك بالمدة التي ينبغي عليك تناول دالاسين سي خلالها. لا توقف علاجك مبكرًا، حيث قد يؤدي ذلك إلى عدم شفائك من العدوى.

 

‌الجرعة الزائدة من دالاسين سي

لا توجد أعراض محددة للجرعة المفرطة.

إذا استخدمت أو أخذت كمية كبيرة جدًا من دالاسين سي، فاتصل بطبيبك أو الصيدلي على الفور.

 

 نسيان تناول جرعة دالاسين سي

نظرًا لأنك تتلقى محلول دالاسين سي المخصص للحقن تحت إشراف طبي دقيق، فمن المستبعد أن تنسى أخذ جرعة. ومع ذلك، إذا اعتقدت أن هذا قد حدث، أخبر طبيبك أو الصيدلي أو الممرضة.

 

 التوقف عن تناول دالاسين سيلا توقف علاجك مبكرًا. فقد تعود الأعراض إذا لم يتم قتل جميع البكتيريا.

 

إذا كان لديك أي أسئلة بشأن استخدام هذا الدواء، فاسأل طبيبك أو الصيدلي أو ممرضة.

كما هو الحال بالنسبة لجميع الأدوية، من الممكن أن يسبب هذا الدواء آثارًا جانبية، إلا أنها لا تصيب الجميع.

 

قد تتضمن الآثار الجانبية لدالاسين سي ما يلي:

 

الآثار الجانبية الشائعة (قد تصيب ما يصل إلى شخص واحد من بين كل ١٠ أشخاص)

·       التهاب الوريد المصحوب بانسداد (التهاب الوريد الخثاري) (بعد الاستعمال عن طريق الوريد)

·       الإسهال، ألم البطن (انظر القسم ٢، "‌الاحتياطات عند استعمال دالاسين سي")

·       اضطرابات الأمعاء الغليظة (التهاب القولون ذو الأغشية الكاذبة والتهاب القولون بالمطثية العسيرة (كلوستريديوم ديفيسيل))

·       نتائج غير طبيعية لاختبارات وظائف الكبد

·       الطفح الجلدي البقعي (الطفح البقعي الحطاطي)

·       زيادة في مستوى أحد أنواع خلايا الدم البيضاء (كثرة اليوزينيات)

 

الآثار الجانبية غير الشائعة (قد تصيب ما يصل إلى شخص واحد من بين كل ١٠٠ شخص)

·       اضطرابات في التذوق (خلل الذوق)

·       مشكلات في القلب مثل الفشل القلبي وانخفاض ضغط الدم (بعد الاستعمال عن طريق الوريد)

·       انخفاض في ضغط الدم (بعد الاستعمال عن طريق الوريد)

·       القيء، الغثيان

·       تهيج الجلد، اضطراب الجلد والغشاء المخاطي الحاد (البقع الحمراء عديدة الأشكال)، الحكة

·       ألم وتكون خراج في موضع الحقن (بعد الحقن عن طريق العضل)

 

الآثار الجانبية النادرة جدًا (يمكن أن تصيب ما يصل إلى شخص واحد من بين كل ١٠٠٠٠ شخص)

·       تفاعل حساسية خطير يحتمل أن يكون مهددًا للحياة (صدمة تأقية) (بعد الاستعمال عن طريق الوريد)

·       التهاب القولون الذي تسببه بكتيريا (التهاب القولون)

 

الآثار الجانبية ذات معدل التكرار غير المعروف (لا يمكن تقدير معدل التكرار من خلال البيانات المتاحة)

·       العدوى المهبلية (بدء عدوى أخرى)

·       اضطراب في تعداد مكونات الدم

·       تفاعلات حساسية خطيرة، فرط الحساسية

·       اليرقان

·       مرض جلدي تقشري (مع تقشر الجلد) (تقشر الأنسجة المتموتة البشروية التسممي)، متلازمة ستيفنز-جونسون، تفاعلات خطيرة تجاه الأدوية مثل متلازمة فرط الحساسية تجاه العقاقير مع كثرة اليوزينيات (زيادة عدد أحد أنواع خلايا الدم البيضاء) وأعراض جهازية (متلازمة التفاعلات الدوائية المصحوبة بكثرة اليوزينيات وأعراض جهازية (DRESS)) والبثار الطفحي المعمم الحاد (AGEP)، التورم، التهاب الجلد في صورة أشرطة طويلة ورفيعة أو بثور

·       تهيج في موضع الحقن (بعد الاستعمال عن طريق الوريد)

·       احتباس السوائل الذي يسبب تورمًا في ساقيك، أو كاحليك أو قدميك، أو ضيق في التنفس أو الغثيان.

·       الأمراض العضلية الهيكلية: تم الإبلاغ عن حالات إصابة بالتهاب المفاصل المتعدد.

 

في حالة حدوث إسهال أثناء العلاج، أوقف العلاج. وقد يستلزم الأمر أحيانًا تلقي علاج خاص.

 

أثناء العلاج، يمكن أن تظهر عدوى خميرية إضافية أثناء العلاج.

 

الإبلاغ عن الأعراض الجانبية

إذا أصبت بأي أعراض جانبية، فتحدث إلى طبيبك أو الصيدلي أو الممرضة.. يتضمن هذا أي أعراض جانبية محتملة غير مدرجة في هذه النشرة.

بالإبلاغ عن الأعراض الجانبية، يمكنك المساعدة في توفير المزيد من المعلومات حول سلامة هذا الدواء.

 

الإبلاغ عن الأعراض الجانبية:

 

·       المملكة العربية السعودية:

 

المركز الوطني للتيقظ‏ الدوائي:

  • مركز الاتصال الموحد: ١٩٩٩٩
  • البريد الإلكتروني: npc.drug@sfda.gov.sa
  • الموقع الإلكتروني: https://ade.sfda.gov.sa

 

·       دول الخليج الأخرى:

 

-        الرجاء الاتصال بالمؤسسات والهيئات الوطنية في كل دولة.

احتفظ بهذا الدواء بعيدًا عن مرأى ومتناول الأطفال.

 

محلول دالاسين سي المخصص للحقن

خزنه في درجة حرارة بين (٢-٨ درجات مئوية).

لا يجمد.

 

لا تستخدم هذا الدواء بعد تاريخ انتهاء الصلاحية المدون على العبوة الكرتونية بعد الرمز EXP. يشير تاريخ انتهاء الصلاحية إلى آخر يوم في الشهر المذكور.  

مدة الصلاحية: ٢٤ شهرًا.  

 

لا تتخلص من أي أدوية عبر مياه الصرف أو مع النفايات المنزلية. اسأل الصيدلي الخاص بك عن كيفية التخلص من الأدوية التي لم تعد تستخدمها. ستساعد هذه الإجراءات في حماية البيئة.

 

-        المادة الفعالة في محلول دالاسين سي ٣٠٠ ملجم/ ٢ مل ، و٦٠٠ ملجم/ ٤ مل  المخصص للحقن هي كليندامايسين، في صورة فوسفات كليندامايسين (١٧٨٫٢٣ ملجم) بما يكافئ ١٥٠ ملجم من كليندامايسين لكل مل.

 

-      المكونات الأخرى هي:

-        محلول دالاسين سي المخصص للحقن:  

الكحول البنزيلي، ثنائي صوديوم الإيديتات، هيدروكسيد الصوديوم، ماء لتحضير المحلول

المحلول المخصص للحقن:

 

محلول صاف عديم اللون.

دالاسين سي ٣٠٠ ملجم/ ٢ مل: عبوة تحتوي على أمبولة واحدة × ٢ مل.

دالاسين سي ٦٠٠ ملجم/ ٤ مل: عبوة تحتوي على أمبولة واحدة × ٤ مل.

مالك تصريح التسويق

Pfizer SA, 17 Boulevard de la Plaine, 1050 Brussels, Belgium، بلجيكا

 

تم التصنيع والتعبئة والتوزيع بواسطة:

Pfizer Manufacturing Belgium N.V., Rijksweg 12, 2870 Puurs, Belgium، بلجيكا

مارس/ آذار ٢٠٢٢
 Read this leaflet carefully before you start using this product as it contains important information for you

Dalacin C 300 mg/2 ml solution for injection Dalacin C 600 mg/4 ml solution for injection

Dalacin C 300 mg/2 ml - 600 mg/4 ml solution for injection The active substance is clindamycin. This is present in the form of clindamycin phosphate (178.23 mg), equivalent to 150 mg clindamycin per ml. Excipients with known effect: Dalacin C solution for injection The solution for injection contains benzyl alcohol (9.45 mg/ml) (see section 4.4). For the full list of excipients, see section 6.1.

Solution for injection: A clear, colourless solution

Clindamycin is indicated in the treatment of serious infections, when caused by clindamycin susceptible strains of gram‑positive aerobes such as streptococci, pneumococci and staphylococci, or by susceptible anaerobic bacteria (see section 5.1):

 

1.     Upper respiratory tract infections: chronic sinusitis caused by anaerobic strains.
Clindamycin can be used for selected cases of chronic suppurative otitis media or as adjunctive therapy along with an antibiotic active against aerobic gram-negative organisms. Infections caused by H. influenzae are not an indication (see section 5.1). Clindamycin can also be used in cases of recurrent pharyngotonsillitis.

2.     Lower respiratory tract infections including infectious exacerbation of chronic bronchitis and pneumonia.

3.     Serious skin and soft tissue infections caused by susceptible organisms.

4.     Bone and joint infections including osteomyelitis and septic arthritis.

5.     Serious gynaecological infections of the pelvis including pelvic inflammatory disease (PID). Clindamycin can also be used in a single therapy in cases of cervicitis due to Chlamydia trachomatis.

6.     Intra‑abdominal infections including peritonitis and abdominal abscess.

7.     Septicaemia and endocarditis.

Selected cases of septicaemia and/or endocarditis due to susceptible organisms have responded well to clindamycin. However, bactericidal drugs are often preferred for these infections.

8.     Dental infections including periodontal abscess and periodontitis.

9.     Toxoplasmic encephalitis in patient with AIDS. In patients who cannot tolerate the usual treatment, clindamycin may be used in combination with pyrimethamine.

10.  Pneumocystis jirovecii pneumonia in patients with AIDS. In patients who cannot tolerate the usual treatment, clindamycin may be used in combination with primaquine.

 

Like other antibiotics information regarding the prevention of local resistance as well as the official recommendations regarding prescription of antibiotics must be reviewed before prescribing clindamycin.

 


Posology

 

The posology and the mode of administration should be determined by the seriousness of the infection, the patient's condition and the sensitivity of the disease causing germ.

 

Clindamycin phosphate IM administration should be used undiluted.

 

Clindamycin phosphate IV administration should be diluted (see dilution for IV use and IV infusion rate below).

 

Adults:

 

Clindamycin phosphate solution for injection (IM or IV administration):

Parenteral (IM or IV administration). Dalacin C Phosphate must be diluted prior to IV administration and should be infused over at least 10-60 minutes.

Serious infections: 600 mg - 1.2 g/day in two, three or four equal doses.

More severe infections: l.2-2.7 g/day in two, three or four equal doses.

 

Adults were successfully treated with doses up to 4800 mg daily.

Intramuscular administration of more than 600 mg in one administration is not recommended.

 

Treatment of Pelvic Inflammatory Disease (PID): clindamycin phosphate I.V. 900 mg every 8 hours, associated to a suitable Gram negative spectre antibiotic (e.g. gentamicin 2 mg/kg, followed by 1.5 mg/kg every 8 hours) in patients with a normal renal function. This treatment should be administered for at least 4 days. From the moment clinical improvement occurs, the treatment should be continued for another 2 days. Then 1800 mg of clindamycin hydrochloride per day should be administered orally, divided over several administrations, up to a total treatment duration of 10 to 14 days.Paediatric population (in children older than 1 month):

Clindamycin should be dosed based on total body weight regardless of obesity (see section 5.2).

 

Clindamycin phosphate (IM or IV administration):

Serious infections: 15-25 mg/kg/day in three or four equal doses.

More severe infections: 25-40 mg/kg/day in three or four equal doses. In severe infections it is recommended that children be given no less than 300 mg/day regardless of body weight.

 

Elderly patients:

 

The half-life, volume of distribution and clearance, and extent of absorption after administration of clindamycin phosphate are not altered by increased age. Analysis of data from clinical studies has not revealed any age-related increase in toxicity. Dosage requirements in elderly patients should not be influenced, therefore, by age alone. See Precautions for other factors which should be taken into consideration

 

Treatment for infections caused by beta-haemolytic streptococci should be continued for at least 10 days to guard against subsequent rheumatic fever or glomerulonephritis.

 

The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml and INFUSION RATES SHOULD NOT EXCEED 30 MG PER MINUTE. The usual infusion rates are as follows:

Dose

Diluent

Time

300 mg

600 mg

900 mg

1200 mg

50 ml

50 ml

50-100 ml

100 ml

10 min

20 min

30 min

40 min

 

Posology in cases of renal and/or liver function impairment:

 

Dose adjustment is not necessary in patients with an impaired renal function. Haemodialysis and peritoneal dialysis are not effective to remove clindamycin from the blood.

 

In patients with moderately to seriously reduced liver function, a prolonged half-life of clindamycin was seen. Accumulation is rare if clindamycin is administered every 8 hours. A dose reduction is, therefore, not considered necessary.

 

Dosage in specific indications:

 

Toxoplasmic encephalitis in patients with AIDS:

Dalacin C solution for injection or Dalacin C hard capsules in a dose of 600-1200 mg every 6 hours for 2 weeks, followed by oral administration of 300-600 mg every 6 hours. The total treatment usually lasts 8 to 10 weeks. Oral administration of 25 mg to 75 mg of pyrimethamine per day for 8 to 10 weeks is necessary. With higher doses of pyrimethamine one should administer 10 to 20 mg of folic acid per day.

 

Pneumocystis jirovecii pneumonia in patients with AIDS:

Dalacin C solution for injection in intravenous infusion in a dose of 600 to 900 mg every 6 hours or Dalacin C solution for injection in intravenous infusion in a dose of 900 mg every 8 hours or Dalacin C hard capsules in a dose of 300 to 450 mg every 6 hours for 21 days, combined with 15 to 30 mg of oral primaquine per day for 21 days.

 


 Hypersensitivity to the active substance, to lincomycin, to any component of the formulation, or to any of the excipients listed in section 6.1.  Clindamycin phosphate solution for injection must not be given to premature babies or neonates because of the benzyl alcohol content.

-        Severe hypersensitivity reactions, including severe skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP) have been reported in patients receiving clindamycin therapy. If a hypersensitivity or severe skin reaction occurs, clindamycin should be discontinued and appropriate therapy should be initiated (see sections 4.3 and 4.8).

 

-        The clindamycin phosphate injectable formulation contains benzyl alcohol (9.45 mg/ml). Benzyl alcohol may cause anaphylactoid reactions.

Intravenous administration of the preservative benzyl alcohol has been associated with serious adverse events, and death in paediatric patients including neonates characterized by central nervous system depression, metabolic acidosis, gasping respirations, cardio-vascular failure and haematological anomalies (“gasping syndrome”). Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome”, the minimum amount of benzyl alcohol at which toxicity may occur is not known. Use only if it is necessary and if there are no alternatives possible. If given in high volumes, should be used with caution and preferably for short term treatment in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).

Premature and low-birth weight infants may be more likely to develop toxicity.
Benzyl alcohol containing products should not be used in pre-term or full-term neonates unless strictly necessary.

 

-        Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of Clostridium difficile. This has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhoea to fatal colitis. C. difficile produces toxins A and B which contribute to the development of Clostridium difficile associated diarrhoea (CDAD) and is a primary cause of “antibiotic-associated colitis”. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. This form of colitis is characterized by mild, watery diarrhoea that may develop to serious, chronic diarrhoea, leukocytosis, fever, serious abdominal cramps that may be accompanied by loss of blood and mucus. Without further treatment peritonitis, shock and toxic megacolon may develop. Antibiotic induced colitis can occur with clindamycin up to 2 to 3 weeks after discontinuation of the treatment. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

 

-        It is important to consider the diagnosis of CDAD in patients who present with diarrhoea during or after the administration of antibacterial agents. This may progress to colitis, including pseudomembranous colitis (see section 4.8), which may range from mild to fatal colitis. If antibiotic-associated diarrhoea or antibiotic-associated colitis is suspected or confirmed, ongoing treatment with antibacterial agents, including clindamycin, should be discontinued and adequate therapeutic measures should be initiated immediately. In moderate-to-severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis. Drugs inhibiting peristalsis are contraindicated in this situation. The diagnosis of an antibiotic induced colitis is usually made based on clinical symptoms. The diagnosis can be confirmed by endoscopic demonstration of pseudomembranous colitis or by demonstrating the presence of Clostridium difficile and toxins in the faeces.

 

-        Medicinal products which slow intestinal motility must be avoided.

 

-        Clindamycin should be prescribed with caution to individuals with a history of gastro‑intestinal conditions, particularly colitis. Antibiotic induced colitis and diarrhoea occur more frequently and in more serious forms in debilitated and/or older patients.

 

-        Since clindamycin does not diffuse adequately in the cerebrospinal fluid, this drug should not be used to treat meningitis (see section 4.3).

 

-        Antagonism between clindamycin and erythromycin was demonstrated in vitro. Because of the possible clinical significance, both drugs should not be used simultaneously (see section 4.5).

 

-        If therapy is prolonged, liver and kidney functions tests should be performed.

 

-        Acute kidney injury, including acute renal failure, has been reported infrequently. In patients receiving prolonged therapy, suffering from pre-existing renal dysfunction or taking concomitant nephrotoxic drugs, monitoring of renal function should be considered (see section 4.8).

 

-        The use of clindamycin phosphate can result in an overgrowth of non-susceptible organisms, particularly yeasts.

 

-        Clindamycin phosphate should not be injected intravenously undiluted as a bolus, but should be infused over at least 10 ‑ 60 minutes (see section 4.2).

 

-        Clindamycin appears to have neuromuscular blocking properties that can enhance the effects of other neuromuscular blocking drugs. In patients that are treated with these drugs, clindamycin should, therefore, be used with caution (see section 4.5).

 

-        In patients with hypersensitivity, clindamycin phosphate should be administered with caution.

 

-        In patients with serious renal and/or serious liver disorders associated to serious metabolic conditions, clindamycin should be administered cautiously. The serum levels of clindamycin should be monitored if high doses are required (see section 4.2).

 

The solution for injection contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.


An antagonism was demonstrated between clindamycin, erythromycin and chemically related macrolides.

 

Clindamycin administered by injection has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, clindamycin must be used cautiously in patient taking medication such as vecuronium, rocuronium, gentamicin, rapacuronium (with magnesium) or pancuronium. Synergistic effects of other antibiotics together with clindamycin on neuromuscular blocking agents have been described. Careful attention is therefore needed when using antibiotics together with muscle relaxants, because the synergy effect triggered by the combination could cause deeper muscle relaxation and delay recovery.

 

Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N‑desmethylclindamycin. Therefore inhibitors of CYP3A4 and CYP3A5 (such as ritonavir, lopinavir, indinavir, cobicistat, ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, grapefruit juice, nefazodone) may reduce clindamycin clearance and inducers of these isoenzymes may increase clindamycin clearance. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness.

In vitro studies indicate that clindamycin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2E1 or CYP2D6 and only moderately inhibits CYP3A4. Therefore, clinically important interactions between clindamycin and co-administered drugs metabolized by these CYP enzymes are unlikely.

 

Vitamin K antagonists

Increased coagulation tests (PT/INR) and/or bleeding, have been reported in patients treated with clindamycin in combination with a vitamin K antagonist (e.g. warfarin, acenocoumarol and fluindione). Coagulation tests, therefore, should be frequently monitored in patients treated with vitamin K antagonists.


Pregnancy

 

There are limited data on the use of clindamycin in pregnant women during the first trimester of pregnancy. Clindamycin crosses the placenta . In clinical trials, the use of DALACIN C in pregnant women and the systemic administration of clindamycin during the second and third trimesters, have not been associated with an increased incidence of congenital abnormalities. Animal studies did not reveal any direct or indirect deleterious effects on reproduction (see section 5.3).

 

The following statement only applies to the solution for injection: Benzyl alcohol can cross the placenta (see section 4.4).

 

As a precautionary measure, it is preferable to avoid the use of DALACIN C during the first trimester of pregnancy. The use of Dalacin C during the second and third trimester of pregnancy may be considered after establishing the proper diagnosis by the doctor.

 

Breastfeeding

 

Orally and parenterally administered clindamycin has been reported to appear in human breast milk in ranges from < 0.5 to 3.8 µg/mL (50 to 100% of the serum level is attained in the breast milk (see section 5.2)).

 

Clindamycin has the potential to cause adverse effects on the breastfed infant’s gastrointestinal flora such as diarrhoea or blood in the stool, or rash. The developmental and health benefits of breastfeeding for the child should be considered along with the mother’s clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition. If possible Dalacin C should not be used during breastfeeding. If a breast-feeding mother needs oral or intravenous clindamycin, it may be considered to temporarily interrupt breastfeeding for the duration of the mother's treatment.

If oral clindamycin is used during breastfeeding, the infant should be closely monitored for adverse drug reactions. If these occur, breastfeeding should be discontinued.

 

Fertility

 

Fertility studies in rats treated orally with clindamycin revealed no effects on fertility or mating ability (see section 5.3). No data are available on man fertility.


Clindamycin has no or negligible influence on the ability to drive and use machines.


The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency. Adverse reactions identified from post-marketing experience are included in italics. The frequency grouping is defined using the following convention: Very common (³ 1/10), Common (³ 1/100, < 1/10), Uncommon (³ 1/1000, < 1/100), Rare (³ 1/10000, < 1/1000), Very rare (< 1/10000) and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

 

Adverse Reactions Table

 

System Organ Class

Common ≥ 1/100

to < 1/10

Uncommon
 1/1000 to
<
 1/100

Rare
≥ 1/10000 to <
 1/1000

Very Rare
<
 1/10000

Frequency not known
(cannot be estimated from available data)

Infections and infestations

Pseudomembranous colitis (see section 4.4)

Clostridium difficile colitis

 

 

 

Vaginal infection

Blood and lymphatic system disorders

Eosinophilia2

 

 

 

Agranulocytosis,

Neutropenia,

Thrombocytopenia, Leukopenia

Immune system disorders

 

 

 

Anaphylactic shock

Anaphylactoid reaction,

Anaphylactic reaction, Hypersensitivity

Nervous system disorders

 

Dysgeusia

 

 

 

Cardiac disorders

 

Cardio-respiratory arrest†§

 

 

 

Vascular disorders

Thrombophlebitis†‡

 

Hypotension†§

 

 

 

 

Gastrointestinal disorders

Diarrhoea5, Abdominal pain2

Vomiting2, Nausea

 

 

Colitis

Oesophageal ulcer*,

Oesophagitis*

Hepatobiliary disorders

Liver function test abnormal

 

 

 

Jaundice

Skin and subcutaneous tissue disorders

Rash maculo-papular

Urticaria,

Erythema multiforme,

Pruritus

 

 

Toxic epidermal necrolysis (TEN),

Steven Johnson syndrome (SJS),

Drug reaction with eosinophilia and systemic symptom (DRESS),

Acute Generalised Exanthematous Pustulosis (AGEP), Angioedema,

Dermatitis exfoliative,

Dermatitis bullous,

Rash morbilliform

Renal and urinary disorders

 

 

 

 

Acute kidney injury#

General disorders and administration site conditions

 

 

Pain, Injection site abscess†‡

 

 

 

Injection site irritation†‡

 

Musculoskeletal

 

 

 

 

Cases of polyarthritis have been reported.

2 Frequency for solution for injection: not known

5 Frequency for solution for injection: uncommon

† Only applicable for solution for injection

* Only applicable for oral formulations

§ Rare instances have been reported following too rapid intravenous administration (see section 4.2).

These reactions can be reduced to a minimum by deep administration of IM injections and by avoiding prolonged catheterisation in the same vein.

# See section 4.4.

 

-    If diarrhoea occurs during treatment, the therapy should be discontinued.

-    In cases of serious anaphylactoid reactions, immediate measures should be taken with the administration of epinephrine (adrenaline), oxygen and intravenous steroids. Mechanical ventilation, possibly with intubation, should also be applied if necessary.

-    The use of clindamycin phosphate can cause overgrowth of insensitive germs, particularly yeasts.

 

Reporting of suspected adverse reactionsReporting suspected adverse reactions after marketing authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions according to their local country requirements.

 

To Report side effects:

 

·       Saudi Arabia:

 

National Pharmacovigilance Center (NPC)

Call center: 19999

E-mail: npc.drug@sfda.gov.sa

Website: https://ade.sfda.gov.sa/    

 

·       Other GCC States

 

-   Please contact the relevant competent authority.


The toxicity of clindamycin is not linked to the dose. An overdose does not cause specific symptoms. Haemodialysis and peritoneal dialysis are not effective to remove clindamycin from the serum.


Pharmacotherapeutic group: antibacterials for systemic administration - lincosamides

ATC code: J01F F 01

 

The active substance is clindamycin, a semi‑synthetic antibiotic obtained by 7‑(S)‑chloro-substitution of the 7‑(R)‑hydroxyl group of lincomycin.

 

Mechanism of action

Clindamycin binds to the 50S subunit of the bacterial ribosome and inhibits protein synthesis. Clindamycin can be either bactericidal or bacteriostatic, depending on the sensitivity of the organisms and the concentration of the antibiotic.

 

 

Mechanisms of resistance

Cross resistance between clindamycin and lincomycin is complete. Resistance in staphylococci and streptococci is most often due to methylation of specific nucleotides in the 23S RNA of the 50S ribosomal subunit, which can determine cross resistance to macrolides and streptogramins B (MLSB phenotype). Macrolide-resistant isolates of these organisms should be tested for inducible resistance to lincomycin/clindamycin using the D‑zone test.

 

Methicilline-sensitive Staphylococcus aureus strains are generally sensitive to clindamycin. Clindamycin has a significant activity against many strains of methicilline-resistent staphylococci (MRSA). However, the occurrence of a significant number of clindamycin-resistant MRSA-strains excludes the use of clindamycin for infections due to these organisms without sensitivity tests. In vitro some erythromycin‑resistant strains of staphylococci rather rapidly develop resistance against clindamycin.

 

The following germs are usually resistant:

-   Aerobic Gram negative bacilli

-   Enterococcus faecalis

-   Nocardia species

-   Neisseria meningitidis

-   Strains of Haemophilus influenzae (in places where resistance to antibiotics is frequent).

 

Breakpoints

EUCAST Breakpoints for Clindamycin (from 2014)

Pathogen

Susceptible

Resistant

Staphylococcus spp.

≤ 0.25 mg/l

> 0.5 mg/l

Streptococcus groups A, B, C, G

≤ 0.5 mg/l

> 0.5 mg/l

Streptococcus pneumoniae

≤ 0.5 mg/l

> 0.5 mg/l

Gram-positive anaerobes (excluding Clostridium difficile)

≤ 4 mg/l

> 4 mg/l

Gram-negative anaerobes

≤ 4 mg/l

> 4 mg/l

 

Prevalence of acquired resistance

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 the agent on at least some types of infections is questionable. Particularly in severe infections or therapy failure microbiological diagnosis with verification of the pathogen and its susceptibility to lincomycin/clindamycin is recommended.

 

The following data is available for clindamycin based on European surveillance studies available in 2013.

 

Commonly susceptible organisms

Remarks

Aerobic gram-positive microorganisms

 

Actinomyces israeliia

 

Staphylococcus aureus
(methicillin-susceptible)

 

Streptococcus agalactiae

 

Viridans group streptococci

 

Anaerobic microorganisms

 

Bacteroides spp.a (excluding B. fragilis)

 

Fusobacterium spp.a

 

Peptococcus spp.a

 

Prevotella spp.

 

Veillonella spp.a

 

Other microorganisms

 

Chlamydia trachomatisa

 

Clamydophila pneumoniaea

 

Gardnerella vaginalisa

 

Mycoplasma hominisa

 

 

Organisms for which acquired resistance may be a problem

Remarks

Aerobic gram-positive microorganisms

 

Staphylococcus aureus (methicillin-resistant)b

 

Staphylococcus epidermidisb

 

Staphylococcus haemolyticus

 

Staphylococcus hominis

 

Streptococcus pneumoniae

Resistance rates between > 20 and 49% in some European countries

Aerobic gram-negative microorganisms

 

Moraxella catarrhalisc

 

Anaerobic microorganisms

 

Bacteroides fragilis

 

Clostridium perfringens

Higher resistance rates in Spain (10-20%)

Peptostreptococcus spp.

Higher resistance rates in Spain (10-20%)

Propionibacterium spp.

 

 

Inherently resistant organisms

 

Aerobic gram-positive microorganisms

 

Enterococcus spp.

 

Listeria monocytogenes

 

Aerobic gram-negative microorganisms

 

Escherichia coli

 

Klebsiella spp.

 

Neisseria gonorrhoeae

 

Pseudomonas aeruginosa

 

Anaerobic microorganisms

 

Clostridium difficile

 

Other microorganisms

 

Mycoplasma pneumoniae

 

Ureaplasma urealyticum

 

aUpdated information not available.

bAt least one European region has reported resistance rates higher than 50%.

cMost isolates have inherently intermediate resistance.

 

Antagonism was demonstrated between clindamycin and erythromycin and chemically related macrolides. Clindamycin does not demonstrate any antagonism with penicillins.

 

Although clindamycin hydrochloride is active both in vivo and in vitro, clindamycin phosphate and clindamycin palmitate are not active in vitro. However, both compounds are in vivo rapidly hydrolysed to the active base.


Absorption

 

1 to 3 hours following intramuscular injection of 600 mg of clindamycin phosphate, serum peak levels of clindamycin of 9 µg/ml were observed. Following intravenous infusion of 300 mg in 10 min. and 600 mg in 20 min. respectively serum peak levels of 7 µg/ml and 10 µg/ml respectively are reached at the end of the infusion.

 

Table 1 gives the mean serum levels after the administration of clindamycin phosphate. Clindamycin serum levels can be maintained above the in vitro MIC's for most sensitive organisms by administering clindamycin phosphate every 8 to 12 hours in adults or every 6 to 8 hours in children by continuous I.V. infusion. Steady state levels are reached after the third dose.

 

Table 1

Dose                                                           Clindamycin Clindamycin phosphate

                                                                  µg/ml                    µg/ml

Adults (after the steady state)

300 mg I.V. in 10 min. every 8 u.                   7                         15

600 mg I.V. in 20 min. every 8 u.                 10                         23

600 mg I.V. in 30 min. every 6 u.                 10.9  

600 mg I.V. in 30 min. every 8 u.                 10.8

900 mg I.V. in 30 min. every 8 u.                 14.1

900 mg I.V. in 30 min. every 12 u.               11                         29

1200 mg I.V. in 45 min. every 12 u.             14                         49

300 mg I.M. every 8 u.                                  6                           3

600 mg I.M. every 12 u.                                9                           3

 

Dose                                                                    Clindamycin

                                                                            µg/ml

Children (first dose) (1)

5‑7 mg/kg I.V. in 1 hour                                                 10

3‑6 mg/kg I.M.                                                                4

5‑7 mg/kg I.M.                                                                8

 

(1) Patients in this group were treated for existing infections.

 

Distribution

 

The protein binding is between 40 and 90 % of the administered dose. No accumulation could be demonstrated with oral administration.

 

Clindamycin easily penetrates in most body fluids and tissues. In bone tissue a level of approx. 40 % (20‑75 %) of the serum level is reached, in the mother's milk 50‑100 %, in synovial fluid 50 %, in the sputum 30‑75 %, in the peritoneal fluid 50 %, in foetal blood 40 %, in pus 30 %, in pleural fluid 50‑90 %. Clindamycin does not penetrate however in the cerebrospinal fluid, not even in the event of meningitis.

 

Biotransformation

 

Clindamycin has a half-life of approx. 1 1/2 ‑ 3 1/2 hours. This is somewhat longer in patients with a significantly reduced function of the liver or of the kidneys. The dose regimen should however not be adjusted in cases of moderately seriously reduced function of the kidneys or of the liver.

 

Clindamycin is relatively extensively metabolised.

 

In vitro studies in human liver and intestinal microsomes indicated that clindamycin is predominantly oxidized by CYP3A4, with minor contribution from CYP3A5, to form clindamycin sulfoxide and a minor metabolite, N‑desmethylclindamycin.

 

Elimination

 

The excretion in the urine is 10‑20 % and in the faeces some 4 % in microbiologically active form. The remainder is excreted as biologically inactive metabolites.

The excretion is mainly via the bile and the faeces.

 

Obese Paediatric Patients Aged 2 to Less than 18 Years and Obese Adults Aged 18 to 20 Years

An analysis of pharmacokinetic data in obese paediatric patients aged 2 to less than 18 years and obese adults aged 18 to 20 years demonstrated that clindamycin clearance and volume of distribution normalized by total body weight are comparable regardless of obesity.


Fertility studies in rats treated orally with up to 300 mg/kg/day (approximately 1.1 times the highest recommended adult human dose based on mg/m2) revealed no effects on fertility or mating ability.

 

In oral embryo foetal development studies in rats and subcutaneous embryo foetal development studies in rats and rabbits, no developmental toxicity was observed except at doses that produced maternal toxicity.


DALACIN C Solution for injection:

Benzyl alcohol, disodium edetate, Sodium Hydroxide, water for injection.

 


The following drugs are physically incompatible with the solution for injection of clindamycin phosphate: ampicillin, sodium phenytoin, barbiturates, aminophyllin, calcium gluconates, magnesium sulphate, sodium ceftriaxon and ciprofloxacin.

 

COMPATIBILITIES:

Solutions of clindamycin phosphate in 5 % dextrose in water and in sodium chloride solutions, to which one of the following antibiotics are added in the usual concentration remain stable for at least 24 hours: amikacin sulphate, aztreonam, cefamandole nafate, cefazolin sodium, cefotaxime sodium, cefoxitin sodium, ceftazidime sodium, ceftizoxime sodium, gentamicin sulphate, netilmicin sulphate, piperacillin and tobramycin.

The compatibility and the stability of these mixtures can vary depending on the concentration and other conditions.


Do not use Dalacin C after the expiry date which is stated on the carton after EXP:. The expiry date refers to the last day of that month. Shelf life: 24 months.

Solution for injection:

Store between (2 ° C – 8 ° C). Do not freeze.

 


Solution for injection

DALACIN C 300 mg/2 ml:

-    Pack containing 1 ampoule of 2 ml.

DALACIN C 600 mg/4 ml:

-    Pack containing 1 ampoule of 4 ml.


Keep out of the sight and reach of children.

 

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.

 

INDICATIONS FOR OPENING THE AMPOULE

Exert pressure on the ampoule with the point towards you, as indicated on the graph.

 

                   

 

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

 


Marketing Authorisation Holder Pfizer SA, Boulevard de la Plaine 17, 1050 Brussels, Belgium Manufactured Packed and Released By: Pfizer Manufacturing Belgium NV Rijksweg 12, 2870, Puurs, Belgium

March 2022
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