Clindamicin Kabi

Warnings and precautions

Before starting treatment with Clindamycin Kabi, consult a doctor, pharmacist, or nurse:
­­­Consult a doctor if any of the above warnings or precautions apply to the patient or have applied in the past.
Patient's using clindamycin have experienced severe hypersensitivity reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP). If symptoms of hypersensitivity or severe skin reactions occur, the doctor should be informed immediately.
Severe allergic reactions can occur even after the first administration of the medicine. In such a case, the doctor will immediately discontinue the administration of Clindamycin Kabi and implement standard procedures for emergency situations.
Rapid intravenous injection can cause side effects and should be avoided.
The doctor will dilute the medicine before intravenous administration and ensure that it is administered over at least 10-60 minutes.
During long-term treatment (over 10 days), the patient's blood count and liver and kidney function should be regularly monitored.
Acute kidney function disorders may occur. The doctor should be informed about all medications being taken and any kidney problems. If the patient experiences a decrease in urine output or fluid retention causing swelling of the legs, ankles, or feet, shortness of breath, or nausea, they should contact their doctor immediately.
Prolonged and repeated use of Clindamycin Kabi may lead to skin and mucous membrane infections with clindamycin-resistant microorganisms. Fungal infections may also occur.
During clindamycin treatment, severe colitis (pseudomembranous colitis) may occur. Therefore, the doctor should be informed immediately if the patient experiences severe and persistent diarrhea, especially if there is blood or mucus in the stool, during or within two months after the end of treatment.
Clindamycin Kabi should not be used in acute viral respiratory infections.
Clindamycin Kabi is not suitable for the treatment of meningitis (meningitis).

Children

Particular caution should be exercised when using the medicine in children under 3 years of age, as the medicine contains benzyl alcohol (see below).

Clindamycin Kabi and other medicines

Tell the doctor, pharmacist, or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Tell the doctor about taking warfarin or similar medicines used to thin the blood. The patient may be more prone to bleeding. The doctor may order regular blood tests to check blood clotting.
Clindamycin Kabi should not be used simultaneously with medicines containing erythromycin, as it cannot be ruled out that the effects of these medicines may be mutually weakened.
Clindamycin Kabi should not be administered after treatment with lincomycin.
Clindamycin Kabi may enhance the effect of muscle relaxants, which can lead to unexpected, life-threatening events during surgery.
Rifampicin may increase the elimination of clindamycin from the blood, so the attending doctor should regularly monitor the clindamycin concentration in the blood.

Pregnancy and breastfeeding

The patient should inform the doctor if:
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she is pregnant or thinks she may be pregnant − after assessing the benefit-risk ratio of using clindamycin, the doctor will decide how to use Clindamycin Kabi;
she is breastfeeding − this medicine may pass into breast milk and cause an allergic reaction (hypersensitivity), diarrhea, or fungal infections in the breastfed infant.
Before using any medicine, consult a doctor or pharmacist.

Driving and using machines

During treatment with this medicine, dizziness or headaches and fatigue may occur. In such cases, the patient should not drive vehicles, use tools, or operate machines.

Clindamycin Kabi contains sodium chloride and benzyl alcohol

Sodium chloride
The medicine contains 8.5 mg of sodium (the main component of table salt) per 1 ml of solution. This corresponds to 0.43% of the maximum recommended daily sodium intake in the diet for adults.
Benzyl alcohol
The medicine contains 9 mg of benzyl alcohol per 1 ml of solution.
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol is associated with the risk of serious side effects, including respiratory problems (so-called respiratory failure syndrome) in small children.
The medicine should not be administered to newborns (up to 4 weeks of age), unless prescribed by a doctor.
The medicine should not be used for more than a week in small children (under 3 years of age), unless prescribed by a doctor or pharmacist.
In case of pregnancy or breastfeeding, consult a doctor or pharmacist, as large amounts of benzyl alcohol may accumulate in the body and cause side effects (so-called metabolic acidosis).
In case of liver or kidney disease, consult a doctor or pharmacist, as large amounts of benzyl alcohol may accumulate in the body and cause side effects (so-called metabolic acidosis).

3. How to use Clindamycin Kabi

Clindamycin Kabi is administered by intramuscular injection (into the muscle) as an undiluted solution or, after dilution, as an intravenous infusion (into a vein). The medicine is usually administered by a doctor or nurse.
The doctor determines the dose of clindamycin suitable for the patient.
Typically, the dose used in adults and adolescents over 12 years of age is:
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for less complicated infections:
8 to 12 ml of Clindamycin Kabi per day (corresponding to 1.2 to 1.8 g of clindamycin)
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for severe infections:
12 to 18 ml of Clindamycin Kabi (corresponding to 1.8 to 2.7 g of clindamycin)
in two to four equal doses.
The maximum daily dose in adults and adolescents over 12 years of age is usually 18 ml of Clindamycin Kabi (corresponding to 2.7 g of clindamycin) in two to four equal doses. In life-threatening infections, doses up to 4.8 g per day can be administered.
In patients with liver or kidney disease, the metabolism of clindamycin is impaired. However, in most cases, dose reduction is not necessary. It is recommended to monitor the clindamycin concentration in the blood.
Clindamycin is not removed from the body during hemodialysis. Therefore, there is no need to administer additional doses to dialyzed patients before or after hemodialysis.

Use in children

Depending on the severity and location of the infection, the dose in children from 4 weeks to 12 years of age is 15 to 40 mg of clindamycin per kilogram of body weight in three or four equal doses.
The duration of treatment depends on the type and severity of the disease.
In case of doubts about the use of the medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Clindamycin Kabi can cause side effects, although not everybody gets them.
Inform the doctor immediately if the patient experiences:
fluid retention causing swelling of the legs, ankles, or feet, shortness of breath, or nausea.
Very common side effects(may affect more than 1 in 10 people)
Gastrointestinal disorders in the form of diarrhea, abdominal pain, vomiting, nausea.
Common side effects(may affect up to 1 in 10 people)
Pseudomembranous colitis, which can be life-threatening and requires immediate treatment.
Blood disorders, such as significant reduction in granulocyte count (agranulocytosis), neutropenia (lack of neutrophils), tendency to bleeding (thrombocytopenia), leukopenia (lack of white blood cells), and eosinophilia (increase in eosinophil count).
Vascular disorders, such as thrombophlebitis.
Skin disorders, such as rash (widespread rash with small nodules), urticaria (hives).
Abnormal liver function test results.
Uncommon side effects(may affect up to 1 in 100 people)
Nervous system disorders, such as neuromuscular blockade (blocking of nerve-muscle signal transmission) and taste disorders.
Cardiovascular disorders, such as cardiorespiratory arrest and hypotension (low blood pressure).
General disorders and administration site disorders, such as pain and abscess (boil) at the injection site.
Rare side effects(may affect up to 1 in 1,000 people)
Drug fever, hypersensitivity reaction to one of the ingredients of the medicine (benzyl alcohol).
Severe skin reactions:
widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form causing widespread skin peeling (toxic epidermal necrolysis);
widespread red skin rash with small pus-filled blisters (pustular exanthematous dermatitis);
angioedema (swelling, especially of the face and neck, wheezing, and difficulty breathing).
Itching.
Vaginitis (inflammation of the vaginal mucosa).
Very rare side effects(may affect up to 1 in 10,000 people)
Severe allergic reaction (anaphylactic reaction).
Transient hepatitis with jaundice.
Hypersensitivity reaction with rash and blistering.
Arthritis (polyarthritis).
Frequency not known(cannot be estimated from the available data)
Colitis (severe infection of the colon caused by Clostridium difficile).
Vaginal infection.
Severe acute allergic reactions, such as significant drop in blood pressure, pallor, weak rapid pulse, cool skin, impaired consciousness (anaphylactic shock), anaphylactoid reaction, hypersensitivity.
Drowsiness.
Dizziness.
Headache.
Jaundice.
Fever, lymph node swelling, or skin rash may be symptoms of a condition known as drug reaction with eosinophilia and systemic symptoms (DRESS), which can be severe and life-threatening.
Rare skin eruptions characterized by rapid onset of areas of red skin with small pus-filled blisters (acute generalized exanthematous pustulosis, AGEP).
Irritation at the injection site.

Reporting side effects

If side effects occur, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Clindamycin Kabi

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of the month.
Do not store above 25°C.
Do not use this medicine if you notice any discoloration, sediment, or other visible particles.
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 protect the environment.

6. Contents of the packaging and other information

What Clindamycin Kabi contains

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The active substance of the medicine is clindamycin.
One milliliter of the solution for injection/infusion concentrate contains 150 mg of clindamycin (in the form of phosphate).
One 2 ml ampoule contains 300 mg of clindamycin.
One 4 ml ampoule contains 600 mg of clindamycin.
One 6 ml ampoule contains 900 mg of clindamycin.
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The other ingredients are: benzyl alcohol (9 mg in each 1 ml of solution), disodium edetate, sodium hydroxide (to adjust pH), and water for injections.

What Clindamycin Kabi looks like and contents of the pack

Clindamycin Kabi is a clear, colorless or slightly colored solution for injection/infusion concentrate.
Clindamycin Kabi is available in colorless glass ampoules containing 2 ml, 4 ml, or 6 ml of solution for injection.
The pack contains: 5 or 10 ampoules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Labesfal - Laboratórios Almiro, S.A.
Zona Industrial do Lagedo
3465-157 Santiago de Besteiros
Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:21.07.2021

Information intended for healthcare professionals only:

For single use only. Unused solution should be discarded.
Do not use Clindamycin Kabi if you notice any particles or intense discoloration of the solution.
The solution should be inspected after dilution. Only use a clear solution free from visible particles. The diluted medicine is for single use only; unused solution should be discarded.
The chemical and physical stability of the solution after dilution has been confirmed for 48 hours at 25°C.
From a microbiological point of view, the medicine should be used immediately after dilution. If the medicine is not used immediately, the user is responsible for the storage conditions prior to use. Usually, the solution should not be stored for more than 24 hours at a temperature between 2°C and 8°C, unless the medicine has been diluted in controlled and validated aseptic conditions.
Before intravenous infusion, Clindamycin Kabi should be diluted (the target concentration should not exceed 18 mg of clindamycin per 1 ml) and administered over at least 10 to 60 minutes (the infusion rate should not exceed 30 mg/min).
The infusion solution should always be administered separately, unless compatibility with other medicines has been confirmed. Clindamycin Kabi can be diluted in 0.9% sodium chloride solution, 5% glucose solution, or Ringer's solution with lactate.