CLINDAMYCIN 150 mg /Ml Solution

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Clindamycin hameln, 150 mg/ml, solution for injection/infusion
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Clindamycin hameln and what is it used for
4. Important information before using Clindamycin hameln
   1. When not to use Clindamycin hameln:
   2. Warnings and precautions
   3. Before starting treatment with Clindamycin hameln, consult a doctor, pharmacist, or nurse if:
   4. Severe skin reactions
   5. Children
   6. Clindamycin hameln and other medicines
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Clindamycin hameln contains benzyl alcohol
   10. Clindamycin hameln contains sodium
5. How to use Clindamycin hameln
   1. Adults, adolescents over 12 years old, and the elderly
   2. Use in children (from 1 month to 12 years old)
   3. Long-term use of Clindamycin hameln
   4. Using a higher dose of Clindamycin hameln than recommended
   5. Missing a dose of Clindamycin hameln
6. Possible side effects
   1. Very common (may affect more than 1 in 10 people)
   2. Common (may affect up to 1 in 10 people)
   3. Uncommon (may affect up to 1 in 100 people)
   4. Rare (may affect up to 1 in 1,000 people)
   5. Very rare (may affect up to 1 in 10,000 people)
   6. Frequency not known (cannot be estimated from available data)
   7. Reporting side effects
7. How to store Clindamycin hameln
8. Contents of the packaging and other information
   1. What Clindamycin hameln contains
   2. What Clindamycin hameln looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names
   6. Date of last revision of the leaflet: 21.08.2024
   7. Clindamycin hameln, 150 mg/ml, solution for injection/infusion In order to obtain full information on the use of the medicine, please refer to theSummary of Product Characteristics.
   8. Method of administration
   9. Dilution
   10. Incompatibilities
   11. Special precautions for storage

Leaflet accompanying the packaging: patient information

Clindamycin hameln, 150 mg/ml, solution for injection/infusion

Clindamycin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Clindamycin hameln and what is it used for
• 2. Important information before using Clindamycin hameln
• 3. How to use Clindamycin hameln
• 4. Possible side effects
• 5. How to store Clindamycin hameln
• 6. Contents of the packaging and other information

1. What is Clindamycin hameln and what is it used for

Clindamycin hameln contains the active substance clindamycin, which is an antibiotic used to treat the following severe bacterial infections in adults and children over 4 weeks old:

• Bone and joint infections
• Chronic sinusitis
• Lower respiratory tract infections
• Complicated intra-abdominal infections
• Infections of the pelvic and female genital organs
• Complicated skin and soft tissue infections

2. Important information before using Clindamycin hameln

When not to use Clindamycin hameln:

• If the patient is allergic to clindamycin, lincomycin, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Clindamycin hameln, consult a doctor, pharmacist, or nurse if:

the patient has::

• previously had gastrointestinal diseases (e.g., colitis);
• liver or kidney function disorders. The patient should consult a doctor or pharmacist if they have liver or kidney disease, as Clindamycin hameln contains benzyl alcohol, which can accumulate in the body and cause side effects (called "metabolic acidosis");
• any form of allergy, such as penicillin allergy, as there have been reports of allergic reactions to clindamycin in patients allergic to penicillin;
• muscle disorders, such as myasthenia gravis (a long-term condition that causes muscle weakness) or Parkinson's disease (also known as shaking palsy);
• previously experienced severe skin rash or skin peeling, blisters, and (or) mouth ulcers after taking clindamycin or other antibiotics.

The patient should consult a doctor if any of the above warnings and precautions apply or have applied to them in the past.

Severe skin reactions

Patients taking clindamycin have reported 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 hypersensitivity or severe skin reaction occurs, the patient should immediately contact a doctor.

• SJS/TEN may initially appear as red, target-like patches or round patches, often with centrally located blisters on the torso. It may also cause mouth ulcers, throat, nose, genital, and eye (red, swollen eyes) ulcers. These severe skin rashes are often preceded by fever and (or) flu-like symptoms. The rashes can progress to widespread skin peeling and life-threatening complications.
• DRESS initially appears as flu-like symptoms and a rash on the face, followed by a spreading rash with high body temperature, elevated liver enzymes visible in blood tests, and an increased white blood cell count (eosinophilia) and swollen lymph nodes.
• AGEP may appear as areas of redness on the skin with small pustules (small blisters filled with white-yellow fluid).

If the patient experiences a severe rash or any of these skin symptoms, they should stop using Clindamycin hameln and immediately contact a doctor or seek medical attention.

Children

Clindamycin hameln should not be given to newborns (up to 4 weeks old) unless absolutely necessary, and special caution should be exercised when administering to children under 3 years old, as this medicine contains benzyl alcohol (see below).

Clindamycin hameln and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription. Some medicines may affect the action of Clindamycin hameln or this medicine may reduce the effectiveness of other medicines used at the same time.

• Muscle relaxants used during surgery. Clindamycin may enhance the effect of muscle relaxants, which can lead to unexpected, life-threatening events during surgery;
• 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;
• Medicines that increase the metabolic activity of liver enzymes (CYP3A4 or CYP3A5 inducers), such as rifampicin (an antibiotic used to treat tuberculosis), St. John's Wort (a herbal product used to treat depression), and carbamazepine, phenytoin, phenobarbital (medicines used to treat epilepsy), as this may cause the loss of clindamycin's antibacterial effect;
• Medicines that slow down the metabolic activity of liver enzymes (CYP3A4 inhibitors), such as itraconazole, voriconazole (used to treat fungal infections); clarithromycin (an antibiotic); ritonavir and cobicistat (antiviral medicines used to treat HIV/AIDS), as this may cause an increase in clindamycin levels in the body and may cause side effects;
• Erythromycin, as there may be mutual reduction in efficacy when both antibiotics are administered at the same time;
• Lincomycin, as Clindamycin hameln should not be administered later.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before using this medicine.

Clindamycin hameln should not be given to breastfeeding women unless absolutely necessary. This medicine may pass into breast milk. In breastfed infants, diarrhea, fungal infections (oral thrush), and allergic reactions may occur. The infant should be closely monitored for signs of side effects, especially blood in the stool or diarrhea (colitis).

The doctor will decide whether to use Clindamycin hameln if the patient is pregnant or breastfeeding.

Driving and using machines

This medicine may cause mild to moderate side effects that can affect the ability to drive and use machines. The patient may experience dizziness, fatigue, or headaches while taking this medicine. If such symptoms occur, the patient should not drive or operate machinery.

Clindamycin hameln contains benzyl alcohol

This medicine contains 9 mg of benzyl alcohol per milliliter.

• Benzyl alcohol may cause allergic reactions.
• Administering benzyl alcohol to small children is associated with a risk of severe side effects, including respiratory disorders (so-called gasping syndrome). Clindamycin hameln should not be given to newborns (up to 4 weeks old) without a doctor's recommendation. It should not be given to small children (under 3 years old) for more than a week without a doctor's recommendation.
• Pregnant or breastfeeding women should consult a doctor before using this medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
• Patients with liver or kidney disease should consult a doctor before using this medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

Clindamycin hameln contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per 2 ml of solution, which means it is considered "sodium-free".

The medicine contains 34.4 mg of sodium (the main component of table salt) per 4 ml of solution. This corresponds to 1.7% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Clindamycin hameln

The doctor will administer the medicine by intravenous injection or intramuscular injection. If the medicine is administered intravenously, it is diluted with glucose or saline solution before use and administered through an infusion. The injection or infusion takes 10 to 40 minutes.

Before administering Clindamycin hameln, the doctor will ensure that the clindamycin concentration does not exceed 18 mg per ml, and the administration rate does not exceed 30 mg per minute.

If Clindamycin hameln is administered too quickly, it may (rarely) cause a heart attack.

Clindamycin hameln is usually administered only to hospitalized patients. The doctor and nurse will closely monitor the patient during administration.

Adults, adolescents over 12 years old, and the elderly

The recommended dose of Clindamycin hameln depends on the severity of the infection.

• Mild infections: 1200 to 1800 mg of clindamycin per day (corresponding to 8 to 12 ml of Clindamycin hameln) in three or four divided doses.
• Severe infections: 1800 to 2700 mg of clindamycin (corresponding to 12 to 18 ml of Clindamycin hameln) in two to four divided doses.

Usually, the maximum daily dose for adults, adolescents over 12 years old, and the elderly is 2700 mg of clindamycin (corresponding to 18 ml of Clindamycin hameln) in two to four divided doses. In life-threatening infections, doses up to 4800 mg per day can be administered.

In patients with liver or kidney function disorders, the dose usually does not need to be adjusted. Clindamycin concentration in the blood should be monitored.

Clindamycin is not removed from the body during hemodialysis (removal of waste products from the blood using artificial filtration, used to treat kidney failure). Therefore, there is no need to administer additional doses to dialyzed patients before or after hemodialysis.

Use in children (from 1 month to 12 years old)

The recommended dose for children (over 1 month old) is 20 to 40 mg of clindamycin per kilogram of body weight per day in three or four divided doses. The duration of treatment depends on the disease and its course.

The medicine should be dosed based on the total body weight, regardless of obesity.

Long-term use of Clindamycin hameln

If the patient's condition requires more than one cycle of clindamycin treatment, the doctor may order monitoring of clindamycin's effect on kidney and liver function in the patient. Long-term use of the medicine may also increase the likelihood of other infections that do not respond to treatment with Clindamycin hameln.

Clindamycin hameln should not be used for more than a week in small children (under 3 years old) without a doctor's recommendation or pharmacist's advice.

Using a higher dose of Clindamycin hameln than recommended

Since this medicine is administered by a doctor or nurse, it is very unlikely that an overdose will occur. However, if the patient thinks they have received too much Clindamycin hameln, they should immediately tell their doctor or nurse. In case of an overdose, the doctor will treat any symptoms that occur.

Missing a dose of Clindamycin hameln

Clindamycin hameln is administered by a doctor or nurse. However, if the patient thinks a dose of the medicine has been missed, they should tell their doctor or nurse.

If the patient has any further questions about using this medicine, they should consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Clindamycin hameln can cause side effects, although not everybody gets them.

The patient should immediately contact a doctorif they experience:

• severe skin reactions
• including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). They may initially appear as red, target-like patches or round patches, often with centrally located blisters on the torso. They may also cause mouth ulcers, throat, nose, genital, and eye (red, swollen eyes) ulcers. These severe skin rashes are often preceded by fever and (or) flu-like symptoms. The rashes can progress to widespread skin peeling and life-threatening complications.
• acute generalized exanthematous pustulosis (AGEP). It may appear as areas of redness on the skin with small pustules (small blisters filled with white-yellow fluid).
• drug reaction with eosinophilia and systemic symptoms (DRESS), which is also known as hypersensitivity syndrome. It initially appears as flu-like symptoms and a rash on the face, followed by a spreading rash with high body temperature, elevated liver enzymes visible in blood tests, and an increased white blood cell count (eosinophilia) and swollen lymph nodes.

If the patient experiences these side effects, they should stop using Clindamycin hameln and contact a doctor or seek medical attention immediately. See also section 2.

• symptoms of severe colitis, such as persistent or bloody diarrhea with abdominal pain or fever. This is a common side effect (may affect up to 1 in 10 people) that can occur during or after antibiotic treatment, potentially life-threatening, and requires immediate appropriate treatment.
• symptoms of a severe allergic reaction, such as sudden wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching (especially affecting the whole body).
• yellowing of the skin and whites of the eyes (jaundice). The frequency of this side effect is unknown (cannot be estimated from available data).
• more frequent infections with fever, chills, sore throat, or mouth ulcers (which may indicate a low white blood cell count in the body). The frequency of this side effect is unknown (cannot be estimated from available data).
• reduced platelet count, which can cause bruising or bleeding (thrombocytopenia). This is a common side effect (may affect up to 1 in 10 people).

Other side effects that may occur are listed according to their frequency:

Very common (may affect more than 1 in 10 people)

• Gastrointestinal disorders, such as diarrhea, abdominal pain, vomiting, nausea.

Common (may affect up to 1 in 10 people)

• Vascular disorders, such as phlebitis (thrombophlebitis).
• Oral mucositis (stomatitis).
• Skin disorders, such as rash (widespread rash with small bumps), urticaria.
• Abnormal liver function test results.

Uncommon (may affect up to 1 in 100 people)

• Decreased count of certain types of white blood cells (granulocytopenia).
• Nervous system disorders, such as neuromuscular blockade (blockage of nerve-muscle impulse transmission) and taste disorders (dysgeusia).
• Cardiovascular disorders, such as cardiac arrest and decreased blood pressure (hypotension).
• General disorders and administration site conditions, such as pain and abscess (injection site abscess).

Rare (may affect up to 1 in 1,000 people)

• Drug fever, hypersensitivity to one of the excipients (benzyl alcohol) or "gasping syndrome" (a condition that can occur in premature infants exposed to benzyl alcohol, used as a preservative in injectable medicines). This syndrome is characterized by continuous gasping breath and may include "metabolic acidosis", worsening of kidney and nervous system function, seizures, brain bleeding, and heart and blood vessel failure to maintain effective blood flow to the brain.
• Swelling, especially of the face and throat, wheezing, and (or) difficulty breathing (angioedema).
• Itching (pruritus).
• Vaginitis (vaginal inflammation).

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

• Severe allergic reaction (anaphylaxis).
• Transient hepatitis with cholestatic jaundice.
• Hypersensitivity reactions with rash and blistering.
• Arthritis (polyarthritis).

Frequency not known (cannot be estimated from available data)

• Severe infection of the colon caused by Clostridioides difficile (pseudomembranous colitis).
• Vaginal infection.
• Severe acute allergic reactions, such as significant drop in blood pressure, paleness, weak pulse, clammy skin, decreased consciousness (anaphylactic shock), anaphylactoid reaction, hypersensitivity.
• Drowsiness.
• Dizziness.
• Headache.
• Altered sense of smell (parosmia)
• Irritation at the injection site.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.

By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Clindamycin hameln

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date (EXP) stated on the label and carton.

The expiry date refers to the last day of the month.

Do not store above 25°C.

This medicine is for single use only.

Any unused solution should be discarded.

Shelf life after dilution - see: Special precautions for storagebelow.

Do not use this medicine if there is any change in color, precipitation, or presence of particles.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Clindamycin hameln contains

The active substance is clindamycin.

Each milliliter of solution contains clindamycin phosphate equivalent to 150 mg of clindamycin.

Excipients: benzyl alcohol (E 1519), disodium edetate, sodium hydroxide (for pH adjustment), and water for injections.

What Clindamycin hameln looks like and contents of the pack

Clindamycin hameln is a clear, colorless or pale yellow solution without visible particles.

It is packaged in boxes of:

• 5, 10, or 100 ampoules containing 2 mL of solution
• 5, 10, or 100 ampoules containing 4 mL of solution Not all pack sizes may be marketed.

Marketing authorization holder

hameln pharma gmbh

Inselstraße 1

31787 Hameln

Germany

Manufacturer

Siegfried Hameln GmbH

Langes Feld 13

31789 Hameln

Germany

hameln rds s.r.o.

Horná 36

90001 Modra

Slovakia

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names

Date of last revision of the leaflet: 21.08.2024

__________________________________________________________________________

The following information is intended for healthcare professionals only:

Clindamycin hameln, 150 mg/ml, solution for injection/infusion In order to obtain full information on the use of the medicine, please refer to theSummary of Product Characteristics.

Method of administration

Intramuscular injection

For intramuscular injection, this medicinal product should be used undiluted. It is not recommended to administer single intramuscular doses greater than 600 mg of clindamycin.

Intravenous infusion

This medicinal product MUST NOT be administered as an intravenous bolus, as rapid intravenous injection of undiluted clindamycin may lead to cardiac arrest.

Dilution

For intravenous infusion, this medicinal product mustbe diluted with 9 mg/ml (0.9%) sodium chloride solution, 50 mg/ml (5%) glucose solution, or Ringer's solution with lactate.

Clindamycin concentration should not exceed 18 mg/ml, and infusion rate should not exceed 30 mg/min.

Dose

Diluent

Minimum infusion time

300 mg

50 ml

10 minutes

600 mg

50 ml

20 minutes

900 mg

50-100 ml

30 minutes

1200 mg

100 ml

40 minutes

Incompatibilities

Clindamycin should not be administered together with ampicillin, sodium phenytoin, barbiturates, aminophylline, calcium gluconate, sodium ceftriaxone, ciprofloxacin, phenytoin, idarubicin hydrochloride, magnesium sulfate, and ranitidine hydrochloride in mixed injection. This medicinal product should be administered separately.

Solutions of clindamycin phosphate have a low pH, and incompatibility with alkaline products or products unstable at low pH can be expected.

Special precautions for storage

For single use only. Any unused solutions should be discarded.

The medicine should not be used if it contains particles or if the solution is strongly colored.

Before use, and also after dilution, the solution should be inspected. Only clear solutions free from visible particles should be used.

Opened ampoules:The product should be used immediately after opening the container.

Diluted solution:

Chemical and physical stability of the solution after dilution with 9 mg/ml (0.9%) sodium chloride solution, 50 mg/ml (5%) glucose solution, or Ringer's solution with lactate has been demonstrated for 48 hours at 25°C.

From a microbiological point of view, the product should be used immediately after dilution. If the product is not used immediately, the responsibility for the storage conditions and duration of the product before use lies with the user. Usually, the solution should not be stored for more than 24 hours at a temperature of 2°C to 8°C, unless the product has been diluted in controlled and validated aseptic conditions.