Clindamycin-mip 150 mg/ml

Package leaflet: information for the patient

Clindamycin-MIP 150 mg/ml, solution for injection and infusion
Clindamycinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Clindamycin-MIP 150 mg/ml is and what it is used for
2. Important information before using Clindamycin-MIP 150 mg/ml
3. How to use Clindamycin-MIP 150 mg/ml
4. Possible side effects
5. How to store Clindamycin-MIP 150 mg/ml
6. Contents of the pack and other information

1. What Clindamycin-MIP 150 mg/ml is and what it is used for
Clindamycin-MIP 150 mg/ml is a systemic antibacterial medicine. It contains the active substance – clindamycin.
It is available as a solution for injection and infusion. Depending on the microorganism's sensitivity and the antibiotic concentration, clindamycin may kill bacteria or only inhibit their growth.
Secondary resistance to the antibiotic is rare.

Indications for use
Infections caused by microorganisms sensitive to clindamycin:

• bone and joint infections,
• ear, nose and throat infections,
• dental and odontogenic osteomyelitis of the jaw and mandible,
• lower respiratory tract infections,
• intra-abdominal infections,
• pelvic and female genital tract infections,
• skin and soft tissue infections,
• septicemia,
• sepsis,
• endocarditis.

2. Important information before using Clindamycin-MIP 150 mg/ml

When not to use Clindamycin-MIP 150 mg/ml

• If the patient is allergic to clindamycin or lincomycin, or to any of the other ingredients of this medicine (listed in section 6).
• In patients known to be hypersensitive to benzyl alcohol or local anaesthetics (e.g. lidocaine or lidocaine derivatives), and in newborns (especially premature infants) – due to the presence of benzyl alcohol.

Warnings and precautions
Before starting treatment with Clindamycin-MIP 150 mg/ml, discuss the following with your doctor:

• if the patient has impaired liver function,
• if the patient has neuromuscular conduction disorders (e.g. myasthenia gravis or Parkinson's disease),
• if the patient has previously suffered from stomach or intestinal diseases (e.g. previous colitis).
  Consult your doctor, even if the above warnings refer to conditions from the past.

During prolonged (longer than 3 weeks) treatment, periodic monitoring of blood count, liver and kidney function is recommended.
Severe kidney function disturbances may occur. Inform your doctor about all concomitantly administered medicines and any existing kidney problems. If the patient's urine output decreases or fluid retention occurs causing swelling of the legs, ankles or feet, shortness of breath or nausea, contact your doctor immediately.

Prolonged and repeated use of clindamycin may lead to infection and overgrowth of resistant bacteria or yeasts, especially on the skin or mucous membranes.
If diarrhoea occurs during treatment, especially if severe or persistent, the patient should consult a doctor. It may be a symptom of pseudomembranous colitis caused by toxins from overgrown Clostridium difficile bacteria in the intestine. The doctor will recommend appropriate treatment – in milder cases discontinuation of Clindamycin-MIP 150 mg/ml may be sufficient, in severe cases effective antibiotic or chemotherapeutic agents and symptomatic treatment may be required. Drugs inhibiting intestinal peristalsis are contraindicated.

If anaphylactic shock occurs, discontinue the medicine and contact a doctor immediately, who will initiate appropriate treatment (e.g. administer suitable drugs, and if necessary, controlled ventilation).

Clindamycin can usually be used in patients allergic to penicillin. Cross-allergic reactions between penicillin and clindamycin are generally not observed. However, in isolated cases, anaphylaxis has been observed during clindamycin treatment in patients with penicillin allergy. A patient allergic to penicillin should inform the doctor before starting clindamycin treatment.

Clindamycin should not be used to treat acute viral respiratory tract infections.
Clindamycin does not achieve therapeutic concentrations in cerebrospinal fluid; therefore, Clindamycin-MIP 150 mg/ml should not be used in the treatment of meningitis.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.
Studies in humans have not revealed harmful effects of the medicine on the foetus. Before prescribing the medicine, the doctor must carefully weigh the benefits against the risks associated with clindamycin use during pregnancy and breastfeeding.
Clindamycin passes into human milk. In a breastfed newborn, hypersensitivity, diarrhoea and yeast infection may occur.

Driving and operating machinery
Clindamycin-MIP 150 mg/ml has no effect on the ability to drive vehicles or operate machinery.

Clindamycin-MIP 150 mg/ml and other medicines
Inform your doctor about all medicines currently used, recently used, or planned for use.
Clindamycin should not be used simultaneously with macrolide antibiotics (e.g. erythromycin) due to antagonistic effects observed in vitro.
Microorganisms resistant to lincomycin are also resistant to clindamycin (so-called cross-resistance).
Clindamycin has neuromuscular blocking properties, which may enhance the effects of muscle relaxants (e.g. ether, tubocurarine, pancuronium bromide). Therefore, during surgery using such agents, unexpected life-threatening situations may occur.
A patient receiving clindamycin and an anticoagulant (warfarin or similar drug) may have an increased tendency to bleed. The doctor may decide to perform regular blood tests to monitor blood coagulation.

Clindamycin-MIP 150 mg/ml contains benzyl alcohol and sodium.
The medicine contains 9 mg of benzyl alcohol in each ml of solution.

• 1 ampoule of 2 ml contains 18 mg of benzyl alcohol.
• 1 vial of 4 ml contains 36 mg of benzyl alcohol.
• 1 vial of 6 ml contains 54 mg of benzyl alcohol.

Benzyl alcohol may cause allergic reactions. Do not administer to small children (under 3 years of age) for longer than one week without medical or pharmacist advice. Pregnant or breastfeeding women should contact their doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis). Patients with liver or kidney disease should contact their doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

• 1 ampoule of 2 ml contains 24 mg of sodium (main component of table salt). This corresponds to 1.2% of the maximum recommended daily sodium intake in the adult diet.
• 1 vial of 4 ml contains 48 mg of sodium (main component of table salt). This corresponds to 2.4% of the maximum recommended daily sodium intake in the adult diet.
• 1 vial of 6 ml contains 72 mg of sodium (main component of table salt). This corresponds to 3.6% of the maximum recommended daily sodium intake in the adult diet.

When used as recommended, the maximum daily dose used in adults for very severe infections (2700 mg clindamycin) contains up to 216 mg of sodium. This corresponds to 10.8% of the maximum recommended daily sodium intake in the adult diet.

In the maximum daily dose used in adults for life-threatening infections (4800 mg clindamycin), up to 384 mg of sodium is present. This corresponds to 19.2% of the maximum recommended daily sodium intake in the adult diet.

In the maximum daily dose used in children, sodium content is 3.2 mg/kg body weight.

The medicine may be diluted – see below "Information intended exclusively for healthcare professionals". The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared diluted solution. For accurate information regarding sodium content in the solution used to dilute the medicine, refer to the patient leaflet of the diluent used.

3. How to use Clindamycin-MIP 150 mg/ml

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Dosage
Clindamycin-MIP 150 mg/ml is administered intramuscularly or intravenously. The medicine should be given regularly,
each time at the same hour.
Your doctor will determine how long you should take Clindamycin-MIP 150 mg/ml. Do not stop treatment earlier, as this may render it ineffective.
Adults and adolescents over 14 years of age
Moderately severe infections: 600 mg to 1,200 mg of clindamycin per day.
Severe infections: 1,200 mg to 2,700 mg of clindamycin per day.
The medicine should be given in 2 to 4 divided doses.
The maximum daily dose for adults and adolescents over 14 years of age is 4,800 mg
of clindamycin, administered in 2 to 4 divided doses.
Children from 4 weeks of age to 14 years
Depending on the severity and site of infection: 20 mg to 40 mg of clindamycin per kilogram of body weight per day, given in 3 or 4 divided doses.
Dosage of Clindamycin-MIP 150 mg/ml in patients with renal and/or hepatic impairment
In patients with moderate or severe hepatic impairment, dosage reduction is usually not necessary when clindamycin is administered every 8 hours. However, in patients with severe hepatic impairment, your doctor may recommend monitoring plasma concentrations of the drug. Depending on the results, dosage reduction or prolongation of the dosing interval may be required.
In patients with mild or moderate renal impairment, dosage adjustment is not necessary. However, in patients with severe renal impairment or anuria, your doctor may recommend monitoring plasma concentrations of the drug. Depending on the results, dosage reduction or prolongation of the dosing interval from 8 to 12 hours may be required.
Dosage of Clindamycin-MIP 150 mg/ml in patients undergoing hemodialysis
Hemodialysis does not remove clindamycin from blood; therefore, additional doses before or after dialysis are not required.
Use of a higher than recommended dose of Clindamycin-MIP 150 mg/ml
Symptoms of clindamycin overdose or poisoning are unknown. Clindamycin cannot be removed from blood by hemodialysis or peritoneal dialysis. No specific antidote is known.
If an overdose is taken, seek immediate medical advice from a doctor or pharmacist.
Missed dose of Clindamycin-MIP 150 mg/ml
Occasional omission of a single dose usually does not cause adverse effects. Continue treatment as originally planned. Do not administer a double dose to make up for a missed dose. However, remember that Clindamycin-MIP 150 mg/ml is effective only when taken regularly.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the reactions listed below occur, treatment with clindamycin must be stopped immediately and
medical advice must be sought:

• severe, persistent diarrhoea
• anaphylactic shock; allergic swelling of the face, mouth, or throat, which may make breathing difficult

Immediate medical advice must be sought if the patient experiences:

• fluid retention causing swelling of the legs, ankles, or feet, shortness of breath, or nausea

Other adverse reactions
Adverse reactions occurring frequently (in 1 to 10 out of 100 patients):

• gastrointestinal adverse effects such as abdominal pain, nausea, vomiting, or mild diarrhoea – these are dose-dependent and usually resolve during or after treatment; oesophagitis, glossitis, or oral mucositis.

Adverse reactions occurring uncommonly (in 1 to 10 out of 1,000 patients):

• transient, slight increase in serum aminotransferase activity,
• pain, irritation, induration, and sterile abscess at the injection site after intramuscular administration,
• pain and thrombophlebitis after intravenous administration.

Adverse reactions occurring rarely (in 1 to 10 out of 10,000 patients):

• neuromuscular blockade,
• allergic reactions with symptoms such as maculopapular rash, pruritus, and urticaria,
• blood disorders (transient, possibly of toxic or allergic origin): thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), eosinophilia (increased eosinophil count), neutropenia (reduced neutrophil count), or granulocytopenia (reduced granulocyte count),
• sensation of warmth, nausea, cardiovascular symptoms (e.g. hypotension and cardiac arrest) following too rapid intravenous administration.

Adverse reactions occurring very rarely (in fewer than 1 out of 10,000 patients):

• pseudomembranous colitis,
• anaphylactic shock, oedema (allergic swelling of the face, mouth, or throat, which may impair breathing, joint oedema), drug fever, severe skin reactions with peeling and blistering [e.g. erythema multiforme (including Stevens-Johnson syndrome), Lyell's syndrome] – these reactions may occur after the first dose,
• transient cholestatic hepatitis,
• pruritus, exfoliative and bullous dermatitis, polyarthritis,
• disturbances in taste and smell perception.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Clindamycin-MIP 150 mg/ml

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Expiry date". The expiry date refers to the last day of the stated month.
Store below 25°C.
After dilution, the medicine retains its chemical and physical properties for 24 hours at room temperature (15°C–25°C). After dilution, the solution should preferably be used immediately. If not used immediately, it should not be stored for longer than 24 hours at 2°C–8°C, provided it has been prepared under aseptic conditions.
During storage in the refrigerator, crystallization of the active substance in the solution may occur. The crystals will dissolve at room temperature. Before use, ensure that all crystals have completely dissolved.
Do not use this medicine if you notice a distinct change in the colour of the solution.

6. Contents of the pack and other information

What Clindamycin-MIP 150 mg/ml contains

• The active substance is clindamycin. 1 ml of solution contains 150 mg clindamycin as phosphate, equivalent to 178.2 mg clindamycin phosphate.

One 2 ml ampoule contains 300 mg clindamycin as phosphate, equivalent to 356.4 mg clindamycin phosphate.
One 4 ml vial contains 600 mg clindamycin as phosphate, equivalent to 712.8 mg clindamycin phosphate.
One 6 ml vial contains 900 mg clindamycin as phosphate, equivalent to 1069.2 mg clindamycin phosphate.

• The other constituents are: benzyl alcohol, disodium edetate dihydrate, sodium hydroxide (2N), water for injections.

What Clindamycin-MIP 150 mg/ml looks like and contents of the pack
Clindamycin-MIP 150 mg/ml solution is clear, ranging from colourless to pale yellow.
Ampoules (Type I glass) contain 2 ml of 150 mg/ml solution.
Vials (Type I glass) sealed with a bromobutyl rubber stopper contain 4 ml or 6 ml of 150 mg/ml solution.
Packaging of Clindamycin-MIP 150 mg/ml contains either 1 or 5 ampoules or vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
MIP Pharma Polska Sp. z o.o.
ul. Orzechowa 5
80-175 Gdańsk
Tel.: 58 303 93 62
Fax: 58 322 16 13
e-mail: [email protected]

Manufacturer
MIP Pharma GmbH
Mühlstrasse 50
D-66386 St. Ingbert
Germany

Information intended exclusively for medical professionals

Administration method
Clindamycin can be administered intramuscularly or by intravenous infusion.
During storage in the refrigerator, crystallization of the active substance in the solution may occur.
Crystals will dissolve at room temperature. Before use, ensure that all crystals have completely dissolved.

Intramuscular administration
The drug should be administered by deep intramuscular injection.
Do not administer more than 600 mg of clindamycin in a single intramuscular injection.

Intravenous administration
Under no circumstances should undiluted Clindamycin-MIP 150 mg/ml solution be administered intravenously!
Before intravenous administration, the solution must be diluted so that the concentration does not exceed 12 mg/ml.
Dilution may be performed using: water for injections, 5% glucose solution, 0.9% sodium chloride solution, or lactated Ringer's solution.

Pharmaceutical incompatibilities
Clindamycin-MIP 150 mg/ml solution for injection and infusion is incompatible with the following drugs: ampicillin, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate; therefore, they should not be administered together in the same injection. If concurrent parenteral administration of clindamycin phosphate and one of these drugs is necessary, they should be given in separate injections or infusions.

Infusion rate
Clindamycin infusion should be administered at a rate not exceeding 30 mg/minute.
In a one-hour intravenous infusion, no more than 1.2 g of clindamycin should be administered.