Clindamicin-mip 150 mg/ml

Package Leaflet: Information for the Patient

Clindamycin-MIP 150 mg/ml, Solution for Injection and Infusion

Clindamycin

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What is Clindamycin-MIP 150mg/ml and what is it 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 is Clindamycin-MIP 150 mg/ml and what is it used for

Clindamycin-MIP 150 mg/ml is an antibacterial medicine for systemic use. It contains the active substance clindamycin.
It is available as a solution for injection and infusion. Depending on the susceptibility of the microorganism and the concentration of the antibiotic, clindamycin can either kill bacteria or inhibit their growth.
Secondary resistance to the antibiotic develops rarely.
Indications for use
Infections caused by bacteria susceptible to clindamycin:
bone and joint infections,
ear, nose, and throat infections,
infections of the teeth and periodontal tissues,
lower respiratory tract infections,
intra-abdominal infections,
infections of the pelvic organs and female genital organs,
skin and soft tissue infections,
erysipelas,
septicaemia,
endocarditis.

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

When not to use Clindamycin-MIP 150 mg/ml

• If the patient is hypersensitive to clindamycin or lincomycin or to any of the other ingredients of this medicine (listed in section 6).
• In patients with known hypersensitivity 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, the patient should discuss the following with their doctor:
if the patient has liver function disorders,
if the patient has disorders of neuromuscular conduction (e.g. myasthenia or Parkinson's disease),
if the patient has had gastrointestinal diseases (e.g. previous colitis).
The patient should consult their doctor, even if the above warnings refer to past situations.
During long-term (longer than 3 weeks) use of the medicine, periodic monitoring of blood count, liver function, and kidney function is recommended.
Acute kidney function disorders may occur. The patient should inform their doctor about all concomitantly used medicines and existing 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 may lead to infection and overgrowth of resistant bacteria or fungi, especially on the skin or mucous membranes.
If the patient experiences diarrhoea during treatment, especially severe or persistent, they should consult their doctor. It may be a sign of pseudomembranous colitis caused by toxins of overgrown bacteria Clostridium difficile. The doctor will prescribe appropriate treatment - in mild cases, it may be sufficient to discontinue the use of Clindamycin-MIP 150 mg/ml, in severe cases, the use of an effective antibiotic or chemotherapeutic agent and symptomatic treatment may be necessary. Medicines that inhibit intestinal peristalsis are contraindicated.
If the patient experiences anaphylactic shock, they should discontinue the medicine and seek medical attention immediately, as the doctor will provide appropriate treatment (e.g. administer appropriate medications, and if necessary, provide controlled breathing).
Clindamycin can usually be used in patients allergic to penicillin. Cross-allergy to clindamycin in patients allergic to penicillin (so-called cross-allergy) usually does not occur. However, anaphylaxis has been observed in individual cases during clindamycin treatment in patients with penicillin allergy. Patients allergic to penicillin should inform their doctor before starting clindamycin treatment.
Clindamycin should not be used to treat acute viral respiratory infections.
Clindamycin does not reach therapeutic concentrations in cerebrospinal fluid, therefore Clindamycin-MIP 150 mg/ml should not be used to treat meningitis.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
In human studies, no harmful effects of the medicine on the fetus have been detected. Before prescribing the medicine, the doctor must carefully weigh the benefits and risks of using clindamycin during pregnancy and breastfeeding.
Clindamycin passes into breast milk. In breastfed newborns, hypersensitivity, diarrhoea, and fungal infections may occur.

Driving and using machines

Clindamycin-MIP 150 mg/ml has no effect on the ability to drive and use machines.

Clindamycin-MIP 150 mg/ml and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Clindamycin should not be used concomitantly with macrolide antibiotics (e.g. erythromycin) due to antagonistic effects observed in vitro.
Microorganisms resistant to lincomycin also exhibit resistance to clindamycin (so-called cross-resistance).
Clindamycin has properties that inhibit neuromuscular conduction, which may enhance the effect of muscle relaxants (e.g. ether, tubocurarine, halogenated pancuronium).
Therefore, during surgery using such agents, unexpected life-threatening situations may occur.
A patient concomitantly treated with clindamycin and a medicine that reduces blood clotting (warfarin or a similar medicine) may exhibit an increased tendency to bleed. The doctor may decide to perform regular blood tests to check its clotting.
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 give to young children (under 3 years) for more than a week without consulting a doctor or pharmacist. Pregnant or breastfeeding women should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis). Patients with liver or kidney disease should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).
1 ampoule of 2 ml contains 24 mg of sodium (the main component of common salt). This corresponds to 1.2% of the maximum recommended daily intake of sodium in the diet for adults.
1 vial of 4 ml contains 48 mg of sodium (the main component of common salt). This corresponds to 2.4% of the maximum recommended daily intake of sodium in the diet for adults.
1 vial of 6 ml contains 72 mg of sodium (the main component of common salt). This corresponds to 3.6% of the maximum recommended daily intake of sodium in the diet for adults.
If the medicine is used as recommended, the maximum daily dose used in adults in very severe infections (2700 mg of clindamycin) contains up to 216 mg of sodium.
This corresponds to 10.8% of the maximum recommended daily intake of sodium in the diet for adults.
In the maximum daily dose used in adults in life-threatening infections (4800 mg of clindamycin), there is up to 384 mg of sodium.
This corresponds to 19.2% of the maximum recommended daily intake of sodium in the diet for adults.
In the maximum daily dose used in children, there is 3.2 mg/kg of sodium.
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 dilution of the medicine. To obtain accurate information about the sodium content in the solution used for dilution, the patient information leaflet of the diluent used should be consulted.

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

This medicine should always be used as directed by the doctor. If you are unsure, consult your doctor or pharmacist.

Dosage

Clindamycin-MIP 150 mg/ml is administered intramuscularly or intravenously. The medicine should be administered regularly, at the same time every day.
The doctor will recommend how long to use Clindamycin-MIP 150 mg/ml. Do not stop treatment earlier, as its effect may be reduced.
Adults and adolescents over 14 years of age
Moderate infections: 600 mg to 1.2 g of clindamycin per day.
Severe infections: 1.2 g to 2.7 g of clindamycin per day.
The medicine is administered in 2 to 4 divided doses.
The maximum daily dose for adults and adolescents over 14 years of age is 4.8 g of clindamycin, administered in 2 to 4 divided doses.
Children from the 4th week of life to 14 years of age
Depending on the severity and location of the infection - 20 mg to 40 mg of clindamycin per kilogram of body weight per day, 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, dose reduction is not usually necessary if clindamycin is administered every 8 hours. In patients with severe hepatic impairment, the doctor will recommend monitoring the concentration of the medicine in the blood serum - depending on the results of these tests, it may be necessary to reduce the dose or extend the interval between individual doses.
In patients with mild or moderate renal impairment, dose reduction is not necessary; however, in patients with severe renal impairment or anuria, the doctor will recommend monitoring the concentration of the medicine in the blood serum - depending on the results of these tests, it may be necessary to reduce the dose or extend the interval between individual doses from 8 to 12 hours.

Dosage of Clindamycin-MIP 150 mg/ml in patients undergoing haemodialysis

Haemodialysis does not remove clindamycin from the blood, so additional doses before starting dialysis or after dialysis are not necessary.

Use of a higher than recommended dose of Clindamycin-MIP 150 mg/ml

Symptoms of overdose and poisoning with clindamycin are unknown. Clindamycin cannot be removed from the blood during dialysis or peritoneal dialysis. A specific antidote is not known.
If a higher dose of the medicine is taken, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Clindamycin-MIP 150 mg/ml

Usually, missing a single dose of the medicine does not cause disease symptoms.
Treatment should be continued without changes. However, the patient should not take a double dose to make up for the missed dose. The patient should remember that Clindamycin-MIP 150 mg/ml is effective only when taken regularly.

4. Possible side effects

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

If the following reactions occur, treatment with clindamycin should be discontinued immediately and medical attention should be sought:

• severe prolonged diarrhoea
• anaphylactic shock; allergic oedema in the face, mouth, throat, which may cause difficulty breathing The patient should immediately inform their doctor if they experience:
• fluid retention causing swelling of the legs, ankles, or feet, shortness of breath, or nausea

Other side effects

Common side effects (in 1 to 10 out of 100 patients):

• unwanted effects related to the gastrointestinal tract, such as abdominal pain, nausea, vomiting, or mild diarrhoea - these depend on the dose and disappear during therapy or after its completion; oesophagitis, glossitis, or stomatitis.

Uncommon side effects (in 1 to 10 out of 1000 patients):

• transient slight elevation of serum aminotransferase activity,
• pain, irritation, induration, and sterile abscesses at the injection site after intramuscular injection,
• pain and thrombophlebitis after intravenous administration.

Rare side effects (in 1 to 10 out of 10,000 patients):

• neuromuscular blockade,
• allergy with symptoms such as urticaria-like rash, itching, and hives,
• blood count disorders (transient and may have a toxic or allergic basis): thrombocytopenia (reduced platelet count), leucopenia (reduced white blood cell count), eosinophilia (increased eosinophil count), neutropenia (reduced neutrophil count), or granulocytopenia (reduced granulocyte count),
• feeling of heat, nausea, cardiovascular symptoms (e.g. hypotension and cardiac arrest) after too rapid intravenous administration.

Very rare side effects (less than 1 in 10,000 patients):

• pseudomembranous colitis,
• anaphylactic shock, allergic oedema (allergic oedema in the face, mouth, throat, which may cause difficulty breathing, joint oedema), fever, severe skin reactions with exfoliation and blisters [erythema multiforme (e.g. Stevens-Johnson syndrome), Lyell's syndrome] - these reactions may occur after the first administration of the medicine,
• transient hepatitis with cholestatic jaundice,
• pruritus, exfoliative and bullous dermatitis, polyarthritis,
• changes in taste and smell.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

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

Keep the medicine out of the 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 month.
Store in a temperature 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 is best used immediately. It should not be stored for longer than 24 hours at a temperature of 2°C-8°C, provided it has been prepared under aseptic conditions.
During storage in the refrigerator, the active substance may crystallize in the solution. The crystals will dissolve at room temperature. Before use, the patient should ensure that all crystals have dissolved.
Do not use this medicine if the solution has changed colour significantly.

6. Contents of the pack and other information

What Clindamycin-MIP 150 mg/ml contains

• The active substance of the medicine is clindamycin. 1 ml of solution contains 150 mg of clindamycin in the form of phosphate, i.e. 178.2 mg of clindamycin phosphate.

1 ampoule of 2 ml contains 300 mg of clindamycin in the form of phosphate, i.e. 356.4 mg of clindamycin phosphate.
1 vial of 4 ml contains 600 mg of clindamycin in the form of phosphate, i.e. 712.8 mg of clindamycin phosphate.
1 vial of 6 ml contains 900 mg of clindamycin in the form of phosphate, i.e. 1069.2 mg of clindamycin phosphate.

• Other ingredients 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, colourless to pale yellow.
Ampoules (type I glass) contain 2 ml of solution 150 mg/ml.
Vials (type I glass) with a bromobutyl rubber stopper contain 4 ml or 6 ml of solution 150 mg/ml.
The pack of Clindamycin-MIP 150 mg/ml contains 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
Phone: 58 303 93 62
Fax: 58 322 16 13
e-mail: [email protected]

Manufacturer

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

Date of last revision of the leaflet:

Information intended exclusively for healthcare professionals

Method of administration

Clindamycin can be administered intramuscularly or as an intravenous infusion.
During storage in the refrigerator, the active substance may crystallize in the solution. The crystals will dissolve at room temperature. Before use, the patient should ensure that all crystals have dissolved.
Intramuscular administration
The medicine is administered by deep intramuscular injection.
Do not administer more than 600 mg of clindamycin intramuscularly in a single injection.
Intravenous administration
Never administer undiluted Clindamycin-MIP 150 mg/ml intravenously!
Before intravenous administration, the solution should be diluted to a concentration not exceeding 12 mg/ml. The following can be used for dilution: water for injections, 5% glucose solution, 0.9% NaCl solution, or Ringer's lactate solution.
Incompatibilities
Clindamycin-MIP 150 mg/ml solution for injection and infusion is incompatible with the following medicines: ampicillin, sodium phenytoin, barbiturates, aminophylline, calcium gluconate, magnesium sulphate; therefore, they should not be administered together in the same injection. If it is necessary to administer one of these medicines parenterally during treatment with clindamycin phosphate, they should be administered in separate injections or infusions.
Clindamycin infusion should be administered at a rate not exceeding 30 mg/minute.
In a one-hour intravenous infusion, do not administer more than 1.2 g of clindamycin.