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Clindamycin 150 mg. / Ml. 4 ml.

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WHAT Clindamycin 150 MG / ML IS AND WHAT IT IS USED?

Clindamycin-MIP 150 mg / ml is an antibiotic from the group of lincosamides. It is used for the treatment of infections requiring parenteral therapy caused by microorganisms susceptible to clindamycin [such as sensitive anaerobic bacteria susceptible strains of aerobic gram-positive bacteria (streptococci, staphylococci and pneumococci), as well as sensitive strains of Chlamydia trachomatis]: infections of the bones and joints; infections of the ear, nose and throat; toothed jaw infections; infections of the lower respiratory tract; intra-abdominal infections; gynecological infections; infections of skin and soft tissues; scarlet fever; septicemia (bacterial infection of the blood); endocarditis. This indication is based only on in-vitro studies of the sensitivity of the causative upon reaching the corresponding plasma concentrations.

2. BEFORE YOU ARE GIVEN clindamycin-M1R 150 MG / ML
Do not take Clindamycin-MIP 150 mg / ml

- If you are allergic (hypersensitive) to clindamycin or any of the other ingredients Clindamycin-MIP 150 mg / ml (described in section 6 "What Clindamycin-MIP 150 mg / ml").
- If you are allergic (hypersensitive) to lincomycin.
- If you have a known hypersensitivity to either benzyl alcohol or local anesthetics (e. Lidocaine or lidocaine derivatives of substances) as well as in infants (especially in premature infants).

Take special care with Clindamycin - MIP 150 mg / ml
Clindamycin-MIP 150 mg / ml must be used with caution in:

• impaired liver function;
• disturbances in neuro-muscular conductivity (eg. Myasthenia gravis: painful muscle weakness and Parkinson's disease, paralysis etc. vibrating);
• previous gastrointestinal disorders (eg. Prior inflammation of the colon).

In case of prolonged treatment (over three weeks) should periodically examine the blood count and liver function and kidney.

If severe and persistent diarrhea during treatment with clindamycin, stop taking the medication and tell your doctor.

Prolonged and repeated use of clindamycin can lead to infection of the skin and mucous membranes of microbes against which Clindamycin-MIP 150 mg / ml is inefficient and populating with blastomitseti. Clindamycin-MIP 150 mg / ml should not apply in cases of acute respiratory infection caused by viruses.
Clindamycin-MIP 150 mg / ml is inefficient for the treatment of meningitis, as achieved concentrations of clindamycin in the cerebrospinal fluid are not sufficient for the treatment.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Clindamycin-MIP 150 mg / ml should not be combined with macrolide antibiotics (eg. Erythromycin), due to mutual suppression efficiency.

It has been demonstrated between clindamycin cross-resistance, which is an active ingredient Clindamycin-MIP 150 mg / ml lincomycin and containing medicines.

Clindamycin-MIP 150 mg / ml may enhance the effects of muscle-relaxing drugs (eg. Ether, tubocurarine and pancuronium bromide) due to its ability to neuromuscular blocking. This effect can lead to unexpected, life-threatening events during surgical operations.

The efficacy of oral contraceptives when taken concurrently with Clindamycin-MIP 150 mg / ml, is not guaranteed. Therefore must use other additional contraceptive methods.

The following drugs are incompatible with Clindamycin-MIP 150 mg / ml and therefore should not be applied in the combined injection: ampicillin, phenytoin, barbiturates, aminophylline, calcium gluconate and magnesium sulfate. If one of these drugs should be administered parenterally during treatment with clindamycin injection / infusion should be administered alone.

Pregnancy and lactation

In use during pregnancy and lactation should be considered carefully benefit / risk ratio. So far, studies in humans showed no teratogenic effect of clindamycin.

In infants can be observed sensitization (developing hypersensitivity), diarrhea and mucosal colonization by blastomitseti.

Ask your doctor or pharmacist before taking any medicine.
Driving and using machines

Clindamycin-MIP 150 mg / ml not affect your ability to drive or operate machinery.

Important information about some of the ingredients of Clindamycin-MIP 150 mg / ml solution for injection

Medicinal product contains benzyl alcohol (18 mg in 2 ml, 36 mg in 4 ml and 54 mg in 6 ml). May cause allergic and toxic reactions in infants and children up to 3 years of age.

3. HOW TO USE clindamycin-MIP 150 MG / ML?

Clindamycin-MIP 150 mg / ml solution for injection will be administered by a doctor or nurse.

Clindamycin may be injected intramuscularly (deep) or by intravenous infusion. Clindamycin-MIP 150 mg / ml in no case should be applied undiluted intravenous injection.

In single intramuscular dose of clindamycin should not exceed 600 mg.

Prior to intravenous administration, the solution should be diluted so that the concentration of the solution should not exceed 12 mg / ml, corresponding to 25 ml of medium dilution of 2 ml ampoule Clindamycin-MIP 150 mg / ml, 50 ml to 4 ml vial and 75 ml in 6 ml of ampoule.

Possible solvents: water for injection, 5% glucose solution, physiological saline and Ringer's solution.

The infusion rate should not exceed 30 mg clindamycin / min. One-time infusions should not exceed 1200 mg / h clindamycin.

Adults and adolescents over 14 years:

• in the case of moderate infections: 8 ml to 12 ml Clindamycin-MIP 150 mg / ml per day (corresponding to 1,2 g to 1,8 g clindamycin) in 2 to 4 single doses.

• In case of severe infections: 16 ml to 18 ml of Clindamycin-MIP 150 mg / ml per day (corresponding to 2,4 g to 2,7 g clindamycin) in 2 to 4 single doses.

The maximum daily dose for adults and adolescents over 14 years is 32 ml Clindamycin-MIP 150 mg / ml (corresponding to 4,8 g clindamycin) in 2 to 4 single doses.

children:

Children above the age of 4 weeks to 14 years depending on the severity and localization of the infection obtained 20 mg to 40 mg clindamycin / Kg of body weight intravenously at 3 or 4, single doses.
Dosage in patients with hepatic impairment

For patients with moderate to severe hepatic impairment time in which the medicinal product is broken in half in the body longer. Dose reduction is not usually necessary if Clindamycin-MIP 150 mg / ml is prescribed every 8 hours. But in patients with severe hepatic impairment concentration of drug in the blood should be controlled. In accordance with the results it is necessary to resort to a reduction in the dose or, alternatively, extend the time between doses.

Dosage in patients with renal impairment

In patients with renal impairment time to separate the half on the amount of medicine is also extended by reducing the dose in most cases is not necessary. However, in patients with severe renal impairment or interruption of urine output (anuria) drug concentration in the blood must be controlled. According to the results it is necessary to reduce the dose or extending the time between doses of 8 to 12 hours.

Dosage in hemodialysis patients

Clindamycin is not removed by hemodialysis. So before and after dialysis is not necessary to change the previous dosage.

If you are given more than the amount Clindamycin-MIP 150 mg / ml

Clindamycin-MIP 150 mg / ml solution for injection administered by medical staff and is unlikely to occur overdose.

If you forget to take Clindamycin-MIP 150 mg / ml

Usually the symptoms of the disease does not aggravate especially if a dose was missed. If you think omitted certain dose, tell your doctor or nurse.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Clindamycin-MIP 150 mg / ml can cause side effects, although not everybody gets them.

Side effects may occur with certain frequencies, which are defined as follows:

- Very common: affects more than 1 user in 10
- Common: affects 1 to 10 users in 100
- Uncommon: affects 1 to 10 users in 1000
- Rare: affects 1 to 10 users in 10,000
- Very rare: affects less than 1 user in 1000
- Not known: frequency can not be estimated from the available data.

Blood and lymphatic system

Rare: thrombocytopenia, leukopenia, eosinophilia, neutropenia or granulocytopenia (violations in a number of different blood cells and platelets in the blood).

Gastrointestinal disorders

Common: Stomach discomfort, nausea, vomiting and diarrhea.

Rare: Esophagitis (inflammation of the esophagus), stomatitis (inflammation of the mouth), and glossitis (inflammation of the tongue).

C Not known: Pseudomembranous enterocolitis (an infection of the intestine caused by the bacterium Clostridium difficile).

Nervous system disorders

Rare: Effect of neuromuscular blocking (violation of transmission of impulses from nerves to muscles).
Skin and subcutaneous tissue disorders

Rare: vaginitis (inflammation of the vulva in women), and flaking of the skin. Very rare: Erythema multiforme exudativum (eg. Stevens - Johnson) and Lyell's syndrome (the latter two are severe skin reactions with blistering of the skin, mouth, eyes and genitals).

Common: Rash, pruritus and urticaria (large red and thickened patches on the skin).

Disorders of the musculoskeletal system and connective tissue disorders Not known: arthralgia (joint pain).

Hepatobiliary disorders:

Rare: Jaundice, abnormal liver function tests. Immune System Disorders

Not known: Anaphylactic shock, swelling of edema (swelling of the mouth, tongue and throat), hypersensitivity to benzyl alcohol.

General disorders and administration site conditions

Rare: Pain, infiltration, abscess (for intramuscular administration); inflammation of the vein wall (intravenous).

5. HOW TO STORE clindamycin-MIP 150 MG / ML?

Keep out of reach of children.

Do not store above 25 ° C in a place protected from light.

Do not use Clindamycin-MIP 150 mg / ml after the expiry date stated on the carton and the bottle label after "EXP". The expiry date refers to the last day of that month.

Ampoule for single use only and any remaining amount of solution in the vial should be discarded.

The shelf life of the reconstituted solution for infusion is 24 hours when stored below 25 ° C.

Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Clindamycin-MIP 150 mg / ml?

- The active substance is clindamycin. 1 ml contains active substance Clindamycin 150 mg, as klindamitsinov Pispa 178,2 mg.

- The other ingredients are: benzyl alcohol, disodium EDTA, sodium hydroxide, water for injections.

Looks like Clindamycin-MIP 150 mg / ml and contents of the pack?

Clindamycin-MIP 150 mg / ml is a colorless solution.
Glass ampoules containing 2 ml, 4 ml or 6 ml.
Cartons 1 ampoule or 5 ampoules (2 ml, 4 ml or 6 ml).
Not all pack sizes may be marketed.

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