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SPC, UK: CLINDAMYCIN 150mg Capsules (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Clindamycin 150 mg capsules, hard.

Qualitative and quantitative composition

Each capsule contains: clindamycin hydrochloride equivalent to 150 mg clindamycin. Excipient with known effect: 214 mg lactose/Clindamycin 150 mg capsules. For the full list of excipients, see section ...

Pharmaceutical form

Capsule. Clindamycin capsules are white/white hard capsules with a marking of CLIN 150 on the capsule body.

Therapeutic indications

Clindamycin is indicated for the treatment of: Serious infections caused by anaerobic bacteria, including intra-abdominal infections, skin and soft tissue infections. As needed, clindamycin should be administered ...

Posology and method of administration

Posology Adults The usual dose is 150-450 mg every six hours, depending on the severity of the infection. Elderly patients Dosage requirements in elderly patients should not be influenced by age alone ...

Contraindications

Hypersensitivity to the active substance, lincomycin or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Severe hypersensitivity reactions, including severe skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), ...

Interaction with other medicinal products and other forms of interaction

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. It should be used with caution, therefore, in patients receiving ...

Fertility, pregnancy and lactation

Pregnancy Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal blood concentrations. In clinical trials with pregnant women, ...

Effects on ability to drive and use machines

Clindamycin has no or negligible influence on the ability to drive and use machines.

Undesirable effects

The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency. The frequency grouping is defined using the ...

Overdose

The serum biological half-life of clindamycin is 2.4 hours. Clindamycin cannot readily be removed from the blood by haemodialysis or peritoneal dialysis. If an allergic adverse reaction occurs, therapy ...

Pharmacodynamic properties

Pharmacotherapeutic group: Lincosamides ATC classification: J01FF01 Mechanism of action Clindamycin is a lincosamide antibiotic with a primarily bacteriostatic action against Gram-positive aerobes and ...

Pharmacokinetic properties

Absorption After oral administration clindamycin is absorbed quickly and almost completely (>90%). The absorption is not affected by food. The peak plasma concentration is achieved within approximately ...

Preclinical safety data

Preclinical data reveal no special hazard for humans based on studies of repeat dose toxicity, reproductive toxicity or genotoxicity. Carcinogenicity studies have not been conducted. In dogs, repeated ...

List of excipients

Lactose monohydrate Maize starch Talc Magnesium Stearate Capsule shell Gelatin Titanium dioxide (E171) Printing ink Shellac Iron oxide black (E172) Propylene glycol (E1520)

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Do not store above 30°C. Store in the original package in order to protect from light.

Nature and contents of container

The blister pack (PVC/aluminium) contains 24, 30, 32, 40 or 100 tablets, respectively. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Rivopharm UK Ltd., 30<sup>th</sup> Floor, 40 Bank Street, Canary Wharf, London, El4 5NR, United Kingdom

Marketing authorization number(s)

PL 33155/0009

Date of first authorization / renewal of the authorization

22/11/2010

Date of revision of the text

08/2018

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