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SPC, UK: CLINDAMYCIN 150mg/ml Solution for Injection or Infusion (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Clindamycin 150mg/ml Solution for Injection or Infusion.

Qualitative and quantitative composition

Each 1ml of solution contains clindamycin phosphate equivalent to 150mg clindamycin. Each 2ml ampoule contains 300mg clindamycin. Each 4ml ampoule contains 600mg clindamycin. Excipients: Sodium 6.57mg ...

Pharmaceutical form

Solution for Injection or Infusion. Clear, colourless, solution.

Therapeutic indications

Clindamycin is indicated for the treatment of severe infections (see section 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. Clindamycin ...

Posology and method of administration

Posology Parenteral (IM or IV administration). Clindamycin 150mg/ml Solution for Injection and Infusion must be diluted prior to I.V. administration and should be infused over at least 10-60 minutes. ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Clindamycin 150mg/ml Solution for Injection and Infusion is contra-indicated in patients previously found to ...

Special warnings and precautions for use

Warnings Clindamycin 150mg/ml Solution for Injection and Infusion should only be used in the treatment of serious infections. In considering the use of the product, the practitioner should bear in mind ...

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 Safety for use in pregnancy has not been established. Animal studies do not indicate reproductive toxicity (see section 5.3). Breast-feeding Clindamycin is excreted in human milk. Caution should ...

Effects on ability to drive and use machines

None known.

Undesirable effects

The frequency of undesirable effects listed below is defined using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), ...

Overdose

Management In cases of overdosage no specific treatment is indicated. The serum biological half-life of Clindamycin is 2.4 hours. Clindamycin cannot readily be removed from the blood by dialysis or peritoneal ...

Pharmacodynamic properties

Pharmacotherapeutic group: Lincosamides ATC Code: J01FF01 Mode of action Clindamycin is a lincosamide antibiotic with a primarily bacteriostatic action against Gram-positive aerobes and a wide range of ...

Pharmacokinetic properties

General characteristics of active substance Absorption Following parenteral administration, the biologically inactive clindamycin phosphate is hydrolysed to clindamycin. When the equivalent of 300mg of ...

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

Disodium edetate Sodium hydroxide (for pH adjustment) Water for injections

Incompatibilities

Solutions of clindamycin salts have a low pH and incompatibilities may reasonably be expected with alkaline preparations or drugs unstable at low pH. Incompatibility has been reported with: ampicillin ...

Shelf life

Shelf life Unopened: 2 years. After dilution: 24 hours. Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used ...

Special precautions for storage

Do not store above 25°C. Keep ampoules in the outer carton. Do not refrigerate or freeze. Please refer to Sections 6.3 and 6.6 for storage after dilution.

Nature and contents of container

Type 1 flint glass ampoule containing 2ml or 4ml sterile, aqueous solution, packed in cardboard carton, together with a leaflet. 1 or 5 ampoules in each pack. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements. Solution for injection is for single use only. Any unused product should be discarded. Infusion Clindamycin ...

Marketing authorization holder

Focus Pharmaceuticals Ltd, Capital House, 85 King William Street, London, EC4N 7BL, United Kingdom

Marketing authorization number(s)

PL 20046/0072

Date of first authorization / renewal of the authorization

11/01/2010

Date of revision of the text

12/05/2018

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