CLINDAMYCIN Solution for Injection or Infusion (2018)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
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
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: