Kemicetine Succinate Injection (2009)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Pharmacia Limited |
|---|---|
| Διεύθυνση | Ramsgate Road, Sandwich, Kent, CT13 9NJ |
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Name of the medicinal product
Kemicetine Succinate Injection or Chloramphenicol Sodium Succinate 1.377g Injection
Qualitative and quantitative composition
Chloramphenicol sodium succinate (BP) 1.377 g * equivalent to laevorotatory chloramphenicol 1.0 g
Pharmaceutical form
Freeze dried powder for injection.
Therapeutic indications
Kemicetine (chloramphenicol) is a broad-spectrum antibiotic and is active against many gram-negative organisms, Spirillae and Rickettsia. Kemicetine should not be used for trivial infections due to the ...
Posology and method of administration
To be given by i.v. or i.m. injection. In order to ensure rapid attainment of high blood levels, Kemicetine succinate is best administered by i.v. injection. Where this is not possible, however, intramuscular ...
Contraindications
Kemicetine succinate is contra-indicated in patients with a previous history of sensitivity and/or toxic reaction to chloramphenicol.
Special warnings and precautions for use
Kemicetine is to be administered only under the direction of a medical practitioner. Chloramphenicol may cause severe bone marrow depression which may lead to agranulocytosis, thrombocytopenic purpura ...
Interaction with other medicinal products and other forms of interaction
Chloramphenicol has been shown to interact with, and enhance the effects of coumarin anticoagulants, some hypoglycaemic agents (e.g. tolbutamide) and phenytoin. When given concurrently, a dose reduction ...
Pregnancy and lactation
The use of chloramphenicol is contra-indicated in pregnancy and whilst breastfeeding.
Effects on ability to drive and use machines
None stated.
Undesirable effects
The following may become apparent after chloramphenicol treatment: dryness of the mouth, nausea and vomiting, diarrhoea, urticaria, optic neuritis with blurring or temporary loss of vision, peripheral ...
Pharmacodynamic properties
After administration chloramphenicol is rapidly released from chloramphenicol sodium succinate. Chloramphenicol is active against many gram-positive and gram negative organisms, Spirillae and Rickettsia. ...
Pharmacokinetic properties
After intravenous administration of chloramphenicol succinate every 6 hours elimination half-lives were 4.03 hours for chloramphenicol and 2.65 hours for chloramphenicol succinate. After intravenous chloramphenicol ...
Preclinical safety data
None stated.
List of excipients
There are no excipients.
Incompatibilities
None stated.
Shelf life
48 months.
Special precautions for storage
Keep container in the outer carton.
Nature and contents of container
Type III colourless glass vials with grey chlorobutyl rubber bung and aluminium seal. Pack size: 1, 20 or 25 vials.
Special precautions for disposal and other handling
To be reconstituted with Water for Injection, Sodium Chloride Injection or Dextrose Injection 5%.
Marketing authorization holder
Pharmacia Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00032/0341
Date of first authorization / renewal of the authorization
13th September 2002 / 2nd March 2009
Date of revision of the text
March 2009