BENZYLPENICILLIN SODIUM Powder for injection (2016)
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Περιεχόμενα
Name of the medicinal product
Benzylpenicillin sodium 600mg Powder for Injection.
Qualitative and quantitative composition
Each vial contains Benzylpenicillin sodium 600 mg.
Pharmaceutical form
Powder for injection. White crystalline, water-soluble sterile powder.
Therapeutic indications
Benzylpenicillin is indicated for most wound infections, pyogenic infections of the skin, soft tissue infections and infections of the nose, throat, nasal sinuses, respiratory tract and middle ear, etc. ...
Posology and method of administration
Route of administration: Intramuscular, intravenous. Preparation of solutions Pharmaceutical preparation Only freshly prepared solutions should be used. Reconstituted solutions of benzylpenicillin sodium ...
Contraindications
Allergy to penicillins. Hypersensitivity to any ingredient of the preparation. Cross allergy to other beta-lactams such as cephalosporins should be taken into account.
Special warnings and precautions for use
600 mg benzylpenicillin contains 1.68 mmol of sodium. Massive doses of Benzylpenicillin Sodium can cause hypokalaemia and sometimes hypernatraemia. Use of a potassium-sparing diuretic may be helpful. In ...
Interaction with other medicinal products and other forms of interaction
The efficacy of oral contraceptives may be impaired under concomitant administration of benzylpenicillin sodium, which may result in unwanted pregnancy. Women taking oral contraceptives should be aware ...
Pregnancy and lactation
Benzylpenicillin sodium has been taken by a large number of pregnant women and women of childbearing age without an increase in malformations or other direct or indirect harmful effects on the foetus having ...
Effects on ability to drive and use machines
None.
Undesirable effects
Blood and Lymphatic System Disorders Rare (0.01%-0.1%): Haemolytic anaemia and granulocytopenia (neutropenia), agranulocytosis, leucopenia and thrombocytopenia, have been reported in patients receiving ...
Overdose
Excessive blood levels of benzylpenicillin sodium can be corrected by haemodialysis.
Pharmacodynamic properties
Pharmacotherapeutic group: Beta-lactamase sensitive penicillins ATC code: J01CE01 General Properties Benzylpenicillin sodium is a beta-lactam antibiotic. It is bacteriocidal by inhibiting bacterial cell ...
Pharmacokinetic properties
Benzylpenicillin sodium rapidly appears in the blood following intramuscular injection of water-soluble salts and maximum concentrations are usually reached in 15-30 minutes. Peak plasma concentrations ...
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
List of excipients
None.
Incompatibilities
Benzylpenicillin sodium and solutions that contain metal ions should be administered separately. Benzylpenicillin sodium should not be administered in the same syringe/giving set as amphotericin B, cimetidine, ...
Shelf life
Unopened 36 months. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the ...
Special precautions for storage
Store below 25°C. For storage conditions after dilution of the medicinal product, see section 6.3.
Nature and contents of container
Tubular type III glass vials sealed with bromobutyl rubber plugs with aluminium overseals or plastic flip-top caps. This product is supplied in vials containing 600 mg of powder in boxes containing 10, ...
Special precautions for disposal and other handling
After contact with skin, wash immediately with water. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice if discomfort persists. Any unused medicinal product or ...
Marketing authorization holder
Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK
Marketing authorization number(s)
PL 06831/0213
Date of first authorization / renewal of the authorization
December 1992/Renewal March 1998
Date of revision of the text
14/09/2016
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