CEFAZOLIN Powder for solution for injection/infusion (2015)
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Περιεχόμενα
Name of the medicinal product
Cefazolin 2 g, powder for solution for injection/infusion.
Qualitative and quantitative composition
One vial contains 2096.72 mg cefazolin sodium corresponding to 2000 mg cefazolin. One vial contains 101.6 mg sodium, corresponding to 4.4 mmol. For the full list of excipients, see section 6.1.
Pharmaceutical form
Powder for solution for injection/infusion. White or almost white powder.
Therapeutic indications
Cefazolin is indicated for the treatment of the following infections caused by cefazolin-susceptible micro-organisms: Skin and soft tissue infections Bone and joint infections Perioperative prophylaxis. ...
Posology and method of administration
The dosage as well as the method of administration are dependent on the location and severity of the infection and on the clinical and bacteriological progress. Adults and adolescents (above 12 years of ...
Contraindications
Hypersensitivity to cefazolin. Patients with known hypersensitivity to cephalosporin antibiotics. History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial ...
Special warnings and precautions for use
Warnings In case of any known hypersensitivity to penicillins or other beta-lactam antibiotics, attention is to be paid to a possible cross-sensitivity (see section 4.3). As with all beta-lactam antibacterial ...
Interaction with other medicinal products and other forms of interaction
Anticoagulants Cephalosporins may very rarely cause bleeding disorders (see 4.4). During concomitant use with oral anticoagulants (for e.g. warfarin or heparin) in high doses, the coagulation parameters ...
Pregnancy and lactation
Pregnancy Cefazolin reaches the embryo/fetus via the placenta. There is not sufficient experience in the human use of cefazolin. As a precautionary measure, cefazolin should only be used during pregnancy ...
Effects on ability to drive and use machines
Cefazolin has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Dependent on the dose and duration of the treatment, patients are expected to experience one or several of the adverse reactions mentioned below. Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) ...
Overdose
Symptoms of an overdose are headache, vertigo, paraesthesia, central nervous states of agitation, myoclonia and convulsions. In case of poisoning, elimination accelerating measures are indicated. A specific ...
Pharmacodynamic properties
Pharmacotherapeutic group: First-generation cephalosporin ATC code: J01DB04 Cefazolin is a bactericidal cephalosporin antibiotic of the first generation for parenteral administration. Cephalosporins inhibit ...
Pharmacokinetic properties
Absorption Cefazolin is administered parenterally. After administration of 500 mg intramuscular injection, maximum serum levels obtained after approximately an hour were 20-40 micrograms/ml. After administration ...
Preclinical safety data
The acute toxicity of cefazolin is low. By intravenous application the LD<sub>50</sub> in rats is 2400-3700 mg/kg body weight. Studies of chronic toxicity in different animal species (rat, dog) revealed ...
List of excipients
None.
Incompatibilities
Cefazolin is incompatible with amikacin disulfate, amobarbital-sodium, bleomycin sulphate, calcium gluceptate, calcium gluconate, cimetidin hydrochloride, colistin methat-sodium, erythromycin gluceptate, ...
Shelf life
Shelf life: 3 years. Shelf-life of the reconstituted solution for injection/infusion The chemical and physical stability of the prepared solution is 12 hours at 25°C and 24 hours at 2-8°C. From a microbiological ...
Special precautions for storage
Do not store above 30°C. Keep the vial in the outer carton in order to protect from light. For storage conditions after reconstitution, see section 6.3.
Nature and contents of container
The product is supplied in 15 ml (type I) and 100 ml colourless glass vials (type II) closed with a chlorobutyl rubber stopper which is sealed with an aluminium flip-off cap, containing a white or almost ...
Special precautions for disposal and other handling
Preparation of the solution For each route of administration see the table for addition volumes and solution concentrations, which may be useful when fractional doses are required. Intravenous injection ...
Marketing authorization holder
MIP Pharma GmbH, Kirkeler Str. 41, 66440, Blieskastel, Germany
Marketing authorization number(s)
PL 26928/0014
Date of first authorization / renewal of the authorization
28/01/2014
Date of revision of the text
16/02/2015
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