ZEPILEN Powder for solution for injection/infusion (2018)
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Περιεχόμενα
1. Name of the medicinal product
Zepilen 500 mg powder for solution for injection/infusion. Zepilen 1g powder for solution for injection/infusion.
2. Qualitative and quantitative composition
Each vial of Zepilen 500 mg contains 500 mg of cefazolin as cefazolin sodium. Each vial of Zepilen 1 g contains 1 g of cefazolin as cefazolin sodium. <u>Excipient with known effect:</u> sodium. Zepilen ...
3. Pharmaceutical form
Powder for solution for injection/infusion. White or almost white, very hygroscopic powder for solution for injection/infusion.
4.1. Therapeutic indications
Zepilen is indicated for the treatment of serious infections caused by cefazolin-susceptible micro-organism: respiratory tract infections caused by <em>S. pneumoniae, Klebsiella, H. influenzae, Staph. ...
4.2. Posology and method of administration
Posology The dosage, the route of administration and the dosing interval depends on the severity of the infection, the susceptibility of the detected pathogen and the patients condition (e.g. kidney function). ...
4.3. Contraindications
Hypersensitivity to the active substance or other cephalosporins. Previous serious hypersensitivity reactions to penicillin or any other type of beta-lactam antibiotics.
4.4. Special warnings and precautions for use
Before initiating Zepilen treatment, it should be determined whether the patient has a history of allergic reactions to cephalosporins, penicillins or other drugs. Zepilen should be administrated with ...
4.5. Interaction with other medicinal products and other forms of interaction
Co-administration of probenecid may reduce the tubular secretion of cephalosporins resulting in increased and prolonged cephalosporin effects. False-positive reactions with Benedicts reagent, Fehlings ...
4.6. Pregnancy and lactation
Pregnancy There is insufficient data about the use of cefazolin during pregnancy to assess the possible harmfulness during pregnancy. Breast-feeding Zepilen should be administered with caution in breast-feeding ...
4.7. Effects on ability to drive and use machines
There are no data available regarding cefazolin effects on the ability to drive and use machines.
4.8. Undesirable effects
The following undesirable effects may occur while using Cefazolin. The frequency of each side-effect is given between parentheses, using the following category classification: Very common (1/10), Common ...
4.9. Overdose
Symptoms Pain, inflammation and phlebitis at the injection site may occur following overdose. Very high doses of parenteral cephalosporins may cause dizziness, paresthesia and headache. Seizures can occur ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Beta-lactam antibiotics, first-generation cephalosporins <b>ATC code:</b> JO1DB04 Mechanism of action Cefazolin is a semisynthetic cephalosporin antibiotic for parenteral ...
5.2. Pharmacokinetic properties
<b>Serum concentrations (ug/ml) after i.m. injection:</b> Dose After ½ h After 1 h After 2 h After 4 h After 6 h After 8 h 250 mg 15,5 17 13 5,1 2,5 500 mg 36,2 36,8 37,9 15,5 6,3 3 1h* 60,1 ...
5.3. Preclinical safety data
No long-term studies in animals regarding mutagenicity or carcinogenic potential were performed. Reproduction studies in rats with doses of 500mg or 1g cefazolin/kg showed no effect on fertility or fetal ...
6.1. List of excipients
Zepilen contains no excipients.
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicines. This medicinal product must not be mixed with other medicinal products except those mentioned in ...
6.3. Shelf life
<u>Powder for solution for injection/infusion:</u> 36 months. <u>Reconstituted solution:</u> The reconstituted solution is preferably to be used immediately. Chemical and physical in-use stability after ...
6.4. Special precautions for storage
Store below 25°C in the original package. For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
6.5. Nature and contents of container
Clear, colourless type I glass vials, sealed with a grey bromobutyl stopper and an aluminium overcap. Each vial contains either 500 mg, or 1 g of cefazolin as cefazolin sodium. Cartons containing 1, 10, ...
6.6. Special precautions for disposal and other handling
Cefazolin 500mg powder for solution for injection/infusion <u>Intramuscular administration:</u> The vial is reconstituted with 2.0ml water for injection. Shake well to completely dissolve. The administration ...
7. Marketing authorization holder
Medochemie Ltd, 1–10 Constantinoupoleus Street 3011 Limassol, Cyprus
8. Marketing authorization number(s)
Zepilen 500mg: 12523 Zepilen 1g: 12771
9. Date of first authorization / renewal of the authorization
Zepilen 500mg: 14.12.1989 / 17.12.2012 Zepilen 1g: 06.07.1990 / 30.07.2013
10. Date of revision of the text
18/05/2018
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