STOPAREN Powder and solvent for solution for injection (2012)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Anfarm Hellas Α.Ε. |
|---|---|
| Διεύθυνση | 53-57 Perikleous str., 15344, Gerakas, Athens, Greece |
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Περιεχόμενα
Name of the medicinal product
STOPAREN.
Qualitative and quantitative composition
<u>STOPAREN 0.5g/VIAL (IV+IM):</u> Each vial contains 0.524g of cefotaxime sodium equivalent to 500mg of cefotaxime. <u>STOPAREN 1g/VIAL (IV):</u> Each vial contains 1.048g of cefotaxime sodium equivalent ...
Pharmaceutical form
Dry powder and solvent for solution for injection.
Therapeutic indications
Cefotaxime is indicated in the treatment of serious infections, either before the infecting organism has been identified or when caused by bacteria of established sensitivity, including osteomyelitis, ...
Posology and method of administration
Cefotaxime may be administered intravenously, by bolus injection or by infusion, or by intramuscular injection. The dosage, route and frequency of administration should be determined by the severity of ...
Contraindications
Known or suspected allergy to cephalosporins. Previous immediate and/or severe hypersensitivity reaction to a penicillin or to any other type of beta-lactam drug. Cefotaxime constituted with 1% lidocaine ...
Special warnings and precautions for use
Preliminary enquiry about hypersensitivity to penicillin and other β-Lactam antibiotics is necessary before prescribing cephalosporins since cross allergy occurs in 5-10% of cases. Cefotaxime is contraindicated ...
Interaction with other medicinal products and other forms of interaction
Aminoglycoside antibiotics and diuretics Cephalosporin antibiotics at high dosage should be given with caution to patients receiving aminoglycoside antibiotics or potent diuretics such as frusemide as ...
Pregnancy and lactation
Pregnancy It is known that cefotaxime crosses the placental barrier. Although studies in animals have not shown an adverse effect on the developing foetus, the safety of cefotaxime in human pregnancy has ...
Effects on ability to drive and use machines
There is no evidence that cefotaxime affect the ability to drive or operate machinery.
Undesirable effects
Adverse reactions to cefotaxime have occurred relatively infrequently and have generally been mild and transient. Effects reported include the following: <u>Genito urinary:</u> Candidiasis <u>Gastrointestinal: ...
Overdose
Serum levels of cefotaxime may be reduced by peritoneal dialysis or haemodialysis. In the case of overdosage, particularly in renal insufficiency, there is a risk of reversible encephalopathy.
Pharmacodynamic properties
Pharmacotherapeutic group: Beta-lactam antibiotics, cephalosporins ATC Code: J01DA10 Mode of action Cefotaxime is a third generation broad spectrum bactericidal cephalosporin antibiotic. The bactericidal ...
Pharmacokinetic properties
After a 1000mg intravenous bolus, mean peak plasma concentrations of cefotaxime usually range between 81 and 102 microgram/ml. Doses of 500mg and 2000mg produce plasma concentrations of 38 and 200 microgram/ml, ...
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber that are additional to those included in other sections.
List of excipients
None.
Incompatibilities
Cefotaxime sodium should not be mixed with alkaline solutions such as sodium bicarbonate injection or solutions containing aminophylline. Cefotaxime should not be admixed with aminoglycosides. If they ...
Shelf life
<u>Unopened:</u> 2 years. From a microbiological point of view, once opened, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility ...
Special precautions for storage
<u>Unopened:</u> Do not store above 25°C. Keep the vials in the outer carton. For storage times following reconstitution, see section 5.3.
Nature and contents of container
Cefotaxime is supplied in Type III glass vials, closed with a rubber stopper. <u>STOPAREN 500mg (IM+IV):</u> BTx1 vial + 1 ampoule solvent (2ml). <u>STOPAREN 1g (IV):</u> BTx 1 vial + 1 ampoule solvent ...
Special precautions for disposal and other handling
For single use only. Discard any unused contents. When dissolved in Water for Injection, cefotaxime forms a straw-coloured solution suitable for intravenous and intramuscular injection. Variations in the ...
Marketing authorization holder
ANFARM HELLAS SA, 53-57 Perikleous str., 153 44, Gerakas, Athens, Greece Tel: (210) 6831632 Fax: (210) 6836540
Marketing authorization number(s)
STOPAREN 500mg (IV+IM): 42877/9-6-2008 STOPAREN 1g (IV): 69858/10/12-5-2011 STOPAREN 1g (IM): 69859/10/12-5-2011
Date of first authorization / renewal of the authorization
28-4-1987 / 9-6-2008
Date of revision of the text
May 2012
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