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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Cefotaxime 2g Powder for solution for injection or infusion (Wockhardt UK Ltd) (2008)

Εκδότης

Εκδότης Wockhardt UK Ltd
Διεύθυνση Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF
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Περιεχόμενα

Name of the medicinal product

Cefotaxime 2g Powder for solution for injection or infusion.

Qualitative and quantitative composition

Each vial contains cefotaxime sodium equivalent to 2g of cefotaxime. Each gram of cefotaxime contains ...

Pharmaceutical form

Powder for solution for injection or infusion (Powder for injection or infusion). White to slightly yellow ...

Therapeutic indications

1. Cefotaxime is indicated in the treatment of serious infections, either before the infecting organism ...

Posology and method of administration

Cefotaxime may be administered intravenously, by bolus injection or by infusion, or by intramuscular ...

Contraindications

Known or suspected allergy to cephalosporins. Previous immediate and/or severe hypersensitivity reaction ...

Special warnings and precautions for use

Preliminary enquiry about hypersensitivity to penicillin and other β-Lactam antibiotics is necessary ...

Interaction with other medicinal products and other forms of interaction

Aminoglycoside antibiotics and diuretics: Cephalosporin antibiotics at high dosage should be given with ...

Pregnancy and lactation

Pregnancy It is known that cefotaxime crosses the placental barrier. Although studies in animals have ...

Effects on ability to drive and use machines

Cefotaxime has been associated with dizziness, which may affect the ability to drive or operate machinery. ...

Undesirable effects

Adverse reactions to cefotaxime have occurred relatively infrequently and have generally been mild and ...

Overdose

Serum levels of cefotaxime may be reduced by peritoneal dialysis or haemodialysis. In the case of overdosage, ...

Pharmacodynamic properties

General Properties ATC Classification Pharmacotherapeutic group: Beta-lactam antibiotics, cephalosporins. ...

Pharmacokinetic properties

After a 1000mg intravenous bolus, mean peak plasma concentrations of cefotaxime usually range between ...

Preclinical safety data

There are no pre-clinical data of relevance to the prescriber that are additional to those included in ...

List of excipients

None.

Incompatibilities

Cefotaxime sodium should not be mixed with alkaline solutions such as sodium bicarbonate injection or ...

Shelf life

Unopened: 2 years. For the reconstituted solution, chemical and physical in-use stability has been demonstrated ...

Special precautions for storage

Unopened: Do not store above 25°C. Keep the vials in the outer carton. For storage times following reconstitution, ...

Nature and contents of container

Cefotaxime is supplied in Type III 10ml glass vials, closed with a Type I rubber stopper coated in Omniflex ...

Special precautions for disposal and other handling

For single use only. Discard any unused contents. When dissolved in Water for Injections PhEur, cefotaxime ...

Marketing authorization holder

Wockhardt UK Ltd Ash Road North Wrexham LL13 9UF UK

Marketing authorization number(s)

PL 29831/0029 PA 1339/2/3

Date of first authorization / renewal of the authorization

Date of first authorisation: 13 October 2007 (UK) 19 December 2007 (Ireland)
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.