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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Fortum 1g Injection (2012)

Εκδότης

Εκδότης GlaxoSmithKline UK
Διεύθυνση Stockley Park West, Uxbridge, Middlesex, UB11 1BT
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Περιεχόμενα

Name of the medicinal product

Fortum® for Injection. Ceftazidime (as pentahydrate) (INN) Injection.

Qualitative and quantitative composition

Fortum for Injection: Vials contain 1g ceftazidime (as pentahydrate) with sodium carbonate (118mg per ...

Pharmaceutical form

Powder for solution for injection.

Therapeutic indications

Fortum is indicated for the treatment of the infections listed below in adults and children including ...

Posology and method of administration

Posology Table 1 Adults and children ≥ 40 kg: Intermittent Administration Infection Dose to be administered ...

Contraindications

Hypersensitivity to ceftazidime, to any other cephalosporin or to any of the excipients. History of severe ...

Special warnings and precautions for use

As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions ...

Interaction with other medicinal products and other forms of interaction

Interaction studies have only been conducted with a probenecid and furosemide. Concurrent use of high ...

Pregnancy and lactation

Pregnancy There are limited amounts of data from the use of ceftazidime in pregnant women. Animal studies ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, undesirable ...

Undesirable effects

The most common adverse reactions are eosinphilia, thrombocytosis, phlebitis or thrombophlebitis with ...

Overdose

Overdosage can lead to neurological sequelae including encephalopathy, convulsions and coma. Symptoms ...

Pharmacodynamic properties

Pharmacotherapeutic group: Anti-bacterials for systemic use. Third-generation cephalosporins ATC code: ...

Pharmacokinetic properties

Absorption After intramuscular administration of 500 mg and 1 g of ceftazidime, peak plasma levels of ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeat ...

List of excipients

Sodium carbonate (anhydrous sterile)

Incompatibilities

Ceftazidime is less stable in Sodium Bicarbonate Injection than other intravenous fluids. It is not recommended ...

Shelf life

Three years when stored below 25°C and protected from light. Two years for Fortum Monovials when stored ...

Special precautions for storage

The unconstituted product should be stored below 25°C and protected from light. Constituted solutions ...

Nature and contents of container

Individually cartoned vials containing 1g ceftazidime (as pentahydrate) for intramuscular or intravenous ...

Special precautions for disposal and other handling

All sizes of vials of Fortum are supplied under reduced pressure. As the product dissolves, carbon dioxide ...

Marketing authorization holder

Glaxo Operations UK Ltd Greenford Middlesex UB6 OHE Trading as: GlaxoSmithKline UK Stockley Park West ...

Marketing authorization number(s)

PL 00004/0293

Date of first authorization / renewal of the authorization

18 May 2001

Date of revision of the text

20 September 2012
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.