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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Rocephin 250mg, 1g and 2g vials (2012)

Εκδότης

Εκδότης Roche Products Limited
Διεύθυνση Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW
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Περιεχόμενα

Name of the medicinal product

Rocephin 250mg vials. Rocephin 1g vials. Rocephin 2g vials.

Qualitative and quantitative composition

Each 250mg vial contains 250mg ceftriaxone as 298.3mg hydrated disodium ceftriaxone. Each 1g vial contains ...

Pharmaceutical form

Powder for solution for injection. Powder for solution for injection. Powder for solution for infusion. ...

Therapeutic indications

Ceftriaxone is indicated for the treatment of the following infections when known or likely to be due ...

Posology and method of administration

Rocephin may be administered by deep intramuscular injection, slow intravenous injection, or as a slow ...

Contraindications

Rocephin is contraindicated in patients with known hypersensitivity to beta-lactam antibiotics. In patients ...

Special warnings and precautions for use

As with other cephalosporins, anaphylactic reactions with fatal outcome were also reported, even if a ...

Interaction with other medicinal products and other forms of interaction

No impairment of renal function has so far been observed after concurrent administration of large doses ...

Pregnancy and lactation

Pregnancy For ceftriaxone, limited clinical data on exposed pregnancies are available. Ceftriaxone crosses ...

Effects on ability to drive and use machines

Since Rocephin sometimes induces dizziness the ability to drive and use machines can be impaired.

Undesirable effects

The most frequently reported adverse events for ceftriaxone are diarrhoea, nausea and vomiting. Other ...

Overdose

In the case of overdose nausea, vomiting, diarrhoea, can occur. Ceftriaxone concentration can not be ...

Pharmacodynamic properties

ATC classification Pharmacotherapeutic group: cephalosporins and related substances ATC code: J01DA13 ...

Pharmacokinetic properties

The pharmacokinetics of Rocephin are largely determined by its concentration-dependent binding to serum ...

Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included ...

List of excipients

None.

Incompatibilities

Solutions containing ceftriaxone should not be mixed with or added to solutions containing other agents. ...

Shelf life

3 years. For shelf life of diluted product see section 6.6.

Special precautions for storage

Do not store above 25°C. Keep vial in the outer carton. For shelf life of diluted product see section ...

Nature and contents of container

Rocephin 250mg and 1g: Type 1 Ph. Eur 15ml glass vial with teflonised rubber stopper and aluminium cap, ...

Special precautions for disposal and other handling

Instructions for use, handling and disposal Preparation of solutions for injection and infusion The use ...

Marketing authorization holder

Roche Products Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom

Marketing authorization number(s)

Vials 250mg: PL 00031/0169 Vials 1g: PL 00031/0171 Vials 2g: PL 00031/0172

Date of first authorization / renewal of the authorization

23 October 2003

Date of revision of the text

7 July 2010
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.