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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Suprax Powder for Paediatric Oral Suspension (2010)

Εκδότης

Εκδότης SANOFI
Διεύθυνση 1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
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Περιεχόμενα

Name of the medicinal product

Suprax Powder for Paediatric Oral Suspension.

Qualitative and quantitative composition

Each 5mL of reconstituted suspension contains 100 mg cefixime (anhydrous).

Pharmaceutical form

For oral administration. Bottles of powder for the preparation of suspension. When reconstituted, each ...

Therapeutic indications

Suprax is an orally active cephalosporin antibiotic which has marked in vitro bactericidal activity against ...

Posology and method of administration

Route of Administration: Oral Absorption of Suprax is not significantly modified by the presence of food. ...

Contraindications

Patients with known hypersensitivity to cephalosporin antibiotics.

Special warnings and precautions for use

Suprax should be given with caution to patients who have shown hypersensitivity to other drugs. Cephalosporins ...

Interaction with other medicinal products and other forms of interaction

A false positive reaction for glucose in the urine may occur with Benedicts or Fehlings solutions or ...

Pregnancy and lactation

Reproduction studies have been performed in mice and rats at doses up to 400 times the human dose and ...

Effects on ability to drive and use machines

None.

Undesirable effects

Suprax is generally well tolerated. The majority of adverse reactions observed in clinical trials were ...

Overdose

There is no experience with overdoses with Suprax. Adverse reactions seen at dose levels up to 2 g Suprax ...

Pharmacodynamic properties

Cefixime is an oral third generation cephalosporin which has marked in vitro bactericidal activity against ...

Pharmacokinetic properties

The absolute oral bioavailability of cefixime is in the range of 22-54%. Absorption is not significantly ...

Preclinical safety data

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

List of excipients

Sucrose Xantham gum Sodium benzoate Strawberry flavour

Incompatibilities

None.

Shelf life

2 years unopened. 2 weeks after reconstitution.

Special precautions for storage

Do not store unreconstituted product above 25°C. Bottled product: To reconstitute, add 33 ml of water ...

Nature and contents of container

Type III amber glass screw necked bottle with child resistant push/turn closure with white polyethylene ...

Special precautions for disposal and other handling

None stated.

Marketing authorization holder

Aventis Pharma Limited 50 Kings Hill Avenue Kings Hill West Malling Kent ME19 4AH UK or trading as: ...

Marketing authorization number(s)

PL 04425/0622

Date of first authorization / renewal of the authorization

14 October 1998

Date of revision of the text

17th 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.