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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
Είσοδος χρηστών
Όνομα χρήστη
Συνθηματικό
Εικονίδιο Είσοδος χρήστη
Εικονίδιο Δωρεάν εγγραφή
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Doribax 500mg powder for solution for infusion (2012)

Εκδότης

Εκδότης Janssen-Cilag Ltd
Διεύθυνση 50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

Doribax 500 mg powder for solution for infusion.

Qualitative and quantitative composition

Each vial contains doripenem monohydrate equivalent to 500 mg doripenem. The medicinal product does not ...

Pharmaceutical form

Powder for solution for infusion (powder for infusion). White to slightly yellowish off-white crystalline ...

Therapeutic indications

Doribax is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1): ...

Posology and method of administration

Posology The recommended dose and administration by infection is shown in the following table: Infection ...

Contraindications

Hypersensitivity to the active substance Hypersensitivity to any other carbapenem antibacterial agent ...

Special warnings and precautions for use

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have occurred in patients receiving ...

Interaction with other medicinal products and other forms of interaction

Doripenem undergoes little to no Cytochrome P450 (CYP450) mediated metabolism. Based on in vitro studies ...

Fertility, pregnancy and lactation

For doripenem, limited clinical data on exposed pregnancies are available. Animal studies are insufficient ...

Effects on ability to drive and use machines

No studies on the effects of Doribax on the ability to drive and use machines have been performed. Based ...

Undesirable effects

In 3,142 adult patients (1,817 of which received Doribax) evaluated for safety in phase II and phase ...

Overdose

In a phase I study in healthy subjects receiving doripenem 2 g infused over 1 hour every 8 hours for ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use, Carbapenems ATC code: J01DH04 Mechanism of ...

Pharmacokinetic properties

The mean Cmax and AUC~0-∞~ of doripenem in healthy subjects across studies following administration of ...

Preclinical safety data

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

List of excipients

None.

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section ...

Shelf life

3 years. Storage of reconstituted solutions: Upon reconstitution with sterile water for injections or ...

Special precautions for storage

This medicinal product does not require any special storage conditions. For storage conditions after ...

Nature and contents of container

Clear 20 ml Type I glass vial. The medicinal product is supplied in cartons containing 10 vials.

Special precautions for disposal and other handling

Each vial is for single use only. Doribax is reconstituted and then further diluted prior to infusion. ...

Marketing authorization holder

Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium

Marketing authorization number(s)

EU/1/08/467/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 25 July 2008

Date of revision of the text

23 August 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.