Doribax 500mg powder for solution for infusion (2012)

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης	Janssen-Cilag Ltd
Διεύθυνση	50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG

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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 contain any excipients.

Pharmaceutical form

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

Therapeutic indications

Doribax is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1): Nosocomial pneumonia (including ventilator–associated pneumonia) Complicated intra-abdominal infections ...

Posology and method of administration

Posology The recommended dose and administration by infection is shown in the following table: Infection Dose Frequency Infusion time Nosocomial pneumonia including ventilator–associated pneumonia ...

Contraindications

Hypersensitivity to the active substance Hypersensitivity to any other carbapenem antibacterial agent Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of beta-lactam ...

Special warnings and precautions for use

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have occurred in patients receiving beta-lactam antibiotics. Before therapy with Doribax is started, careful inquiry should be made ...

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 it is not expected that doripenem will inhibit or induce the activities of CYP450. Therefore, no ...

Fertility, pregnancy and lactation

For doripenem, limited clinical data on exposed pregnancies are available. Animal studies are insufficient with respect to pregnancy, embryonal/foetal development, parturition or postnatal development ...

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 on reported adverse drug reactions, it is not anticipated that Doribax will affect the ability to ...

Undesirable effects

In 3,142 adult patients (1,817 of which received Doribax) evaluated for safety in phase II and phase III clinical trials, adverse reactions due to Doribax 500 mg every 8 hours occurred at a rate of 32%. ...

Overdose

In a phase I study in healthy subjects receiving doripenem 2 g infused over 1 hour every 8 hours for 10 to 14 days, the incidence of rash was very common (5 of 8 subjects). The rash resolved within 10 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use, Carbapenems ATC code: J01DH04 Mechanism of action Doripenem is a synthetic carbapenem antibacterial agent. Doripenem exerts its bactericidal ...

Pharmacokinetic properties

The mean C<sub>max</sub> and AUC<sub>0-∞</sub> of doripenem in healthy subjects across studies following administration of 500 mg over 1 hour are approximately 23 μg/ml and 36 µg.h/ml, respectively. The ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and genotoxicity. However, because of the design of the repeat dose toxicity studies and differences ...

List of excipients

None.

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.3.

Shelf life

3 years. Storage of reconstituted solutions: Upon reconstitution with sterile water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection, Doribax suspension in the vial may be held for ...

Special precautions for storage

This medicinal product does not require any special storage conditions. For storage conditions after reconstitution of the medicinal product, and infusion solutions, see section 6.3.

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. Preparation of 500 mg dose of solution for infusion using the 500 mg vial Add 10 ml of sterile water ...

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