DORIBAX Powder for solution for infusion (2014)
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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.
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
General The selection of doripenem to treat an individual patient should take into account the appropriateness of using a carbapenem antibacterial agent based on factors such as severity of the infection, ...
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
Pregnancy 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
Summary of the safety profile 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 ...
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
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 ...
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
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