ZINPLAVA Concentrate for solution for infusion (2018)
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Περιεχόμενα
Name of the medicinal product
ZINPLAVA 25 mg/mL concentrate for solution for infusion.
Qualitative and quantitative composition
Each mL of concentrate contains 25 mg bezlotoxumab. One 40 mL vial contains 1,000 mg of bezlotoxumab. Bezlotoxumab is a human monoclonal antibody produced in Chinese hamster ovary cells by recombinant ...
Pharmaceutical form
Concentrate for solution for infusion. Clear to moderately opalescent, colourless to pale yellow liquid.
Therapeutic indications
ZINPLAVA is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDI (see sections 4.2, 4.4 and 5.1).
Posology and method of administration
Posology ZINPLAVA should be administered during the course of antibacterial therapy for CDI (see sections 4.4 and 5.1). ZINPLAVA should be administered as a single intravenous infusion of 10 mg/kg (see ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
ZINPLAVA is not a treatment for CDI and has no effect on the current CDI episode. ZINPLAVA should be administered during the course of antibacterial therapy for CDI. There is no data regarding the efficacy ...
Interaction with other medicinal products and other forms of interaction
No formal interactions studies with other medicinal products were conducted. Therapeutic monoclonal antibodies do not typically have significant drug-drug interaction potential, as they do not directly ...
Fertility, pregnancy and lactation
Pregnancy There are limited data from the use of bezlotoxumab in pregnant women. Animal studies do not indicate reproductive toxicity (see section 5.3). ZINPLAVA should not be used during pregnancy unless ...
Effects on ability to drive and use machines
Bezlotoxumab has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The safety profile of ZINPLAVA was assessed in two Phase 3 clinical studies. The most common adverse reactions following treatment with ZINPLAVA (reported in ≥4% of patients ...
Overdose
There is no clinical experience with overdosage of ZINPLAVA. In clinical trials, healthy subjects received up to 20 mg/kg, which was generally well tolerated. In case of overdose, patients should be closely ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antiinfectives for systemic use, specific immunoglobulins ATC code: J06BB21 Mechanism of action Bezlotoxumab is a human monoclonal antitoxin antibody that binds with high affinity ...
Pharmacokinetic properties
Absorption Bezlotoxumab is dosed via the IV route and therefore is immediately and completely bioavailable. After a single IV dose of 10 mg/kg bezlotoxumab, mean AUC<sub>(0-∞)</sub> and C<sub>max</sub> ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity. Genotoxicity and carcinogenic potential have not been evaluated. Animal reproduction or developmental ...
List of excipients
Citric acid monohydrate (E330) Diethylenetriaminepentaacetic acid Polysorbate 80 (E433) Sodium chloride Sodium citrate dihydrate (E331) Water for injections Sodium hydroxide (E524) (for pH adjustment) ...
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life Unopened vial: 3 years. Solution for infusion: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C–8°C or 16 hours at room temperature (at or below 25°C). These ...
Special precautions for storage
Store in a refrigerator 2 °C to 8 °C. Do not freeze. Keep vial in the outer carton in order to protect from light. For storage conditions after dilution of the medicinal product, see section 6.3.
Nature and contents of container
Type I glass vial containing 40 mL solution, with a chlorobutyl stopper, and a flip-off cap seal. Each carton contains one vial.
Special precautions for disposal and other handling
Preparation of diluted solution: Prepare the diluted solution immediately after removal of the vial(s) from refrigerated storage, or the vial(s) may be stored at room temperature protected from light for ...
Marketing authorization holder
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Marketing authorization number(s)
EU/1/16/1156/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 18 January 2017
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