RECARBRIO Powder for solution for infusion (2022)
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Περιεχόμενα
1. Name of the medicinal product
Recarbrio 500 mg/500 mg/250 mg powder for solution for infusion.
2. Qualitative and quantitative composition
Each vial contains imipenem monohydrate equivalent to 500 mg imipenem, cilastatin sodium equivalent to 500 mg cilastatin, and relebactam monohydrate equivalent to 250 mg relebactam. <u>Excipient(s) with ...
3. Pharmaceutical form
Powder for solution for infusion. A white to light yellow powder.
4.1. Therapeutic indications
Recarbrio is indicated for: Treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), in adults (see sections 4.4 and 5.1). Treatment of bacteraemia that occurs in ...
4.2. Posology and method of administration
It is recommended that Recarbrio should be used to treat infections due to aerobic Gram-negative organisms in adult patients with limited treatment options only after consultation with a physician with ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Hypersensitivity to any other carbapenem antibacterial agent. Severe hypersensitivity (e.g., anaphylactic reaction, ...
4.4. Special warnings and precautions for use
Hypersensitivity reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams (see sections 4.3 and 4.8). These ...
4.5. Interaction with other medicinal products and other forms of interaction
Ganciclovir Generalised seizures have been reported in patients who received ganciclovir concomitantly with imipenem/cilastatin, components of Recarbrio. Ganciclovir should not be used concomitantly with ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no adequate and well-controlled studies for the use of imipenem, cilastatin, or relebactam in pregnant women. Animal studies with imipenem/cilastatin have shown reproductive toxicity ...
4.7. Effects on ability to drive and use machines
Recarbrio has moderate influence on the ability to drive and use machines. CNS adverse reactions, such as seizures, confusional states, and myoclonic activity, have been reported during treatment with ...
4.8. Undesirable effects
Summary of the safety profile The most frequently occurring adverse reaction (≥2%) in patients receiving imipenem/cilastatin plus relebactam in pooled Phase 2 trials of complicated intra-abdominal infections ...
4.9. Overdose
In the event of overdose, discontinue Recarbrio, treat based on symptoms, and institute general supportive treatment. Imipenem, cilastatin, and relebactam can be removed by haemodialysis. No clinical information ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antibacterials for systemic use, carbapenems <b>ATC code:</b> J01DH56 Mechanism of action The bactericidal activity of imipenem results from the inhibition of penicillin ...
5.2. Pharmacokinetic properties
General introduction The steady-state pharmacokinetic parameters of imipenem, cilastatin, and relebactam in healthy adults with normal renal function (CrCl 90 mL/min or greater), after multiple 30-minute ...
5.3. Preclinical safety data
Imipenem/cilastatin Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and genotoxicity studies. Animal studies showed that ...
6.1. List of excipients
Sodium hydrogen carbonate
6.2. Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3. Shelf life
<u>Dry powder:</u> 30 months. <u>After constitution and dilution:</u> Diluted solutions should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous ...
6.4. Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Keep vials in the outer carton in order to protect from light. For storage conditions after constitution and dilution ...
6.5. Nature and contents of container
20 mL glass vial, with 20 mm rubber stopper and aluminium crimp cap seal. This medicinal product is supplied in packs of 25 vials.
6.6. Special precautions for disposal and other handling
Recarbrio is supplied as a dry powder in a single-dose vial that must be constituted and further diluted using aseptic technique prior to intravenous infusion as outlined below: To prepare the infusion ...
7. Marketing authorization holder
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
8. Marketing authorization number(s)
EU/1/19/1420/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 13 February 2020
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