RENAPIME Powder for solution for injection / infusion (2017)

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Περιεχόμενα

Name of the medicinal product

Renapime 1 g powder for solution for injection/infusion. Renapime.

Qualitative and quantitative composition

Renapime 1 g powder for solution for injection or infusion: One vial contains 1 g of cefepime (as dihydrochloride monohydrate). Renapime. For the full list of excipients, see section 6.1.

Pharmaceutical form

Powder for solution for injection/infusion. White to pale yellow powder.

Therapeutic indications

Renapime is indicated in the treatment of infections caused by bacteria that are cefepime-sensitive: lower respiratory tract infections, including nosocomial pneumonia and community acquired pneumonia, ...

Posology and method of administration

Renapime can be administered via intravenous use or intramuscular use. After reconstitution, the solution is yellow to yellow-brown. The usual dose and the route of administration vary in accordance with ...

Contraindications

Hypersensitivity to cefepime, to any other cephalosporin or to any of the excipients listed in section 6.1. History of severe hypersensitivity reaction (e.g. anaphylactic reaction) to any other type of ...

Special warnings and precautions for use

Hypersensitivity reactions As with all beta-lactam antibacterial agents, severe and occasionally fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment ...

Interaction with other medicinal products and other forms of interaction

Concomitant treatment with bacteriostatic antibiotics may interfere with the action of beta-lactam antibiotics. The monitoring of renal function is recommended during the treatment with Renapime if other ...

Fertility, pregnancy and lactation

Pregnancy In what concerns cefepime there are no sufficient data on its exposure in pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal ...

Effects on ability to drive and use machines

The effects of the medicinal product on the ability to drive and use machines have not been studied. However, possible adverse reactions like altered state of consciousness, dizziness, confusional state ...

Undesirable effects

In clinical trials (N=5598), the more common adverse events were gastrointestinal symptoms and hypersensitivity reactions. The undesirable effects considered as definitively, probably or possibly related ...

Overdose

In case of severe overdose, especially in patients with renal function impairment, haemodialysis can help remove cefepime from the body (peritoneal dialysis is not useful). Accidental overdose occurred ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use. Other beta-lactam antibacterials. Fourth-generation cephalosporins, ATC code: J01DE01 Mechanism of action Cefepime is a broad-spectrum, bactericidal ...

Pharmacokinetic properties

Absorption Cefepime is completely absorbed after IM administration. Distribution Adults Average plasma concentrations of cefepime observed in the male adult, after a single IV infusion (30 minutes) or ...

Preclinical safety data

No long term studies were performed in the animal to assess the carcinogenic potential. In in vitro and in vivo genotoxicity tests, cefepime did no show to be genotoxic. In the rat no decreased fertility ...

List of excipients

L-arginine

Incompatibilities

Cefepime must not be mixed with other medicinal products or solutions except those mentioned in section 6.6 Special precautions for disposal and other handling. There is a physical-chemical incompatibility ...

Shelf life

Medicinal product in the original container: 3 years. Reconstituted solution for injection, reconstituted with water for injections: The in use physical and chemical stability was demonstrated ...

Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Keep the container in the outer carton. For storage conditions after dilution of the medicinal product, see section 6.3. ...

Nature and contents of container

Colourless type II 20 ml glass vial closed with chlorobutyl rubber stopper and sealed with an aluminium cap and a plastic flip-off. Pack size: 1, 5, 10, 20, 25, 50 and 100 vials. Not all pack sizes may ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Preparation and administration of the reconstituted solution: Renapime, powder for solution for ...

Marketing authorization holder

Renascience Pharma Ltd, 11 George Street West, Luton, Bedfordshire, LU1 2BJ, United Kingdom

Marketing authorization number(s)

PL 44696/0001

Date of first authorization / renewal of the authorization

08/12/2017

Date of revision of the text

08/12/2017

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