RENOXITIN Powder for solution for injection / infusion (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Renoxitin 1 g Powder for solution for injection/ infusion.
Qualitative and quantitative composition
Each vial contains 1,0515 g of cefoxitin sodium equivalent to 1 g of cefoxitin. For the full list of excipients, see section 6.1.
Pharmaceutical form
Powder for solution for injection/infusion. A white or almost white powder.
Therapeutic indications
Renoxitin is indicated in adults and adolescents, Cefoxitin should only be prescribed after consultation with physicians with appropriate expertise in the treatment of infectious diseases. Cefoxitin may ...
Posology and method of administration
Posology There are very limited clinical safety and efficacy data supporting the dose of cefoxitin. Therapeutic guidelines should be adhered to. Based on these very limited clinical data and some supporting ...
Contraindications
Hypersensitivity to the active substance, to any other cephalosporin antibiotics or to any of the excipients listed in section 6.1. History of severe hypersensitivity (e.g. anaphylactic reaction) to any ...
Special warnings and precautions for use
Hypersensitivity reactions As with all beta-lactam antibacterial agents, serious 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
Problems specific to uncontrolled INR There are numerous reports of potentiation of oral anticoagulant activity in patients on antibiotic therapy. The infectious or inflammatory disease background, the ...
Pregnancy and lactation
Pregnancy Animal studies have not shown evidence of a teratogenic effect. As teratogenic effects have not been observed in animals, malformations are not expected in humans. To date, substances that have ...
Effects on ability to drive and use machines
Renoxitin has a major influence on the ability to drive and use machines especially because of the possible occurrence of encephalopathy (see sections 4.4, 4.8 and 4.9).
Undesirable effects
Undesirable effects are classified by frequency and system organ class. The following terminologies have been used in order to classify the occurrence of undesirable effects: Very common (≥1/10), common ...
Overdose
Βeta-lactam antibiotics exposes to a risk of encephalopathy (confusion, disorders of consciousness, seizure, abnormal movements) and, particularly, in case of overdose or reduced renal function.
Pharmacodynamic properties
Pharmacotherapeutic group: Antiinfectives for systemic use. Antibacterials for systemic use. Second-generation cephalosporins ATC code: J01DC01 Cefoxitin is a beta-lactam antibiotic of the group of the ...
Pharmacokinetic properties
Distribution <u>In adults:</u> After an intravenous injection of 1 g, plasma concentrations of cefoxitin reached 125 µg/mL in 3 minutes, 72 µg/ml in 30 minutes and 15 µg/mL in 120 minutes. After an intravenous ...
Preclinical safety data
Repeated dose toxicity studies and studies on reproduction and development did not reveal special hazard for humans. No safety pharmacology studies, genotoxicity assays nor carcinogenic study were performed. ...
List of excipients
None.
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
3 years. After reconstitution: Chemical and physical in-use stability has been demonstrated for 8 hours at 25°C and 2-8°C with Water for Injections. From a microbiological point of view, the product should ...
Special precautions for storage
This medicinal product does not require any special storage conditions. For storage conditions after reconstitution of the medicinal product, see section 6.3.
Nature and contents of container
Renoxitin is supplied in vials containing 1 g or 2 g cefoxitin as the sodium salt, closed with chlorobutyl rubber stopper and sealed with an aluminium capsule with polypropylene flip-off. Renoxitin 1 g ...
Special precautions for disposal and other handling
Cefoxitin may be reconstituted with 10 ml water for injections. Immediately after reconstitution, this Cefoxitin solution can be also added to 40 ml of the following solutions, frequently used in infusion(1g ...
Marketing authorization holder
RENASCIENCE PHARMA LIMITED, 11 George Street West, Luton, LU1 2BJ, United Kingdom
Marketing authorization number(s)
PL 44696/0003
Date of first authorization / renewal of the authorization
16/04/2019
Date of revision of the text
16/04/2019
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