FOMICYT Powder for solution for infusion (2017)
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Περιεχόμενα
Name of the medicinal product
Fomicyt 40 mg/ml powder for solution for infusion.
Qualitative and quantitative composition
One ml of reconstituted solution contains 40 mg fosfomycin. Each bottle with 2.69 g of powder contains 2.64 g disodium fosfomycin, corresponding to 2 g fosfomycin and 0.64 g sodium, for reconstitution ...
Pharmaceutical form
Powder for solution for infusion. White to cream-coloured powder.
Therapeutic indications
Fosfomycin is indicated for the treatment of the following infections in adults and children including neonates (see section 5.1): Osteomyelitis. Complicated urinary tract infections. Nosocomial lower ...
Posology and method of administration
The daily dose of fosfomycin is determined based on the indication, severity and site of the infection, susceptibility of the pathogen(s) to fosfomycin and the renal function. In children, it is also determined ...
Contraindications
Hypersensitivity to the active substance, fosfomycin, or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Consideration should be given to co-administering intravenous fosfomycin with another antibacterial agent, taking into account the remaining susceptibilities of the pathogen(s) under treatment. As it is ...
Interaction with other medicinal products and other forms of interaction
No drug-drug interaction studies have been performed with fosfomycin. To date, no clinically relevant pharmacological interactions between fosfomycin and other agents (drugs, stimulants or foodstuffs) ...
Fertility, pregnancy and lactation
Fertility To date, in humans no reduction in fertility after therapy with fosfomycin has been reported. In male and female rats, reduced fertility was observed after the oral administration of fosfomycin ...
Effects on ability to drive and use machines
Occasionally, even if the product is correctly administered, side effects may occur which impair the ability to drive and use machines (see also section 4.8).
Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions during treatment are gastrointestinal disturbances and injection site reactions. Other important adverse reactions include hypokalaemia ...
Overdose
To date, no cases of accidental overdose with clinically relevant intolerances have been reported. If an overdose is believed to have taken place, the patient must be monitored (particularly for plasma/serum ...
Pharmacodynamic properties
Pharmacotherapeutic group: antibiotics for systemic use, other antibacterials ATC code: J01XX01 Mode of action Fosfomycin exerts a bactericidal effect on proliferating pathogens by preventing the enzymatic ...
Pharmacokinetic properties
Pharmacokinetics A single intravenous infusion of 4 g and 8 g of fosfomycin in young healthy males resulted in maximum serum concentrations (C<sub>max</sub>) of approx. 200 and 400 μg/ml, respectively. ...
Preclinical safety data
Subacute and chronic toxicity The toxicity of fosfomycin following repeated administration for up to 6 months was evaluated in rats, dogs, rabbits and monkeys. At high intra-peritoneal doses of fosfomycin ...
List of excipients
Succinic acid
Incompatibilities
Although no chemical/pharmaceutical incompatibilities have been found, Fomicyt solutions should not be mixed together with other parenteral preparations with the exception of those listed in section 6.6. ...
Shelf life
4 years. Chemical and physical in-use stability of the reconstituted solution that has been produced under aseptic conditions has been demonstrated for 24 hours at 25°C if protected from light. From a ...
Special precautions for storage
This medicinal product does not require any special storage conditions. For storage of the reconstituted solution see section 6.3.
Nature and contents of container
Clear type-II glass bottles with a rubber stopper (bromobutyl rubber) and pull-off cap containing 2 g (in 100 ml bottle), 4 g (in 100 ml bottle) or 8 g (in 250 ml bottle) of Fomicyt, respectively, in packs ...
Special precautions for disposal and other handling
For single use only. Any unused product or waste material should be disposed of in accordance with local requirements. Preparation of the solution for infusion In order to prepare the solution for infusion: ...
Marketing authorization holder
INFECTOPHARM Arzneimittel und Consilium GmbH, Von-Humboldt-Str. 1, 64646 Heppenheim, Germany Distributor: Nordic Pharma UK Ltd, Abbey House, 1650 Arlington Business Park, Theale, Berkshire, RG7 4SA
Marketing authorization number(s)
PL 15011/0017
Date of first authorization / renewal of the authorization
19/06/2015
Date of revision of the text
11/06/2017
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