GENTAMICIN Solution for injection (2018)
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Περιεχόμενα
Name of the medicinal product
Gentamicin 40 mg/ml Injection.
Qualitative and quantitative composition
1 ml of solution for injection contains 40 mg of gentamicin (as sulphate). 1 vial of 2 ml solution for injection contains 80 mg of gentamicin (as sulphate). For excipients, see 6.1.
Pharmaceutical form
Solution for injection. Vials containing a clear colourless solution.
Therapeutic indications
Gentamicin is bactericidal and is active against many strains of Gram-positive and Gram-negative pathogens including species of Escherichia, Enterobacter, Klebsiella, Salmonella, Serratia, Shigella, Staphylococcus ...
Posology and method of administration
Gentamicin is normally given by the intramuscular route, but can be given intravenously when intramuscular administration is not feasible. Gentamicin is normally given by the intramuscular route, but can ...
Contraindications
Patients being treated with gentamicin should be under close clinical observation because of its potential toxicity. Hypersensitivity to gentamicin, any other ingredient or other aminoglycosides. Myasthenia ...
Special warnings and precautions for use
Patients being treated with gentamicin should be under close clinical observation because of its potential toxicity. As with other aminoglycosides toxicity is related to serum concentration. At serum levels ...
Interaction with other medicinal products and other forms of interaction
Antibacterials: increased risk of nephrotoxicity with cephalosporins notably cephalothin. Gentamicin has been known to potentiate anticoagulants such as warfarin and phenindione. Antifungals: increased ...
Pregnancy and lactation
Use in Pregnancy Although no teratogenic effects have been observed, gentamicin is known to cross the placenta. Ototoxicity in the foetus is also a potential hazard. The benefits should, therefore, be ...
Effects on ability to drive and use machines
Not applicable.
Undesirable effects
Ototoxicity and nephrotoxicity are the most common side effects associated with Gentamicin therapy. Both effects are related to renal impairment and hence the dosage in such patients should be altered ...
Overdose
As in the case of other aminoglycosides, toxicity is associated with serum levels above a critical value. In patients with normal renal function it is unlikely that toxic serum levels (in excess of 10 ...
Pharmacodynamic properties
Gentamicin is usually bactericidal in action. Although the exact mechanism of action has not been fully elucidated, the drug appears to inhibit protein synthesis in susceptible bacteria by irreversibly ...
Pharmacokinetic properties
Distribution The distribution volume of gentamicin is about equivalent to the volume of extracellular water. In the newborn water makes up 70 to 75% of bodyweight, compared with 50 to 55% in adults. The ...
Preclinical safety data
There is no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Sodium metabisulphite Disodium edetate Methyl hydroxybenzoate Propyl hydroxybenzoate Water for Injections Sulphuric acid (2.5N) Sodium hydroxide (2.5N)
Incompatibilities
Gentamicin Injection should not be mixed with other drugs before injection and where co-administration of penicillins, cephalosporins, erythromycin, sulphadiazine, furosemide and betalactam antibiotics ...
Shelf life
Shelf life: 36 months.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
80 mg/2 ml: Clear, Type I glass vials in packs of 5 vials.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom
Marketing authorization number(s)
PL 04515/0037
Date of first authorization / renewal of the authorization
5<sup>th</sup> February 1998
Date of revision of the text
05/2018
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