TOBRAMYCIN Solution for injection (2018)
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Περιεχόμενα
Name of the medicinal product
Tobramycin 40 mg/ml Solution for injection.
Qualitative and quantitative composition
Each ml of solution for injection contains 40 mg tobramycin. Each 1 ml vial contains 40 mg of tobramycin. Each 2 ml vial contains 80 mg of tobramycin. Each 6 ml vial contains 240 mg of tobramycin. Excipient(s) ...
Pharmaceutical form
Solution for injection. Clear colourless solution.
Therapeutic indications
Tobramycin Injection is indicated in the treatment of the following serious infections caused by susceptible micro-organisms: The treatment of central nervous system infections including meningitis, septicaemia ...
Posology and method of administration
Posology Tobramycin Injection may be given intramuscularly or intravenously and the dosage is the same for either route of administration. To calculate the correct dosage, the patients pre- treatment body ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Because of the known cross-allergenicity of drugs in this class, hypersensitivity to any aminoglycoside is a ...
Special warnings and precautions for use
Warnings Tobramycin injection contains sodium metabisulphite which may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes, in certain ...
Interaction with other medicinal products and other forms of interaction
Antibacterials: Tobramycin used in conjunction with other antibacterials such as cephalosporins notably cephalothin, there is an increased risk of nephrotoxicity. Antifungals: Amphotericin B may produce ...
Pregnancy and lactation
Pregnancy Aminoglycosides can cause foetal harm when administered to a pregnant woman. Aminoglycosides such as tobramycin cross the placenta and there have been several reports of total irreversible bilateral ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Renal and urinary disorders Renal function changes such as rising blood urea and serum creatinine and by oliguria, cylindruria and increased proteinuria, have been reported, especially in patients with ...
Overdose
Severity of the manifestations of a tobramycin overdose depend on the dose, the patients renal function, state of hydration, age and whether concurrent medication with similar toxicities is being given. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Aminoglycoside Antibacterials ATC Code: J01GB01 Mechanism of action Tobramycin is bactericidal in activity. It enters the cells via complex active transport mechanism and exerts ...
Pharmacokinetic properties
Absorption Following intramuscular administration of a single dose of tobramycin 1 mg/kg in adults with normal renal function, peak plasma tobramycin concentrations averaging 4-6 micrograms/ml are obtained ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to the information already included in other sections of the SPC.
List of excipients
Sodium metabisulphite Disodium edetate Sulphuric acid Water for injections
Incompatibilities
Incompatibility or loss of activity has been reported between tobramycin sulfate and some cephalosporins and penicillins and also heparin sodium. Solutions with clindamycin phosphate in glucose injection ...
Shelf life
Shelf life: As packaged for sale: 40 mg/1 ml and 80 mg/2 ml presentations: 3years 240 mg/6 ml presentation: 2 years After dilution: Chemical and physical in-use stability has been demonstrated in dextrose ...
Special precautions for storage
As packaged for sale – Do not store above 25°C. Keep the vial in the outer carton in order to protect from light. After dilution – see section 6.3.
Nature and contents of container
40 mg/1 ml and 80 mg/2 ml presentation – clear Type I glass vials with elastomeric stoppers in packs of 5 vials. 240 mg/6 ml presentation – clear Type I glass vials with elastomeric stoppers in packs of ...
Special precautions for disposal and other handling
Single use only. Discard any unused contents. When given by infusion, Tobramycin Injection may be diluted (with 0.9% Sodium Chloride Intravenous Infusion BP or 5% Dextrose Intravenous Infusion BP) to volumes ...
Marketing authorization holder
Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK
Marketing authorization number(s)
PL 04515/0066
Date of first authorization / renewal of the authorization
Date of first authorisation: 22/09/1993 Date of latest renewal: 26/02/2009
Date of revision of the text
10/2018
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