TARGOCID Powder for solution for injection, infusion or oral solution (2019)
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Περιεχόμενα
Name of the medicinal product
Targocid 200mg powder for solution for injection/infusion or oral solution.
Qualitative and quantitative composition
Each vial contains 200 mg teicoplanin equivalent to not less than 200,000 IU. For the full list of excipients, see section 6.1.
Pharmaceutical form
Powder for solution for injection/infusion or oral solution. Powder for solution for injection/infusion or oral solution: spongy ivory coloured homogeneous mass.
Therapeutic indications
Targocid is indicated in adults and in children from birth for the parenteral treatment of the following infections (see sections 4.2, 4.4 and 5.1): complicated skin and soft tissue infections, bone and ...
Posology and method of administration
Posology The dose and duration of treatment should be adjusted according to the underlying type and severity of infection and clinical response of the patient, and patient factors such as age and renal ...
Contraindications
Hypersensitivity to teicoplanin or to any of the excipients listed in section 6.
Special warnings and precautions for use
Hypersensitivity reactions Serious, life-threatening hypersensitivity reactions, sometimes fatal, have been reported with teicoplanin (e.g. anaphylactic shock). If an allergic reaction to teicoplanin occurs, ...
Interaction with other medicinal products and other forms of interaction
No specific interaction studies have been performed. Teicoplanin and aminoglycoside solutions are incompatible and must not be mixed for injection; however, they are compatible in dialysis fluid and may ...
Fertility, pregnancy and lactation
Pregnancy There are a limited amount of data from the use of teicoplanin in pregnant women. Studies in animals have shown reproductive toxicity at high doses (see section 5.3): in rats there was an increased ...
Effects on ability to drive and use machines
Targocid has minor influence on the ability to drive and use machines. Teicoplanin can cause dizziness and headache. The ability to drive or use machines may be affected. Patients experiencing these undesirable ...
Undesirable effects
Tabulated list of adverse reactions In the table below all the adverse reactions, which occurred at an incidence greater than placebo and more than one patient are listed using the following convention: ...
Overdose
Symptoms Cases of accidental administration of excessive doses to paediatric patients have been reported. In one case agitation occurred in a 29-day-old newborn who had been administered 400 mg intravenously ...
Pharmacodynamic properties
Pharmacotherapeutic group: Glycopeptide Antibacterials ATC code: J01XA02 Mechanism of action Teicoplanin inhibits the growth of susceptible organisms by interfering with cell-wall biosynthesis at a site ...
Pharmacokinetic properties
Absorption Teicoplanin is administered by parenteral route (intravenously or intramuscularly). After intramuscular administration, the bioavailability of teicoplanin (as compared to intravenous administration) ...
Preclinical safety data
Following repeated parenteral administration to the rat and dog, effects on the kidney were observed and were shown to be dose-dependent and reversible. Studies to investigate the potential to cause ototoxicity ...
List of excipients
Sodium chloride Sodium hydroxide (for pH adjustment)
Incompatibilities
Teicoplanin and aminoglycoside are incompatible when mixed directly and must not be mixed before injection. If teicoplanin is administered in combination therapy with other antibiotics, the preparation ...
Shelf life
Shelf life Shelf life of powder as packaged for sale: 3 years. Shelf life of reconstituted solution: Chemical and physical in-use stability of the reconstituted solution prepared as recommended has been ...
Special precautions for storage
Powder as packaged for sale: This medicinal product does not require any special storage condition. For storage conditions of the reconstituted/diluted medicinal product, see section 6.3.
Nature and contents of container
Primary packaging: The freeze-dried medicinal product is packaged in: Type I, colourless glass vial of useful volume of 10 mL for 200 mg closed with bromobutyl rubber stopper and plastic flip-off top aluminium ...
Special precautions for disposal and other handling
This medicinal product is for single use only. Preparation of reconstituted solution The solution is reconstituted by adding 3.14 mL of water for injection to the 200 mg and 400 mg powder vial. The water ...
Marketing authorization holder
Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK or trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Marketing authorization number(s)
PL 04425/0088
Date of first authorization / renewal of the authorization
Date of first authorisation: 2 August 1989 Date of latest Renewal: 12 December 2017
Date of revision of the text
23<sup>rd</sup> August 2019
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