TYGACIIL Powder for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Tygacil 50 mg powder for solution for infusion.
Qualitative and quantitative composition
Each 5 ml Tygacil vial contains 50 mg of tigecycline. After reconstitution, 1 ml contains 10 mg of tigecycline. For the full list of excipients, see section 6.1.
Pharmaceutical form
Powder for solution for infusion (powder for infusion). Orange cake or powder.
Therapeutic indications
Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections (see sections 4.4 and 5.1): Complicated skin and soft tissue infections (cSSTI), ...
Posology and method of administration
Posology Adults The recommended dose for adults is an initial dose of 100 mg followed by 50 mg every 12 hours for 5 to 14 days. The duration of therapy should be guided by the severity, site of the infection, ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients hypersensitive to tetracycline class antibiotics may be hypersensitive to tigecycline.
Special warnings and precautions for use
In clinical studies in complicated skin and soft tissue infections (cSSTI), complicated intra-abdominal infections (cIAI), diabetic foot infections, nosocomial pneumonia and studies in resistant pathogens, ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. Concomitant administration of tigecycline and warfarin (25 mg single-dose) to healthy subjects resulted in a decrease in clearance of R-warfarin ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of tigecycline in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. ...
Effects on ability to drive and use machines
Dizziness may occur and this may have an effect on driving and use of machines (see section 4.8).
Undesirable effects
Summary of safety profile The total number of cSSTI and cIAI patients treated with tigecycline in Phase 3 and 4 clinical studies was 2,393. In clinical trials, the most common medicinal product-related ...
Overdose
No specific information is available on the treatment of overdosage. Intravenous administration of tigecycline at a single dose of 300 mg over 60 minutes in healthy volunteers resulted in an increased ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antibacterials for systemic use, tetracyclines ATC code: J01AA12 Mechanism of action Tigecycline, a glycylcycline antibiotic, inhibits protein translation in bacteria by binding ...
Pharmacokinetic properties
Absorption Tigecycline is administered intravenously and therefore has 100% bioavailability. Distribution The in vitro plasma protein binding of tigecycline ranges from approximately 71% to 89% at concentrations ...
Preclinical safety data
In repeated dose toxicity studies in rats and dogs, lymphoid depletion/atrophy of lymph nodes, spleen and thymus, decreased erythrocytes, reticulocytes, leukocytes, and platelets, in association with bone ...
List of excipients
Lactose monohydrate Hydrochloric acid Sodium hydroxide (for pH adjustment)
Incompatibilities
The following active substances should not be administered simultaneously through the same Y-site as tigecycline: Amphotericin B, amphotericin B lipid complex, diazepam, esomeprazole, omeprazole and intravenous ...
Shelf life
Shelf life: 2 years. Once reconstituted and diluted in the bag or other suitable infusion container (e.g. glass bottle), tigecycline should be used immediately.
Special precautions for storage
Store below 25°C. For storage conditions after reconstitution of the medicinal product, see section 6.3.
Nature and contents of container
5 ml Type 1 clear glass vials fitted with grey butyl rubber stoppers and snap-off aluminium crimp seals. Tygacil is distributed in a ten vial tray pack.
Special precautions for disposal and other handling
The powder should be reconstituted with 5.3 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, dextrose 50 mg/ml (5%) solution for injection, or Lactated Ringers solution for injection to achieve ...
Marketing authorization holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Marketing authorization number(s)
EU/1/06/336/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 24 April 2006 Date of latest renewal: 22 February 2016
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