INVANZ Powder for concentrate for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
INVANZ 1 g powder for concentrate for solution for infusion.
Qualitative and quantitative composition
Each vial contains 1.0 g ertapenem. Excipient with known effect: Each 1.0 g dose contains approximately 6.0 mEq of sodium (approximately 137 mg). For the full list of excipients, see section 6.1.
Pharmaceutical form
Powder for concentrate for solution for infusion. White to off-white powder.
Therapeutic indications
Treatment INVANZ is indicated in paediatric patients (3 months to 17 years of age) and in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible ...
Posology and method of administration
Posology Treatment Adults and adolescents (13 to 17 years of age) The dose of INVANZ is 1 gram (g) given once a day by the intravenous route (see section 6.6). Infants and children (3 months to 12years ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to any other carbapenem antibacterial agent. Severe hypersensitivity (e.g. anaphylactic reaction, ...
Special warnings and precautions for use
Hypersensitivity Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. These reactions are more likely to occur in ...
Interaction with other medicinal products and other forms of interaction
Interactions caused by inhibition of P-glycoprotein-mediated clearance or CYP-mediated clearance of medicinal products are unlikely (see section 5.2). Decreases in valproic acid levels that may fall below ...
Fertility, pregnancy and lactation
Pregnancy Adequate and well-controlled studies have not been performed in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo-foetal development, ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. INVANZ may influence patients' ability to drive and use machines. Patients should be informed that dizziness and ...
Undesirable effects
Summary of the safety profile Adults The total number of patients treated with ertapenem in clinical studies was over 2,200 of which over 2,150 received a 1 g dose of ertapenem. Adverse reactions (i.e., ...
Overdose
No specific information is available on the treatment of overdose with ertapenem. Overdosing of ertapenem is unlikely. Intravenous administration of ertapenem at a 3 g daily dose for 8 days to healthy ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antibacterials for systemic use, carbapenems ATC code: J01DH03 Mechanism of action Ertapenem inhibits bacterial cell wall synthesis following attachment to penicillin binding ...
Pharmacokinetic properties
Plasma concentrations Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 1 g dose in healthy young adults (25 to 45 years of age) were 155 micrograms/mL (C ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated-dose toxicity, genotoxicity and toxicity to reproduction and development. Decreased ...
List of excipients
Sodium bicarbonate (E500) Sodium hydroxide (E524) to adjust pH to 7.5
Incompatibilities
Do not use solvents or infusion fluids containing dextrose for reconstitution or administration of ertapenem. In the absence of compatibility studies, this medicinal product must not be mixed with other ...
Shelf life
2 years. After reconstitution: Diluted solutions should be used immediately. If not used immediately, in use storage times are the responsibility of the user. Diluted solutions (approximately 20 mg/mL ...
Special precautions for storage
Do not store above 25°C. For storage conditions after reconstitution of the medicinal product, see section 6.3.
Nature and contents of container
15 mL Type I glass vials with a grey butyl stopper and a white plastic cap on a coloured aluminium band seal. Supplied in packs of 1 vial or 10 vials. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Instructions for use For single use only. Reconstituted solutions should be diluted in sodium chloride 9 mg/mL (0.9%) solution immediately after preparation. <u>Preparation for intravenous administration: ...
Marketing authorization holder
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Marketing authorization number(s)
EU/1/02/216/001 EU/1/02/216/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 18 April 2002 Date of latest renewal: 22 December 2011
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