CLARITHROMYCIN Powder for concentrate for solution for infusion (2018)
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Περιεχόμενα
Name of the medicinal product
Clarithromycin 500 mg powder for concentrate for solution for infusion.
Qualitative and quantitative composition
Each vial contains 739.5 mg clarithromycin lactobionate, corresponding to 500 mg clarithromycin. Excipient(s) with known effect: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, ...
Pharmaceutical form
Powder for concentrate for solution for infusion. White to off white cake lyophilized sterile powder for reconstitution and administration by intravenous infusion.
Therapeutic indications
Clarithromycin is indicated in adults and children 12 years and older. Clarithromycin is indicated when parenteral therapy is required for treatment of infections caused by susceptible organisms in the ...
Posology and method of administration
Posology Intravenous therapy may be given for 2 to 5 days in the very ill patient and should be changed to oral clarithromycin therapy whenever possible as determined by the physician. The total duration ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Clarithromycin 500 mg powder for concentrate for solution for infusion is contra-indicated in patients with known ...
Special warnings and precautions for use
The physician should not prescribe clarithromycin to pregnant women without carefully weighing the benefits against risk, particularly during the first three months of pregnancy (see section 4.6). Clarithromycin ...
Interaction with other medicinal products and other forms of interaction
The use of the following drugs is strictly contraindicated due to the potential for severe drug interaction effects Cisapride, pimozide, astemizole and terfenadine Elevated cisapride levels have been reported ...
Pregnancy and lactation
Pregnancy The safety of clarithromycin for use during pregnancy has not been established. Based on variable results obtained from studies in mice, rats, rabbits and monkeys, the possibility of adverse ...
Effects on ability to drive and use machines
There are no data on the effect of clarithromycin on the ability to drive or use machines. The potential for dizziness, vertigo, confusion and disorientation, which may occur with the medication, should ...
Undesirable effects
a. Summary of the safety profile The most frequent and common adverse reactions related to clarithromycin therapy for both adult and paediatric populations are abdominal pain, diarrhoea, nausea, vomiting ...
Overdose
Reports indicate that the ingestion of large amounts of clarithromycin orally can be expected to produce gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antibacterial for systemic use, macrolide ATC code: J01FA09 Mechanism of action Clarithromycin is an antibiotic belonging to the macrolide antibiotic group. It exerts its antibacterial ...
Pharmacokinetic properties
Distribution Following IV administration, the blood levels of clarithromycin achieved are well in excess of the MIC 90s for the common pathogens and the levels of 14-hydroxyclarithromycin exceed the necessary ...
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
List of excipients
Sodium hydroxide (pH adjuster)
Incompatibilities
None known. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life Unopened: 3 years. Reconstituted and diluted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C/48 hours at 2-8°C for the reconstituted solution. Chemical ...
Special precautions for storage
This medicinal product does not require any special storage conditions. For storage conditions after reconstitution/dilution of the medicinal product, see section 6.3.
Nature and contents of container
Uncoloured clear glass vial type I (15 ml), sealed with brombutyl rubber stopper and aluminium cap with plastic flip-off seal. The following pack sizes are available for Clarithromycin 500 mg powder for ...
Special precautions for disposal and other handling
Reconstitution Clarithromycin 500 mg powder for concentrate for solution for infusion is reconstituted with 10 ml of water for injections, a solution with a concentration of 50 mg/ml is obtained. Dilution ...
Marketing authorization holder
hameln pharma plus gmbh, Langes Feld 13, 31789, Hameln, Germany
Marketing authorization number(s)
PL 25215/0033
Date of first authorization / renewal of the authorization
16/05/2018
Date of revision of the text
16/05/2018
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