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CLARITHROMYCIN Powder for concentrate for solution for infusion (2018)

Αναφορές

Βιβλιογραφική αναφορά

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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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