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ERYTHROMYCIN Powder for solution for infusion (2016)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Erythromycin Panpharma 1g powder for solution for infusion.

Qualitative and quantitative composition

Erythromycin 1g (as Erythromycin Lactobionate). For 1 vial. For the complete list of excipients, see section 6.1.

Pharmaceutical form

White or slightly yellow hygroscopic powder for solution for infusion.

Therapeutic indications

Erythromycin Panpharma is indicated for treatment of the following appropriately diagnosed bacterial infections in adults and children caused by susceptible strains of organisms (see section 5.1) when ...

Posology and method of administration

Intravenous therapy must be replaced by oral administration at the appropriate time. Posology Adults and children over 12 years old or weighing >40 kg The usual dose is 1 to 2 g per day equivalent to 25 ...

Contraindications

Patients with known hypersensitivity to erythromycin, to any of the drugs excipients, or to other macrolide antibiotics. Concomitant treatment with astemizole, terfenadine, disopyramide, cisapride, pimozide, ...

Special warnings and precautions for use

It is generally not recommended to combine erythromycin with: Alfuzosine, dopaminergic rye ergot alkaloids, buspirone, carbamazepine, cyclosporine, colchicine, disopyramide, ebastine, halofantrine, lumefantrine, ...

Interaction with other medicinal products and other forms of interaction

Effects of erythromycin on other medicinal products Erythromycin is an inhibitor of CYP3A4 and the transport protein P-glycoprotein. The extent of inhibition with different CYP3A4 substrates is difficult ...

Fertility, pregnancy and lactation

Pregnancy There are no animal reproductive toxicology studies with erythromycin available, but studies with other macrolides, that similar to erythromycin are potent hERG-channels blockers, have shown ...

Effects on ability to drive and use machines

The occurrence of side effects of erythromycin may affect the ability to drive and use machines. Experience to date shows that erythromycin has negligible influence on the ability to concentrate and react. ...

Undesirable effects

Summary of the safety profile The adverse event profile presented below is based on post-marketing experience. The most frequently reported adverse reactions were gastrointestinal disorders mostly mild ...

Overdose

The toxicity is low. Overdosage may be associated with ototoxicity, hearing loss, cholestasis, ventricular arrhythmias, severe nausea, vomiting and diarrhoea. The symptoms are typically reversible and ...

Pharmacodynamic properties

Pharmacotherapeutic group: ANTIBACTERIAL FOR SYSTEMIC USE ATC code: J01FA01 Erythromycin is a semi-synthetic macrolide with a 14-membered lactone ring. Mode of action Erythromycin exerts its antimicrobial ...

Pharmacokinetic properties

Distribution The apparent volume of distribution of erythromycin is around 45% of body weight in normal subjects. This large distribution volume is consistent with the extensive tissue penetration of erythromycin. ...

Preclinical safety data

The acute and chronic oral toxicity of erythromycin is low. No evidence has been verified of teratogenicity or any other adverse reaction in the reproduction of female rats, who received oral tube administration ...

List of excipients

None.

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. Erythromycin lactobionate in solution does not blend, mainly because of the pH shifts, with ...

Shelf life

Shelf life: 36 months. For the reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 h in the refrigerator (2 to 8°C). For the diluted solution: Chemical and physical ...

Special precautions for storage

No special storage condition. For storage conditions after reconstitution of the medicinal product, see section 6.3 and section 6.6.

Nature and contents of container

Colourless type III vials clear glass vial. Pack size of 1, 10 or 25 glass vials. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Each vial is for single use only. Erythromycin is reconstituted and then further diluted prior to infusion. Preparation of the solution for administration A double dilution is required. An initial solution ...

Marketing authorization holder

PANPHARMA, ZI DU CLAIRAY, 35133 LUITRE, FRANCE

Marketing authorization number(s)

PL 44124/0002

Date of first authorization / renewal of the authorization

Date of first authorisation: 27/06/2016

Date of revision of the text

27/06/2016

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