ERYTHROMYCIN Granules for oral suspension Ref.[6824] Active ingredients: Erythromycin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Pinewood Laboratories limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland

Product name and form

Erythromycin 500mg/5ml Sugar Free Granules for Oral suspension.

Pharmaceutical Form

Granules for oral suspension.

Sugar free, orange flavour oral suspension.

Qualitative and quantitative composition

Each 5 ml of reconstituted suspension contains 500 mg of Erythromycin (as ethylsuccinate ester).

Excipients with known effect:

Each 5 ml of oral suspension contains 1.288 g of sorbitol.

Each 5 ml of oral suspension contains 18.91 mg of sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Erythromycin

Erythromycin exerts its antimicrobial action by binding to the 50S ribosomal sub-unit of susceptible microorganisms and suppresses protein synthesis. Erythromycin is bacteriostatic and bactericidal depending on its concentration and the type of organism.

List of Excipients

Colloidal anhydrous silica
Sorbitol
Riboflavin-5-sodium phosphate
Orange flavour (contain propylene glycol)
Glycerly mono and distearate (Atmer 122 (Atmos))
Anhydrous disodium hydrogen phosphate
Carmellose sodium

Pack sizes and marketing

Amber (Type III) glass bottles with tamper evident polypropylene cap (100 ml, 140 ml, and 150ml).

White HDPE plastic bottles with wadded, tamper evident polypropylene cap (100 ml, 125 ml 140 ml and 150 ml)

Pack sizes 60 ml, 100 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Pinewood Laboratories limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland

Marketing authorization dates and numbers

PL 04917/0050

22/06/2009

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