Erythromycin granules for oral suspension

País: Armènia

Idioma: anglès

Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

ingredients actius:

erythromycin

Disponible des:

Arpimed LLC

Codi ATC:

J01FA01

Designació comuna internacional (DCI):

erythromycin

Dosis:

40mg/ml

formulario farmacéutico:

granules for oral suspension

Unidades en paquete:

glass bottle 40g

tipo de receta:

Prescription

Estat d'Autorització:

Registered

Data d'autorització:

2019-11-22

Fitxa tècnica

SUMMARY PRODUCT CHARACTERISTIC (SPC)
ERYTHROMYCIN 200MG/5ML GRANULES FOR ORAL SUSPENSION
1.
NAME OF THE MEDICINAL PRODUCT
1.1
TRADE NAME – Erythromycin
1.2
INTERNATIONAL NON-PROPERTY NAME – Erythromycin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 gram (5 ml
suspension
) contains_ _
_ACTIVE INGREDIENT:_ erythromycin (as ethylsuccinate) - 200 mg (234
mg);
_For a full list of excipients, see section 6.1._
3.
PHARMACEUTICAL FORM
Granules for oral suspension.
A white, raspberry flavoured granules, which reconstitutes with water
to give a white,
raspberry flavoured suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Erythromycin
200mg/5ml
granules
for
oral
suspension
and
other
antibacterial
drugs,
Erythromycin 200mg/5ml granules for oral suspension should be used
only to treat or prevent
infections that are proven or strongly suspected to be caused by
susceptible bacteria. When
culture and susceptibility information are available, they should be
considered in selecting or
modifying
antibacterial
therapy.
In
the
absence
of
such
data,
local
epidemiology
and
susceptibility patterns may contribute to the empiric selection of
therapy.
Erythromycin 200mg/5ml granules for oral suspension is indicated in
the treatment of
infections caused by susceptible strains of the designated organisms
in the diseases listed
below:
Upper respiratory tract infections of mild to moderate degree caused
by _ Streptococcus _
_pyogenes, Streptococcus pneumoniae, _or _Haemophilus influenzae
_(when used concomitantly
with adequate doses of sulfonamides, since many strains of _H.
influenzae _are not susceptible
to the erythromycin concentrations ordinarily achieved).
Lower-respiratory tract infections of mild to moderate severity caused
by _ Streptococcus _
_pneumoniae _or _Streptococcus pyogenes_.
Listeriosis caused by _Listeria monocytogenes_.
Pertussis (whooping cough) caused by _ Bordetella pertussis_.
Erythromycin is effective in
elimin