Hiconcil powder for oral suspension

Valsts: Armēnija

Valoda: angļu

Klimata pārmaiņas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktīvā sastāvdaļa:

amoxicillin (amoxicillin trihydrate)

Pieejams no:

KRKA d.d.

ATĶ kods:

J01CA04

SNN (starptautisko nepatentēto nosaukumu):

amoxicillin (amoxicillin trihydrate)

Deva:

250mg/5ml

Zāļu forma:

powder for oral suspension

Vienības iepakojumā:

100ml glass bottle and measuring spoon

Receptes veids:

Prescription

Autorizācija statuss:

Registered

Autorizācija datums:

2018-05-07

Produkta apraksts

1.3.1
Amoxicillin trihydrate
SPC, Labeling and Package Leaflet
AM
SmPCPIL111423_2
16.04.2018 – Updated: 16.04.2018
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Hiconcil powder for oral suspension 250 mg/5 ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 ml of oral suspension (1 measuring spoon) contains 250 mg
amoxicillin as amoxicillin trihydrate.
Excipient of Hiconcil powder for oral suspension: aspartame.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral suspension.
The powder for oral suspension is white to yellowish, fruit-flavoured
powder. The ready-made
suspension is white to yellowish suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Infections caused by amoxicillin-susceptible microorganisms:
-
infections of the upper respiratory tract (otitis media, sinusitis,
pharyngitis, tonsillitis),
-
infections of the lower respiratory tract (acute bacterial bronchitis,
acute bacterial exacerbation
of chronic bronchitis, pneumonia),
-
infections of the urogenital organs (pyelonephritis, pyelitis,
cystitis, urethritis, endometritis,
cervicitis, gonorrhea
)
,
-
infections of the skin and soft tissue
(
erysipelas, impetigo, secondary infections in patients with
dermatitis),
-
abdominal infections (peritonitis, cholangitis, cholecystitis
)
-
infections of the gastrointestinal tract (enterocolitis, typhoid
fever, dysentery, salmonelloses,
when _Salmonella typhi_ is susceptible to amoxicillin),
-
eradication of _Helicobacter pylori_ in gastric and duodenal ulcers
(always in combination with
other drugs),
-
Lyme borreliosis,
-
prophylaxis of bacterial endocarditis in surgical procedures in the
mouth and upper respiratory
tract.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage range of Hiconcil is very wide. Dose size, frequency of
administration and duration of
treatment should be adjusted according to the disease and patient.
_Adults_ _and children over 40 kg of body weight_ usually take 250 mg
to 500 mg Hiconcil three times a
day or