Tiamox capsules

Maa: Armenia

Kieli: englanti

Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiivinen ainesosa:

amoxicillin (amoxicillin trihydrate)

Saatavilla:

A LAB PHARMACEUTICALS LLC

ATC-koodi:

J01CA04

INN (Kansainvälinen yleisnimi):

amoxicillin (amoxicillin trihydrate)

Annos:

500mg

Lääkemuoto:

capsules

Kpl paketissa:

(10/1x10/) in blister

Prescription tyyppi:

Prescription

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2022-08-10

Valmisteyhteenveto

A - L A B P H A R M A C E U P T I C A L S , L L C
Address: Kochinyan 13/16 street Yerevan - Armenia
Tell: ( [phone] Web: www.alab.am E-Mail: [e-mail]
C O N F I D E N T I A L P a g e 1 2 o f 2 3
1.3 PRODUCT INFORMATION
1.3.1 SPC, LABELING & PACKAGE LEAFLET
SPC – SUMMARY OF THE PRODUCT CHARACTERISTICS
1)
NAME OF THE MEDICINAL PRODUCT
TIAMOX
(Amoxicillin Capsules 500 mg)
2)
QUALITATIVE AND QUANTITATIVE COMPOSITION TIAMOX
(AMOXICILLIN CAPSULES 500 MG) Each hard gelatin
capsule contains Amoxicillin Trihydrate
Eq. to Amoxicillin ……………….500 mg
Excipients…………………….q.s.
Approved colours used in empty capsule shell. Gelatin, Erythrosine
(E127), Titanium dioxide (E171),
Indigotine (E132), Iron oxide yellow (E172), Silica, Bronopol, Sodium
Lauryl Sulphate, Glycerin, Purified
Water.
3)
PHARMACEUTICAL FORM
Hard gelatin Capsule
4)
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of infection:
Amoxicillin capsules is indicated for the treatment of the following
infections in adults and children (see
sections 4.2, 4.4 and 5.1):
_Oral indications _

Acute bacterial sinusitis

Acute Otitis media

Acute streptococcal tonsillitis and pharyngitis

Acute exacerbations of chronic bronchitis

Community acquired pneumonia

Acute cystitis

Asymptomatic Bacteriuria in pregnancy

Acute pyelonephritis

Typhoid and paratyphoid fever

Dental abscess with spreading cellulitis

Prosthetic joint infections

Helicobacter pylori eradication

Lyme disease
Amoxicillin is also indicated for the prophylaxis of endocarditis
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose of Amoxicillin that is selected to treat an individual
infection should take into account:

The expected pathogens and their likely susceptibility to
antibacterial agents (see section 4.4)

The severity and the site of the infection
A - L A B P H A R M A C E U P T I C A L S , L L C
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