Apo-Amoxi Clav 250mg+125mg tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate)

Available from:

Apotex Inc.

ATC code:

J01CR02

INN (International Name):

amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate)

Dosage:

250mg+125mg

Pharmaceutical form:

tablets

Units in package:

(100) plastic container

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-06-09

Patient Information leaflet

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Summary of Product characteristics

APPENDIX 1.9
THE SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
APO-AMOXI CLAV
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
with
indication
of
active
substances
(international nonproprietary name or chemical name), indication of
other excipients knowledge
of which is essential for safe and proper administration of the
medicinal product.
COMPONENT AND QUALITY STANDARD
(AND GRADE, IF APPLICABLE)
FUNCTION OF
COMPONENT
STRENGTH (LABEL CLAIM)
250/125 MG
500/125 MG
875/125 MG
%
(OMIT FOR
SOLUTIONS)
QUANTITY
PER UNIT
(MG/TABLET)
%
(OMIT FOR
SOLUTIONS)
QUANTITY
PER UNIT
(MG/TABLET)
%
(OMIT FOR
SOLUTIONS)
QUANTITY
PER UNIT
(MG/TABLET)
CORE TABLET
Amoxicillin Trihydrate USP
(Compacted)
Active
46.46
300
*
62.31
600
*
73.07
1050
*
Clavulanate Potassium and MCC 1
to 1
Active
48.48
313
**
32.50
313
**
21.78
313
**
Magnesium Stearate NF
Lubricant
0.62
4.0
0.62
6.0
0.63
9
Croscarmellose Sodium NF
Disintegrant
1.55
10.0
1.66
16.0
1.67
24
Colloidal Silicon Dioxide NF
Glidant and
Disintegrant
0.31
2.0
0.31
3.0
0.28
4
FILM COATING
Hydroxypropyl Cellulose NF Type
LF
Film forming
polymer
1.17
7.53
1.17
11.3
1.18
16.95
Polyethylene Glycol 8000 NF
Plasticizer
0.69
4.47
0.70
6.70
0.70
10.05
Titanium Dioxide USP
Colouring
Agent/Opacifier
0.72
4.67
0.73
7.00
0.70
10.05
Methanol NF
Solvent
---
100.0
---
150.0
---
225
TOTAL (EXCLUDING METHANOL):
100
645.67
100
963.00
100.0
1437.05
*
83.3% Amoxicillin on anhydrous basis: Amount required per tablet =
Strength in mg per tablet/83.3%.
**
40% Clavulanate: Amount required per tablet = Strength in mg per
tablet/40%.
3.
PHARMACEUTICAL FORM
Tablets
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
APO-AMOXI CLAV (amoxicillin and clavulanate potassium) is indicated
for the treatment of the
following infections when caused by APO-AMOXI CLAV-susceptible strains
of the designated
bacteria:
Sinusitis
when
caused
by
β-lactamase
producing
strains
of
_H. _
_influenzae _
or
_Moraxella _
_(Branhamella) catarrhalis_._ _
Otitis Media when caused by β-lactamase producing strains of _ H