Apo-Amoxi Clav 875mg+125mg tablets

Country: Armenia

Bahasa: Inggeris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

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

Boleh didapati daripada:

Apotex Inc.

Kod ATC:

J01CR02

INN (Nama Antarabangsa):

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

Dos:

875mg+125mg

Borang farmaseutikal:

tablets

Unit dalam pakej:

(100) plastic container

Jenis preskripsi:

Prescription

Status kebenaran:

Registered

Tarikh kebenaran:

2015-06-09

Risalah maklumat

ÿþýüûúùøú÷ ýöõùôõ ûõùó
ÿþýü û¿ úù ø÷
úý÷ÞûøÈþ ð÷Çýþøõùðý÷
ÿÍ
öÿÙÓöÒÙÑÐ îÖöÏ
öõúôóòóññóðâîñþíìñþðóò öòóï
ëþêñüéè þðï ÿúÚïüÞ ùúÞ ÙÞþñ
æìèØüðèóúð çæÿ
ëÝóè ñüþùñüé óè ïüèóýðüï èØüòóùóòþññÜ
ùúÞ òúðèìõüÞè× ëÝóè ñüþùñüé óè
þ èìõõþÞÜ þðï Úóññ ðúé éüññ Üúì
üíüÞÜéÝóðý þêúìé öÿÙÓ
öÒÙÑÐîÖöÏ×
îúðéþòé ÜúìÞ ïúòéúÞ úÞ ØÝþÞõþòóèé óù
Üúì Ýþíü
þðÜ Èìüèéóúðè þêúìé éÝü ïÞìý×
õÃýûù ùôðÞ øÈüðúõùðý÷
ÁÔæà àÔá íáåêéæàêìç êß ãßáå
ÐìóÆ
öÿÙÓöÒÙÑÐ îÖöÏ óè þð þðéóêóúéóò ÚÝóòÝ
óè ìèüï éú éÞüþé
íþÞóúìè êþòéüÞóþñ óðùüòéóúðèÊ þè
ïüéüÞõóðüï êÜ ÜúìÞ ïúòéúÞ×
Ðé
òúðéþóðè éÚú õüïóòóðþñ óðýÞüïóüðéèÎ
úðü óè þ Øüðóòóññóð òþññüï
þõúôóòóññóð þðï éÝü úéÝüÞ óè
òñþíìñþðóò þòóï×
ÁÔæà êà åìáßÆ
öÿÙÓöÒÙÑÐ îÖöÏ ÚúÞÌè óð å ÚþÜè×
öõúôóòóññóð óðéüÞùüÞüè
ÚóéÝ êþòéüÞóþñ òüññ Úþññ ýÞúÚéÝ
ñüþïóðý éú êþòéüÞóþñ ïüþéÝ× öÿÙÓ
öÒÙÑÐ îÖöÏ óðéüÞùüÞüè ÚóéÝ êþòéüÞóþñ
üðÄÜõüè ÚÝóòÝ
ïüèéÞúÜ þðéóêóúéóòè þññúÚóðý
þðéóêóúéóòè éú òúðéóðìü Ìóññóðý
êþòéüÞóþ×
ÁÔáç êà ßÔìãèå çìà âá ãßáåÆ
Âú ðúé ìèü öÿÙÓöÒÙÑÐ îÖöÏóùÎ
i
Ðù Üúì úÞ ÜúìÞ òÝóñï òìÞÞüðéñÜ Ýþíü úÞ
Ýþíü Ýþï þ ÝóèéúÞÜ
úù
þð þññüÞýÜ éú þõúôóòóññóð úÞ
êüéþÓñþòéþõ þðéóêóúéóòè ßèìòÝ þè
Øüðóòóññóðè þðï òüØÝþñúèØúÞóðèÛ ú�

Ciri produk

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