ZINNAT TABLETS 250 MG

国家: 以色列

语言: 英文

来源: Ministry of Health

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资料单张 资料单张 (PIL)
26-03-2019
产品特点 产品特点 (SPC)
26-03-2019
公众评估报告 公众评估报告 (PAR)
18-08-2016

有效成分:

CEFUROXIME AS AXETIL

可用日期:

NOVARTIS ISRAEL LTD., ISRAEL

ATC代码:

J01DC02

药物剂型:

TABLETS

组成:

CEFUROXIME AS AXETIL 250 MG

给药途径:

PER OS

处方类型:

Required

厂商:

SANDOZ AG, SWITZERLAND

治疗组:

CEFUROXIME

治疗领域:

CEFUROXIME

疗效迹象:

Zinnat is indicated for the treatment of the infections listed below in adults and children from the age of 3 months .• Acute streptococcal tonsillitis and pharyngitis.• Acute bacterial sinusitis.• Acute otitis media.• Acute exacerbations of chronic bronchitis.• Cystitis.• Pyelonephritis.• Uncomplicated skin and soft tissue infections. •Treatment of early Lyme disease.Consideration should be given to official guidance on the appropriate use of antibacterial agents.

授权日期:

2014-06-30

资料单张

                                ראורבפ
2019
:ןודנה
TABLETS 125 MG
ZINNAT תוילבט טניז
125
ג"מ
CEFUROXIME (AS AXETIL ) 125MG
ZINNAT TABLETS 250 MG תוילבט טניז
250
ג"מ
CEFUROXIME (AS AXETIL ) 250MG
ZINNAT TABLETS 500 MG תוילבט טניז
500
ג"מ
CEFUROXIME (AS AXETIL ) 500MG
ה/דבכנ ה/אפור
,ה/דבכנ ת/חקור
ג תרבח
ןיילקתימסוסקל
) מ"עב לארשי
GSK
ןולעה ןוכדע לע עידוהל תשקבמ (
לש אפורל
תוילבט טניז ירישכת
ןודנבש
ב
וז העדוה
םינוכדעה םינייוצמ
דבלב םייתוהמה
ב
.אפורל ןולע
ולעב
ן
םנשי
.םיפסונ םייוניש
היוותה
לארשיב רישכתל המושרה :
Zinnat is indicated for the treatment of the infections listed below
in adults and children from the
age of 3 months .
• Acute streptococcal tonsillitis and pharyngitis.
• Acute bacterial sinusitis.
• Acute otitis media.
• Acute exacerbations of chronic bronchitis.
• Cystitis.
• Pyelonephritis.
• Uncomplicated skin and soft tissue infections.
•Treatment of early Lyme disease.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents
ע
: אפורל ןולעב םיאבה םיפיעסב ושענ
םייתוהמ םינוכד
2.
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Excipient(s) with known effect:
Each 125mg tablet contains:
0.00152 mg sodium benzoate (E211)
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Each 250mg tablet contains:
0.00203 mg sodium benzoate (E211)
Methyl parahydroxybenzoate (E218)
Propylparahydroxybenzoate (E216)
Each 500mg tablet contains:
0.00506 mg sodium benzoate (E211)
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
For the full list of excipients, see section 6.1
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Important information about excipients
This medicine contains:
0.00152 mg sodium benzoate in each 125 mg tablet
0.00203 mg sodium benzoate in each 250 mg tablet
0.00506 mg sodium benzo
                                
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产品特点

                                _ _
_The format of this leaflet was determined by the Ministry of Health
and its content was checked and approved by the _
_Ministry of Health in May 2014 and updated according to the
guidelines of the Ministry of Health in February 2019 _
SUMMARY OF PRODUCT CHARACTERISTICS
ZINNAT
TABLETS 125 MG
ZINNAT TABLETS 250 MG
ZINNAT TABLETS 500 MG
1.
NAME OF THE MEDICINAL PRODUCT
Zinnat Tablets 125 mg
Zinnat Tablets 250 mg
Zinnat Tablets 500 mg
2.
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
ZINNAT TABLETS 125 MG
Each tablet contains 125 mg cefuroxime (as axetil).
ZINNAT TABLETS 250 MG
Each tablet contains 250 mg cefuroxime (as axetil).
ZINNAT TABLETS 500 MG
Each tablet contains 500 mg cefuroxime (as axetil).
Excipient(s) with known effect:
Each 125mg tablet contains:
0.00152 mg sodium benzoate (E211)
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Each 250mg tablet contains:
0.00203 mg sodium benzoate (E211)
Methyl parahydroxybenzoate (E218)
Propylparahydroxybenzoate (E216)
Each 500mg tablet contains:
0.00506 mg sodium benzoate (E211)
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
FILM-COATED TABLET (TABLET)
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zinnat is indicated for the treatment of the infections listed below
in adults and children from
the age of 3 months (see sections 4.4 and 5.1).
•
Acute streptococcal tonsillitis and pharyngitis.
•
Acute bacterial sinusitis.
•
Acute otitis media.
•
Acute exacerbations of chronic bronchitis.
•
Cystitis.
•
Pyelonephritis.
•
Uncomplicated skin and soft tissue infections.
•
Treatment of early Lyme disease.
Consideration should be given to official guidance on the appropriate
use of antibacterial
agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual course of therapy is seven days (may range from five to ten
days).
_Table 1. Adults and children (_

_40 kg) _
_ _
INDICATION
DOSAGE
Acute tonsillitis and pharyngitis, acute bacteri
                                
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