Zyrtec 10mg tablets film-coated

国家: 亚美尼亚

语言: 英文

来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有效成分:

cetirizine (cetirizine dihydrochloride)

可用日期:

Aesica Pharmaceuticals S.r.l.

ATC代码:

R06AE07

INN（国际名称）:

cetirizine (cetirizine dihydrochloride)

剂量:

10mg

药物剂型:

tablets film-coated

每包单位数:

(7/1x7/) blister

处方类型:

OTC

授权状态:

Registered

授权日期:

2017-10-10

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zyrtec 10 mg, film-coated tablets
Zyrtec 10 mg/ml oral drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Cetirizine dihydrochloride, 10 mg, film-coated tablet _
Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.
_Cetirizine dihydrochloride, 10 mg/ml, oral drops, solution _
Each 1 ml contains 10 mg of cetirizine dihydrochloride.
3.
PHARMACEUTICAL FORM
_Cetirizine dihydrochloride, 10 mg, film-coated tablet _
White, oblong, film-coated tablet, with a bisect line and Y-Y logo.
_Cetirizine dihydrochloride, 10 mg/ml, oral drops, solution _
Clear and colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of:
- nasal and ocular symptoms of seasonal and perennial allergic
rhinitis,
- symptoms of chronic idiopatic urticaria.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
10 mg (20 drops or 10 ml of oral solution or 1 tablet or 1 capsule)
once daily. A 5 mg starting dose (10 drops or 5 ml
of oral solution or half of the tablet) may be proposed if this leads
to satisfactory control of the symptoms.
CHILDREN
_Children aged from 2 to 6 years _
2.5 mg (5 drops or 2.5 ml of oral solution) twice daily.
_Children aged from 6 to 12 years _
5 mg (10 drops or 5 ml of oral solution or half of the tablet) twice
daily.
_Children over 12 years of age _
10 mg (20 drops or 10 ml of oral solution or 1 tablet or 1 capsule)
once daily.
ELDERLY
Data does not suggest that the dose needs to be reduced in elderly
subjects provided that the renal function is normal.
_Patients with moderate to severe renal impairment _
Since cetirizine is mainly excreted via renal route, in cases no
alternative treatment can be used, the dosing intervals
must be individualised according to renal function. Refer to the
following table and adjust the dose as indicated. To
use this dosing table, an estimate of the patient’s creatinine
clearance (CLcr) in ml/min is needed. The CLcr (ml/min)
may be estimated from serum creatinine (mg/dl) d