Cetriwina tablets film-coated

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

cetirizine (cetirizine hydrochloride)

Dostopno od:

Akriti Pharmaceuticals Pvt. Ltd.

Koda artikla:

R06AE07

INN (mednarodno ime):

cetirizine (cetirizine hydrochloride)

Odmerek:

10mg

Farmacevtska oblika:

tablets film-coated

Enote v paketu:

(10/1x10/) in blister

Tip zastaranja:

OTC

Status dovoljenje:

Registered

Datum dovoljenje:

2018-08-07

Lastnosti izdelka

CETRIWINA
_CONFIDENTIAL_
6. SUMMARY OF PRODUCT CHARACTERISTICS:
1.
NAME OF A MEDICINAL MEANS: CETRIWINA
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
LABEL CLAIM:
Each film coated tablet contains:
Cetirizine Hydrochloride …….10 mg
Excipients
q.s.
Colour: Titanium Dioxide
SR.
NO.
INGREDIENTS
QUANTITY /
TAB
QTY. /BATCH
% OVERAGES
ACTIVE INGREDIENTS
1
*Cetirizine Hydrochloride
10.0 mg
1.000 Kg
Nil
EXCIPIENTS
2
**Maize Starch (Mixing)
46.50 mg
4.650 Kg
10%
3
Lactose
10.00 mg
1.000 Kg
Nil
4
**Maize Starch (Paste)
6.63 mg
0.663 Kg
10%
5
Dibasic Calcium Phosphate
(Calcium Hydrogen Phosphate)
47.54 mg
4.754 Kg
Nil
6
Povidone (P.V.P.K.30)
0.83 mg
0.083 Kg
Nil
7
Purified Water
q. s.
q. s.
Nil
LUBRICANT
8
Purified Talc
5.00 mg
0.500 Kg
Nil
9
Magnesium Stearate
2.50 mg
0.250 Kg
Nil
10
Colloidal Anhydrous Silica
(Aerosil)
1.00 mg
0.100 Kg
Nil
11
Ready Coat (White)
2.80 mg
0.280 kg
Nil
12
Isopropyl alcohol
q. s.
q. s.
Nil
13
Dichloromethane
q. s.
q. s.
Nil
NOTE-
* Quantity of active ingredient in the batch shall be added based on
the reported Assay
and LOD values.
* * 10 % Starch added to compensate loss on drying.
CETRIWINA
_CONFIDENTIAL_
3.
PHARMACEUTICAL FORM
:
Film coated tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS:
Cetirizine is used for the relief symptoms of seasonal and perennial
allergic rhinitis
and chronic idiopathic urticaria
4.2
POSOLOGY AND METHOD OF ADMINISTRATION:
-
Children aged 6 to 12 years: 5 mg twice daily (a half tablet twice
daily)
-adolescents above 12 years and adults: 10 mg once daily (1 tablet)
-not recommended in children aged less than 6 years
4.3
CONTRAINDICATIONS:
Patients
with
known
hypersensitivity
to
cetirizine
or
any
of
the
ingredients
of
Cetirizine Tablets.
Cetirizine should be contraindicated in patients with severe renal
impairement with a
creatinine clearance below 10 ml /min
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
Cetirizine
use
should
be
avoided
in
pregnancy,
renal
impairment,
elderly
task
requiring mental alertness.
Contains lactose monohydrate. Patients with r