Stadeltine Film-Coated Tablet 5mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

LEVOCETIRIZINE DIHYDROCHLORIDE

Boleh didapati daripada:

STADPHARM SDN. BHD.

INN (Nama Antarabangsa):

LEVOCETIRIZINE DIHYDROCHLORIDE

Unit dalam pakej:

10’s x 5 Tablets

Dikeluarkan oleh:

STELLAPHARM J.V. Co., LTD. - BRANCH 1

Risalah maklumat

PL070921
Pharmacode
Pharmacode
COMPOSITION:
Each film-coated tablet contains:
Levocetirizine dihydrochloride.......5 mg
INDICATIONS AND DOSAGE:
As directed by physicians.
Please read the package insert inside.
Do not store above 30˚C.
_IN MALAYSIA:_
Product Registration Holder in Malaysia:
STADPHARM SDN. BHD.
E-9-01, Oasis Square, Ara Damansara
No: 2, Jalan PJU 1A/7A, 47301 Petaling
Jaya, Selangor Darul Ehsan, Malaysia
UBAT TERKAWAL.
Registration No.:
_IN SINGAPORE:_
Product Registrant in Singapore:
AUXILTO IMPEX PTE. LTD.
152 Beach Road #26-02 Gateway
East Singapore 189721
Registration No.:
For oral use.
KEEP MEDICINE OUT OF REACH
OF CHILDREN.
Jauhkan dari kanak-kanak.
Batch No. :
Mfg. date :
Exp. date :
Stadeltine Film-Coated Tablet 5mg _Cardbox_PL070921
LEVOCETIRIZINE
DIHYDROCHLORIDE
Box of
5
blisters x
10
film-coated tablets
5
MG
STADELTINE
FILM-COATED TABLET 5MG
LEVOCETIRIZINE
DIHYDROCHLORIDE
Box of
5
blisters x
10
film-coated tablets
5
MG
STADELTINE
FILM-COATED TABLET 5MG
STADELTINE
FILM-COATED TABLET 5MG
HOLOGRAM
Manufactured by:
STELLAPHARM J.V. CO., LTD. - BRANCH 1
(A Joint Venture Company of Auxilto GmbH, Germany)
No. 40 Tu Do Avenue, Vietnam - Singapore Industrial
Park, An Phu Ward, Thuan An Town, Binh Duong
Province, Vietnam
STADELTINE
FILM-COATED TABLET 5MG
LEVOCETIRIZINE
DIHYDROCHLORIDE
5 mg
STADELTINE
FILM-COATED TABLET 5MG
MALSTA5290921

Ciri produk

27.5 mm
25 mm
STADELTINE FILM-COATED TABLET 5MG
1.
NAME OF THE MEDICINAL PRODUCT
STADELTINE FILM-COATED TABLET 5MG
2.
SPECIAL NOTICE AND RECOMMENDATION
Keep out of reach of children
Read the package insert carefully before use
3.
COMPOSITION
_Each film-coated tablet contains:_
Levocetirizine
dihydrochloride................................................................5
mg
4.
PHARMACEUTICAL FORM
Film-coated tablet.
White, caplet-shaped, film-coated tablet, biconvex, engraved with
“5” on one
side and plain on the other side.
5.
INDICATIONS
Levocetirizine is indicated for the symptomatic treatment of allergic
rhinitis
(including persistent allergic rhinitis) and chronic idiopathic
urticaria.
6.
ADMINISTRATION AND DOSAGE
_ADMINISTRATION_
_ _
Oral use. Swallow whole with liquid and may be taken with or without
food.
It is recommended to take the daily dose in one single intake.
_DOSAGE_
_Adults and adolescents 12 years and above_
The daily recommended dose is 5 mg (one film-coated tablet).
_Elderly_
Adjustment of the dose is recommended in elderly patients with
moderate to
severe renal impairment (see Renal impairment below).
_Renal impairment_
The dosing intervals must be individualized 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) determination using the following formula:
Dosing adjustments for patients with impaired renal function:
In paediatric patients suffering from renal impairment, the dose will
have to
be adjusted on an individual basis taking into account the renal
clearance of
the patient and his body weight. There are no specific data for
children with
renal impairment.
_Hepatic impairment_
No dose adjustment is needed in patients with solely hepatic
impairment. In
patients with hepatic impairment and renal impairment adjustment of
the
dose is recommended (see Renal impairment above).
_Pa