Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVOCETIRIZINE DIHYDROCHLORIDE
STADPHARM SDN. BHD.
LEVOCETIRIZINE DIHYDROCHLORIDE
10’s x 5 Tablets
STELLAPHARM J.V. Co., LTD. - BRANCH 1
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 Прочетете целия документ
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 Прочетете целия документ