Država: Novi Zeland
Jezik: engleski
Izvor: Medsafe (Medicines Safety Authority)
Clonidine 5.04mg equivalent to 0.2 mg/24hr
Viatris Limited
Clonidine 5.04 mg (equivalent to 0.2 mg/24hr)
0.2 mg/24h
Transdermal patch
Active: Clonidine 5.04mg equivalent to 0.2 mg/24hr Excipient: Adhesive 8400E/000 Colloidal silicon dioxide Durotak 87-613A Ethylenevinylacetate copolymer Heptane Light liquid paraffin No Tox ink brown- FGN4476
Prescription
PCAS Finland Oy
Clonidine transdermal system USP is indicated for the treatment of mild to moderate hypertension. It can be used as monotherapy or concomitantly with other antihypertensive agents if required to enhance hypotensive effect.
Package - Contents - Shelf Life: Individual wrap, Individual wrap Paper/LDPE/Aluminium foil/Adhesive/Sealant film with 4 adhesive covers - 4 patches - 24 months from date of manufacture stored at or below 25°C
2011-12-16
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION CLONIDINE TRANSDERMAL SYSTEM USP _CLONIDINE TRANSDERMAL PATCH _ _0.1 MG/DAY, 0.2 MG/DAY, 0.3 MG/DAY_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Clonidine Transdermal System USP. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Clonidine Transdermal System USP against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CLONIDINE TRANSDERMAL SYSTEM USP IS USED FOR Clonidine Transdermal System USP lowers high blood pressure. The patch contains a medicine called clonidine, which belongs to a group of medicines called antiadrenergic agents. It works by slowing your heart rate, and widening your blood vessels making it easier for your blood to flow which results in lower blood pressure. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor’s prescription. There is not enough information to recommend the use of this medicine in children or adolescents. BEFORE YOU USE CLONIDINE TRANSDERMAL SYSTEM USP _WHEN YOU MUST NOT USE _ _IT_ DO NOT USE CLONIDINE TRANSDERMAL SYSTEM USP IF YOU HAVE AN ALLERGY TO: any medicine containing clonidine any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: shortness of breath; wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. DO NOT USE THIS MEDICINE IF YOU HAVE AN ABNORMALLY SLOW OR IRREGULAR HEARTBEAT. DO NOT USE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF T Pročitajte cijeli dokument
Page 1 of 11 NEW ZEALAND DATA SHEET CLONIDINE TRANSDERMAL SYSTEM USP 1. PRODUCT NAME CLONIDINE TRANSDERMAL SYSTEM USP, 0.1 mg/day, 0.2 mg/day or 0.3 mg/day, transdermal patch. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each CLONIDINE TRANSDERMAL SYSTEM USP contains 0.1 mg/day, 0.2 mg/day or 0.3 mg/day of clonidine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM CLONIDINE TRANSDERMAL SYSTEM USP 0.1 mg/day: ( 2.52 mg/3.33 cm 2 ). A rectangular patch with rounded corners consisting of a peach-coloured backing labelled with ‘Mylan ® Clonidine 0.1 mg/day’ in brown ink, a solid matrix drug reservoir layer, an adhesive formulation layer, and an oversized removable release liner. CLONIDINE TRANSDERMAL SYSTEM USP 0.2 mg/day: ( 5.04 mg/6.67 cm 2 ). A rectangular patch with rounded corners consisting of a peach-coloured backing labelled with ‘Mylan ® Clonidine 0.2 mg/day’ in brown ink, a solid matrix drug reservoir layer, an adhesive formulation layer, and an oversized removable release liner. CLONIDINE TRANSDERMAL SYSTEM USP 0.3 mg/day: ( 7.56 mg/10.0 cm 2 ). A rectangular patch with rounded corners consisting of a peach-coloured backing labelled with ‘Mylan ® Clonidine 0.3 mg/day’ in brown ink, a solid matrix drug reservoir layer, an adhesive formulation layer, and an oversized removable release liner. The rate of release of clonidine and content of clonidine in each system is given in the table below: Programmed Delivery _In vivo _/ day Over 1 week Clonidine content (mg) Size (cm 2 ) Clonidine Transdermal System USP, 0.1 mg/day 0.1 mg 2.52 3.33 Clonidine Transdermal System USP, 0.2 mg/day 0.2 mg 5.04 6.67 Clonidine Transdermal System USP, 0.3 mg/day 0.3 mg 7.56 10.0 Page 2 of 11 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ CLONIDINE TRANSDERMAL SYSTEM USP is indicated for the treatment of mild to moderate hypertension. It can be used as monotherapy or concomitantly with other antihypertensive agents if required to enhance hypotensive effect. _4.2_ _DOSE AND METHOD OF Pročitajte cijeli dokument