Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
colecalciferol, Quantity: 175 microgram
Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare
colecalciferol
Capsule, soft
Excipient Ingredients: Soya Oil; purified water; patent blue V; Gelatin; glycerol; dl-alpha-tocopherol; allura red AC; titanium dioxide; propylene glycol; ethyl acetate; ethanol; isopropyl alcohol; strong ammonia solution; polyvinyl acetate phthalate; macrogol 400
Oral
24, 48, 4
(S3) Pharmacist Only Medicine
For the treatment of vitamin D deficiency in adults and adolescents as directed by your medical practitioner or pharmacist.,For the prevention of vitamin D deficiency in high risk individuals under the supervision of a medical practitioner.
Visual Identification: Translucent blue oval shaped softgel capsule with 7000 printed in white ink lengthwise on shell and filled with a translucent pale yellow solution; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-09-07
OSTELIN SPECIALIST RANGE VITAMIN D 7000IU (WEEKLY) O S T E L I N S P E C I A L I S T R A N G E V I T A M I N D 7 0 0 0 I U CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING OSTELIN SPECIALIST RANGE VITAMIN D 7000IU? Ostelin Specialist Range Vitamin D 7000IU contains the active ingredient Colecalciferol. Ostelin Specialist Range Vitamin D 7000IU is a supplement that is used for the treatment of vitamin D deficiency in adults and adolescents as directed by your medical practitioner or pharmacist, and the prevention of vitamin D deficiency in high risk individuals under the supervision of a medical practitioner. For more information, see Section 1. Why am I using Ostelin Specialist Range Vitamin D 7000IU? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE OSTELIN SPECIALIST RANGE VITAMIN D 7000IU? Do not use if you have ever had an allergic reaction to Ostelin Specialist Range Vitamin D 7000IU or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. DO NOT GIVE TO CHILDREN UNDER 12 YEARS OLD. For more information, see Section 2. What should I know before I use Ostelin Specialist Range Vitamin D 7000IU? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Ostelin Specialist Range Vitamin D 7000IU and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE OSTELIN SPECIALIST RANGE VITAMIN D 7000IU? • Swallow the whole capsule with a glass of water. • The usual dose is one capsule once a week. Take the capsule on the same day each week. More instructions can be found in Section 4. How do I use Ostelin Specialist Range Vitamin D 7000IU? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING OSTELIN SPEC Prečítajte si celý dokument
Property of the Sanofi group - strictly confidential Ostelin-specialist-range-7000iu-ccdsv1-piv3-1sept22 Page 1 of 8 AUSTRALIAN PRODUCT INFORMATION – OSTELIN SPECIALIST RANGE VITAMIN D 7000IU (COLECALCIFEROL) SOFT CAPSULE 1 NAME OF THE MEDICINE Colecalciferol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Ostelin Specialist Range Vitamin D 7000IU capsule contains 175mcg of colecalciferol. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Colecalciferol is a naturally occurring form of Vitamin D. It is produced from 7-dehydro cholesterol, a sterol present in mammalian skin, by ultraviolet irradiation. Colecalciferol appears as white/almost white crystals. Ostelin Specialist Range Vitamin D are formulated as soft capsules for oral administration. Ostelin Specialist Range Vitamin D 7000IU are blue coloured capsules printed with ‘7000’. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS For: The treatment of vitamin D deficiency in adults and adolescents as directed by your medical practitioner or pharmacist. The prevention of vitamin D deficiency in high risk individuals under the supervision of a medical practitioner or pharmacist. 4.2 D OSE AND METHOD OF ADMINISTRATION Adults and adolescents from 12 years of age. Swallow the capsule with a glass of water. Recommended doses: Ostelin Specialist Range Vitamin D 7000IU: one capsule to be taken weekly. Take the capsule on the same day each week. Property of the Sanofi group - strictly confidential Ostelin-specialist-range-7000iu-ccdsv1-piv3-1sept22 Page 2 of 8 4.3 C ONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients. Colecalciferol should not be given to patients with hypercalcaemia (see Section 4.8 Adverse Effects (undesirable Effects) and 4.9 Overdose). Diseases and/or conditions, which lead to hypercalcaemia (e.g. nephrocalcinosis, myeloma, bone metastases, primary hyperparathyroidism, sarcoidosis, prolonged immobilisation accompanied by hypercalcaemia). Hypervitaminosis D. 4.4 S PE Prečítajte si celý dokument