Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Colecalciferol
Consilient Health Ltd
A11CC05
Colecalciferol
25000unit/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09060400; GTIN: 5391512451981
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist, or nurse. • This medicine has been prescribed for you only. Do not pass it onto others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What invitaD3 is and what it is used for 2. What you need to know before you use invitaD3 3. How to use invitaD3 4. Possible side effects 5. How to store invitaD3 6. Contents of the pack and other information 1. WHAT INVITAD3 IS AND WHAT IT IS USED FOR invitaD3 is a vitamin product containing colecalciferol (equivalent to vitamin D 3 ). Vitamin D can be found in some foods and also produced by the body when skin is exposed to sunlight. Vitamin D helps the kidneys and intestine absorb calcium and it helps build bones. invitaD3 25,000 IU is used: • for the prevention of vitamin D deficiency when there is a significant risk of deficiency or an increased demand for vitamin D • with other medicines to treat certain bone conditions, such as thinning of the bone (osteoporosis) • to treat vitamin D deficiency that has been confirmed by laboratory tests. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE INVITAD3 Do not use invitaD3 • if you are allergic to vitamin D or any of the other ingredients of invitaD3 (listed in section 6) • if you have hypercalcaemia (high levels of calcium in the blood) • if you have hypercalciuria (high levels of calcium in the urine) • if you have pseudohypoparathyroidism (disturbed parathyroid hormone metabolism) • if you have renal calculi (kidney stones) • if you have hypervitaminosis D (high levels of vitamin D in the blood). Warnings and precautions Talk to your doctor, pharmacist or nurse bef Lire le document complet
OBJECT 1 INVITA D3 25,000 IU ORAL SOLUTION Summary of Product Characteristics Updated 11-May-2017 | Consilient Health Ltd 1. Name of the medicinal product InvitaD3 25,000 IU oral solution 2. Qualitative and quantitative composition 1 ml solution (1 single-dose oral solution) contains 0.625 mg colecalciferol, equivalent to 25,000 IU vitamin D. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Oral solution Clear, slightly yellow, oily liquid with an orange odour. 4. Clinical particulars 4.1 Therapeutic indications The prevention and treatment of vitamin D deficiency. As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency. 4.2 Posology and method of administration Posology Paediatric posology: - Prevention of deficiency 0-1 years 25,000 IU (1 single-dose oral solution) every 8 weeks. - Prevention of deficiency 1-18 years 25,000 IU (1 single-dose oral solution) every 6 weeks. - Treatment of deficiency 0-18 years 25,000 IU (1 single-dose oral solution) once every 2 weeks for 6 weeks (followed by maintenance therapy of 400-1000 IU/day, such as 25,000 IU (single-dose oral solution) per month). Pregnancy and breastfeeding: - The high strength formulation is not recommended. Adults: - Prevention of vitamin D deficiency 25,000 IU/month (1 single-dose oral solution). Higher doses may be required in certain situations, see below - As an adjunct to specific therapy for osteoporosis: 25,000 IU/month (1 single-dose oral solution. - Treatment of vitamin D deficiency (<25 nmol/l) 50,000 IU/week (2 single-dose oral solutions) for 6-8 weeks, followed by maintenance therapy (1400-2000 IU /day may be required such as 50,000 IU (2 single-dose oral solutions) per month); follow-up 25(OH)D measurements should be made approximately three to four months after initiating maintenance therapy to confirm that the target level has been achieved). Certain populations are at high risk of vitamin D deficiency, and may require higher doses and monitoring Lire le document complet