STRIVIT-D3 800 IU Capsule, soft (2018)
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Περιεχόμενα
Name of the medicinal product
STRIVIT-D3 800 IU Capsules, Soft.
Qualitative and quantitative composition
Each capsule contains 800IU Colecalciferol (equivalent to 20 micrograms vitamin D<sub>3</sub>). Excipients: Maize oil, refined. For the full list of excipients, see section 6.1
Pharmaceutical form
Capsule, soft (Capsule).
Therapeutic indications
For 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. Colecalciferol ...
Posology and method of administration
Posology For Vitamin D deficiency in adults and the elderly (serum levels <25 nmol/l (<10 ng/ml)), 1-4 capsules (800-3200 IU) daily for up to 12 weeks dependent upon the severity of the disease and the ...
Contraindications
Hypersensitivity to vitamin D or any of the excipients in the product. Hypervitaminosis D. Nephrolithiasis. Nephrocalcinosis. Diseases or conditions resulting in hypercalcaemia and/or hypercalciuria. ...
Special warnings and precautions for use
Vitamin D should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken ...
Interaction with other medicinal products and other forms of interaction
Thiazide diuretics reduce the urinary excretion of calcium. Due to the increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics. Concomitant ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of colecalciferol in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The recommended daily intake for ...
Effects on ability to drive and use machines
Colecalciferol has no influence on the ability to drive and use machines.
Undesirable effects
Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (>1/1,000, <1/100) or rare (>1/10,000, <1/1,000). Immune system disorders Not known (cannot ...
Overdose
The most serious consequence of acute or chronic overdose is hypercalcaemia due to vitamin D toxicity. Symptoms may include nausea, vomiting, polyuria, anorexia, weakness, apathy, thirst and constipation. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Vitamin D and analogues ATC code: A11CC05 In its biologically active form vitamin D<sub>3</sub> stimulates intestinal calcium absorption, incorporation of calcium into the osteoid, ...
Pharmacokinetic properties
The pharmacokinetics of vitamin D is well known. Vitamin D is well absorbed from the gastro-intestinal tract in the presence of bile. It is hydroxylated in the liver to form 25-hydroxycolecalciferol and ...
Preclinical safety data
Colecalciferol has been shown to be teratogenic in high doses in animals (4-15 times the human dose). Offspring from pregnant rabbits treated with high doses of vitamin D had lesions anatomically similar ...
List of excipients
Capsule content: Maize oil, refined Capsule shell: Gelatin Glycerol (E422) Brilliant Blue Supra containing Brilliant blue for coloring of food (E-133), sodium chloride and sodium sulphate Purified water ...
Incompatibilities
Not applicable.
Shelf life
24 months.
Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Keep the blister in the outer carton in order to protect from light.
Nature and contents of container
Coated PVC film with aluminum blister foil packed in cartons. Pack sizes: 28, 30, 56, 60 and 90 capsules.
Special precautions for disposal and other handling
Any unused product should be disposed of in accordance with local requirements.
Marketing authorization holder
Strides Arcolab International Ltd., Unit 4, Metro Centre, Tolpits Lane, Watford, Hertfordshire WD18 9SS, United Kingdom
Marketing authorization number(s)
PL 28176/0170
Date of first authorization / renewal of the authorization
07/01/2016
Date of revision of the text
25/01/2018
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