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Qualitative and quantitative composition 1 ml solution 36 drops contains 0. For a full list of excipients, see section 6. Pharmaceutical form Clear, slightly yellow, oily liquid with an orange odour 4. Patients should be advised to take InVita D3 preferably with a meal see section 5.
The product should be shaken before use. InVita D3 can be taken as is or to facilitate the intake it can also be mixed with a spoonful or a small amount of cold or lukewarm food immediately prior to use. The patient should be sure to take the entire dose. In children, InVita D3 can be mixed with a small amount of children's foods, yogurt, milk, cheese or other dairy products.
The parents should be warned not to mix InVita D3 into a bottle of milk or container of soft foods in case the child does not consume the whole portion, and does not receive the full dose. The parents should ensure that their child takes the entire dose. In children who are not breast-feeding, the prescribed dose should be administered with a meal. See also section 6. The risk of soft tissue calcification should be taken into account.
Caution is required in patients receiving treatment for cardiovascular disease see section 4. InVita D3 should be prescribed with caution in patients with sarcoidosis, due to a possible increase in the metabolism of vitamin D in its active form. In these patients the serum and urinary calcium levels should be monitored. Allowances should be made for the total dose of vitamin D in cases associated with treatments already containing vitamin D, foods enriched with vitamin D, cases using milk enriched with vitamin D, and the patient's level of sun exposure.
There is no clear evidence for causation between vitamin D supplementation and renal stones, but the risk is plausible, especially in the context of concomitant calcium supplementation. The need for additional calcium supplementation should be considered for individual patients. Calcium supplements should be given under close medical supervision.
Oral administration of high-dose vitamin D , IU by single annual bolus was reported to result in an increased risk of fractures in elderly subjects, with the greatest increase occurring during the first 3 months after dosing. In cases of treatment with thiazide diuretics, which decrease urinary elimination of calcium, monitoring of serum calcium concentration is recommended. Concomitant use of glucocorticoids can decrease the effect of vitamin D.
In cases of treatment with drugs containing digitalis and other cardiac glycosides, the administration of vitamin D may increase the risk of digitalis toxicity arrhythmia. Strict medical supervision is needed, together with serum calcium concentration and electrocardiographic monitoring if necessary. Simultaneous treatment with ion exchange resin such as cholestyramine, colestipol hydrochloride, orlistat or laxative such as paraffin oil may reduce the gastrointestinal absorption of vitamin D.
The cytotoxic agent actinomycin and imidazole antifungal agents interfere with vitamin D activity by inhibiting the conversion of hydroxyvitamin D to 1, dihydroxyvitamin D by the kidney enzyme, hydroxyvitamin Dhydroxylase. There are no or limited amount of data from the use of cholecalciferol in pregnant women. Studies in animals have shown reproductive toxicity see section 5.
During pregnancy women should follow the advice of their medical practitioner as their requirements may vary depending on the severity of their disease and their response to treatment vitamin D and its metabolites are excreted in breast milk. Vitamin D can be prescribed while the patient is breast-feeding if necessary.
This supplementation does not replace the administration of vitamin D in the neonate. Overdose in infants induced by nursing mothers has not been observed; however, when prescribing additional vitamin D to a breast-fed child the practitioner should consider the dose of any additional vitamin D given to the mother.
However, an effect on this ability is unlikely. Frequencies are defined as: Metabolism and nutrition disorders: Hypercalcaemia and hypercalciuria Skin and subcutaneous disorders: Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: An overdose manifests as hypercalcaemia and hypercalciuria, the symptoms of which include the following: Chronic overdosage may lead to vascular and organ calcification, as a result of hypercalcaemia. Treatment in cases of overdose. Discontinue administration of InVita D3 and initiate rehydration.
A11CC05 In its biologically active form, vitamin D stimulates intestinal calcium absorption , incorporation of calcium into the osteoid, and release of calcium from bone tissue. In the small intestine it promotes rapid and delayed calcium uptake. The passive and active transport of phosphate is also stimulated. In the kidney, it inhibits the excretion of calcium and phosphate by promoting tubular resorption. The production of parathyroid hormone PTH in the parathyroids is inhibited directly by the biologically active form of vitamin D.
PTH secretion is inhibited additionally by the increased calcium uptake in the small intestine under the influence of biologically active vitamin D. Vitamin D is well absorbed from the gastro-intestinal tract in the presence of bile, so the administration with the major meal of the day might therefore facilitate the absorption of Vitamin D.
It is hydroxylated in the liver to form hydroxy-cholecalciferol and then undergoes further hydroxylation in the kidney to form the active metabolite 1, dihydroxycholecalciferol calcitriol.
Characteristics in Specific Groups of Subjects or Patients. Decreased absorption and increased elimination of vitamin D occurs in subjects with malabsorption.
Obese subjects are less able to maintain vitamin D levels with sun exposure, and are likely to require larger oral doses of vitamin D to replace deficits. In toxicity studies at repeated doses, the effects most commonly reported were increased calciuria and decreased phosphaturia and proteinuria. Hypercalcaemia has been reported in high doses. In a state of prolonged hypercalcaemia, histological alterations calcification were more frequently borne by the kidneys, heart, aorta, testes, thymus and intestinal mucosa.
Cholecalciferol has been shown to be teratogenic at high doses in animals. At doses equivalent to those used therapeutically, cholecalciferol has no teratogenic activity. Cholecalciferol has no potential mutagenic or carcinogenic activity. Central dropper made of polyethylene, white. Screw cap made of polypropylene, white.
Not all pack sizes may be marketed. This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Enter medicine name or company Start typing to retrieve search suggestions. Continue typing to refine. Back to top Consilient Health Ltd contact details. Active ingredient colecalciferol; cholecalciferol.
Last updated on eMC: Show table of contents Hide table of contents 1. Name of the medicinal product 2. Qualitative and quantitative composition 3. Marketing authorisation holder 8. Marketing authorisation number s 9. Date of revision of the text. This information is intended for use by health professionals. Posology 1 drop contains 67 IU vitamin D3.
Method of administration Patients should be advised to take InVita D3 preferably with a meal see section 5. 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. Concomitant use of anticonvulsants such as phenytoin or barbiturates and possibly other drugs that induce hepatic enzymes may reduce the effect of vitamin D3 by metabolic inactivation.
Pregnancy There are no or limited amount of data from the use of cholecalciferol in pregnant women. Breast-feeding Vitamin D can be prescribed while the patient is breast-feeding if necessary. There are no data on the effects of InVita D3 on the ability to drive. Adverse reactions are listed below, by system organ class and frequency. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Discontinue InVita D3 when calcaemia exceeds Treatment in cases of overdose Discontinue administration of InVita D3 and initiate rehydration. The pharmacokinetics of vitamin D is well known. Absorption Vitamin D is well absorbed from the gastro-intestinal tract in the presence of bile, so the administration with the major meal of the day might therefore facilitate the absorption of Vitamin D.
Distribution and biotransformation It is hydroxylated in the liver to form hydroxy-cholecalciferol and then undergoes further hydroxylation in the kidney to form the active metabolite 1, dihydroxycholecalciferol calcitriol. Pre-clinical studies conducted in various animal species have demonstrated that toxic effects occur in animals at doses much higher than those required for therapeutic use in humans.
Store in the original package, in order to protect from light. No special requirements Any unused product or waste material should be disposed of in accordance with local requirements. Company contact details Consilient Health Ltd. To bookmark a medicine you must be a registered user. To email a medicine you must be a registered user.
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