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Microsoft word - pi718w0908 - vitamin d3 oral liquid.doc

Bio-Logical Vitamin D3 Solution 1000 IU per 0.2 mL
Concentrated Vitamin D3 Oral Liquid – 50mL bottle
Information for doctors
» Hypercalcemia
Use in pregnancy and during
» Hypervitaminosis D
lactation:
» Renal osteodystrophy with
There are not sufficient data on the use Name of Medicine
pregnancy. In principle, the preparation Cholecalciferol
Interactions with other medicines:
Description
Precautions
The following drug interactions and/or related problems have been selected on Risk-benefit should be considered
when the following medical problems
exist:
» Arteriosclerosis or
necessarily inclusive (» = major clinical
» Cardiac function impairment
Note: Combinations containing any of
» Hyperphosphatemia (risk of
Note: A full 50mL bottle of Bio-Logical
» Hypersensitivity to effects of vitamin
to aluminum bone toxicity, especially in » Renal function impairment (toxicity
» Antacids, magnesium-containing
Indications
osteoporosis in later life. Vitamin D is Particular caution is advised in patients Particular caution is advised in patients with a history of raised urinary oxalates. Contraindications
Medical considerations /
» Calcium-containing preparations, in
Contraindications
» Diuretics, thiazide (concurrent use
Patient monitoring:
selected on the basis of their potential parentheses where appropriate) (» =
Except under special circumstances,
this medication should not be used
when the following medical problems
exist:
pi718w0908 – Bio-Logical Vitamin D3 Solution Oral Liquid corticosteroids or bisphosphonates (e.g. intestinal absorption of vitamin D since Signs of potential side effects:
(continuing), increased thirst, increase in frequency of urination (especially at night) or in the amount of urine, loss of Presentation and
storage conditions
or weakness, cloudy urine, conjunctivitis to light or irritation of eyes, irregular heartbeat, itching of skin, lethargy, loss digitalis glycosides, resulting in cardiac calcifications (particularly in the kidneys) Dosage and
Administration
Ingredients (each 0.2 mL)
1,000 IU (0.2 mL) per day.
» Vitamin D and analogs, other
A note on high doses: Doses of 100
Supplier
administered orally or intramuscularly 6- Adverse effects
Manufactured by
Note: Ingestion of excessive doses of
participants. The therapy was effective, Biological Therapies.
several months in children) can result in deterioration in renal function, although toxicity, but there are insufficient data to Overdosage
i Diamond TH, Ho KW, Rohl PG, Meerkin M. Annual intramuscular injection of a megadose of vascular calcification, nephrocalcinosis, cholecalciferol for treatment of vitamin D and other soft tissue calcification that deficiency: efficacy and safety data. Med J Aust. failure. These effects are more likely to cardiovascular failure caused by vitamin Such monitoring is critical in patients receiving digitalis. Dosage necessary to cause toxicity varies with individual sensitivity, but in pi718w0908 – Bio-Logical Vitamin D3 Solution Oral Liquid

Source: http://www.biologicaltherapies.com.au/sites/default/files/PI%20Vitamin%20D3%20Oral%20Liquid%20-%20pi718w0908_0.pdf

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