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| Devarol-S Ampoules - Cholecalciferol |
Devarol-S Ampoule
Cholecalciferol (Vit. D3) 5 mg
(equivalent to 200000 I.U.)Company Name
Memphis - EgyptDevarol-S Therapeutic Group
VITAMIN D PLAINDevarol-S Pharmaceutical form
AmpouleDevarol-S Package
Carton box contains one Amber glass ampoule of 2 mlDevarol-S Indications
Prophylaxis and/or treatment of vitamin D deficiency.Devarol-S Warning & Precautions
". To avoid Devarol-S overdosage, consider the total doses of vitamin D in case of combining multiple treatments containing this vitamin. - Monitor calciuria and calcemia and stop intakes of vitamin D when calcemia exceeds 105 mg/ml (2.62 mmol/l) or when calciuria exceeds 4 mg/kg/day for adult or 4-6 mg/kg/day for children. - In case of high calcium intake, regular monitoring of calciuria is essential. Pregnancy/ Lactation: Pregnancy: There is no available teratogenesis study in animals. Clinically, a significant decline seems to exclude the effect of malformation or foetotoxicity of vitamin D. Accordingly, vitamin D may be described during pregnancy if needed. Lactation: In case of need, vitamin D may be described during breastfeeding.Devarol-S Dosage
"IM route.The Devarol-S ampoule may be also administrated by oral route.
- Prevention of vitamin D deficiency:
It is generally accepted that the prophylaxis of vitamin D deficiency should be systematic, in newborns and infants, in pregnant women (last trimester) and breastfeeding women in the late winter and spring, in the elderly subjects, possibly in children and adolescents in case of insufficient sun exposure, in the following conditions:- Non-exposure to sunlight or high skin pigmentation with unbalanced diet (low in calcium, vegetarian,...) or extended dermatological pathology or granulomatous disease (tuberculosis, leprosy ...)
- Subjects under anticonvulsants (barbiturates, phenytoin, primidone)
- Subjects receiving long-term corticosteroid
- Digestive pathology (intestinal malabsorption and mucoviscidosis)
- Hepatic insufficiency.
Doses are as follows:
- Infant receiving milk fortified with vitamin D: 1/2 ampoule (100 000 IU) every 6 months.
- Breastfed infant or not receiving milk fortified with vitamin D and young children up to 5 years old: 1 ampoule (200 000 IU) every 6 months.
- Adolescent: 1 ampoule (200 000 IU) every 6 months during the winter.
- Pregnant woman: 1/2 ampoule (100 000 IU) in the 6th and 7th month of pregnancy, possibly repeated once after a month, when the last trimester begins in winter or in case of non-exposure to sunlight.
- Elderly subject: 1/2 ampoule (100 000 IU) every 3 months.
- Child or adult with digestive disorders: 1/2 to 1 ampoule (100 000 to 200 000 IU) every 3 months.
- Child or adult under anticonvulsive treatment: 1/2 to 1 ampoule
(100 000 to 200 000 IU) every 3 months.
- Child or adult in cases other than those listed above: 1 ampoule
(200 000 IU) every 6 months.
Treatment of vitamin D deficiency (rickets, osteomalacia, neonatal hypocalcemia): 1 ampoule (200 000 IU) possibly repeated once after 1 to 6 months.
Devarol-S Contraindications
. Hypersensitivity to one of the components, especially to vitamin D.. Hypercalcemia, hypercalciuria, calcic lithiasis.
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