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Devarol-S

Company name: Memphis Co. for Pharm. & Chem. Ind.

Trade name: Devarol-S 200000 IU ampoule

Generic name: Cholecalciferol (Vit. D3)

Composition:
Each 2 ml contains:
Cholecalciferol (Vit. D3)              5 mg
(equivalent to 200000 I.U.)
 
Excipients: Polysorbate 80, propylene glycol.

Pharmaceutical form: Ampoule.

Pharmacological actions:
Vitamin D acts mainly in the intestine where it increases the absorption of calcium and phosphate, and it acts also on the skeleton where it increases mineralization due to its direct effect on bone formation.
  
Pharmacokinetics:
Vitamin D is absorbed in the small intestine, then rejoins the general circulation incorporated to chylomicrons.
After absorption, it is transported to the liver and kidney and stored in the fatty tissues, muscles and blood. 
Elimination of vitamin D and its metabolites is done through fecal way.

Indications:
Devarol-S ampoule is indicated in prophylaxis and/or treatment of deficiency in Vitamin D3.
 
Dosage & administration:
Devarol-S ampoule can be administered orally.
Devarol-S ampoule is administered by intramuscular way.
- Infants receiving milk enriched with Vitamin D:
½ ampoule (100000 I.U.) every 6 months.

- Infants breastfeeding and up to 5 years of age and do not receive milk enriched with vitamin D:
1 ampoule (200000 I.U.) every 6 months.

 - Adolescents:
1 ampoule (200000 I.U.) every 6 months (in winter).

- Pregnant women:
½ ampoule (100000 I.U.) at the sixth or seventh month of pregnancy, repeated once at the end of a month if the final trimester starts up in winter or in case of non solar exposure.
- Elderly:
Ampoule (100000 I.U.) every 3 months.

- In case of digestive disease:
½ to 1 ampoule (100000 - 200000 I.U.) every 3 months.

- In patients receiving anticonvulsant treatment:
½ to 1 ampoule (100000 - 200000 I.U.) every 3 months.

 - Deficiency in vitamin D (rickets, osteomalacia, hypocalcaemia) in new born:
 1 ampoule (200000 I.U.) repeated after 1 to 6 months.

Contraindication:
Devarol-S ampoule is contraindicated in:
- Hypercalcaemia, hypercalciuria, calcic lithiasis.   
- Hypersensitivity to any of the components of the product.
- Kidney insufficiency or renal impairment.

Pregnancy& Lactation:
Devarol-S ampoule may be prescribed during pregnancy & lactation if necessary.

Precautions & warnings:
- Treatment with Devarol-S ampoule must be discontinued, if hypercalcaemia and hypercalciuria occur.
- To avoid any overdosage, total doses of Vitamin D must be taken in consideration in case of association of other drugs containing this vitamin.
 
Overdosage:
Sign of overdosage include:
Headache, anorexia, nausea, vomiting, hypercalcaemia, hypercalciuria, hyperphosphatemia, hyperphosphaturia and dehydration.

Treatment:
- Discontinue administration of Devarol-S ampoule.
- Increase diuresis.
- Administration of fluids.  
 
Therapeutic category: Vitamins.

Legal category: POM.

Package:

Storage:
 

THIS IS A MEDICAMENT
Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.