Summary of Product Characteristics
1. Name of the Medicinal Product
Decapreno 200, 000 IU / 1 ml, ampoule injection solution
2. Qualitative And Quantitative Composition
Cholecalciferol 200 000 IU For a 1 ml ampoule..
3. Pharmaceutical Form
Solution for injection.
4. Clinical Data/Particulars
4.1. Therapeutic Indications
Prophylaxis and/or treatment of vitamin D deficiency
4.2. Dose and Method of Administration
1 ampoule contains 200,000 IU of vitamin D3.
Method of administration
IM route.
The ampoule can also be administered through Oral route.
Prevention of vitamin D deficiency
It is generally accepted that prophylaxis for vitamin D deficiency should be:
systematic:
o In newborns and infants,
o In pregnant women (last trimester) and breastfeeding women at the end of winter and spring,
o In elderly,
o Possibly in children and adolescents if there is insufficient sun exposure.
Under the following conditions:
o No sun exposure or high skin pigmentation with:
o Unbalanced diet (poor in calcium, vegetarian,...)
o Extended skin diseases,
o Granulomatous disease (tuberculosis, leprosy, ...)
o Patients with anticonvulsants (barbiturates, phenytoin, primidone),
o Patients receiving long-term corticosteroid therapy,
o Digestive diseases (intestinal malabsorption and cystic fibrosis),
o Liver failure.
The dosages are as follows:
In infants receiving milk enriched with vitamin D: 1/2 ampoule (i.e.100,000 IU) every 6 months.
In breastfed infants or not receiving milk enriched with vitamin D in children and young up to 5 years:1 ampoule (i.e. 200,000 IU) every 6 months.
In adolescents: 1 ampoule (i.e. 200,000 IU) every 6 months in winter.
In pregnant women: 1/2 ampoule (i.e.100,000 IU) at 6th or 7th month of pregnancy, possibly repeated once after one month, when the last trimester of pregnancy begins in winter or in case of lack of sun exposure.
In the elderly: 1/2 ampoule (total dose 100,000 IU) every 3 months.
In children or adults with digestive diseases: 1/2 to 1 ampoule (i.e.100,000 to 200,000 IU) every 3 months.
In children or adults on anticonvulsant treatment: 1/2 to 1 ampoule ( i.e.100,000 to 200,000 IU) every 3 months.
In children or adults with special conditions other than those described above:1 ampoule (i.e. 200,000 IU) every 6 months.
Treatment of vitamin D deficiency (rickets, osteomalacia, neonatal hypocalcemia):
1 ampoule (i.e. 200,000 IU) possibly repeated once after 1 to 6 months.
4.3. Contradictions
o Hypersensitivity to active substance or to any of the excipients listed in section 6.1.
o Hypercalcemia, hypercalciuria, nephrolithiasis.
4.4. Special Warnings and Precautions for Use
o Take into consideration the total doses of vitamin D in combination with other several treatments containing this vitamin to avoid any overdose.
o Monitor urinary calcium and serum calcium and stop using vitamin D if serum calcium levels exceed 105 mg/ml (2.62 mmol/l) or the urinary calcium exceeds 4 mg/kg/day in adults or 4-6 mg/kg/day in children.
o In case of high calcium overdose, regular monitoring of urinary calcium is essential.
4.5. Interaction with other medicinal products and other forms of interaction
Combinations requiring precautions for use
+Enzyme-inducing anticonvulsants:
A decrease in vitamin D levels more observed than in the absence of inducer. Dosage levels of vitamin D and supplementation if necessary.
+ Rifampicin:
A decrease in vitamin D levels more observed than in the absence of rifampicin treatment. Dosage levels of vitamin D and supplementation if necessary.
Combinations to be taken into consideration
+ Orlistat:
Decreased absorption of vitamin D.
4.6. Fertility, Pregnancy and Lactation
There are no teratogenicity studies available in animals.
Clinically, a significant decline appears to exclude a teratogenic or fetotoxic effect of vitamin D. Therefore, vitamin D may be prescribed during pregnancy if necessary.
If necessary, vitamin D may be prescribed during lactation.
4.7. Effects on Ability to Driving and Using Machines
Not applicable.
4.8. Side effects
Adverse effects that may occur with Decapreno 200,000 IU / 1 ml, ampoule IM injection solution, are listed as classified by MedDRA System Organ and listed below by frequency using the following convention: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1000 to <1/100), rare (≥1 / 10 000 <1/1 000), very rare ( <1/100000),
o Reactions at the injection site (pain, nodules, panniculitis, granulomas, hives, infection, rash, pruritus):Common
o Immune system disorders: Very Rare
o Metabolism and nutrition disorders: Very Rare
o Renal and urinary tract disorders: Very Rare
Reporting of suspected Side effects
It is important to Report if there are any suspected Side effects after taking of this medicine. It allows continuous monitoring of the benefits/risks ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system: Egyptian Pharmaceutical vigilance system – Pharmacovigilance department - Email: pv.center@eda.mohealth.gov.eg
4.9. Overdose
Signs resulting from the administration of excessive doses of vitamin D or its metabolites:
• Clinical signs associated hypercalcemia
o Headache, asthenia, anorexia, weight loss, depression, stunting
o Nausea, vomiting, constipation
o Polyuria, polydipsia, dehydration,
o High blood pressure,
o Nephrolithiasis, tissue calcifications, in particular renal and vascular,
o Renal failure,
o Heart rhythm disorders,
o Even coma,
• Biological signs:
o Hypercalciuria
o Hypercalcemia,
o Hyperphosphatemia,
o Low level of parathyroid hormone,
o High level of 25-hydroxyvitamin D.
What to do: stop giving vitamin D, reduce calcium dose, increase diuresis, plentiful drinks.
5. Pharmacological Properties
5.1. Pharmacodynamics Properties
Pharmacotherapeutic group: vitamin D
ATC code: A11CC05.
The essential role of vitamin D is in the intestine, which increases the ability to absorb calcium and phosphates, and the skeleton, where it promotes mineralization (through its direct action on bone formation and its indirect actions involving the intestine, parathyroids and bone mineralization already).
5.2. Pharmacodynamics properties
Vitamin D is absorbed in the small intestine passively, and then joined the general circulation by lymphatic system, incorporated in chylomicrons.
After absorption, it binds to a specific carrier protein and is transported to the liver to be converted to 25-hydroxyvitamin D. The latter binds in turn to the same carrier protein and is transported to the kidneys where it is converted into its active form, 1,25-dihydroxyvitamin D.
Its main storage sites are adipose tissue, muscles, but also the blood. The 25-hydroxyvitamin D linked to its carrier protein is the major circulating form of reserves of vitamin D. Its half-life in blood is 15 to 40 days.
The elimination of vitamin D and its metabolites is done in the feces, in non-transformed or water-soluble form (acid calcitroïque derived glucuronides).
5.3. Preclinical safety data
Not applicable.
6. Pharmaceutical Data
6.1. List of Excipients
Medium chain triglycerides.
6.2. Incompatibilities
In the absence of compatibility studies, this vitamin must not be mixed with other medicinal products.
6.3. Shelf life:
2 years.
6.4. Special precautions for storage
Store at temperature not exceeding 30°C, protect from light.
6.5. Nature and contents of the container
Carton box contains amber glass ampoules type I, containing 1 ml solution with (white O.P.C.) constriction mark kept in plastic drawer.
6.6. Special precautions for disposal and handling
Procedure for opening ampoules:
Note that the opening of the ampoule must be at the constriction of the ampoule, with a compress (or equivalent).
Tap the top of the ampoule to lower the liquid.
Hold the ampoule by the body, the left hand, the body being clamped between the thumb and forefinger, the two fingers being positioned on the edge of the cylinder (near the neck).
Seize the olive (bulged portion on the head of the ampoule) of the right hand between the thumb and forefinger at the contour of the ampoule.
Apply a force with the right thumb (leverage) resisting with the left index finger (fulcrum). Both hands should neither deviate (tear-out), or move closer to each other or perform twisting. The effect applied must be constant and must not be disproportionate as for the force that requires opening. It should not be acceleration in the effort.
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