4.1. Therapeutic Indications:
- Provides an ideal method of increasing calcium intake in children only.
- During dentition.
-When resistance to illness is lowered by malnutrition or ad versed seasonal condit

4.2. Posology and Method of Administration:
6 months-1 year: 2.5 ml.
> 1 year: 5 ml.
- These doses should be taken once a day.
- Decal B12 Syrup can be taken with milk or water or directly from the spoon.

Take care to ensure correct dose in infants.

Bran decreases the gastrointestinal absorption of calcium, and may therefore decrease the efficacy of calcium supplements. Corticosteroids also reduce calcium absorption. Calcium salts reduce the absorption of a number of other drugs Such as bisphosphonates, fluoride, some fluoroquinolones, and tetracyclines. Doses should be separated by at least 3 hours.
- Vitamin D requirements possibly increased when given with antiepileptics (as carbamazepine, phenytoin or primidone) or barbiturates.
- Absorption of vitamin B12 from the gastrointestinal tract may be reduced by neomycin, aminosalicylic acid, histamine H2-antagonists, and colchicine.
- Serum concentrations may be decreased by concurrent use of oral contraceptives. Many of these interactions are unlikely to be of clinical significance but Should be taken into account when performing assays for blood concentrations.
DECAL B12 Syrup
- Parenteral chloramphenicol may attenuate the effect of vitamin B12 in anaemia.

This medication is not intended for pregnant and lactating women.

None.

Sensitivity reactions are reported and these are extremely rare.

- There is no upper tolerable intake for vitamin B12 as it is a water soluble vitamin.
- A normal healthy body can tolerate a calcium intake up to 2.5 gm daily.
- Doses that may exceed 250 micrograms (10,000 IU) daily of vitamin D may cause undesired effects.

Vitamin D is a fat-soluble vitamin that is naturally present in very few foods, added to others, and available as a dietary supplement. It is also produced endogenously when ultraviolet rays from sunlight strike the skin and trigger vitamin D synthesis. Vitamin D obtained from sun exposure, food, and supplements is biologically inert and must undergo two hydroxylations in the body for activation. The first occurs in the liver and converts vitamin D to 25-hydroxyvitamin D [25(OH)D], also known as calcidiol. The second occurs primarily in the kidney and forms the physiologically active 1,25-
DECAL B12 Syrup
dihydroxyvitamin D [1,25(OH)2D], also known as calcitriol.
Vitamin D promotes calcium absorption in the gut and maintains adequate serum calcium and phosphate concentrations to enable normal mineralization of bone and to prevent hypocalcemic tetany. It is also needed for bone growth and bone remodeling by osteoblasts and osteoclasts. Without sufficient vitamin D, bones can become thin, brittle, or misshapen. Vitamin D sufficiency prevents rickets in children and osteomalacia in adults . Together with calcium, vitamin D also helps protect older adults from osteoporosis.
Vitamin D has other roles in the body, including modulation of cell growth, neuromuscular and immune function, and reduction of inflammation . Many genes encoding proteins that regulate cell proliferation, differentiation, and apoptosis are modulated in part by vitamin D . Many cells have vitamin D receptors, and some convert 25(OH)D to 1,25(OH)2D. A vitamin D deficiency can occur when usual intake is lower than recommended levels over time, exposure to sunlight is limited, the kidneys cannot convert 25(OH)D to its active form, or absorption of vitamin D from the digestive tract is inadequate. Vitamin D-deficient diets are associated with milk allergy, lactose intolerance, ovo-vegetarianism, and veganism. Rickets and osteomalacia are the classical vitamin D deficiency diseases. In children, vitamin D deficiency causes rickets, a disease characterized by a failure of bone tissue to properly mineralize, resulting in soft bones and skeletal deformities.
The adult body contains approximately 1,200 g of calcium, approximately 99% of which is present in the skeleton. Bone mineral consists of two chemically and physically distinct calcium phosphate pools—an amorphous phase and a loosely crystallized phase. The skeleton contains two major forms of bone: trabecular (spongy) bone, exemplified by the vertebral bodies, and denser cortical bone, such as the femur. Bone is constantly turning over, a continuous process of resorption and formation. In children and adolescents, the rate of formation of bone mineral predominates over the rate of resorption. In later life, resorption predominates over formation. Therefore, in normal aging, there is a gradual loss of bone.
The postmenopausal rate of decline in bone mineral is strongly dependent on estrogen status. Estrogen replacement slows the rate of bone loss. Evidence that supplementary calcium (1.5 to 2.5 g/day) can retard the rate of postmenopausal bone loss is mixed (NRC, 1989), but the balance of evidence suggests that calcium alone has only a small effect on cortical bone loss and none on trabecular bone (Freudenheim, 1986; Riis et al., 1987). Is the generic name for a specific group of cobalt-containing corrinoids with biological activity in humans. This group of biologically active corrinoids is also described as cobalamins. Cyanocobalamin is the commercialy available form used in food supplements
DECAL B12 Syrup
and food fortification. In foods, hydroxo-, methyl- and 5'-deoxyadenosyl-cobalamins are the main cobalamins present. Sulphitocobalamin, with a sulphite ligand chelated to the central cobalt atom in the corrin ring, may occur is some processed foods. Vitamin B12 functions primarily as a coenzyme in intermediary metabolism. Only two vitamin B12 dependent reactions have been identified thus far for humans: 1) the methionine synthase reaction with methylcobalamin, and 2) the methylmalonyl CoA mutase reaction with 5-deoxyadenosylcobalamin as the active coenzyme, respectively.
A dietary vitamin B12 deficiency can occur in strict vegetarians or after gastrectomy, and other diseases affecting cobalamin absorption. About two-thirds of patients with vitamin B12 deficiency have pernicious anemia (PA), an autoimmune disorder associated with gastric atrophy and absence of Intrinsic Factor (IF) which results in vitamin B12 malabsorption. The key symptom in vitamin B12 deficiency is macrocytic megaloblastic anemia. These haematological abnormalities are indistinguishable from those seen in folate deficiency, because of the interrelated function of both vitamins.
Vitamin B12 may affect the absorption of Calcium through the small intestine.

- Calcium is absorbed mainly from the small intestine by active transport and passive diffusion. About one-third of ingested calcium is absorbed although this can vary depending upon dietary factors and the state of the small intestine, also absorption is increased in calcium deficiency and during periods of high physiological requirement such as during childhood. 1,25-Dihydroxycholecalciferol (calcitriol), a metabolite of vitamin D, enhances the active phase of absorption. Excess calcium is predominantly excreted renally. Unabsorbed calcium is eliminated in the faeces, together with that secreted in the bile and pancreatic juice. Minor amounts are lost in the sweat, skin, hair, and nails.
Calcium crosses the placenta and is distributed into breast mille.
- There is no definite data available on tile pharmacokinetics of vitamin D3.
- In presence of calcium, vitamin B12 is absorbed systemically in lower half of ileum. Initially, bound to intrinsic factor, this complex passes down intestine, binding to receptor sites on ileal mucosa. Protein binding is high. Vitamin B12 is metabolized in tile liver and primarily eliminated unchanged in tile urine. Its half-life is 6 days.

None.

- Sucrose
- Sodium Methylparaben
- Sodium Propylparaben
- Ethanol
- Glycerin
- Hydrochloric Acid
- Poloxamer 407
- Butylated Hydroxyanisole
- Potassium Sorbate
- Tutti Fruitti
- Ponceau 4 R color
- Purified water

Not applicable.

.Store at temperature below 30ºC

A chromo-duplex carton box containing a pamphlet and an amber plastic bottle closed with a Cap.

No special requirements.