CALVIT 0.6

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COMPOSITION:

Tricalcium phosphate…………..........….. 1.65 g

(Equivalent to 0.6 g of calcium)

Excipients q.s ……….........................1 sachet

(Blueberry flavor, sucralose, carboxymethylcellulose sodium, colloidal silicon dioxide).

PHARMACEUTICAL FORM: Powder for oral suspension.

PHARMACODYNAMIC PROPERTIES: ATC code: A12AA01.

Calcium is an important bivalent intracellular ion. Adults normally have about 1300 g of calcium (male) or 1000 g of calcium (female); approximately 99% of total body calcium is found in bones, primarily as hydroxyapatite and the remainder is present within the extracellular fluid, and a very small number occurring in cells.

Calcium ions are essential for many biological processes: neuron stimulation, release of neurotransmitter, muscle contraction, preservation of membranes, and clotting blood. Calcium ions play an important role in signal transduction, where it acts as a second messenger.

PHARMACOKINETIC PROPERTIES: Calcium is absorbed mainly from the small intestine by active transport and passive diffusion; absorption is increased in calcium deficiency and during periods of high physiological requirements such as during childhood or pregnancy and lactation. After oral administration, calcium ions are excreted in the urine and are filtered by the renal glomeruli; a certain amount is reabsorbed. The tubular reabsorption is huge because approximately 98% of the reabsorbed calcium ions come back circulation. Calcium is distributed into breast milk; minor amounts are lost in the sweat and are eliminated in the faeces.

PRESENTATION: Box of 24 sachets x 1.75 g   

THERAPEUTIC INDICATIONS: Treatment of rickets in children.

Treatment of osteoporosis and osteomalacia in adults (by using corticosteroids, menopausal women, older people).

Treatment of calcium deficiency in children during growth phase, pregnant women and lactating mothers.

DOSAGE & ADMINISTRATION:

The drug should be orally taken 1 - 1.5 hours after a meal, dissolved with 30 - 50 ml of water, and shaken well before use.

Children aged less than 5 years: 1/2 sachet/day.

Children aged 5 years and older: 1 - 2 sachets/day.

Adults: 2 sachets/day.

CONTRAINDICATIONS: Hypercalcemia, hypercalciuria; kidney stones and severe renal impairment; patients receiving digitalis, epinephrine; malignant bone disease; motionless osteoporosis, ventricular fibrillation in cardiac resuscitation.

PRECAUTIONS: Caution should be exercised in patients with a history of kidney stones.

In the long-term therapy, urinary calcium concentrations should be frequently monitored. If calciuria levels exceed 7.5 mmol (300 mg)/24 hours, dosage should be reduced or treatment should be temporarily interrupted.

Pregnancy and lactation: No adverse effects have been reported with the daily recommended dose.

Effects of on works: The drug does not affect the ability to drive, use machines, work at height, and other cases.

INTERACTIONS: Hypercalcemia has occurred when calcium is given with thiazide diuretics.

Calcium enhances the effects of digoxin on the heart.

Calcium may reduce the absorption of bisphosphonates, sodium fluoride, quinolone and tetracycline antibiotics or iron. The oral interval between calcium and the above substances should be at least 3 hours.

UNDESIRABLE EFFECTS: Gastrointestinal irritation, mild gastrointestinal disorders, including flatulence, constipation, nausea, diarrhea.

OVERDOSE: A serum calcium concentration exceeding 2.6 mmol per liter (10.5 mg per 100 ml) is considered a hypercalcaemic condition. Withholding additional administration of calcium and any other medications that may cause hypercalcaemia usually resolves mild hypercalcaemia in asymptomatic patients, when renal function is adequate. When serum calcium concentrations are greater than 2.9 mmol per liter (12 mg per 100 ml), immediate measures may be required with possible use of the following:

Hydrating with intravenous 0.9% sodium chloride injection. Forcing diuresis with furosemide or ethacrynic acid may be used to rapidly increase calcium and sodium excretion when saline overload occurs.

Monitoring of potassium and magnesium serum concentrations and starting replacement early to prevent complications of therapy.

ECG monitoring and the possible use of beta-adrenergic blocking agents to protect the heart against serious arrhythmias.

Possibly including hemodialysis, calcitonin, and adrenocorticoids in the treatment.

Determining serum calcium concentrations at frequent intervals to guide therapy adjustments.

Read the direction carefully before use.

STORAGE CONDITIONS: Store in dry places, not exceeding 30oC, protect from light.

SHELF-LIFE: 36 months from the manufacturing date.

DATE OF REVISION OF THE TEXT: July 24, 2018.

Read all of this leaflet carefully before you start taking this medicine.

Keep out of reach of children

Immediately tell your doctor or pharmacist of undesirable effects encountered during the treatment.

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Tricalcium phosphate…………...........….. 1.65 g

(Equivalent to 0.6 g of calcium)

Excipients q.s ……….........................1 sachet

(Blueberry flavor, sucralose, carboxymethylcellulose sodium, colloidal silicon dioxide).

PRODUCT DESCRIPTION: White to off-white, dry, fragrant powder.

PRESENTATION: Box of 24 sachets x 1.75 g powder for oral suspension. 

WHAT THE DRUG IS USED FOR: Treatment of rickets in children.

Treatment of osteoporosis and osteomalacia in adults (by using corticosteroids, menopausal women, older people).

Treatment of calcium deficiency in children during growth phase, pregnant women and lactating mothers.

HOW TO TAKE THIS MEDICINE:

The drug should be orally taken 1 - 1.5 hours after a meal, dissolved with 30 - 50 ml of water, and shaken well before use.

Children aged less than 5 years: 1/2 sachet/day.

Children aged 5 years and older: 1 - 2 sachets/day.

Adults: 2 sachets/day.

Or as directed by a physician. For more information, please consult your doctor or pharmacist.

WHEN SHOULD YOU NOT TAKE THIS MEDICINE: Hypercalcemia, hypercalciuria; kidney stones and severe renal impairment; patients receiving digitalis, epinephrine; malignant bone disease; motionless osteoporosis, ventricular fibrillation in cardiac resuscitation.

UNDESIRABLE EFFECTS: Gastrointestinal irritation, mild gastrointestinal disorders, including flatulence, constipation, nausea, diarrhea.

Please inform your doctor of all adverse effects upon drug administration.

WHAT OTHER MEDICINE OR FOOD SHOULD BE AVOIDED WHILE TAKING THIS MEDICINE:

Hypercalcemia has occurred when calcium is given with thiazide diuretics.

Calcium enhances the effects of digoxin on the heart.

Calcium may reduce the absorption of bisphosphonates, sodium fluoride, quinolone and tetracycline antibiotics or iron. The oral interval between calcium and the above substances should be at least 3 hours.

WHAT SHOULD YOU DO IF YOU MISS A DOSE:

The next dose should be taken as directed. Do not take extra medicine to make up the missed dose to avoid overdose.

HOW TO STORE THIS MEDICINE: Store in dry places, not exceeding 30oC, protect from light.

SIGNS AND SYMPTOMS OF DRUG OVERDOSE: A serum calcium concentration exceeding 2.6 mmol per liter (10.5 mg per 100 ml) is considered a hypercalcaemic condition. Withholding additional administration of calcium and any other medications that may cause hypercalcaemia usually resolves mild hypercalcaemia in asymptomatic patients, when renal function is adequate.

WHAT TO DO WHEN YOU HAVE TAKEN MORE THAN THE RECOMMENDED DOSAGE: When serum calcium concentrations are greater than 2.9 mmol per liter (12 mg per 100 ml), immediate measures may be required with possible use of the following:

Hydrating with intravenous 0.9% sodium chloride injection. Forcing diuresis with furosemide or ethacrynic acid may be used to rapidly increase calcium and sodium excretion when saline overload occurs.

Monitoring of potassium and magnesium serum concentrations and starting replacement early to prevent complications of therapy.

ECG monitoring and the possible use of beta-adrenergic blocking agents to protect the heart against serious arrhythmias.

Possibly including hemodialysis, calcitonin, and adrenocorticoids in the treatment.

Determining serum calcium concentrations at frequent intervals to guide therapy adjustments.

WHAT ARE THE PRECAUTIONS WHEN TAKING THIS MEDICINE: Caution should be exercised in patients with a history of kidney stones.

In the long-term therapy, urinary calcium concentrations should be frequently monitored. If calciuria levels exceed 7.5 mmol (300 mg)/24 hours, dosage should be reduced or treatment should be temporarily interrupted.

Pregnancy and lactation: No adverse effects have been reported with the daily recommended dose.

Effects of on works: The drug does not affect the ability to drive, use machines, work at height, and other cases.

WHEN SHOULD YOU CONSULT YOUR DOCTOR, PHARMACIST: If you need further information, please consult your doctor or pharmacist.

SHELF-LIFE: 36 months from the manufacturing date.

DATE OF REVISION OF THE TEXT: July 24, 2018.

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