部分中文凯思立处方资料(仅供参考)
产品名称:
凯思立d calcichew d3
成 分:
本品每片含主要成份碳酸钙1.25克(相当于钙0.5克),维生素D3200国际单位。 辅料为山梨醇、PVP K30、橘味颗粒、阿斯巴甜和硬脂酸镁。
适 应 症:
用于防治骨质疏松,也可作为儿童、妊娠、哺乳期妇女、更年期妇女、老年人等的钙补充剂。
用法用量:
咀嚼后咽下。成人,~次一片,一日一至二次,一日最大量不超过3片;儿童, 一次半片,一日一至二次。个别情况请遵医嘱
CALCICHEW D3 TAB
Calcichew-D3 Chewable Tablets
Per tablet:
Calcium carbonate
1250mg(equivalent to 500mg of elemental calcium)
Colecalciferol 200iu
(equivalent to 5 micrograms vitamin D3)Calcichew-D3 Chewable Tablets may be used as an adjunct to specific therapy for osteoporosis or as a therapeutic supplement in established osteomalacia, pregnant patients at high risk of needing such a therapeutic supplementation or malnutrition when dietary intake is less than that required
Therapeutic indications
Calcichew-D3 Chewable Tablets should be used only as a therapeutic and not as a food supplement when the diet is deficient or when normal requirement of both components is increased.
Calcichew-D3 Chewable Tablets may be used as an adjunct to specific therapy for osteoporosis or as a therapeutic supplement in established osteomalacia, pregnant patients at high risk of needing such a therapeutic supplementation or malnutrition when dietary intake is less than that required.
method of administration
Oral.
Adjunctive therapy in osteoporosis:
One chewable tablet 2-3 times per day
Calcium and vitamin D deficiency:
Adults
One chewable tablet 2-3 times per day.
Children
One chewable tablet 1-2 times per day.
The tablet may be chewed or sucked.
Dosage in hepatic impairment:
No dose adjustment is required.
Dosage in renal impairment:
Calcichew-D3 chewable tablets should not be used in patients with severe renal impairment.
Contraindications
· Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria
· Nephrolithiasis
· Hypervitaminosis D
· Hypersensitivity to soya or peanut
· Hypersensitivity to the active substances or to any of the excipients
Special warnings and precautions for use
During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurement of serum creatinine. Monitoring is especially important in elderly patients on concomitant treatment with cardiac glycosides or diuretics (see section 4.5) and in patients with a high tendency to calculus formation. In case of hypercalcaemia or signs of impaired renal function, the dose should be reduced or the treatment discontinued.
Vitamin D should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account. In patients with severe renal insufficiency, vitamin D in the form of colecalciferol is not metabolised normally and other forms of vitamin D should be used (see section 4.3, contraindications).
Calcichew-D3 chewable tablets should be prescribed with caution to patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active form. These patients should be monitored with regard to the calcium content in serum and urine.
Calcichew-D3 Chewable Tablets should be used with caution in immobilised patients with osteoporosis due to the increased risk of hypercalcaemia.
The content of colecalciferol (200 IU) in Calcichew-D3 Chewable Tablets should be considered when prescribing other medicinal products containing vitamin D or nutrients (such as milk). Additional doses of calcium or vitamin D increase the risk of hypercalcaemia with subsequent kidney function impairment and milk-alkali syndrome; therefore they should be taken under close medical supervision. In such cases it is necessary to monitor serum calcium levels and urinary calcium excretion frequently.
Calcichew-D3 Chewable Tablets contain aspartame (a source of phenylalanine) which may be harmful for people with phenylketonuria.
Calcichew-D3 Chewable Tablets contain sorbitol (E420), isomalt and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Interaction with other medicinal products and other forms of interaction
Thiazide diuretics reduce the urinary excretion of calcium. Due to increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.
Systemic corticosteroids reduce calcium absorption. During concomitant use, it may be necessary to increase the dose of Calcichew-D3 Chewable Tablets.
Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D.
Calcium carbonate may interfere with the absorption of concomitantly administered tetracycline preparations. For this reason, tetracycline preparations should be administered at least two hours before, or four to six hours after, oral intake of calcium.