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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。
不良反应：
1．嗳气、便秘。
2．大剂量服用可发生高钙血症。
3．偶可发生奶一碱综合症，表现为高血钙、碱中毒及肾功能不全。
注意事项：
1．心肾功能不全者慎用。
2．尿钙或血钙浓度过高者禁用。
3．洋地黄化病人禁用。
4．当药品性状发生改变时禁止服用。
5．儿童必须在成人监护下使用。
6．请将此药品放在儿童不能接触的地方。
药物相互作用：
钙是维持人体神经、肌肉、骨骼系统、细胞膜和毛细血管通透性正常功能所必需，特别是对牙齿、骨骼的生长发育尤为重要。维生素D能参与钙和磷的代谢．能辅助“钙结合蛋白”的形成，进而使肠道中吸收钙送至血液及骨骼等组织。
贮 藏：
遮光，密封保存。
 
Calcichew-D3 1000 mg/800IU Once Daily chewable tablets
Calcichew-D3 500 mg/400 IU Caplets(http://www.medicines.org.uk/emc/medicine/28501)
1. Name of the medicinal product
Calcichew-D3 1000 mg/800 IU Once Daily chewable tablets
2. Qualitative and quantitative composition
One tablet contains:
Calcium carbonate equivalent to 1000 mg calcium
Colecalciferol concentrate (powder form) equivalent to 800 IU (20 microgram) colecalciferol (vitamin D3)
Excipient(s) with known effect:
One tablet contains 88.7 mg isomalt (E953) (contained in the flavour), 3 mg sucrose, 0.6 mg soya-bean oil, hydrogenated
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Chewable tablet
Round, white, uncoated and convex tablets of 18 mm. May have small specks.
4. Clinical particulars
4.1 Therapeutic indications
Prevention and treatment of vitamin D and calcium deficiency in the elderly.
Vitamin D and calcium supplement as an adjunct to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency.
4.2 Posology and method of administration
Adults and elderly
One chewable tablet once daily. The tablet may be chewed or sucked.
Dosage in hepatic impairment
No dose adjustment is required
Dosage in renal impairment
Calcichew-D3 Once Daily chewable tablets should not be used in patients with severe renal impairment.
Calcichew-D3 Once Daily chewable tablets are not intended for use in children.
4.3 Contraindications
Diseases and/or conditions resulting in hypercalcaemia and/or hypercalcuria
Severe renal impairment
Nephrolithiasis
Hypervitaminosis D
Hypersensitivity to soya or peanut
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1
4.4 Special warnings and precautions for use
During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurements 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).
Calcichew-D3 Once Daily chewable tablets should be prescribed with caution to patients suffering from sarcoidosis, due to the risk of increased metabolism of vitamin D into its active form. These patients should be monitored with regard to the calcium content in serum and urine.
Calcichew-D3 Once Daily chewable tablets should be used cautiously in immobilised patients with osteoporosis due to increased risk of hypercalcaemia.
The content of vitamin D (800 IU) in Calcichew-D3 Once Daily chewable tablets should be considered when prescribing other medicinal products containing vitamin D. Additional doses of calcium or vitamin D should be taken under close medical supervision. In such cases it is necessary to monitor serum calcium levels and urinary calcium excretion frequently. Milk-alkali syndrome (Burnett's syndrome), i.e. hypercalcaemia, alkalosis and renal impairment, can develop when large amounts of calcium are ingested with absorbable alkali.
Co-administration with tetracyclines or quinolones is usually not recommended, or must be done with precaution (see section 4.5).
Calcichew-D3 Once Daily chewable tablets contain isomalt (E953) and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.5 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.
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.
Hypercalcaemia may increase the toxicity of cardiac glycosides during treatment with calcium and vitamin D. Patients should be monitored with regard to electrocardiogram (ECG) and serum calcium levels.
If a bisphosphonate is used concomitantly, this preparation should be administered at least one hour before the intake of Calcichew-D3 Once Daily chewable tablets since gastrointestinal absorption may be reduced.
The efficacy of levothyroxine can be reduced by the concurrent use of calcium, due to decreased levothyroxine absorption. Administration of calcium and levothyroxine should be separated by at least four hours.
The absorption of quinolone antibiotics may be impaired if administered concomitantly with calcium. Quinolone antibiotics should be taken two hours before or six hours after intake of calcium.
Calcium salts may decrease the absorption of iron, zinc and strontium ranelate. Consequently, iron, zinc or strontium ranelate preparations should be taken two hours before or after Calcichew-D3 Once Daily chewable tablets
4.6 Fertility, pregnancy and lactation
Pregnancy
During pregnancy the daily intake should not exceed 1500 mg calcium and 600 IU vitamin D, and Calcichew-D3 Once Daily chewable tablets are therefore not suitable during pregnancy. Studies in animals have shown reproductive toxicity of high doses of vitamin D. In pregnant women, overdoses of calcium and vitamin D should be avoided as permanent hypercalcaemia has been related to adverse effects on the developing foetus.
Breast-feeding
Calcichew-D3 Once Daily chewable tablets can be used during breast-feeding. Calcium and vitamin D3 pass into breast milk. This should be considered when giving additional vitamin D to the child.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. An effect is however, unlikely.
4.8 Undesirable effects
Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), or very rare (<1/10,000).
Metabolism and nutrition disorders
Uncommon: Hypercalcaemia and hypercalciuria.
Very rare: Seen usually only in overdose (see section 4.9) Milk-alkali syndrome.
Gastrointestinal disorders
Rare: Constipation, flatulence, nausea, abdominal pain, and diarrhoea.
Very rare: Dyspepsia.
Skin and subcutaneous tissue disorders
Very rare: Pruritus, rash and urticaria.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in United Kingdom as Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
Overdose can lead to hypervitaminosis and hypercalcaemia. Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polidipsia, polyuria, bone pain, nephrocalcinosis, renal calculi and in severe cases, cardiac arrhythmias. Extreme hypercalcaemia may result in coma and death. Persistently high calcium levels may lead to irreversible renal damage and soft tissue calcification.
Milk-alkali syndrome may occur in patients who ingest large amounts of calcium and absorbable alkali. Symptoms are frequent urge to urinate, continuing headache, continuing loss of appetite, nausea or vomiting, unusual tiredness or weakness, hypercalcaemia, alkalosis and renal impairment.
Treatment: The treatment with calcium and vitamin D must be discontinued. Treatment with thiazide diuretics, lithium, vitamin A, vitamin D and cardiac glycosides must also be discontinued. Emptying of the stomach in patients with impaired consciousness. Rehydration, and, according to severity, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids. Serum electrolytes, renal function and diuresis must be monitored. In severe cases, ECG and CVP should be followed.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Calcium, combination with other drugs
ATC code: A12AX
Vitamin D increases the intestinal absorption of calcium.
Administration of calcium and vitamin D3 counteracts the increase of parathyroid hormone (PTH) which is caused by calcium deficiency and which causes increased bone resorption.
A clinical study of institutionalised patients suffering from vitamin D deficiency indicated that a daily intake of 1000 mg calcium and 800 IU vitamin D for six months normalised the value of the 25-hydroxylated metabolite of vitamin D3 and reduced secondary hyperparathyroidism and alkaline phosphatases.
An 18 month double-blind, placebo controlled study including 3270 institutionalised women aged 84+/- 6 years who received supplementation of vitamin D (800 IU/day) and calcium phosphate (corresponding to 1200 mg/day of elemental calcium), showed a significant decrease of PTH secretion. After 18 months, an "intent-to treat" analysis showed 80 hip fractures in the calcium-vitamin D group and 110 hip fractures in the placebo group (p=0,004). A follow-up study after 36 months showed 137 women with at least one hip fracture in the calcium-vitamin D group (n=1176) and 178 in the placebo group (n=1127) (p<0,02).
5.2 Pharmacokinetic properties
Calcium
Absorption: Generally, the amount of calcium absorbed through the gastrointestinal tract is approximately 30% of the swallowed dose.
Distribution and biotransformation: 99% of the calcium in the body is concentrated in the hard structure of bones and teeth. The remaining 1% is present in the intra- and extracellular fluids. About 50% of the total blood-calcium content is in the physiologically active ionised form with approximately 10% being complexed to citrate, phosphate or other anions, the remaining 40% being bound to proteins, principally albumin.
Elimination: Calcium is eliminated through faeces, urine and sweat. Renal excretion depends on glomerular filtration and calcium tubular reabsorption.
Vitamin D
Absorption: Vitamin D is easily absorbed in the small intestine.
Distribution and biotransformation: Colecalciferol and its metabolites circulate in the blood bound to a specific globulin. Colecalciferol is converted in the liver by hydroxylation to 25-hydroxycolecalciferol. It is then further converted in the kidneys to the active form 1,25 dihydroxycolecalciferol. 1,25 dihydroxycolecalciferol is the metabolite responsible for increasing calcium absorption. Vitamin D which is not metabolised is stored in adipose and muscle tissues.
Elimination: Vitamin D is excreted in faeces and urine.
5.3 Preclinical safety data
At doses far higher than the human therapeutic range teratogenicity has been observed in animal studies. There is further no information of relevance to the safety assessment in addition to what is stated in other parts of the SPC.
6. Pharmaceutical particulars
6.1 List of excipients
Xylitol (E967)
Povidone
Isomalt (E953)
Flavouring (lemon)
Magnesium stearate
Sucralose (E955)
Mono- and diglycerides of fatty acids
All-rac-alpha-tocopherol
Soya-bean oil, hydrogenated
Sucrose
Gelatin
Maize starch
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
HDPE tablet container: 3 years
Blister: 2 years
6.4 Special precautions for storage
HDPE tablet container: Do not store above 30°C. Store in the original container in order to protect from light. Keep the container tightly closed in order to protect from moisture.
Blister: Do not store above 25°C. Store in the original package in order to protect from moisture. Keep blister in the outer carton in order to protect from light.
6.5 Nature and contents of container
The chewable tablets are packed in:
HDPE containers with HDPE screw caps: 15, 30, 40, 60 and 90 tablets.
PVC/PE/PVdC/Aluminium blisters: 7, 14, 28, 50x1 (unit dose), 56, 84, 112, 140 and 168 tablets
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorisation holder
Takeda UK Limited
Building 3
Glory Park
Glory Park Avenue
Wooburn Green
BUCKS
HP10 0DF
UK
8. Marketing authorisation number(s)
PL 16189/0028
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 04-Nov-2009
Date of last renewal: 04-06-2013
10. Date of revision of the text
26-Sept-2014
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注：以下产品不同规格和不同价格，购买时请以咨询为准！
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产地国家: 英国
原产地英文商品名:
CALCICHEW -D3(500mg/400iu)/Caplets 60Caplets/bottle
原产地英文药品名:
CALCIUM CARBONATE/VITAMIN D3
中文参考商品译名:
凯思立D3 囊片 (500毫克/400单位)/囊片 60囊片/瓶
中文参考药品译名:
碳酸钙/维生素D3
生产厂家中文参考译名:
武田制药
产厂家英文名:
Takeda
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产地国家: 英国
原产地英文商品名:
CALCICHEW-D3 (1000mg/800iu)/Caplets 100Caplets /bottle
原产地英文药品名:
CALCIUM CARBONATE/VITAMIN D3
中文参考商品译名:
凯思立D3 囊片 (1000毫克/800单位)/片 60囊片/瓶
中文参考药品译名:
碳酸钙/维生素D3
生产厂家中文参考译名:
武田制药
产厂家英文名:
Takeda
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产地国家: 英国
原产地英文商品名:
CALCICHEW D3 CHEWABLE 12.5mg/850mg 100tabs (Minimum order qty: 7)
原产地英文药品名:
CALCIUM CARBONATE/VITAMIN D3
中文参考商品译名:
凯思立D3 咀嚼片 (12.5毫克/800毫克)/片 100片/瓶 (最低订货量：7)
中文参考药品译名:
碳酸钙/维生素D3
生产厂家中文参考译名:
武田制药
生产厂家英文名:
Takeda
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产地国家: 英国
原产地英文商品名:
CALCICHEW D3 FORTE CHEWABLE (1250mg/400iu)/tab 100tabs/bottle
原产地英文药品名:
CALCIUM CARBONATE/VITAMIN D3
中文参考商品译名:
凯思立D3 FORTE咀嚼片 (1250毫克/400单位)/片 100片/瓶
中文参考药品译名:
碳酸钙/维生素D3
生产厂家中文参考译名:
奈科明制药
产厂家英文名:
Nycomed Pharma AS
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产地国家: 英国
原产地英文商品名:
CALCICHEW D3 FORTE CHEWABLE (1250mg/200iu)/tab 100tabs/bottle
原产地英文药品名:
CALCIUM CARBONATE/VITAMIN D3
中文参考商品译名:
凯思立D3 FORTE咀嚼片 (1250毫克/200单位)/片 100片/瓶
中文参考药品译名:
碳酸钙/维生素D3
生产厂家中文参考译名:
奈科明制药
产厂家英文名:
Nycomed Pharma AS
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