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Rosuvastatin calcium tablets (Keding)

This product is applicable to primary hypercholesterolemia (type IIA, including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIB) that can not properly control dyslipidemia after diet control and other non drug treatments (such as exercise therapy and weight loss). This product is also suitable for patients with homozygous familial hypercholesterolemia as an adjuvant treatment of dietary control and other lipid-lowering measures (such as LDL removal therapy), or when these methods are not applicable. More role
App download minus 10 yuan
Common name:
rosuvastatin calcium tablets
Product No.:
B14202159178
Approval No.:
Gyzz j20170008 (original h20160545) (inquired by the State Drug Administration)
Jianke price:
¥65.00
Product specification:
10mg*7s 10mg * 28 tablets 10mg * 7 pieces * 4 boxes + 0.6g * 60 pieces 10mg * 7 tablets * 6 boxes + 10mg * 30s 10mg * 28 tablets + 0.6g * 60 Tablets 10mg * 28 tablets * 2 boxes + 10mg * 30s
Manufacturer:
AstraZeneca Pharmaceutical (China) Co., Ltd
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Product name Rosuvastatin calcium tablets (Keding)
Main raw materials The active ingredient of this product is rosuvastatin calcium.
Main role This product is applicable to primary hypercholesterolemia (type IIA, including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIB) that can not properly control dyslipidemia after diet control and other non drug treatments (such as exercise therapy and weight loss). This product is also suitable for patients with homozygous familial hypercholesterolemia as an adjuvant treatment of dietary control and other lipid-lowering measures (such as LDL removal therapy), or when these methods are not applicable.
Product specification 10mg*7s
Usage and dosage Before treatment, patients should be given standard cholesterol lowering diet control, and maintain diet control during treatment. The use of this product should follow the principle of individualization, and comprehensively consider the individual cholesterol level, expected cardiovascular risk and potential risk of adverse reactions. Oral. The common starting dose of this product is 5 mg, once a day. The selection of the initial dose should comprehensively consider the individual cholesterol level, the expected cardiovascular risk and the potential risk of adverse reactions. For those patients who need to reduce low density lipoprotein cholesterol (LDL-C) more effectively, 10mg once a day can be considered as the starting dose, which can control the blood lipid level of most patients. If necessary, the dose level to the higher level can be adjusted after 4 weeks of treatment. The maximum daily dose of this product is 20mg. This product can be administered at any time of the day. It can be taken when eating or fasting. Medication for patients with renal insufficiency Patients with mild and moderate renal impairment do not need to adjust the dose. All doses of this product are prohibited for patients with severe renal impairment. Medication for patients with liver function impairment In subjects with child Pugh score no higher than 7, the systemic exposure of rosuvastatin did not increase. In subjects with child Pugh scores of 8 and 9, an increase in systemic exposure was observed. In these patients, the evaluation of renal function should be considered. There is no experience of using this product in patients with a child Pugh score of more than 9. This product is forbidden for patients with active liver disease. race Increased systemic exposure has been observed in Asian subjects. This factor should be taken into account when determining the dosage of patients with Asian descent.
manufacturing enterprise AstraZeneca Pharmaceutical (China) Co., Ltd
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[drug name] Rosuvastatin calcium tablets (Keding)

[common name] rosuvastatin calcium tablets

[specification and model] 10mg*7s

[manufacturer] AstraZeneca Pharmaceutical (China) Co., Ltd

[drug type] Western medicine

[approval No.] Gyzz j20170008 (original h20160545)

[validity period] 36 months

[functional indications] This product is applicable to primary hypercholesterolemia (type IIA, including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIB) that can not properly control dyslipidemia after diet control and other non drug treatments (such as exercise therapy and weight loss). This product is also suitable for patients with homozygous familial hypercholesterolemia as an adjuvant treatment of dietary control and other lipid-lowering measures (such as LDL removal therapy), or when these methods are not applicable.

[usage and dosage] Before treatment, patients should be given standard cholesterol lowering diet control, and maintain diet control during treatment. The use of this product should follow the principle of individualization, and comprehensively consider the individual cholesterol level, expected cardiovascular risk and potential risk of adverse reactions. Oral. The common starting dose of this product is 5 mg, once a day. The selection of the initial dose should comprehensively consider the individual cholesterol level, the expected cardiovascular risk and the potential risk of adverse reactions. For those patients who need to reduce low density lipoprotein cholesterol (LDL-C) more effectively, 10mg once a day can be considered as the starting dose, which can control the blood lipid level of most patients. If necessary, the dose level to the higher level can be adjusted after 4 weeks of treatment. The maximum daily dose of this product is 20mg. This product can be administered at any time of the day. It can be taken when eating or fasting. Medication for patients with renal insufficiency Patients with mild and moderate renal impairment do not need to adjust the dose. All doses of this product are prohibited for patients with severe renal impairment. Medication for patients with liver function impairment In subjects with child Pugh score no higher than 7, the systemic exposure of rosuvastatin did not increase. In subjects with child Pugh scores of 8 and 9, an increase in systemic exposure was observed. In these patients, the evaluation of renal function should be considered. There is no experience of using this product in patients with a child Pugh score of more than 9. This product is forbidden for patients with active liver disease. race Increased systemic exposure has been observed in Asian subjects. This factor should be taken into account when determining the dosage of patients with Asian descent.

[adverse reactions] The adverse reactions seen with this product are usually mild and transient. In foreign controlled clinical trials, less than 4% of patients withdrew from the trial due to adverse events. The frequency of adverse events is in the following order: common (incidence > 1 / 100, < 1 / 10); Rare (> 1 / 1000, < 1 / 100); Rare (> 1 / 10000, < 1 / 1000); Extremely rare (< 1 / 10000). Immune system abnormalities are rare: allergic reactions, including angioneuroedema. Nervous system abnormalities are common: headache, dizziness, gastrointestinal abnormalities are common: constipation, nausea, abdominal pain, skin and subcutaneous tissue abnormalities are rare: pruritus, rash and urticaria, skeletal muscle, joint and bone abnormalities are common: myalgia is rare: myopathy and rhabdomyolysis, systemic abnormalities are common: weakness is the same as other HMG CoA reductase inhibitors, The incidence of adverse reactions increased with the increase of dose. Effect on kidney: proteinuria (detected by test paper method) was observed in patients receiving this product, and most of the protein came from renal tubules. In about 1% of patients, proteinuria increased from no or slight to + + or more at some time during 10mg and 20mg treatment, and in about 3% of patients receiving 40mg treatment. In the 20 mg dose treatment, a slight increase in proteinuria from no or slight increase to + was observed. In most cases, proteinuria decreased or disappeared automatically after continued treatment. See the inner packaging instructions for details.

[precautions] Effect on kidney: Proteinuria (detected by test paper method) was observed in patients treated with high dose, especially 40mg. Most of the protein came from renal tubules. In most cases, proteinuria was transient or intermittent. Proteinuria is not considered a precursor of acute or progressive nephropathy (see "adverse reactions"). Effects on skeletal muscle: There are reports of effects on skeletal muscle in patients treated with various doses of this product, such as myalgia, myopathy, and rare rhabdomyolysis, especially in patients with doses greater than 20 mg. Very rare rhabdomyolysis has been reported when ezetimib is combined with HMG CoA reductase inhibitor. Do not rule out the interaction of efficacy, these drugs should be used carefully. Creatine kinase assay Creatine kinase (CK) should not be detected after strenuous exercise or when there are plausible factors causing the increase of CK, which will confuse the interpretation of the results. If the basic value of CK increases significantly (]5) × ULN) shall be tested and confirmed within 5 ~ 7 days. If repeated tests confirm the patient's basic CK value]5 × ULN, treatment cannot be started. Before treatment Like other HMG CoA reductase inhibitors, patients with predisposing factors of myopathy / rhabdomyolysis should be cautious when using this product. See the inner packaging instructions for details. Please read the instructions carefully and follow the doctor's advice.

[taboo] This product is prohibited in: 1. Those who are allergic to rosuvastatin or any component in this product. 2. Patients with active liver disease, including patients with unexplained continuous increase of serum aminotransferase and patients with any increase of serum aminotransferase exceeding 3 times the upper limit of normal value (ULN). 3. Patients with severe renal impairment (creatinine clearance < 30ml / min). 4. Myopathy patients. 5. Patients using cyclosporine at the same time. 6. Women who do not use appropriate contraceptives during pregnancy, lactation and possible pregnancy.

[listing Permit Holder] AstraZeneca UK Limited (sub packaged by AstraZeneca Pharmaceutical (China) Co., Ltd.)

[packaging unit] box

[main ingredients] The active ingredient of this product is rosuvastatin calcium.

[character] This product is pink film coated tablets.

[applicable population] adult

[medication for pregnant and lactating women] This product is forbidden for pregnant and lactating women. Women who are likely to become pregnant should take appropriate contraceptive measures. Because cholesterol and other cholesterol biosynthetic products are important for embryonic development, the risk from HMG CoA reductase inhibition outweighs the benefits of treatment for pregnant women. Animal studies provide limited evidence of reproductive toxicity. If the patient becomes pregnant during the use of this product, the treatment should be stopped immediately. Rosuvastatin can be secreted into rat milk. There is no data on the secretion of rosuvastatin into human milk.

[medication for children] The safety and effectiveness of this product in children have not been established. The experience of pediatric use is limited to a small number of children (age ≥ 8 years) with homozygous familial hypercholesterolemia. Therefore, this product is not recommended for pediatrics.

[medication for elderly patients] There is no need to adjust the dose.

[storage] Seal and store in a dry place

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    Rosuvastatin calcium tablets (Keding)

    ¥65.00

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