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Shagliptin tablets (amlizer)

For type 2 diabetes. Monotherapy: it can be used as monotherapy to improve blood glucose control on the basis of diet and exercise. Combined treatment: when metformin hydrochloride alone has poor blood glucose control, it can be used in combination with metformin hydrochloride to improve blood glucose control on the basis of diet and exercise. Important use restriction: because the effectiveness of type 1 diabetes and diabetic ketoacidosis has not yet been determined, this product is not used in patients with type 1 diabetes or diabetic ketoacidosis. More role
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Common name:
Shagliptin tablets
Product No.:
B14202168607
Approval No.:
Gyzz j20160069 (former gyzz j20150066) (inquired by the State Drug Administration)
Jianke price:
¥78.50
Product specification:
2.5mg/1000mg*14s 5mg / 1000mg * 14 tablets 5mg*7s 5mg*30s
Manufacturer:
AstraZeneca Pharmaceuticals LP
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Product name Shagliptin tablets (amlizer)
Main raw materials The active ingredient of this product is shagliptin.
Main role For type 2 diabetes. Monotherapy: it can be used as monotherapy to improve blood glucose control on the basis of diet and exercise. Combined treatment: when metformin hydrochloride alone has poor blood glucose control, it can be used in combination with metformin hydrochloride to improve blood glucose control on the basis of diet and exercise. Important use restriction: because the effectiveness of type 1 diabetes and diabetic ketoacidosis has not yet been determined, this product is not used in patients with type 1 diabetes or diabetic ketoacidosis.
Product specification 5mg*7s
Usage and dosage Oral administration, the recommended dose is 5mg, once a day, and the medication time is not affected by meals.
manufacturing enterprise AstraZeneca Pharmaceuticals LP
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[drug name] Shagliptin tablets (amlizer)

[common name] Shagliptin tablets

[specification and model] 5mg*7s

[manufacturer] AstraZeneca Pharmaceuticals LP

[drug type] Western medicine

[approval No.] Gyzz j20160069 (former gyzz j20150066)

[validity period] 36 months

[functional indications] For type 2 diabetes. Monotherapy: it can be used as monotherapy to improve blood glucose control on the basis of diet and exercise. Combined treatment: when metformin hydrochloride alone has poor blood glucose control, it can be used in combination with metformin hydrochloride to improve blood glucose control on the basis of diet and exercise. Important use restriction: because the effectiveness of type 1 diabetes and diabetic ketoacidosis has not yet been determined, this product is not used in patients with type 1 diabetes or diabetic ketoacidosis.

[usage and dosage] Oral administration, the recommended dose is 5mg, once a day, and the medication time is not affected by meals.

[adverse reactions] Clinical trials: Due to the great differences in the conditions of various clinical trials, the incidence of adverse reactions of one drug in clinical trials can not be directly compared with that of another drug in clinical trials, and this incidence can not reflect the incidence of adverse reactions of drugs in practical application. Monotherapy and combination therapy: In two 24 week placebo-controlled monotherapy trials, patients were given shagliptin 2.5 mg / day, 5 mg / day and placebo, respectively. In addition, three 24 week, placebo-controlled and combined treatment trials were conducted, which were combined with metformin, thiazolidinediones (TZD) drugs (pioglitazone or rosiglitazone) and glibenclamide respectively. Patients were randomly assigned to shagliptin 2.5 mg / day, 5 mg / day or placebo combined treatment group. In one single drug treatment trial and one metformin combination treatment trial, the 10 mg dose group of shagliptin was also included. See the inner packaging instructions for details.

[precautions] Use with caution for the following symptoms: 1. Shah Glenn Dean can not be used in patients with type 1 diabetes or diabetic ketoacidosis. The combination of shagliptin and insulin has not been studied. 2. Renal insufficiency. 3. Impaired liver function. 4. Hypersensitivity. 5. Skin diseases. 6. Heart failure. 7. Immunocompromised patients. 8. Lactose. 9. Combined with drugs known to cause hypoglycemia. See the inner packaging instructions for details. Please read the instructions carefully and follow the doctor's advice.

[taboo] Patients who are allergic to any active substance or excipient in the drug.

[listing Permit Holder] AstraZeneca pharmaceuticals LP (sub packaged by AstraZeneca Pharmaceutical Co., Ltd.)

[packaging unit] box

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

[character] This product is a pink film coated tablet, which turns white after removing the coating.

[applicable population] adult

[medication for pregnant and lactating women] Adequate and well controlled studies have not been carried out in pregnant women and are not recommended for pregnant women. See the inner packaging instructions for details.

[medication for children] The safety and efficacy study of shagliptin has not been carried out in children, and it is not recommended for children.

[medication for elderly patients] In 6 double-blind and controlled clinical trials on the safety and efficacy of shagliptin, a total of 4148 randomized patients participated, of which 634 (15.3%) were ≥ 65 years old and 59 (1.4%) were ≥ 75 years old. There was no overall difference in safety or efficacy between patients ≥ 65 years old and young patients. This clinical trial has not determined the difference in drug response between the elderly and young people, so it cannot rule out the possibility that some older patients may be more sensitive to drugs. Shagliptin and its active metabolites are partially eliminated by the kidney. Because the possibility of renal function reduction in elderly patients is higher, the dosage of elderly patients should be carefully selected according to renal function.

[storage] Store below 30 ℃.

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    Shagliptin tablets (amlizer)

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