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Gefitinib tablets (Iressa)

The single drug of this product is applicable to the first-line treatment of patients with locally advanced or metastatic non-small cell carcinoma (NSCLC) with sensitive mutation of epidermal growth factor receptor (EGFR) gene and locally advanced or metastatic non-small cell carcinoma (NSCLC) who have previously received chemotherapy. See the instructions for details. More role
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Common name:
Gefitinib tablets
Product No.:
S14202011832
Approval No.:
Gyzz j20180014 (former gyzz j20142) (inquired by the State Drug Administration)
Jianke price:
¥3200.00
Product specification:
150mg * 7 tablets 0.25g*10s 0.25g*10s
Manufacturer:
AstraZeneca UK Limited (UK)
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      Product name Gefitinib tablets (Iressa)
      Main raw materials Main ingredient: gefitinib Chemical name: n - (3-chloro-4-fluorophenyl) - 7-methoxy-6 - (3-morpholine propoxy) quinazoline-4-amine Molecular formula: c22h24clfn4o Molecular weight: 446.90
      Main role The single drug of this product is applicable to the first-line treatment of patients with locally advanced or metastatic non-small cell carcinoma (NSCLC) with sensitive mutation of epidermal growth factor receptor (EGFR) gene and locally advanced or metastatic non-small cell carcinoma (NSCLC) who have previously received chemotherapy. See the instructions for details.
      Product specification 0.25g*10s
      Usage and dosage The recommended dose is 250mg (1 tablet) once a day, on an empty stomach or with food. It is not recommended for children or adolescents, and the safety and efficacy of this patient group have not been studied. If you have difficulty swallowing, disperse the tablets in half a cup of drinking water (non carbonated beverage), and do not use other liquids. Drop the tablet into water without crushing, stir until completely dispersed (about 10 minutes), and drink the liquid immediately. Rinse the cup with half a glass of water and drink. The solution can also be administered through a nose stomach tube. There is no need to adjust the dosage according to the following conditions: age, weight, gender, race, renal function, moderate to severe liver function damage caused by liver metastasis. Dose adjustment: when the patient has intolerable diarrhea or adverse skin reactions, it can be solved by short-term suspension of treatment (up to 14 days), and then resume the dose of 250 mg per day.
      manufacturing enterprise AstraZeneca UK Limited (UK)
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      [drug name] Gefitinib tablets (Iressa)

      [common name] Gefitinib tablets

      [specification and model] 0.25g*10s

      [manufacturer] AstraZeneca UK Limited (UK)

      [drug type] Western medicine

      [approval No.] Gyzz j20180014 (former gyzz j20142)

      [validity period] 24 months

      [functional indications] The single drug of this product is applicable to the first-line treatment of patients with locally advanced or metastatic non-small cell carcinoma (NSCLC) with sensitive mutation of epidermal growth factor receptor (EGFR) gene and locally advanced or metastatic non-small cell carcinoma (NSCLC) who have previously received chemotherapy. See the instructions for details.

      [usage and dosage] The recommended dose is 250mg (1 tablet) once a day, on an empty stomach or with food. It is not recommended for children or adolescents, and the safety and efficacy of this patient group have not been studied. If you have difficulty swallowing, disperse the tablets in half a cup of drinking water (non carbonated beverage), and do not use other liquids. Drop the tablet into water without crushing, stir until completely dispersed (about 10 minutes), and drink the liquid immediately. Rinse the cup with half a glass of water and drink. The solution can also be administered through a nose stomach tube. There is no need to adjust the dosage according to the following conditions: age, weight, gender, race, renal function, moderate to severe liver function damage caused by liver metastasis. Dose adjustment: when the patient has intolerable diarrhea or adverse skin reactions, it can be solved by short-term suspension of treatment (up to 14 days), and then resume the dose of 250 mg per day.

      [adverse reactions] The most common adverse drug reactions (with an incidence of more than 20%) were diarrhea, rash, pruritus, dry skin and acne. They were usually reversible within the first month after taking the drug. About 8% of patients had serious adverse drug reactions (CTC standard grade 3 or 4). Only 1% of patients stopped treatment due to adverse reactions. Adverse events occurred in each body system were ranked in descending order according to the frequency of occurrence (common: & Ge; (greater than equal) 10%; common: & Ge; (greater than equal) 1% and & lt; 10%; rare: & Ge; (greater than equal) 0.1% and & lt; 1%; rare: & Ge; (greater than equal) 0.01% and & lt; 0.1%; extremely rare: & lt; 0.01%). The possible adverse events are summarized as follows: Digestive system: diarrhea is common, mainly mild (ctc1 level), rarely moderate (ctc2 level), and severe diarrhea with dehydration (ctc3 level) is reported in some cases. Common nausea, mainly mild (ctc1); Vomiting, mainly mild or moderate (ctc1 or grade 2); Anorexia, mild or moderate (ctc1 or grade 2); Oral mucositis, mostly mild (ctc1); Dehydrated oral ulcer secondary to diarrhea, nausea, vomiting or anorexia. Pancreatitis is rare. Skin and accessories: common skin reactions, mainly

      [precautions] Patients treated with gefitinib may occasionally develop acute interstitial lung disease, and some patients may die (see section 'possible adverse reactions'). Mortality increases in patients with congenital pulmonary fibrosis / interstitial pneumonia / pneumoconiosis / radiation pneumonia / drug-induced pneumonia. If the patient's respiratory symptoms such as shortness of breath, cough and fever worsen, the treatment should be interrupted and the cause should be found out in time. When interstitial lung disease is confirmed, gefitinib should be stopped and the patient should be treated accordingly. Asymptomatic elevated hepatic aminotransferase has been observed (see section 'possible adverse reactions'). Therefore, it is recommended to check liver function regularly. It can be used cautiously in patients with mild to moderate increase of liver transaminase. If liver function damage is serious, drug withdrawal should be considered. Substances that induce CYP3A4 activity can increase the metabolism of gefitinib and reduce its plasma concentration. Therefore, combination with CYP3A4 inducers (such as phenytoin, carbamoyl diazepine, rifampicin, barbital salts or St John's wort) can reduce the efficacy (see section 'drug interactions'). Elevated international normalized ratio (INR) and / or bleeding events have been reported in some patients taking warfarin (see section 'possible adverse reactions'). Patients taking warfarin should regularly monitor the changes of prothrombin time or INR. If yes, please read the instructions carefully and follow the doctor's advice.

      [taboo] Known to have severe hypersensitivity to the active substance or any excipient of the product.

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

      [packaging unit] box

      [main ingredients] Main ingredient: gefitinib Chemical name: n - (3-chloro-4-fluorophenyl) - 7-methoxy-6 - (3-morpholine propoxy) quinazoline-4-amine Molecular formula: c22h24clfn4o Molecular weight: 446.90

      [character] Brown, round, film coated piece; Iressa 250 printed on one side.

      [applicable population] adult

      [medication for pregnant and lactating women] At present, there is no data for pregnant or lactating women. Reproductive toxicity has been observed in animal experiments. Gefitinib and some of its metabolites were also detected in rabbit milk in animal experiments (see section & lsquo; preclinical safety information related to prescribers & rsquo. During treatment, women of childbearing age should be advised to avoid pregnancy and lactating mothers should stop breastfeeding.

      [medication for children] At present, there is no data on the safety and efficacy of this product for children or adolescent patients, so it is not recommended.

      [medication for elderly patients] Not yet clear.

      [storage] Store below 30 ℃.

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        Gefitinib tablets (Iressa)

        ¥3200.00

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