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Tiotropium bromide powder spray (Tianqing Sule) (without inhaler)

It is applicable to the maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, maintenance treatment of concomitant dyspnea and prevention of acute attack. More role
App download minus 10 yuan
Common name:
Tiotropium bromide powder spray
Product No.:
B14200779382
Approval No.:
Gyzz h20060454 (inquired by the State Drug Administration)
Jianke price:
¥219.00
Product specification:
eighteen μ g*10s eighteen μ g*30s eighteen μ g*10s eighteen μ g*30s eighteen μ g*24s
Manufacturer:
Zhengda Tianqing Pharmaceutical Group Co., Ltd
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Product name Tiotropium bromide powder spray (Tianqing Sule) (without inhaler)
Main raw materials The main component of this product is tiotropium bromide. Excipients: lactose.
Main role It is applicable to the maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, maintenance treatment of concomitant dyspnea and prevention of acute attack.
Product specification eighteen μ g*30s
Usage and dosage Before use, take one capsule and put it into the puncture slot of the special inhaler, press the button with your fingers, and the two ends of the capsule are respectively pierced by fine acupuncture holes. Then put the oral inhaler into the deep part of the mouth and inhale with force. The capsule rotates rapidly with the air flow, and the powder in the capsule is ejected from the capsule shell and enters the respiratory tract with the air flow. Adults: 1 capsule at a time, once a day. There is no need to adjust the dose for elderly patients, patients with liver insufficiency and renal insufficiency, but patients with moderate and severe renal insufficiency (clcr < 50ml / min) must be closely monitored.
manufacturing enterprise Zhengda Tianqing Pharmaceutical Group Co., Ltd
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[drug name] Tiotropium bromide powder spray (Tianqing Sule) (without inhaler)

[common name] Tiotropium bromide powder spray

[specification and model] eighteen μ g*30s

[manufacturer] Zhengda Tianqing Pharmaceutical Group Co., Ltd

[drug type] Western medicine

[approval No.] Gyzz h20060454

[validity period] 24 months

[functional indications] It is applicable to the maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, maintenance treatment of concomitant dyspnea and prevention of acute attack.

[usage and dosage] Before use, take one capsule and put it into the puncture slot of the special inhaler, press the button with your fingers, and the two ends of the capsule are respectively pierced by fine acupuncture holes. Then put the oral inhaler into the deep part of the mouth and inhale with force. The capsule rotates rapidly with the air flow, and the powder in the capsule is ejected from the capsule shell and enters the respiratory tract with the air flow. Adults: 1 capsule at a time, once a day. There is no need to adjust the dose for elderly patients, patients with liver insufficiency and renal insufficiency, but patients with moderate and severe renal insufficiency (clcr < 50ml / min) must be closely monitored.

[adverse reactions] In a clinical trial of 906 patients treated with tiotropium bromide for 1 year, the most frequent adverse reaction was dry mouth. About 14% of patients developed dry mouth. The dry mouth reaction is usually mild and will disappear with continuous treatment. b) The following table lists the reporting rate of this kind of adverse reaction. These data are from the clinical trial of patients receiving tiotropium bromide for 1 year (according to the WHO organ system classification): adverse reaction frequency, systemic allergic reaction: rare (i.e. > 0.1%, < 1%), gastrointestinal system disorder: dry mouth is very common (i.e. > 10%) and constipation is common (i.e. > 1%, < 10%) Arrhythmia of heart rate and rhythm: tachycardia is rare (i.e. > 0.1%, < 1%), palpitation is rare (i.e. > 0.1%, < 1%), resistance system disorder: Candida infection is common (i.e. > 1%, < 10%), respiratory system disorder: sinusitis is common (i.e. > 1%, < 10%), pharyngitis is is common (i.e. > 1%, < 10%), urinary system disorder: dysuria is rare (i.e. > 0.1%, < 1%) Rare urinary retention * (i.e. > 0.1%, < 1% = all adverse events listed as common refer to the reported occurrence frequency of more than 1% to 2% compared with the placebo group. Post marketing experience: reports of spontaneous adverse reactions related to nausea, hoarseness and dizziness have been received. C) for individual serious and / or frequent adverse reactions, the most common adverse reaction of anticholinergic therapy in COPD patients is anticholinergic therapy in COPD patients The most common adverse reaction of alkaline therapy is dry mouth. In most cases, dry mouth symptoms are mild. In general, dry mouth symptoms occur in the 3rd to 5th weeks after treatment. Dry mouth symptoms usually disappear after continuous treatment. In the clinical trial of 906 patients for 1 year, 3 patients (0.3% of the total treated patients) terminated the trial due to poor dry mouth reaction During the 1 year clinical trial, severe and persistent adverse reactions reported in individual cases were constipation and urinary retention. Urinary retention was found only in elderly men with * * risk factors (such as prostatic hypertrophy). D) there were individual cases of ventricular tachycardia and atrial fibrillation after the application of tiotropium bromide, which are usually seen in susceptible patients. Like all inhalation treatments, tiotropium bromide may cause bronchospasm caused by inhalation stimulation. Allergic reactions reported by spontaneous adverse reactions include angioedema, rash, rubella and skin pruritus. D) * the pharmacological classification of adverse reactions is that many organs and functions are controlled by the parasympathetic nervous system. Therefore, it is susceptible to the effects of anticholinergic agents. The adverse reactions of systemic anticholinergic effects include dry mouth, dry throat, increased heart rate, blurred vision, blue eyes, dysuria, urinary retention and constipation. The incidence of dry mouth and constipation increased with age.

[precautions] 1. Tiotropium bromide, as a bronchodilator for once daily maintenance treatment, should not be used as the initial treatment of acute attack of bronchospasm, that is, rescue treatment. 2. Allergic reactions may occur immediately after inhalation of tiotropium bromide powder. 3. As with other anticholinergic drugs, it should be used with caution in patients with narrow-angle glaucoma, benign prostatic hyperplasia, or bladder neck obstruction. 4. Inhaled drugs may cause inhaled bronchospasm. 5. Like all drugs mainly excreted through the kidney, tiotropium can only be used in patients with moderate and severe renal insufficiency (creatinine clearance ≤ 50ml / min) when the expected benefits outweigh the possible hazards. There is no experience of long-term use of tiotropium in patients with severe renal insufficiency. 6. The capsule should be sealed in the vesicle for storage. It should only be taken out during medication. It should be used as soon as possible after taking out, otherwise the efficacy will be reduced. The capsule accidentally exposed to the air should be discarded. 7. Patients should pay attention to avoid getting the drug powder into the eye. Patients must be informed that the accidental entry of the drug powder into the eye may cause or aggravate narrow-angle glaucoma, eye pain or discomfort, transient blurred vision, visual halo or color image, accompanied by symptoms of red eye and corneal edema caused by conjunctival congestion. If there are signs of narrow-angle glaucoma, stop using tiotropium bromide and go to hospital immediately see a doctor. 8. Dry mouth, caused by anticholinergic therapy, can cause dental caries for a long time. 9. Tiotropium bromide should not be used more than once a day. 10. This capsule is for inhalation only and cannot be taken orally. 11. No study has been conducted on the impact on the ability to drive and operate the machine. According to the pharmacology and adverse reaction characteristics obtained at the recommended dose, there is no evidence that it will affect the ability to drive and operate the machine. Please read the instructions carefully and follow the doctor's instructions.

[taboo] 1. Tiotropium bromide inhalation powder is prohibited for those who are allergic to tiotropium bromide or other components contained in this product. 2. It is forbidden to be used in patients allergic to atropine or its derivatives

[listing Permit Holder] Zhengda Tianqing Pharmaceutical Group Co., Ltd

[packaging unit] box

[main ingredients] The main component of this product is tiotropium bromide. Auxiliary material: lactose.

[character] This product is a hard capsule for inhalation, containing white powder.

[applicable population] adult

[medication for pregnant and lactating women] For tiotropium, there is no clinical data on the use of tiotropium in pregnancy. Animal experimental studies have shown maternal related reproductive toxicity. There is no data on the use of tiotropium in lactating women. According to the study of lactating rodents, a small amount of tiotropium can be secreted into milk. Therefore, tiotropium should not be used in pregnant or lactating women unless The expected benefits outweigh the possible risks to unborn fetuses or infants.

[medication for children] There is no experience of tiotropium bromide in pediatric patients, so it is not recommended for patients younger than 18 years old.

[medication for elderly patients] Elderly patients can use this product at the recommended dose.

[storage] seal up.

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    Tiotropium bromide powder spray (Tianqing Sule) (without inhaler)

    ¥219.00

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