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Pramipexole hydrochloride tablets (senfrol) (imported)

This product is used to treat the signs and symptoms of adult idiopathic Parkinson's disease, that is, in the whole process of the disease, including the later stage of the disease, when the efficacy of levodopa gradually weakens or changes and fluctuations (end of dose phenomenon or "switch" fluctuation), this product can be used alone (without levodopa) or in combination with levodopa. This product is also used to treat the symptoms of moderate to severe idiopathic restless legs syndrome, with a dose of up to 0.75mg (see [usage and dosage]). More role
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Common name:
Pramipexole Hydrochloride Tablets
Product No.:
B14202068555
Approval No.:
H20140917 (inquired by the State Drug Administration)
Jianke price:
¥235.00
Product specification:
0.75mg*10s 0.375mg*10s 0.25mg*30s 1.0mg*30s 0.25mg*30s
Manufacturer:
Boehringer Ingelheim Pharma GmbH & Co.KG (Germany)
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Product name Pramipexole hydrochloride tablets (senfrol) (imported)
Main raw materials The main component of this product is pramipexole hydrochloride. The chemical name is: dihydrochloride (s) - 2-amino-4,5,6,7-tetrahydro-6-propylamine benzothiazole monohydrate = pramipexole hydrochloride monohydrate.
Main role This product is used to treat the signs and symptoms of adult idiopathic Parkinson's disease, that is, in the whole process of the disease, including the later stage of the disease, when the efficacy of levodopa gradually weakens or changes and fluctuations (end of dose phenomenon or "switch" fluctuation), this product can be used alone (without levodopa) or in combination with levodopa. This product is also used to treat the symptoms of moderate to severe idiopathic restless legs syndrome, with a dose of up to 0.75mg (see [usage and dosage]).
Product specification 0.25mg*30s
Usage and dosage Oral medication, swallowed with water, with or without food. Three times a day. Initial treatment: the initial dose is 0.375 mg per day, and then the dose is increased every 5-7 days. If the patient can tolerate it, the dose should be increased to achieve the maximum effect. Weekly dose (mg) daily total dose (mg) 1 3 × 0.125 0.3752 3 × 0.25 0.753 3 × 0.5.1.50 if it is necessary to further increase the dose, it should be added once a week, with a daily dose increase of 0.75mg and a maximum daily dose of 4.5mg. However, it should be noted that the incidence of drowsiness increases when the daily dose is higher than 1.5mg (see [adverse reactions]). Maintenance treatment: the individual dose should be between 0.375 mg and 4.5 mg per day. In the three important studies with increasing dose, the drug efficacy can be observed from the daily dose of 1.5mg. Further dose adjustment should be based on clinical response and tolerance. In clinical trials, about 5% of patients took a dose of less than 1.5mg per day. When reducing levodopa treatment, daily doses greater than 1.5mg may be effective in patients with advanced Parkinson's disease. In the dosage and maintenance treatment stage of this product, it is recommended to reduce the dosage of levodopa according to the individual reaction of the patient. Treatment discontinuation: sudden discontinuation of dopaminergic therapy can lead to non nerve blocking malignant syndrome. Therefore, pramipexole should be gradually stopped at the rate of reducing 0.75 mg per day until the daily dose is reduced to 0.75 mg. Thereafter, it shall be reduced by 0.375 mg per day (see [precautions]). Medication for patients with renal impairment: the clearance of pramipexole depends on renal function. For initial treatment, the following dose regimen is recommended: Patients with creatinine clearance higher than 50ml / min do not need to reduce the daily dose. For patients with creatinine clearance rate between 20-50ml / min, the initial daily dose of this product should be taken twice, 0.125mg each time, twice a day. For patients whose creatinine clearance rate is lower than 20ml / min, the daily dose of this product should be taken once, starting from 0.125mg per day. If the renal function decreases during the maintenance treatment phase, the daily dose of the product is reduced by the same percentage as the decrease of creatinine clearance. For example, when the creatinine clearance decreases by 30%, the daily dose of the product is also reduced by 30%. If the creatinine clearance rate is between 20-50ml / min, the daily dose should be taken twice; If the creatinine clearance rate is less than 20ml / min, the daily dose should be taken once. Medication for patients with liver impairment: dose adjustment may not be necessary for patients with liver failure, because about 90% of the drugs absorbed are excreted through the kidney. (for details, please refer to the instructions inside the package)
manufacturing enterprise Boehringer Ingelheim Pharma GmbH & Co.KG (Germany)
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[drug name] Pramipexole hydrochloride tablets (senfrol) (imported)

[common name] Pramipexole Hydrochloride Tablets

[specification and model] 0.25mg*30s

[manufacturer] Boehringer Ingelheim Pharma GmbH & Co.KG (Germany)

[drug type] Western medicine

[approval No.] H20140917

[validity period] 36 months

[functional indications] This product is used to treat the signs and symptoms of adult idiopathic Parkinson's disease, that is, in the whole process of the disease, including the later stage of the disease, when the efficacy of levodopa gradually weakens or changes and fluctuations (end of dose phenomenon or "switch" fluctuation), this product can be used alone (without levodopa) or in combination with levodopa. This product is also used to treat the symptoms of moderate to severe idiopathic restless legs syndrome, with a dose of up to 0.75mg (see [usage and dosage]).

[usage and dosage] Oral medication, swallowed with water, with or without food. Three times a day. Initial treatment: the initial dose is 0.375 mg per day, and then the dose is increased every 5-7 days. If the patient can tolerate it, the dose should be increased to achieve the maximum effect. Weekly dose (mg) daily total dose (mg) 1 3 × 0.125 0.3752 3 × 0.25 0.753 3 × 0.5.1.50 if it is necessary to further increase the dose, it should be added once a week, with a daily dose increase of 0.75mg and a maximum daily dose of 4.5mg. However, it should be noted that the incidence of drowsiness increases when the daily dose is higher than 1.5mg (see [adverse reactions]). Maintenance treatment: the individual dose should be between 0.375 mg and 4.5 mg per day. In the three important studies with increasing dose, the drug efficacy can be observed from the daily dose of 1.5mg. Further dose adjustment should be based on clinical response and tolerance. In clinical trials, about 5% of patients took a dose of less than 1.5mg per day. When reducing levodopa treatment, daily doses greater than 1.5mg may be effective in patients with advanced Parkinson's disease. In the dosage and maintenance treatment stage of this product, it is recommended to reduce the dosage of levodopa according to the individual reaction of the patient. Treatment discontinuation: sudden discontinuation of dopaminergic therapy can lead to non nerve blocking malignant syndrome. Therefore, pramipexole should be gradually stopped at the rate of reducing 0.75 mg per day until the daily dose is reduced to 0.75 mg. Thereafter, it shall be reduced by 0.375 mg per day (see [precautions]). Medication for patients with renal impairment: the clearance of pramipexole depends on renal function. For initial treatment, the following dose regimen is recommended: Patients with creatinine clearance higher than 50ml / min do not need to reduce the daily dose. For patients with creatinine clearance rate between 20-50ml / min, the initial daily dose of this product should be taken twice, 0.125mg each time, twice a day. For patients whose creatinine clearance rate is lower than 20ml / min, the daily dose of this product should be taken once, starting from 0.125mg per day. If the renal function decreases during the maintenance treatment phase, the daily dose of the product is reduced by the same percentage as the decrease of creatinine clearance. For example, when the creatinine clearance decreases by 30%, the daily dose of the product is also reduced by 30%. If the creatinine clearance rate is between 20-50ml / min, the daily dose should be taken twice; If the creatinine clearance rate is less than 20ml / min, the daily dose should be taken once. Medication for patients with liver impairment: dose adjustment may not be necessary for patients with liver failure, because about 90% of the drugs absorbed are excreted through the kidney. (for details, please refer to the instructions inside the package)

[adverse reactions] Based on the pooled placebo-controlled trials, including 1351 patients taking this product and 1131 patients taking placebo, the analysis showed that adverse events occurred frequently in both groups. 88% of patients taking this product and 83.6% of patients taking placebo reported at least one adverse event. When the daily dose of this product is higher than 1.5mg (see [usage and dosage]), the incidence of drowsiness increases. The most common adverse reaction when combined with levodopa is dyskinesia. Constipation, nausea and dyskinesia often disappear gradually with treatment. Hypotension may occur at the beginning of treatment, especially when the dosage of this product increases too fast. The following are the adverse drug reactions (the number is higher than the incidence of placebo): mental disorders: common (1% - 10%): insomnia, hallucination, insanity, nervous system abnormalities: common (1% - 10%): vertigo, dyskinesia, lethargy (see below) vascular abnormalities: uncommon (0.1% - 1%): hypotension gastrointestinal abnormalities: common (1% - 10%): nausea, constipation and general abnormalities: common (1% - 10%): peripheral edema. This product is related to drowsiness, occasional excessive daytime drowsiness and sudden sleep attack. This product may be related to abnormal sexual desire (increase or decrease). See also [precautions]

[precautions] When patients with renal impairment take this product, it is recommended to reduce the dose according to [usage and dosage]. Hallucinations are side effects of dopaminergic receptor agonists and levodopa treatment. Patients should be informed that hallucinations may occur (mostly visual) For advanced Parkinson's disease, the combined application of levodopa may cause dyskinesia in the initial dosage stage of this product. If the above side effects occur, the dosage of levodopa should be reduced. This product is related to drowsiness and sudden sleep attack, especially for patients with Parkinson's disease. Sudden sleep attack in daily activities sometimes has no consciousness or omen, but this situation Less reported. Patients must be informed of this side effect and advised to drive the vehicle or operate the machine carefully during the treatment of this product. Patients who have experienced side effects of drowsiness and / or sudden sleep attack must avoid driving or operating the machine, and should consider reducing the dose or terminating the treatment. Due to the possible cumulative effect, patients should be careful when taking pramipexole Use other sedative drugs or alcohol with caution (see [effects on driving and operating machine ability] and [adverse reactions]). Patients with mental disorders should only be treated with dopaminergic receptor agonists if the potential benefits outweigh the risks. Pramipexole should not be used simultaneously with antipsychotics (see [drug interaction]) . ophthalmic examination should be performed regularly or in the event of visual abnormalities. Attention should be paid to patients with severe cardiovascular diseases. Since dopaminergic treatment is related to the occurrence of postural hypotension, it is recommended to monitor blood pressure, especially in the early stage of treatment. It has been reported that the symptoms of non nerve blocking malignant syndrome will occur when dopaminergic treatment is suddenly terminated (see [usage and dosage]) . please read the instructions carefully and follow the doctor's advice.

[taboo] Allergic to any excipients of the active ingredients of this product.

[listing Permit Holder] Boehringeringelheim Pharma GmbH & Co.KG (Germany)

[packaging unit] box

[main ingredients] The main component of this product is pramipexole hydrochloride. The chemical name is: dihydrochloride (s) - 2-amino-4,5,6,7-tetrahydro-6-propylamine benzothiazole monohydrate = pramipexole hydrochloride monohydrate.

[character] This product is white.

[applicable population] adult

[medication for pregnant and lactating women] The effects of pramipexole on human pregnancy and lactation have not been discussed. It has exotic teratogenic effects on rats and rabbits, but it is toxic to rat embryos at maternal toxic doses (see toxicological discussion) This product is forbidden during pregnancy, but it is not exactly necessary. For example, the potential benefit to the fetus is greater than the harm. Because this product inhibits the secretion of human prolactin, it inhibits lactation. Whether this product can be secreted into the skirt hairpin milk has not been discussed. The emission intensity of drugs related to rat milk is higher than that of plasma. Because the figure value of poor people should be as high as possible Do not use this product during lactation. However, if its use cannot be stopped, lactation should be interrupted.

[medication for children] Due to the lack of safety and efficacy data, it is not recommended to use this product in children and adolescents under the age of 18.

[medication for elderly patients] See the instructions for details.

[storage] Sealed and stored away from light

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    Pramipexole hydrochloride tablets (senfrol) (imported)

    ¥235.00

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