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Sodium valproate sustained release tablets (I) (debakin)

Epilepsy can be treated as either monotherapy or addition therapy: For the treatment of generalized epilepsy: including absence seizures, myoclonic seizures, tonic clonic seizures, tonic seizures and mixed seizures, special types of syndromes (West, Lennox Gastaut syndrome), etc. For the treatment of partial epilepsy; Local seizures, with or without generalized seizures. Mania: used to treat manic episodes associated with bipolar disorder. More role
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Common name:
Sodium valproate sustained release tablets (I)
Product No.:
C14202003316
Approval No.:
Gyzz h20010595 (inquired by the State Drug Administration)
Jianke price:
¥85.00
Product specification:
12g:300ml 500mg*30s(I)
Manufacturer:
Sanofi (Hangzhou) Pharmaceutical Co., Ltd
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Product name Sodium valproate sustained release tablets (I) (debakin)
Main raw materials This product is a compound preparation. Its components are: each tablet contains 0.333g sodium valproate and 0.145g valproate (equivalent to 0.5g sodium valproate).
Main role Epilepsy can be treated as either monotherapy or addition therapy: For the treatment of generalized epilepsy: including absence seizures, myoclonic seizures, tonic clonic seizures, tonic seizures and mixed seizures, special types of syndromes (West, Lennox Gastaut syndrome), etc. For the treatment of partial epilepsy; Local seizures, with or without generalized seizures. Mania: used to treat manic episodes associated with bipolar disorder.
Product specification 500mg*30s(I)
Usage and dosage epilepsy This product is a sustained-release preparation. After taking this drug, the peak blood concentration can be reduced, and the blood concentration can be maintained at a normal level within 24 hours. This dose is suitable for adults and children weighing more than 17 kg. This dosage form is not suitable for children younger than 6 years old. (there is a risk of accidental entry into the trachea) the use of this product can control seizures. In those patients who use drugs to prevent major seizures, antiepileptic drugs should not be stopped suddenly, because if they are stopped suddenly, there is a great possibility of status epilepticus with hypoxia and life-threatening. dose The initial dose is usually 10-15mg / kg per day, and then increased until the curative effect is satisfactory (see initial treatment). The general dose is 20-30mg / kg per day. However, if the seizure state can not be controlled within this dose range, it can be considered to increase the dose, but the patient must be closely monitored. When children take this product, the routine dose is 30mg / kg per day When adults take this product, the routine dose is 20 ~ 30mg / kg per day. When elderly patients take this product, the dosage should be determined according to the control of seizure state. The daily dose should be determined according to the patient's age and weight. However, it should be considered that there are obvious individual differences in clinical sensitivity to valproate. So far, the correlation between daily dose, blood concentration level and curative effect is still not very clear. The dosage is mainly determined according to clinical curative effect. When the attack cannot be controlled or side effects are suspected, in addition to clinical monitoring, the determination of valproic acid plasma level should be considered. The reported effective range is 40-100mg / L (300-700umol / L). Medication method Oral. The daily dose should be taken 1 ~ 2 times. When epilepsy has been well controlled, it can be considered to take medicine once a day. This product should be swallowed as a whole. It can be taken in half, but can not be crushed or chewed.
manufacturing enterprise Sanofi (Hangzhou) Pharmaceutical Co., Ltd
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[drug name] Sodium valproate sustained release tablets (I) (debakin)

[common name] Sodium valproate sustained release tablets (I)

[specification and model] 500mg*30s(I)

[manufacturer] Sanofi (Hangzhou) Pharmaceutical Co., Ltd

[drug type] Western medicine

[approval No.] Gyzz h20010595

[validity period] 36 months

[functional indications] Epilepsy can be treated as either monotherapy or addition therapy: For the treatment of generalized epilepsy: including absence seizures, myoclonic seizures, tonic clonic seizures, tonic seizures and mixed seizures, special types of syndromes (West, Lennox Gastaut syndrome), etc. For the treatment of partial epilepsy; Local seizures, with or without generalized seizures. Mania: used to treat manic episodes associated with bipolar disorder.

[usage and dosage] epilepsy This product is a sustained-release preparation. After taking this drug, the peak blood concentration can be reduced, and the blood concentration can be maintained at a normal level within 24 hours. This dose is suitable for adults and children weighing more than 17 kg. This dosage form is not suitable for children younger than 6 years old. (there is a risk of accidental entry into the trachea) the use of this product can control seizures. In those patients who use drugs to prevent major seizures, antiepileptic drugs should not be stopped suddenly, because if they are stopped suddenly, there is a great possibility of status epilepticus with hypoxia and life-threatening. dose The initial dose is usually 10-15mg / kg per day, and then increased until the curative effect is satisfactory (see initial treatment). The general dose is 20-30mg / kg per day. However, if the seizure state can not be controlled within this dose range, it can be considered to increase the dose, but the patient must be closely monitored. When children take this product, the routine dose is 30mg / kg per day When adults take this product, the routine dose is 20 ~ 30mg / kg per day. When elderly patients take this product, the dosage should be determined according to the control of seizure state. The daily dose should be determined according to the patient's age and weight. However, it should be considered that there are obvious individual differences in clinical sensitivity to valproate. So far, the correlation between daily dose, blood concentration level and curative effect is still not very clear. The dosage is mainly determined according to clinical curative effect. When the attack cannot be controlled or side effects are suspected, in addition to clinical monitoring, the determination of valproic acid plasma level should be considered. The reported effective range is 40-100mg / L (300-700umol / L). Medication method Oral. The daily dose should be taken 1 ~ 2 times. When epilepsy has been well controlled, it can be considered to take medicine once a day. This product should be swallowed as a whole. It can be taken in half, but can not be crushed or chewed.

[adverse reactions] Hepatotoxicity, including death, usually occurs in the first 6 months of treatment and has higher fatal hepatotoxicity in children under 2 years old. Patients should be closely monitored before and during treatment, and liver function should be examined regularly. Teratogenicity, including neural tube defects and other major malformations, and decreased intelligence quotient (IQ). Pancreatitis, including reports of fatal hemorrhagic pancreatitis. The incidence of adverse reactions was classified by CIOMS frequency: Very common ≥ 10%; Common ≥ 1 and < 10%; Rare 20.1% and < 1%; Rare 20.01 and < 0.1%; Extremely rare < 0.01%, unknown (cannot be estimated from existing data). Congenital and familial / genetic abnormalities. (see [medication for pregnant and lactating women]) Abnormal blood and lymphatic system Common: anemia and thrombocytopenia (see [precautions]). Rare: pancytopenia and leucopenia. Rare: bone marrow failure, including simple red cell aplasia, agranulocytosis, macrocytic anemia and macroerythrocytic disease. (see instructions for details)

[precautions] When starting antiepileptic drug treatment, in addition to spontaneous changes in some specific epilepsy types, very few cases will have increased seizure frequency or new seizure types. This is mainly related to the interaction of other antiepileptic drugs or pharmacokinetics (see [drug interaction]), toxic reactions (liver disease or encephalopathy, see [precautions] and [adverse reactions]) or drug overdose. Since the drug is converted into valproic acid in the body after taking this product, other drugs containing active ingredients that can be converted into the same compound should not be taken in combination with this product to prevent excess valproic acid in the body (such as dipropionate, valproamide, etc.). *For women of childbearing age, in some cases, if the patient and her therapist make an informed choice after careful evaluation of all relevant factors, this product is a suitable choice for women of childbearing age (see [precautions] and [medication for pregnant and lactating women]). (see instructions for details) Liver function test Liver function should be measured before treatment (see [contraindication]) and regularly monitored within the first 6 months of treatment, especially for high-risk patients (see the warning in [precautions]). Blood test Blood routine examination (blood cell count, including platelet count, bleeding time and agglutination test) should be done before treatment, before operation or in case of spontaneous bruise or bleeding, and monitored during treatment. Urea cycle disease Because valproate has the risk of causing hyperammonemia, when it is suspected that the patient has urea cycle enzyme defect, metabolic examination should be done before treatment. Please read the instructions carefully and follow the doctor's advice.

[taboo] For patients with epilepsy During pregnancy, this product can only be used unless there is no suitable other treatment scheme, and it should be prohibited in other cases; Women of childbearing age can only use this product unless they meet the conditions of contraceptive plan, and should be prohibited in other cases. For patients with bipolar disorder ·Forbidden during pregnancy; Women of childbearing age can only use this product unless they meet the conditions of contraceptive plan, and should be prohibited in other cases. For all indications, it is forbidden for patients with the following conditions -Acute hepatitis -Chronic hepatitis -Have a history or family history of severe hepatitis, especially related to medication -Allergic to sodium valproate, sodium dipropionate and valproamide -Hepatic porphyria -It is known that patients with mitochondrial diseases (polg, such as Alpers huttenlocher syndrome) caused by mitochondrial enzyme polymerase y mutation encoded by nuclear gene and children under 2 years old suspected of polg related diseases -Patients with known disorders of the urea cycle

[listing Permit Holder] Sanofi (Hangzhou) Pharmaceutical Co., Ltd

[packaging unit] bottle

[main ingredients] This product is a compound preparation. Its components are: each tablet contains 0.333g sodium valproate and 0.145g valproate (equivalent to 0.5g sodium valproate).

[character] This product is a white oval film coat with a notch on both sides. It turns white after removing the film coat.

[applicable population] adult

[medication for pregnant and lactating women] Valproate is prohibited for the treatment of bipolar disorder during pregnancy Valproate is prohibited for the treatment of epilepsy during pregnancy unless there is no appropriate other treatment for epilepsy. Valproate is forbidden to be used in fertile women unless the conditions for contraceptive planning are met (see [contraindications] and [precautions]). In some special cases, when valproate is the only treatment for pregnant women with epilepsy, it is best to use the single drug treatment with the lowest effective dose of this product. If possible, use the sustained-release dosage form. During pregnancy, the daily dose of non sustained release dosage form should be taken at least twice. (see instructions for details)

[medication for children] Monotherapy is recommended when children use sodium valproate, but the possible benefits of debarkin should be weighed against the risk of liver damage or pancreatitis before such patients begin treatment (see [precautions]). Due to the risk of hepatotoxicity and bleeding, children should avoid the use of acetylsalicylic acid. Children with liver and gastrointestinal disorders of unknown etiology (such as anorexia, vomiting, cytolysis), depression or coma, mental retardation, or neonatal or infant death in the family must be tested for metabolic indicators, especially fasting and postprandial blood ammonia levels, before receiving any valproate treatment. For children and young people under the age of 18, the safety and efficacy of debarkin in the treatment of mania associated with bipolar disorder have not been studied.

[medication for elderly patients] Compared with young adult patients, the ability of sodium valproate clearance in elderly patients (older than 68 years) decreases, and the incidence may increase, so the initial dose should decrease in these patients. At the same time, the dosage should be increased more slowly, and the intake of liquid and nutrients, dehydration, sleepiness and other adverse events should be monitored regularly. When the patient's food and liquid intake decreases, or the patient has excessive drowsiness, it should be considered to reduce the dosage of sodium valproate or stop sodium valproate treatment. The final therapeutic dose should be determined based on tolerance and clinical response. Refer to the relevant contents under other items in this manual, or follow the doctor's advice.

[storage] Sealed and stored in a dry place

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    Sodium valproate sustained release tablets (I) (debakin)

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