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  药店国别: 日本药房
产地国家: 日本
所属类别: 作用于呼吸系统药物->肺结核
处方药:处方药
包装规格: 100毫克/20毫升/安瓿, 20安瓿/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
第一三共株式会社
生产厂家英文名:
Daiichi Sankyo Company Limited
该药品相关信息网址1:
https://www.kegg.jp/medicus-bin/japic_med_product?id=00054957-001
该药品相关信息网址2:
http://www.info.pmda.go.jp/go/pack/6222400A1035_1_04/
原产地英文商品名:
ISCOTIN INJECTION (イスコチン注) 100mg/20ml, 20 ampoules (Minimum order: 10)
原产地英文药品名:
Isoniazid
中文参考商品译名:
爱扫痨注射液 (イスコチン注) 100毫克/20毫升/安瓿 (最少订购量: 10)
中文参考药品译名:
异烟肼
中文参考化合物名称:
4-吡啶甲酰肼
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
tuberculosis
临床试验期:
完成
中文适应病症参考翻译1:
肺结核
药品信息:

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 详细处方信息以本药内容附件PDF文件(2018102421275011.pdf)的“原文Priscribing Information”为准
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部分Iscochin处方信息仅供参考

通用名称:Iscochin

俗名:异烟肼

欧洲通用名称:异烟肼

药物分类名称:结核病化疗药物

药物分类号:6222

ATC代码:J04AC01

处理注意事项

由于本产品使用“单点切割安瓿”,因此与安瓿分支的标记向相反方向折叠。

包装

Iscotin Note 100 mg(日本药典异烟肼注射液)

(2mL)20安瓿

药物分类名称:结核病化疗药物 药物分类号:6222 ATC代码J04AC01

禁忌

不要给予以下患者

严重肝功能损害的患者[肝脏损害可能会加剧。 ]

适应症,疗效和剂量方案

疗效

<适应性真菌种类>

结核分枝杆菌对该药敏感

<指示>

肺结核和其他结核病

剂量方案

通常成人肌肉注射或静脉注射异烟肼,每日剂量为200至500毫克(4至10毫克/千克)<4至10毫升>。对于鞘内,胸腔内注射或局部分配,使用50至200 mg <1至4 mL>一次。

根据年龄和症状适当变化。 希望将其与其他抗结核药物联合使用。

使用说明

精心管理

肝脏疾病或其既往病史或疑似患者[肝脏疾病可能恶化或复发。 ]

患有肾脏疾病或疑似功能障碍的患者[增加该药物的血液水平,这可能会引起周围神经炎等副作用。 ]

有精神障碍病史的患者[精神疾病可能会复发。 ]

酗酒患者[可能发生肝脏疾病,精神疾病]。 ]

患有癫痫等痉挛性疾病或有癫痫病史的患者[有可能引起抽搐,因此如果不可避免地要进行彻底观察。 ]

患有药物过敏症的患者

血液病患者,出血倾向[这些症状可能会加剧。 ]

重要的基本关注

与其他抗结核药物联合使用可能会导致严重的肝脏疾病。因此,在组合使用时,定期进行肝功能检查(参见“严重的副作用”)。

副作用

副作用发展概要

(不受重新审查)

严重的副作用和副作用

严重的副作用

(频率未知注1)) 可能会出现以下严重的副作用,因此如果观察到异常,请立即进行彻底观察,停止给药并采取适当措施。

暴发性肝炎等严重肝脏疾病

定期进行肝功能检查。

毒性表皮坏死松解症(TEN),皮肤粘膜眼综合征(Stevens-Johnson综合征),红皮病(剥脱性皮炎)

药物过敏综合征[1]

(初始症状:皮疹,发烧)

(次要发现:肝功能不全,淋巴结肿大,白细胞增多,嗜酸性粒细胞增多,非典型淋巴细胞出现等)

请注意,人类疱疹病毒6(HHV-6)等病毒的频繁复苏是常见的,即使停止给药后,皮疹,发热,肝功能障碍等症状也可能复发或延长。

SLE样症状

(症状:发烧,红斑,肌肉疼痛,关节痛,淋巴结肿大,胸痛等) (治疗方法:肾上腺皮质激素给药等)

间质性肺炎

(症状:发烧,咳嗽,呼吸困难,胸部X线异常,嗜酸性粒细胞增多等) (治疗方法:肾上腺皮质激素给药等)

肾功能衰竭,间质性肾炎,肾病综合征

(症状:发热,皮疹,少尿,水肿,蛋白尿,肾功能检查值异常等)

粒细胞缺乏症,血小板减少症

惊厥

视神经炎

(症状:视力下降,中央暗点等) (治疗方法:给予维生素B 6等)

周围神经炎

(症状:四肢异常感,麻木,感觉障碍,肌腱反射减弱,肌肉无力,肌肉萎缩等) (治疗方法:给予维生素B 6等)

对老年人的管理

一般老年人生理功能下降,所以注意不要减肥等。

对孕妇,孕妇,哺乳期妇女等进行管理。

建议不要给可能怀孕的孕妇或哺乳期妇女服用。 [动物实验(小鼠)报告了胎儿生长障碍的影响。还有流行病学发现,氨基水杨酸盐制剂患者同时给药,畸形儿童的发病率很高。 ]

哺乳期妇女在服药期间应避免母乳喂养。 [它可能会迁移到人类母乳中。 ]

药物过量

通过口服异烟肼报告以下报告。

症状

可能发生惊厥,昏迷,代谢性酸中毒,高血糖症。

治疗

施用地西泮用于抑制惊厥,并且静脉内注射碳酸氢钠用于代谢性酸中毒。

保护呼吸道并确保充分呼吸。

以异烟肼剂量静脉内注射相同量的吡哆醇。

在严重的情况下,需要进行血液灌注或血液透析。

应用说明

在肌肉注射期间

肌内注射时,请注意以下几点,以免影响组织,神经等。

对于注射部位,应避免小心给药,避免神经运动部位。

在重复进样的情况下,通过左右注射交替避免使用相同的部件。注意低出生体重婴儿,新生儿,婴儿,幼儿和儿童。

注射针头时,如果您抱怨剧烈疼痛或看到血液回流,请立即取下针头,更换部位并注射。

开场时

为防止异物污染安瓿,用乙醇消毒棉花等擦拭并切割。

其他说明

在小鼠实验中报道了肺肿瘤的发生[例如:饲料中0.01至0.25%的污染(口服约15至375mg / kg体重,持续7个月)]。然而,在大鼠和仓鼠的实验中尚未报道肿瘤诱导作用。此外,还报道了流行病学研究结果,报告与人类肿瘤发展无关。

药代动力学

蛋白质结合[2] 异烟肼与血清蛋白(主要是白蛋白)结合,每1mol人血清白蛋白结合异烟肼的摩尔比为0.08。

代谢

给药后,异烟肼大部分在肝脏中乙酰化,变为1-乙酰基-2-异烟酰肼,进一步代谢,成为1,2-二乙酰肼和乙酰肼,并在尿液中排出[3] 4]。 > 在这种N-乙酰化代谢速率中存在遗传多样性(快速或慢速乙酰化剂),并且看到种族差异(日本和慢乙酰化剂小于10%)。

药物药理学

抗菌力[5]

针对结核分枝杆菌H37 Rv菌株的最小抑制浓度(MIC)为0.1μg/ mL(在10%血清Kirchner培养基中测量)。 另外,对小鼠实验性结核病(H37Rv株)也有显着的治疗效果。

有效成分的物理化学知识

俗名:异烟肼

通用名称(欧洲名称):异烟肼

缩写名称:INH

化学名称:4-吡啶甲酰肼

<分子式:C 6 H 7 N 3 O p

分子量:137.14

熔点:170-173℃

性状:无色结晶或白色结晶粉末,无气味。易溶于水或乙酸(100),微溶于乙醇(95),几乎不溶于乙酸酐,极不溶于乙醚。

处理注意事项

由于本产品使用“单点切割安瓿”,因此与安瓿分支的标记向相反方向折叠。

包装

Iscotin Note 100 mg(日本药典异烟肼注射液)

(2mL)20安瓿

Generic name: Iscochin

common name: Isoniazid

European general name: Isoniazid

Name of drug classification: Tuberculosis chemotherapeutic agent

Drug classification number: 6222

ATC code: J04AC01

Contraindication

Do not administer to the following patients

Patients with severe hepatic impairment [Liver damage may be exacerbated. ]

Indications, efficacy and dosage regimen

Efficacy effect

Mycobacterium tuberculosis sensitive to this drug

Pulmonary tuberculosis and other tuberculosis

Dosage regimen

Usually adults are intramuscularly or intravenously injected as isoniazid in a daily dose of 200 to 500 mg (4 to 10 mg / kg) <4 to 10 mL>. For intrathecal, intrathoracic injection or local dispensation, use 50 to 200 mg <1 to 4 mL> once.

Change according to age and symptoms as appropriate. It is desirable to use it in combination with other anti-tuberculosis drugs.

Usage notes

Careful Administration

Liver disorder or its past history or a patient suspected of it [Liver disorder may deteriorate or recur. ]

Patients with kidney disorder or suspected dysfunction [Increase blood levels of this drug, which is likely to cause side effects such as peripheral neuritis. ]

Patients with a history of mental disorders [Psychiatric disorders may recur. ]

Patients with alcoholism [liver disorder, psychiatric disorder may occur]. ]

Patients with convulsive disorders such as epilepsy or those with a history of these [It is possible to cause convulsions, so if it is inevitable to administer observe thoroughly. ]

Patient with drug hypersensitivity

Patients with blood disorders, bleeding tendencies [These symptoms may be exacerbated. ]

Important basic attention

Severe hepatic disorder may occur by combination with other anti-tuberculosis drugs. Therefore, when using in combination, conduct a liver function test at regular intervals (see "Serious side effects").

Side effect

Outline of side effect development

(Not subject to reexamination)

Serious side effects and side effect terms

Serious side effects

(Frequency unknown Note 1)) The following serious side effects may appear, so observe thoroughly, if abnormalities are observed discontinue administration and take appropriate measures.

Serious liver disorder such as fulminant hepatitis

To perform liver function test on a regular basis.

Toxic epidermal necrolysis (TEN), skin mucosa ocular syndrome (Stevens-Johnson syndrome), erythroderma (exfoliative dermatitis)

Drug hypersensitivity syndrome [1]

(Initial symptoms: rash, fever)

(Secondary findings: liver dysfunction, lymph node swelling, leukocytosis, eosinophilia, emergence of atypical lymphocytes, etc.)

Be aware that frequent revitalization of viruses such as Human Herpesvirus 6 (HHV-6) is frequent and symptoms such as rash, fever, liver dysfunction may recur or prolong even after administration is discontinued.

SLE-like symptoms

(Symptoms: fever, erythema, muscle pain, arthralgia, lymph node swelling, chest pain etc.) (Treatment method: adrenocortical hormone drug administration etc.)

Interstitial pneumonia

(Symptoms: fever, cough, dyspnea, chest x-ray abnormality, eosinophilia etc.) (Treatment method: adrenocortical hormone drug administration etc.)

Renal failure, interstitial nephritis, nephrotic syndrome

(Symptoms: fever, rash, oliguria, edema, proteinuria, renal function test value abnormality etc.)

Agranulocytosis, thrombocytopenia

convulsions

Optic neuritis

(Symptoms: visual acuity reduction, central scotoma etc.) (Treatment method: administration of vitamin B 6 etc.)

Peripheral neuritis

(Symptom: abnormal sensation of limbs, numbness, sensory disorder, decreased tendon reflex, muscle weakness, muscle atrophy etc.) (Treatment method: administration of vitamin B 6 etc.)

Administration to the elderly

In general elderly people have decreased physiological function, so be careful not to lose weight etc.

Administration to pregnant women, maternity women, nursing women, etc.

It is advisable not to administer to pregnant women or lactating women who may be pregnant. [An animal experiment (mouse) reports the fetal growth hindrance effect. There is also epidemiological findings that patients with aminosalicylate formulation are administered concomitantly, and the incidence of malformed children is high. ]

To lactating women should avoid breast feeding during this drug administration. [It may migrate into human breast milk. ]

Overdosage

The following reports are reported by oral administration of isoniazid.

Symptom

Convulsions, coma, metabolic acidosis, hyperglycemia may occur.

treatment

Diazepam is administered for suppression of convulsions and sodium bicarbonate is injected intravenously for metabolic acidosis.

Secure the respiratory tract and ensure adequate respiration.

Intravenously inject the same amount of pyridoxine as isoniazid dose.

In severe cases, it is desirable to perform blood perfusion or hemodialysis.

Application note

During intramuscular injection

When intramuscular injections, please pay attention to the following points in order to avoid influences on tissues, nerves, etc.

For the injection site, careful administration should be avoided avoiding the nerve running site.

In case of repetitive injections, avoid the same parts by injecting left and right alternately. Beware of low birth weight infants, newborns, infants, young children, and children.

When injecting a needle, if you complain of severe pain or seeing backflow of blood, immediately remove the needle, change the site and inject it.

At opening

To avoid contamination of ampule at the time of foreign matter, wipe with ethanol disinfecting cotton etc and cut it.

Other notes

The occurrence of lung tumor has been reported in an experiment with mice [example: 0.01 to 0.25% contamination in feed (about 15 to 375 mg / kg body weight orally for 7 months)]. However, tumor-inducing effects have not been reported in experiments with rats and hamsters. Also, epidemiological findings reporting that no association with tumor development was observed in humans has been reported.

Pharmacokinetics

Protein binding [2] Isoniazid binds to serum proteins (mainly albumin), and the molar ratio of isoniazid bound per 1 mol of human serum albumin was 0.08.

metabolism

After dosing, isoniazid was mostly acetylated in the liver, became 1-acetyl-2-isonicotinylhydrazine, was further metabolized, and became 1,2-diacetylhydrazine and acetylhydrazine and was excreted in the urine [3] 4].

There is genetic diversity (rapid or slow acetylator) in this metabolic rate of N-acetylation, and racial differences are seen (Japanese and slow acetylator is less than 10%).

Medicinal pharmacology

Antimicrobial power [5]

The minimum inhibitory concentration (MIC) against M. tuberculosis H37 Rv strain is 0.1 μg / mL (measured in 10% serum Kirchner medium).

Also, a remarkable therapeutic effect is recognized for mouse experimental tuberculosis (H37Rv strain).

Physicochemical knowledge on active ingredients

common name: Isoniazid

Common name (European name): Isoniazid

Abbreviated name: INH

Chemical name: Pyridine-4-carbohydrazide

Molecular formula: C 6 H 7 N 3 O

Molecular weight: 137.14

Melting point: 170 - 173 ° C

Property: It is colorless crystal or white crystalline powder, it has no odor. It is easily soluble in water or acetic acid (100), slightly soluble in ethanol (95), hardly soluble in acetic anhydride, and very insoluble in diethyl ether.

Handling Precautions

Since this product uses "one-point cut ampule", fold in the opposite direction with the mark of the ampoule branch up.

Packaging

Iscotin Note 100 mg (Japanese Pharmacopoeia Isoniazid injection)

(2 mL) 20 ampoules


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 详细处方信息以本药内容附件PDF文件(2018102421275011.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2018-10-24
附件:




2018102421275011.pdf    

 
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