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  药店国别: 美国药房
产地国家: 美国
所属类别: 动物用药->抗生素
处方药:处方药
包装规格: 100 mL/vial, 1 vial/pack
计价单位:
   
生产厂家中文参考译名:
辉瑞
生产厂家英文名:
Pfizer
该药品相关信息网址1:
https://www.drugs.com/vet/draxxin-injectable-solution.html
该药品相关信息网址2:
https://en.wikipedia.org/wiki/Tulathromycin
原产地英文商品名:
DRAXXIN 100 mg/ml, 100 mL/pack, 100 mL/vial
原产地英文药品名:
Tulathromycin
中文参考商品译名:
瑞可新100 毫克/毫升, 100毫升/包, 100毫升/小瓶
中文参考药品译名:
泰拉霉素注射液
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Pasteurella haemolyticus
英文适应病症2:
Pasteurella
英文适应病症3:
Haemophilus haemophilus
英文适应病症4:
Bovine respiratory disease caused by mycoplasma
英文适应病症5:
Porcine respiratory diseases caused by Actinobacillus pleuropneumoniae, Pasteurella multocida and Mycoplasma pneumoniae.
临床试验期:
完成
中文适应病症参考翻译1:
溶血巴氏杆菌
中文适应病症参考翻译2:
多杀巴氏杆菌
中文适应病症参考翻译3:
睡眠嗜血杆菌
中文适应病症参考翻译4:
支原体引起的牛呼吸道疾病
中文适应病症参考翻译5:
胸膜肺炎放线杆菌、多杀巴氏杆菌和肺炎支原体引起的猪呼吸道疾病
药品信息:

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件(201891619361213.pdf)的“原文Priscribing Information”为准
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部分中文瑞可新处方资料(仅供参考)

通用名:泰拉霉素注射液

商品名:瑞可新(Draxxin®)

英文名:Tulathromycin Injection

汉语拼音:Tailameisu zhusheye

主要成分:泰拉霉素

【性状】 本品为无色至微黄色澄明液体。

【药理作用】

泰拉霉素是一个半合成的大环内酯类抗生素,大环内酯抗生素通过与细菌核糖体RNA选择性地结合来抑制必需蛋白质的生物合成。它们通过在易位过程中促进多肽‐ RNA从核糖体解离而起作用。与其他许多大环内酯类抗生素不同的是,它的药物作用保持时间较长,部分原因是由于其结构中有3个氨基基团。泰拉霉素在体外可有效抑制牛溶血巴氏杆菌、多杀巴氏杆菌、睡眠嗜血杆菌和牛支原体以及猪胸膜肺炎放线杆菌、多杀巴氏杆菌和肺炎支原体。

牛一次皮下注射(2.5mg/kg体重)的药动学研究表明,该药可快速而广泛的吸收,然后大量分布和缓慢消除。血浆中的最大浓度(Cmax)约为0.5μg/ml,给药后约30分钟(Tmax)达最大浓度。在肺匀浆中的浓度比血浆高。有充分的证据说明,泰拉霉素在嗜中性粒细胞和肺泡巨噬细胞中有大量蓄积。药物达峰后,缓慢衰减,血浆中的表观消除半衰期(t1/2)为90小时。血浆蛋白结合率较低,约为40%。牛皮下注射的生物利用度约为90%。

猪一次肌内注射(2.5mg/kg体重)的药动学研究表明,该药可快速而广泛的吸收,然后大量分布和缓慢消除。血浆中的最大浓度(Cmax)约为0.6μg/ml,给药后约30分钟(Tmax)达最大浓度。在肺匀浆中的浓度比血浆高。有充分的证据说明,泰拉霉素在嗜中性粒细胞和肺泡巨噬细胞中有大量蓄积。药物达峰后,缓慢衰减,血浆中的表观消除半衰期(t1/2)为91小时。血浆蛋白结合率较低,约为40%。猪肌内注射的生物利用度约为88%。

【适应症】

用于治疗和预防对泰拉霉素敏感的溶血巴氏杆菌、多杀巴氏杆菌、睡眠嗜血杆菌和支原体引起的牛呼吸道疾病;胸膜肺炎放线杆菌、多杀巴氏杆菌和肺炎支原体引起的猪呼吸道疾病。

【用法与用量】

皮下注射一次量 牛每1kg体重 2.5mg(相当于1ml/40kg体重) 一个注射部位的给药剂量不超过7.5 ml

颈部肌内注射一次量 猪 每1kg体重 2.5mg(相当于1ml/40kg体重) 一个注射部位的给药剂量不超过2 ml

【禁忌症】

1、对大环内酯类抗生素过敏者不能使用。

2、本品不能与其它大环内酯类抗生素或林可霉素同时使用。

3、供生产人用乳品的泌乳期奶牛禁用。

4、预计在2个月内分娩的可能生产人用乳品的怀孕母牛或小母牛禁用本品。

【不良反应】

牛皮下注射本品时常会引起注射部位出现短暂性的疼痛反应和局部肿胀,并可持续长达30天。猪肌内注射后未见上述反应。在注射后约30天内,两种动物的注射部位仍有组织病理学变化。

【注意事项】

1、在首次开启或抽取药液后应在28天内使用。当多次取药时,建议使用专用吸取针头或多剂量注射器,以避免在瓶塞上扎孔过多。

2、建议在疾病的早期进行治疗,在给药后48小时内评价治疗效果。如果呼吸道疾病的症状仍然存在或增加,或出现复发,应改变治疗方案。

3、泰拉霉素对眼睛有刺激性,如果眼睛意外接触到本品,请立即用清水冲洗。

4、泰拉霉素接触到皮肤时,可引起过敏反应。如果皮肤意外接触到本品,请立即用肥皂和水冲洗。

5、用后请洗手。

6、应放在远离儿童的地方。

【休药期】 牛49日; 猪33日。

【规格】 (1)20ml:2g (2)50ml:5g (3)100ml:10g (4)250ml:25g (5)500ml:50g

【包装】

【贮藏】 遮光,密闭,在凉暗处保存。

Common name: Taramycin injection

Product Name: Draxin®

English name: Tulathromycin Injection

Chinese Pinyin: Tailameisu zhusheye

Main Ingredients: Teramycin

[Properties] This product is a colorless to slightly yellow clear liquid.

[Pharmacological action]

    Taramycin is a semi-synthetic macrolide antibiotic that inhibits the biosynthesis of essential proteins by selectively binding to bacterial ribosomal RNA. They act by promoting the dissociation of polypeptide-tRNA from ribosomes during translocation. Unlike many other macrolide antibiotics, its drug action lasts longer, in part because of its three amino groups in its structure. Teramycin is effective in inhibiting Pasteurella bovis, Pasteurella multocida, Haemophilus typhimurium, and M. bovis, as well as Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma pneumoniae in vitro.   

Pharmacokinetic studies of a subcutaneous injection of cattle (2.5 mg/kg body weight) showed that the drug was rapidly and widely absorbed, then distributed and slowly eliminated. The maximum concentration (Cmax) in plasma was about 0.5 μg/ml, and the maximum concentration was reached about 30 minutes (Tmax) after administration. The concentration in the lung homogenate is higher than in plasma. There is ample evidence that taramycin has a large accumulation in neutrophils and alveolar macrophages. After the drug peaked, it slowly decayed, and the apparent elimination half-life (t1/2) in plasma was 90 hours. Plasma protein binding rate is low, about 40%. The bioavailability of subcutaneous injection is approximately 90%.

    

Pharmacokinetic studies of an intramuscular injection of pigs (2.5 mg/kg body weight) showed that the drug was rapidly and widely absorbed, then distributed and slowly eliminated. The maximum concentration (Cmax) in plasma was about 0.6 μg/ml, and the maximum concentration was reached about 30 minutes (Tmax) after administration. The concentration in the lung homogenate is higher than in plasma. There is ample evidence that taramycin has a large accumulation in neutrophils and alveolar macrophages. After the drug peaked, it slowly decayed, and the apparent elimination half-life (t1/2) in plasma was 91 hours. Plasma protein binding rate is low, about 40%. The bioavailability of intramuscular injection of pigs is approximately 88%.

[Indications]

Used to treat and prevent bovine respiratory diseases caused by tylosin-sensitive hemolytic bacteria, Pasteurella multocida, Haemophilus typhimurium and Mycoplasma; Actinobacillus pleuropneumoniae , porcine respiratory disease caused by Pasteurella multocida and Mycoplasma pneumoniae.

[Usage and Dosage]

Subcutaneous injection of bovines 2.5mg per 1kg of body weight (equivalent to 1ml/40kg body weight) The dosage of one injection site does not exceed 7.5 ml

Intramuscular injection of a small amount of pigs 2.5mg per 1kg body weight (equivalent to 1ml/40kg body weight) The dose of one injection site is not more than 2 ml

[Contraindications]

1. Those who are allergic to macrolide antibiotics cannot use it.

2. This product cannot be used simultaneously with other macrolide antibiotics or lincomycin.

3. Lactating dairy cows for dairy products are forbidden.

4. It is expected that the probationary child who delivers within 2 months will ban this product with pregnant cows or heifers.

[Adverse Reactions]

Injecting this product under the cowhide often causes transient painful reactions and local swelling at the injection site, which can last up to 30 days. The above reaction was not observed after intramuscular injection of pigs. There were histopathological changes in the injection site of both animals within about 30 days after the injection.

[Notes]

1. It should be used within 28 days after the first opening or taking of the liquid. When taking multiple doses, it is recommended to use a dedicated suction needle or multiple dose syringe to avoid excessive hole punching in the stopper.

2. It is recommended to treat the disease early, and evaluate the therapeutic effect within 48 hours after administration. If the symptoms of respiratory disease persist or increase, or if a recurrence occurs, the treatment plan should be changed.

3. Taramycin is irritating to the eyes. If the eyes are accidentally exposed to this product, rinse immediately with water.

4. Tylamycin can cause an allergic reaction when it comes into contact with the skin. If the skin comes into contact with this product, wash it off immediately with soap and water.

5, please wash your hands after use.

6, should be placed away from children.

[Payment period] Cattle 49 days; Pig 33 days.

【Specifications】 (1) 20ml: 2g (2) 50ml: 5g (3) 100ml: 10g (4) 250ml: 25g (5) 500ml: 50g

[Packaging]

[Storage] Shade, seal, and store in cool and dark places.

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 详细处方信息以本药内容附件PDF文件(201891619361213.pdf)的“原文Priscribing Information”为准
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更新日期: 2018-01-08
附件:
201891619361213.pdf    

 
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