Tecon Biology Co.,ltd

［ 兽药名称 ］Veterinary Drug Name

通用名称 ：猪口蹄疫O型灭活疫苗(O/Mya98/XJ/2010株+O/GX/09-7株)

Generic Name: Foot and Mouth Disease Vaccine, Inactivated (Type O, Strain O/Mya98/XJ/2010 + Strain O/GX/09-7)

商品名称 ：无

trade Name: None

英文名称 ：Foot and Mouth Disease Vaccine,Inactivated(Type O, Strain O/Mya98/XJ/2010+Strain O/GX/09-7)

English name: Foot and Mouth Disease Vaccine,Inactivated(Type O, Strain O/Mya98/XJ/2010+Strain O/GX/09-7)

汉语拼音 ：Zhukoutiyi O Xing Miehuoyimiao (O/Mya98/XJ/2010Zhu+O/GX/09-7 Zhu)

Chinese Pronunciation : Zhukoutiyi O Xing Miehuoyimiao (O/Mya98/XJ/2010 Zhu + O/GX/09-7 Zhu)

［主要成分与含量 ］ 含灭活的猪口蹄疫O型病毒变异毒O/GX/09-7株和东南亚拓扑型缅甸-98毒O/Mya98/XJ/2010株,灭活前每毫升病毒含量应至少为107.0TCID50或每0.2ml病毒含量应至少为107.0LD50。每头份疫苗对猪口蹄疫O型O/GX/09-7株和O/Mya98/XJ/2010株两个毒的效力应至少各含6个PD50。

Main ingredient and Composition

This product contains a mixture of inactivated Foot and Mouth Disease (FMD) Virus Type O (Strain O/GX/09-7) and Southeast Asian topological type Myanmar-98 (Strain O/Mya98/XJ/2010). Before inactivation, the minimum virus level should be 10^7.0TCID₅₀/mL or 10^7.0LD₅₀/0.2mL. The potency of the vaccine for each dose of Strain O/GX/09-7 and Strain O/Mya98/XJ/2010 should be 6 PD₅₀ at least.

［性      状 ］ 淡粉红色或乳白色略带粘滞性乳状液。

［character ］Slightly viscous, light pink emulsion.

［作用与用途 ］用于预防猪O型口蹄疫。免疫期为6个月。

Indication and Usage

This product is indicated to prevent FMD virus Type O. The immunity period is 6 months.

［用法与用量 ］ 耳根后肌肉注射。体重10~25kg猪,每头1ml(1/2头份);25kg以上猪,每头2ml(1头份)。

Dosage and Administration

Perform intramuscular injection behind the root of the ear: 1 mL (1/2 dose) for pigs weigh between 10 and 25 kg; 2 mL (1 dose) for pigs weigh over 25 kg.

[不良反应 ］

一般反应: 注射部位肿胀,一过性体温反应,减食或停食1~2日,随着时间延长,症状逐渐减轻,一般注苗3日后即可恢复正常。严重反应: 因品种、个体的差异,个别动物接种后可能出现急性过敏反应,如焦躁不安、呼吸加快、肌肉振颤、可视黏膜充血、呕吐、鼻腔出血等,抢救不及时可造成死亡;少数怀孕母猪可能会出现流产。

Adverse Reactions

General symptoms after the vaccination include: swelling at the injection site; transient temperature response; less food intake or stop eating for 1 to 2 days. Transient decrease in lactation yield may occur on cows. The symptom will be alleviated with time until it disappears. Severe adverse reactions may occur due to species and individual differences, some animals may show acute anaphylactic reaction after vaccination, e.g. restlessness, rapid breathing, muscle tremors, hyperemia in visible mucous membranes, rumen bloat, nasal bleeding, etc. Some may even die if not being rescued in time; few pregnant pigs may have miscarriages.

[注意事项］

Precautions

(1)疫苗应在2~8℃下冷藏运输,严禁冻结,运输和使用过程中,应避免日光直接照射, 疫苗在使用前应将疫苗恢复至室温并充分摇匀。The vaccine should be transported between 2 and 8 °C (at no stage should the vaccine be allowed to freeze). Exposure to direct sunlight during shipping and usage should be avoided. Before vaccination, the vaccine should be at room temperature and well shaken.

(2) 注射前检查疫苗性状是否正常,并对猪只严格进行体态检查,对于患病、体弱、临产怀孕母猪和长途运输后处于应激状态猪只暂不注射,待其恢复正常后方可再注射。注射器械、吸苗操及注射部位均应严格消毒,保证一头猪更换一次针头;注射时,入针深度适中,确实注入耳根后肌肉(剂量大时应考虑肌肉内多点注射法)。Before vaccination, check the characters of the vaccine, and perform strict and thorough physical examination on the pigs. For the sick, weak, pregnant pigs or pigs in stressful situation after long distance transportation, delay the vaccination until they return to normal. The injection equipment, operation and injection sites should be strictly sterilized. Make sure one needle for one pig. During injection, the insertion depth behind the root of the ears should be appropriate (when large dosage is injected, multi-point intramuscular injection is recommended).

(3) 注射工作必须由专业人员进行,防止打飞针。注苗人员要严把三关:猪的体态检查、消毒及注射深度、注后观察。The vaccination must be performed by professionals to avoid misoperation. The professionals should focus on physical examination, sterilization and injection depth, and post-injection observation.

(4) 疫苗在疫区使用时,必须遵守先注安全区(群),然后受威胁区(群),最后疫区(群)的原则;并在注苗过程中做好环境卫生消毒工作,注苗21日后方可进行调运The vaccination should be used in the order of safe area (flock), threatened area (flock) and endemic area (flock). During vaccination, staffs must ensure sanitation and disinfection of the operation environment. The animals can only be transported 21 days after vaccination.

(5) 注射疫苗前必须对人员予以技术培训,严格遵守操作规程,曾接触过病猪的人员,在更换衣服、鞋、帽和进行必要的消毒之后,方可参与疫苗注射。25kg以下仔猪苗时,应提倡肌肉内分点注射法。 Before vaccination, the staffs must receive technical training and follow the operating instructions strictly. The staff that has been exposed to the affected animals should change clothes, hats and shoes, and receive necessary disinfection before participating in the vaccination process. Multi-point intramuscular injection is recommended when vaccinating piglets that weigh less than 25 kg.

(6) 疫苗在使用过程中做好各项登记记录工作。 Recordings and registrations should be done during vaccination.

(7) 过的疫苗瓶、器具和未用完的疫苗等污染物必须进行消毒处理或深埋。The waste vaccine bottles, tools and unspent vaccine should be processed by disinfection or deep burial.

(8) 免疫注射是预防控制猪口蹄疫措施之一,免疫注射同时还应采取消毒、隔离、封锁等生物安全防范措施。 Vaccination is one of the measures to prevent and control FMD. Bio-security measures such as disinfection, quarantine and blockade should be also taken.

(9) 怀孕后期的母畜慎用。Vaccination should be exercised with caution when injecting to animals in late pregnancy.

(10) 当发生严重过敏反应时,可用肾上腺素或地塞米松脱敏施救When severe anaphylaxis occurs, the animal should be treated with adrenaline or dexamethasone.

规格

Specification

(1) 50 mL/瓶; (2) 100 mL/瓶

(1) 50 mL/bottle; (2) 100 mL/bottle

包装

Package

 (1)50ml×50瓶/箱   (2)100ml×50瓶/箱   (3)50ml×10瓶/盒×10盒/箱

(1) 50 mL×50 bottles/carton; (2) 100 mL×50 bottles/carton; (3) 50 mL×10 bottles/box×10 boxes/carton

[贮藏与有效期]  2~8℃保存，有效期为12个月。

Storage and validity

Store between 2 to 8 °C. validity period is 12 months

[批准文号］ 兽药生字(2014)310011093

Approval Number ANOVDP. (2014) 310011093