Tecon Biology Co.,ltd

口蹄疫0型、A型、亚洲1型三价灭活疫苗

（OHM/02株+AKT-III株+Asia1KZ/03株）（悬浮培养工艺）

Manual of  Foot and Mouth Disease Trivalent Vaccine, Inactivated (TypeO,StrainOHM 02,TypeA ,Strain AKT-Ⅲ and Type Asia 1,Strain KZ/03) （Suspension Culture）

兽用名称Veterinary Drug Name

通用名称 ：口蹄疫0型、A型、亚洲1型三价灭活疫苗（OHM/02株+AKT-III株+Asia1KZ/03株）（悬浮培养工艺）

Generic Name: Foot and Mouth Disease Trivalent Vaccine, Inactivated (Type O, Strain OHM/02, Type A, Strain AKT-III and Type Asia 1, Strain KZ/03)

商品名称 ：无

Trade Name: None

英文名称 ： Foot and Mouth Disease Trivalent Vaccine, Inactivated (TypeO,StrainOHM 02,TypeA ,Strain AKT-Ⅲ and Type Asia 1,Strain KZ/03) （Suspension Culture）

English name: Foot and Mouth Disease Trivalent Vaccine, Inactivated (TypeO, StrainOHM 02,TypeA ,Strain AKT-Ⅲ and Type Asia 1,Strain KZ/03) （Suspension Culture）

汉语拼音 ： Koutiyi O Xing A Xing Yazhou 1 Xing Sanjia Miehuoyimiao(OHM/02Zhu+AKT-ⅢZhu+Asia1

KZ/03Zhu) （Xuanfupeiyang Gongyi）

Chinese Pronunciation : Koutiyi O Xing A Xing Yazhou 1 Xing Sanjia Miehuoyimiao(OHM/02Zhu+AKT-ⅢZhu+Asia1

KZ/03Zhu) （Xuanfupeiyang Gongyi）

［主要成分与含量 ］  疫苗中含有灭活的口蹄疫0型毒（OHM/02株 ）、A型III系鼠化弱毒株和亚洲1型毒 （Asia1  KZ/03株），灭活前的病毒含量分别至少为 107.5LD50/0.2ml 。

Main ingredient and Composition

The product contains a mixture of inactivated Foot and Mouth Disease (FMD) Virus Type O (Strain OHM/02), A (Strain AKT-III) and Asia 1 (Strain KZ/03). Before inactivation, the minimum virus level should be 10^7.5LD₅₀/0.2mL.

［性      状 ］ 乳白色或淡粉红色的粘滞性乳状液。

Character

Slightly viscous, milk white or pale pink emulsion.

［作用与用途 ］ 用于预防牛、羊O型、A型和亚洲1型口蹄疫。免疫期为6个月。

Usage and Indication

This product is indicated to prevent FMD virus (Type O, A, and serotype Asia1) of cattle and sheep. The immunity period is 6 months.

［用法与用量 ］ 颈部肌肉注射。牛每头2.0ml，羊每只1.0ml。

Administration

Perform intramuscular injection in the neck: 2 mL per cattle; 1 mL per sheep.

[不良反应 ］

一般不良反应  注射部位肿胀，一过性体温反应，减食或停食1~2日，奶牛可出现一过性泌乳量减少，随着时间延长，症状逐渐减轻，直至消失。严重不良反应   因品种、个体的差异，个别牛接种后可能出现急性过敏反应，如焦躁不安、呼吸加快，肌肉震颤、可视黏膜充血、瘤胃鼓气、鼻腔出血等，甚至因抢救不及时而死亡；少数怀孕母牛可能出现流产。

Adverse Reactions

General adverse reactions 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 animals may have miscarriages.

[注意事项］Precautions

(1) 严禁冻结。使用前应将疫苗恢复至室温并充分摇匀。At no stage should the vaccine be allowed to freeze. Before use, the vaccine should be at room temperature and well shaken.

(2) 病牛慎用。Vaccination should be exercised with caution when injecting to the diseased cattle.

(3) 接种时，应使用灭菌注射器械，并注意对注射部位进行消毒。Vaccination should be exercised with sterilized injection equipment. The injection sites should be strictly sterilized.

(4) 大面积使用前，应先小面积试用，在确认安全后，再逐渐扩大使用范围。Before vaccinating in a large scale, the vaccine should be tested among a small group of animals. The scale of vaccination can be extended gradually after safety of use is confirmed.

(5) 在紧急防疫中，除用本品紧急接种外，还应同时采用其他综合防制措施。During emergency vaccination, other comprehensive prevention measures should also be taken.

(6) 个别牛出现严重过敏反应时，应及时使用肾上腺素等药物进行治疗，同时采用适当的辅助治疗措施。When severe anaphylaxis occurs on individual cattle, the cattle should be treated with drugs such as adrenaline, while appropriate adjuvant therapy should also be applied.

(7) 在运输过程中应冷藏 ，防止阳光照射。The vaccine should be transported in cold storage. Exposure to direct sunlight should be avoided.

(8) The waste vaccine vials, tools and unspent vaccine should be processed by harmless treatment.

规格

Specification

(1) 20ml/瓶 (2) 50ml/瓶  (3) 100ml/瓶

(1) 20 mL/bottle; (2) 50mL/bottle；（3）100ml/bottle

Package

【包装】 (1) 50ml x 50瓶/箱 （2）100ml x 50瓶/箱 （3）50ml x 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 °C to 8 °C. validity period is 12 months

[批准文号］ 兽药生字（2015）310017525

Approval Number

Veterinary medicine (2015) 310017525