INGELVAC MYCOFLEX SUSPENSION FOR INJECTION FOR PIGS

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

INACTIVATED MYCOPLASMA HYOPNEUMONIAE, J STRAIN ISOLATE B-3745

可用日期:

Boehringer Ingelheim Ltd

ATC代码:

QI09AB13

INN（国际名称）:

INACTIVATED MYCOPLASMA HYOPNEUMONIAE, J STRAIN ISOLATE B-3745

剂量:

Unknown

药物剂型:

Suspension for Injection

处方类型:

LM-Licensed Merchant

治疗组:

Porcine

治疗领域:

Mycoplasma vaccine

疗效迹象:

Immunological - Inactivated vaccine

授权状态:

Authorised

授权日期:

2009-07-24

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ingelvac MycoFLEX suspension for injection for pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Inactivated _Mycoplasma hyopneumoniae_, J Strain Isolate B-3745.
Each dose (1 ml) of inactivated vaccine contains:
ACTIVE SUBSTANCE:
_Mycoplasma hyopneumoniae_: > 1 RP*
*Relative potency (ELISA test) by comparison with a reference vaccine.
ADJUVANT:
Carbomer:
1 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
Clear to slightly opalescent, pink to brown suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (fattening pigs or future breeders until first reproductive service).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of pigs from 3 weeks of age to reduce lung lesions following infection with _Mycoplasma_
_hyopneumoniae_.
Onset of protection occurs by 2 weeks post vaccination and lasts for at least 26 weeks.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 10/02/2016_
_CRN 7022210_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinate healthy animals only.
In case of anaphylactic-type reactions, the administration of epinephrine is recommended.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Not applicable.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Adverse reactions are very rare (less than 1 animal in 10,000 animals, including isolated reports):
-
anaphylactic-type reactions may occur and should be treated symptomatically (e.g. epinephrine)
-
tra