INGELVAC MYCOFLEX SUSPENSION FOR INJECTION FOR PIGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-02-2016
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Active ingredient:
INACTIVATED MYCOPLASMA HYOPNEUMONIAE, J STRAIN ISOLATE B-3745
Available from:
Boehringer Ingelheim Ltd
ATC code:
QI09AB13
INN (International Name):
INACTIVATED MYCOPLASMA HYOPNEUMONIAE, J STRAIN ISOLATE B-3745
Dosage:
Unknown
Pharmaceutical form:
Suspension for Injection
Prescription type:
LM-Licensed Merchant
Therapeutic group:
Porcine
Therapeutic area:
Mycoplasma vaccine
Therapeutic indications:
Immunological - Inactivated vaccine
Authorization status:
Authorised
Authorization date:
2009-07-24
Summary of Product characteristics
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
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_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)
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tra
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