Stellamune Mycoplasma

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: VMD (Veterinary Medicines Directorate)

Aktif bileşen:

Mycoplasma hyopneumoniae

Mevcut itibaren:

Eli Lilly and Company Limited

ATC kodu:

QI09AB13

INN (International Adı):

Mycoplasma hyopneumoniae

Farmasötik formu:

Emulsion for injection

Reçete türü:

POM-V - Prescription Only Medicine – Veterinarian

Terapötik grubu:

Pigs

Terapötik alanı:

Inactivated Bacterial Vaccine

Yetkilendirme durumu:

Expired

Yetkilendirme tarihi:

1996-02-19

Ürün özellikleri

Revised: April 2015
AN: 00352/2014
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Stellamune Mycoplasma
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml dose contains:
_Active ingredients_
Inactivated _Mycoplasma hyopneumoniae_ at least 15272 RU/2ml dose
(Relative ELISA units) at release to ensure 15272 RU dose throughout
shelf-life.
_Excipients_
Thiomersal
Max. 0.185 mg
_Adjuvants_
Mineral oil
Max. 0.09 ml
Lecithin
Max. 0.01 ml
For a full list of excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
Emulsion for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Stellamune Mycoplasma is intended for use as an aid, together with
management
and
hygiene
measures,
in
the
control
of
enzootic
pneumonia in fattening pigs caused by _Mycoplasma hyopneumoniae_.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate only healthy animals.
The use of immunosuppressant drugs or procedures is contraindicated
within one month of vaccination.
Revised: April 2015
AN: 00352/2014
Page 2 of 5
In any animal population, a small number of individuals may fail to
respond fully to vaccination.
If an anaphylactic reaction occurs, administer adrenaline or an
equivalent.
4.5
SPECIAL PRECAUTIONS FOR USE
i. Special precautions for use in animals
None
ii. Special precautions to be taken by the person administering the
veterinary medicinal product to animals
To the user:
This product contains mineral oil. Accidental injection/self injection
may
result in severe pain and swelling, particularly if injected into a
joint or
finger, and in rare cases could result in the loss of the affected
finger if
prompt medical attention is not given.
If you are accidentally injected with this product, seek prompt
medical
advice even if only a small amount is injected and take the package
leaflet with you.
If pain persists for more than 12 hours after medical examination,
seek
medical advice again.
To the physician:
This product