MASTIVET, injectable suspension
QUALITATIVE AND QUANTITATIVE COMPOSITION per ml
Name of the substances Quantity per unit Action Reference standard
Active substances
Inactivated culture of Streptococcus agalactiae ≥9x108UFC Active substance
Inactivated culture of Streptococcus dysgalactiae ≥3x108UFC Active substance
Inactivated culture of Streptococcus uberis ≥3x108UFC Active substance
Inactivated culture of Streptococcus pyogenes ≥3x108UFC Active substance
Inactivated culture of Staphylococcus aureus ≥10x108UFC Active substance
Inactivated culture of Escherichia coli ≥18x108UFC Active substance
Inactivated culture of Arcanobacterium pyogenes ≥10x108UFC Active substance
Excipients
Aluminium hydroxide (expressed as Aluminium oxide) 20% of the final volume
Immune excipient British Ph., 765 (1993)
Diluents
CINa(Sodium chloride) 0,16 g (±1%) Diluent Eu. Ph.,3rd Ed.,193, 1997
CIK(Potassium chloride) 0,0004 g (±1%) Diluent Eu. Ph.,3rd Ed.,185, 1997
Na2HPO4 12 H2O (Disodium Phosphate Dodecahydrate) 0,0023 g (±1%) Diluent Eu. Ph.,3rd Ed.,193, 1997
KH2PO4(Potassium Dihydrogen Phosphate) 0,0004 g (±1%) Diluent Eu. Ph.,3rd Ed.,193, 1997
Water for injections 1 ml (±1%) Diluent Eu. Ph.,3rd Ed., 008, 1997
Eu. Ph.,3rd Ed., 169, 1997
Other substances
Formaldehyde Less than 20 μg/ml Inactive factor Eu. Ph.,3rd Ed., 826,1997
PHARMACOTECHNICAL FORM:
Injectable suspension
Target species
Cattle
Indications for the use in detail for every target specie
It contributes in the prevention of mastitis from the micro-organisms that are reported in the composition.
Contraindications
Not be used in animals with hypersensitivity in somebody of the substances of product.
Is not recommended for other species except cows
Special precautions for each target animal specie
None are known
Special precautions for use
Special precautions for use in animals
The administration of the vaccine during the lactating period causes probably important reduction of lactation for duration of 10 days at least
Special precautions to be taken by the person administering the product
In case of auto vaccination you have to ask immediately medical advice and show the product or the Leaflet of Directives of Use to the doctor.
Undesirable effects in the animals for which is intended the product, frequency and seriousness
In certain animals is observed rise of temperature from the rectum per 1-1, 5 0 C the first days following the vaccination.
It can be observed irritation at the point of the injection which is disappeared few days after the vaccination.
Attributes of the rubor: Size: Approximately 5 mm of diameter
Consistence: Redness of skin with small hardening.
Interactions with other vaccines and medicines
No information is available for the safety and the vaccine action with regard to its parallel use with any other medical product. For this it is recommended not to be administered with any other vaccine 10 days before and after the administration of this product.
Quantity and method of administration
5 ml
Administration rout: Subcutaneously
Two vaccinations with interval of 21 days.
The first vaccination two months before the parturition and second 21 days afterwards.
Commemorative vaccination every 6 months with one only dose of vaccine.
Overdose
None
Withdrawal period
It is not required.
Incompatibilities
Not to be mixed with no other vaccine or immunological product.
Expiry date, shelf-life afterwards the reconstitution or the opening of the container
24 months, in temperature 4ο C ± 2ο C
When it is opened the packing should be consumed its content within the same day.
Special precautions for storage
Store in temperature 4ο C ± 2ο C.
Protect the product from the sunlight and do not freeze it.
Nature and content of container
Flacons of 10 ml, 25 ml, 50 ml, 100 ml, 250 ml of sterile and depyrogenated glass, type I and II, which is described in the European Pharmacopoeia (Eu. Ph., 3rd Ed., 1997). All the flacons have rubber closures as it is described in the European Pharmacopoeia (Eu. Ph., 3rd Ed., 1997) as type I. The closures are sterilized and are closed using silicone before their use. These apply on the flacons orifice by metal wrapping.
Special precautions for the disposal of partially used medicines or empty flacons
The flacons and any residual content should be eliminated according to current rules with about toxic and dangerous waste type IV.
