BioBos L(6), suspension for injection

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Pharmaceutical form

Suspension for injection.

Whitish to pinkish milky fluid, divided at longer standing into white sediment and almost clear supernatant.

Composition

Leptospira pomona inact. min. titre 16 determined by ALR*

Leptospira hardjo type hardjo-prajitno inact. min. titre 35 determined by ALR*

Leptospira hardjo type hardjo-bovis inact. min. titre 32 determined by ALR*

Leptospira grippotyphosa inact. min. titre 64 determined by ALR*

Leptospira icterohaemorrhagiae inact. min. titre 81 determined by ALR*

Leptospira canicola inact. min. titre 35 determined by ALR*

*The values were determined on the basis of the titres of the reference serum obtained from 5 rabbits vaccinated with a batch compliant with the challenge potency test on the target species (ALR = agglutination-lytic reaction).

Indication

For the active immunisation of cattle from 4 weeks of age against leptospirosis (6 serovares contained in the vaccine) to prevent infection, foetal infection and Leptospira excretion, mainly in the urine.

Onset of immunity: 4 weeks after primary vaccination (i.e. after administration of the first 2 doses).

Duration of immunity: 12 months after basic immunisation.

Dosage, application and vaccination scheme

Dose – 2 ml subcutaneously behind the shoulder blade, calves from 4 weeks of age, heifers and cows.

Before use the vaccine must be heated to a temperature between 15 °C and 25 °C and the contents of the vial should be shaken well.

Primary vaccination:

Primovaccination – requires the administration of two vaccine doses in interval of 4–6 weeks, the second dose should be administered not later than 4 weeks prior to mating. The main effect is prevention of Leptospira excretion in the urine.

If the second vaccine dose is administered not later than 2 weeks before mating, there is also a significant prevention of foetal infection.

Calves can be vaccinated from 4 weeks of age using primovaccination (i.e. administration of two doses). Heifers are vaccinated once before mating.

Revaccination:

To maintain protective immunity, annual revaccination with one dose, administered not later than 2 weeks prior to mating, is necessary.

The product can be used during pregnancy and lactation.

Storage

Store and transport refrigerated (2 °C–8 °C).

Protect from frost.

Protect from light.

Store in a dry place.

Withdrawal period

Not applicable.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening of package: 10 hours.

Package

10 ml, 50 ml, 100 ml in glass or plastic bottle.

Not all pack sizes may be marketed.