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For Animal Health Only

BioBos Respi 4. Inj.

PHARMACEUTICAL FORM:Suspension

COMPOSITION:at 2 ml

Active ingredients:

Virus respiratoris syncytialis bovis inactivatum, BIO-24 Strain, min.105.0, max.106.0  TCID50*  RP ≥ 1***

Virus parainfluensis 3 bovis inactivatum, BIO-23 Strain,  min.107.5, max.108.6 TCID50*  RP ≥ 1***

Virus diarrhoeae bovis inactivatum, BIO-25 Strain   min.106.0, max.107.5 TCID50* _cc781905-5cde≥58-3194- **

Mannheimia (Pasteurella) haemolytica inactivata, DSM 5283 Strain , Serovar1A : min.5x109, max.1x1010  CFU**_cc781905-5cde-3194-bb3b-136_bad5cf

 

(* ) 50% tissue culture Infective dose.

(**) Colony forming unit

(***) Relative potency (RP) is given by comparing antibody levels in serum prepared with the reference vaccine series, which is compatible with challenge testing in target animals.

adjuvants:

Aqueous aluminum hydroxide for absorption %2    0.4 ml

Quillaja saponin (Quil A) % 1    0.04 ml

Excipients:

Thiomersal  0.01%

Formaldehyde 35%   0.05%

 

Immunological features:

Pharmacotherapeutic group:Immunologics for cattle; inactivated viral and bacterial vaccines.

ATCvet code: QI02AL04 inactivated viral vaccine against bovine parainfluenza + inactive viral vaccine against bovine respiratory syntitial virus+ inactive viral vaccine against diarrhoea + inactivated vaccine against pasteurellosis.

Vaccine   bovine respiratory syntitial virus, parainfluenza 3 virus, bovine viral diarrhoea and Mannheimia (Pasteurella) haemolytica.

 

AREA OF USE / INDICATIONS

 In cattle,

- bovine parainfluenza 3 virus (PI3),

- bovine respiratory and syntytial virus (BRSV),

- bovine viral diarrhoea virus (BVD),

- Mannheimia (Pasteurella) haemolytica serotype A1 (PHA1) is used to create active immunity against systemic diseases caused by its agents.

 

UNDESIRED /SIDE EFFECTS

When the vaccine is administered under appropriate and correct conditions, no obvious reaction is observed following vaccination. A temporary swelling may be seen in susceptible animals. This swelling, which can reach up to 6 cm, usually disappears within 2-3 weeks after vaccination.

some  in animals  two-three  a moderate rise in body temperature during the day_cc781905-5cde-13365cf.

Rarely, sensitization reactions can occur with all vaccines. In such cases, appropriate treatment choices such as antihistamines   should be applied when necessary.

 

DRUG INTERACTIONS

No information is available on the safety and efficacy of this vaccine when used with or mixed with any other  medicinal product. For this reason, it should not be used with or mixed with another product that is not approved for safe use in the package insert. The decision to use immediately before or immediately after other veterinary medicinal products should be made on a case-by-case basis under the responsibility of the Veterinarian.

This vaccine should never be mixed with other veterinary medicinal products or with any other product.

 

SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE

Double dose,  safe in all target strains.

After subcutaneous administration of the high dose, local reactions are higher than the standard dose (the diameter of the swelling can reach 9 cm).

No adverse effects other than those mentioned in Undesirable effects were observed.

 

CONTRAINDICATIONS

Only healthy animals are vaccinated.

Do not use in animals with signs of disease.

 

DRUG RESIDUAL WARNINGS IN FOOD

Drug Residue Clearance Time (withdrawal): Szero is “0” days.

“CONSULT YOUR VET PHYSICIAN BEFORE USING”

“KEEP IT OUT OF THE REACH OF CHILDREN”

“IF AN UNEXPECTED EFFECT IS OBSERVED, CONSULT YOUR VET PHYSICIAN”


STORAGE AND SHELF LIFE

It should be stored between + 2 ° C and + 8 ° C, it should be transported in the cold chain,   should be protected from light and the vaccine should never be frozen. If these conditions are met, the effective shelf life of the vaccine in the unopened bottle is 24 months.

The shelf life of the bottle opened for use is 10 hours after opening.

 

WARNINGS FOR END DISPOSAL AND NON-TARGET SPECIES:

The packaging and waste disposal of the preparation must be carried out in accordance with the applicable regulations.

The vaccine should not be used for any purpose  other  as reported in the package insert.

 

COMMERCIAL PRESENTATION

The vaccine is presented in glass vials that are hermetically sealed with rubber stoppers and aluminum caps.

All (Commercial) Presentations:

A) 10 or 20 vials in a plastic box with a lid;

1 x 2 ml, 10 x 2 ml, 20 x 2 ml, 1 x 10 ml, 10 x 10 ml vials.

B) In a cardboard box;

1 x 10 ml, 1 x 20 ml, 1 x 50 ml, 1 x 100 ml vials.

C) In a multi-product box;

10 x 10 ml, 5 x 20ml, 10 x 20 ml vials.

 

SALESPLACE AND TERMS

Sold in veterinary clinics, outpatient clinics, animal hospitals and pharmacies with a veterinary prescription (VHR).

 

PROSPECTUSAPPROVAL DATE:20.03.2013

MINISTRY OF FOOD, AGRICULTURE AND LIVESTOCK  MARKETING PERMISSION DATE - NO:

28.02.2013 – p0041

MARKETING PERMISSION HOLDER AND ADDRESS:

İNTERMED Pharmaceutical Warehouse, Import, Export Trade and Contracting Ltd. Sti.

Health St. 32/4 Yenişehir/ANKARA  

Tel: (312) 435 95 60   Fax: (312) 435 73 51 _cc-5819f-1365cbad interhas.com.tr

MANUFACTURER AND ADDRESS:

BIOVETA as, Komenskeho 212, 683 23 Ivanovice na Hane, Czech Republic

Biobos Respi 4

  • Inactivated vaccine against Paraifluenza 3 virus, Viral diarrhea virus, Respiratoric syncytial virus, and Pasteurella haemolytica infections in cattle.

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