Hiprabovis IBR Marker Live – patient leaflet, side effects, dosage

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release:

LABORATORIOS HIPRA, S.A.

Avda la Selva, 135

17170 Amer (Girona)

SPAIN

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

HIPRABOVIS IBR MARKER LIVE lyophilisate and solvent for suspension for injection for cattle.

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Lyophilisate:

Each dose of 2 ml contains: Live gE^- tk^- double-gene deleted bovine herpes virus type 1 (BoHV-1), strain CEDDEL: 10^6.3 - 10^7.3 CCID50.

Abbreviations:

gE^-: deleted glycoprotein E; tk^-: deleted thymidine kinase; CCID: cell culture infectious dose

Solvent:

Phosphate buffer solution.

Suspension after reconstitution: transparent pinkish liquid.

Lyophilisate: white to yellowish powder.

Solvent: transparent homogenous liquid.

4. INDICATION(S)

For the active immunisation of cattle from 3 months of age against bovine herpes virus type 1 (BoHV-1) to reduce the clinical signs of Infectious bovine rhinotracheitis (IBR) and field virus excretion.

Vaccinated animals can be differentiated from field virus infected animals due to the marker deletion (gE^-) by means of commercial diagnostic kits, unless the animals were previously vaccinated with a conventional vaccine or infected with field virus.

Onset of immunity: 21 days after completion of the basic vaccination scheme.

Duration of immunity: 6 months after completion of the basic vaccination.

5. CONTRAINDICATIONS

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

6. ADVERSE REACTIONS

Common adverse reactions:

A slight increase in body temperature up to 1 °C is common within 4 days following vaccination. Commonly, an increase in rectal temperature up to 1.63 °C in adult cows and up to 2.18 °C in calves may be observed. This transient rise in temperature is spontaneously resolved within 48 hours without treatment and it is not related to a febrile process.

A transient inflammation at the inoculation site is common in cattle within 72 hours post-vaccination. This slight swelling lasts for less than 24 hours in most cases.

Very rare adverse reactions:

Vaccination might very rarely cause hypersensitivity reactions. In such cases, an appropriate symptomatic treatment should be administered.

The frequency of adverse reactions is defined using the following convention:

• very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
• common (more than 1 but less than 10 animals in 100 animals)
• uncommon (more than 1 but less than 10 animals in 1,000 animals)
• rare (more than 1 but less than 10 animals in 10,000 animals)
• very rare (less than 1 animal in 10,000 animals, including isolated reports).

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

7. TARGET SPECIES

Cattle (calves and adult cows).

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Cattle from the age of 3 months onwards.

Administer one dose of 2 ml by intramuscular injection in the neck muscles

9. ADVICE ON CORRECT ADMINISTRATION

Reconstitute the lyophilisate with the entire contents of the supplied solvent to obtain a suspension for injection.

Recommended vaccination programme:

The recommended initial dose is 1 injection of 2 ml of the reconstituted vaccine per animal. The animal should be revaccinated 3 weeks later with the same dose. Thereafter a single booster dose of 2 ml should be administered every six months.

The method of administration is by intramuscular route, in the neck muscles. The injections should be preferably administered on the alternate sides of the neck. The solvent should be allowed to warm to a temperature between 15 and 20 °C before reconstitution of the lyophilisate. Shake well before use. Avoid the introduction of contamination during reconstitution and use. Use only sterile needles and syringes for administration.

10. WITHDRAWAL PERIOD(S)

Zero days.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Lyophilisate of 5, 25 and 30 doses: Store and transport refrigerated (2 °C - 8 °C).

Solvent of 5 and 25 doses: Store and transport refrigerated (2 °C - 8 °C).

Solvent of 30 doses: Do not store and transport above 25 °C.

Do not freeze.

Keep the bottles in the box in order to protect from light.

Do not use after the expiry date (EXP) stated on the box and the label.

Shelf-life after reconstitution according to directions: 6 hours.

12. SPECIAL WARNING(S)

Special precautions for use in animals: Vaccinate healthy animals only.

Pregnancy and lactation:

Can be used during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction:

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

Overdose (symptoms, emergency procedures, antidotes):

No adverse reactions except those mentioned in section 6 “Adverse reactions” were observed after the administration of a 10-fold vaccine dose.

Incompatibilities:

Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http: //www.ema.europa.eu/).

15. OTHER INFORMATION

Pack sizes:

Cardboard box containing 1 bottle with 5 doses of lyophilisate and 1 bottle with 10 ml of solvent.

Cardboard box containing 1 bottle with 25 doses lyophilisate and 1 bottle with 50 ml of solvent.

Cardboard box containing 1 bottle with 30 doses of lyophilisate.

Cardboard box containing 1 bottle with 60 ml of solvent.

Not all pack sizes may be marketed.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

24

¹

Lyophilisate and solvent for suspension for injection.

²

PACKAGE SIZE

5 doses

25 doses

³

TARGET SPECIES

Cattle (calves and adult cows).

⁴

INDICATION(S)

⁵

METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular use.

Read the package leaflet before use.

⁶

WITHDRAWAL PERIOD(S)

Withdrawal period: Zero days.

⁷

SPECIAL WARNING(S), IF NECESSARY

⁸

METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular use.

Read the package leaflet before use.

⁹

WITHDRAWAL PERIOD(S)

Withdrawal period: Zero days.

¹⁰

SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.