Startvac - summary of medicine characteristics

SUMMARY OF PRODUCT CHARACTERISTICS

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

STARTVAC emulsion for injection for cattle

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One dose (2 ml) contains:

Active substances:

Escherichia coli J5 inactivated..­.............­.............­.............­.............­.............­.......... > 50 RED60*

Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC).......­.............­.............­.............­.............­.....> 50 RED80**

• * RED60: Rabbit effective dose in 60% of the animals (serology).

• * * RED80: Rabbit effective dose in 80% of the animals (serology).

Adjuvant:

Liquid paraffin.....­.............­.............­.............­.............­.............­........18.2 mg

Excipient:

Benzyl alcohol......­.............­.............­.............­.............­.............­..21 mg.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Emulsion for injection.

Ivory-coloured homogeneous emulsion.

4. CLINICAL PARTICULARS4.1 Target species

Cattle (cows and heifers).

• 4.2 Indications for use, specifying the target species

For herd immunisation of healthy cows and heifers, in dairy cattle herds with recurring mastitis problems, to reduce the incidence of sub-clinical mastitis and the incidence and the severity of the clinical signs of clinical mastitis caused by Staphylococcus aureus , coliforms and coagulase-negative staphylococci.

The full immunisation scheme induces immunity from approximately day 13 after the first injection until approximately day 78 after the third injection.

4.3 Contraindications

None.

• 4.4 Special warnings for each target species

The whole herd should be immunised.

Immunisation has to be considered as one component in a complex mastitis control program that addresses all important udder health factors (e.g. milking technique, dry-off and breeding management, hygiene, nutrition, housing, bedding, cow comfort, air and water quality, health monitoring) and other management practices.

• 4.5 Special precautions for use

Special precautions for use in animals

Vaccinate healthy animals only.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

To the user:

This veterinary medicinal 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 veterinary medicinal product, seek prompt medical advice even if only a very 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 veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.

• 4.6 Adverse reactions (frequency and seriousness)

Very rare adverse reactions:

• – Slight to moderate transient local reactions may occur after the administration of one dose of vaccine based on post-authorisation pharmacovigilance reporting. They would mainly be: swelling (up to 5 cm2 on average), which disappears within 1 or 2 weeks at most. In some cases, there may also be pain at the inoculation site that spontaneously subsides in a maximum of 4 days.

• – A mean transient increase in body temperature of about 1 °C, in some cows up to 2 °C, may occur in the first 24 hours after injection based on post-authorisation pharmacovigilance reporting.

• – Anaphylactic-type reactions may occur in some sensitive animals which might be life-threatening based on post-authorisation pharmacovigilance reporting. Under these circumstances, appropriate and rapid symptomatic treatment should be administered.

The frequency of adverse reactions is defined using the following convention: – very common (more than 1 in 10 animals treated displaying adverse reactions) – common (more than 1 but less than 10 animals in 100 animals treated) – uncommon (more than 1 but less than 10 animals in 1,000 animals treated) – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

• 4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy and lactation.

4.8 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.

• 4.9 Amounts to be administered and administration route

Intramuscular use.

The injections should be preferably administered on the alternate sides of the neck. Allow the vaccine to reach a temperature of 15 °C to 25 °C before administration. Shake before use.

Administer one dose (2 ml) by deep intramuscular injection in the neck muscles at 45 days before the expected parturition date and 1 month thereafter administer a second dose (at least 10 days before calving). A third dose should be administered 2 months thereafter.

The full immunisation program should be repeated with each gestation.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No adverse reactions other than those mentioned in section 4.6 were observed after the administration of a double dose of vaccine.

• 4.11 Withdrawal period(s)

Zero days.

• 5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Immunologicals for bovidae, inactivated bacterial vaccines for cattle. ATCvet code: QI02AB17.

To stimulate active immunity against Staphylococcus aureus , coliforms and coagulase-negative staphylococci.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Benzyl alcohol

Liquid paraffin

Sorbitan monooleate

Polysorbate 80

Sodium alginate

Calcium chloride, dihydrate

Simeticone

Water for injections

6.2 Major incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 18 months.

Shelf life after first opening the immediate packaging: 10 hours stored at 15 °C to 25 °C.

6.4. Special precautions for storage

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

Do not freeze.

• 6.5 Nature and composition of immediate packaging

Type I colourless glass vials of 3, 10 and 50 ml.

Polyethylene (PET) vials of 10, 50 and 250 ml.

The vials are closed with a rubber stopper and aluminium cap.

Pack sizes:

Cardboard box with 1 glass vial of 1 dose.

Cardboard box with 10 glass vials of 1 dose.

Cardboard box with 20 glass vials of 1 dose.

Cardboard box with 1 glass vial of 5 doses.

Cardboard box with 10 glass vials of 5 doses.

Cardboard box with 1 glass vial of 25 doses.

Cardboard box with 10 glass vials of 25 doses.

Cardboard box with 1 PET vial of 5 doses.

Cardboard box with 1 PET vial of 25 doses.

Cardboard box with 1 PET vial of 125 doses.

Not all pack sizes may be marketed.

• 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

7. MARKETING AUTHORISATION HOLDER

Laboratorios Hipra S.A.

Avda. la Selva, 135

17170 Amer (Girona)

SPAIN

Tel. +34 972 430660

Fax +34 972 430661

E-mail:

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/08/092/001–010

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 11/02/2009

Date of last renewal: 10/02/2014