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Date: Friday, May 3, 2024 11:06

Description: 2021 logo_HIPRA
Release 3.43
Startvac
 
Species: Cattle
Therapeutic indication: Immunological veterinary medical products: For cattle
Active ingredient: Vaccine Antigens
Product:Startvac
Product index: Startvac
Cattle - milk: Zero hours
Cattle - meat: Zero days
Incorporating:
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
Pharmaceutical form
Emulsion for injection.
Clinical particulars
Target species
Cattle (cows and heifers)
Indications for use
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 (equivalent to 130 days post-parturition).
Contra-Indications
None
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.
Special precautions for use
Special precautions for use in animals
Only healthy animals should be immunised.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
To the user:
This 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 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 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.
Adverse reactions
Very rare (<1 animal/10,000 animals treated including isolated reports)
Slight to moderate transient local reactions may occur after the administration of one dose of vaccine. 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.
Anaphylactic-type reactions may occur in some sensitive animals which might be life threatening. Under these circumstances, appropriate and rapid symptomatic treatment should be administered.
Use during pregnancy, lactation or lay
Can be used during pregnancy and lactation
Interactions
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.
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 to + 25 °C before administration. Shake before use.
Administer one dose (2 ml) by deep intramuscular injection in the neck muscles and according to the following schedule:
-First injection at 45 days before the expected parturition date.
-Second injection 35 days thereafter (corresponding to 10 days before the expected parturition date).
-Third injection 62 days after the second injection (equivalent to 52 days post-parturition).
The full immunisation program should be repeated with each gestation.
Overdose
No adverse reactions other than those mentioned earlier were observed after the administration of a double dose of vaccine.
Withdrawal periods
Zero days
Pharmacological particulars
Immunological properties
To stimulate active immunity against Staphylococcus aureus, coliforms and coagulase-negative staphylococci.
ATCvet code: QI02 AB (Inactivated bacterial vaccines for bovidae).
Pharmaceutical particulars
Excipients
Benzyl alcohol
Liquid paraffin
Sorbitan monooleate
Polysorbate 80
Sodium alginate
Calcium chloride, dihydrate
Simeticone
Water for injections
Major incompatibilities
Do not mix with any other vaccine or immunological product.
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 to +25 ºC.
Special precautions for storage
Store and transport refrigerated (2 to 8 °C) and protected from light.
Do not freeze.
Immediate packaging
3 ml, 10 ml and 50 ml Type I colourless glass vials, closed with rubber stoppers and aluminium caps.
Polyethylene (PET) vials of 10, 50 and 250 ml.
Pack sizes:
- Cardboard box with 1, 10 and 20 vials of 1 dose.
- Cardboard box with 1 and 10 vials of 5 doses.
- Cardboard box with 1 and 10 vials of 25 doses.
- Cardboard box with 1 PET vial of 5, 25 and 125 doses.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
LABORATORIOS HIPRA, S.A.
Avda. La Selva, 135
17170- AMER (Girona)
SPAIN
Tel. +34 972 430660
Fax. +34 972 430661
E-mail: hipra@hipra.com
Marketing Authorisation Number
UK(GB): Vm 17533/5010
UK(NI): EU/02/08/092/001-010
Significant changes
Date of the first authorisation or date of renewal
11.02.2009
Date of revision of the text
Date of last renewal 10/02/2014.
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:STARTVAC 1ds*20
GTIN:08427711121992
GTIN description:STARTVAC 25ds
GTIN:08427711122012
GTIN description:STARTVAC 5ds
GTIN:08427711122005