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Date: Wednesday, December 12, 2018 21:10

MSD-AH
Telephone: 01908 685685 (Customer Support Centre)
Release 2.15
Ovivac P Plus
 
Species: Sheep
Therapeutic indication: Immunological veterinary medical products: For sheep
Active ingredient: Vaccine Antigens
Product:Ovivac® P Plus
Product index: Ovivac P Plus
Sheep - meat: Zero days
Qualitative and quantitative composition
Active ingredients
Per ml
Cl. perfringens type D, strain 603 epsilon toxoid
inducing ≥ 5 IU
Cl. septicum, strain S1110/85 toxoid
inducing ≥ 2.5 IU
Cl. tetani, strain 51123/91 toxoid
inducing ≥ 2.5 IU
Cl. chauvoei, strains 655, 656, 657, 658, 1048
cells and equivalent toxoid inducing ≥ 0.5 guinea pig PD90 per strain
M. haemolytica, strains A1, A2, A6, A7, A9
5 x 108 cells per strain
P.trehalosi, strains T3, T4, T10, T15
5 x 108 cells per strain
* PD90 = protective dose 90% survival
Aluminium hydroxide (Adjuvant): 350 mg
Thiomersal (Preservative) : 0.067 - 0.15 mg
For a full list of excipients see section “Pharmaceutical Particulars”.
Pharmaceutical form
Suspension for injection.
Clinical particulars
Target species
Sheep
Indications for use
For the active immunisation of lambs as an aid in the control of pulpy kidney, tetanus, braxy and blackleg caused by Cl.perfringens type D, Cl.septicum, Cl.tetani and Cl.chauvoei. The vaccine may be used as an aid in the control of pneumonic pasteurellosis in sheep of all ages from a minimum age of 3 weeks and in the control of systemic pasteurellosis in weaned fattening and breeding sheep.
Contra-indications
None.
Special warnings for each target species
Ovivac P Plus should not be used in lambs less than 3 weeks of age. Should Ovivac P Plus be used in breeding stock, the nutritional and metabolic status of pregnant ewes is extremely important at the time of vaccination. If in doubt, advice should be sought from a veterinary surgeon.
Special precautions for use
In any group of animals, a small number of individuals may fail to respond to vaccination as a result of immunological incompetence. Satisfactory immune responses will only be attained in healthy animals, thus it is important to avoid vaccination of animals which have intercurrent infection or metabolic disorder. As with most killed vaccines, significant levels of immunity cannot be expected until two weeks after the second dose of vaccine in the primary vaccination course.
User warnings:
In the case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions
Occasional hypersensitivity reactions may occur. The vaccine contains an adjuvant and, as with most adjuvanted vaccines, may result in small transient injection site reactions possibly lasting for up to 3‑4 months after vaccination.
Use during pregnancy, lactation or lay
Although not recommended, ewes may be vaccinated during pregnancy as an aid in the control of pulpy kidney, tetanus and pasteurellosis in their lambs provided that the lambs receive sufficient immune colostrum during the first 1-2 days of life.
Although the vaccine may be safely used in pregnant ewes as an aid in the control of pulpy kidney, tetanus and pasteurellosis in their lambs, the vaccine contains no lamb dysentery component and therefore control of this important disease cannot be achieved by its use. Use of Ovivac P Plus as a breeding stock vaccine is therefore not recommended. The combined 7 in 1 clostridial plus pasteurella vaccine, Heptavac P Plus, is the recommended breeding stock vaccine since it provides optimal aid in the control of the predominant clostridial diseases in adult sheep by active immunisation and in young lambs by passive immunisation.
Should Ovivac P Plus be used as a breeding stock vaccine, when handling sheep, stress should be avoided, particularly during the later stages of pregnancy when there is a risk of inducing metabolic disorders which may lead to abortion.
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
Dose : 2 ml
Administration: The vaccine should be administered by subcutaneous injection in the lateral side of the upper neck observing aseptic precautions.
All lambs not previously vaccinated with Ovivac P Plus must receive two injections, each of 2.0 ml, separated by an interval of 4-6 weeks.
Thereafter they must receive booster injections at intervals of not more than 12 months.
On farms where the incidence of pasteurellosis is high, a supplementary booster vaccination with Ovipast Plus (Pasteurella vaccine) may be required 2-3 weeks prior to expected seasonal outbreaks.
Ovivac P Plus should not be used in lambs less than 3 weeks of age due to the possible immunological incompetence of the very young lamb and competition from any maternally derived colostral antibodies. Lambs born to Heptavac P Plus vaccinated ewes will, provided they receive sufficient immune colostrum during the first 1-2 days of life, have adequate initial levels of antibody to aid in the control of lamb dysentery, pulpy kidney, tetanus and pasteurellosis. To maintain aid in the control of pulpy kidney, tetanus and pasteurellosis, lambs being retained for late fattening or storing will require a full vaccination course of Ovivac P Plus. At a minimum age of 3 weeks these lambs should receive two injections, each of 2.0 ml, separated by an interval of 4-6 weeks.
Lambs being retained for subsequent breeding will require a full course of vaccination with a suitable breeding stock vaccine. The combined 7 in 1 Clostridial plus Pasteurella vaccine, Heptavac P Plus, is the recommended breeding stock vaccine since it provides optimal aid in the control of the predominant clostridial diseases in adult sheep by active immunisation and in young lambs by passive immunisation.
The use of automatic vaccination equipment is recommended. The vaccine may be administered using a sterile needle and syringe, providing a fresh sterile needle is used each time the rubber cap is punctured, to avoid contamination of the remaining contents.
Evidence of efficacy of the Pasteurella component of Heptavac P Plus was generated in an experimental infection model and it is not possible to provide duration of immunity information using this system. There are reports that active immunity will last for up to one year and that passive immunity will persist for up to 4 weeks after birth in lambs from ewes vaccinated with conventional Pasteurella vaccines. Heptavac P Plus, Ovivac P Plus and Ovipast Plus have been developed following research and development which resulted in the application of the ‘IRP’ technology for the manufacture of the pasteurella components of these vaccines. The inclusion of these IRP components should provide enhanced efficacy and cross protection e.g. protection against serotype A12, which is not included in the vaccine, has been demonstrated. Studies on the response of sheep to these vaccines show that two injections separated by an interval of 4‑6 weeks are required to gain the full benefit of the ‘IRP’.
The vaccine bottle must be shaken well before use. Do not freeze.
 
The vaccine may be administered using a sterile needle and syringe, provided a fresh needle is used each time the rubber cap is punctured, to avoid contamination of the remaining contents.  
Syringes and needles must be from gamma irradiated packs or freshly sterilised by boiling for 20 minutes. No alcohol or other disinfectants should be used for sterilisation.  
It is recommended that an automatic vaccinator is used. Since the bottle containing this product is non-collapsible the vaccinator must have a vented draw-off spike or similar device. The instructions supplied with such syringes should be noted and care should be taken to ensure the delivery of the full dose, particularly with the final few doses from the bottle.
Overdose
Accidental overdosage is unlikely to cause any reaction other than described in section “Adverse Reactions”. No adverse local or systemic reactions were noted in overdose studies performed in lambs.
Withdrawal periods
Zero days.
Pharmacological particulars
Immunological properties:
ATC Vet code QI04AB05
For the immunisation of sheep as an aid in the control of clostridial diseases and pasteurellosis.
Pharmaceutical particulars
Excipients
Thiomersal, Aluminium hydroxide, Tris Maleic Acid, Sodium Chloride, Formaldehyde and Purified Water.
Major incompatibilities
Do not mix with any other veterinary medicinal products.
Shelf life
Shelf life of veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 10 hours.
Partially used containers must be discarded at the end of each day's operations.
Special precautions for storage
Store in a refrigerator between 2 °C to 8 °C. Protect from light. Do not freeze. Use before the expiry date printed on the pack.
Immediate packaging
Carton with one LDPE bottle containing 100 ml or 500 ml closed with a combination seal.
Not all presentations 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 the local requirements.
Marketing Authorisation Number
Vm 01708/4388
Significant changes
Date of the first authorisation or date of renewal
27 November 2006.
Date of revision of the text
29 May 2015.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Ovivac-P Plus 1x100ml:
GTIN:08713184028303,
GTIN description:Ovivac-P Plus 1x250ds/500ml:
GTIN:08713184028310