This product is only licensed for sale in the Republic Of Ireland
Active Ingredient: Clostridium perfringens beta toxoid inducing, Clostridium perfringens epsilon toxoid inducing , Clostridium septicum toxoid inducing, Clostridium tetani toxoid inducing, Clostridium novyi toxoid inducing, Clostridium chauvoei cells and equivalent toxoid inducing
Target Species: Sheep and Lambs from 3 weeks
Treats and Controls: Pneumonia, lamb dysentery, pulpy kidney, struck, tetanus,braxy, blackleg and black disease
Administration Method: Subcutaneous injection (under the skin)
Withdrawal Time: There is no withdrawal time for this product
Dosage: 2 ml per animal.After the initial vaccination a second dose should be given no less than 4 weeks and no more than 6 weeks after.
|Body Weight||Dose Volume||Doses Per Pack|
Always read the label and all enclosed information for Heptavac P Plus before administering to animals!
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Heptavac P Plus (IT: Heptavac P)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Clostridium perfringens beta toxoid inducing ≥ 10 IU
Clostridium perfringens epsilon toxoid inducing ≥ 5 IU
Clostridium septicum toxoid inducing ≥ 2.5 IU
Clostridium tetani toxoid inducing ≥ 2.5 IU
Clostridium novyi toxoid inducing ≥ 3.5 IU
Clostridium chauvoei cells and equivalent toxoid inducing ≥ 0.5 guinea pig PD90
Formalin killed cells of the epidemiologically most important serotypes of Mannheimia haemolytica and Pasteurella trehalosigrown under iron restricted conditions: 5x108 cells per strain
Aluminium hydroxide gel 400 mg
Thiomersal 0.13 mg (preservative)
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Suspension for injection.
4. CLINICAL PARTICULARS
4.1 Target species
4.2 Indications for use, specifying the target species
For the active immunisation of sheep as an aid in the control of lamb dysentery, pulpy kidney, struck, tetanus, braxy, blackleg, black disease, clostridial metritis caused by Clostridium perfringens types B, C and D, Cl.septicum, Cl.novyi, Cl.chauvoei and Cl.tetani. 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.
The vaccine may be used in pregnant ewes as an aid in the control of lamb dysentery, pulpy kidney, tetanus and pasteurellosis in their lambs provided that the lambs receive sufficient immune colostrum during the first 1-2 days of life.
4.4 Special warnings for each target species
Heptavac P Plus should not be used in lambs less than 3 weeks of age. 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.
4.5 Special precautions for use
i. Special precautions for use in animals
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.
When handling sheep, stress should be avoided, particularly during the later stages of pregnancy when there is a risk of inducing abortion and metabolic disorders.
Because sheep are very sensitive to contamination of the injection site (which may result in non-product related tissue reactions and even in abscesses), it is advised to follow strict aseptic injection techniques.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals
In the case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician.
4.6 Adverse reactions (frequency and seriousness)
Occasionally hypersensitivity reactions may occur. In the event of an anaphylactic reaction appropriate treatment should be administered without delay.
Vaccination may result in small transient injection site reactions, usually characterised by swelling, possibly lasting for up to 3‑4 months after vaccination.
4.7 Use during pregnancy, lactation or lay
Ewes may be vaccinated during pregnancy as an aid in the control of lamb dysentery, pulpy kidney, tetanus and pasteurellosis in their lambs provided that the lambs receive sufficient immune colostrum during the first 1-2 days of life.
Regarding the handling of pregnant sheep see also section 4.5.
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
The vaccine should be administered by subcutaneous injection in the lateral side of the upper neck observing aseptic precautions. All breeding sheep not previously vaccinated with Heptavac 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. In adult breeding ewes these yearly booster injections should be given during the pre-lambing period, 4-6 weeks pre-lambing, as an aid in control of disease in their lambs.
On farms where the incidence of pasteurellosis is high, a supplementary booster injection using a Pasteurella vaccine may be required 2-3 weeks prior to expected seasonal outbreaks.
Heptavac 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 being retained for fattening or subsequent breeding will require a full course of vaccination. 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. It should be noted that Heptavac P Plus is the recommended vaccine for breeding stock 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 vaccine bottle must be shaken well before use. The use of automatic vaccination equipment is recommended. Since the bottle is non-collapsible, a vaccinator with a vented draw-off spike or similar device must be used. The instructions supplied with such equipment 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.
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. Syringes and needles must be from gamma irradiated packs or freshly sterilised by boiling for at least 20 minutes. No alcohol or other disinfectants should be used for sterilisation.
Evidence of efficacy of the Pasteurella/Mannheimia 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 has been developed following research and development which resulted in the application of Plus ‘IRP’ technology for the manufacture of the Pasteurella/Mannheimia components of this vaccine. 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 this vaccine show that two injections separated by an interval of 4-6 weeks are required to gain the full benefit of the ‘IRP’.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Accidental overdosage is unlikely to cause any reaction other than described in section 4.6. No adverse local or systemic reactions were noted in overdose studies (double dose) performed in pregnant ewes and lambs.
4.11 Withdrawal period
5. IMMUNOLOGICAL PROPERTIES
For the immunisation of sheep as an aid in the control of clostridial diseases and pasteurellosis.
ATCvet code: QI04AB05
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf-life: 24 months.
Once opened, the vaccine must be used within 10 hours.
6.4. Special precautions for storage
Store between +2°C and +8°C in the dark. Do not freeze.
6.5 Nature and composition of immediate packaging
Low density polyethylene containers of 50, 100, 250 or 500 ml with rubber closure and aluminium cap.
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
Any unused product or waste materials should be disposed of in accordance with national requirements.
7. MARKETING AUTHORISATION HOLDER
Intervet UK Ltd
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
Date: July 2010
PROHIBITION OF SALE, SUPPLY AND/OR USE
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|Country||Orders Under €70||Orders Over €70|
|Ireland (ROI & NI)||€4.99||€0.00|
|United Kingdom (Mainland Only)||€14.99||€10.00|
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All purchases can be returned to us within 14 days of delivery and returned goods must be received within 14 days from the date you informed us of the return.
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If you wish to begin the return process, please email us at email@example.com and ensure the following information is included in your email. Your name, phone number, Order id, the item you wish to return, reason for return and if the product is damaged we require photos of the product.
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