Multivax-P

FOR ANIMAL USE ONLY

MULTIVAX-P

Reg. No. G1517 (Act 36/1947)

Namibia Reg. No. V92/24.4/521 [NS0]

INDICATIONS

For the active immunisation of sheep as an aid in the control of pulpy kidney, malignant oedema, black quarter, tetanus and pasteurellosis caused by the organisms listed below. In particular, Multivax-P is recommended as an aid in the prevention of pneumonic and septicaemic pasteurellosis in lambs.

COMPOSITION

An opaque fluid vaccine prepared from the purified formol toxoids of Clostridium perfringens
(Cl. welchii) type D, Clostridium septicum, Clostridium tetani, purified formalin killed cultures of Clostridium chauvoei and iron-regulated antigens from the epidemiologically most important serotypes of Mannheimia haemolytica (A1, A2, A6, A7, A9) and Biberstenia (Pasteurella) trehalosi (T3, T4, T10, T15) in buffered physiological saline and adsorbed onto aluminium hydroxide.

Preservative: Thiomersal 0,013 %.

STORAGE INSTRUCTIONS

• Store between 2 ºC and 8 ºC in a refrigerator to retain the potency up to the expiry date printed on the package.
• Do not freeze.
• Protect from light.

WARNINGS

• Withdrawal period: Do not slaughter animals for human consumption for at least 21 days after vaccination.
• Vaccinate healthy animals only.
• Do not mix Multivax-P with any other vaccine or immunological product. No information is available on the compatibility of this vaccine with any other vaccine or medication.
• Do not over- or under-dose the vaccine.
• Multivax-P contains an adjuvant which may cause a temporary nodule at the site of injection.
• Ensure that marketed animals do not have local reactions (swellings) at the site of vaccine administration, or elevated temperature reactions (fever) as this may result in the condemnation of the carcasses.
• In any group of animals, a small number of individuals may fail to respond to vaccination as a result of immunological incompetence or for some other reason. Satisfactory immune responses will only be attained in healthy animals. Thus, it is important to avoid vaccination of animals which have intercurrent disease or which have a poor nutritional status.
• As with most inactivated vaccines, significant levels of immunity cannot be expected until 2 weeks after the second dose of the primary vaccination course.
• When vaccinating animals, stress should be avoided, particularly during later stages of pregnancy when there is a risk of inducing abortion or metabolic disorders.
• As with all vaccines, occasional hypersensitivity reactions may occur.
• In case of accidental self-injection, seek medical advice immediately and show the package insert to the physician.
• KEEP OUT OF REACH FROM CHILDREN, UNINFORMED PERSONS AND ANIMALS.
• Although this remedy has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.

PRECAUTIONS

• Observe aseptic precautions. Ensure that all vaccination equipment (containers, syringes and needles) is clean and sterile prior to and during use.
• Do not use disinfectants or antiseptics to sterilise any equipment.
• Wear protective clothing, masks, gloves etc., according to hazard standards.
• Avoid contact of the product with skin, eyes, and mouth.
• Do not eat, drink, or smoke whilst handling the product.
• Use the entire contents when the container is first opened and do not store partially used containers for future use.
• Adhere to the vaccination programme to obtain optimum results.
• Destroy any unused vaccine and dispose of all the vaccine containers and disposable equipment after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).
• Do not contaminate rivers, dams or any water sources with containers or waste.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

• Shake well before use.
• Administration is by subcutaneous injection in the loose skin on the side of the upper neck, observing aseptic precautions.
• Syringes and needles should 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.
• The Multivax-P bottle is collapsible, and it is not necessary to inject air into the bottle to enable vaccine to be withdrawn. It is, therefore, suitable for use with an automatic reloading injection syringe without using an air tube through the bottle cap.
• 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.

DOSAGE

• Sheep of all ages should be given a 2 mℓ subcutaneous injection with the dosage repeated after an interval of 4 to 6 weeks.
• Lambs born to vaccinated ewes could be expected to have colostrum protection for up to
  4 weeks against Mannheimia haemolytica and for up to 12 weeks against the clostridial diseases listed above.
• Lambs being retained will thus require a full vaccination programme themselves. The timing of the first injection should be carefully considered so that the full vaccination programme can be completed before the period of expected risk of diseases due to Mannheimia haemolytica or clostridia.
• Pasteurellosis due to infection with Mannheimia haemolytica A serotypes usually occurs in late spring or early summer, whereas septicaemic pasteurellosis associated with infection due to Biberstenia trehalosi T serotypes usually occurs in late summer or autumn.
• Lambs born to unvaccinated ewes should be given a first injection of 2 mℓ vaccine during the first week of life and a second 2 mℓ injection 4 to 6 weeks later.
• In areas of high incidence of pulpy kidney disease, it may be advisable to give a third dose of vaccine to lambs born early in the year during the first year of life.

PRESENTATION

An opaque fluid vaccine presented in 100 mℓ (50 doses), 250 mℓ (125 doses) and 500 mℓ (250 doses) collapsible low density polyethylene containers.

REGISTRATION HOLDER

Intervet South Africa (Pty) Ltd.

20 Spartan Road, Spartan

1619, RSA

Tel: +27 (0) 11 923 9300

E-mail: msdahza@msd.com

www.msd-animal-health.co.za

DATE OF APPROVAL OF THIS PACKAGE INSERT

30 January 2003