Lumpyvax®

  

FOR ANIMAL USE ONLY

LUMPYVAX®

Reg. No. G3673 (Act 36/1947)

Namibia Reg. No. V06/24.4/184 NS0

Injectable Solution

Lumpy skin disease is a notifiable disease in terms of the Animal Diseases Act 

(Act 35/1984). The occurrence or suspicion of this disease must be reported to the

responsible state veterinarian immediately.

INDICATIONS

For the prophylactic immunisation of cattle against lumpy skin disease (LSD).

IMMUNITY

Onset of immunity: Starts to develop about 10 days after vaccination and cattle should be

fully protected after 3 weeks (the vaccine may not necessarily confer absolute immunity to all

cattle). Duration of immunity: 1 year.

COMPOSITION

Each 1 mℓ (1 dose) of the vaccine contains 1 x 10⁴ TCID₅₀ – 5 x 10⁵ TCID₅₀ of freeze-dried, live, attenuated virus (SIS Neethling-type).

STORAGE INSTRUCTIONS

• Store between 2 °C – 8 °C in a refrigerator.
• Do not freeze.
• Protect from sunlight.
• Once reconstituted, use within 8 hours.

WARNINGS

• Withdrawal period: Do not slaughter cattle for human consumption within 21 days* after vaccination.
• Vaccinate healthy cattle only.
• Do not mix Lumpyvax® with any other veterinary medicinal product.
• Do not over- or under-dose the vaccine.
• Do not inject intravenously.
• KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
• Although this vaccine 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.

* 21 days is a standard withdrawal period set according to South African legislation for all vaccine products. If required by national legislation, another withdrawal period may also be licensed e.g. 0 days.

PRECAUTIONS

• Observe aseptic precautions. Ensure that all vaccination equipment (containers,
• syringes and needles) is clean and sterile prior to and during use. Use sterile equipment when administering the vaccine.
• Sterilise all equipment before use, by boiling it in water for at least 15 minutes. Do not use disinfectants or methylated spirits for sterilising.
• It is good vaccination practice, when handling the vaccine, to avoid contact with

the eyes, hands and clothing.

• Keep the vaccine cool and avoid exposure to direct sunlight and high temperatures

during vaccination.

• Do not eat, drink or smoke whilst handling Lumpyvax®.
• Adhere to the vaccination programme to obtain optimum results.
• Destroy any unused vaccine and dispose of all the empty 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.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

• Vaccinated cattle that develop an antibody response will confer maternal immunity

against lumpy skin disease by means of colostrum and this immunity lasts for 4 – 6 months. Maternal antibodies in calves may have an influence on the vaccine efficacy.

• Do not use in cattle showing LSD skin lesions.

ADVERSE REACTIONS

• A temporary decrease in milk production may occur in very rare cases.
• In regions where lumpy skin disease is not endemic, small lumps, sometimes accompanied by fever, may occur in very rare cases. These lumps usually resolve without treatment.
• Injection site swelling may occur in very rare cases.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

• Shake well before use.
• Administer 1 mℓ per cattle subcutaneously.
• Use a sterile syringe to transfer approximately 5 mℓ of sterile diluent to the vial containing the freeze-dried vaccine.
• Mix until all the powder is dissolved. Using the same sterile syringe, transfer this

suspension back to the remaining sterile diluent bottle and mix well again.

• If possible, all cattle should be vaccinated during spring.
• Calves born from vaccinated cows should be vaccinated from 4 – 6 months of age.
• Calves born from non-vaccinated cows may be vaccinated at any age.
• Pregnant cows may be vaccinated with Lumpyvax®.
• A booster vaccination should be given annually.
• A small percentage of cattle are naturally immune to lumpy skin disease virus and do not develop antibodies following vaccination. When this occurs, there is no colostrum antibody protection, and the calves of these cows may be at risk from an early age.

IDENTIFICATION

White or off white-pinkish freeze-dried pellet and a colourless sterile diluent.

PRESENTATION

Lyophilisate: Type I glass vial closed with a butyl rubber stopper and sealed with an aluminium cap.

Diluent: PET vial sealed with a combination cap.

Pack sizes: Cardboard boxes with 20 doses or 100 doses of vaccine and diluent.

Not all pack sizes may necessarily be marketed.

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 PUBLICATION OF PACKAGE INSERT

03 May 2023