Lumpyvax®

FOR ANIMAL USE ONLY

LUMPYVAX^®
Reg. No. G3673 (Act 36/1947)
Namibia Reg. No. V06/24.4/184 NS0

INDICATIONS
For the prophylactic immunisation of cattle against lumpy skin disease.

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

STORAGE

• Store between 2 °C and 8 °C. 
• Do not freeze.

WARNINGS

• Withdrawal period: Do not slaughter cattle for human consumption within 21 days of vaccination*.
• Vaccinate healthy animals only.
• A temporary decrease in milk production may occur.
• 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 for 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.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

• Vaccinated cows that develop an antibody response will confer maternal immunity to lumpy skin disease by means of colostrum and this lasts for 4 to 6 months. Maternal antibodies in calves may have an influence on the vaccine efficacy.
• Only healthy animals should be vaccinated

ADVERSE REACTIONS

• A temporary decrease in milk production may occur in very rare cases.
• In regions in which 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.

PRECAUTIONS

• Sterilise all equipment before using, by boiling in water for at least 15 minutes. Do not use disinfectants or methylated spirits for sterilising.
• Ensure that all equipment is kept clean and sterile during vaccination.
• Keep the vaccine cool and avoid exposure to direct sunlight and high temperatures during inoculation.
• Destroy any unused vaccine as well as all empty vaccine containers and all vaccination equipment according to local disposal regulations after vaccination.
• Do not store partially used containers for future use and use the entire contents when opened.
• It is good vaccination practice, when handling the vaccine, to avoid contact with the eyes, hands and clothing.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED
Use a sterile syringe to transfer approximately 5 mℓ of sterile diluent to the bottle containing the freeze-dried vaccine.
Mix until all the powder is dissolved and then transfer this suspension back to the remaining sterile diluent and again mix well using the sterile syringe.
Shake the bottle before filling the syringe.

DOSAGE
Inject 1 mℓ per animal subcutaneously.

RECOMMENDATIONS FOR USE

• If possible, all animals should be vaccinated during spring.
• Calves from vaccinated cows should be vaccinated at 6 months of age. Calves from unvaccinated cows may be vaccinated at any age.
• Pregnant cows may be vaccinated with Lumpyvax^®.
• A booster vaccination should be given annually.
• Immunity starts to develop about 10 days after immunisation and animals should be fully protected after 3 weeks. (The vaccine may not necessarily confer absolute immunity to all animals.)
• 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.

PRESENTATION
Vials containing 20 mℓ (20 doses) and 100 mℓ (100 doses).

REGISTRATION HOLDER
Intervet South Africa (Pty) Ltd.
20 Spartan Road, Spartan
1619, RSA
Tel: +27 (0) 11 923 9300
Fax: +27 (0) 11 392 3158
www.msd-animal-health.co.za

MANUFACTURER
Design Biologix CC
Meiring Naude Street
Lynnwood, Pretoria

DATE OF PUBLICATION OF PACKAGE INSERT
28 September 2017   

SLEGS VIR DIEREGEBRUIK

LUMPYVAX^®
Reg. Nr. G3673 (Wet 36/1947)
Namibië Reg. Nr. V06/24.4/184 NS0

INDIKASIES
Vir die profilaktiese inenting van beeste teen knopvelsiekte.

SAMESTELLING
Elke 1 mℓ (1 dosis) van die entstof bevat 10⁴ TCID₅₀ gevriesdroogde, lewende, verswakte virus (SIS Neethling-tipe).

BERGING

• Berg tussen 2 °C en 8 °C. 
• Moenie vries nie.

WAARSKUWINGS

• Onttrekkingsperiode: Moenie beeste binne 21 dae* na inenting vir menslike verbruik slag nie.
• Slegs gesonde diere moet ingeënt word.
• Enting mag ‘n tydelike daling in melkproduksie veroorsaak.
• HOU BUITE BEREIK VAN KINDERS, DIERE EN ONINGELIGTE PERSONE.
• Alhoewel hierdie entstof breedvoerig onder ‘n wye verskeidenheid toestande getoets is, mag dit faal as gevolg van verskeie redes. lndien dit vermoed word, raadpleeg ‘n veearts en verwittig die registrasiehouer.

* 21 dae is ‘n standaard onttrekkingsperiode vasgestel volgens Suid-Afrikaanse wetgewing vir alle entstowwe. lndien voorgeskryf deur nasionale wetgewing, mag ‘n ander onttrekkingsperiode ook gelisensieërd wees, bv. 0 dae.

SPESIALE WAARSKUWING EN VOORSORGMAATREëLS VIR GEBRUIK

• lngeënte koeie wat ‘n teenliggaamreaksie ontwikkel, sal moederlike immuniteit teen knopvelsiekte oordra deur middel van kolostrum wat vir 4 tot 6 maande duur. Moederlike teenliggaampies in kalfies mag ‘n invloed op die effektiwiteit van die entstof hê.
• Slegs gesonde diere moet ingeënt word.

NEWE-EFFEKTE

• ‘n Tydelike daling in melkproduksie mag voorkom in rare gevalle.
• In streke waar knopvelsiekte nie endemies is nie, kan klein knoppies, soms geassosieer met koors, in rare gevalle voorkom. Die knoppies verdwyn gewoonlik sonder behandeling.
• lnspuitingsplekswelling mag in rare gevalle voorkom.

VOORSORGMAATREëLS

• Steriliseer alle toerusting voor gebruik deur dit ten minste 15 minute in water te kook. Moenie ontsmettingsmiddels of brandspiritus gebruik om toerusting te steriliseer nie.
• Sorg dat alle toerusting skoon en steriel gehou word gedurende inenting.
• Hou die entstof koel en vermy blootstelling aan hoë omgewingstemperature en direkte sonlig gedurende inenting.
• Vernietig enige ongebruikte entstof, leë entstofhouers en alle entstoftoerusting volgens plaaslike afvalbestuursregulasies, na afloop van die inentingsproses. Gedeeltelik gebruikte houers moet nie vir latere gebruik gebêre word nie en die hele inhoud moet gebruik word as die entstof eers oopgemaak is.
• Dit is goeie inentingspraktyk om kontak met die oë, hande en klere te vermy wanneer entstowwe hanteer word.

GEBRUIKSAANWYSINGS – GEBRUIK SLEGS SOOS AANGEDUI
Gebruik ‘n steriele spuit om ongeveer 5 mℓ steriele verdunningsmiddel na die bottel wat die gevriesdroogde entstof bevat, oor te dra.
Meng deeglik totdat die poeier opgelos is, spuit hierdie suspensie terug in die oorblywende steriele verdunningsmiddel en meng weer deeglik met behulp van die steriele spuit.
Skud die bottel goed voor gebruik.

DOSIS
Dien 1 mℓ per dier onderhuids toe.

AANBEVELINGS VIR GEBRUIK

• lndien moontlik moet alle diere gedurende die lente ingeënt word.
• Kalwers van ingeënte koeie behoort op ‘n ouderdom van 6 maande ingeënt te word.
• Kalwers van nie-geënte koeie mag op enige ouderdom ingeënt word.
• Dragtige koeie mag ingeënt word met Lumpyvax^®.
• Beeste behoort jaarliks heringeënt te word.
• lmmuniteit begin na 10 dae ontwikkel en diere behoort na 3 weke ten volle beskermd te wees. (Die entstof kan nie volledige beskerming in alle diere waarborg nie.)
• ‘n Klein persentasie beeste het ‘n natuurlike weerstand teen knopvelsiekte en ontwikkel geen teenliggame na inenting nie. In hierdie geval is geen kolostrum teenliggaamproduksie moontlik nie en is die kalwers van die koeie reeds op ‘n jong ouderdom vatbaar vir knopvelsiekte.

AANBIEDING
Bottels wat 20 mℓ (20 dosisse) en 100 mℓ (100 dosisse) bevat.

REGISTRASIEHOUER
Intervet South Africa (Pty) Ltd.
Spartanweg 20, Spartan
1619, RSA
Tel: +27 (0) 11 923 9300
Faks: +27 (0) 11 392 3158
www.msd-animal-health.co.za

VERVAARDIGER
Design Biologix CC
Meiring Naude Street
Lynnwood, Pretoria

DATUM VAN PUBLIKASIE VAN VOUBILJET
28 September 2017