Multiclos

FOR ANIMAL USE ONLY

MULTICLOS
Reg. No. G3392 Act 36/1947
Namibia Reg. No. V04/24.4/723 NS0

INDICATIONS
Multiclos is a vaccine for the active immunisation of healthy cattle and sheep against blackleg, malignant oedema (gas gangrene), bacillary haemoglobinuria, black disease (infectious necrotic hepatitis), diarrhoea, haemorragic enterotoxaemia and pulpy kidney disease.

COMPOSITION
Multiclos is a water based injectable, including an alum precipitate, containing toxoids obtained from cultures in liquid media of suitable strains of Clostridium septicum, Clostridium novyi type B (also known as Clostridium oedematiens type B), Clostridium sordellii and Clostridium Perfringens type C and D (also known as Clostridium welchii type C and D), as well as anacultures of Clostridium chauvoei and Clostridium haemolyticum (also known as Clostridium novyi type D), inactivated and concentrated in such manner that immunogenic activity is retained.
Although Clostridium perfringens type B is not a component of the vaccine, immunity may be provided against the beta and epsilon toxins produced by Clostridium perfringens type B as a result of the combination of type C (beta toxin) and type D (epsilon toxin) fractions.

STORAGE

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

WARNINGS

• Withdrawal period: animals should not be slaughtered for human consumption within 3 weeks of vaccination.
• Vaccinate only healthy cattle and sheep.
• As with all vaccines, occasional hypersensitivity reactions may occur. In such cases, appropriate treatment such as adrenaline and/or antihistamines should be administered without delay.
• As usual with all vaccines, absolute immunity cannot be guaranteed in all animals. Therefore, it is advisable to consult a veterinarian regarding additional control measures, instead of relying on the vaccine alone.
• Usually no marked reaction follows vaccination although a transient swelling may appear at the site of inoculation, and some animals may show a moderate rise of temperature for one or two days.
• Partly used containers containing left-over vaccine, should be disposed of at the end of each day’s operation as per local waste disposal regulations, since under field conditions it may be difficult to avoid accidental contamination of the vaccine.
• 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.

PRECAUTIONS

• Only sterile needles and properly sterilized vaccinator should be used. In order to maintain proper hygiene, it is advisable to change to clean sterile needles as frequently as possible.
• In case of long fleece, it is necessary to make sure that the needle has penetrated the skin before injecting the product.
• Do not mix the vaccine with other veterinary medicinal products.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

• Shake well before use.
• Vaccinate by subcutaneous injection.

DOSAGE AND ADMINISTRATION

• For animals that have never been immunised before, two doses should be given separated by an interval of 3 to 4 weeks.
• Animals should be revaccinated annually prior to periods of extreme risk or parturition.
• For Clostridium haemolyticum and Clostridium novyi, a booster inoculation should be administered every 5 to 6 months.
• Animals vaccinated before 3 months of age should be revaccinated at weaning or 4 to 6 months of age.
• Immunity is established within 3 to 4 weeks after inoculation, and should last for ± 1 year, except for Clostridium haemolyticum and Clostridium novyi – as indicated above.

DOSAGE
Cattle  :           5 mℓ subcutaneously
Sheep :           3 mℓ subcutaneously

PRESENTATION
Multiclos is a yellowish liquid with an off-white precipitate, which resuspends on shaking and is packed in polypropylene containers.

REGISTRATION HOLDER
Intervet South Africa (Pty) Ltd
20 Spartan Road, Spartan
1619, RSA
Tel: +27 (0) 11 923 9300
Fax: +27 (0) 11 974 9320
www.msd-animal-health.co.za

MANUFACTURER
Prondil S.A
Barros Arana 5402
Montevideo, Uruguay

DATE OF PUBLICATION OF THIS PACKAGE INSERT
07 January 2004

SLEGS VIR DIEREGEBRUIK

MULTICLOS
Reg. Nr. G3392 Wet 36/1947
Namibia Reg. Nr. V04/24.4/723 NS0

INDIKASIES
Multiclos is ‘n entstof vir die aktiewe immunisering van gesonde beeste en skape teen sponssiekte, kwaadaardige edeem (gasgangreen), basillêre hemoglobinurie, aansteeklike nekrotiese hepatitis, diarree, hemorragiese enterotoksemie en bloednier.

SAMESTELLING
Multiclos is ‘n water-basis inspuiting, met gepresipiteerde aluin, wat geïnaktiveerde stamme van Clostridium septicum, Clostridium novyi tipe B (ook bekend as Clostridium oedematiens tipe B), Clostridium sordellii en Clostridium perfringens tipes C en D (ook bekend as Clostridium welchii tipe C en D), asook anakulture van Clostridium chauvoei en Clostridium haemolyticum (ook bekend as Clostridium novyi tipe D) bevat, geïnaktiveer en gekonsentreer op so ‘n manier om immuunstimulerende aktiwiteit te behou.
Alhoewel Clostridium perfringens tipe B nie ‘n bestanddeel van die entstof is nie, kan hierdie entstof immuniteit verskaf teen beta en epsilon toksiene (geproduseer deur Clostridium perfringens tipe B). Dit is as gevolg van die kombinasie van tipe C (beta toksien) en tipe D (epsilon toksien) fraksies.

BERGING

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

WAARSKUWINGS

• Onttrekkingsperiode: Diere moet nie binne 3 weke na toediening van entstof vir menslike gebruik geslag word nie.
• Net gesonde beeste en skape mag ingeënt word.
• Soos met alle entstowwe, kan daar af en toe hipersensitiwiteits-reaksies voorkom. In sulke gevalle moet adrenalien en/of antihistamiene sonder versuim toegedien word.
• Soos met alle entstowwe, kan volkome beskerming in all diere nie gewaarborg word nie. Dit is dus raadsaam om ‘n veearts oor addisionele beheermetodes te raadpleeg, en nie alleenlik op die doeltreffendheid van die entstof staat te maak nie.
• Gewoonlik is daar geen merkbare reaksie na enting nie, alhoewel ‘n tydelike swelsel by die plek van inenting mag voorkom. Party diere mag ‘n matige verhoging in temperatuur vir een of twee dae toon.
• Houers wat gedeeltelik gebruik is en nog entstof bevat, moet na daaglikse gebruik vernietig word aangesien dit onder veld toestande moeilik is om te verhoed dat entstof besmet word.
• HOU BUITE BEREIK VAN KINDERS, ONINGELIGTE PERSONE EN DIERE.
• Alhoewel hierdie entstof breedvoerig onder ‘n wye verskeidenheid van toestande getoets is, mag dit faal as gevolg van verskeie redes. Indien dit vermoed word, raadpleeg ‘n veearts en verwittig die registrasiehouer.

VOORSORGMAATREëLS

• Slegs steriele naalde en behoorlik gesteriliseerde spuite moet gebruik word. Om higiëne te verseker is dit raadsaam om naalde gereeld te vervang met skoon steriele naalde.
• In die geval waar skape met lang wol ingeënt word, is dit noodsaaklik om seker te maak dat die naald die vel deurdring voor daar ingespuit word.
• Moenie die entstof met enige ander veeartsenymiddels meng nie.

GEBRUIKSAANWYSINGS – GEBRUIK SLEGS SOOS AANGEDUI

• SKUD DEEGLIK VOOR GEBRUIK.
• Toediening deur onderhuidse inspuiting.

DOSERING EN TOEDIENING

• By diere wat nog nie voorheen ingeënt is nie, moet twee dosisse, met ‘n tussenpose van 3 tot 4 weke toegedien word.
• Diere moet jaarliks ‘n skraagdosis ontvang, veral voor tydperke van groter risiko en parturisie.
• Vir Clostridium haemolyticum en Clostridium novyi moet ‘n skraagdosis elke 5 tot 6 maande toegedien word.
• Diere wat ingeënt word voor die ouderdom van 3 maande moet ‘n skraagdosis op speenouderdom of op 4 tot 6 maande ouderdom ontvang.
• Immuniteit word 3 tot 4 weke na inenting teweeggebring en is vir ± 1 jaar doeltreffend, behalwe in die geval van Clostridium haemolyticum en Clostridium novyi – soos hierbo aangewys.

DOSIS
Beeste  :         5 mℓ onderhuids
Skape    :         3 mℓ onderhuids

AANBIEDING
Multiclos is ‘n geel-kleurige vloeistof met ‘n naaswit presipitaat, wat maklik na skud oplos en word verpak in polipropileen houers.

REGISTRASIEHOUER
Intervet South Africa (Pty) Ltd.
Spartanweg 20, Spartan
1619, RSA
Tel: +27 (0) 11 923 9300
Faks: +27 (0) 11 974 9320
www.msd-animal-health.co.za

VERVAARDIGER
Prondil S.A
Barros Arana 5402
Montevideo, Uruguay

DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET
07 Januarie 2004