PRONDIVAX Multi C8 + B Reg. No. G4207 Act/Wet 36/1947

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1 LABEL: IMMEDIATE CONTAINER Reg. No. G4207 Act/Wet 36/1947 Clostridial vaccine for the vaccination of Cattle and Sheep against: Enterotoxaemia, haemorrhagic enteritis, blackleg, malignant oedema (gas gangrene), lamb dysentery, infectious necrotic hepatitis (black disease), pulpy kidney disease, sudden death syndrome, tetanus and botulism. Klostridiale entstof vir die enting van Beeste en Skape teen: Enterotoksemie, rooiderm, sponssiekte, kwaadaardige edeem (gasgangreen), bloedpens, aansteeklike nekrotiese hepatitis, bloednier, skielike dood sindroom, klem in die kaak en lamsiekte STORAGE BERGING Store between 2 8 ⁰C. Protect from light. Do not freeze. Berg tussen 2 8 ⁰C. Beskerm teen lig. Moenie vries nie. COMPOSITION SAMESTELLING Contains Clostridium spp. bacterins and toxoids to provide immunity against: Bevat Clostridium spp. bakterienes en toksoïdes om immuniteit te gee teen: C. septicum, C. novyi type/tipe B, C. botulinum type/tipe C, C. botulinum type/tipe D, C. perfringens type/tipe C, C. perfringens type/tipe D, C. tetani, C. sordellii and C. chauvoei 100 ml (or 150 ml or 250 ml or 500 ml) FOR FULL PARTICULARS SEE ENCLOSED PACKAGE INSERT VIR VOLLE BESONDERHEDE SIEN INGESLOTE VOUBILJET Registration holder/registrasiehouer Co./Mpy Reg. No. 1998/017802/07 24 Ellon Street/Ellonstraat 24 South Africa/Suid-Afrika Distributed by/versprei deur: P O Box/Posbus 2009, Faerie Glen, 0043 R.S.A. Lot No: Expires/Verval: Page 1 of 5

2 LABEL: OUTER CARTON: Reg. No. G4207 Act/Wet 36/1947 Clostridial vaccine for the vaccination of Cattle and Sheep against: Enterotoxaemia Haemorrhagic Enteritis Blackleg (black quarter, quarter evil) Malignant Oedema (gas gangrene) Lamb Dysentery Infectious Necrotic Hepatitis (black disease) Pulpy Kidney Disease Sudden Death Syndrome Tetanus Botulism Klostridiale entstof vir die enting van Beeste en Skape teen: Enterotoksemie Rooiderm Sponssiekte Kwaadaardige Edeem (gasgangreen) Bloedpens Aansteeklike Nekrotiese Hepatitis Bloednier Skielike Dood Sindroom Klem in die Kaak Lamsiekte STORAGE BERGING Store between 2 8 ⁰C. Protect from light. Do not freeze. Berg tussen 2 8 ⁰C. Beskerm teen lig. Moenie vries nie. COMPOSITION SAMESTELLING Contains Clostridium spp. bacterins and toxoids to provide immunity against: Bevat Clostridium spp. bakterienes en toksoïdes om immuniteit te gee teen: C. septicum, C. novyi type/tipe B, C. botulinum type/tipe C, C. botulinum type/tipe D, C. perfringens type/tipe C, C. perfringens type/tipe D, C. tetani, C. sordellii and C. chauvoei Dose/Dosis Cattle and Calves over 2 months of age / Beeste en Kalwers ouer as 2 maande 5 ml subcutaneous / onderhuids Sheep and lambs over 2 months of age/ Skape en Lammers ouer as 2 maande 3 ml subcutaneous / onderhuids 100 ml (or 150 ml or 250 ml or 500 ml) FOR FULL PARTICULARS SEE ENCLOSED PACKAGE INSERT VIR VOLLE BESONDERHEDE SIEN INGESLOTE VOUBILJET Registration holder/registrasiehouer: Animal Health Registration World Wide (Pty) Limited Co/Mpy. Reg. No. 1998/17802/07 24 Ellon Street/Ellonstraat 24, South Africa/Suid-Afrika Distributed by/versprei deur: P O Box/Posbus 2009, Faerie Glen, 0043 R.S.A. Lot No: Expires/Verval: Page 2 of 5

3 : PACKAGE INSERT Reg. No. G4207 Act 36/1947 Clostridial vaccine for Cattle and Sheep. STORAGE INSTRUCTIONS Store between 2 8 ⁰C. Protect from light. Do not freeze. INDICATIONS A vaccine for the active immunisation of healthy cattle and sheep over 2 months of age against: Enterotoxaemia, haemorrhagic enteritis, blackleg, malignant oedema (gas gangrene), lamb dysentery, infectious necrotic hepatitis (black disease), pulpy kidney disease, sudden death syndrome, tetanus and botulism. COMPOSITION Contains bacterin and toxoids of Clostridium spp. to meet the following potency values Reg. No. G4207 Wet 36/1947 Klostridiale entstof vir Beeste en Skape BERGINGSAANWYSINGS Berg tussen 2 8 ⁰C. Beskerm teen lig. Moenie vries nie. AANDUIDINGS n Entstof vir die aktiewe immunisering van gesonde beeste en skape ouer as 2 maande teen: Enterotoksemie, rooiderm, sponssiekte, kwaadaardige edeem (gasgangreen), bloedpens, aansteeklike nekrotiese hepatitis, bloednier, skielike dood sindroom, klem in die kaak en lamsiekte. SAAMESTELLING Bevat bakterienes en toksoïdes van Clostridium spp. wat voldoen aan die onderstaande potensie waarde C. septicum C. novyi type B C. botulinum type C C. botulinum type D C. perfringens type C C. perfringens type D C. tetani C. sordellii C. chauvoei Potency value/dose > 3,5 IU > 5 IU > 2 IU > 10 IU β toxoid > 2 IU ξ toxoid > 1 IU Complies Ph. Eur. and CFR (USA) C. septicum C. novyi tipe B C. botulinum tipe C C. botulinum tipe D C. perfringens tipe C C. perfringens tipe D C. tetani C. sordellii C. chauvoei Potensie waarde/dosis > 3,5 IU > 5 IU > 2 IU > 10 IU β toksoïed > 2 IU ξ toksoïed > 1 IU Voldoen Ph. Eur. en CFR (VSA) Although Clostridium perfringens type B is not a component of the vaccine, immunity is provided against the beta- and epsilon toxins produced by Clostridium perfringens type B. This is due to the combination of C. perfringens type C (beta toxin) and type D (epsilon toxin) fractions. WARNINGS DO NOT SLAUGHTER ANIMALS FOR HUMAN CONSUMPTION WITHIN 3 WEEKS OF LAST ADMINISTRATION. Vaccinate only healthy cattle and sheep over 2 months of age. Concurrent use of other vaccines is not recommended. This product is not a substitute for the supplementary feeding of phosphorus. Do not mix the vaccine with other veterinary Alhoewel Clostridium perfringens tipe B nie ʼn bestanddeel van die entstof is nie, word immuniteit verskaf teen beta- en epsilon toksiene geproduseer deur Clostridium perfringens tipe B. Dit is as gevolg van die kombinasie van C. perfringens tipe C (beta toksien) en tipe D (epsilon toksien) gedeeltes. WAARSKUWINGS MOENIE DIERE VIR MENSLIKE VERBRUIK SLAG BINNE 3 WEKE NA LAASTE TOEDIENING NIE. Net gesonde beeste en skape ouer as 2 maande moet ingeënt word. Gelyktydige gebruik met ander entstowwe word nie aanbeveel nie. Hierdie produk is nie n plaasvervanger vir fosfaat byvoeding nie. Moenie die entstof met enige ander veeartsenymiddels meng nie. Soos met enige entstof, kan daar af en toe Page 3 of 5

4 medicinal products. As with any vaccine, occasional hypersensitivity reactions may occur. In such cases, appropriate treatment such as adrenaline and/or antihistamines should be administered without delay. Consult a veterinarian. As with any vaccine, absolute immunity cannot be guaranteed in all animals. It is, therefore, 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. Part used containers should be disposed of at the end of each day s operation since under field conditions it may be difficult to avoid accidental contamination of the vaccine. Burn or bury used containers. 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 vaccinators 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. Vaccination of stressed animals should be avoided. DIRECTIONS FOR USE: USE ONLY AS DIRECTED SHAKE WELL BEFORE AND DURING USE. Method of administration: Subcutaneous injection. Dose: Cattle and calves over 2 months of age Primary vaccination: Two injection of 5 ml each, with an interval of 4 weeks. Revaccinate with a single dose. Sheep and lambs over 2 months of age Primary vaccination: Two injections of 3 ml each, with an interval of 4 weeks. Revaccinate with a single dose. hipersensitiewe reaksies voorkom. In sulke gevalle moet adrenalien en/of antihistamiene sonder versuim toegedien word. Raadpleeg n veearts. Soos met enige entstof, kan volkome beskerming in alle diere nie gewaarborg word nie. Dit is dus raadsaam om n veearts oor addisionele beheer metodes 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 swelling by die plek van inspuiting mag voorkom. Party diere mag n matige verhoging in temperatuur vir een of twee dae toon. Houers wat gedeeltelik gebruik is moet na daaglikse gebruik vernietig word aangesien dit onder veld toestande moeilik is om te verhoed dat die entstof besmet word. Verbrand of begrawe gebruikte houers. 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 van lang wol is dit noodsaaklik om seker te maak dat die naald die vel deurdring voor daar ingespuit word. Vermy inenting van diere wat gestres is. GEBRUIKSAANWYSINGS: GEBRUIK SLEGS SOOS AANGEDUI SKUD GOED VOOR EN GEDURENDE GEBRUIK. Metode van toediening: Onderhuidse inspuiting. Dosis: Beeste en kalwers ouer as 2 maande Primêre enting: Twee inspuitings van 5 ml elk, met n tussenpose van 4 weke. Herent met n enkele dosis. Skape en lammers ouer as 2 maande Primêre enting: Twee inspuitings van 3 ml elk, met n tussenpose van 4 weke. Herent met n enkele dosis. Administration Toediening Page 4 of 5

5 Subcutaneous injection in loose skin, preferably on the side of the neck. After primary vaccination course, animals must receive booster injections at intervals of not more than 12 months. In high risk areas where animals are likely to be exposed to exceptionally severe infection or high concentrations of botulism toxins in food, water or environment, vaccination every 4-6 months is necessary, especially for young animals with little or no previous vaccination history. The vaccine course should be completed at least 2 weeks before maximum immunity is required i.e. a period of risk or pregnancy. Previously sensitized cows/ewes should be injected at least 2 weeks prior to calving/ lambing as this will provide passive protection for several weeks via the colostrum. When animals under 3 months of age have been vaccinated it may be advisable to revaccinate at 4-6 months of age, especially in high risk conditions/areas. Vaccinate annually thereafter. Consult a veterinarian. Registration holder Co. Reg. No. 1998/017802/07 24 Ellon Street South Africa Distributed by: Co. Reg. No. 2000/011263/07 P O Box 2009, Faerie Glen, 0043 R.S.A. Helpline: 0860 VEEARTS Onderhuidse inspuiting in los vel, verkieslik op die sykant van die nek. Na afloop van primêre enting moet diere skraagdosisse ontvang met tussenposes van nie meer as 12 maande nie. In hoë risiko areas waar diere blootgestel mag wees aan ernstige infeksie of hoë konsentrasie Lamsiekte of toksiene in kos, water of omgewing, behoort diere elke 4-6 maande ingeënt te word. Dit is veral belangrik vir jong diere met min of geen entings geskiedenis. Die entingskursus behoort voltooi te word ten minste 2 weke voor maksimum immuniteit verlang word b.v. n tydperk van risiko of dragtigheid. Koeie/ooie wat reeds gesensitiseer is behoort ten minste 2 weke voor kalwing/lamming geënt te word. Dit sal passiewe beskerming vir etlike weke oordra via die biesmelk. Wanneer diere jonger as 3 maande oud geënt was mag dit raadsaam wees om 4-6 maande ouderdom te herent, veral in hoë risiko omstandighede/areas. Herent jaarliks daarna. Raadpleeg n veearts. Registrasiehouer Mpy Reg. No. 1998/017802/07 Ellonstraat 24 Suid-Afrika Versprei deur: Posbus 2009, Faerie Glen, 0043 R.S.A. Page 5 of 5

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