Package insert for Enterisol Ileitis (English)

Transcription

1 FOR ANIMAL USE ONLY Package insert for Enterisol Ileitis (English) Enterisol Ileitis abcd Vaccine (Reg. No. G3743 Act 36/1947) NAMIBIA: V10/24.5/878 (ACT 13 OF 2003) Dosage form: Lyophilisate and diluent for oral suspension. Storage Instructions: Store between +2 C and +8 C. Do not freeze. Composition: Attenuated live bacteria Lawsonia intracellularis (MS B3903). One 2 ml dose of reconstituted vaccine contains: Lawsonia intracellularis: At least 1 x TCID* 50, maximum 1 x TCID* 50 *Tissue Culture Infective Dose. Diluent: Sterile water for oral administration. Recommendations for use: Enterisol Ileitis is a Lawsonia intracellularis vaccine (avirulent live culture) for the immunisation of weaned pigs from 3 weeks of age to prevent porcine proliferative enteropathy (ileitis) and to reduce growth variability and loss of weight associated with the disease. Under field conditions, the difference in average daily weight gain was seen to be up to 30 g/day when vaccinated pigs were compared to unvaccinated pigs. Warnings: Keep out of reach of children, uninformed persons and animals. The vaccine has not been tested in breeding boars, therefore do not vaccinate breeding boars. No undesirable effect was observed after administration of the vaccine in breeding and pregnant animals. Since the vaccine isolate is a live bacterium, simultaneous use of antimicrobials which are effective against Lawsonia spp. should be avoided for a minimum of three days before and after vaccination with the product. The vaccine is an attenuated live vaccine and the potential for spreading to nonvaccinated animals cannot be excluded. However, based on the studies conducted with sentinel pigs, the apparent frequency for spreading to non-vaccinated animals and associated risk is very low. Lawsonia intracellularis DNA could be detected up 1

2 to 3 days post vaccination in faecal samples of more than half of vaccinated animals, therefore transmission to pen-mates cannot be excluded at this time point. Efficacy of revaccination is unknown. Vaccinate only clinically healthy 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. Withdrawal period: zero days. Precautions for use: No information is available on the concurrent use of this vaccine with any other. It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with the product. It is good vaccination practice when handling the vaccine to avoid contact with the eyes, hands and clothing. In the event of accidental skin contact, wash with soap or antibacterial wash and rinse well. Directions for use use only as directed: All materials used in administering the vaccine must be free of antimicrobials, detergent, or disinfectant residues to prevent inactivation. 10 and 50 dose presentation: Reconstitute the vaccine by adding the full content of the accompanying diluent to the vaccine. Shake well and use immediately. 100 dose presentation: Reconstitute the vaccine by adding half the contents of the accompanying diluent to the vaccine. Shake well and transfer the suspension back into the diluent bottle, mix with the remaining diluent to obtain a total volume of 200 ml. Shake well and use immediately. Dosage for administration: Vaccination by oral drench application: Administer a single 2 ml dose orally to pigs (from 3 weeks of age), irrespective of body weight. Vaccination via the drinking water: Do not reconstitute the vaccine until ready to vaccinate. The systems have to be cleaned and thoroughly rinsed with untreated water to avoid any residues of antimicrobials, detergents, or disinfectants. Reconstitute vaccine according to directions above. The final solution containing the vaccine should be consumed within 4 hours after reconstitution. Calculate the number of vials required to vaccinate all the pigs according to the table below. The appropriate amount of vaccine is added to clean, non-treated drinking water. 2

3 No. of pigs Vaccine vial Diluent vial dose (20 ml) 50 dose (100 ml) 100 dose (100 ml) 20 ml 100 ml 200 ml Dilute the vaccine in drinking water on the basis of pre-measured water intake during a four-hour time period of the previous day at the time of the planned vaccination. Pigs will generally drink 8 to 12 % of their body weight per day, depending on environmental temperatures. The actual amount of water consumed may vary considerably depending on several factors. It is essential for the efficacy of the product that pigs receive at least the recommended dose. Therefore, it is recommended to assess the actual water intake over the four-hour period the day before vaccination at the same time the vaccination is planned to occur. It is recommended to add skimmed milk powder or sodium thiosulphate solution as a stabiliser into the drinking water prior to adding the vaccine. The final concentration of the skimmed milk powder should be 2,5 g/litre. The final concentration of sodium thiosulphate should be approximately 0,055 g/litre. After filling the calculated water amount into the trough, skimmed milk powder or sodium thiosulphate should be added to the water. Afterwards the reconstituted vaccine is to be diluted either in the water/skimmed milk or in the water/thiosulphate mixture in the trough. Effects of the vaccine: Onset of immunity occurs as early as 3 weeks post vaccination and lasts for at least 17 weeks. Immunity, however, cannot be guaranteed in all animals. Presentation: Vaccine lyophilisate: Type 1 amber glass vial of 20 ml (10 doses), 100 ml (50, 100 doses**), closed with a bromobutyl stopper with lacquered aluminium seal. Vaccine diluent: Type 1 clear glass vial containing 20 ml (10 doses), 100 ml (50 doses), 200 ml (100 doses**) closed with a chlorobutyl stopper with lacquered aluminium seal. High density polyethylene vial containing 20 ml (10 doses), 100 ml (50 doses), 200 ml (100 doses**) closed with a chlorobutyl stopper with lacquered aluminium seal. **The 100 dose pack size is only sold in large boxes of 12 x 100 ml lyophilisate and 12 x 200 ml diluent. Not all pack sizes may be marketed. 3

4 Registration holder: Ingelheim Pharmaceuticals (Pty) Ltd (Reg No. 1966/008618/07) 407 Pine Avenue Randburg 2125 Tel No. +27 (011)

5 SLEGS VIR DIEREGEBRUIK Voubiljet vir Enterisol Ileitis (Afrikaans) Enterisol Ileitis abcd Entstof (Reg. Nr. G3743 Wet 36/1947) Doseringsvorm: Gevriesdroogde entstof en verdunningsmiddel vir mondelikse suspensie. Bergingsaanwysings: Bewaar tussen +2 C en +8 C. Moenie vries nie. Samestelling: Verswakte lewende bakterieë Lawsonia intracellularis (MS B3903). Een 2 ml dosis van die hersaamgestelde entstof bevat: Lawsonia intracellularis: Ten minste 1 x WKID* 50, maksimaal 1 x WKID* 50 *Weefselkultuur Infektiewe Dosis. Verdunningsmiddel: Steriele water vir mondelikse toediening. Aanbevelings vir gebruik: Enterisol Ileitis is n Lawsonia intracellularis entstof (avirulente lewende kultuur) vir die immunisering van gespeende varke vanaf 3 weke oud, om uitgebreide enteropatie (ileïtis) by varke te voorkom en om die variasie in groei en gewigsverlies wat met die siekte geassosieer word, te verminder. In die praktyk is n verskil van tot 30 g/dag in daaglikse gewigstoename waargeneem wanneer geënte varke met ongeënte varke vergelyk was. Waarskuwings: Hou buite bereik van kinders, oningeligte persone en diere. Die entstof is nie by teelbere getoets nie. Dus moet teelbere nie geënt word nie. Geen ongewensde effekte is na toediening van die entstof by teel- en dragtige diere waargeneem nie. Aangesien die entstofisolaat n lewende bakterium is, moet gesamentlike gebruik van antimikrobiese middels wat werksaam is teen Lawsonia spp. vermy word vir ten minste drie dae vóór en ná enting met die produk. Die entstof is n verswakte lewende entstof en die moontlikheid van verspreiding na ongeënte diere kan nie uitgesluit word nie. Gebaseer op navorsingsstudies op waakvarke is die oënskynlike voorkoms van verspreiding na ongeënte diere en die risikos wat daarmee geassosieer word, baie laag. Lawsonia intracellularis - DNA kon vir tot 3 dae na enting in ontlastingsmonsters van meer as die helfte van die 5

6 ingeënte diere, waargeneem word, dus kan oordrag na hokmaats nie op hierdie tydstip uitgeskakel word nie. Die doeltreffendheid van her-inenting is onbekend. Ent slegs klinies gesonde diere. Hoewel die middel omvattend onder ʼn groot verskeidenheid van toestande getoets is, mag dit om verskeie redes faal. As dit vermoed word, raadpleeg ʼn veearts en verwittig die registrasiehouer. Onttrekkingstydperk: nul dae. Voorsorgmaatreëls vir gebruik: Geen inligting is beskikbaar oor die gesamentlike gebruik van hierdie entstof met ander nie. Dit word dus aanbeveel dat geen ander entstowwe binne 14 dae voor of na enting met die produk toegedien word nie. Dit is goeie entingspraktyk om kontak met die oë, hande en klere te vermy terwyl die entstof hanteer word. In geval van toevallige velkontak, was met seep of antibakteriese wasmiddel en spoel goed af. Aanwysings vir gebruik gebruik slegs soos aangedui: Alle materiale wat gebruik word vir die toediening van die entstof moet vry wees van antimikrobiese middels, reiniger- of ontsmettingsmiddelreste, om inaktivering te verhoed. 10 en 50 dosis aanbieding: Stel die entstof saam deur die hele inhoud van die gepaardgaande verdunningsmiddel by die entstof te voeg. Skud goed en gebruik dadelik. 100 dosis aanbieding: Stel die entstof saam deur die helfte van die gepaardgaande verdunningsmiddel by die entstof te voeg. Skud goed en verplaas die suspensie terug na die verdunningsmiddel se bottel, meng met die agtergeblewe verdunningsmiddel om sodoende n totale volume van 200 ml te bereik. Skud goed en gebruik dadelik. Dosis vir toediening: Enting d.m.v. mondelinge toediening: Gee n enkel 2 ml dosis mondelings aan varke (vanaf 3 weke oud), ongeag die liggaamsgewig. Enting deur die drinkwater: Moenie die entstof hersaamstel voordat alles gereed gemaak is vir enting nie. Die stelsels moet skoongemaak word en deeglik gespoel word met onbehandelde water om enige neerslag van antimikrobiese middels, skoonmaakmiddels of ontsmettingsmiddels uit te skakel. Stel die entstof saam volgens die aanwysings hierbo. Die finale oplossing wat die entstof bevat moet binne 4 ure na hersamestelling opgebruik word. Bereken die aantal flessies wat benodig word om al die varke te ent, volgens die onderstaande tabel. Die geskikte hoeveelheid entstof word by skoon, onbehandelde drinkwater gevoeg. 6

7 Aantal varke Entstof flessie Verdunningsmiddel flessie dosis (20 ml) 50 dosis (100 ml) 100 dosis (100 ml) 20 ml 100 ml 200 ml Verdun die entstof in drinkwater op grond van die voorafbepaalde waterinname gedurende n vier uur tydperk op die dag voor die beplande enting. Varke sal oor die algemeen daagliks 8 % tot 12 % van hulle liggaamsgewig drink, afhangende van die omgewingstemperatuur. Die werklike hoeveelheid water wat ingeneem word kan aansienlik varieer, afhangende van verskeie faktore. Dit is noodsaaklik vir die doeltreffende werking van die produk dat varke ten minste die aanbevole dosis ontvang. Om hierdie rede word dit aanbeveel om die drinkwater inname oor die vier uur tydperk van die dag voor beplande enting, op dieselfde tyd as wat die enting beplan word, te bepaal. Dit word aanbeveel om afgeroomde melkpoeier of natriumtiosulfaatoplossing as n stabiliseerder by die drinkwater te voeg voordat die entstof bygevoeg word. Die finale konsentrasie van die afgeroomde melkpoeier moet 2,5 g/liter wees. Die finale konsentrasie van natriumtiosulfaat moet ongeveer 0,055 g/liter wees. Nadat die trog met die berekende hoeveelheid water gevul is, moet afgeroomde melkpoeier of natriumtiosulfaat by die water gevoeg word. Die bereide entstof moet daarna óf in die water/afgeroomde melk óf in die water/tiosulfaatmengsel in die trog verdun word. Effekte van die entstof: Aanvang van immuniteit vind so gou as 3 weke na enting plaas en duur vir ten minste 17 weke. Immuniteit kan egter nie in alle diere gewaarborg word nie. Aanbieding: Gevriesdroogde entstof: Tipe 1 bruinglasflessie - 20 ml (10 dosisse), 100 ml (50, 100 dosisse**) en toegemaak met n bromobutielprop met n gelakte aluminiumseël. Entstof-verdunningsmiddel: Tipe 1 helderglasflessie wat 20 ml (10 dosisse), 100 ml (50 dosisse) en 200 ml (100 dosisse**) bevat, toegemaak met n chlorobutielprop en gelakte aluminiumseël. Hoë-digtheid poliëtileenflessie wat 20 ml (10 dosisse), 100 ml (50 dosisse) en 200 ml (100 dosisse**) bevat, toegemaak met n chlorobutielprop met gelakte aluminiumseël. **Die 100 dosis verpakkingsgrootte word net in n groot kartondoos van 12 x 100 ml gevriesdroogde entstof en 12 x 200 ml verdunningsmiddel verkoop. Nie alle verpakkingsgroottes word noodwendig bemark nie. 7

8 Registrasiehouer: Ingelheim Pharmaceuticals (Edms) Bpk (Reg. Nr. 1966/008618/07) Pinelaan 407 Randburg 2125 Telnr. +27 (011)