APPROVED PACKAGE INSERT FOR INGELVAC MYCOFLEX

Transcription

1 APPROVED PACKAGE INSERT FOR INGELVAC MYCOFLEX Only for use by or under the supervision of persons registered in terms of or authorised in terms of section 23 (1) (c) of the Veterinary and Para-Veterinary Professions Act, (Act No. 19 of 1982) FOR ANIMAL USE ONLY Ingelvac MycoFLEX Vaccine (Reg. No. G3933 Act 36/1947) Namibian reg. no.: V11/24.3/1018 (Act 13/2003) Dosage form: Suspension for injection. Storage Instructions: Keep out of reach and sight of children. Store and transport refrigerated (2-8 C). Do not freeze. Protect from light. Do not use after the expiry date (EXP) stated on the carton and bottle. Use immediately after opening.

2 Composition: Inactivated Mycoplasma hyopneumoniae, strain J, isolate B-3745 Each dose of 1 ml inactivated vaccine contains: Mycoplasma hyopneumoniae Minimum RP* 1.0, Maximum RP* 4.61 *Relative potency (ELISA test) when compared to a reference vaccine. Adjuvant: Carbomer. Target species: Pigs. Indications: For active immunisation of pigs from 3 weeks of age to reduce lung lesions following infection with Mycoplasma hyopneumoniae. Onset of immunity: by 2 weeks post vaccination. Duration of immunity: at least 26 weeks

3 Adverse reactions: Adverse reactions are uncommon: transient swelling up to 4 centimetres in diameter, sometimes associated with redness of the skin, may sometimes be observed at the injection site. These swellings may last up to 5 days. A transient mean increase in rectal body temperature of about 0.8 C lasting up to 20 hours after vaccination may be observed. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. Warnings: Keep out of reach of children, uninformed persons and 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. In case of accidental self injection, seek medical advice immediately and show the package leaflet or label to the medical doctor. Destroy any unused vaccine by for example burning; dispose of all the vaccine containers once the vaccination is completed Withdrawal period: 21 days.

4 Precautions for use: Ingelvac MycoFLEX can be mixed aseptically with Ingelvac CircoFLEX and administered together. Apart from the combined use with Ingelvac CircoFLEX, no information is available on the safety and efficacy of the combined use of Ingelvac MycoFLEX with any other veterinary medicinal product. Vaccinate only clinically healthy animals. In case of anaphylactic reactions, the administration of epinephrine (adrenaline) is recommended. Directions for use use only as directed: Shake well before use. Avoid introduction of contamination during use. Avoid multiple broaching from bottle. Vaccination devices should be used in accordance with the device instructions provided by the manufacturer. Use equipment that prevents backflow of the veterinary medicinal product. Dosage for administration: Single use of Ingelvac MycoFLEX only: Single intramuscular injection of one dose (1 ml) preferably in the neck of pigs three weeks of age and older.

5 Combined use with Ingelvac CircoFLEX : Shake each bottle before use. Aseptically mix the full contents of each bottle. Shake well. Inject a single 2 ml dose intramuscularly. Effects of the vaccine: Immunological properties: The vaccine is designed to stimulate the development of an active immune response to Mycoplasma hyopneumoniae. Presentation: *Bottle of 10 ml (10 dose), 50 ml (50 dose), 100 ml (100 dose) or 250 ml (250 dose). Not all pack sizes may be marketed. *The vaccine is available in either conventional capacity bottles or larger headspace bottles. These larger size bottles with more space above the suspension facilitate the convenient mixing of the Ingelvac MycoFLEX and Ingelvac CircoFLEX vaccines together. Registration holder: Ingelheim Pharmaceuticals (Pty) Ltd (Reg. No. 1966/008618/07) 407 Pine Avenue Randburg South Africa 2125 Tel No.: + 27 (0)

6 Voubiljet vir Ingelvac MycoFLEX (Afrikaans) Slegs vir gebruik deur of onder die toesig van persone geregistreer in gevolge van of wat magtiging ontvang het in gevolge seksie 23 (1) (c) van die Veterinêre en Para-Veterinêre Professies Wet, (Wet Nr. 19 van 1982). SLEGS VIR DIEREGEBRUIK: Ingelvac MycoFLEX Entstof (Reg. Nr. G3933 Wet 36/1947) Doseringsvorm: Suspensie vir inspuiting. Bergingsaanwysings: Hou buite bereik en sig van kinders. Bewaar en vervoer tussen + 2 C en + 8 C. Moenie vries nie. Beskerm teen lig. Moet nie gebruik na die vervaldatum (EXP) soos aangetoon op die kartonhouer en botteletiket nie.

7 Gebruik onmiddellik na oopgemaak. Samestelling: Geïnaktiveerde Mycoplasma hyopneumoniae, stam J, isolaat B-3745 Elke 1 ml geïnaktiveerde entstof bevat Mycoplasma hyopneumoniae Minimum RS* 1.0, Maksimum RS* * Relatiewe sterkte (ELISA toets) vergeleke met n verwysingsentstof. Adjuvant: Karbomeer. Teikenspesie: Varke. Aanbevelings vir gebruik: Vir die aktiewe enting van varke, drie weke of ouer, om long letsels na infeksie met Mycoplasma hyopneumoniae, te verminder. Aanvang van immuniteit: teen 2 weke na inenting Duur van immuniteit: ten minste 26 weke. Newe-effekte: Newe-effekte kom nie dikwels voor nie: Daar kan soms by die inspuitplek n verbygaande swelsel, tot 4 cm in deurnsee, soms tesame met n rooi velverkleuring, waargeneem word. Hierdie swelsels kan tot 5 dae duur. Daar kan n verbygaande gemiddelde verhoging in rektale liggaamstemperatuur van ongeveer 0.8 C, wat tot 20 ure na enting kan duur, waargeneem word.

8 Stel jou veearts in kennis indien jy enige ernstige newe-effekte, of enige ander effekte nie genoem in hierdie voubiljet nie, waarneem. Waarskuwings: Hou buite bereik van kinders, oningeligte persone en diere. Hoewel die middel omvattend onder n groot verskeidenheid van toestande getoets is, mag dit om verskeie redes faal. As dit vermoed word, raadpleeg ʼn veearts en verwittig die registrasiehouer. In geval van toevallige selfinspuiting, kry dadelik mediese advies en wys die voubiljet of etiket vir die geneesheer. Onttrekkingstydperk: 21 dae. Voorsorgmaatreëls vir gebruik: Ingelvac MycoFLEX kan asepties vermeng word met Ingelvac CircoFLEX en saam toegedien word. Afgesien van die gesamentlike toediening met Ingelvac CircoFLEX, is daar is geen inligting beskikbaar oor die veiligheid en doeltreffendheid van die gesamentlike gebruik van hierdie entstof met enige ander veterinêre medisinale produk nie. Enige ongebruikte entstof en alle entstof houers moet na inenting weggegooi word. Ent slegs klinies gesonde diere. Indien anafilaktoïede reaksies voorkom word die toediening van epinefrien (adrenalien) aanbeveel.

9 Aanwysings vir gebruik gebruik slegs soos aangedui: Skud goed voor gebruik. Voorkom kontaminasie tydens gebruik. Vermy veelvuldige onttrekkings uit bottel. Entingstoestelle moet in ooreenstemming met die gebruiksaanwysings, soos aanbeveel deur die vervaardiger, aangewend word. Gebruik apparaat wat die terugvloei van die veterinêre medisinale produk voorkom. Dosis vir toediening: Enkel toediening van Ingelvac MycoFLEX : Dien n enkele 1 ml dosis binnespiers (verkieslik in die nek) toe aan varke drie weke of ouer. Gekombineerde toediening met Ingelvac CircoFLEX : Skud elke bottel voor gebruik. Meng asepties die volle inhoud van elke bottel. Skud goed. Dien n enkele 2 ml dosis binnespiers toe. Effekte van die entstof: Immunologiese eienskappe: Die entstof is ontwerp om die ontwikkeling van n aktiewe immuunreaksie teen Mycoplasma hyopneumoniae te stimuleer.

10 Aanbieding: * Bottel met 10 ml (10 dosisse), 50 ml (50 dosisse), 100 ml (100 dosisse) of 250 ml (250 dosisse). Nie alle verpakkingsgroottes word noodwendig bemark nie. * Die entstof is beskikbaar in óf konvensionele kapasiteit bottels óf die groter headspace bottels. Die groter bottels met meer spasie bo die suspensie fasiliteer gerieflik die gelyktydige vermenging van die Ingelvac MycoFLEX en Ingelvac CircoFLEX entstowwe. Registrasiehouer: Ingelheim Pharmaceuticals (Edms) Bpk (Reg. Nr. 1966/008618/07) Pinelaan 407 Randburg 2125 Tel nr (0)