qanastek/EMEA-V3 huggingface dataset:
Do not use in dogs with known hypersensitivity to sevoflurane or other halogenated anaesthetic agents.
Tużax fuq klieb li huma magħrufa li għandhom sensittività eċċessiva għal sevoflurane jew sustanzi oħra ta ’ llupjar ħaloġenati.
Do not use in dogs with a known or suspected genetic susceptibility to malignant hyperthermia.
Tużax fi klieb li huma tqal jew qed ireddgħu (ara sezzjoni 12.) Tużax fi klieb li huma magħrufa jew suspettati li għandhom suxxetibilità ġenetika għal żieda fit- temperatura għolja malinna.
The most frequently reported adverse reactions associated with SevoFlo administration were hypotension, followed by tachypnoea, muscle tenseness, excitation, apnoea, muscle fasciculations and emesis.
L- aktar effetti mhux mixtieqa rapportati li huma assoċjati mal- amministrazzjoni ta ’ SevoFlo kienu pressjoni baxxa, sussegwit b’ nifs mgħaġġel, tensjoni fil- muskoli, eċċitament, qtugħ ta ’ nifs, faxxikli fil- muskoli, u remettar.
18/ 24 Sevoflurane causes dose-dependant respiratory depression, therefore respiration should be closely monitored during sevoflurane anaesthesia and the inspired concentration of sevoflurane adjusted accordingly.
Sevoflurane jikkawża tnaqqis respiratorju dipendentement fuq id- doża mogħtija, għalhekk in- nifs irid jiġi mgħasses mill- qrib waqt l- illupjar bis- sevoflurane, u l- konċentrazzjoni ta ’ sevoflurane aġġustata skond kif meħtieġ.
Transient elevations in aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), bilirubin and white blood cell count may occur with sevoflurane, as with the use of other halogenated anaesthetic agents.
Elevazzjoni temporanja fl- aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), bilirubin, u l- għadd ta ’ ċelloli bojod fid- demm jistgħu jiġru bħala riżultat ta ’ sevoflurane, kif ukoll bl- użu ta ’ aġenti anestetiċi ħaloġenati oħra.
The possibility of sevoflurane triggering episodes of malignant hyperthermia in susceptible dogs cannot be ruled out.
Il- possibilità li sevoflurane jikkaġuna każi ta ’ ipertermija mhux ikkontrollata fi klieb suxxetibli ma għandhiex tiġi eskluża.
If any serious effects or other effects not mentioned in this leaflet are noticed, please ensure the veterinary surgeon is informed.
Jekk tinnota xi effetti serji jew effetti oħra mhux msemmija f’ dan il- fuljett, jekk jogħġbok informa lit- tabib veterinarju tiegħek.
These concentrations can be expected to produce surgical anaesthesia in 3 to 14 minutes and may be set initially, or may be achieved gradually over the course of 1 to 2 minutes.
Dawn il- konċentrazzjonijiet għandhom iwasslu għal anesteżija kirurġika fi żmien bejn 3 sa 14- il minuta, u jistgħu jiġu ssettjati mill- bidu, jew jiġu meħudin matul il- kors ta ’ 1 jew 2 minuti.
The use of premedicants does not affect the concentration of sevoflurane required for induction.
L- użu ta ’ trattamenti mediċinali ta’ qabel ma jaffetwax il- konċentrazzjoni ta ’ sevoflurane meħtieġa fil- bidu għal induzzjoni.
Maintenance of anaesthesia:
Iż- żamma ta ’ l- anesteżija:
Sevoflurane may be used for maintenance anaesthesia following mask induction using sevoflurane or following induction with injectable agents.
Sevoflurane jista ’ jintuża biex tinżamm l- anesteżija wara l- induzzjoni bil- maskra bi sevoflurane jew sussegwentement wara l- induzzjoni b’ aġenti oħra permezz ta ’ titqib.
The concentration of sevoflurane necessary to maintain anaesthesia is much less than that required for induction.
Id- doża meħtieġa ta ’ sevoflurane biex tinżamm l- anesteżija hi inqas minn dik meħtieġa għal induzzjoni.
Surgical levels of anaesthesia in the healthy dog may be maintained with inhaled concentrations of 3.3 to 3.6% in the presence of premedication.
Livelli kirurġiċi ta ’ anesteżija f’ kelb b’ saħħtu jistgħu jinżammu b’ konċentrazzjonijiet miġbuda minn nifs ta ’ bejn 3. 3 sa 3. 6% meta tkun ġiet amministrata pre- medikazzjoni.
In the absence of premedication, inhaled concentrations of sevoflurane in the range of 3.7 to 3.8% will provide surgical levels of anaesthesia in the healthy dog.
Fejn ma kienx hemm pre- medikazzjoni, konċentrazzjonijiet ta ’ sevoflurane fin- nifs ta ’ bejn 3. 7 u 3. 8% għandhom jipprovdu livell kirurġiku ta ’ loppju f’ kelb b’ saħħtu.
The
Minħabba l- preżenza ta ’ stimulazzjoni kirurġika, jista ’ jkun hemm bżonn żieda fil- konċentrazzjoni ta’ sevoflurane.
19/ 24 use of injectable induction agents without premedication has little effect on the concentrations of sevoflurane required for maintenance.
L- użu ta’ aġenti permezz ta ’ titqib li jinduċu, mingħajr pre- medikazzjoni għandu ftit effett fuq il- konċentrazzjonijiet ta ’ sevoflurane meħtieġ biex tinżamm l- anesteżija.
For inhalation use only, using a suitable carrier gas.
Għat- teħid man- nifs uża gass portatur adattat.
SevoFlo contains no stabiliser and does not affect the calibration or operation of these vaporisers.
SevoFlo ma fihx stabilizzatur u ma jaffettwax il- kalibrazzjoni jew ħidma ta ’ dawn il- fawwâra b’ ebda mod.
The administration of general anaesthesia must be individualised based on the dog's response.
It- teħid ta ’ sevoflurane għandu jkun individwalizzat skond ir- rispons tal- kelb.
Interaction with other veterinary medicinal products and other forms of interaction
Effetti fuq prodotti mediċinali oħra jew effetti oħra
The concurrent administration of thiopental, however, may slightly increase sensitivity to adrenaline- induced cardiac arrhythmias.
L- għoti konġunt ma 'thiopental, madankollu jista ’ jżid is- sensittività għal arritmiji tal- qalb indotti bl- adrenalina.
Sevoflurane administration is compatible with benzodiazepines and opioids commonly used in veterinary practice.
Sevoflurane huwa kompatibbli ma ’ benzodijażepini u opijojdi użati ta ’ spiss fix- xogħol veterinarju.
In common with other inhalational anaesthetics, the minimum alveolar concentration (MAC) of sevoflurane is reduced by the concurrent administration of benzodiazepines and opioids.
Bħalma hu komuni f’ loppji oħra bin- nifs, il- MAC tas- sevoflurane jitnaqqas bil- għoti konġunt ta ’ benżodijażepini u opijojdi.
Α lpha-2-agonists have an anaesthetic sparing effect and therefore the dose of sevoflurane should be reduced accordingly.
Àlpha- 2- agonisti għandhom effett kemmxejn ta ’ loppju u għalhekk id- doża ta ’ sevoflurane għandha titnaqqas kif meħtieġ.
Limited data are available on the effects of the highly potent alpha-2- agonists (medetomidine and romifidine) as premedication.
Hemm informazzjoni ristretta disponibbli fuq l- effetti qawwija tal- agonisti alpha- 2, (medetomidine u romifidine) bħala trattament mediku ta ’ qabel.
Studies using sevoflurane anaesthetic protocols that included atropine or glycopyrrolate as premedicants showed these anticholinergics to be compatible with sevoflurane in dogs.
Studji li saru fi protokolli tal- loppju sevoflurane li kienu jinkludu l- atropina jew glycopyrrolate bħala trattamenti mediċinali ta ’ qabel urew li dawn l- antikolinerġiċi huma kompattibli ma ’ sevoflurane fil- klieb.
In a laboratory study, the use of an acepromazine/ oxymorphone/ thiopental/ sevoflurane anaesthetic regimen resulted in prolonged recoveries in all the dogs treated, compared to recoveries in dogs anaesthetised with sevoflurane alone.
Fi studju fil- laboratorju, l- użu ta ’ reġimen anestetiku ta ’ acepromazine / oxymorphone / thiopental / sevoflurane rriżulta f’ dewmien fil- fejqan tal- klieb kollha li kienu ttrattati bihom, meta mqabbla ma ’ fejqan fi klieb li kienu lluppjati b’ sevoflurane biss.
The use of sevoflurane with nondepolarising muscle relaxants has not been evaluated in dogs.
L- użu ta’ sevoflurane ma ’ aġenti oħra li jirilassaw il- muskoli mhux depolariżżanti ma ġiex valutat fuq il- klieb.
However, in humans the use of sevoflurane increases both the intensity and duration of neuromuscular blockade induced by nondepolarising muscle relaxants.
Madankollu, l- użu ta ’ sevoflurane fil- bniedem iżid kemm l- intensità u t- tul ta ’ l- imblokk newromuskolari taħt l- effett ta ’ rilassanti tal- muskoli mhux depolariżżanti.
Not applicable.
PERJODU TA 'TIŻMIM Mhux applikabbli
Do not use after the expiry date stated on the label.
Taħżinx f' temperatura 'l fuq minn 25°C Tagħmlux fil- friġġ Żomm il- flixkun magħluq tajjeb Tużax wara d- data ta ’ l- iskadenza fuq it- tikketta
Halogenated volatile anaesthetics can react with desiccated carbon dioxide (CO2) absorbents to produce carbon monoxide (CO) that may result in elevated levels of carboxyhaemoglobin in some dogs.
Prekawzjonijiet speċjali għall- użu fl- annimali Loppji volatili ħaloġenati jistgħu jirreaġixxu ma assorbenti ta ’ diossidu tal- karbonju (CO2) niexef sabiex jipproduċu monossidu tal- karbonju (CO) li jista ’ jirriżulta f’ livelli ogħla ta ’ carboxyhaemoglobin f’ ċerti klieb.
The exothermic reaction that occurs between sevoflurane and CO2 absorbents is increased when the CO2 absorbent becomes desiccated (dried out), such as after an extended period of dry gas flow through the CO2 absorbent canisters.
Ir- reazzjoni esotermika li sseħħ bejn l- aġenti li jittieħdu bin- nifs (inkluż sevoflurane) u assorbenti tal- CO2, tiżdied, meta l- assorbent tal- CO2 jinxef bħalma jiġri f’ każ ta ’ perjodu estiż ta ’ influss ta ’ gass niexef li jgħaddi miċ- ċilindri li jassorbu l- CO2.
An unusual decrease in the expected depth of anaesthesia compared to the vaporiser setting may indicate excessive heating of the CO2 absorbent canister.
Tnaqqis mhux tas- soltu fil- profondità mistennija ta ’ l- anesteżija meta mqabbel mal- ikkalibrar tal- fawwar jista ’ jindika sħana eċċessiva taċ- ċilindru li jassorbi CO2.
The colour indicator of most CO2 absorbents does not necessarily change as a result of desiccation.
L- indikatur tal- kulur tal- biċċa l- kbira tal- assorbenti tal- CO2 mhux bil- fors jibdel il- kulur bħala riżultat ta ’ nixfa.
Therefore, the lack of significant colour change should not be taken as an assurance of adequate hydration.
Għalhekk in- nuqqas ta ’ bidla sostanzjali fil- kulur m’ għandhiex tittieħed bħala assikurazzjopni li hemm l- umdità.
CO2 absorbents should be replaced routinely regardless of the state of the colour indicator.
L- assorbenti tal- CO2 għandhom jinbidlu regolarment ikun xi jkun l- istat tal- kulur ta ’ l- indikatur.
1,1,3,3,3-pentafluoro-2-(fluoromethoxy)propene (C4H2F6O), also known as Compound A, is produced when sevoflurane interacts with soda lime or barium hydroxide.
1, 1, 3, 3, 3- pentafluoro- 2 - (fluoromethoxy) propene (C4H2F6O), magħruf ukoll bħala Kompost A, jiġi ffurmat meta sevoflurane jitħallat ma soda lime jew barium hydroxide.
Reaction with barium hydroxide results in a greater production of Compound A than does the reaction with soda lime.
Ir- reazzjoni ma ’ barium hydroxide tipproduċi aktar Kompost A milli dik mal- soda lime.
Sevoflurane degradation in soda lime has been shown to increase with temperature.
Id- degradazzjoni ta ’ sevoflurane fis- soda lime ġiet murija li tiżdied bit- temperatura.
During the maintenance of anaesthesia, increasing the concentration of sevoflurane produces a dose dependent decrease in blood pressure.
Matul iż- żamma ta ’ l- anesteżija, żieda fil- konċentrazzjoni ta ’ sevoflurane tipproduċi nuqqas ta ’ pressjoni fid- demm li hu dipendenti fuq id- doża.
Due to sevoflurane ’ s low solubility in blood, these haemodynamic changes may occur more rapidly than with other volatile anaesthetics.
Minnħabba li sevoflurane għandu solubilità baxxa fid- demm, dawn il- bidliet emodinamiċi jistgħu jiġru aktar malajr minn loppji oħra volatili.
Excessive decreases in blood pressure or respiratory depression may be related to the depth of anaesthesia and may be corrected by decreasing the inspired concentration of sevoflurane.
Tnaqqis żejjed fil- pressjoni tad- demm jew nuqqas ta ’ nifs jistgħu jkunu relatati mal- profondità ta ’ l- anesteżija u jistgħu jiġu kkoreġuti bit- tnaqqis ta ’ konċentrazzjoni inspirata ta ’ sevoflurane.
In order to preserve renal blood flow, prolonged episodes of hypotension (mean arterial pressure below 60 mmHg) should be avoided in dogs during sevoflurane anaesthesia.
Sabiex jinżamm l- influss ta ’ demm fil- kliewi, perijodi fit- tul ta ’ pressjoni baxxa fl- arterji (inqas minn 60 mmHg) għandhom jiġu evitati fil- klieb matul loppju bis- sevoflurane.
The use of sevoflurane in humans increases both the intensity and duration of neuromuscular blockade induced by nondepolarising muscle relaxants.
Madankollu, l- użu tas- sevoflurane fil- bniedem iżid kemm l- intensità u t- tul ta ’ l- imblokk newromuskolari taħt l- effett ta ’ rilassanti tal- muskoli mhux depolariżżanti.
21/ 24 Sevoflurane may trigger episodes of malignant hyperthermia in susceptible dogs.
Sevoflurane jista ’ jikkauna episodji ta ’ temperatura golja malinna fi klieb suxxettibbli.
Compromised or debilitated dogs:
Klieb magħdura jew dgħajfa:
Doses of sevoflurane may need adjustment for geriatric or debilitated dogs.
Dożi ta ’ sevoflurane għandu mnejn ikollhom jiġu kkalibrati għall- klieb xjuħ jew dgħajfa.
2.8 to 3.1% in premedicated geriatric dogs and 3.2 to 3.3% in unpremedicated geriatric dogs).
2. 8% sa 3. 1% fil- klieb xjuħ li ngħatalhom trattament qabel u 3. 2 sa 3. 3% fi klieb xjuħ biss, li ma ngħatalhomx trattament qabel).
Do not use during pregnancy and lactation because the safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Użu fit- Tqala, fi żmien il- ħalib u meta jbidu l- bajd M’ għandekx tuża waqt it- tqala u t- treddigħ peress li s- sigurtà tal- prodott mediċinali veterinarju għadha ma ġietx stabbilita waqt it- tqala jew waqt it- treddigħ.
However, there is limited clinical experience of the use of sevoflurane, after propofol induction, in bitches undergoing caesarean section, without any ill effects being detected in either the bitch or the puppies.
Madankollu hemm esperjenza klinika ristretta dwar l- użu ta ’ sevoflurane, wara l- induzzjoni bi propofol, fuq klieb nisa waqt ċesarji, mingħajr effetti ħżiena kemm fuq il- kelba jew fuq il- ġriewi.
Use only according to the risk/ benefit assessment of the responsible veterinarian.
Uża biss b’ konformità ma ’ l- analiżi dwar ir- riskju/ siwi tal- veterinarju responsabbli.
SevoFlo overdose may result in profound respiratory depression.
Doża excesiva Doża eċċessiva ta ’ SevoFlo tista ’ toħloq nuqqas respiratorju qawwi.
In cases of severe cardiopulmonary depression, discontinue sevoflurane administration, ensure the existence of a patent airway and initiate assisted or controlled ventilation with pure oxygen.
F’ każ ta ’ dipressjoni kardjopulmonari serja, l- għoti tas- sevoflurane għandu jitwaqqaf, tiġi żgurata l- preżenza ta ’ passaġġ tal- arja, u tinbeda il- ventilazzjoni mgħejjuna jew ikkontrollata b’ ossiġnu pur.
Cardiovascular depression should be treated with plasma expanders, pressor agents, antiarrhythmic agents or other appropriate techniques.
Dipressjoni karjovaskulari għandha tiġi ttrattata bi plasma expanders, b’ agenti li jistimulaw il- pressjoni, aġenti kontra l- aritmija u teknikalitajiet oħra xierqa.
Due to sevoflurane ’ s low solubility in blood, increasing the concentration may result in rapid haemodynamic changes (dose-dependent decreases in blood pressure) compared to other volatile anaesthetics.
Minħabba li sevoflurane ma tantx jinħall fid- demm, żieda fid- doża tista ’ tikkaġuna tibdil emodinamiku malajr (tnaqqis fil- pressjoni tad- demm dipendentement fuq id- doża) meta mqabbel ma ’ loppji oħra volatili.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali Biex tnaqqas l- espożizzjoni għall- fwar ta ’ sevoflurane, qed jiġu mogħtija dawn ir- rakkomandazzjonijiet li ġejjin:
This is an idiosyncratic response very occasionally seen after repeated exposure.
• Uża tubu endotrakeali mxammar fejn hu possibli għal għoti ta ’ SevoFlo waqt iż- żamma ta ’ l- anesteżija. • Evita li tuża maskri għal induzzjoni fit- tul u żamma ta ’ anesteżija ġenerali. • Żgura li l- kmamar ta ’ l- operazzjoni u l- lokal ta ’ irkupru għall- annimali għandhom ventilazzjoni xierqa jew sistema ta ’ tindif li tevita li jinġemgħa fwar tal- loppju. • Is- sistemi kollha tat- tindif u l- bdil ta ’ l- arja għandhom ikunu miżmuma kif suppost. • Nisa tqal jew li jreddgħu m’ għandu jkollhom l- ebda kuntatt mal- prodott u ma għandhomx jersqu lejn il- kmamar ta ’ l- operazzjoni jew żoni ta ’ irkupru ta ’ l- annimali. • It- teħid tas- SevoFlo irid isir b’ attenzjoni, u f’ każ ta ’ tixrid għandu jitneħħa minnufiħ. • Tiġbidx il- fwar direttament bin- nifs. • Evita kuntatt mal- ħalq. • Aġenti anestetiċi ħaloġenati jistgħu jagħmlu ħsara lill- fwied.
22/ 24 • From an environmental point of view, it is considered good practice to use charcoal filters with scavenging equipment.
Dan hu riżultat idjosinkratiku li kultant jidher wara espożizzjoni ta ’ diversi drabi. • Bħala konsiderazzjoni ambjentali, hija prattika tajba li jintużaw filtri tal- faħam mat- tagħmir li jnaddaf.
If eye exposure occurs, wash with plenty of water for 15 minutes.
Jekk ikun hemm espożizzjoni mal- għajn, laħlaħ b’ ħafna ilma għal 15- il minuta.
Seek medical attention if irritation persists.
Jekk il- ħruq ma jmurx fittex il- għajnuna ta ’ tabib.
Symptoms of human overexposure (inhalation) to sevoflurane vapours include respiratory depression, hypotension, bradycardia, shivering, nausea and headache.
Sintomi ta ’ espożizzjoni żejda min- nies (bix- xamm) għal fwar ta’ sevoflurane jinkludu qtugħ ta ’ nifs, pressjoni baxxa, bradikardja, rogħda, dardir u wġigħ ta ’ ras.
If these symptoms occur, remove the individual from the source of exposure and seek medical attention.
Jekk dawn is- sintomi jseħħu, l- individwu għandu jitneħħa mil- lok fejn hu espost u tiġi mfittxija attenzjoni medika.
For animal treatment only.
Għal tratatment ta ’ l- annimali biss.
España Veterinaria Esteve Laboratorios Dr.
España Veterinaria Esteve
This document is a summary of the European Public Assessment Report.
Dan id- dokument huwa sommarju tar- Rapport Pubbliku Ewropew ta ’ Valutazzjoni (EPAR).
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
L - iskop tiegħu huwa li jispjega kif il- valutazzjoni li saret mill- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) abbażi tad- dokumentazzjoni pprovduta, wasslet għar - rakkomandazzjonijiet dwar il- kundizzjonijiet tal- użu.
This document cannot replace a face-to-face discussion with your veterinarian.
Dan id- dokument ma jistax jissostitwixxi d- diskussjoni wiċċ imb’ wiċċ mal- veterinarju tiegħek.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk teħtieġ aktar informazzjoni dwar il- kundizzjoni medika jew it- trattament tal- kundizzjoni medika tal- annimal tiegħek, ikkuntattja lill- veterinarju tiegħek.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni abbażi tar- rakkomandazzjonijiet tas- CVMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill - EPAR).
What is Startvac?
X’ inhu Startvac?
Startvac is a vaccine for cows that contains inactivated (killed) bacteria called Escherichia coli and Staphylococcus aureus.
Startvac huwa tilqima għall- baqar li fih batterji inattivi (maqtula) msejħa Escherichia coli u Staphylococcus aureus.
Startvac is an emulsion for injection that is available in vials (3, 10 and 50 ml).
Startvac huwa emulsjoni għal injezzjoni li jiġi f’ kunjetti (3, 10 u 50 ml).
What is Startvac used for?
Għal xiex jintuża Startvac?
Startvac is used to strengthen the immunity of whole herds of otherwise healthy dairy cows in herds that are known to have problems due to mastitis (inflammation of the udder due to infection).
Startvac jintuża biex isaħħaħ l- immunità ta ’ merħliet sħaħ ta ’ baqar tal- ħalib li altrimenti huma b’ saħħithom f’ merħliet li huma magħrufin li għandhom problemi minħabba l- mastite (infjammazzjoni tal- beżżula minħabba infezzjoni).
The strengthened immunity reduces the number of cows affected and the severity of clinical signs.
L- immunità msaħħa tnaqqas in- numru ta ’ baqar affettwati u s- severità ta ’ sinjali kliniċi.
Startvac is given to all healthy cows in a herd, during and after pregnancy.
Startvac jingħata lill- baqar kollha b’ saħħithom f’ merħla, waqt u wara t- tqala.
It is given as three injections into the neck muscle: the first is given 45 days before the cow is expected to give birth, the second 35 days later, and the third after another 62 days.
Dan jingħata bħala tliet injezzjonijiet fil- muskolu tal- għonq: l- ewwel waħda tingħata 45 jum qabel ma l - baqra tkun mistennija li twelled, it- tieni 35 jum wara, u t- tielet wara 62 jum ieħor.
The full course of injections should be repeated for every pregnancy.
Il- kors kollu ta ’ injezzjonijiet għandu jiġi ripetut għal kull tqala.
How does Startvac work?
Kif jaħdem Startvac?
Startvac is a vaccine.
Startvac huwa tilqima.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
It- tilqim jaħdem billi ‘ jgħallem ’ lis- sistema immuni (id- difiżi naturali tal- ġisem) kif tiddefendi ruħha kontra marda.
Startvac contains killed forms of two bacteria that normally cause mastitis (Escherichia coli and Staphylococcus aureus).
Startvac fih forom maqtula ta ’ żewġ batterji li normalment jikkawżaw il- mastite (Escherichia coli u Staphylococcus aureus).
When it is given to a cow, the animal’ s immune system recognises the bacteria as ‘ foreign ’ and makes antibodies against them.
Meta jingħata lil baqra, is- sistema immuni tal- annimal tagħraf il- batterji bħala ‘ barranin ’ u tipproduċi antikorpi kontrihom.
In the future, the immune system will be able to make the antibodies more quickly when it is exposed to the bacteria again.
Fil- futur, is- sistema immuni tkun kapaċi tipproduċi l- antikorpi aktar malajr meta terġa ’ tkun esposta għall- batterji.
The antibodies will help to fight the bacteria, preventing mastitis occurring or reducing the severity of its symptoms.
L- antikorpi jgħinu fil- ġlieda kontra l- batterji, jipprevjenu milli sseħħ il- mastite jew inaqqsu s- severità tas- sintomi tagħha.
The vaccine also contains an ‘ adjuvant’ (liquid paraffin) to stimulate a better response.
It- tilqima fiha wkoll ‘ sustanza miżjuda ’ (paraffina likwida) biex tistimula rispons aħjar.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2009 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Startvac shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2009 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat Startvac?
The studies showed that Startvac reduced the number of cows with mastitis due to Staphylococcus aureus and related bacteria and it reduced the severity of the symptoms in the cows that had mastitis.
L- istudji wrew li Startvac naqqas in- numru ta ’ baqar bil- mastite minħabba Staphylococcus aureus u batterji relatati u naqqas is- severità tas- sintomi fil- baqar li kellhom il- mastite.
Vaccination with Startvac also led to an increased number of cows being cured of the infection, a reduction in the number of cows that needed treatment for mastitis, and an increase in the quantity and quality of milk production.
It - tilqim bi Startvac wassal ukoll għal numru akbar ta ’ baqar li kienu qed jiġu kkurati mill - infezzjoni, tnaqqis fin- numru ta ’ baqar li kellhom bżonn it- trattament għall- mastite, u żieda fil- kwantità u l- kwalità tal- produzzjoni tal- ħalib.
Startvac injections did not have any harmful effects on pregnancy or giving birth, or on the cows’ calves.
L- injezzjonijiet ta ’ Startvac ma kellhom l- ebda effett fuq it- tqala jew il- ħlas, jew fuq l - għoġġiela tal- baqar.
What is the risk associated with Startvac?
X’ inhu r- riskju assoċjat ma ’ Startvac?
The vaccine may cause temporary swelling and pain at the site of injection.
It- tilqima tista ’ tikkawża nefħa temporanja u wġigħ fis- sit tal- injezzjoni.
It may also cause a temporary increase in body temperature.
Din tista ’ tikkawża wkoll żieda temporanja fit- temperatura tal- ġisem.
Startvac contains liquid paraffin (a type of mineral oil).
Startvac fih il- paraffina likwida (tip ta ’ żejt minerali).
Accidental injection or self-injection could cause severe pain and swelling, particularly if the vaccine is injected into a joint or finger.
L- injezzjoni aċċidentali jew li wieħed jinjetta lilu nnifsu tista ’ tikkawża wġigħ kbir u nefħa, b’ mod partikolari jekk it- tilqima tkun injettata f’ ġog jew suba ’.
In rare cases, this could result in the loss of the affected finger if prompt medical attention is not given.
F’ każijiet rari, dan jista ’ jirriżulta fit- telf tas- suba ’ affettwat jekk ma tingħatax attenzjoni medika minnufih.
If you are accidentally injected with this product, seek medical advice promptly, even if only a very small amount is injected, and take the Package Leaflet with you.
Jekk inti tkun injettat b’ dan il- prodott b’ mod aċċidentali, fittex parir mediku minnufih, anki jekk ikun injettat ammont żgħir ħafna, u ħu l- Fuljett ta ’ Tagħrif miegħek.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Kemm għandu jkun iż- żmien li wieħed għandu jħalli qabel ma l- annimal ikun jista ’ jinqatel u jintuża l- laħam tiegħu għall- konsum mill- bniedem (perjodu ta ’ rtirar)?
The withdrawal period is zero days.
Il- perjodu ta ’ rtirar huwa ta ’ żero ġranet.
The animal can be slaughtered for food at any time after injection.
L- annimal jista ’ jinqatel għall- ikel f’ kull ħin wara l - injezzjoni.
What is the time to allow before milk can be taken from the animal for human consumption?
Kemm għandu jkun iż- żmien li wieħed għandu jħalli qabel ma ’ jkun jista ’ jittieħed il- ħalib mill - annimal għall- konsum mill- bniedem?
Milk can be taken at any time after injection.
Il- ħalib jista ’ jittieħed f’ kull ħin wara l- injezzjoni.
Why has Startvac been approved?
Għaliex ġie approvat Startvac?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Startvac exceed the risks for herd immunisation of healthy cows and heifers, in dairy cattle herds with recurring mastitis problems, to reduce the incidence of sub-clinical mastitis and the incidence and severity of the clinical signs of clinical mastitis caused by Staphylococcus aureus, coliforms and coagulase-negative staphylococci, and recommended that Startvac be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Startvac huma akbar mir- riskji għat- tilqim ta ’ merħliet ta ’ baqar u frat b’ saħħithom, f’ merħliet ta ’ baqar tal- ħalib bi problemi ta ’ mastite rikorrenti, sabiex titnaqqas l- inċidenza ta ’ mastite sub- klinika u l- inċidenza u s- severità tas- sinjali kliniċi ta ’ mastite klinika kkawżata minn Staphylococcus aureus, koliformi u stafilokokki koagulażi negattivi u rrakkomanda li Startvac jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Startvac:
Paġna 2/ 3 ©EMEA 2009 Informazzjoni oħra dwar Startvac:
The European Commission granted a marketing authorisation valid throughout the European Union, for Startvac to Laboratorios Hipra, S. A. on 11 February 2009.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea, għal Startvac lil Laboratorios Hipra, S. A nhar fi 11/ 02/ 2009.
Information on the prescription status of this product may be found on the label/ outer package.
L- informazzjoni dwar l- istejtus tal- preskrizzjoni ta ’ dan il- prodott tista ’ tinstab fuq it- tikketta/ pakkett ta ’ barra.
Invented Name
Qawwa
Pharmaceutical Form
Speċi li fuqhom
Target species
Mod ta ’
Route of administration
Ippakkjar
Packaging
Kontenut
Content
Daqs tal - Perjodu
Package size
kummerċjali
Withdraw al period
Amministrazzj oni
Emulsion for injection.
Emulsjoni għal injezzjoni.
Cattle (cows and heifers)
Frat (baqar u ħajfers)
Intramuscular
Għal ġol - muskoli
Cardboard box, glass 1 dose vial with a rubber stopper and aluminium cap
1 doża
1 vial
1 kunjett < Xejn. >
EU/ 2/ 08/ 092/ 002 STARTVAC Escherichia coli J5: > 50 RED60 * Staph. aureus (CP8): > 50 RED80 **
Emulsjoni għal Frat > 50 RED60 * injezzjoni.
Cattle (cows and heifers)
(baqar u ħajfers)
Zero days.
< Xejn. >
EU/ 2/ 08/ 092/ 003 STARTVAC Escherichia coli J5: > 50 RED60 * Staph. aureus (CP8): > 50 RED80 **
Emulsjoni għal Frat > 50 RED60 * injezzjoni.
EU/ 2/ 08/ 092/ 004 STARTVAC Escherichia coli J5: > 50 RED60 * Staph. aureus (CP8): > 50 RED80 **
Emulsjoni għal Frat > 50 RED60 * injezzjoni.
Cardboard box, glass 5 doses vial with a rubber stopper and aluminium cap
5 dożi
EU/ 2/ 08/ 092/ 005 STARTVAC Escherichia coli J5: > 50 RED60 * Staph. aureus (CP8): > 50 RED80 **
Emulsjoni għal Frat > 50 RED60 * injezzjoni.
10 vials
10 < Xejn. > kunjetti
EU/ 2/ 08/ 092/ 006 STARTVAC Escherichia coli J5: > 50 RED60 * Staph. aureus (CP8): > 50 RED80 **
Emulsjoni għal Frat > 50 RED60 * injezzjoni.
Cardboard box, glass 25 doses vial with a rubber stopper and aluminium cap
25 doża
EU/ 2/ 08/ 092/ 007 STARTVAC Escherichia coli J5: > 50 RED60 * Staph. aureus (CP8): > 50 RED80 **
Emulsjoni għal Frat > 50 RED60 * injezzjoni.
Rabbit effective dose in 80% of the animals (serology).
Doża effettiva għall- fniek fi 80% tal- annimali (seroloġija).
STARTVAC Emulsion for injection for cattle
STARTVAC Emulsjoni għal injezzjoni għal baqar
One dose (2 ml) contains:
KOMPOŻIZZJONI KWALITATTIVA U KWANTITATTIVA
Escherichia coli J5 inactivated............................................................................ > 50 RED60 * Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing Slime Associated Antigenic Complex (SAAC)......... .…………………………………………… > 50 RED80 ** * RED60:
Escherichia coli J5 inattivat................................................................................ > 50 RED60 * Staphylococcus aureus (CP8) strejn SP 140 inattivata, li jipproduċi Kumpless Antiġeniku Assoċjat mal- Islajm( SAAC)......................... …………………………………………… > 50 RED80 ** * RED60:
Rabbit effective dose in 60% of the animals (serology). ** RED80:
Doża effettiva għall- fniek f’ 60% tal- annimali (seroloġija). ** RED80:
Adjuvant:
Sustanza miżjuda:
Liquid paraffin..............................................................................
Paraffina likwida..............................................................................
18.2 mg
18. 2 mg
Excipient:
Sustanza attiva:
Benzyl alcohol ……………..........................................................
Benzyl alcohol ……………..........................................................
Cattle (cows and heifers).
Baqar u erieh.
For herd immunisation of healthy cows and heifers, in dairy cattle herds with recurring mastitis problems, to reduce the incidence of sub-clinical mastitis and the incidence and the severity of the clinical signs of clinical mastitis caused by Staphylococcus aureus, coliforms and coagulase-negative staphylococci.
Għat- tilqim ta ’ merħla ta ’ baqar u erieh b’ saħħithom, f’ merħliet ta ’ baqar tal- ħalib bi problemi ta ’ mastite rikorrenti, sabiex titnaqqas l- inċidenza ta ’ mastite sub- klinika u l- inċidenza u s- severità tas - sinjali kliniċi ta ’ mastite klinika kkawżata minn Staphylococcus aureus, koliformi u Stafilokoċċi li huma coagulase- negative..
The full immunisation scheme induces immunity from approximately day 13 after the first injection until approximately day 78 after the third injection (equivalent to 130 days post-parturition).
L- iskema sħiħa tat- tilqim twassal għall- immunità minn bejn wieħed u ieħor jum 13 wara l- ewwel injezzjoni sa bejn wieħed u ieħor 78 jum wara t- tielet injezzjoni (ekwivalenti għal 130 jum wara t - twelid).
2 4.4 Special warnings
2 4. 4 Twissijiet speċjali
The whole herd should be immunised.
Il- merħla kollha għandha titlaqqam.
Immunisation has to be considered as one component in a complex mastitis control program that addresses all important udder health factors (e. g. milking technique, dry-off and breeding management, hygiene, nutrition, housing, bedding, cow comfort, air and water quality, health monitoring) and other management practices.
It- tilqim għandu jiġi kkunsidrat bħala komponent wieħed fi programm kumpless ta ’ kontroll ta ’ mastite li jindirizza fatturi mportanti kollha tas- saħħa tas- sider (eż. it- teknika tal- ħlib, maniġġjar tat - tnixxif u tgħammir, l- iġjene, l- ikel, l- akkomodazzjoni, il- friex, il- kumdità tal- baqra, il- kwalità tal- arja u tal- ilma, il- monitoraġġ tas- saħħa) u prattiċi ta ’ oħra ta ’ maniġġjar.
Only healthy animals should be immunised.
Annimali b’ saħħithom biss għandhom jitlaqqmu.
Accidental injection/ self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Injezzjoni aċċidentali jew jekk tinjetta lilek innifsek jista 'jirriżulta f' uġigħ kbir u nefħa speċjalment jekk tinjetta f' ġog jew subgħa u f' każijiet rari jista ’ jkun il- kawża li jkollok taqta' subgħajk jekk ma tikkonsultax tabib mal- ewwel.
Slight to moderate transient local reactions may occur after the administration of one dose of vaccine.
Reazzjonijiet lokali temporanji ħfief għal moderati jistgħu jseħħu wara l- għoti ta ’ doża waħda tal - vaċċin.
They would mainly be: swelling (up to 5 cm2 on average), which disappears within 1 or 2 weeks at most.
Dawn normalment ikunu: nefħa (sa medja ta ’ 5 ċm2), li tgħib fi żmien mhux iktar minn ġimgħa jew ġimagħtejn.
In some cases, there may also be pain at the inoculation site that spontaneously subsides in a maximum of 4 days.
F’ xi każijiet, jista ’ jkun hemm xi uġigħ fis- sit tat- titqiba li jisparixxi spontanjament fi żmien massimu ta ’ 4ijiem.
A mean transient increase in body temperature of about 1°C, in some cows up to 2°C, may occur in the first 24 hours after injection.
Żieda medja temporanja fit- temperatura tal- ġisem ta ’ madwar 1°C, f’ xi baqar sa 2°C, tista ’ sseħħ fl - ewwel 24 siegħa wara l- injezzjoni.
4.7 Use during pregnancy or lactation
4. 7 Użu fit- Tqala, fi żmien il- ħalib u meta jbidu l- bajd
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
M' hemmx informazzjoni dwar is- sigurtà u l- effikaċja ta ’ din it- tilqima jekk tintuża flimkien ma ’ kwalunkwe prodott ieħor mediċinali veterinarju.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Għalhekk għandha tittieħed deċiżjoni biex jintuża dan il- vaċċin qabel jew wara kwalunkwe prodott mediċinali veterinarju ieħor fuq bażi ta ’ każ, każ.
3 4.9 Amounts to be administered and administration route
3 4. 9 Doża rakkomandata u l- metodu ta 'amministrazzjoni
Intramuscular use.
Użu għal ġol- muskolu.
The injections should be preferably administered on the alternate sides of the neck.
L- injezzjonijiet għandhom preferibbilment jingħataw darba fuq naħa u darb’ oħra fuq in- naħa l- oħra tal- għonq.
Allow the vaccine to reach a temperature of +15 to + 25 °C before administration.
Ħalli l- vaċċin jilħaq temperatura +15 sa + 25 °C qabel jingħata.
Shake before use.
Ħawwad sewwa qabel l- użu.
Administer one dose (2 ml) by deep intramuscular injection in the neck muscles and according to the following schedule:
Agħti doża waħda (2 ml) permezz ta ’ injezzjoni fonda intramuskolari fil- muskoli tal- għonq u skont l - iskeda li ġejja:
- First injection at 45 days before the expected parturition date.
- L- ewwel injezzjoni fi żmien 45 jum qabel id- data mistennija tal- ħlas.
- Second injection 35 days thereafter (corresponding to 10 days before the expected parturition
- It- tieni injezzjoni 35 jum wara (li tikkorrespondi għal 10 ijiem qabel id- data tal- ħlas mistennija).
- Third injection 62 days after the second injection (equivalent to 52 days post-parturition).
- Tielet injezzjoni 62 jum wara t- tieni injezzjoni (ekwivalenti għal 52 jum wara l- ħlas).
The full immunisation program should be repeated with each gestation.
Il- programm sħiħ tat- tilqima għandu jkun ripetut ma kull tqala.
No adverse reactions other than those mentioned in section 4.6. were observed after the administration of a double dose of vaccine.
Ebda reazzjoni avversa għajr dawk imsemmija fis- sezzjoni 4. 6 ma ġiet osservata wara l- għoti ta ’ doża doppja tal- vaċċin.
To stimulate active immunity against Staphylococcus aureus, coliforms and coagulase-negative staphylococci.
Biex tistimula immunità attiva kontra Staphylococcus aureus, koliformi u coagulase- negative staphylococci.
ATCvet code:
Kategorija ATCvet:
QI02 AB (Inactivated bacterial vaccines for bovidae).
QI02 AB (Vaċċini batterjali inattivati għall- bovini).
Benzyl alcohol Liquid paraffin Sorbitan monooleate Polysorbate 80 Sodium alginate Calcium chloride, dihydrate Simeticone Water for injections
Benzyl alcohol Paraffin likwidu Sorbitan monooleate Polysorbate 80 Sodium alginate Calcium chloride, dihydrate Simeticone Ilma għall- injezzjoni
10 hours stored at +15 to +25 ºC.
10 sigħat maħżun f’ +15 sa +25 ºC.
Store and transport refrigerated (2 to 8 °C) and protected from light.
Aħżen u ttrasporta fi friġġ (2 sa 8 °C) u ipproteġi mid- dawl.
3 ml, 10 ml and 50 ml Type I colourless glass vials, closed with rubber stoppers and aluminium caps.
Kunjetti tal- ħġieġ ta ’ 3 ml, 10 ml u 50 ml bla kulur, magħluqin b’ tapp tal- gomma u b’ kapep tal - aluminju.
- Cardboard box with 1, 10 and 20 vials of 1 dose.
- Kaxxa tal- kartun b’ 1, 10 u 20 kunjett ta ’ doża 1.
- Cardboard box with 1 and 10 vials of 5 doses.
- Kaxxa tal- kartun b’ kunjett 1 u b’ 10 kunjetti ta ’ 5 dożi.
- Cardboard box with 1 and 10 vials of 25 doses
- Kaxxa tal- kartun b’ kunjett 1 u b’ 10 kunjetti ta ’ 25 doża
La Selva, 135 17170- AMER (Girona) SPAIN Tel. +34 972 430660 Fax. +34 972 430661 E-mail: hipra@hipra. com
La Selva, 135 17170 - AMER (Girona) SPANJA Tel.: +34 972 430660 Fax. +34 972 430661 < {e- mail} > hipra@ hipra. com
11/ 02/ 2009
XX/ SSSS
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCEs AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZI BIOLOĠIĊI ATTIVI U S- SID/ S- SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZI BIOLOĠIĊI ATTIVI U S- SID/ S- SIDIEN TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL - LOTT
Name and address of the manufacturer of the biological active substances Laboratorios Hipra, S. A.
Isem u indirizz tal- manufattur( i) tas- sustanza( i) bioloġika( ċi) attiva( i) Laboratorios Hipra, S. A.
La Selva, 135 17170 Amer (Girona) Spain
La Selva, 135 17170 Amer (Girona) Spanja
Name and address of the manufacturer responsible for batch release Laboratorios Hipra S. A.
Laboratorios Hipra S. A.
The printed package insert of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Fuq il- fuljett ta 'tagħrif tal- prodott mediċinali għandu jkun hemm l- isem u l- indirizz tal- manifattur responsabbli mill- ħruġ tal- lott konċernat.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Id- detentur ta ’ din l- awtorizzazzjoni għat- tqegħid fis- suq għandu jinforma lill- Kummissjoni Ewropea dwar il- pjanijiet ta ’ tqegħid fis- suq għall- prodott mediċinali awtorizzat b’ din id- deċiżjoni.
which are be accepted in accordance with Council Regulation (EEC) No 2377/ 90 and in accordance with Article 31 (3b) of Council Regulation (EEC) No 2309/ 93 of 22 July 1993, as amended.
Li għandhom ikunu aċċettati skond ir- Regoalment tal- Kunsill (KE) Nru 2377/ 90, kif emendat u skond l- Artikolu 34. 4b tar- Regolament (KE) Nru 726/ 2004 tal- 31 ta ’ Marzu 2004.
Pharmacologically active substances
Sustanzi farmakoloġikament attivi
Council Regulation (EEC) No 1442/ 95.
Regolament tal- Kunsill (KEE) Nru 1442/ 95.
For use as excipient.
Għal użu bħala sustanza mhux attiva.
Mineral hydrocarbons, low to high viscosity including microcrystalline waxes, approximately C10-C60; aliphatic, branched aliphatic and alicyclic compounds.
Idrokarburi minerali, b’ viskożita baxxa għal għolja inkluż xama mikrokristallina, bejn wieħed u ieħor C10- C60; komposti alifatiċi, alifatiċi b’ fergħat u komposti aliċikliċi.
CR No 2804/ 95.
CR Nru 2804/ 95.
7 Sorbitan monooleate
7 Sorbitan monooleate
Approved food additive (E494).
Addittiv approvat għall- ikel (E494).
CR No 2034/ 96
CR Nru 2034/ 96
Polysorbate 80
Polysorbejt 80
CR No.
CR Nru.
Sodium alginate
Sodium alginate
Approved food additive (E401).
Addittiv approvat għall- ikel (E401).
Calcium chloride, dihydrate
Calcium chloride, di - idrat
Council Regulation (EEC) No 1102/ 95
Regolament tal- Kunsill (KEE) Nru 1102/ 95
Council Regulation (EEC) No 2796/ 95
Regolament tal- Kunsill (KEE) Nru 2796/ 95
{CARDBOARD BOXES}
{KAXEX TAL- KARTUN}
One dose (2 ml) contains:
DIKJARAZZJONI TAS- SUSTANZA ATTIVA U SUSTANZI OĦRA
E. coli J5 inactivated > 50 RED60 (Rabbit effective dose in 60% of the animals (serology)).
E. coli J5 inattivat > 50 RED60 (Doża effettiva għall- fniek f’ 60% tal- annimali (seroloġija)).
S. aureus (CP8) strain SP140 inactivated, expressing Slime Associated Antigenic Complex (SAAC) > 50 RED80 (In 80% of the animals).
S. aureus (CP8) strejn SP140 inattivata, li tipproduċi Kumpless Antiġeniku Assoċjat mal- Islajm (SAAC) > 50 RED80 (Fi 80% tal- annimali).
Liquid paraffin:
Paraffina likwida:
18.2 mg Benzyl alcohol:
18. 2 mg Benzyl alcohol:
1 vial of 1 dose (2ml) 10 vials of 1 dose (2 ml) 20 vials of 1 dose (2 ml) 1 vial of 5 doses (10 ml) 10 vials of 5 doses (10 ml) 1 vial of 25 doses (50 ml) 10 vials of 25 doses (50 ml)
1 kunjett ta ’ doża 1 (2ml) 10 kunjetti ta ’ doża 1 (2 ml) 20 kunjett ta ’ doża 1 (2 ml) 1 kunjett ta ’ 5 dożi (10 ml) 10 kunjetti ta ’ 5 dożi (10 ml) 1 kunjett ta ’ 25 doża (50 ml) 10 kunjetti ta ’ 25 doża (50 ml)
Intramuscular use.
Użu ġol- muskoli.
Withdrawal period:
Perjodu ta ’ tżmim:
Special warnings:
Twissijiet speċjali:
Accidental self-injection is dangerous – read the package leaflet before use.
Injezzjoni personali aċċidentali hija perikoluża – aqra l- fuljett ta ’ tagħrif qabel l- użu.
EXP {month/ yyyy}
JISKADI {Xahar/ sena}
Once opened, use within a 10-hour period, stored at +15 to + 25 ºC.
Ladarba miftuħ, uża fi ħdan perjodu ta ’ 10 sigħat, maħżun f’ temperatura ta ’ bejn +15 u + 25 ºC.
Store and transport refrigerated (+2 to +8 °C) and protected from light.
Aħżen u ttrasporta fil- friġġ (+2 to +8 °C) u ipproteġi mid- dawl.
Dispose of waste material in accordance with local requirements.
Armi l- materjal ta ’ skart skont il- ħtiġijiet lokali.
FOR ANIMAL TREATMENT ONLY To be supplied only on veterinary prescription.
Sabiex jiġu mogħtija biss bi preskrizzjoni veterinarja.
La Selva, 135 17170- AMER (Girona) SPAIN
La Selva, 135 17170 - AMER (Girona) SPANJA
Batch{number}
Lott{ numru}
13 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {LABEL OF 1 DOSE VIAL}
13 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR {TIKKETTA TA ’ KUNJETT TA ’ DOŻA 1}
STARTVAC Emulsion for injection.
STARTVAC Emulsjoni għal injezzjoni.
E. coli J5 inactivated; S. aureus CP8 strain SP140 inactivated; Liquid paraffin; Benzyl alcohol.
E. coli J5 inattivata; S. aureus CP8 strejn SP140 inattivata; Paraffina likwida; Benzyl alcohol.
Intramuscular use.
Għal użu ġol- muskoli.
Withdrawal period:
Perjodu ta ’ Tiżmim:
EXP {month/ yyyy} Once opened, use within a 10-hour period, stored at +15 to + 25 ºC.
JIS {xahar/ sena} Ladarba miftuħ, uża fi żmien perjodu ta ’ 10 sigħat, maħżun f’ temperatura ta ’ +15 sa + 25 ºC.
14 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {LABEL OF 5 DOSES VIAL}
14 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR {TIKKETTA TA ’ KUNJETT TA ’ 5 DOŻI}
One dose (2 ml) contains:
KWANTITÀ TAS- SUSTANZA ATTIVA / SUSTANZI ATTIVI
E. coli J5 inactivated > 50 RED60 S. aureus CP8 strain SP140 inactivated > 50 RED80 Liquid paraffin:
E. coli J5 inattivat > 50 RED60 S. aureus CP8 strejn SP140 inattivata > 50 RED80 Paraffina likwida:
5 doses (10 ml)
5 dożi (10 ml)
Zero days.
Perjodu ta ’ Tiżmim Xejn.
EXP {month/ yyyy} Once opened, use within a 10-hour period, stored at +15 to + 25 ºC.
JIS {Xahar/ ssss} Ladarba miftuħ, uża fi żmien perjodu ta ’ 10 sigħat, maħżun f’ temperatura ta ’ +15 sa + 25 ºC.
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {LABEL OF 25 DOSES VIAL}
15 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR {TIKKETTA TA ’ KUNJETT TA ’ 25 DOŻA}
E. coli J5 inactivated > 50 RED60 * S. aureus CP8 strain SP140 inactivated, expressing SAAC > 50 RED80 * * RED:
E. coli J5 inattivata > 50 RED60 * S. aureus CP8 strejn SP140 inattivata, li tipproduċi SAAC > 50 RED80 * * RED:
Rabbit effective dose in 60% or in 80% of the animals (serology).
Doża effettiva għall- fniek f’ 60% jew fi 80% tal- annimali (seroloġija).
25 doses (50 ml)
25 doża (50 ml)
Withdrawal period:
Perjodu ta ’ tiżmim:
EXP {month/ yyyy} Once opened, use within a 10-hour period, stored at +15 to + 25 ºC.
JIS {xahar/ ssss} Ladarba miftuħ, uża fi żmien perjodu ta ’ 10 sigħat, maħżun f’ temperatura ta ’ +15 sa + 25 ºC.
17 PACKAGE LEAFLET
17 FULJETT TA ’ TAGĦRIF FIL- PAKKETT STARTVAC Emulsjoni għal injezzjoni ta ’ baqar u ħajfers
STARTVAC emulsion for injection for cattle
STARTVAC emulsjoni għal injezzjoni għall- baqar
Escherichia coli (J5) inactivated......................................................................... > 50 RED60 * Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing Slime Associated Antigenic Complex (SAAC)............................................................................................... > 50 RED80 ** * RED60:
Escherichia coli (J5) inattivat.............................................................................. > 50 RED60 * Staphylococcus aureus (CP8) strejn SP140 inattivata, li tipproduċi Kumpless Antiġeniku Assoċjat mal- Islajm (SAAC)............................................................................................ > 50 RED80 ** * RED60:
Rabbit effective dose in 60% of the animals (serology). ** RED80:
Doża effettiva fil- fniek f’ 60% tal- annimali (seroloġija). ** RED80:
Rabbit effective dose in 80% of the animals (serology).
Doża effettiva fil- fniek fi 80% tal- annimali (seroloġija).
STARTVAC is an ivory-coloured homogeneous emulsion for injection.
STARTVAC huwa emulsjoni għal injezzjoni omoġenja kulur l- ivorju.
A mean transient increase in body temperature of about 1°C, in some cows up to 2°C, may occur in the first 24 hours after injection.
18 Żieda medja temporanja fit- temperatura tal- ġisem ta ’ madwar 1°C, f’ xi baqar sa 2°C, tista ’ sseħħ fl - ewwel 24 siegħa wara l- injezzjoni.
Animals immunised with an overdose did not show adverse reactions other than those observed after the administration of one dose of vaccine.
Annimali mlaqqma b’ doża eċċessiva ma wrew ebda reazzjoni avversa għajr dawk osservati wara l - għoti ta ’ doża ta ’ vaċċin.
Cattle (cows and heifers).
Baqar (baqar u ħajfers).
Administer one dose (2 ml) be deep intramuscular injection in the neck muscles and according to the following schedule:
Agħti doża waħda (2 ml) permezz ta ’ injezzjoni fonda intramuskolari fil- muskoli tal- għonq u skont l - iskeda li ġejja:
- Second injection 35 days thereafter (corresponding to 10 days before the expected
- It- tieni injezzjoni 35 jum wara (li tikkorrespondi għal 10 ijiem qabel id- data tal- ħlas mistennija).
Allow the vaccine to reach a temperature of +15 to + 25 °C before administration.
Ħalli l- vaċċin jilħaq temperatura +15 sa + 25 °C qabel l- għoti.
Store and transport refrigerated (+2 to +8 °C) and protected from light.
Aħżen u ttrasporta fi friġġ (2 sa 8 °C) u ipproteġi mid- dawl.
10 hours stored +15 to +25 ºC.
10 sigħat maħżun f’ +15 sa +25 ºC.