FrancophonIA/ELRC3.0 huggingface dataset:
English: Each cartridge of 1.7 ml contains 68 mg of articaine hydrochloride and 8.5 micrograms of adrenaline (as adrenaline tartrate).
Maltese: Kull skartoċċ ta' 1.7 ml fih 68 mg ta' articaine hydrochloride u 8.5-il mikrogramma ta' adrenaline (bħala adrenaline tartrate).
English: Each cartridge of 1.7 ml contains 68 mg of articaine hydrochloride and 17 micrograms of adrenaline (as adrenaline tartrate).
Maltese: Kull skartoċċ ta' 1.7 ml fih 68 mg ta' articaine hydrochloride u 17-il mikrogramma ta' adrenaline (bħala adrenaline tartrate).
English: paralysis and paresis) Horner's syndrome (eyelid ptosis, enophthalmos, miosis).
Maltese: Sindrome ta' Horner (jiddendel il kappell tal-għajn, enoftalmos,
English: Gingivitis
Maltese: Nistagmus
English: The maximum safe dose of local anaesthetic may be reduced in sedated patients due to an additive effect on central nervous system depression.
Maltese: Id-doża massima sigura ta' anestetiku lokali tista' tiġi mnaqqsa f'pazjenti li jkunu ngħataw sedattiv minħabba l-effett ta' dipendenza fuq id-depressjoni tas-sistema nervuża ċentrali.
English: {(Invented) name and associated names (see Annex I)} is indicated in adults, adolescents and children above 4 years of age (or from 20 kg (44 lbs) of body weight).
Maltese: {Isem (Ivvintat) u ismijiet assoċjati (ara Anness I)} hu indikat għall-użu fl-adulti, fl-adolexxenti u fittfal li għandhom aktar minn 4 snin (jew b'piż tal-ġisem minn 20 kg (44 lbs)).
English: • swollen face, tongue or pharynx, difficulty to swallow, hives or difficulties to breath (angioedema)
Maltese: • raxx, ħakk, nefħa fil-griżmejn u diffikultà biex tieħu nifs: dawn jistgħu jkunu sintomi ta' reazzjoni allerġika (sensittività eċċessiva).
English: These medicines may intensify the effects of adrenaline.
Maltese: Dawn il-mediċini jistgħu jżidu l-effetti tal-adrenaline.
English: For more complex procedures, such as requiring pronounced hemostasis, it is preferable to use {(Invented) name and associated names (see Annex I)} 40 mg/ml + 10 micrograms/ml.
Maltese: Għal proċeduri aktar kumplessi, bħal dawk li jeħtieġu emostasi sinifikanti, huwa preferibbli l-użu ta' {Isem (ivvintat) u ismijiet assoċjati (ara Anness I)} 40 mg/ml + 10 mikrogrammi/ml.
English: • Acute decompensated heart failure (acute congestive heart failure)
Maltese: • Insuffiċjenza dekompensata u akuta tal-qalb (insuffiċjenza konġestiva u akuta tal-qalb)
English: If signs of acute systemic toxicity appear, injection of the local anaesthetic should be stopped immediately.
Maltese: Jekk iseħħu sinjali ta' tossiċità sistemika akuta, l-injezzjoni tal-anestetiku lokali għandha titwaqqaf minnufih.
English: Elevated product plasma levels may occur in patients with cholinesterase deficiency or under acetylcholinesterase inhibitors treatment since the product is inactivated at 90% by plasmatic esterases.
Maltese: Żieda fil-livelli tal-prodott fil-plażma tista' sseħħ f'pazjenti li għandhom nuqqas ta' cholinesterase jew li qed jingħataw trattament b'inibituri ta' acetylcholinesterase billi l-prodott jiġi inattivat b'90% minn esterases tal-plażma.
English: If there is any risk of an allergic reaction, your dentist will choose a different medicine for anesthesia.
Maltese: Jekk hemm ir-riskju ta' kwalunkwe reazzjoni allerġika, id-dentist tiegħek se jagħżel mediċina differenti għall-anesteżija.
English: Not known: frequency cannot be estimated from the available data
Maltese: Mhux magħrufa: ma tistax tittieħed stima tal-frekwenza mid-data disponibbli
English: {(Invented) name and associated names (see Annex I)} 40 mg/ml + 5 micrograms/ml, solution for injection {(Invented) name and associated names (see Annex I)} 40 mg/ml + 10 micrograms/ml, solution for injection [See Annex I - To be completed nationally]
Maltese: {Isem (Ivvintat) u ismijiet assoċjati (Ara Anness I)} 40 mg/ml + 10 mikrogrammi/ml, soluzzjoni għall-injezzjoni [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Drugs causing arrhythmias (e.g., antiarrhythmics like digitalis, quinidine): Dose of administration of this medicinal product should be reduced due to the increased risk of arrhythmia when both adrenaline and digital glucosides are administered concomitantly to patients.
Maltese: Sabiex tevita r-riskju ta' infezzjoni (eż. it-trażmissjoni tal-epatite), is-siringa u l-labar użati biex jiġbdu s-soluzzjoni għandhom dejjem ikunu ġodda u sterili.
English: During pregnancy, {(Invented) name and associated names (see Annex I)} 40 mg/ml + 10 micrograms/ml should only be used after a careful analysis of the benefit-to-risk ratio has been made.
Maltese: Matul it-tqala, {Isem (ivvintat) u ismijiet assoċjati (ara Anness I)} 40 mg/ml + 10 mikrogrammi/ml għandu jintuża biss wara analiżi b'attenzjoni tal-benefiċċji u r-riskji.
English: {(Invented) name and associated names (see Annex I)} 40 mg/ml + 5 micrograms/ml, solution for injection {(Invented) name and associated names (see Annex I)} 40 mg/ml + 10 micrograms/ml, solution for injection
Maltese: {Isem (Ivvintat) u ismijiet assoċjati (ara Anness I)} 40 mg/ml + 10 mikrogrammi/ml, soluzzjoni għall injezzjoni 1 ml ta' soluzzjoni għall-injezzjoni fiha 40 mg ta' articaine hydrochloride u 10 mikrogrammi ta'
English: • relative overdose such as: - inadvertent injection into a blood vessel, or - abnormal rapid absorption into the systemic circulation, or - delayed metabolism and elimination of drug.
Maltese: - assorbiment rapidu anormali fis-sistema ċirkolatorja, jew - dewmien fil-metaboliżmu u l-eliminazzjoni tal-mediċina.
English: Very rare side effects: may affect up to 1 in 10,000 people: • persistent loss of sensitivity, extended numbness and loss of taste
Maltese: Effetti sekondarji rari ħafna: jistgħu jaffettwaw sa persuna waħda minn kull 10,000:
English: • epilepsy, not adequately controlled by drug treatment.
Maltese: • epilessija, li mhijiex ikkontrollata b'mod adegwat bil-mediċini.
English: Hypotension (with possible circulatory collapse) Uncommon Hypertension Rare
Maltese: Ipotensjoni (bil-potenzjal ta' kollass ċirkolatorju)
English: • Burning mouth syndrome
Maltese: Mhux magħruf Burdata ewforika
English: On account of its lower adrenaline content, the use of {(Invented) name and associated names (see Annex I)} 40 mg/ml + 5 micrograms/ml, solution for injection over {(Invented) name and associated names (see Annex I)} 40 mg/ml + 10 micrograms/ml, solution for injection should be preferred.
Maltese: Minħabba l-kontenut aktar baxx ta' adrenaline tiegħu, għandu jiġi ppreferut l-użu ta' {Isem (ivvintat) u ismijiet assoċjati (ara Anness I)} 40 mg/ml + 5 mikrogrammi/ml, soluzzjoni għall-injezzjoni minflok {Isem (ivvintat) u ismijiet assoċjati (ara Anness I)} 40 mg/ml + 10 mikrogrammi/ml, soluzzjoni għall injezzjoni.
English: At therapeutic doses, adverse effects on human fertility are not expected.
Maltese: F'dożi terapewtiċi, mhumiex mistennija effetti avversi fuq il-fertilità tal bniedem.
English: Due to adrenaline:
Maltese: Minħabba adrenaline:
English: 2 A 2 week delay in the onset of facial paralysis has been described following administration of articaine combined with adrenaline, and the condition was unchanged 6 months later.
Maltese: 2 Dewmien ta' ġimagħtejn għall-bidu tal-paraliżi fil-wiċċ kien deskritt wara l-għoti ta' articaine kombinat ma' adrenaline, u l-kondizzjoni baqgħet l-istess 6 xhur wara.
English: • redness of the skin (erythema)
Maltese: • ħmurija tal-ġilda (eritema)
English: Teratogenecity was observed in animals treated with adrenaline only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Maltese: Teratoġeneċità kienet osservata f'annimali ttrattati b'adrenaline biss f'esponimenti meqjusa ferm aktar għolja mill-massimu ta' esponiment fil-bniedem, li juru ftit li xejn rilevanza għall-użu kliniku.
English: [(Invented) name and associated names (see Annex I)} 40 mg/ml + 5 micrograms/ml, solution for injection]
Maltese: {Isem (Ivvintat) u ismijiet assoċjati (ara Anness I)} 40 mg/ml + 5 mikrogrammi/ml, soluzzjoni għall injezzjoni
English: COMT inhibitors (Catechol-O-methyl transferase inhibitors) (e.g., entacapone, tolcapone): Arrhythmias, increased heart rate and blood pressure variations may occur.
Maltese: Inibituri ta' COMT (inibituri ta' Catechol-O-methyl transferase) (eż., entacapone, tolcapone):
English: • abnormal rapid heartbeat
Maltese: • taħbit tal-qalb bil-mod anormali
English: Patients with plasma cholinesterase deficiency
Maltese: cholinesterase fil-plażma);
English: • heart attack in the last 3 to 6 months;
Maltese: • attakk tal-qalb f'dawn l-aħħar 3 sa 6 xhur;
English: Sodium metabisulfite (E223) Sodium hydroxide (for pH-adjustment) Water for injections
Maltese: Sodium chloride Disodium edetate Sodium metabisulfite (E223)
English: The patient's state of consciousness should be monitored after each local anaesthetic injection.
Maltese: L-istat ta' kuxjenza tal-pazjent għandu jiġi mmonitorjat wara kull injezzjoni anestetika lokali.
English: • a combination of drooping of the eyelid and constriction of the pupil (Horner's syndrome) These side effects happen rarely (may affect up to 1 in 1,000 people).
Maltese: Dawn l-effetti sekondarji jseħħu rarament (jistgħu jaffettwaw sa persuna waħda minn kull 1,000).
English: ATC code: N01BB58
Maltese: • Sindrome ta' ħruq fil-ħalq
English: • hives (urticarial)
Maltese: Tikketta (skartoċċ)
English: • drooping of the eyelid, and constriction of the pupil (Horner's syndrome)
Maltese: • il-kappell tal-għajnejn jinżel 'l isfel, u kostrizzjoni tal-pupilla (sindrome ta' Horner)
English: [(Invented) name and associated names (see Annex I)} 40 mg/ml + 10 micrograms/ml, solution for injection]
Maltese: {Isem (Ivvintat) u ismijiet assoċjati (ara Anness I)} 40 mg/ml + 10 mikrogrammi/ml, soluzzjoni għall injezzjoni
English: The application was withdrawn at ‘day 180'.
Maltese: L-applikazzjoni ġiet irtirata ‘f'jum 180'.
English: It was to be available as tablets (0.5, 1 and 2 mg).
Maltese: Kellu jkun disponibbli bħala pilloli (0.5, 1 u 2 mg).
English: On 23 March 2010, Sun Pharmaceutical Industries Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Repaglinide Sun for the treatment of type 2 diabetes.
Maltese: Fit-23 ta' Marzu 2010, Sun Pharmaceutical Industries Europe B.V. innotifikat uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li xtaqet tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Repaglinide Sun għat-trattament tad-dijabete ta' tip 2.
English: What is Repaglinide Sun?
Maltese: X'inhu Repaglinide Sun?
English: Repaglinide Sun is a medicine that contains the active substance repaglinide.
Maltese: Repaglinide Sun huwa prodott mediċinali li fih is-sustanza attiva repaglinide.
English: Repaglinide Sun was developed as a ‘generic medicine'.
Maltese: Repaglinide Sun ġie żviluppat bħala ‘mediċina ġenerika'.
English: Withdrawal of the marketing authorisation application for Repaglinide Sun (repaglinide)
Maltese: Irtirar tal-applikazzjoni għall-awotorizzazzjoni għat-tqegħid fis-suq għal Repaglinide Sun (repaglinide)
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar mediċini ġeneriċi, ara d-dokument ta' mistoqsija-u-tweġiba hawn.
English: What were the reasons given by the company for withdrawing the application?
Maltese: F'hiex kienet waslet l-evalwazzjoni meta ġiet irtirata l-applikazzjoni?
English: This means that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Maltese: Dan ifisser li is-CHMP kien evalwa d-dokumentazzjoni pprovduta mill-kumpanija u fformula lista ta' mistoqsijiet.
English: Repaglinide Sun is expected to work in the same way as the reference medicine, NovoNorm, by helping the pancreas to produce more insulin at mealtimes.
Maltese: Repaglinide Sun huwa mistenni li jaħdem bl-istess mod bħall-mediċina ta' referenza, NovoNorm, billi jgħin lill-frixa biex tipproduċi aktar insulina waqt il-ħin tal-ikel.
English: What was Repaglinide Sun expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Repaglinide Sun?
English: Repaglinide Sun was to be used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) could not be controlled by diet, weight reduction and exercise.
Maltese: Repaglinide Sun kellu jintuża flimkien ma' dieta u eżerċizzju biex inaqqas il-livelli tal-glukożju (zokkor) fid-demm f'pazjenti li l-ipergliċemija tagħhom (livelli għoljin ta' glukosju fid-demm) ma setgħetx tiġi kkontrollata bid-dieta, tnaqqis fil-piż u eżerċizzju.
English: Because Repaglinide Sun was developed as a generic medicine, the company presented the results of a study carried out to investigate whether it is ‘bioequivalent' to the reference medicine or not.
Maltese: Dan ifisser li Repaglinide Sun kien maħsub biex ikun simili għal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea, imsemmija NovoNorm.
English: Repaglinide Sun was expected to be used in patients who have type 2 diabetes.
Maltese: Repaglinide Sun kien mistenni li jintuża f'pazjenti li għandhom id-dijabete ta' tip 2.
English: Repaglinide Sun was also to be used together with metformin (another antidiabetes medicine) in type 2 diabetes patients whose blood glucose levels were not satisfactorily controlled on metformin alone.
Maltese: Repaglinide Sun kellu jintuża wkoll flimkien ma' metformin (mediċina oħra kontra d-dijabete) f'pazjenti bid-dijabete ta' tip 2 li l-livelli tal-glukożju fiddemm tagħhom ma kienux ikkontrollati b'mod sodisfaċenti b'metformin waħdu.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Maltese: Id-dijabete ta' tip 2 hija marda li fiha l-frixa ma tagħmilx biżżżejjed insulina sabiex ikun ikkontrollat il-livell taz-zokkor fiddemm jew meta l-ġisem ma jkunx kapaċi juża l-insulina b'mod effettiv.
English: The CHMP was concerned about an impurity in the medicine and about the way the company had analysed the results of the bioequivalence study.
Maltese: Is-CHMP kien imħasseb dwar impurità fil-mediċina u dwar il-mod kif il-kumpanija analizzat ir-riżultati tal-istudju ta' bijoekwivalenza.
English: Name Strength Pharmaceutical Form
Maltese: Numru ta' l-EU Isem Qawwa Għamla farmaċewtika
English: Package size bottle (HDPE)
Maltese: Reċipjent tal-pilloli (HDPE) 250 Pillola
English: Route of Administration
Maltese: Mnejn jingħata
English: 85716 Unterschleissheim GERMANY
Maltese: 85716 Unterschleissheim
English: The mean terminal half-life is 4.4 days.
Maltese: Il-medja half-life terminali hija 4.4 ijiem.
English: Range (µg/ml) MIC50 (µg/ml) MIC90 (µg/ml)
Maltese: MIC50 (µg/ml) MIC90 (µg/ml)
English: Intervet International GmbH Feldstrasse 1 a 85716 Unterschleissheim GERMANY
Maltese: Intervet International GmbH Feldstrasse 1 a 85716 Unterschleissheim Germanja
English: ATCvet code: QJ01FA96.
Maltese: QJ01FA96
English: S: susceptible; I: intermediate; R: resistant
Maltese: S: suċċeptibli; I: intermedji; R: reżiżtenti
English: Marketing authorisation holder: Intervet International B. V.
Maltese: Intervet International B. V.
English: Zone diameter (mm) MIC breakpoint (µg/ml) S
Maltese: Zone diameter (mm) MIC breakpoint (µg/ml)
English: Intervet International B. V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Intervet International B.V Wim de Korverstraat 35 5831 AN Boxmeer L-Olanda
English: Overdose (symptoms, emergency procedures, antidotes):
Maltese: Doża eċċessiva (sintomi, proċeduri ta'emerġenza, antidoti):
English: B. bronchiseptica
Maltese: P. multocida B. bronchiseptica
English: Pharmacotherapeutic group: antibacterials for systemic use, macrolides.
Maltese: Grupp farmakoterapewtiku: antibatteriċi għall-użu sistemiku.makrolidi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 6 May 2011.
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni 6 ta' Mejju 2011
English: Interaction with other medicinal products and other forms of interaction:
Maltese: Interazzjonijiet ma' prodotti mediċinali oħra u forom oħra ta'interazzjonijiet:
English: These swellings resolved within 1 to 6 days.
Maltese: Dawn in-nefħiet għaddew fi żmien ta' bejn 1 sa 6 ijiem.
English: Vial (100 ml, 250 ml)
Maltese: Kunjett (100 ml, 250 ml)
English: 5831 AN Boxmeer The NETHERLANDS
Maltese: Wim de Körverstraat 35 5831 AN Boxmeer L-Olanda
English: 5.1 Pharmacodynamic properties
Maltese: 5.1 KWALITAJIET FARMAKODINAMIĊI
English: There is cross resistance with other macrolides.
Maltese: Hemm cross-resistance ma makrolidi oħra.
English: Tildipirosin is a 16-membered semi-synthetic macrolide antimicrobial agent.
Maltese: Tildiprosin huwa antimikrobiku makrolajd, aġent semi-sintetiku ta' 16-membr.
English: PACKAGE SIZE 100 ml
Maltese: DAQS TAL-PAKKETT 100 ml
English: Date of first authorisation: 6 May 2011.
Maltese: Data ta'l-ewwel awtorizzazzjoni: 6 ta' Mejju 2011
English: For E. coli, Campylobacter and Enterococci, both wild type and non-wild type phenotypes were observed (MIC range 1-> 64 µg/ml).
Maltese: Għall- E.coli, Campylobacter u Enterococci, kollha tat-tip 'wild' u non-wild phenotypes kienu osservati(MIC bejn 1-≥64µg/ml).
English: Meat and offal: 9 days
Maltese: Laħam u ġewwieni: 9 ijiem
English: In vitro, the effect of tildipirosin is bacteriostatic against Pasteurella multocida and B. bronchiseptica, and bactericidal for A. pleuropneumoniae and H. parasuis.
Maltese: In vitro l-effett tal-tildipirosin huwa batterjostatiku kontra Pasteurella multocida u B bronchiseptica, u batteriċida kontra A. pleuropneumoniae u H.parasuis.
English: Minimum inhibitory concentration (MIC) data for the target pathogens (wild type distribution) are presented in the table below.
Maltese: Data minimum inhibitory concentrationMIC fuq patoġeni (distribuzzjoni wild type) huma preżentati fit-tabella hawn taħt:
English: NO ENTRY Antiinfectious agents/
Maltese: L'EBDA DĦUL Aġent antiinfettiv/Antibijotiku
English: In vitro binding of tildipirosin to bovine plasma and bronchial fluid proteins is limited with approximately 30%.
Maltese: Fit-twaħħil in vitro ta' tildipirosin ma' proteini bovini tal-plażma hija limitata b'madwar 30%.
English: Needle diameter (mm)
Maltese: Dijametru tal-labbra (mm)
English: Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis, which are the bacterial pathogens most commonly associated with swine respiratory disease (SRD).
Maltese: Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica u Haemophilus parasuis, li huma l-patoġeni l-aktar komuni assoċjati mal-mard respiratorju fil-majjali.(SRD).
English: The antimicrobial activity spectrum of tildipirosin includes:
Maltese: Il-firxa tal-attiva antimikrobjali tad-tildipirosin tinkludi:
English: Box
Maltese: Kaxxa
English: Tildipirosin Porcine 1,200 μg/kg
Maltese: Tildipirosin Tildipirosin Porċini 1200 µ/kg µ/kg µ/kg µ/kg
English: Date of last renewal:
Maltese: Data ta' l-aħħar awtorizzazzjoni:
English: Pathomorphological injection site reactions resolved completely within 21 days.
Maltese: Reazzjonijiet patoformologiċi fil-post tal-injezzjoni fiequ kompletament fi żmien 21 ġurnata.
English: Carton Box
Maltese: Kaxxa tal-kartun
English: Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis sensitive to tildipirosin.
Maltese: Trattamnet u metafilassi ta' mard respiratorju tal-majjali assoċjat mal- Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis sensittivi għall-tildipirosin.
English: Administer 4 mg tildipirosin/kg body weight (equivalent to 1 ml/10 kg body weight) once only.
Maltese: Agħti 4mg tildipirosin/kg piż tal-ġisem (ekwivalenti għall 1ml/10kg piż tal-ġisem) darba waħda.
English: Tildipirosin administered subcutaneously to cattle at a single dose of 4 mg/kg body weight resulted in rapid absorption with average peak plasma concentration of 0.7 µg/ml within 23 minutes (Tmax) and high absolute bioavailability (78.9%).
Maltese: Amministrazzjoi ta'Tildipirosin taħt il-ġilda lill-baqar fuq doża waħda ta '4 mg / kg piż tal-ġisem irriżulta f' assorbiment rapidu b'konċentrazzjoni fil-plażma medja massima ta '0.7 mg / ml fi żmien 23 minuta (Tmax) u l-bijodisponibilità assoluta għolja (78.9%).
English: Administer 4 mg tildipirosin/kg body weight (equivalent to 1 ml/45 kg body weight) once only.
Maltese: Amministra 4 mg / kg piż tal-ġisem ta 'tildipirosin (ekwivalenti għal 1ml/45 piż tal-ġisem kg) darba biss.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains:
Maltese: U KWANTITATTIVA ml wieħed fih:
English: Vial (20 ml, 50 ml)
Maltese: Majjal Kunjett (20 ml, 50 ml)
English: 180 mg. For the full list of excipients, see section 6.1.
Maltese: 180 mg Għal-lista sħiħa ta' l-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: Needle length (cm)
Maltese: Tul tal-labbra (cm)
English: Pigs
Maltese: Biss.
English: The following tildipirosin breakpoints have been established for swine respiratory disease (according to CLSI Guideline VET02 A3):
Maltese: Tildiprosin breakpoints ġew stabbiliti għall-mard respiratorju tal-ħnieżer (skond is-CLSI gwidi linja VET02 A3) kif ġej:
English: Box containing 1 vial of 20 ml, 50 ml, 100 ml or 250 ml.
Maltese: Kaxxa li fiha kunjett 1 ta '20 ml, 50 ml, 100 ml jew 250 ml.
English: ADVERSE REACTIONS
Maltese: MANIFATTURRESPONSABBLI
English: In calves, a single subcutaneous injection of 10 times the recommended dose (40 mg/kg body weight) and repeated subcutaneous administration of tildipirosin (on three occasions in intervals of 7 days) at 4, 12 and 20 mg/kg (1, 3 and 5 times the recommended clinical dose) were well tolerated, apart from transient clinical signs attributed to injection site discomfort and injection site swellings associated with pain in some animals.
Maltese: Fil-għoġġiela, injezzjoni waħda taħt il-ġilda ta ' doża10 darbiet akbar milli rrakkomandata (40 mg / kg piż korporali) u amministrazzjoni ripetuti taħt il-ġilda ta' tildipirosin (fi tliet okkażjonijiet fl f'intervalli ta ' 7 ijiem) f' 4, 12 u 20 mg / kg (1, 3 u 5 darbiet id-doża klinika rrakkomandata) kienu tollerati sew, apparti minn sinjali kliniċi li ma damux attribwiti għal skumdità fil-post tal-injezzjoni u nefħa fil-post talinjezzjoni assoċjata ma 'uġigħ f'xi annimali.
English: In piglets, intramuscular administration of tildipirosin (on three occasions in intervals of 4 days) at 8, 12 and 20 mg/kg body weight (BW) (2, 3 and 5 times the recommended clinical dose), resulted in transient slightly subdued behaviour in one piglet each from the 8 and 12 mg/kg BW group and 2 piglets from the 20 mg/kg BW group following the first or second injection.
Maltese: Fil-qżieqeż, amministrazzjoni fil-muskolu ta' tildipirosin (fuq tlett okkażjonijiet b'intervall ta' 4 ijiem) ta' 8, 12 u 20 mg/kg piż tal-ġisem (BW) (2,3 u 5 darba d-doża klinika rrakkomandata), irriżultat f'nuqqas ta' ħeġġa li ma damitx f'qasqus wieħed minn kull grupp tat 8 u 12/kg BW u 2 qżieqeż mill grupp tat 12 u 20 mg/kg BW wara l-ewwel jew t-tieni injezzjoni.
English: In very rare cases, transient lethargy in piglets has been observed.
Maltese: F'każijiet rari ħafna, letarġija tranżitorja ġiet osservata.
English: The active substance in Zuprevo is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanza attiva fi Zuprevo hija sustanza aċċetata kif murija f'tabella 1 tal-anness tar-Regolamenti tal-Kunsill (KE) Nru 37/2010: