FrancophonIA/ELRC3.0 huggingface dataset:
English: More than 15,000 patients with type 2 diabetes participated in double-blind placebo- or activecontrolled clinical trials of up to more than 2 years' treatment duration.
Maltese: Aktar minn 15,000 pazjent b'dijabete tat-tip 2 ħadu sehem fi provi kliniċi double-blind kontrollati bi plaċebo jew attivi b'kura li damet għaddejja għal aktar minn sentejn.
English: In patients with moderate or severe renal impairment or with end-stage renal disease (ESRD), the recommended dose of Jalra is 50 mg once daily (see also sections 4.4, 5.1 and 5.2).
Maltese: F'pazjenti b'indeboliment tal-kliewi moderat jew qawwi jew b'mard talkliewi fl-aħħar stadju (ESRD), id-doża rrakkomandata ta' Jalra hija ta' 50 mg darba kuljum (ara wkoll sezzjonijiet 4.4, 5.1 u 5.2).
English: Drug-drug interaction studies in healthy subjects were conducted with amlodipine, ramipril, valsartan and simvastatin.
Maltese: Kombinazzjoni ma' amlodopine, ramipril, valsartan jew simvastatin Studji ta' interazzjonijiet bejn il-mediċini f'individwi b'saħħithom saru b'amlodipine, ramipril, valsartan u simvastatin.
English: Each tablet contains 50 mg vildagliptin.
Maltese: Kull pillola fiha 50 mg vildagliptin.
English: The safety and efficacy of vildagliptin as triple oral therapy in combination with metformin and a thiazolidinedione have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' vildagliptin bħala terapija orali tripla flimkien ma' metformin u thiazolidinedione għadhom mhumiex stabbiliti.
English: Nasopharyngitis Metabolism and nutrition disorders Uncommon
Maltese: Nażofarinġite Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux komuni
English: In the subgroup with NYHA class III, the decrease in HbA1c compared to placebo was lower (difference 0.3%) but this conclusion is limited by the small number of patients (n=44).
Maltese: Fis-sottogrupp bi klassi III NYHA, it-tnaqqis tal-HbA1c imqabbel mal-plaċebo kien aktar baxx (differenza ta' 0.3%) imma din il-konklużjoni hi limitata minħabba l-għadd żgħir ta' pazjenti (n=44).
English: Nervous system disorders Uncommon
Maltese: Ipogliċemija Disturbi fis-sistema nervuża Komuni
English: In controlled clinical trials with the combination of vildagliptin 100 mg daily+ a thiazolidinedione, no withdrawal due to adverse reactions was reported in either the vildagliptin 100 mg daily + thiazolidinedione or the placebo + thiazolidinedione treatment groups.
Maltese: Fi provi kliniċi bil-kontrol meta vildagliptin 100 mg kuljum ingħata flimkien ma' metformin, l-ebda twaqqif minħabba reazzjonijiet avversi ma kien irrappurtat kemm fil-gruppi ta' kura b'vildagliptin 100 mg kuljum flimkien ma' metformin jew fil grupp tal-plaċebo flimkien ma' metformin.
English: Clinical studies performed with healthy subjects have shown no clinically relevant pharmacokinetic interactions.
Maltese: F'dawn l-istudji, ma dehrux interazzjonijiet farmakokinetiċi li kienu klinikament relevanti wara li ngħataw ma' vildagliptin.
English: No dose adjustment is required in patients with mild renal impairment (creatinine clearance ≥ 50 ml/min).
Maltese: M'hemmx bżonn ta' aġġustamenti fid-doża f'pazjenti b'indeboliment ħafif renali (tneħħija talkrejatinina ≥ 50 ml/min).
English: Intra-cardiac impulse conduction delays were observed in dogs with a no-effect dose of 15 mg/kg (7fold human exposure based on Cmax).
Maltese: Il-konduzzjoni ta' l-impulsi fil-qalb dehru ttardjati fi klieb b'doża mingħajr effett ta' 15 mg/kg (7darbiet l-esponiment fil-bniedem ibbażat fuq is-Cmax).
English: • Uncommon: Headache, constipation, swollen hands, ankle or feet (oedema), joint pain, low blood glucose
Maltese: • Mhux komuni: Uġigħ ta' ras, stitikezza, idejn, għaksa jew saqajn minfuħin (edema), uġigħ fil ġogi, zokkor fid-demm baxx
English: In this patient population, vildagliptin 100 mg daily was no more effective than vildagliptin 50 mg once daily.
Maltese: F'din il-popolazzjoni ta' pazjenti, vildagliptin 100 mg kuljum ma kienitx aktar effettiva minn vildagliptin 50 mg darba kuljum.
English: However, the major hydrolysis metabolite (LAY 151) can be removed by haemodialysis.
Maltese: Madankollu, il-metabolu ta' l-idroliżi ewlieni (LAY 151) jista' jitneħħa b'emodijalisi.
English: Limited data from patients with end stage renal disease (ESRD) indicate that vildagliptin exposure is similar to that in patients with severe renal impairment.
Maltese: Dejta limitata minn pazjenti b'mard tal-kliewi fl-aħħar stadju (ESRD) tindika li esponiment għal vildagliptin jixbah lil dak ta' pazjenti b'indeboliment qawwi tal-kliewi.
English: C] vildagliptin, approximately 85% of the dose was excreted into the urine and 15% of the dose is recovered in the faeces.
Maltese: C] vildagliptin jittieħed mill-ħalq, madwar 85% tad-doża kienet eskretata fl-awrina u 15% tad-doża kienet irkuprata fl-ippurgar.
English: A 24-week, multi-centre, randomised, double-blind, placebo-controlled trial was conducted to evaluate the treatment effect of vildagliptin 50 mg once daily compared to placebo in 515 patients with type 2 diabetes and moderate renal impairment (N=294) or severe renal impairment (N=221).
Maltese: Prova f'ħafna ċentri, randomised, double blind u kkontrollata bi plaċebo li damet għaddejja 24 ġimgħa saret biex tistma l-effett tal-kura b'50 mg ta' vildagliptin darba kuljum meta mqabbel ma' plaċebo f'515-il pazjent b'dijabete tat-tip 2 u indeboliment moderat tal-kliewi (N=294) jew indeboliment qawwi tal-kliewi (N=221). 68.8% u 80.
English: Vildagliptin is indicated in the treatment of type 2 diabetes mellitus in adults:
Maltese: Xi sintomi jista' jkollhom bżonn attenzjoni medika immedjata:
English: • 100 mg daily taken as 50 mg in the morning and 50 mg in the evening if you are taking Jalra alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulphonylurea, or with insulin.
Maltese: • 100 mg kuljum li tittieħed bħala 50 mg filgħodu u 50 mg filgħaxija jekk qed tieħu Jalra waħdu, ma' mediċina oħra li tissejjaħ metformin jew xi glitazone, flimkien ma' metformin u xi sulphonylurea, jew mal-insulina.
English: Safety data were obtained from a total of 3,784 patients exposed to vildagliptin at a daily dose of 50 mg (once daily) or 100 mg (50 mg twice daily or 100 mg once daily) in controlled trials of at least 12 weeks duration.
Maltese: Tagħrif dwar is-sigurtà inkiseb minn 3,784 pazjent espost għal vildagliptin b'doża ta' 50 mg kuljum (darba kuljum) jew 100 mg (50 mg darbtejn kuljum jew 100 mg darba kuljum) fi provi kliniċi kontrollati li damu mill-anqas 12-il ġimgħa.
English: A 52-week multi-centre, randomised, double-blind trial was conducted in patients with type 2 diabetes and congestive heart failure (NYHA functional class I-III) to evaluate the effect of vildagliptin 50 mg twice daily (N=128) compared to placebo (N=126) on left-ventricular ejection fraction (LVEF).
Maltese: NYHA) sabiex jitqies leffett ta' 50 mg vildagliptin darbtejn kuljum (N=128) imqabbel mal-plaċebo (N=126) fuq il-porzjon imbuttat 'il barra mill-ventrikolu tax-xellug (LVEF).
English: A two-year carcinogenicity study was conducted in rats at oral doses up to 900 mg/kg (approximately 200 times human exposure at the maximum recommended dose).
Maltese: Studju dwar il-kanċeroġeniċità li dam sentejn sar fuq firien b'dożi orali sa 900 mg/kg (madwar 200 darba l-esponiment fil-bniedem bl-ogħla doża rakkomandata).
English: Findings were only observed in association with maternal toxicity at ≥ 150 mg/kg and included a transient decrease in body weight and reduced motor activity in the F1 generation.
Maltese: Is-sejbiet dehru biss ma' tossiċità fl-omm b'≥ 150 mg/kg u kienu jinkludu tnaqqis mumentanju fil-piż tal-ġisem u tnaqqis fl-attività motorjali fil-ġenerazzjoni F1.
English: Jalra works by making the pancreas produce more insulin and less glucagon.
Maltese: Jalra jaħdem billi jġiegħel il-marrara tgħamel aktar insulina u anqas glukagon.
English: Flaking skin, peeling skin, scabs and tail sores with correlating histopathological changes were noted at doses ≥ 20 mg/kg/day (approximately 3 times human AUC exposure at the 100 mg dose).
Maltese: Ġilda li tfarfar, ġilda li titqaxxar, skorċa u selħiet fid-demb bil-bidliet istopatoloġici korrelatati kienu nnutati b'dożi ta' ≥ 20 mg/kg/jum (madwar 3 darbiet l-esponiment AUC fil-bniedem bid-doża ta' 100 mg). Leżjonijiet nekrotiċi tad-demb dehru b' ≥ 80 mg/kg/jum.
English: Animal studies have shown excretion of vildagliptin in milk.
Maltese: Madankollu, dan ma ġiex stabbilit fil-popolazzjoni milquta.
English: • Angioedema (rare: may affect up to 1 in 1,000 people): Symptoms include swollen face, tongue or throat, difficulty swallowing, difficulties breathing, sudden onset rash or hives, which may indicate a reaction called “angioedema”.
Maltese: • Anġjoedema (rari: tista' taffettwa sa persuna waħda minn kull 1,000):
English: Rare cases of hepatic dysfunction (including hepatitis) have been reported.
Maltese: Każijiet rari ta' funzjoni mhux normali tal-fwied (inkluża l-epatite) kienu rrappurtati.
English: DPP-4 contributes partially to the hydrolysis of vildagliptin based on an in vivo study using DPP-4 deficient rats.
Maltese: DPP-4 jieħu sehem b'mod parzjali fl-idroliżi ta' vildagliptin skond studji in vivo bl-użu ta' firien li għandhom deffiċjenza ta' DPP-4.
English: • Common: Headache, chills, nausea (feeling sick), low blood glucose, heartburn
Maltese: • Komuni: Uġigħ ta ras, sirdat, dardir (tħossok ma tiflaħx), glukosju baxx fid-demm, uġigħ fl istonku
English: Use of vildagliptin has been associated with a risk of developing acute pancreatitis.
Maltese: L-użu ta' vildagliptin kien assoċjat ma' riskju li tiżviluppa pankreatite qawwija.
English: Cardiac failure
Maltese: Insuffiċejnza kardijaka
English: In addition, in controlled monotherapy trials with vildagliptin the overall incidence of withdrawals due to adverse reactions was no greater for patients treated with vildagliptin at doses of 100 mg daily (0.3%) than for placebo (0.6%) or comparators (0.5%).
Maltese: Minbarra hekk, fi provi kontrollati b'monoterapija b'vildagliptin, l-inċidenza globali ta' dawk li kellhom iwaqqfuh minħabba reazzjonijiet avversi ma kienitx akbar għal pazjenti ikkurati b'vildagliptin b'dożi ta' 100 mg kuljum (0.3%) milli għall-plaċebo (0.6%) jew kumparaturi (0.5%).
English: However, there were imbalances in baseline cardiovascular risk favouring placebo and the number of events was low, precluding firm conclusions.
Maltese: Madanakollu, kien hemm żbilanċi fir-riskju kardjovaskulari fil-linja bażi li jiffavorixxu l-plaċebo u lgħadd ta' episodji kien baxx, li jipprevjenu konklużjonijiet b'saħħithom.
English: Some patients have had the following side effects while taking Jalra and insulin (with or without metformin):
Maltese: Xi pazjenti kellhom l-effetti sekondarji li ġejjin waqt li kienu qed jieħdu Jalra u l-insulina (flimkien ma' metformin jew mingħajru):
English: No dose adjustments are necessary in elderly patients (see also sections 5.1 and 5.2).
Maltese: M'hemmx bżonn ta' aġġustar tad-doża f'pazjenti anzjani (ara wkoll sezzjonijiet 5.1 u 5.2).
English: LAY151 concentrations were approximately 2-3-fold higher than in patients with severe renal impairment.
Maltese: Il-konċentrazzjonijiet ta' LAY151 kienu madwar darbtejn sa 3 darbiet ogħla minn dawk ta' pazjenti b'indeboliment qawwi tal-kliewi.
English: How to store Jalra
Maltese: Kif jaħdem Jalra
English: Liver enzyme monitoring
Maltese: IL-PRODOTT MEDIĊINALI
English: ATCvet code: QI09AA07
Maltese: QI09AA07
English: MARKETING AUTHORISATION NUMBERS EU/2/17/223/001-006
Maltese: EU/2/17/223/001-006
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 07/02/2018.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 07/02/2018.
English: Store and transport refrigerated (2 °C - 8 °C).
Maltese: Aħżen u ttrasporta b'mod kiesaħ (2°C - 8°C).
English: White homogenous emulsion.
Maltese: Emulsjoni bajda omoġena.
English: 0.2 mg *Relative potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.
Maltese: 0.2 mg * Unità ta' qawwa relattiva determinata mill-ammont ta' antiġeni bl-ELISA (test ta' qawwa in vitro) imqabbel ma' tilqima ta' referenza.
English: Squalane Poloxamer 401 Polysorbate 80
Maltese: Poloxamer 401 Polysorbate 80
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali ttrattati li juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ittrattat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ittrattat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ittrattat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ittrattat, inklużi rapporti iżolati).
English: PACKAGE SIZE 125 doses
Maltese: 125 doża
English: 10 vial pack: 10 x 25 doses (50 ml) 10 vial pack: 10 x 50 doses (100 ml) 4 vial pack: 4 x 125 doses (250 ml)
Maltese: Pakkett b'10 kunjetti: 10 x 25 doża (50 ml) Pakkett b'10 kunjetti: 10 x 50 doża (100 ml) Pakkett b'4 kunjetti: 4 x 125 doża (250 ml)
English: 25 doses (50 ml) 50 doses (100 ml) 125 doses (250 ml)
Maltese: 25 doża (50 ml) 50 doża (100 ml) 125 doża (250ml)
English: PHARMACEUTICAL FORM Emulsion for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Emulsjoni għal injezzjoni.
English: Pharmacotherapeutic group: immunologicals for Suidae, inactivated viral vaccines for pigs.
Maltese: Grupp farmako-terapewtiku: immunoloġiċi għas-Suidae, vaċċini virali inattivati għal ħnieżer.
English: It is intended to stimulate active immunity against PCV2 in pigs.
Maltese: Huwa intenzjonat biex jistimola immunità attiva kontra PCV2 fil-ħnieżer.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/223/001-006
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/2/17/223/001-006
English: Zoetis WHC 2 LLC 2000 Rockford Road, Charles City IA 50616 USA
Maltese: Charles City IA 50616
English: High density polyethylene vials of 50 ml, of 100 ml and of 250 ml (25, 50 and 125 doses), with a chlorobutyl elastomer closure and sealed with an aluminium cap.
Maltese: Kunjetti tal-high density polyethylene ta' 50 ml, ta' 100 ml u ta' 250 ml (25, 50 u 125 doża), b'tapp tal- chlorobutyl elastomer u ssiġillat b'għatu tal-aluminju.
English: 4.8 Interactions with other medicinal products and other forms of interaction
Maltese: .8 Interazzjoni ma' prodotti mediċinali oħra jew forom oħra ta' interazzjoni
English: 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' ingredjenti Thiomersal
English: Onset of immunity: from 3 weeks after vaccination.
Maltese: Bidu tal-immunità: minn 3 ġimgħat wara t-tilqima.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: DIKJARAZZJONI TAL-MRLs Is-sustanza attiva billi hi ta' prinċipju t'oriġini bijoloġika intenzjonata biex tipproduċi immunità attiva ma taqax fl-iskop tar-Regolament tal-Kummissjoni (UE) Nru 470/2009.
English: MANUFACTURER'S BATCH NUMBER Lot: {number}
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (2 ml) contains:
Maltese: Kull doża (2 ml) fiha:
English: Inactivated recombinant chimeric PCV type 1 containing the PCV type 2 ORF2 protein
Maltese: Rikombinant kimeriku tal-PCV tip 1 inattivat li fih il-proteina ORF2 tal-PCV tip 2
English: Cardboard box of 4 vials of 250 ml (125 doses)
Maltese: Kaxxa tal-kartun b'4 kunjetti ta' 250 ml (125 doża).
English: 4.3 Contraindications
Maltese: 4.3 Kontraindikazzjonijiet Xejn
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: The vaccine is to be administered aseptically.
Maltese: Il-vaċċin għandu jiġi amministrat b'mod asettiku.
English: Cardboard box of 10 vials of 50 ml (25 doses ) or 100ml (50 doses).
Maltese: Kaxxa tal-kartun b'10 kunjetti ta' 50 ml (25 doża) jew 100 ml (50 doża).
English: This resolves spontaneously within 48 hours without treatment.
Maltese: Din tgħaddi waħidha fi żmien 48 siegħa mingħajr trattament.
English: The area of local tissue reactions is in general below 2 cm in diameter.
Maltese: B'mod ġenerali l-firxa tar-reazzjonijiet lokali tat-tessuti hija anqas minn 2 cm fid-dijametru.
English: Cardboard box of 1 vial of 50 ml (25 doses), 100ml (50 doses) or 250 ml (125 doses).
Maltese: Kaxxa tal-kartun b'kunjett ta' 50 ml (25 doża), 100 ml (50 doża) jew 250 ml (125 doża).
English: Duration of immunity: 23weeks after vaccination
Maltese: Tul tal-immunità: 23 ġimgħa wara t-tilqima
English: Adjuvant:
Maltese: Ingredjenti oħra:
English: For active immunisation of pigs from 3 weeks of age against Porcine Circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues and fecal shedding caused by infection with PCV2.
Maltese: Għal tilqim attiv ta' ħnieżer minn età ta' 3 ġimgħat kontra l-porcine circovirus tip 2 (PCV2) biex inaqqas il-piż virali fid-demm u t-tessuti limfojdi u t-tixrid fl-ippurgar ikkawżat minn infezzjoni b'PCV2.
English: BATCH NUMBER Lot {number}
Maltese: DATA TA' SKADENZA JISK {xahar/sena}
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Suvaxyn Circo emulsion for injection for pigs
Maltese: Suvaxyn Circo emulsjoni għal injezzjoni fil-ħnieżer.
English: 4.2 Indications for use, specifying the target species For active immunisation of pigs from 3 weeks of age against porcine circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues and fecal shedding caused by infection with PCV2.
Maltese: INDIKAZZJONI(JIET) Għal tilqim attiv ta' ħnieżer minn età ta' 3 ġimgħat kontra l-porcine circovirus tip 2 (PCV2) biex inaqqas il-piż virali fid-demm u t-tessuti limfojdi u t-tixrid fl-ippurgar ikkawżat minn infezzjoni b'PCV2.
English: Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein
Maltese: Rikombinant kimeriku tal-porcine circovirus tip 1 inattivat li fih il-proteina ORF2 tal-porcine circovirus tip 2
English: Local tissue reaction in the form of swelling (below 2 cm in diameter) at the injection site was commonly observed and resolved within 2 days.
Maltese: Reazzjoni lokali tat-tessuti f'forma ta' nefħa (anqas minn 2 cm fid-dijametru) fis-sit tal-injezzjoni kienet osservata b'mod komuni u għaddiet fi żmien jumejn.
English: Pigs
Maltese: IEĦOR
English: A transient increase in body temperature (on average 0.8°C) was observed 4 hours after administration of a 2fold overdose.
Maltese: Żieda li tgħaddi fit-temperatura tal-ġisem (medja ta 0.8°C) ġiet osservata 4 sigħat wara lamministrazzjoni ta' doża eċċessiva b'darbtejn.
English: The vaccine contains an inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein.
Maltese: Il-vaċċin fih rikombinant kimeriku tal-porcine circovirus tip 1 inattivat li fih il-proteina ORF2 tal porcine circovirus tip 2.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One dose (2 ml) contains:
Maltese: U INGREDJENT(I) OĦRA Kull doża (2 ml) fiha:
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals: Not applicable.
Maltese: Prekawzjonijiet speċjali li għandhom jittieħdu mill-persuna li tamministra l-prodott mediċinali veterinarju lill-annimali: Mhux applikabbli.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Għal użu fil-muskolu.
English: CONTENTS BY WEIGHT, VOLUME OR BY NUMBER OF DOSES 25 doses
Maltese: PIŻ, VOLUM JEW NUMRU TA' DOŻI 25 doża
English: This resolved spontaneously within 24 hours without treatment.
Maltese: Din għaddiet waħidha fi żmien 24 siegħa mingħajr trattament.
English: Marketing authorization holder and manufacturer responsible for batch release: Zoetis Belgium SA
Maltese: Isem u indirizz tal-manufattur tas-sustanza(i) bijoloġika(ċi) attiva(i) Zoetis WHC 2 LLC
English: In individual pigs the temperature increase compared to pre-treatment may commonly exceed 2 °C.
Maltese: Huwa komuni li fi ħnieżer individwali t-temperatura taqbeż iż-2°C meta mqabbla ma' dik ta' qabel it-trattament.
English: Immediate mild hypersensitivity-like reactions may occur uncommonly after vaccination, resulting in transient clinical signs such as vomiting, diarrhea or depression.
Maltese: M' humiex komuni reazzjonijiet ippersensittivi ħfief immedjati wara t-tilqim, li jwasslu għal sinjali kliniċi li jgħaddu bħal remettar, dijarea jew depressjoni.
English: Local tissue reactions in the form of swelling at the injection site, which may be associated with local heat, redness and pain at palpation, are very common and may last for up to 2 days (based on laboratory safety studies).
Maltese: Reazzjonijiet lokali tat-tessuti f'forma ta' nefħa fis-sit tal-injezzjoni, li jistgħu jkunu assoċjati ma' sħana lokali, ħmura w uġigħ jekk jingħafsu, huma komuni ħafna u jistgħu jdumu sa' jumejn (ibbażata fuq studji fil-laboratorju dwar is-sigurtà).
English: Do not freeze.
Maltese: Tqala u treddigħ
English: Excipients: Thiomersal
Maltese: KWALITAJIET IMMUNOLOĠIĊI
English: Vaccination schedule: One injection from 3 weeks of age.
Maltese: Skeda ta' tilqim: Injezzjoni waħda minn età ta' 3 ġimgħat.
English: very rare
Maltese: Rari ħafna
English: Study No. (CSR No.)
Maltese: Studju Nru. (Nru CSR)
English: Endoscopic healing erosive esophagitis
Maltese: Fejqan endoskopiku esofaġite erożiva
English: Secondary Objective
Maltese: Objettiv Sekondarju
English: Primary Objective Secondary Objective Treatment Duration
Maltese: Objettiv Sekondarju Trattament
English: Pan 10, 20, 40, Pla weeks
Maltese: Pan 10, 20, 40, Pla ġimgħat
English: 270 Pantoprazole was superior to ranitidine
Maltese: 270 Pantoprazole kien superjuri għal ranitidine
English: 322 There was no statistically significant difference between the treatment groups
Maltese: Ma kien hemm ebda differenza statistikament sinifikanti bejn il-gruppi ta' trattament
English: Results are similar to published studies (FK3059, VMG306, FK3034 and BGSA006)
Maltese: Ir-riżultati huma simili tal-istudji ppubblikati (FK3059, VMG306, FK3034 u BGSA006)
English: CSR = Clinical Study Report, N = Number of Patients, Eso = Esomeprazole, Lan = Lansoprazole, Niz = Nizatidine, Ome = Omeprazole, Pan = Pantoprazole, Pla = Placebo, Ran = Ranitidine, bid =twice daily
Maltese: CSR = Rapport tal-Istudju Kliniku, N = Numru ta' Pazjenti, Eso = Esomeprazole, Lan = Lansoprazole, Niz = Nizatidine, Ome = Omeprazole, Pan = Pantoprazole, Pla = Plaċebo, Ran = Ranitidine, bid = darbtejn kuljum
English: Similar results were shown by study FK3059, VMG306, FK3034, BGSA006, which also showed superiority of 20 mg pantoprazole compared to 300 mg ranitidine in the treatment of reflux symptoms.
Maltese: Intwerew riżultati simili mill-istudju FK3059, VMG306, FK3034, BGSA006, li wera wkoll superjorità ta' 20 mg pantoprazole meta mqabbel ma' 300 mg ranitidine fit-trattament tas-sintomi ta' rifluss.