FrancophonIA/ELRC3.0 huggingface dataset:
English: • Treatment of tumour-induced hypercalcaemia - added to 500 ml isotonic sodium chloride solution or 500 ml 5% dextrose solution and infused over 2 hours
Maltese: • Kura ta' iperkalċimija kkawżata minn tumur - miżjud ma' 500 ml ta' soluzzjoni isotonika ta' sodium chloride jew 500 ml ta' soluzzjoni ta' 5% dextrose u infuż fuq medda ta' sagħtejn.
English: Children and adolescents Iasibon should not be used in children and adolescentsbelow the age of 18 years.
Maltese: Iasibon m'għandux jintuża fi tfal u adolexxenti b'età inqas minn 18-il sena.
English: • fluid build up and swelling (‘lymphoedema')
Maltese: • livell għoli ta' alkaline phosphatase fid-demm tiegħek • akkumulazzjoni ta' fluwidu u nefħa (‘limfoedima')
English: Fasting should be continued for at least 30 minutes after taking the tablet.
Maltese: Is-sawma għandha tkompli għal mill-inqas 30 minuta wara li tieħu lpillola.
English: Exposure to ibandronic acid in patients with various degrees of renal impairment is related to creatinine clearance (CLcr).
Maltese: Espożizzjoni għal ibandronic acid f'pazjenti bi gradi varji ta' indeboliment tal-kliewi hija relatata mat-tneħħija tal-kreatinina (CLcr).
English: The following information is intended for healthcare professionals only Dose: Prevention of skeletal events in patients with breast cancer and bone metastases The recommended dose for prevention of skeletal events in patients with breast cancer and bone metastases is 6 mg intravenously given every 3-4 weeks.
Maltese: Id-doża rrakkomandata għall-prevenzjoni ta' episodji skeletriċi f'pazjenti b'kanċer tas-sider u metastasi fl-għadam hija ta' 6 mg ġol-vina li tingħata kull 3-4 ġimgħat.
English: Table 3 Secondary efficacy results (breast cancer patients with metastatic bone disease) Placebo n=158
Maltese: Tabella 3 Riżultati sekondarji tal-effikaċja (pazjenti b'kanċer tas-sider b'mard metastatiku tal-Għadam)
English: The inhibition of endogenous bone resorption has also been documented by45 Ca kinetic studies and by the release of radioactive tetracycline previously incorporated into the skeleton.
Maltese: L-inibizzjoni ta' assorbiment endoġenu tal-għadam kien dokumentat ukoll permezz ta' studji kinetiċi b'45Ca u l-liberazzjoni ta'
English: This belongs to a group of medicines called bisphosphonates.
Maltese: Dan jagħmel parti minn grupp ta' mediċini msejħa bisfosfonati.
English: There was a marked depression of urinary markers of bone resorption (pyridinoline and deoxypyridinoline) in patients treated with Ibandronate that was statistically significant compared to placebo.
Maltese: Kien hemm tnaqqis sinifikanti ta' markaturi fl-awrina ta' assorbiment mill-ġdid tal-għadam (pyridinoline u deoxypyridinoline) f'pazjenti kkurati b'ibandronic acid li kien statistikament sinifikanti meta mqabbel mal-plaċebo.
English: The safety and efficacy of Iasibon in children and adolescents below the age of 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Iasibon fit-tfal u l-adoloxxenti b'età t'inqas minn 18-il sena ma ġewx stabbiliti.
English: Other medicines and Iasibon
Maltese: Mediċini oħra u Iasibon
English: Haemorrage, duodenal ulcer, gastritis, dysphagia, dry mouth
Maltese: Emorraġija, ulċera duwodenali, gastrite,
English: For patients with moderate renal impairment (CLcr ≥30 and
Maltese: Pazjenti b'indeboliment sever tal-kliewi (CLcr
English: Benign skin neoplasm
Maltese: Popolazzjoni pedjatrika
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ampoule with 1 ml concentrate for solution for infusion contains 1 mg ibandronic acid (as sodium monohydrate).
Maltese: U KWANTITATTIVA Ampulla waħda b'1 ml ta' konċentrat għal soluzzjoni għall-infużjoni fiha 1 mg ta' ibandronic acid (bħala sodium monohydrate).
English: No difference was observed in the indicators of renal function.
Maltese: L-ebda differenza ma kienet osservata fl-indikaturi tal-funzjoni renali.
English: The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration.
Maltese: Assorbiment L-assorbiment ta' ibandronic acid fl-apparat gastro-intestinali ta' fuq huwa mgħaġġel wara għoti orali.
English: • memory loss
Maltese: • telf tal-memorja
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment (CLcr <30 mL/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease an adjustment in the dose is recommended (see section 4.2).
Maltese: Għall-pazjenti b'indeboliment moderat tal-kliewi (CLcr ≥30 u <50 ml/min) jew indeboliment sever tal-kliewi (CLcr <30 ml/min) b'kanċer tas-sider u marda metastatika ta' l-għadam li qed jiġu kkurati għall-prevenzjoni ta' avvenimenti skeletriċi huwa rrakkomandat aġġustament fiddoża (are sezzjoni 4.2).
English: In the dose range recommended for treatment, the following response rates with the respective confidence intervals have been shown in clinical trials for patients with baseline albumin-corrected serum calcium ≥ 3.0 mmol/l after adequate rehydration.
Maltese: Fil-firxa tad-doża rrakkomandata għall-kura, ir-rati ta' rispons li ġejjin, bl-intervalli ta' konfidenza rispettivi, intwerew fi provi kliniċi għall-pazjenti b'kalċju fis-serum fil-linja bażi kkoreġut bl albumina ta' ≥ 3.0 mmol/l wara idrattazzjoni adegwata mill-ġdid.
English: (dead bone tissue) in the jaw bone)
Maltese: (tagħmel imsarnek)
English: Ocular inflam mation
Maltese: .8 Effetti mhux mixtieqa
English: After dilution the infusion solution is stable for 24 hours at 2 °C - 8 °C (in a refrigerator)
Maltese: Wara li jiġi dilwit is-soluzzjoni għall-infużjoni hija stabbli għal 24 siegħa f'temperatura ta' 2 °C - 8
English: Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
Maltese: Osteonekrosi tax-xedaq kienet irrappurtata wkoll f'pazjenti b'osteoporożi li kienu qed jirċievu bisfosfonati orali.
English: • mouth ulcers, swollen lips (‘cheilitis'), oral thrush
Maltese: • ulċeri fil-ħalq, xufftejn minfuħin (‘kelite'), infezzjoni mill-moffa ġol-ħalq
English: Irritation, inflammation or ulceration of the gullet/food pipe (oesophagus) often with symptoms of severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting may occur, especially if you do not drink a full glass of water and/or if you lie down within an hour of taking Iasibon.
Maltese: Jistgħu jseħħu irritazzjoni, infjammazzjoni jew ulċerazzjoni tal-gerżuma/pajp tal-ikel (esofagu) ħafna drabi b'sintomi ta' uġigħ sever fis-sider, uġigħ sever wara li tibla' l-ikel u/jew xorb, tqalligħ sever, jew rimettar, speċjalment jekk inti ma tixrob tazza ilma sħiħa u/jew jekk timtedd fi żmien siegħa wara li tieħu Iasibon.
English: The safety and efficacy of Iasibonin children and adolescents below the age of 18 years have not been established.
Maltese: .2) Is-sigurtà u l-effikaċja ta' Iasibon fit-tfal u l-adoloxxenti b'età inqas minn 18-il sena ma ġewx stabbiliti.
English: Pharmathen S.A. 6, Dervenakion str 15351 Pallini, Attiki Greece
Maltese: 6, Dervenakion str 15351 Pallini, Attiki
English: Biotransformation There is no evidence that ibandronic acid is metabolized in animals or humans.
Maltese: M'hemm l-ebda evidenza li ibandronic acid jiġi metabolizzat fl-annimali jew fil-bnedmin.
English: Oesophagitis, abdominal pain, dyspepsia, nausea
Maltese: Esofaġite, uġigħ addominali, dispepsja,
English: Pharmaco-therapeutic group: Medicinal products for treatment of bone diseases, bisphosphonate, ATC Code: M05BA06
Maltese: Prodotti mediċinali għall-kura ta' disturbi fl-għadam, bisfosfonat,
English: Ibandronic acid is eliminated by renal excretion only and does not undergo any biotransformation.
Maltese: Ibandronic acid huwa eliminat biss permezz ta' eskrezzjoni millkliewi u ma jkollu l-ebda biotrasformazzjoni.
English: Pyrexia, influenzalike illness**, oedema peripheral, asthenia, thirst
Maltese: Deni, marda li tixbaħ lill influwenza**, edima periferali,
English: use
Maltese: Ażotimja
English: If you have been told by your doctor that you cannot tolerate or digest some sugars (e.g. if you have a galactose intolerance, the Lapp lactase deficiency or have problems with glucose-galactose absorption), talk to your doctor before taking this medicine.
Maltese: (eż. jekk għandek intolleranza għal galactose, defiċjenza ta' Lapp lactase jew għandek problemi bl-assorbiment ta' glucose-galactose), kellem lit-tabib tiegħek qabel tieħu din il-mediċina.
English: • problems with your parathyroid gland
Maltese: • problemi fil-ġilda
English: Albumin-corrected serum calcium (mmol/l) = serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8 or Albumin-corrected serum calcium (mg/dl) =serum calcium (mg/dl) + 0.8 x [4 - albumin (g/dl)]
Maltese: Iż-żmien medju biex il-livell jerġa jgħola (ritorn għal-livelli ta' kalċju fis-serum ikkoreġut bl albumina ta' aktar minn 3 mmol/l) kien ta' 18 - 19-il ġurnata b'dożi ta' 2 mg u 4 mg.
English: However, oral overdosage may result in upper gastrointestinal events, such as upset stomach, heartburn, oesophagitis, gastritis or ulcer.
Maltese: Madankollu, doża eċċessiva orali tista' twassal għall-avvenimenti fl-apparat gastro-intestinali ta' fuq, bħal taqlib fl-istonku, ħruq fl-istonku, esofaġite, gastrite jew ulċera.
English: • kidney cyst (fluid-filled sac in the kidney)
Maltese: • riġlejn jew saqajn minfuħin
English: There are no data on the effects of ibandronic acid in humans.
Maltese: M'hemmx dejta dwar l-effetti ta' ibandronic acid fuq il-bniedem.
English: Physicians should be alert to any signs or symptoms signaling a possible oesophageal reaction and patients should be instructed to discontinue Iasibon and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
Maltese: It-tobba għandhom ikunu attenti għal kull sinjal jew sintomu li jindikaw il-possibbiltà ta' reazzjoni esofaġali, u l-pazjenti għandhom jiġu informati biex iwaqqfu Iasibon u jfittxu attenzjoni medika jekk jiżviluppaw disfaġja, odinofaġja, uġigħ retrosternali, jew ħruq ta' stonku ġdid jew li rkada.
English: Hypersensitivity†, bronchospasm†, angioedema† anaphylactic reaction/shock†**
Maltese: • sensittività akbar għal ħoss, togħma jew mess jew bidliet fix-xamm • diffikultà biex tibla'
English: Chest pain, influenzalike illness, malaise, pain
Maltese: Uġigħ fis sider, marda li tixbaħ lill influwenza,
English: Ibandronic acid selectively inhibits osteoclast activity, reducing bone resorption and thereby reducing skeletal complications of the malignant disease.
Maltese: Ibandronic acid jinibixxi b'mod selettiv l-attività tal-osteoclasts, u b'hekk inaqqas l-assorbiment mill-ġdid tal-għadam u b'hekk inaqqas il-komplikazzjonijiet skeletriċi tal-marda malinna.
English: Nevertheless, according to clinical assessment of the individual patient, it is recommended that renal function, serum calcium, phosphate and magnesium should be monitored in patients treated with Iasibon (see section 4.2).
Maltese: Madankollu, skont l-eżami kliniku tal-pazjent individwali, huwa rrakkomandat li jsir monitoraġġ tal-funzjoni renali, tal-kalċju fis-serum, tal-fosfat u tal-manjesju f'pazjenti li jiġu kkurati b'Iasibon(ara sezzjoni 4.2). .
English: Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma.
Maltese: Il-fatturi ta' riskju possibbli għal osteonekrożi tal-kanal estern tas-smigħ jinkludu l-użu ta' sterojdi u kimoterapija u/jew fatturi ta' riskju lokali bħal infezzjoni jew trawma.
English: For the prevention of skeletal events in patients with breast cancer and bone metastases, the Iasibon infusion is repeated at 3-4 week intervals.
Maltese: Għall-prevenzjoni ta' episodji skeletriċi f'pazjenti b'kanċer tas-sider u metastażi fl-għadam, l infużjoni ta' Iasibon hija ripetuta f'intervalli ta' 3-4 ġimgħat.
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment
Maltese: Għall-pazjenti b'indeboliment moderat tal-kliewi (CLcr ≥ 30 u <50 mL/min) jew b'indeboliment sever tal-kliewi (CLcr <30 mL/min) li qed jiġu kkurati għall-prevenzjoni ta'
English: If you develop these symptoms, stop taking Iasibon and tell your doctor straight away (see sections 3 and 4).
Maltese: Jekk tiżviluppa dawn is-sintomi, waqqaf it-teħid ta' Iasibon u għid lit-tabib tiegħek minnufih (ara sezzjonijiet 3 u 4).
English: In order to avoid potential incompatibilities Iasibon concentrate for solution for infusion should only be diluted with isotonic sodium chloride solution or 5% dextrose solution.
Maltese: Biex jiġu evitati inkompatabiltajiet potenzjali Iasibon konċentrat għal soluzzjoni għall-infużjoni għandu jiġi dilwit biss ma' soluzzjoni isotonika ta' sodium chloride jew soluzzjoni ta' dextrose 5 %.
English: - Hypersensitivity to ibandronic acid or to any of the excipients listed in section 6.1.
Maltese: • jekk inti allerġiku għal ibandronic acid jew għal xi sustanza oħra din il-mediċina (elenkati fis sezzjoni 6)
English: Clinical studies have not shown any evidence of deterioration in renal function with long term Iasibon therapy.
Maltese: Studji kliniċi ma wrewx evidenza ta' deterjorazzjoni fil-funzjoni renali b'terapija fit-tul ta' Iasibon.
English: While no increased risk was observed in controlled clinical trials there have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications.
Maltese: Filwaqt li ma kienet osservata l-ebda żjieda fir-riskju fi provi kliniċi kkontrollati kien hemm rapporti ta' wara t-tqegħid fis-suq ta' ulċeri gastriċi u duwodenali bl-użu ta' bisfosfonati orali, uħud severi u b'kumplikazzjonijiet.
English: Table 2 Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease)
Maltese: Tabella 2 Riżultati tal-Effikaċja (Pazjenti b'Kanċer tas-Sider b'Mard Metastatiku flGħadam)
English: STATEMENT OF ACTIVE SUBSTANCE(S) One ampoule with 1 ml concentrate for solution for infusion contains 1 mg ibandronic acid (sodium monohydrate).
Maltese: Kunjett wieħed b'1 ml ta' konċentrat għal soluzzjoni għall-infużjoni fih 1 mg ibandronic acid (bħala sodiummonohydrate).
English: Cystitis, vaginitis, oral candidiasis
Maltese: li għandhom esperjenza fil-kura tal-kanċer
English: Renal clearance (about 60 ml/min in healthy postmenopausal females) accounts for 50-60% of total clearance and is related to creatinine clearance.
Maltese: It-tneħħija mill-kliewi (madwar 60 ml/min f'nisa f'saħħithom li għaddew mill-menopawża) hija responsabbli għal 50-60 % tat-tneħħija totali u hija relatata mat-tneħħija tal-kreatinina.
English: • if you have any swallowing or digestion problems
Maltese: • problemi fil-ġilda • problemi fis-snien
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: UŻU Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal- Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: Cholelithiasis
Maltese: tqalligħ
English: Table 1 Adverse Drug Reactions Reported for Oral Administration of Ibandronate
Maltese: Tabella 1 Reazzjonijiet Avversi għall-Mediċina Irrappurtati mill-Għoti Orali ta' ibandronic acid
English: The risk of severe oesophageal adverse experiences appears to be greater in patients who do not comply with the dosing instruction and/or who continue to take oral bisphosphonates after developing symptoms suggestive of oesophageal irritation.
Maltese: Ir-riskju ta' esperjenzi avversi esofagali severi jidher li huwa akbar f'pazjenti li ma jikkonformawx mal-istruzzjoni ta' dożaġġ u/jew li jkomplu jieħdu bisfosfonati orali wara li jiżviluppaw sintomi li jissuġġerrixxu irritazzjoni esofagali.
English: Gamma-GT increased, creatinine increased
Maltese: Żieda f'gamma-GT, zieda filkrejatinina
English: What Iasibon looks like and contents of the pack The film-coated tablets are white, round biconvex tablets supplied in Polyamide/Al/PVC - Aluminum foil blister.
Maltese: Ma kienu osservati l-ebda evidenza ta' tossiċità diretta fuq il-fetu jew effetti teratoġeniċi għal ibandronic acid fil-firien u fil-fniek ikkurati fil-vini.
English: ATCvet code: QI09AD03.
Maltese: QI09AD03.
English: 25 doses 50 doses 125 doses
Maltese: 25 doża 50 doża 125 dożi
English: It stimulates active immunity against PRRS virus.
Maltese: Huwa jistimola l-immunità attiva kontra l-virus PRRS.
English: * Porcine respiratory and reproductive syndrome virus ** Cell culture infectious dose 50%
Maltese: * Porcine Respiratory and Reproductive Syndrome Virus ** Doża infettiva ta' 50% f'kultura taċ-ċelloli
English: The vaccine contains a modified live PRRS virus (genotype 1, subtype 1).
Maltese: Il-vaċċin fih il-virus PRRS ħaj modifikat (genotype 1, subtype 1).
English: Date of first authorization: 24/08/2017.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 24/08/2017.
English: Casein hydrolysate Lactose monohydrate Sorbitol 70% (solution) Sodium hydroxide Water for injections Dilution medium
Maltese: Casein hydrolysate Lattożju monoidrat Sorbitol 70% (soluzzjoni) Sodium hydroxide Ilma għall-injezzjonijiet
English: Pharmacotherapeutic group: immunologicals for Suidae, live viral vaccines.
Maltese: Grupp farmako-terapewtiku: immunoloġiċi għas-Suidae, vaċċini virali ħajjin.
English: Vaccine efficacy has been demonstrated in laboratory vaccination and challenge studies using a genotype 1 subtype 1 strain.
Maltese: L-effikaċja tal-vaċċin intweriet fi studji ta' tilqim u sfida fil-laboratorju bi strejn genotype 1 subtype 1.
English: High-density polyethylene (HDPE) vials of 50, 100 or 250 ml of solvent, with a chlorobutyl elastomer closure and sealed with an aluminium cap.
Maltese: Kunjetti tal-High-density polyethylene (HDPE) ta' 50, 100 jew 250 ml solvent, b'għeluq talchlorobutyl elastomer u ssiġillat b'tapp tal-aluminjum.
English: Use sterile syringes and needles.
Maltese: Uża siringi u labar sterilizzati.
English: Sodium chloride 0.9% solution
Maltese: TAS-SUSTANZA ATTIVA Soluzzjoni kloru tas-sodju 0.9%
English: Solvent: Sodium chloride 0.9% solution: qs 1 dose.
Maltese: Kloru tas-sodju 0.9% soluzzjoni: qs doża waħda.
English: Type 1 hydrolytic glass vials of 15 ml (25, 50 or 125 doses), with a bromobutyl elastomer closure and sealed with an aluminium cap.
Maltese: Tip 1 ta' 15 ml (25, 50 jew 125 doża), b'għeluq tal-bromobutyl elastomer u ssiġillat b'tapp tal-aluminjum.
English: For active immunisation of clinically healthy pigs from 1 day of age in a porcine respiratory and reproductive syndrome (PRRS) virus contaminated environment, to reduce viraemia and nasal shedding caused by infection with European strains of PRRS virus (genotype 1).
Maltese: Għat-tilqim attiv ta' ħnieżer klinikament f'saħħithom minn età ta' ġurnata f'ambjent ikkontaminat bilvirus porcine respiratory and reproductive syndrome (PRRS), biex inaqqas il-virimja u tixrid millimnieħer ikkawżat minn infezzjoni bi strejns Ewropej tal-virus PRRS (genotype 1).
English: Each dose (2 ml) contains: Lyophilisate:
Maltese: Kull doża (2 ml) fiha:
English: EU/2/17/215/002 (100 ml) EU/2/17/215/003 (250 ml)
Maltese: EU/2/17/215/003 (250 ml)
English: In addition, pre-pregnancy vaccination of clinically healthy gilts and sows, non-PRRS virus-naïve (i.e. either previously immunised against PRRS virus via vaccination or exposed to PRRS virus via field infection) or PRRS virus-naïve, was demonstrated to reduce the transplacental infection caused by PRRS virus during the last third of pregnancy, and to reduce the associated negative impact on reproductive performance (reduction of the occurrence of stillbirths, of piglet viraemia at birth and at weaning, of lung lesions and of viral load in lungs in piglets at weaning).
Maltese: Barra minn hekk, tilqim qabel it-tqala ta' ħnieżer nisa żgħar u majjaliet klinikament f'saħħithom, li mhumiex PRRS virus-naïve (i.e. jew imlaqqma qabel kontra l-virus PRRS permezz tal-vaċċin jew ġew esposti għall-virus PRRS minn infezzjoni fl-ambjent) jew PRRS virus-naïve, wera li jnaqqas linfezzjoni li tgħaddi minn ġol-plaċenta kkawżata mill-virus PRRS waqt l-aħħar terz tat-tqala, u jnaqqas l-impatt negattiv assoċjat fuq il-prestazzjoni riproduttiva (tnaqqis fin-numru ta' stillbirths, tnaqqis f'virimja ta' qżieqeż tat-twelid u tal-ftama, tnaqqis ta' leżjonijiet u ammont ta' virus filpulmun ta' qżieqeż waqt il-ftama).
English: Transfer back the reconstituted solution into the solvent vial (containing the remaining solvent): 25 doses are reconstituted into 50 ml solvent, 50 doses are reconstituted into 100 ml solvent, and 125 doses are reconstituted into 250 ml solvent.
Maltese: Ittrasferixxi lura s-soluzzjoni rikostitwita għal ġol-kunjett bissolvent (li fih il-bqija tas-solvent): 25 doża huma rikostitwiti għal f'50 ml solvent, 50 doża huma rikostitwiti għal f'100 ml solvent, u 125 doża huma rikostitwiti f'250 ml solvent.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Maltese: Skont l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, kif emendata, Stat Membru jista', skont il-liġijiet nazzjonal tiegħu, jipprojbixxi l-manifattura, l-importazzjoni, ilpussess, il-bejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fit-territorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: A transient increase in rectal temperature (0.3 °C on average, and up to 1.2 °C individually) very commonly occurred 24 hours post vaccination.
Maltese: Żieda li tgħaddi fit-temperatura tar-rektum (medja ta' 0.3 °C u sa 1.2 °C b'mod individwali) kienet komuni ħafna sa 24 siegħa wara t-tilqima.
English: Vaccination of seronegative 2-weeks-old piglets was demonstrated to significantly reduce lung lesions and oral shedding against challenge administered at 28 days and at 16 weeks post-vaccination.
Maltese: Tilqim ta' qżieqeż seronegattivi ta' età ta' ġimagħtejn wera li naqqas b'mod sinifikattiv il-leżjonijiet fil-pulmun u tixrid mill-ħalq kontra sfida amministrata 28 ġurnata u 16-il ġimgħa wara t-tilqima.
English: Modified live PRRSV, strain 96V198: 102.2 - 105.2 CCID50
Maltese: TAS-SUSTANZA ATTIVA PRRSV ħaj modifikat, strejn 96V198: 102.2 - 105.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/ ).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: Modified live PRRSV*, strain 96V198: 102.2 - 105.2 CCID50**
Maltese: PRRSV* ħaj modifikat, strejn 96V198: 102.2 - 105.
English: Fattening pigs:
Maltese: U LUŻU
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE HDPE vials (100 ml or 250 ml)
Maltese: Kunjetti HDPE (50 ml)
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR
English: Lyophilisate: off-white freeze-dried pellet.
Maltese: Lijofiliżat: pelit offwajt imnixxfa bl-iffriżar.
English: Cardboard box of 1 vial of 15 ml (125 doses) and 1 vial of 250 ml of solvent.
Maltese: Kaxxa tal-kartun b'kunjett wieħed ta' 15 ml (125 doża) u kunjett wieħed b'250 ml solvent.
English: In addition, vaccination of seronegative 1-day-old piglets was demonstrated to significantly reduce lung lesions against challenge administered at 26 weeks post vaccination.
Maltese: Barra minn hekk, it-tilqim ta' qżieqeż seronegattivi ta' età ta' ġurnata wera li naqqas b'mod sinifikattiv il-leżjonijiet fil-pulmun kontra sfida amministrata 26 ġimgħa wara t-tilqima.
English: Onset of immunity: 21 days after vaccination.
Maltese: Bidu tal-immunità: 21 ġurnata wara t-tilqima.