FrancophonIA/ELRC3.0 huggingface dataset:
English: Women of childbearing potential must use effective contraception during treatment with zonisamide and for one month after discontinuation (see section 4.6).
Maltese: Nisa li jistgħu joħorġu tqal iridu jużaw kontraċettiv effettiv waqt it trattament b'zonisamide u sa xahar wara t-trattament (ara sezzjoni 4.6).
English: Caution should be used in adults when zonisamide is prescribed with other medicinal products that predispose patients to heat related disorders; these include carbonic anhydrase inhibitors and medicinal products with anticholinergic activity (see also section 4.4 Paediatric Population).
Maltese: Għandha tingħata attenzjoni fl-adulti meta tingħata riċetta għal zonisamide ma' prodotti mediċinali oħrajn li jippredisponu lil pazjenti għal mard assoċjat mas-sħana; dawn jinkludu inibituri ta' carbonic anhydrase u prodotti mediċinali b'attività antikolinerġika (ara wkoll sezzjoni 4.4
English: MonotherapyNewly diagnosed adult patients
Maltese: Id-doża rakkomandata għall-adulti
English: If you are younger than 6 years old, Zonisamide Mylan is not recommended for you - are elderly, as your dose of Zonisamide Mylan may need adjusting, and you may be more likely to develop an allergic reaction, severe skin rash, swelling of the feet and legs, and itchiness when taking Zonisamide Mylan (see section 4 Possible Side Effects) - suffer from liver problems, as your dose of Zonisamide Mylan may need adjusting - have eye problems such as glaucoma - suffer from kidney problems as your dose of Zonisamide Mylan may need adjusting - have previously suffered from kidney stones, as you may be at increased risk of developing more kidney stones.
Maltese: • inti anzjan/a, għax id-doża tiegħek ta' Zonisamide Mylan jista' jkollha bżonn li tiġi aġġustata, u inti tista' tkun mistenni aktar li tiżviluppa reazzjoni allerġika, raxx sever tal-ġilda, nefħa tassaqajn u tar-riġlejn, u ħakk meta tieħu Zonisamide Mylan (ara sezzjoni 4 Effetti Sekondarji Possibbli)
English: Renal ultrasound should be performed at the discretion of the physician.
Maltese: Ultrasound tal-kliewi għandu jitwettaq fid-diskrezzjoni tat-tabib.
English: Zonisamide is almost completely absorbed after oral administration, generally reaching peak serum or plasma concentrations within 2 to 5 hours of dosing.
Maltese: Zonisamide hu kważi kompletament assorbit wara l-għoti mill-ħalq, u ġeneralment jilħaq ilkonċentrazzjonijiet massimi fis-serum jew fil-plażma fi żmien minn sagħtejn sa 5 sigħat mid-dożaġġ.
English: INFORMATION IN BRAILLE Zonisamide Mylan 25 mg
Maltese: Zonisamide Mylan 25 mg
English: Zonisamide Mylan 100 mg hard capsules.
Maltese: Zonisamide Mylan 100 mg kapsuli iebsin
English: Pruritus Ecchymosis
Maltese: Fażi ta' Titrazzjoni
English: Changes in renal histopathology and clinical pathology parameters were considered to be related to carbonic anhydrase inhibition by zonisamide.
Maltese: Tibdil fl-istopatoloġija tal-kliewi u parametri tal-patoloġija klinika kienu kkunsidrati li huma relatati malinibizzjoni ta' carbonic anhydrase minn zonisamide.
English: Adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adolescent and paediatric patients (aged 6 years and above) In paediatric patients (aged 6 years and above), efficacy has been demonstrated with zonisamide in a double-blind, placebo-controlled study, which included 207 subjects and had a treatment duration of up to 24 weeks.
Maltese: F'pazjenti pedjatriċi (li kellhom 6 snin u aktar), l-effikaċja ntweriet b'zonisamide fi studju doubleblind, ikkontrollati bi plaċebo, li kien jinkludi 207 individwi u li kellu tul ta' żmien ta' kura sa 24 ġimgħa.
English: - The recommended dose is 300 mg once a day.
Maltese: • Id-doża rakkomandata hi ta' 300 mg kuljum.
English: BGP Products UAB Tel: + 370 5 205 1288
Maltese: Tel: + 370 5 205 1288
English: Zonisamide Mylan must be added to existing therapy for paediatric patients aged 6 years and above.
Maltese: Zonisamide Mylan irid jiżdied mat-terapija eżistenti għal pazjenti pedjatriċi li jkollhom 6 snin u aktar.
English: In a zonisamide placebo-controlled study conducted in paediatric and adolescent patients, the proportion of patients with impaired cognition was numerically greater in the zonisamide group compared with the placebo group.
Maltese: Fi studju dwar zonisamide ikkontrollat bi plaċebo li sar fuq pazjenti pedjatriċi u adolexxenti, il-proporzjon ta' pazjenti b'indeboliment konoxxittiv kien numerikament akbar fil-grupp ta' zonisamide meta mqabbel mal-grupp tal-plaċebo.
English: Zonisamide Mylan 50 mg hard capsules.
Maltese: Zonisamide Mylan 50 mg kapsuli iebsin
English: Potential medicinal product interactions affecting zonisamide In clinical studies co-administration of lamotrigine had no apparent effect on zonisamide pharmacokinetics.
Maltese: Interazzjonijiet potenzjali tal-prodott mediċinali li jaffettwaw zonisamide Fi studji kliniċi, l-għoti flimkien ta' lamotrigine ma kellu l-ebda effett apparenti fuq il-farmakokinetiċi ta' zonisamide.
English: Most adverse effects observed in the juvenile rats were similar to those seen in the repeated-dose toxicity studies of zonisamide in adult rats, but renal tubular hyaline droplets and transitional hyperplasia were observed in the juvenile study only.
Maltese: Il-biċċa l-kbira tal-effetti avversi osservati fil-ġrieden ġuvenili kienu simili għal dawk li dehru fl-istudji dwar it-tossiċità minn dożi ripetuti ta' zonisamide f'firien adulti, iżda qtar hyaline tubulari renali u iperplasija transitorja ġew osservati fl-istudju ġuvenili biss.
English: Increase at weekly intervals in increments of 1 mg/kg
Maltese: Żid f'intervalli ta' ġimgħa f'inkrementi ta' 1 mg/kg
English: Each capsule contains 100 mg of zonisamide.
Maltese: Kull kapsula iebsa tafiha 100 mg ta' zonisamide.
English: Week 2 Week 3 to 5
Maltese: Ġimgħa 1 Ġimgħa 2 Ġimgħa 3 sa 5
English: Cases of decreased sweating and elevated body temperature have been reported mainly in paediatric patients (see section 4.4 Paediatric Population for full warning).
Maltese: Każijiet ta' nuqqas ta' għaraq u temperatura tal-ġisem għolja kienu rrappurtati primarjament f'pazjenti pedjatriċi (ara sezzjoni 4.4
English: Each capsule contains 25 mg of zonisamide.
Maltese: Kull kapsula iebsa fiha 25 mg ta' zonisamide.
English: Multiple antiepileptic medicinal product therapy may be associated with a higher risk of congenital malformations than monotherapy.
Maltese: Terapija bi prodotti mediċinali multipli kontra l-epilessija tista' tiġi assoċjata ma' riskju ogħla ta' malformazzjonijiet konġenitali milli minn terapija bi prodott wieħed (monoterapija).
English: Each capsule contains 50 mg of zonisamide.
Maltese: Kull kapsula fiha 50 mg ta' zonisamide.
English: Studies in animals have shown changes in fertility parameters (see section 5.3).
Maltese: Studji fl-annimali wrew tibdil fil-parametri tal-fertilità (ara sezzjoni 5.3).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Zonisamide Mylan 25 mg hard capsules
Maltese: U KWANTITATTIVA Zonisamide Mylan 25 mg kapsuli iebsin
English: - if you are allergic to other sulfonamide medicines.
Maltese: • jekk inti allerġiku għal mediċini tat-tip sulfonamide.
English: Apparent clearance of zonisamide at steady-state after oral administration is about 0.70 l/h and the terminal elimination half-life is about 60 hours in the absence of CYP3A4 inducers.
Maltese: L/h u l-halflife ta' l-eliminazzjoni terminali hi ta' madwar 60 siegħa fl-assenza ta' inducers ta' CYP3A4.
English: Zonisamide should not be used as co-medication in paediatric patients with other carbonic anhydrase inhibitors such as topiramate and acetazolamide (see section 4.5).
Maltese: Zonisamide m'għandux jintuża bħala komedikazzjoni f'pazjenti pedjatriċi ma' inibituri oħrajn ta' carbonic anhydrase bħal topiramate u acetazolamide (ara sezzjoni 4.5).
English: Ophthalmologic findings can include myopia, anterior chamber shallowing, and ocular hyperaemia (redness) and increased intraocular pressure.
Maltese: Sejbiet oftalmoloġiċi jistgħu jinkludu mijopija, kavità anterjuri li titbaxxa, u iperemija okulari (ħmura) u żieda fil-pressjoni intraokulari.
English: Tel: + 34 900 102 712
Maltese: Mylan Pharmaceuticals S.L. Tel: + 34 900 102 712
English: These effects were considered likely related to the decreased body weight and exaggerated pharmacologic effects of zonisamide at the maximum tolerated dose.
Maltese: Dawn l-effetti kienu kkunsidrati li x'aktarx kienu marbuta ma' tnaqqis fil-piż tal-ġisem u effetti farmakoloġiċi esaġerati ta' zonisamide fid-doża massima ttollerata.
English: Zonisamide should not be used as co-medication in paediatric patients with other medicinal products that predispose patients to heat related disorders; these include carbonic anhydrase inhibitors and medicinal products with anticholinergic activity.
Maltese: Zonisamide m'għandux jintuża bħala komedikazzjoni f'pazjenti pedjatriċi ma' prodotti mediċinali oħrajn li jippredisponu lil pazjenti għal disturbi assoċjati mas-sħana; dawn jinkludu inibituri ta' carbonic anhydrase u prodotti mediċinali b'attività antikolinerġika.
English: Zonisamide Mylan may be taken as monotherapy or added to existing therapy in adults.
Maltese: Zonisamide Mylan jista' jittieħed bħala monoterapija jew jiżdied mat-terapija eżistenti fl-adulti.
English: PP-population* ITT-population < 4 seizures during 3 month baseline period > 4 seizures during 3 month baseline period
Maltese: Popolazzjoni PP* Popolazzjoni ITT < 4 puplesiji matul il-perjodu ta' 3 xhur fil-linja bażi > 4 puplesiji matul il-perjodu ta' 3 xhur fil-linja bażi
English: - without
Maltese: Tista'
English: Data from a registry study suggest an increase in the proportion of babies born at a low birth weight (LBW), pre-term or small for gestational age (SGA).
Maltese: Dejta minn studju tar-reġistru jissuġġerixxi żieda fil-proporzjon ta' trabi li jitwieldu b'piż tat-twelid baxx (LBW, low birth weight), qabel iż-żmien jew li jkun żgħar għall-età ġestazzjonali (SGA, small for gestational age).
English: Zonisamide should be used with caution in adult patients being treated concomitantly with carbonic anhydrase inhibitors such as topiramate or acetazolamide, as there are insufficient data to rule out a pharmacodynamic interaction (see also section 4.4 Paediatric Population and section 4.5).
Maltese: Zonisamide għandu jintuża bl-attenzjoni f'pazjenti adulti li jkunu qed jiġu kkurati fl-istess ħin blinibituri ta' carbonic anhydrase bħal topiramate jew acetazolamide, għax hemm huma informazzjoni insuffiċjenti biex tiġi eskluża interazzjoni farmakodinamika (ara wkoll sezzjoni 4.4 Popolazzjoni Pedjatrika u sezzjoni 4.5).
English: Each hard capsule contains 25 mg of zonisamide.
Maltese: Kull kapsula iebsa ta' fiha 25 mg ta' zonisamide.
English: A white opaque body and a white opaque cap, marked ‘Z 25' in black containing white/almost white powder.
Maltese: Korp opak abjad b'għatu opak abjad, immarkat b'‘Z 25' bl-iswed li fih trab abjad/kważi abjad.
English: Serious immune based adverse reactions that are associated with medicinal products containing a sulfonamide group include rash, allergic reaction and major haematological disturbances, including aplastic anaemia, which very rarely can be fatal.
Maltese: Reazzjonijiet avversi serji bbażati fuq l-immunità li huma assoċjati ma' prodotti mediċinali li fihom grupp sulfonamide jinkludu raxx, reazzjoni allerġika u disturbi maġġuri ematoloġiċi, li jinkludu anemija aplastika, li b'mod rari ħafna jistgħu jkunu fatali.
English: Zonisamide Mylan 100 mg hard capsules have a white body and white cap, marked ‘Z 100' in black and contain a white/almost white powder.
Maltese: Zonisamide Mylan 100 mg kapsuli iebsin għandhom korp abjad u għatu abjad, immarkat b'‘Z 100' bliswed u fihom trab abjad/kważi abjad.
English: Zonisamide Mylan 25 mg hard capsules
Maltese: Zonisamide Mylan 25 mg kapsuli iebsin
English: Zonisamide caused developmental abnormalities in mice, rats, and dogs, and was embryolethal in monkeys, when administered during the period of organogenesis at zonisamide dosage and maternal plasma levels similar to or lower than therapeutic levels in humans.
Maltese: Zonisamide kkawża anormalitajiet waqt l-iżvilupp fil-ġrieden, firien, u klieb, u kien embrijoletali fixxadini, meta mogħti matul il-perjodu ta' l-organoġenesi fid-dożaġġ ta' zonisamide u livelli tal-plażma materni simili għal, jew iktar baxxi mil-livelli terapewtiċi fil-bnedmin.
English: Abdominal pain
Maltese: Uġigħ addominali
English: Each hard capsule contains 50 mg of zonisamide.
Maltese: Kull kapsula iebsa ta fiha 50 mg ta zonisamide.
English: A small number of people being treated with anti epileptics such as Zonisamide Mylan have had thoughts of harming or killing themselves- have pain in your muscles or a feeling of weakness, as this may be a sign of abnormal muscle breakdown which can lead to kidney problems - get a sudden pain in your back or stomach, have pain on urinating (passing water) or notice blood in your urine, as this may be a sign of kidney stones - develop visual problems such as eye pain or blurred vision while taken zonisamide.
Maltese: Minħabba li zonisamide u l-metaboliti tiegħu jitneħħew mill-kliewi, dan għandu jitwaqqaf f'pazjenti li jiżviluppaw insuffiċjenza renali jew fejn żieda sostnuta fil-kreatinina tas-serum li tkun klinikament sinifikanti, tkun osservata.
English: Zonisamide Mylan can make you perspire less, which can cause your body temperature to increase.
Maltese: Zonisamide Mylan ser titnaqqas gradwalment biex tnaqqas ir-riskju ta' iktar puplesiji.
English: Acute myopia and secondary angle closure glaucoma A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in adult and paediatric patients receiving zonisamide.
Maltese: Mijopija akuta u glawkoma tat-tip angle closure sekondarja Sindrome li jikkonsisti minn mijopija akuta assoċjata ma' glawkoma tat-tip angle closure sekondarja kien irrappurtat f'pazjenti adulti u pedjatriċi li jirċievu zonisamide.
English: General dosing recommendations for Zonisamide Mylan in special patient populations
Maltese: Jekk tinsa tieħu Zonisamide Mylan
English: Zonisamide should be used with caution in adult patients treated concomitantly with carbonic anhydrase inhibitors such as topiramate and acetazolamide, as there are insufficient data to rule out a possible pharmacodynamic interaction (see section 4.4).
Maltese: Zonisamide għandu jintuża b'kawtela f'pazjenti adulti li jiġu kkurati b'mod konkomitanti b'impedituri ta' carbonic anhydrase bħal topiramate u acetazolamide, peress li m'hemmx biżżejjed informazzjoni li tista' teskludi xi interazzjoni farmakodinamika possibbli (ara sezzjoni 4.4).
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-folja u l-kartuna wara EXP.
English: Very Common Common
Maltese: Komuni Ħafna Komuni
English: Risk factors for nephrolithiasis include prior stone formation, a family history of nephrolithiasis and hypercalciuria.
Maltese: Żieda fil-pressjoni intraokulari ta' kwalunkwe etjoloġija, jekk ma tiġix ikkurata, tista' twassal għal konsegwenzi serji inkluż telf permanenti tal-vista.
English: 50 mg/day (in two divided doses)
Maltese: 50 mg/kuljum (f'żewġ dożi maqsuma)
English: Ecchymosis
Maltese: Anidrosi
English: A very high plasma concentration of 100.1 μg/ml zonisamide was recorded approximately 31 hours after a patient took an overdose of zonisamide and clonazepam; the patient became comatose and had respiratory depression, but recovered consciousness five days later and had no sequelae.
Maltese: 1 µg/mL zonisamide kienet irreġistrata madwar 31 siegħa wara li pazjent ħa doża eċċessiva ta' zonisamide u clonazepam; il-pazjent sar komatuż u kellu dipressjoni respiratorja, iżda ġie f'sensih ħamest ijiem wara u ma ġarrab l-ebda kundizzjonijiet jew mard b'konsegwenza ta' dan.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: BGP Products UAB
English: - are pregnant or could become pregnant (see section ‘pregnancy, breast-feeding and fertility' for further information).
Maltese: • li huma tqal jew li jistgħu joħorġu tqal (ara sezzjoni ‘Tqala, treddigħ u fertilità' għal aktar informazzjoni).
English: There are insufficient data for the withdrawal of concomitant antiepileptic medicines once seizure control with zonisamide has been achieved in the add-on situation, in order to reach monotherapy with zonisamide.
Maltese: M'hemm l-ebda antidoti speċifiċi disponibbli għal doża eċċessiva ta' zonisamide.
English: 100 mg/day (in two divided doses)
Maltese: 100 mg/kuljum (f'żewġ dożi maqsuma)
English: - shortness of breath, inflammation of the lungs - inflammations of the pancreas (severe pain in the stomach or back) - liver problems, kidney failure - severe rashes or skin peeling (at the same time you may feel unwell or develop a fever) - abnormal muscle breakdown (you may feel pain or weakness in your muscles) which can lead to kidney problems - swollen glands, blood disorders (reduction in the number of blood cells, which can make infection more likely and can make you look pale, feel tired and feverish, and bruise more easily) - decreased sweating, overheating - problems with your urine - increased blood levels of creatine phosphokinase or urea which can be seen in a blood test - abnormal results from liver function tests - glaucoma, which is a blockage of fluid in the eye causing increased pressure in the eye.
Maltese: Il-mekkaniżmu ta' l-azzjoni ta' zonisamide mhuwiex spegat b'mod sħiħ, iżda jidher li jaġixxi fuq ilkanali tal-voltage-sensitive sodium u calcium, u b'hekk jinterrompi s-synchronised neuronal firing, u jnaqqas il-firxa tad-discharges tal-puplesiji u jinterrompi l-attività epilettika sussegwenti.
English: All generalized Tonic-Clonic
Maltese: Indeboliment tal-kliewi
English: There are no clinical data available on the effects of zonisamide on human fertility.
Maltese: M'hemm l­ebda dejta klinika disponibbli dwar l-effetti ta' zonisamide fuq il-fertilità tal-bniedem.
English: Findings not observed in clinical studies, but seen in the dog at exposure levels similar to clinical use, were liver changes (enlargement, dark-brown discolouration, mild hepatocyte enlargement with concentric lamellar bodies in the cytoplasm and cytoplasmic vacuolation) associated with increased metabolism.
Maltese: Is-sejbiet ma kienux osservati fl-istudji kliniċi, iżda kienu osservati fil-klieb f'livelli ta' espożizzjoni simili għal dawk ta' l-użu kliniku, u dawn kienu bidliet fil-fwied (tkabbir, tibdil fil-kulur kannella skur, tkabbir ħafif ta' l-epatoċiti ma' korpi lamellari konċentriċi fis-cytoplasm u fis-cytoplasmic vacuolation) assoċjat ma' żieda fil-metaboliżmu.
English: Cases of decreased sweating and elevated body temperature have been reported mainly in paediatric patients.
Maltese: Każijiet ta' nuqqas ta' għaraq u temperatura tal-ġisem għolja ġew irrappurtati primarjament f'pazjenti pedjatriċi.
English: In these cases it is therefore recommended that the zonisamide total dose should be rounded up or down to the nearest available dose that can be achieved with commercially available capsule strengths of zonisamide (25 mg, 50 mg and 100 mg).
Maltese: F'każijiet bħal dawn, għalhekk, huwa rakkomandat li d-doża totali ta' zonisamide titqarreb 'il fuq jew 'l isfel lejn l-eqreb doża disponibbli li tista' tinkiseb bis-qawwiet talkapsuli disponibbli kummerċjalment ta' zonisamide (25 mg, 50 mg u 100 mg).
English: Zonisamide Mylan 25 mg hard capsules have a white body and a white cap, marked ‘Z 25' in black and contain a white/almost white powder.
Maltese: Zonisamide Mylan 25 mg kapsuli iebsin għandhom korp abjad u għatu abjad, immarkat b'‘Z 25' bliswed u fihom trab abjad/kważi abjad.
English: The risk of zonisamide induced metabolic acidosis appears to be more frequent and severe in paediatric and adolescent patients.
Maltese: Ir-riskju ta' aċidożi metabolika kkaġunata minn zonisamide jidher li hu iktar frekwenti u sever f'pazjenti pedjatriċi u adolexxenti.
English: Zonisamide Mylan 50 mg hard capsules have a white body and white cap, marked ‘Z 50' in red and contain a white/almost white powder.
Maltese: Zonisamide Mylan 50 mg kapsuli iebsin għandhom korp abjad u għatu abjad, immarkat b'‘Z 50' blaħmar u fihom trab abjad/kważi abjad.
English: There is no evidence that zonisamide induces its own metabolism.
Maltese: M'hemm l-ebda evidenza li zonisamide jikkaġuna l-metaboliżmu tiegħu stess.
English: If a higher dose is required: increase at two-weekly intervals in increments of 100 mg up to a maximum of 500 mg.
Maltese: Jekk ikun hemm bżonn ta' doża ogħla: żid f'intervalli ta' ġimagħtejn f'inkrementi ta' 100 mg sa massimu ta' 500 mg.
English: - The recommended daily dose is 6 to 8 mg per kg for a child with a body weight of up to 55 kg or
Maltese: Ġimgħa 1 Ġimgħat 2 sa 8 Pazjenti li jiżnu 20 sa 55 kg a
English: Ingelvac CircoFLEX EMA/595160/2007
Maltese: Ingelvac CircoFLEXEMA/595160/2007
English: The full EPAR for Ingelvac CircoFLEX can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Ingelvac CircoFLEX contains the active substance porcine circovirus type 2 ORF2 protein.
Maltese: Ingelvac CircoFLEX fih is-sustanza attiva ċirkovirus tal-ħnieżer tat-tip 2 proteina ORF-2.
English: PCV2 infections can produce clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty breathing, pale skin and jaundice (yellowing of the skin).
Maltese: L-infezzjonjiet b'PCV2 jistgħu jipproduċu sinjali kliniċi bħal telf fil-piż jew nuqqas ta' żvilupp, limfonodi mkabbra, diffikultà fit-teħid tan-nifs, ġilda pallida u suffejra (sfurija tal-ġilda).
English: This is a summary of the European public assessment report (EPAR) for Ingelvac CircoFLEX.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ingelvac CircoFLEX.
English: This summary was last updated in March 2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 03-2017.
English: Ingelvac CircoFLEX is a vaccine.
Maltese: Ingelvac CircoFLEX huwa vaċċin.
English: Ingelvac CircoFLEX is a vaccine used to protect pigs from the two weeks of age against porcine circovirus type 2 (PCV2).
Maltese: Ingelvac CircoFLEX huwa vaċċin li jintuża biex jipproteġi lill-ħnieżer mill-età ta' ġimagħtejn kontra ċċirkovirus tal-ħnieżer tat-tip 2 (PCV2).
English: The European Commission granted a marketing authorisation valid throughout the EU for Ingelvac CircoFLEX on 13 February 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Ingelvac CircoFLEX fit-13 ta' Frar 2008.
English: Why is Ingelvac CircoFLEX approved?
Maltese: Għaliex ġie approvat Ingelvac CircoFLEX?
English: porcine circovirus type 2 vaccine
Maltese: vaċċin taċ-ċirkovirus tal-ħnieżer tat-tip 2
English: For the full list of restrictions and all side effects reported with Ingelvac CircoFLEX, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet u tal-effetti sekondarji kollha rrapportati b'Ingelvac CircoFLEX, ara l-fuljett ta' tagħrif.
English: What are the risks associated with Ingelvac CircoFLEX?
Maltese: X'inhuma r-riskji assoċjati ma' Ingelvac CircoFLEX?
English: The most common side effect with Ingelvac CircoFLEX (which may affect more than 1 in 10 animals) is a mild and short lived increase in body temperature on the day of vaccination.
Maltese: L-effett sekondarju l-aktar komuni b'Ingelvac CircoFLEX (li jista' jaffettwa aktar minn 1 minn kull 10) huwa żieda ħafifa u li ma ddumx fit-temperatura tal-ġisem fil-jum tat-tilqim.
English: When a pig is given the vaccine, the pig's immune system recognises the protein as ‘foreign' and reacts by building up an active immune response.
Maltese: proteina bħala ‘barranija' u tirreaġixxi billi tibni rispons immuni attiv.
English: How does Ingelvac CircoFLEX work?
Maltese: Kif jaħdem Ingelvac CircoFLEX?
English: Ingelvac CircoFLEX is available as a suspension for injection and can only be obtained with a prescription.
Maltese: Ingelvac CircoFLEX jiġi bħala sospensjoni għall-injezzjoni u jista' jinkiseb biss b'riċetta ta' tabib.