FrancophonIA/ELRC3.0 huggingface dataset:
English: Results of a 12-week placebo-controlled study of 295 paediatric patients aged 4 to 16 years performed to evaluate the efficacy and safety of pregabalin as adjunctive therapy for the treatment of partial onset seizures and a 1 year open label safety study in 54 paediatric patients from 3 months to 16 years of age with epilepsy indicate that the adverse events of pyrexia and upper respiratory infections were observed more frequently than in adult studies of patients with epilepsy (see sections 4.2, 4.8 and
Maltese: Ir-riżultati ta' studju ta' 12-il ġimgħa kkontrollat bil-plaċebo ta' 295 pazjent pedjatriku li kellhom bejn 4 u 16il sena li sar biex jevalwa l-effikaċja u s-sigurtà ta' pregabalin bħala terapija aġġuntiva għall-kura ta' aċċessjonijiet ta' bidu parzjali u studju open label dwar is-sigurtà li dam sena, li sar fuq 54 pazjent pedjatriku li kellhom minn 3 xhur sa 16-il sena, bl-epilessija, jindikaw li l-avvenimenti avversi ta' deni u infezzjonijiet respiratorji fil-parti ta' fuq, ġew osservati b'mod aktar frekwenti milli fl-istudji li saru fuq l-adulti ta' pazjenti b'epilessija (ara sezzjonijiet 4.2, 4.8 u 5.2).
English: • When Pregabalin Mylan is taken with other medicines that may cause constipation (such as some types of pain medicines) it is possible that gastrointestinal problems may occur (e.g., constipation, blocked or paralysed bowel).
Maltese: • Meta Pregabalin Mylan tkun qed tittieħed ma' mediċini oħrajn li jikkawżaw l-istitikezza (bħal ċerti tipi ta' mediċini li jingħataw għall-uġigħ) jista' jkun possibli li jkun hemm problemi gastroinestinali (eż. stitikezza, imsaren imblukkati jew paralizzati).
English: How to store Pregabalin Mylan
Maltese: Tiħux Pregabalin Mylan
English: The pregabalin safety profile observed in three paediatric studies in patients with partial seizures with or without secondary generalization (12-week efficacy and safety study in patients with partial onset seizures, n=295; (pharmacokinetic and tolerability study, n=65; and 1 year open label follow on safety study, n=54) was similar to that observed in the adult studies of patients with epilepsy.
Maltese: Il-profil tas-sigurtà ta' pregabalin osservat fi tliet studji pedjatriċi f'pazjenti b'aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja (studju ta' 12-il ġimgħa dwar l-effikaċja u s-sigurtà f'pazjenti b'aċċessjonijiet ta' bidu parzjali, n=295; (studju farmakokinetiku u studju dwar it tollerabilità, n=65; studju dwar is-sigurtà open label follow on, n=54, li dam sena) kien simili għal dakosservat fl-istudji fuq l-adulti ta' pazjenti b'epilessija.
English: Pregabalin Mylan is indicated for the treatment of peripheral and central neuropathic pain in adults.
Maltese: Pregabalin Mylan huwa indikat għall-kura ta' uġigħ periferali u ċentrali f'persuni adulti.
English: Pregabalin Mylan is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Maltese: Pregabalin Mylan huwa indikat għall-kura tad-Disturb ta' Ansjetà Ġeneralizzata (GAD - Generalised Anxiety Disorder) f'persuni adulti.
English: Pregabalin Mylan may be taken with oral contraceptives.
Maltese: Pregabalin Mylan jista' jittieħed ma' kontraċettivi orali.
English: PVC/PVDC-Al blister pack containing 14, 21, 56, 84 and 100 hard capsules.
Maltese: Pakkett bil-folji tal-PVC/PVDC-Al li jkun fih 14, 21, 56, 84 u 100 kapsula iebsa.
English: EU/1/15/997/028 EU/1/15/997/029 EU/1/15/997/030 EU/1/15/997/034 EU/1/15/997/031 EU/1/15/997/032 EU/1/15/997/033
Maltese: EU/1/15/997/028 EU/1/15/997/029 EU/1/15/997/030 EU/1/15/997/031 EU/1/15/997/032 EU/1/15/997/033
English: • Some patients taking Pregabalin Mylan have reported symptoms suggesting an allergic reaction.
Maltese: • Xi pazjenti li jużaw Pregabalin Mylan irrappurtaw sintomi li jindikaw reazzoni allerġika.
English: INFORMATION IN BRAILLE Pregabalin Mylan 225 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Mylan 225 mg
English: EU/1/15/997/016 EU/1/15/997/017 EU/1/15/997/018 EU/1/15/997/022 EU/1/15/997/019 EU/1/15/997/020 EU/1/15/997/021
Maltese: EU/1/15/997/016 EU/1/15/997/017 EU/1/15/997/018 EU/1/15/997/019 EU/1/15/997/020
English: Pregabalin Mylan 75 mg hard capsules EU/1/15/997/016
Maltese: Pregabalin Mylan 75 mg kapsuli iebsin EU/1/15/997/016
English: Reduced lower gastrointestinal tract function There are post-marketing reports of events related to reduced lower gastrointestinal tract function (e.g. intestinal obstruction, paralytic ileus, constipation) when pregabalin was co-administered with medications that have the potential to produce constipation, such as opioid analgesics.
Maltese: Tnaqqis fil-funzjoni gastrointestinali fil-parti t'isfel Kien hemm rapporti ta' episodji assoċjati mal-funzjoni gastrointestinali fil-parti t'isfel (eż. imblukkar tal-intestini, ileus paralitiku, stitikezza) fl-esperjenza ta' wara t-tqegħid fis-suq, meta pregabalin ġie mogħti flimkien ma' mediċini li għandhom potenzjal li jikkawżaw stitikezza, bhal analġesiċi opjojdi.
English: Pregabalin Mylan 225 mg hard capsule
Maltese: Pregabalin Mylan 225 mg kapsula iebsa
English: EU/1/15/997/040 EU/1/15/997/041 EU/1/15/997/042 EU/1/15/997/043 EU/1/15/997/044
Maltese: EU/1/15/997/041 EU/1/15/997/042 EU/1/15/997/043 EU/1/15/997/044
English: Pregabalin Mylan 100 mg hard capsules EU/1/15/997/023
Maltese: Pregabalin Mylan 100 mg kapsuli iebsin EU/1/15/997/023
English: Pregabalin Mylan contains the active substance pregabalin which belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults.
Maltese: Pregabalin Mylan fih is-sustanza attiva pregabalin li tjappartjeni għal grupp ta' mediċini li jintużaw għall-kura ta' l-epilessija, l-uġigħ nevrotiku u d-Disturb ta' Ansjetà Ġeneralizzata (GAD - Generalised Anxiety Disorder) fl-adulti.
English: Jaundice
Maltese: FOLJA
English: INFORMATION IN BRAILLE Pregabalin Mylan 75 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Mylan 75 mg
English: EU/1/15/997/035 EU/1/15/997/036 EU/1/15/997/037 EU/1/15/997/038 EU/1/15/997/039
Maltese: EU/1/15/997/036 EU/1/15/997/037 EU/1/15/997/038 EU/1/15/997/039
English: Pregabalin Mylan 75 mg hard capsule
Maltese: Pregabalin Mylan 75 mg kapsula iebsa
English: At therapeutic exposures, there was evidence of CNS clinical signs of hyperactivity and bruxism and some changes in growth (transient body weight gain suppression).
Maltese: B'esponimenti terapewtiċi, kien hemm evidenza ta' sinjali kliniċi tas-CNS ta' attività eċċessiva u tgħażżiż tas-snien u xi bidliet fit-tkabbir (trażżin temporanju taż-żieda fil-piż tal-ġisem).
English: INFORMATION IN BRAILLE Pregabalin Mylan 150 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Mylan 150 mg
English: BID or TID BID or TID
Maltese: BID jew TID BID jew TID Darba Kuljum jew BID Darba Kuljum
English: If you are an older patient (over 65 years of age), you should take Pregabalin Mylan normally except if you have problems with your kidneys.
Maltese: Jekk int pazjent aktar anzjan ('il fuq minn 65 sena), inti għandek tieħu Pregabalin Mylan b'mod normali ħlief jekk ikollok problemi bil-kliewi.
English: Pregabalin Mylan 200 mg hard capsules EU/1/15/997/035
Maltese: Pregabalin Mylan 200 mg kapsuli iebsin EU/1/15/997/035
English: Pregabalin Mylan 225 mg hard capsules EU/1/15/997/040
Maltese: Pregabalin Mylan 225 mg kapsuli iebsin EU/1/15/997/040
English: In controlled clinical trials in peripheral neuropathic pain 35% of the pregabalin treated patients and 18% of the patients on placebo had a 50% improvement in pain score.
Maltese: Fi provi kliniċi kkontrollati dwar uġigħ nevrotiku periferali, 35% tal-pazjenti kkurati bi pregabalin u 18% tal-pazjenti fuq/ il-plaċebo kellhom titjib ta' 50% fil-punteġġ ta' l-uġigħ.
English: INFORMATION IN BRAILLE Pregabalin Mylan 200 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Mylan 200 mg
English: The safety and efficacy of Pregabalin Mylan in children below the age of 12 years and in adolescents (12-17 years of age) have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Pregabalin Mylan fit-tfal ta' taħt it-12 -il sena u l-adoloxxenti (12-17 -il sena) ma ġewx determinati s'issa.
English: Pregabalin Mylan 300 mg hard capsules EU/1/15/997/045
Maltese: Pregabalin Mylan 300 mg kapsuli iebsin EU/1/15/997/045
English: Pregabalin Mylan 150 mg hard capsule
Maltese: Pregabalin Mylan 150 mg kapsula iebsa
English: Pregabalin Mylan 200 mg hard capsule
Maltese: Pregabalin Mylan 200 mg kapsula iebsa
English: Other medicines and Pregabalin Mylan
Maltese: Mediċini oħra u Pregabalin Mylan
English: Pregabalin Mylan 100 mg hard capsule
Maltese: Pregabalin Mylan 100 mg kapsula iebsa
English: EU/1/15/997/045 EU/1/15/997/046 EU/1/15/997/047 EU/1/15/997/050 EU/1/15/997/048 EU/1/15/997/049
Maltese: EU/1/15/997/046 EU/1/15/997/047 EU/1/15/997/048 EU/1/15/997/049
English: The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Mylan is taken together with medicinal products containing:
Maltese: Il-livell ta' sturdament, irqad u konċentrazzjoni mnaqqsa jista' jiżdied jekk Pregabalin Mylan jittieħed ma' prodotti mediċinali oħra li fihom:
English: EU/1/15/997/001 EU/1/15/997/002 EU/1/15/997/003 EU/1/15/997/004 EU/1/15/997/005 EU/1/15/997/006 EU/1/15/997/007 EU/1/15/997/008
Maltese: EU/1/15/997/005 EU/1/15/997/006 EU/1/15/997/007 EU/1/15/997/008
English: PVC/PVDC-Al blister pack containing 21, 84 and 100 hard capsules.
Maltese: Pakkett bil-folji tal-PVC/PVDC-Al li jkun fih 21, 84 u 100 kapsula iebsa.
English: INFORMATION IN BRAILLE Pregabalin Mylan 100 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Mylan 100 mg
English: PVC/PVDC-Al blister pack containing 14, 56 and 100 hard capsules.
Maltese: Pakkett bil-folji tal-PVC/PVDC-Al li jkun fih 14, 56 u 100 kapsula iebsa.
English: Pregabalin Mylan 300 mg hard capsule
Maltese: Pregabalin Mylan 300 mg kapsula iebsa
English: Pregabalin Mylan 50 mg hard capsule
Maltese: Pregabalin Mylan 50 mg kapsula iebsa
English: INFORMATION IN BRAILLE Pregabalin Mylan 300 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Mylan 300 mg
English: Pregabalin Mylan is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Maltese: Pregabalin Mylan huwa indikat bħala terapija aġġuntiva f'persuni adulti li jbatu minn aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja.
English: INFORMATION IN BRAILLE Pregabalin Mylan 25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Mylan 25 mg
English: HDPE bottle pack containing 200 hard capsules.
Maltese: FARMAĊEWTIKA U KONTENUT Kapsula, iebsa. 200 kapsula iebsa
English: Pregabalin Mylan 150 mg hard capsules EU/1/15/997/028
Maltese: Pregabalin Mylan 150 mg kapsuli iebsin EU/1/15/997/028
English: Pregabalin Mylan 50 mg hard capsules EU/1/15/997/009
Maltese: Pregabalin Mylan 50 mg kapsuli iebsin EU/1/15/997/009
English: Pregabalin Mylan 75 mg hard capsules Pregabalin Mylan 100 mg hard capsules Pregabalin Mylan 150 mg hard capsules Pregabalin Mylan 200 mg hard capsules Pregabalin Mylan 225 mg hard capsules Pregabalin Mylan 300 mg hard capsules pregabalin
Maltese: X'għandek tkun taf qabel ma tieħu Pregabalin Mylan Kif għandek tieħu Pregabalin Mylan Effetti sekondarji possibbli Kif taħżen Pregabalin Mylan Kontenut tal-pakkett u informazzjoni oħra
English: Generalised Anxiety Disorder
Maltese: Disfunzjoni tal-erezzjoni
English: INFORMATION IN BRAILLE Pregabalin Mylan 50 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Mylan 50 mg
English: Pregabalin Mylan 25 mg hard capsules EU/1/15/997/001
Maltese: Pregabalin Mylan 25 mg kapsuli iebsin EU/1/15/997/001
English: Pregabalin Mylan 225 mg hard capsules Each hard capsule contains 225 mg of pregabalin.
Maltese: Pregabalin Mylan 225 mg kapsuli iebsin Kull kapsula iebsa fiha 25 mg ta' pregabalin.
English: Pregabalin Mylan 75 mg hard capsules Each hard capsule contains 75 mg of pregabalin.
Maltese: Pregabalin Mylan 75 mg kapsuli iebsin Kull kapsula iebsa fiha 25 mg ta' pregabalin.
English: EU/1/15/997/023 EU/1/15/997/024 EU/1/15/997/025 EU/1/15/997/026 EU/1/15/997/027
Maltese: EU/1/15/997/025 EU/1/15/997/026 EU/1/15/997/027
English: Immune system disorders Uncommon
Maltese: Mhux komuni Newtropenja Disturbi fis-sistema immuni Mhux komuni
English: PVC/PVDC-Al perforated unit dose blister pack containing 14 x 1, 56 x 1 and 100 x 1 hard capsules.
Maltese: Pakkett bil-folji perforati tal-PVC/PVDC-Al b'doża tal-unità li jkun fih jkun fih 14 x 1, 56 x 1 u 100 x 1 kapsula iebsa.
English: Pregabalin Mylan 25 mg hard capsules Each hard capsule contains 25 mg of pregabalin.
Maltese: Pregabalin Mylan 25 mg kapsuli iebsin Kull kapsula iebsa fiha 25 mg ta' pregabalin.
English: Total pregabalin daily dose *
Maltese: Doża totali ta' pregabalin kuljum * Reġim tad-doża Doża inizjali (mg/ġurnata)
English: Logiters Logistica Portugal S.A. Estrada dos Arneiros 4 Azambuja
Maltese: 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà
English: EU/1/15/997/009 EU/1/15/997/010 EU/1/15/997/011 EU/1/15/997/012 EU/1/15/997/013 EU/1/15/997/014 EU/1/15/997/015
Maltese: EU/1/15/997/011 EU/1/15/997/012 EU/1/15/997/013 EU/1/15/997/014
English: Pregabalin Mylan 100 mg hard capsules Each hard capsule contains 100 mg of pregabalin.
Maltese: Pregabalin Mylan 100 mg kapsuli iebsin Pregabalin
English: In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions in general, CNC adverse reactions and especially somnolence was increased (see section 4.4).
Maltese: Fil-kura ta' uġigħ nevrotiku ċentrali minħabba leżjoni fil-korda spinali, l-inċidenza ta' reazzjonijiet avversi b'mod ġenerali, reazzjonijiet avversi ta' CNS u b'mod speċjali tan-ngħas żdiedet (ara sezzjoni 4.4).
English: • Pregabalin Mylan has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients.
Maltese: • Pregabalin Mylan ġie assoċjat ma' sturdament u ngħas, li jistgħu jżidu l-okkorrenza ta' korriment aċċidentali (waqgħat) f'pazjenti anzjani.
English: Pregabalin has been studied in 3 controlled clinical trials of 12 week duration with either twice a day dosing (BID) or three times a day (TID) dosing.
Maltese: Pregabalin ġie studjat fi 3 provi kliniċi kkontrollati li damu 12-il ġimgħa fejn ingħataw dożi BID jew TID.
English: 14 hard capsules 56 hard capsules 100 hard capsules 200 hard capsules 56 x 1 hard capsules 100 x 1 hard capsules
Maltese: 14 kapsula iebsa 56 kapsula iebsa 100 kapsula iebsa 200 kapsula iebsa 56 x 1 kapsula iebsa 100 x 1 kapsula iebsa
English: An increased incidence of retinal atrophy commonly observed in aged albino rats was seen after long term exposure to pregabalin at exposures ≥ 5 times the mean human exposure at the maximum recommended clinical dose.
Maltese: Wara esponiment fit-tul għal pregabalin f'esponimenti ta' ≥ 5 darbiet l-esponiment uman medju bid-doża klinika massima rakkomandata kienet osservata inċidenza akbar ta' atrofija tar-retina li normalment tidher f'firien albini xjuħ.
English: Pregabalin Mylan 200 mg hard capsules Each hard capsule contains 200 mg of pregabalin.
Maltese: Pregabalin Mylan 200 mg kapsuli iebsin Pregabalin
English: Dark peach opaque cap and dark peach opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Maltese: Dawn il-bidliet fil-pjastrini ma kinux preżenti fil-firien u fil-bniedem skond informazzjoni klinika fuq perijodu qasir u perijodu twil limitat.
English: Epilepsy: Pregabalin Mylan is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults.
Maltese: Pregabalin Mylan tintuża sabiex tiġi kkurata ċerta forma ta' epilessija (aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja) fl-adulti.
English: Hepatobiliary disorders Uncommon
Maltese: • Diffikultà biex tibla.
English: Pregabalin Mylan 75 mg hard capsules No. 4, light peach opaque cap and light peach opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Maltese: Il-kapsula hi stampata b'mod assjali b'MYLAN fuq PB75 b'linka sewda fuq l-għatu u fuq il-korp.
English: Pregabalin Mylan 25 mg hard capsule
Maltese: Pregabalin Mylan 25 mg kapsuli iebsin
English: Pregabalin Mylan 300 mg hard capsules Each hard capsule contains 300 mg of pregabalin.
Maltese: Pregabalin Mylan 300 mg kapsuli iebsin Pregabalin
English: PVC/PVDC-Al perforated unit dose blister pack containing 56 x 1 and 100 x 1 hard capsules.
Maltese: Pakkett bil-folji perforati tal-PVC/PVDC-Al b'doża tal-unità li jkun fih jkun fih 56 x 1 and 100 x 1 kapsula iebsa.
English: Pregabalin Mylan 150 mg hard capsules Each hard capsule contains 150 mg of pregabalin.
Maltese: Pregabalin Mylan 150 mg kapsuli iebsin Pregabalin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan 25 mg hard capsules pregabalin
Maltese: Pregabalin Mylan 25 mg kapsuli iebsa Pregabalin
English: Investigations Common Uncommon
Maltese: Mhux kommuni Rari
English: PVC/PVDC-Al perforated unit dose blister pack containing 84 x 1 and 100 x 1 hard capsules.
Maltese: Pakkett bil-folji perforati tal-PVC/PVDC-Al b'doża tal-unità li jkun fih jkun fih 84 x 1 and 100 x 1 kapsula iebsa.
English: Pregabalin Mylan 50 mg hard capsules Each hard capsule contains 50 mg of pregabalin.
Maltese: Pregabalin Mylan 50 mg kapsuli iebsin Pregabalin
English: Visual field changes were detected in 12.4% of pregabalin-treated, and 11.7% of placebo-treated patients.
Maltese: Bdil fil-kamp viżiv kien innutat fi 12.4% ta' dawk trattati bi pregabalin, u
English: Withdrawal of concomitant anti-epileptic medicinal products There are insufficient data for the withdrawal of concomitant anti-epileptic medicinal products, once seizure control with pregabalin in the add-on situation has been reached, in order to reach monotherapy on pregabalin.
Maltese: Twaqqif ta' prodotti mediċinali konkomitanti kontra l-epilessija M'hemmx informazzjoni biżżejjed dwar it-twaqqif ta' prodotti mediċinali konkomitanti kontra lepilessija, ladarba jkun inkiseb kontroll ta' l-aċċessjonijiet bi pregabalin fis-sitwazzjoni add-on, bilgħan li tintlaħaq terapija waħdanija bi pregabalin.
English: • A small number of people being treated with anti-epileptics such as Pregabalin Mylan have had thoughts of harming or killing themselves.
Maltese: • Numru zgħir ta' pazjenti li jkunu qed jirċievu kura bi prodotti mediċinali kontra l-epilessija bħal-Pregabalin Mylan, kellhom ħsibijiet li jweġġgħu lilhom infushom jew li jagħmlu suwiċidju.
English: Hepatic impairment No dose adjustment is required for patients with hepatic impairment (see section 5.2).
Maltese: Indeboliment tal-fwied Mhux meħtieġ aġġustament fid-doża għal pazjenti b'indeboliment tal-fwied (ara sezzjoni 5.2).
English: Erectile dysfunction Sexual dysfunction, ejaculation delayed, dysmenorrhoea, breast pain Amenorrhoea, breast discharge, breast enlargement, gynaecomastia
Maltese: Disfunzjoni ta' natura sesswali, dewmien fl-ejakulazzjoni, diżmenorreja, uġigħ fis-sider
English: EMA/359520/2014 EMEA/H/C/000387
Maltese: EMEA/H/C/000387
English: The full EPAR for Vfend can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Vfend
Maltese: Informazzjoni oħra dwar Vfend
English: The most common side effects with Vfend (seen in more than 1 patient in 10) are peripheral oedema (swelling of the arms and legs), headache, visual disturbances (including blurred vision, changes in colour perception and excessive sensitivity to light), respiratory distress (difficulty breathing), abdominal pain (stomach ache), nausea (feeling sick), vomiting, diarrhoea, rash and pyrexia (fever) and abnormal liver function test results.
Maltese: L-effetti sekondarji l-aktar komuni b'Vfend (li dehru f'aktar minn pazjent 1 minn kull 10) kienu edema periferali (nefħa tad-dirgħajn u tar-riġlejn), uġigħ ta' ras, disturbi fil-vista (inkluż vista mċajpra, bidla fil-perċezzjoni tal-kuluri u sensittività eċċessiva għad-dawl), diffikultà respiratorja (diffikultà fit-teħid tan-nifs), uġigħ addominali (uġigħ fl-istonku), nawżja (tħossok ma tiflaħx), rimettar, dijarea, raxx u piressija (deni) u riżultati ta' testijiet tal-funzjoni tal-fwied anormali.
English: • St John's wort (a herbal preparation used to treat depression);
Maltese: • St John's wort (preparazzjoni erbali użata għall-kura tad-depressjoni);
English: In a study involving 465 patients, Vfend was compared with another antifungal medicine, itraconazole.
Maltese: Fi studju li involva 465 pazjent, Vfend tqabbel ma' mediċina antifungali oħra, l-itrakonażol.
English: It is available as tablets (50 mg or 200 mg), as an oral suspension (40 mg/ml) and as a powder to be made up into a solution for infusion (drip into a vein).
Maltese: Jiġi f'pilloli (50 mg jew 200 mg), f'sospensjoni orali (40 mg/ml) u fi trab biex isir soluzzjoni għal infużjoni (dripp fil-vina).
English: Vfend was compared with amphotericin B (another antifungal medicine).
Maltese: Vfend tqabbel mal-amfoteriċina B (mediċina antifungali oħra).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vfend on 19 March 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Vfend fid-19 ta' Marzu 2002.
English: EPAR summary for the public voriconazole
Maltese: Sommarju tal-EPAR għall-pubbliku vorikonażol
English: Vfend is an antifungal medicine that contains the active substance voriconazole.
Maltese: Vfend huwa mediċina antifungali li fiha s-sustanza attiva vorikonażol.
English: The active substance in Vfend, voriconazole, belongs to the ‘triazole' class of antifungal medicines.
Maltese: Is-sustanza attiva f'Vfend, vorikonażol, tappartjeni lill-klassi "triażol” tal-mediċini antifungali.
English: Preventive treatment should last for as short a time as possible.
Maltese: Kura preventiva għandha ddum l-inqas possibbli.
English: What is the risk associated with Vfend?
Maltese: X'inhu r-riskju assoċjat ma' Vfend?
English: • invasive aspergillosis (a type of fungal infection due to Aspergillus);
Maltese: • asperġillożi invażiva (tip ta' infezzjoni fungali kkaġunata mill-Aspergillus);
English: • ergot alkaloids such as ergotamine and dihydroergotamine (used to treat migraine headache);
Maltese: • l-alkalojdi tal-ergotina bħall-ergotamina u d-diidroergotamina (użati għall-kura tal-emigranja);
English: In the study on prevention in patients who had blood stem-cell transplantation, around 49% of patients who were given Vfend (109 out of 224) had a successful treatment compared with around 33% of patients who received itraconazole (80 out of 241).
Maltese: Fl-istudju dwar il-kura f'pazjenti li jkun sarilhom trapjant ta' ċelloli staminali tad-demm, madwar 49% tal-pazjenti li ngħataw Vfend (109 minn 224) kellhom kura li rnexxiet meta mqabbla ma' madwar 33% tal-pazjenti li rċevew l-itrakonażol (80 minn 241).
English: The study of Vfend in the treatment of invasive aspergillosis involved 277 immunocompromised patients (patients whose immune system was not working properly).
Maltese: L-istudju ta' Vfend fil-kura ta' asperġillożi invażiva involva 277 pazjent immunodefiċjenti (pazjenti li ssistema immunitarja tagħhom ma kinitx qiegħda taħdem sew).
English: A successful outcome was seen in 44% of the patients with serious refractory Candida infections (24 out of 55).
Maltese: Riżultat pożittiv deher f'44% tal-pazjenti b'infezzjonijiet rifrattorji serji tal-Candida (24 minn 55).
English: • rifampicin (used to treat tuberculosis);
Maltese: • ir-rifampiċina (użata għall-kura tat-tuberkulożi);
English: Vfend has also been studied in 285 children.
Maltese: Vfend ġie studjat ukoll fuq 285 tifel u tifla.
English: This is a summary of the European public assessment report (EPAR) for Vfend.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Vfend.
English: The study of Vfend in the treatment of candidaemia compared Vfend with a treatment of amphotericin B followed by fluconazole in 370 patients.
Maltese: L-istudju ta' Vfend fil-kura ta' kandidaemija qabbel Vfend ma' kura bl-amfoteriċina B segwita b'kura bil-flukonażol fi 370 pazjent.