FrancophonIA/ELRC3.0 huggingface dataset:
English: 0.52 mg: White or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P2 on one side, with bevelled edges and possible spots.
Maltese: 0.52 mg: Pilloli ta' lewn abjad jew kważi abjad, tondi (dijametru ta' 10 mm), u huma kemxejn bikunvessi bi P2 imnaqqax fuq naħa waħda, bi xfar mċanfrin u possibiltà ta' dbabar.
English: The treatment of patients with a creatinine clearance below 30 ml/min with Oprymea prolonged release tablets is not recommended as no data are available for this patient population.
Maltese: Reazzjoni avversa aktar frekwenti għall-mediċina fil-kura flimkien ma' levodopa kienet id-diskinesija.
English: - Hyperkinesia (increased movements and inability to keep still) - Weight increase - Allergic reactions (e.g. rash, itching, hypersensitivity) - Fainting - Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)* - Inappropriate antidiuretic hormone secretion* - Restlessness - Dyspnoea (difficulties to breathe) - Hiccups - Pneumonia (infection of the lungs) - Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
Maltese: - Iħossok ħażin - Insuffiċjenza kardijaka (problemi tal-qalb li jistgħu jikkawża qtugħ ta' nifs jew nefħa fl għekiesi)* - Tnixxija mhux kif suppost ta' ormon antidijuretiku* - Nuqqas ta' kwiet f'ġismek - Dispnea (diffikultajiet biex tieħu n-nifs) - Sulluzzu - Pnewmonja (infezzjoni tal-pulmun) - Ma tkunx kapaċi tirreżisti l-impuls, ix-xewqa jew it-tentazzjoni li twettaq azzjoni li tista' tkun ta' ħsara għalik jew għall-oħrajn, li tista' tinkludi:
English: In humans, the protein binding of pramipexole is very low (< 20%) and the volume of distribution is large (400 l).
Maltese: Fil-bnedmin, it-twaħħil ta' pramipexole mal-proteina hu baxx ħafna (< 20%) u l-volum taddistribuzzjoni hu kbir (400 l).
English: - Hallucinations (seeing, hearing or feeling things that are not there) - Confusion - Excessive daytime sleepiness and suddenly falling asleep - Weight increase - Hypotension (low blood pressure) - Excess of fluid, usually in the legs (peripheral oedema) - Allergic reactions (e.g. rash, itching, hypersensitivity) - Fainting - Restlessness - Visual impairment - Weight loss including decreased appetite - Dyspnoea (difficulties to breathe) - Hiccups - Pneumonia (infection of the lungs)* - Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
Maltese: - Iħossok ħażin - Nuqqas ta' kwiet f'ġismek - Indeboliment tal-vista - Tnaqqis fil-piż li jinkludi nuqqas t'aptit - Dispnea (diffikultajiet biex tieħu n-nifs) - Sulluzzu - Pnewmonja (infezzjoni tal-pulmun) - Ma tkunx kapaċi tirreżisti l-impuls, ix-xewqa jew it-tentazzjoni li twettaq azzjoni li tista' tkun ta' ħsara għalik jew għall-oħrajn, li tista' tinkludi:
English: Each prolonged-release tablet contains 0.52 mg pramipexole (as 0.75 mg pramipexole dihydrochloride monohydrate).
Maltese: Kull pillola li terħi l-mediċina bil-mod fiha 0.52 mg ta'pramipexole (bħala 0.75 mg pramipexole dihydrochloride monohydrate).
English: Oprymea 3.15 mg prolonged-release tablets 10 prolonged-release tablets: EU/1/08/469/050 30 prolonged-release tablets: EU/1/08/469/051 90 prolonged-release tablets: EU/1/08/469/052 100 prolonged-release tablets: EU/1/08/469/053
Maltese: 30 pillola li jerħu l-mediċina bil-mod: EU/1/08/469/051 90 pillola li jerħu l-mediċina bil-mod: EU/1/08/469/052 100 pillola li jerħu l-mediċina bil-mod: EU/1/08/469/053
English: Oprymea 0.26 mg prolonged-release tablets Each prolonged-release tablet contains 0.26 mg pramipexole (as 0.375 mg pramipexole dihydrochloride monohydrate).
Maltese: Oprymea 0.26 mg pilloli li jerħu l-mediċina bil-mod Kull pillola li terħi l-mediċina bil-mod fiha 0.26 mg ta' pramipexole (bħala 0.375 mg pramipexole dihydrochloride monohydrate).
English: OUTER BOX (treatment initiation pack containing 3 boxes of 7 prolonged-release tablets)
Maltese: KAXXA TA' BARRA (pakkett tal-bidu tat-trattament li fih 3 kaxxi ta' 7 pilloli li jer]u lmedi`ina bil-mod)
English: Oprymea 2.1 mg prolonged-release tablets Pramipexole
Maltese: Oprymea 2.1 mg pilloli li jerħu l-mediċina bil-mod Pramipexole
English: Restless Legs Syndrome, most common adverse reactions The most commonly (≥ 5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with pramipexole were nausea, headache, dizziness and fatigue.
Maltese: Sindrome tar-Riġlejn Irrekwieti, l-iktar reazzjonijiet avversi komuni L-aktar reazzjonijiet avversi għall-mediċina (≥ 5%) li kienu rrappurtati b'mod komuni fil-pazjenti li kellhom is-Sindrome tar-Riġlejn Irrekwieti, ikkurati bi pramipexole kienu nawseja, uġigħ ta' ras u għeja kbira.
English: In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson' s disease.
Maltese: Fil-pazjenti, pramipexole itaffi s-sinjali u s-sintomi tal-marda idjopatika ta' Parkinson.
English: Oprymea 0.26 mg prolonged-release tablets 10 prolonged-release tablets: EU/1/08/469/026 30 prolonged-release tablets: EU/1/08/469/027 90 prolonged-release tablets: EU/1/08/469/028 100 prolonged-release tablets: EU/1/08/469/029
Maltese: Oprymea 0.26 mg pilloli li jerħu l-mediċina bil-mod 10 pilloli li jerħu l-mediċina bil-mod: EU/1/08/469/026 30 pillola li jerħu l-mediċina bil-mod: EU/1/08/469/027 90 pillola li jerħu l-mediċina bil-mod: EU/1/08/469/028 100 pillola li jerħu l-mediċina bil-mod:
English: Take care if you are taking the following medicines: - cimetidine (to treat excess stomach acid and stomach ulcers) - amantadine (which can be used to treat Parkinson's disease) - mexiletine (to treat irregular heartbeats, a condition known as ventricular arrhythmia) - zidovudine (which can be used to treat the acquired immune deficiency syndrome (AIDS), a disease of the human immune system) - cisplatin (to treat various types of cancers) - quinine (which can be used for the prevention of painful night-time leg cramps and for the treatment of a type of malaria known as falciparum malaria (malignant malaria)) - procainamide (to treat irregular heart beat)
Maltese: Oqgħod attent jekk qed tieħu l-mediċini li ġejjin: - cimetidine (għall-kura ta' aċidu eċċessiv fl-istonku u ulċeri fl-istonku) - amantadine (li jista' jintuża għall-kura tal-marda ta' Parkinson) - mexiletine (għall-kura ta' taħbit irregolari tal-qalb, kundizzjoni magħrufa bħala arritmija ventrikulari) - zidovudine (li jista' jintuża għall-kura tas-Sindrome tad-Defiċjenza Immuni Miksuba (AIDS),
English: Oprymea 0.35 mg tablets are white, oval, with bevelled edges, both sides scored, with imprint "P8" on both halves of one side of the tablet.
Maltese: Oprymea 0.088 mg pilloli Bajda, tonda, bi truf iċċanfrati u b'intaljar "P6" fuq naħa waħda tal-pillola.
English: Oprymea 3.15 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P5 on one side and 315 on the other side, with bevelled edges and possible spots.
Maltese: Oprymea 3.15 mg pilloli li jerħu l-mediċina bil-mod Pilloli ta' lewn abjad jew kważi abjad, tondi (dijametru ta' 10 mm), u huma kemxejn bikunvess bi P5 imnaqqax fuq naħa waħda u 315 fuq naħa l-oħra, bi xfar mċanfrin u possibiltà ta' dbabar.
English: Nervous system disorders headache dizziness somnolance sudden onset of sleep syncope dyskinesia amnesia hyperkinesia
Maltese: PAKKETT TAL-BIDU TAT-TRATTAMENT BISS TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-FOLJI JEW FUQ L-ISTRIXXI
English: Oprymea 0.52 mg prolonged-release tablets 10 prolonged-release tablets: EU/1/08/469/030 30 prolonged-release tablets: EU/1/08/469/031 90 prolonged-release tablets: EU/1/08/469/032 100 prolonged-release tablets: EU/1/08/469/033
Maltese: Oprymea 0.52 mg pilloli li jerħu l-mediċina bil-mod 10 pilloli li jerħu l-mediċina bil-mod: EU/1/08/469/030 30 pillola li jerħu l-mediċina bil-mod: EU/1/08/469/031 90 pillola li jerħu l-mediċina bil-mod: EU/1/08/469/032 100 pillola li jerħu l-mediċina bil-mod:
English: Intake of a high fat meal induced an increase in peak concentration (Cmax) of about 24% after a single dose administration and about 20% after multiple dose administrations and a delay of about 2 hours in time to reach peak concentration in healthy volunteers.
Maltese: It-teħid ta' ikla b'ammont għoli ta' xaħam ikkaġuna żieda ta' madwar 24% fil-konċentrazzjoni massima (Cmax) wara l-għoti ta' doża waħda u madwar 20% wara l-għoti ta' dożi multipli, u dewmien ta' madwar sagħtejn fil-ħin biex tintħaħaq il-konċentrazzjoni massima f'voluntiera b'saħħithom.
English: What Oprymea looks like and contents of the pack Oprymea 0.26 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P1 on one side, with bevelled edges and possible spots.
Maltese: Oprymea 0.26 mg pilloli li jerħu l-mediċina bil-mod Pilloli ta' lewn abjad jew kważi abjad, tondi (dijametru ta' 10 mm), u huma kemxejn bikunvessi bi P1 imnaqqax fuq naħa waħda, bi xfar mċanfrin u possibiltà ta' dbabar.
English: Total Daily Dose (mg of salt)
Maltese: Doża Totali ta' Kuljum (mg ta' melħ)
English: Oprymea 1.57 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P12 on one side, with bevelled edges and possible spots.
Maltese: Oprymea 1.57 mg pilloli li jerħu l-mediċina bil-mod Pilloli ta' lewn abjad jew kważi abjad, tondi (dijametru ta' 10 mm), u huma kemxejn bikunvessi bi P12 imnaqqax fuq naħa waħda, bi xfar mċanfrin u possibiltà ta' dbabar.
English: One Oprymea 0.52 mg prolonged-release tablet on blister "Week 2".
Maltese: Pillola li terħi l-mediċina bil-mod ta' Oprymea 0.52 mg fuq il-folja ta' “Ġimgħa 2”.
English: If a further dose increase is necessary, doses should be increased by 0.26 mg pramipexole base at weekly intervals up to a maximum dose of 1.57 mg pramipexole base (2.25 mg of salt) per day.
Maltese: Jekk ikun hemm bżonn ta' żieda addizzjonali fid-doża, id-dożi għandhom jiżdiedu b'0.26 mg ta' bażi ta' pramipexole f'intervalli ta' darba f'ġimgħa sa doża massima ta' 1.57 mg ta' bażi ta' pramipexole (2.25 mg ta' melħ) kuljum.
English: Take care if you are taking the following medicines: - cimetidine (to treat excess stomach acid and stomach ulcers); - amantadine (which can be used to treat Parkinson's disease); - mexiletine (to treat irregular heartbeats, a condition known as ventricular arrhythmia); - zidovudine (which can be used to treat the acquired immune deficiency syndrome (AIDS), a disease of the human immune system); - cisplatin (to treat various types of cancers); - quinine (which can be used for the prevention of painful night-time leg cramps and for the treatment of a type of malaria known as falciparum malaria (malignant malaria)); - procainamide (to treat irregular heart beat).
Maltese: Oqgħod attent/a jekk qed tieħu l-mediċini li ġejjin: - cimetidine (għall-kura ta' aċidu eċċessiv fl-istonku u ulċeri fl-istonku) - amantadine (li jista' jintuża għall-kura tal-marda ta' Parkinson) - mexiletine (għall-kura ta' taħbit irregolari tal-qalb, kundizzjoni magħrufa bħala arritmija ventrikulari) - zidovudine (li jista' jintuża għall-kura tas-Sindrome tad-Defiċjenza Immuni Miksuba (AIDS),
English: EU/1/08/469/050 [10 prolonged-release tablets] EU/1/08/469/051 [30 prolonged-release tablets] EU/1/08/469/052 [90 prolonged-release tablets] EU/1/08/469/053 [100 prolonged-release tablets]
Maltese: EU/1/08/469/050 [10 pilloli li jerħu l-mediċina bil-mod] EU/1/08/469/051 [30 pillola li jerħu l-mediċina bil-mod] EU/1/08/469/052 [90 pillola li jerħu l-mediċina bil-mod] EU/1/08/469/053 [100 pillola li jerħu l-mediċina bil-mod]
English: Oprymea 2.62 mg prolonged-release tablets 10 prolonged-release tablets: EU/1/08/469/046 30 prolonged-release tablets: EU/1/08/469/047 90 prolonged-release tablets: EU/1/08/469/048 100 prolonged-release tablets: EU/1/08/469/049
Maltese: 30 pillola li jerħu l-mediċina bil-mod: EU/1/08/469/047 90 pillola li jerħu l-mediċina bil-mod: EU/1/08/469/048 100 pillola li jerħu l-mediċina bil-mod: EU/1/08/469/049
English: Most hallucinations are visual - Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs).
Maltese: - Żieda fil-piż - Reazzjonijiet allerġiċi (eż. raxx, ħakk, sensittività eċċessiva)
English: INNER BOX (week 1)
Maltese: KAXXA TA' ĠEWWA (ġimgħa 1)
English: Dose Schedule of Oprymea Titration Step Once Daily Evening Dose
Maltese: Skeda tad-Doża ta' Oprymea Pass tat
English: A delay in sexual development (i.e., preputial separation and vaginal opening) was observed in rats.
Maltese: Dewmien fl-iżvilupp sesswali (i.e. separazzjoni prepuzjali u ftuħ tal-vaġina) kien osservat fil-firien.
English: Oprymea 1.05 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P3 on one side, with bevelled edges and possible spots.
Maltese: Oprymea 1.05 mg pilloli li jerħu l-mediċina bil-mod Pilloli ta' lewn abjad jew kważi abjad, tondi (dijametru ta' 10 mm), u huma kemxejn bikunvessi bi P3 imnaqqax fuq naħa waħda, bi xfar mċanfrin u possibiltà ta' dbabar.
English: Take care if you are taking the following medicines: - cimetidine (to treat excess stomach acid and stomach ulcers) - amantadine (which can be used to treat Parkinson's disease) - mexiletine (to treat irregular heartbeats, a condition known as ventricular arrhythmia) - zidovudine (which can be used to treat the acquired immune deficiency syndrome (AIDS), a disease of the human immune system) - cisplatin (to treat various types of cancers) - quinine (which can be used for the prevention of painful night-time leg cramps and for the treatment of a type of malaria known as falciparum malaria (malignant malaria)) - procainamide (to treat irregular heart beat).
Maltese: Fi prova ta' Fażi I, fejn pramipexole pilloli li jerħu b'mod immedjat u pilloli li jerħu l-mediċina bilmod kienu evalwati fl-istat sajjem, il-konċentrazzjoni minima u massima fil-plażma (Cmin, Cmax) u espożizzjoni (AUC) tal-istess doża ta' kuljum ta' pramipexole pilloli li jerħu l-mediċina bil-mod mogħtija darba kuljum u pramipexole pilloli mogħtija tliet darbiet kuljum, kienu ekwivalenti.
English: Oprymea 1.57 mg prolonged-release tablets 10 prolonged-release tablets: EU/1/08/469/038 30 prolonged-release tablets: EU/1/08/469/039 90 prolonged-release tablets: EU/1/08/469/040 100 prolonged-release tablets: EU/1/08/469/041
Maltese: Oprymea 1.57 mg pilloli li jerħu l-mediċina bil-mod 10 pilloli li jerħu l-mediċina bil-mod: EU/1/08/469/038 30 pillola li jerħu l-mediċina bil-mod: EU/1/08/469/039
English: Oprymea 1.57 mg prolonged-release tablets Pramipexole
Maltese: Oprymea 1.57 mg pilloli li jerħu l-mediċina bil-mod Pramipexole
English: EU/1/08/469/042 [10 prolonged-release tablets] EU/1/08/469/043 [30 prolonged-release tablets] EU/1/08/469/044 [90 prolonged-release tablets] EU/1/08/469/045 [100 prolonged-release tablets]
Maltese: EU/1/08/469/042 [10 pilloli li jerħu l-mediċina bil-mod] EU/1/08/469/043 [30 pillola li jerħu l-mediċina bil-mod] EU/1/08/469/044 [90 pillola li jerħu l-mediċina bil-mod] EU/1/08/469/045 [100 pillola li jerħu l-mediċina bil-mod]
English: However, it should be noted that the incidence of somnolence is increased at doses higher than 1.05 mg of base (1.5 mg of salt) per day (see section 4.8).
Maltese: Madankollu, wieħed għandu jinnota li l-inċidenza tan-ngħas tiżdied f'dożi ogħla minn 1.05 mg ta' bażi (1.5 mg ta' melħ) kuljum (ara sezzjoni 4.8).
English: KRKA-POLSKA Sp. z o.o.
Maltese: Kif għandek tieħu Oprymea 4.
English: Common: - Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness - Tiredness (fatigue) - Headache - Abnormal dreams - Constipation - Dizziness - Vomiting (being sick)
Maltese: Komuni: - Tibdil fir-rittmu tal-irqad, bħal problemi biex torqod (insomnja) u rqad - Għeja - Uġigħ ta' ras - Ħolm anormali - Stitikezza - Sturdament - Rimettar (tkun imdardar)
English: România KRKA Romania S.R.L., Bucharest
Maltese: E. J. Busuttil Ltd.
English: EU/1/08/469/046 [10 prolonged-release tablets] EU/1/08/469/047 [30 prolonged-release tablets] EU/1/08/469/048 [90 prolonged-release tablets] EU/1/08/469/049 [100 prolonged-release tablets]
Maltese: EU/1/08/469/046 [10 pilloli li jerħu l-mediċina bil-mod] EU/1/08/469/047 [30 pillola li jerħu l-mediċina bil-mod] EU/1/08/469/048 [90 pillola li jerħu l-mediċina bil-mod] EU/1/08/469/049 [100 pillola li jerħu l-mediċina bil-mod]
English: Uncommon: - Urge to behave in an unusual way* - Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)* - Inappropriate antidiuretic hormone secretion* - Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs) - Hyperkinesia (increased movements and inability to keep still)* - Paranoia (e.g. excessive fear for one's own well-being)* - Delusion* - Amnesia (memory disturbance)*
Maltese: Mhux komuni: - Paranojja (eż. biża' eċċessiv għall-benesseri tiegħek) - Delużjoni - Irqad eċċessiv matul il-ġurnata u li torqod għal għarrieda - Amnesija (disturb fil-memorja) - Iperkinesija (żieda fil-movimenti tal-ġisem u ma tkunx kapaċi toqgħod ma titħarrikx)
English: OR
Maltese: Tqala
English: In advanced Parkinson's disease, pramipexole doses higher than 1.05 mg of base (1.5 mg of salt) per day can be useful in patients where a reduction of the levodopa therapy is intended.
Maltese: Fil-marda ta' Parkinson fl-istadju avvanzat, dożi ta' pramipexole, ogħla minn 1.05 mg ta' bażi (1.5 mg ta' melħ) kuljum jistgħu jkunu utli f'pazjenti fejn tnaqqis tat-terapija ta' levodopa jkun intenzjonat.
English: INNER BOX (week 2)
Maltese: KAXXA TA' ĠEWWA (ġimgħa 2)
English: In advanced Parkinson's disease, pramipexole doses higher than 1.1 mg of base (1.5 mg of salt) per day can be useful in patients where a reduction of the levodopa therapy is intended.
Maltese: Fil-marda ta' Parkinson fl-istadju avvanzat, dożi ta' pramipexole, ogħla minn 1.1 mg ta' bażi (1.5 mg ta' melħ) kuljum jistgħu jkunu utli f'pazjenti fejn tnaqqis tat-terapija ta' levodopa jkun intenzjonat.
English: In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
Maltese: Fi studju dwar il-karċinoġeneċità, il-firien irġiel żviluppaw iperplasija u adenomi taċ-ċelluli ta' Leydig, u dawn kienu spjegati mill-effett inibitorju fuq il-prolactin ta' pramipexole.
English: If a further dose increase is necessary the daily dose should be increased by 0.52 mg of base (0.75 mg of salt) at weekly intervals up to a maximum dose of 3.15 mg of base (4.5 mg of salt) per day.
Maltese: Jekk ikun hemm bżonn ta' żieda addizzjonali fid-doża, id-doża ta' kuljum għandha tiżdied b'0.52 mg ta' bażi (0.75 mg ta' melħ) f'intervalli ta' darba f'ġimgħa sa doża massima ta' 3.15 mg ta' bażi (4.5 mg ta' melħ) kuljum.
English: Approximately 90% of C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Maltese: C titneħħa minn ġol-kliewi, filwaqt li inqas minn 2% tinstab fl-ippurgar.
English: Oprymea 2.1 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P4 on one side, with bevelled edges and possible spots.
Maltese: Oprymea 2.1 mg pilloli li jerħu l-mediċina bil-mod Pilloli ta' lewn abjad jew kważi abjad, tondi (dijametru ta' 10 mm), u huma kemxejn bikunvessi bi P4 imnaqqax fuq naħa waħda, bi xfar mċanfrin u possibiltà ta' dbabar.
English: The expected adverse drug reactions would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
Maltese: Ir-reazzjonijiet avversi mistennija ser ikunu dawk relatati mal-profil farmakodinamiku ta' agonist ta' dopamine, li jinkludu nawseja, rimettar, iperkinesija, alluċinazzjonijiet, aġitazzjoni u pressjoni tad-demm baxxa.
English: EU/1/08/469/030 [10 prolonged-release tablets] EU/1/08/469/031[30 prolonged-release tablets] EU/1/08/469/032[90 prolonged-release tablets] EU/1/08/469/033[100 prolonged-release tablets]
Maltese: EU/1/08/469/030 [10 pilloli li jerħu l-mediċina bil-mod] EU/1/08/469/031 [30 pillola li jerħu l-mediċina bil-mod] EU/1/08/469/032 [90 pillola li jerħu l-mediċina bil-mod] EU/1/08/469/033 [100 pillola li jerħu l-mediċina bil-mod]
English: EU/1/08/469/026 [10 prolonged-release tablets] EU/1/08/469/027 [30 prolonged-release tablets] EU/1/08/469/028 [90 prolonged-release tablets] EU/1/08/469/029 [100 prolonged-release tablets]
Maltese: EU/1/08/469/026 [10 pilloli li jerħu l-mediċina bil-mod] EU/1/08/469/027 [30 pillola li jerħu l-mediċina bil-mod] EU/1/08/469/028 [90 pillola li jerħu l-mediċina bil-mod] EU/1/08/469/029 [100 pillola li jerħu l-mediċina bil-mod]
English: Viread (tenofovir disoproxil)
Maltese: Viread (tenofovir disoproksil)
English: Further information on Viread can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/viread.
Maltese: Aktar informazzjoni dwar Viread tinstab fis-sit elettroniku talAġenzija: ema.europa.eu/medicines/human/EPAR/viread.
English: Other information about Viread:
Maltese: Informazzjoni oħra dwar Viread:
English: Tenofovir is a nucleotide reverse transcriptase inhibitor (NRTI).
Maltese: Tenofovir huwa inibitur nukleotidiku tat-transkriptażi inversa (NRTI).
English: A study carried out in 87 adolescents (12 to 18 years of age) investigated the effects of adding Viread to existing treatment.
Maltese: Studju li sar fuq 87 adoloxxenti (minn 12 sa 18-il sena) investiga l-effetti taż-żieda ta' Viread ma' kura eżistenti.
English: Viread contains the active substance tenofovir disoproxil.
Maltese: Viread fih is-sustanza attiva tenofovir disproksil.
English: Viread is a medicine used to treat patients aged 2 years and above infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Viread huwa mediċina li tintuża għall-kura ta' pazjenti minn sentejn ‘il fuq infettati bil-virus talimmunodefiċjenza umana tat-tip 1 (HIV 1), virus li jikkawża s-sindrome tal-immunodefiċjenza akkwiżita (AIDS).
English: The figure for the combination treatment of Viread and emtricitabine was 88%.
Maltese: Iċ-ċifra għall-kura ta' kombinazzjoni ta' Viread u emtriċitabina kienet ta' 88 %.
English: For the treatment of hepatitis B, two studies involving 641 adult patients compared Viread with another medicine, adefovir dipivoxil.
Maltese: Għall-kura tal-epatite B, żewġ studji li involvew 641 pazjent adult qabblu Viread ma' mediċina oħra, adefovir dipivoksil.
English: The most common side effects with Viread (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, dizziness, hypophosphataemia (low levels of phosphate in the blood), rash and asthenia (weakness).
Maltese: L-effetti sekondarji l-aktar komuni b'Viread (li dehru f'aktar minn pazjent 1 minn kull 10) huma nawżja (tħossok ma tiflaħx), rimettar, dijarea, sturdament, ipofosfatemija (livelli baxxi ta' fosfat fid-demm), raxx u astenja (dgħufija) .
English: What are the risks associated with Viread?
Maltese: X'inhuma r-riskji assoċjati ma' Viread?
English: Viread received a marketing authorisation valid throughout the EU on 5 February 2002.
Maltese: Viread irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-5 ta' Frar 2002.
English: The active substance in Viread, tenofovir disoproxil, is a ‘prodrug' that is converted into tenofovir in the body.
Maltese: Is-sustanza attiva f'Viread, it-tenofovir disoproksil, hi “prodroga” li fil-ġisem tinbidel f'tenofovir.
English: Tenofovir also interferes with the action of an enzyme produced by the hepatitis B virus called DNA polymerase, which is involved in the formation of viral DNA.
Maltese: Tenofovir jinterferixxi wkoll mal-azzjoni ta' enzima prodotta mill-virus tal-epatite B li tissejjaħ polimerażi tad-DNA, li hija involuta fil-formazzjoni ta' DNA virali.
English: How is Viread used?
Maltese: Kif jaħdem Viread?