FrancophonIA/ELRC3.0 huggingface dataset:
English: Helixate NexGen powder should only be reconstituted with the supplied solvent (2.5 ml water for injections) using the supplied sterile Mix2Vial filter transfer device.
Maltese: Trab ta' Helixate NexGen għandu jiġi rrikostitwit biss bis-solvent ipprovdut (2,5 ml ilma għallinjezzjonijiet) permezz tat-tagħmir Mix2Vial filter transfer device, li huwa provdut.
English: • If you have previously developed a factor VIII inhibitor and you switch factor VIII products, you may be at risk of your inhibitor coming back.
Maltese: • Jekk qabel tkun żviluppajt inibitur ta' fattur VIII u tbiddel il-prodotti ta' fattur VIII, tista' tkun f'riskju li l-inibitur jerġa' jitfaċċa.
English: No studies were performed on the mutagenic potential of Helixate NexGen, since no mutagenic potential could be detected in vitro or in vivo for the predecessor product of Helixate NexGen.
Maltese: Ma sarux studji dwar il-possibbiltà ta' effetti mutaġeniċi minn Helixate NexGen peress li ma kien hemm ebda effett mutaġeniku potenzjali kemm in vitro kif ukoll in vivo minn prodott predeċessur ta'
English: Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Maltese: A hija marda ereditarja li taffettwa l-koagulazzjoni tad-demm, li tgħaddi mill-kromosoma tas-sess u hija kkawżata minn livelli mnaqqsa ta' fattur VIII:C u twassal għall- kwantità kbira ta' fsada fil-ġogi, muskoli, u organi interni, kemm b'mod spontanju kif ukoll wara xi aċċident jew trawma kirurġika.
English: What Helixate NexGen 3000 IU is and what it is used for What you need to know before you use Helixate NexGen 3000 IU How to use Helixate NexGen 3000 IU Possible side effects
Maltese: X'għandek tkun taf qabel ma tuża Helixate NexGen 3000 IU Kif għandek tuża Helixate NexGen 3000 IU Effetti sekondarji possibbli
English: However, the possibility of allergic reactions to constituents, e.g. trace amounts of mouse and hamster protein in the preparation exists in certain predisposed patients (see sections 4.3 and 4.4).
Maltese: Madankollu, f'ċertu pazjenti predisposti xorta hemm il-possibbiltà ta' reazzjonijiet allerġiċi għas-sustanzi kostitwenti, eż. ammonti żgħar ħafna ta' proteina mill-ġrieden u mill-ħamster preżenti fil-preparazzjoni (ara sezzjoni 4.3 u 4.4).
English: Helixate NexGen powder should only be reconstituted with the supplied solvent (5.0 ml water for injections) using the supplied sterile Mix2Vial filter transfer device.
Maltese: Trab ta' Helixate NexGen għandu jiġi rrikostitwit biss bis-solvent ipprovdut (5,0 ml ilma għallinjezzjonijiet) permezz tat-tagħmir Mix2Vial filter transfer device, li huwa provdut.
English: After administration of Helixate NexGen, peak factor VIII activity decreased by a two-phase exponential decay with a mean terminal half-life of about 15 hours.
Maltese: Distribuzzjoni u eliminazzjoni Wara l-għoti ta' Helixate NexGen, l-ogħla attività tal-fattur VIII naqset permezz ta' degradazzjoni esponenzjali f'żewġ fażijiet b'half-life terminali medja ta' madwar 15-il siegħa.
English: Medical devices for reconstitution and administration are provided with each package of Helixate NexGen 3000 IU.
Maltese: Tagħmir mediku għar-rikostituzzjoni u l-għoti huwa pprovdut ma' kull pakkett ta' Helixate NexGen 3000 IU.
English: Other medicines and Helixate NexGen 3000 IU
Maltese: Mediċini oħra u Helixate NexGen 3000 IU
English: How to store Helixate NexGen 3000 IU Contents of the pack and other information
Maltese: Kif jidher Helixate NexGen 3000 IU u l- kontenut tal-pakkett
English: NAME OF THE MEDICINAL PRODUCT Helixate NexGen 3000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
Maltese: Helixate NexGen 3000 IU trab u solvent għal soluzzjoni għall-injezzjoni Fattur VIII rikombinanti tal-koagulazzjoni (octocog alfa)
English: • If you are allergic to octocog alfa or to any of the other ingredients of this medicine (listed in section 6 and end of section 2).
Maltese: • jekk inti allerġiku għal octocog alfa jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis sezzjoni 6 u t-tmiem ta' sezzjoni 2).
English: Determination of activated partial thromboplastin time (aPTT) is a conventional in vitro assay method for biological activity of factor VIII.
Maltese: Determinazzjoni tal-ħin ta' tromboplastin parzjali attivat (aPTT) huwa metodu konvenzjonali ta' assaġġ in vitro li jkejjel l-attività bijoloġika ta' fattur VIII. aPTT huwa itwal fil-pazjenti kollha li għandhom l-emofilja.
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteremia and catheter site thrombosis should be considered.
Maltese: Jekk tagħmir ta' aċċess venuż ċentrali (CVADs) ikun meħtieġ, ir-riskju ta' kumplikazzjonijiet relatati ma' CVAD inkluż infezzjonijiet lokali, batterimja u trombożi fis-sit tal-kateter, għandu jiġi kkunsidrat.
English: • dysgeusia
Maltese: L-emofilja
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Maltese: IU Kontenut tal-pakkett u informazzjoni oħra
English: Do not use Helixate NexGen 3000 IU
Maltese: Tużax Helixate NexGen 3000 IU
English: May be stored at temperatures up to 25°C for up to 12 months within the expiry date indicated on the label.
Maltese: Jista' jinħażen f'temperaturi sa 25°C għal sa 12-il xahar sad-data ta' skadenza indikata fuq it-tikketta.
English: Desired plasma FVIII level
Maltese: Livell mixtieq ta' FVIII fil-plażma
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 3000 IU octocog alfa (600 IU/ml after reconstitution).
Maltese: IU octocog alfa (600 IU/ml wara r-rikostituzzjoni).
English: It has been shown in a clinical study performed with adult haemophilia A patients who undergo a major surgery that Helixate NexGen can be used for continuous infusion in surgeries (pre-, during and postoperative).
Maltese: Fi studju kliniku li twettaq fuq pazjenti adulti b'emofilja A li kellhom operazzjoni maġġuri, intwera li Helixate NexGen jista' jintuża għall-infużjoni kontinwa fl-operazzjonijiet (qabel, matul u wara l operazzjoni).
English: • If you experience tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing, you may be experiencing a rare severe sudden allergic reaction (a socalled anaphylactic reaction) to this medicine.
Maltese: • pressjoni baxxa tad-demm ħafifa (pressjoni tad-demm mnaqqsa kemmxejn, li tista' tagħmlek sturdut waqt li tkun bil-wieqfa) • dardir jista' jkun li din tkun indikazzjoni bikrija tas-sensittività eċċessiva u reazzjonijiet anafilattiċi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 250 IU octocog alfa (100 IU/ml after reconstitution).
Maltese: IU octocog alfa (100 IU/ml wara r-rikostituzzjoni).
English: Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial adapter from the syringe.
Maltese: Issa li s-soluzzjoni ġiet ittrasferita fis-siringa, żomm sew it-tubu tas-siringa (waqt li żżomm il-planġer tas-siringa iħares 'l isfel) u neħħi l- adattatur trasparenti tal-Mix2Vial minn mas-siringa.
English: One ml of Helixate NexGen 3000 IU contains approximately 600 IU (3000 IU / 5.0 ml) of human coagulation factor VIII (INN: octocog alfa) after reconstitution.
Maltese: X'inhu Helixate NexGen 3000 IU u gћalxiex jintuża Helixate NexGen 3000 IU fih il-Fattur VIII tal-koagulazzjoni humana (octagon alpha).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 500 IU octocog alfa (200 IU/ml after reconstitution).
Maltese: IU octocog alfa (200 IU/ml wara r-rikostituzzjoni).
English: If the inhibitor is present at levels less than 10 Bethesda Units (BU) per ml, administration of additional recombinant coagulation factor VIII may neutralise the inhibitor and permit continued clinically effective therapy with Helixate NexGen.
Maltese: aktar fattur VIII rikombinanti tal-koagulazzjoni għandu mnejn jinnewtralizza l-inibitur u jippermetti li titkompla terapija effettiva klinika b'Helixate NexGen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/144/004
Maltese: EU/1/00/144/004
English: Helixate NexGen 3000 IU contains the active substance human recombinant coagulation factor VIII (octocog alfa).
Maltese: Helixate NexGen 3000 IU trab għal soluzzjoni għall-injezzjoni Fattur VIII rikombinanti tal-koagulazzjoni (octocog alfa)
English: In extensive post-registration observational studies with Helixate NexGen, involving more than 1000 patients the following was observed: Less than 0.2% PTP developed de-novo inhibitors.
Maltese: Fi studji estensivi ta' osservazzjoni wara r-reġistrazzjoni b'Helixate NexGen, li kienu jinvolvu aktar minn 1000 pazjent kienu osservati dawn li ġejjin:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/144/003
Maltese: EU/1/00/144/003
English: After reconstitution, the chemical and physical in-use stability has been demonstrated for 3 hours in in vitro studies.
Maltese: Wara r-rikostituzzjoni, , l-istabbilità kimika u fiżika waqt l-użu ntweriet għal 3 sigħat fi studji in vitro.
English: Other medicines and Helixate NexGen 1000 IU
Maltese: Mediċini oħra u Helixate NexGen 1000
English: Data on Immune Tolerance Induction have been collected in patients with haemophilia A who had developed inhibitors to FVIII.
Maltese: Dejta dwar Induzzjoni ta' Tolleranza Immuni nġabret f'pazjenti b'emofilja A li kienu żviluppaw inibituri għal FVIII.
English: The aPTT is prolonged in all haemophiliacs.
Maltese: Twissijiet speċjali u prekawzjonijiet għall-użu Sensittività eċċessiva
English: This will usually be in the range of 20 to 40 IU of octocog alfa per kg of body weight, given every 2 to 3 days.
Maltese: Din ġenerlament tkun fuq firxa ta' 20 sa 40 IU ta' octocog alfa għal kull kg ta' piż talġisem, mogħtija kull jumejn sa 3 ijiem.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/144/002
Maltese: EU/1/00/144/002
English: NAME OF THE MEDICINAL PRODUCT Helixate NexGen 3000 IU powder and solvent for solution for injection.
Maltese: Ġeneralment, it-terapija ta' sostituzzjoni b'Helixate NexGen 3000 IU hija kura tul il-ħajja kollha talpazjent.
English: Do not use Helixate NexGen 500 IU
Maltese: Helixate NexGen 500
English: In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.
Maltese: B'mod ġenerali l-pazjenti kkurati bi prodotti ta' fattur VIII tal-koagulazzjoni, għandhom jiġu ssorveljati bir-reqqa għall-iżvilupp ta' inibituri permezz ta' osservazzjonijiet kliniċi u testijiet tal laboratorju xierqa.
English: While keeping the syringe plunger pressed, turn the system upside down and draw the solution into the syringe by pulling the plunger back slowly.
Maltese: sseħħ tiswija temporanjament tad-defiċjenza tal-fattur u tnaqqas it-tendenza ta' fsada.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/144/005
Maltese: EU/1/00/144/005
English: Do not use Helixate NexGen 1000 IU
Maltese: Helixate NexGen 1000
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/144/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT- TQEGĦID FIS-SUQ EU/1/00/144/002
English: • If your bleeding is not being controlled with your usual dose of this medicine, consult your doctor immediately.
Maltese: • Jekk il-fsada tiegħek mhux qed tiġi kkontrollata bid-doża tiegħek tas-soltu ta' din il-mediċina, ikkonsulta t-tabib tiegħek minnufih.
English: More extensive haemarthrosis, muscle bleed or haematoma
Maltese: chlorobutyl rubber blend, li ma fihx latex, u ssiġillat bl-aluminju).
English: Other medicines and Helixate NexGen 500 IU
Maltese: Mediċini oħra u Helixate NexGen 500
English: Other medicines and Helixate NexGen 2000 IU
Maltese: Mediċini oħra u Helixate NexGen 2000
English: Do not use Helixate NexGen 250 IU
Maltese: Helixate NexGen 250
English: Do not use Helixate NexGen 2000 IU
Maltese: Helixate NexGen 2000
English: In patients where immune tolerance was achieved the bleedings could be prevented or controlled with Helixate NexGen again, and the patients could continue with prophylactic treatment as maintenance therapy.
Maltese: F'pazjenti fejn tkun inkisbet tolleranza immuni, il-ħruġ ta' demm jista' jiġi evitat jew ikkontrollat mill-ġdid b'Helixate NexGen, u l-pazjent ikun jista' jkompli b'kura profilattika bħala terapija ta' manteniment.
English: Only the provided administration sets can be used because treatment failure can occur as a consequence of human recombinant coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.
Maltese: IU aktar milli suppost Ma kienu rrapurtati l-ebda każijiet ta' doża eċċessiva bil-fattur VIII rikombinanti tal-koagulazzjoni.
English: Rare: may affect up to 1 in 1,000 users
Maltese: INDIVIDWALI 1000
English: Helixate NexGen 3000 IU contains sodium This medicinal product contains less than 23 mg sodium per vial, i.e. essentially “sodium-free”.
Maltese: Dan il-prodott mediċinali fih anqas minn 23 mg sodium f'kull kunjett, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Other medicines and Helixate NexGen 250 IU
Maltese: Mediċini oħra u Helixate NexGen 250
English: NAME OF THE MEDICINAL PRODUCT Helixate NexGen 2000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: For long term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of Helixate NexGen per kg body weight at intervals of 2 to 3 days.
Maltese: Għall-profilassi kontra fsada li ddum għal żmien twil, f'pazjenti li għandhom emofilija A severa, iddożi tas-soltu huma ta' 20 sa 40 IU ta' Helixate NexGen għal kull kg ta' piż tal-ġisem f' intervalli ta'
English: Each vial contains nominally 2000 IU human coagulation factor VIII (INN: octocog alfa).
Maltese: IU ta' fattur VIII tal-koagulazzjoni umana (INN: octocog alfa).
English: Powder
Maltese: Maġġuri
English: Take special care with Helixate NexGen 250 IU
Maltese: Jekk tuża Helixate NexGen 250
English: Very
Maltese: Minuri
English: How to use Helixate NexGen 500 IU
Maltese: Kemm Helixate NexGen 500
English: What you need to know before you take Levonelle 1500
Maltese: X'għandek tkun taf qabel ma tieħu Levonelle 1500
English: Drugs suspected of having the similar capacity to reduce the efficacy of levonorgestrel containing medication due to similar effects on plasma levels of levonorgestrel include barbiturates (including primidone), phenytoin, carbamazepine, herbal medicines containing Hypericum perforatum (St. John's Wort), rifampicin, ritonavir, rifabutin, and griseofulvin.
Maltese: Mediċini suspettati li għandhom il-kapaċità simili li jnaqqsu l-effikaċja mediċini li fihom levonorgestrel minħabba l-effetti simili fuq livelli ta' levonorgestrel fil-plażma jinkludu barbiturati (li jinkludu primidone), phenytoin, carbamazepine, mediċini ta' ħxejjex li fihom Hypericum perforatum (St. John's Wort), rifampicin, ritonavir, rifabutin u griseofulvin.
English: - barbiturates and other medicines (used to treat epilepsy (for example, primidone, phenytoin, and carbamazepine) - medicines used to treat tuberculosis (for example, rifampicin, rifabutin) - a treatment for HIV infection (ritonavir, efavirenz) - a medicine used to treat fungal infections (griseofulvin) - herbal remedies containing St John's wort (Hypericum perforatum) - a medicine called cyclosporin (suppresses the immune system).
Maltese: - barbiturati u mediċini oħra (użati għal trattament ta' epilessija (pereżempju, primidone, phenytoin u carbamazepine) - mediċini użati għal trattament ta' tuberkolosi (pereżempju rifampicin, rifabutin) - trattament għal infezzjoni b'HIV (ritonavir, efavirenz) - mediċina użata għal trattament ta' infezzjonijiet bil-moffa (griseofulvin) - Taħlitiet ta' ħxejjex li fihom St John's wort (Hypericum perforatum) - Mediċina li fiha cyclosporin (trażżan is-sistema immuni)
English: Medicines containing levonorgestrel may increase the risk of cyclosporin toxicity due to possible inhibition of cyclosporin metabolism.
Maltese: Mediċini li fihom levonorgestrel jistgħu jżidu r-riskju ta' tossiċità għal cyclosporin minħabba l-impediment possibbli ta' metaboliżmu ta' cyclosporin.
English: C. Package leaflet
Maltese: Tikkettar Propost
English: B. Labelling (outer carton)
Maltese: Sommarju tal-Karatteristiċi tal-Prodott (SKP)
English: The metabolism of levonorgestrel is enhanced by concomitant use of liver enzyme inducers, mainly CYP3A4 enzyme inducers.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni [Il-kliem ta' din is-sezzjoni għandu jiġi emendat kif ġej] Il-metaboliżmu ta' levonorgestrel jitħarrax bl-użu konkomitanti ta' indutturi ta' enzimi tal-fwied, prinċipalment indutturi tal-enzima CYP3A4.
English: Concomitant administration of efavirenz has been found to reduce plasma levels of levonorgestrel (AUC) by around 50%.
Maltese: L-użu fl-istess waqt ta' efavirenz instab li jnaqqas il-livelli ta' levonorgestrel fil-plażma (AUC) b'madwar 50%.
English: • If you are already using a regular method of contraception such as the contraceptive pill, you can continue to take this at your regular times.
Maltese: • Jekk inti diġà qed tuża metodu regolari ta' kontraċezzjoni bħall-pillola ta' kontraċezzjoni, tista' tibqa' teħodha fil-ħinijiet regolari tiegħek.
English: Consult your doctor as soon as possible after taking the tablets for further advice on a reliable form of regular contraception and to exclude a pregnancy.before using Levonelle 1500 if you use any of the above mentioned medicines.
Maltese: Ikkonsulta t-tabib tiegħek kemm jista' jkun malajr wara li tieħu l-pilloli għal aktar pariri fuq għamla affidabbli ta' kontraċezzjoni regolari u sabiex teskludi tqala. qabel tuża Levonelle 1500 jekk tuża xi wieħed mill-mediċini msemmija hawn fuq.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Maltese: TWISSIJ(A/IET) SPEĊJALI
English: Section 4.2 Posology and method of administration [The wording below should be inserted in this section]
Maltese: Sezzjoni 4.2 Pożoloġija u metodu ta' kif għandu jingħata [Il-kliem t'hawn taħt għandu jiġi inserit f'din is-sezzjoni]
English: Women who have used enzyme-inducing drugs during the last 4 weeks and need emergency contraception are recommended to use a non-hormonal EC, i.e. Cu-IUD or take a double dose of levonorgestrel (i.e. 2 tablets taken together) for those women unable or unwilling to use Cu-IUD (see section 4.5).
Maltese: Nisa li użaw mediċini li jinduċu l-enżimi matul l-aħħar 4 ġimgħat u jeħtieġu kontraċezzjoni ta' emerġenza huma rakkomandati sabiex jużaw EC mhux ormonali, jiġifieri Cu-IUD jew jieħdu doża doppja ta' levonorgestrel (jiġifieri 2 pilloli flimkien) għal dawk in-nisa li mhux kapaċi jew m'għandhomx ir-rieda li jużaw Cu-IUD (ara sezzjoni 4.5).
English: Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD).
Maltese: It-tabib tiegħek għandu mnejn jippreskrivi tip ieħor ta' kontraċettiv ta' emerġenza (mhux ormonali), jiġifieri tagħmir ta' ġol-utru tar-ram (Cu-IUD, copper intrauterine device).
English: Taking a double dose of levonorgestrel (i.e. 3000 mcg within 72 hours after the unprotected intercourse) is an option for women who are unable or unwilling to use a Cu-IUD, although this specific combination (a double dose of levonorgestrel during concomitant use of an enzyme inducer) has not been studied.
Maltese: It-teħid ta' doża doppja ta' levonorgestrel (jiġifieri 3000 mcg fi żmien 72 siegħa wara l-att sesswali mingħajr protezzjoni) hija għażla għal nisa li mhux kapaċi jew li ma jridux jużaw Cu-IUD, għalkemm din il-kombinazzjoni speċifika (doża doppja ta' levonorgestrel waqt l-użu fl-istess ħin ta' induttur tal-enzimi) għadha ma ġietx studjata.
English: It may harm them,
Maltese: Konvulżj oni,
English: Date of first authorisation: 15 February 2006 Date of latest renewal: 22 January 2016
Maltese: Data ta' l-ewwel awtorizzazzjoni: 15 Frar 2006 Data ta' l-aħħar tiġdid: 22 Jannar 2016
English: UCB Pharma S.A. Chemin du Foriest B-1420 Braine l'Alleud Belgium
Maltese: UCB Pharma S.A. Chemin du Foriest B-1420
English: The patches of 2 mg/24 h are used for the treatment of Parkinson's disease and Restless Leg Syndrome.
Maltese: Limpjastri ta' 2 mg/24 h jintużaw għat-trattament ta' Restless Leg Syndrome ta Parkinson's disease u Restless Leg Syndrome.
English: Perception disturbancesa
Maltese: Disturbi talperċezzjonia
English: Dopamine dysregulation syndromec, perception disturbancese
Maltese: Sindromu ta' disregulazzjoni ta' dopamina, disturbi filperċessjonie
English: Palpitationse, atrial fibrillatione, supraventricular tachycardia e
Maltese: Palpitazzjonijiet e, fibrillazzjoni atrijalie, supraventrikular i takikardjae
English: EU/1/05/331/001 EU/1/05/331/002 EU/1/05/331/015 EU/1/05/331/018 EU/1/05/331/057
Maltese: EU/1/05/331/001 EU/1/05/331/002 EU/1/05/331/015
English: Chemin du Foriest B-1420 Braine l'Alleud Belgium
Maltese: Braine l'Alleud Belgium
English: Convulsion Dropped head syndromec,e
Maltese: Sindrome ta' Ras Baxxutac, e
English: Neupro is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) in adults.
Maltese: Neupro huwa indikat għat-trattament tas-sintomi tas-sindromu ta' Restless Legs (RLS) idjopatiku moderat għal sever fl-adulti.
English: Other medicines and Neupro
Maltese: Mediċini oħra u Neupro
English: Sleep (PDSS) improved by 4.1 ± 13.8 points for rotigotine-treated patients, and by 2.5 ± 13.5 points for ropinirole-treated patients.
Maltese: L-irqad (PDSS) tjieb b' 4.1 ± 13.8 punti f'pazjenti trattati b' rotigotine, u b' 2.5 ± 13.5 punt għal pazjenti fuq ropinirole.
English: Neupro contains sodium metabisulphite (E223) Sodium metabisulphite (E223) may rarely cause severe hypersensitivity (allergic) reactions and bronchospasm (breathing distress caused by narrowing of the airways).
Maltese: Sodium metabisulphite (E223) rarament jista' jikkawża reazzjonijiet severi ta' ipersensittivita` (allerġija) u bronkospażmu (problemi fin-nifs ikkawżat minn djuq fil-pajpijiet tan-nifs).
English: Dizzinesse, disturbances in consciousness NECe (incl.
Maltese: Nagħas sturdamente, disturbi filkoxxjenza NECe (inkl.
English: Aggressive behaviour/ aggressionb, disorientationd
Maltese: Aġir aggressiv/ aggressjonib, diżorjentazzjon
English: Transdermal use.
Maltese: Użu transdermali.
English: Psychotic disorder, obsessivecompulsive disorder, aggressive behaviour/ aggressionb, delusiond, deliriumd
Maltese: Mard psikożi, mard ossessiv kompulsiv , aġir aggressiv/ aggressjon ib, delużjonid, delirjud
English: Neupro is available in the following pack-sizes:
Maltese: Neupro hu disponibbli fid-daqsijiet tal-pakketti li ġejjin:
English: Neupro with food, drink and alcohol
Maltese: Neupro ma' ikel, xorb u alkoħol
English: Do not use Neupro if:
Maltese: Tużax Neupro jekk:
English: Improvements in the mean PDSS-2 total score were 5.9 (rotigotine, baseline19.3) and 1.9 points (placebo, baseline 20.5).
Maltese: It-titjib fil-medja tar-riżult totali tal-PDSS-2 kien 5.9 (rotigotine, linja bażi 19.3) u 1.9 punt (plaċebo, linja bażi 20.5).
English: Somnolence, dizziness, headache
Maltese: , delużjonid, delirjud
English: The box contains 7, 14, 28, 30 or 84 (multipack containing 3 packs of 28) transdermal patches, individually sealed in sachets.
Maltese: Kaxxi li fihom 7, 14, 28, 30, or 84 (pakkett multiplu li fih 3 pakketti ta' 28) impjastru, li huma ssiġillati individwalment fi qratas.
English: Fall e a High Level Term b Observed in open-label studies c Observed during post-marketing d Observed in 2011 data pool of double-blind placebo-controlled studies e Observed in studies performed in patients with Parkinson's disease
Maltese: Waqgħate a Terminu ta' Livell Għoli b Osservat f'studji open label c Osservat wara t-tqegħid fis-suq d Osservat f' ġabra ta' dejta tal-2011 minn studji double-blind kkontrollati bil-plaċebo e Osservat f'studji li saru f'pazjenti bil-marda ta' Parkinson's