FrancophonIA/ELRC3.0 huggingface dataset:
English: For guidance regarding posology for patients experiencing IRR symptoms see section 4.2.
Maltese: Għal gwida dwar pożoloġija għal pazjenti li jkollhom sintomi ta' IRR ara sezzjoni 4.2.
English: Ocrevus is a monoclonal antibody and cleared via catabolism (i.e. breakdown into peptides and amino acids), and a change in dose is not expected to be required for patients with renal impairment (see section 5.2).
Maltese: Ocrevus huwa antikorp monoklonali u jitneħħa permezz ta' kataboliżmu (jiġifieri jitkisser f'peptides u aċidi amminiċi), u mhux mistenni li tkun meħtieġa bidla fid-doża għal pazjenti b'indeboliment tal-kliewi (ara sezzjoni 5.2).
English: One patient with grade 3 (between 500 and 1000 cells/mm3) and one patient with grade 4 (< 500 cells/mm3) neutropenia required specific treatment with granulocyte-colony stimulating factor, and remained on ocrelizumab after the episode.
Maltese: Pazjent wieħed b'newtropenija ta' Grad 3 (bejn 500 u 1000 ċellula/mm 3) u pazjenti wieħed b'newtropenija ta' Grad 4 (< 500 ċellula/mm
English: Animal studies (embryo-foetal toxicity) do not indicate teratogenic effects.
Maltese: Studji f'annimali (dwar l-effett tossiku fuq l-embrijun u l-fetu) ma jindikawx effetti teratoġeniċi.
English: In the Phase III studies, between each dose of Ocrevus, up to 5% of patients showed B-cell repletion (> lower limit of normal (LLN) or baseline) at least at one time point.
Maltese: III, bejn kull doża ta' Ocrevus, sa 5% tal-pazjenti wrew żieda mill-ġdid ta' ċelluli B (> limitu l-aktar baxx tan-normal (LLN - lower limit of normal) jew linja bażi) għall-anqas f'punt ta' żmien wieħed.
English: Ocrevus should be avoided during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.
Maltese: Ocrevus għandu jiġi evitat waqt it-tqala sakemm il-benefiċċju potenzjali għall-omm ma jkunx akbar mir-riskju potenzjali għall-fetu.
English: Patients enrolled in the ongoing clinical trials continue to be dosed with 600 mg ocrelizumab every six months after they become 55 and older.
Maltese: Il-pazjenti rreġistrati fil-provi kliniċi li għaddejjin bħalissa jibqgħu jingħataw id-doża ta' 600 mg ocrelizumab kull sitt xhur wara li jagħlqu 55 sena u aktar.
English: Defined as an increase of ≥ 1.0 point from the baseline Expanded Disability Status Scale (EDSS) score for patients with baseline score of 5.5 or less, or ≥ 0.5 when the baseline score is > 5.5, Kaplan-Meier estimates at Week 96
Maltese: 2 Analiżi mhux konfermattiva tal-valur p; mhux parti mill-ġerarkija tal-ittestjar speċifikata minn qabel Definita bħala żieda ta' ≥ 1.0 punt mill-punteġġ fil-linja bażi tal-Skala tal-Istat Mifrux tad-Diżabilità (EDSSExpanded Disability Status Scale) għal pazjenti b'punteġġ fil-linja bażi ta' 5.5 jew inqas, jew ta' ≥ 0.5 meta lpunteġġ fil-linja bażi huwa > 5.5, stimi Kaplan-Meier f'Ġimgħa 96
English: In addition, innate immunity and total T-cell numbers are not affected.
Maltese: Barra dan, limmunità intrinsika u n-numru totali ta' ċelluli T mhumiex affettwati.
English: Infections were predominantly mild to moderate in severity and patients recovered with treatment by standard therapies.
Maltese: L-infezzjonijiet fil-biċċa l-kbira kienu ħfief sa moderati fis-severità u l-pazjenti rkupraw bi trattament b'terapiji standard.
English: Breakdown of the myelin sheath stops the nerves working properly.
Maltese: It-tkissir tal-myelin sheath iwaqqaf in-nervaturi milli jaħdmu kif suppost.
English: Ocrevus is administered as an intravenous infusion.
Maltese: Ocrevus jingħata bħala infużjoni ġol-vini.
English: · Premedication: Patients must receive premedication to reduce the frequency and severity of IRRs (see section 4.2.
Maltese: • Medikazzjoni minn qabel: Il-pazjenti għandhom jirċievu medikazzjoni minn qabel biex titnaqqas il-frekwenza u s-severità tal-IRRs (ara sezzjoni 4.2.).
English: Injury, poisoning and procedura complications
Maltese: Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura
English: Proportion of patients with 24 week Confirmed Disability Progression Risk Reduction (Pooled Analysis Risk Reduction (Individual Studies2)
Maltese: Proporzjon ta' pazjenti bi Progressjoni Kkonfermata tad-Diżabilità ta' 24 ġimgħa Tnaqqis tar-riskju
English: · While you are being treated with Ocrevus, you should not be given live or live attenuated vaccines (for example BCG for tuberculosis or vaccines against yellow fever).
Maltese: • Waqt li tkun qed tiġi ttrattat b'Ocrevus, m'għandekx tingħata tilqim ħaj jew ħaj u attenwat (pereżempju BCG għat-tuberkulożi jew tilqim kontra d-deni l-isfar).
English: The majority of IRRs in both treatment groups were mild to moderate.
Maltese: Il-maġġoranza tal-IRRs fiż-żewġ gruppi ta' trattament kienu ħfief sa moderati.
English: · At the request of the European Medicines Agency; · Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: · In Relapsing forms of MS (RMS),Ocrevus helps to significantly reduce the number of attacks (relapses) and significantly slow down the progression of the disease.
Maltese: • F'forom li Jirkadu ta' MS (RMS - Relapsing Multiple Sclerosis), Ocrevus jgħin biex inaqqas b'mod sinifikanti n-numru ta' attakki (rikaduti) u jnaqqas b'mod sinifikanti l-progressjoni talmarda.
English: Renal impairment
Maltese: Wara l-infużjoni
English: Very common: may affect more than 1 in 10 people · decrease in specific proteins in the blood (immunoglobulins) which help protect against infection
Maltese: • tnaqqis fi proteini speċifiċi fid-demm (immunoglobulini) li jgħinu jipproteġu kontra l infezzjonijiet
English: Instructions for dilution
Maltese: Istruzzjonijiet għad-dilwizzjoni
English: Women of child bearing potential should use contraception while receiving Ocrevus and for 12 months after the last infusion of Ocrevus (see below and section 5.1 and 5.2).
Maltese: Nisa li jistgħu joħorġu tqal għandhom jużaw kontraċettiv waqt li jkunu qed jirċievu Ocrevus u għal 12-il xahar wara l-aħħar infużjoni ta' Ocrevus (ara hawn taħt u sezzjoni 5.1 u 5.2).
English: There is no PK information available in patients with moderate or severe renal impairment.
Maltese: M'hemm l-ebda informazzjoni PK disponibbli f'pazjenti b'indeboliment moderat jew sever tal-kliewi.
English: Symptoms can include, but are not limited to: itchy skin rash hives redness of the skin throat irritation or pain shortness of breath swelling of the throat flushing low blood pressure fever feeling tired headache feeling dizzy feeling sick (nausea) fast heart beat.
Maltese: Issintomi jistgħu jinkludu, iżda mhumiex limitati għal: ħakk fil-ġilda raxx ħorriqija ħmura tal-ġilda irritazzjoni jew uġigħ fil-griżmejn qtugħ ta' nifs nefħa fil-griżmejn fwawar pressjoni baxxa deni tħossok għajjien uġigħ ta' ras tħossok stordut tħossok imdardar (dardir) taħbit tal-qalb mgħaġġel.
English: Relative Increase (Pooled Analysis1) Relative Increase (Individual Studies
Maltese: Tnaqqis tar-Riskju (Analiżi Globali1)
English: Subsequent doses of Ocrevus thereafter are administered as a single 600 mg intravenous infusion every 6 months (Table 1).
Maltese: Wara dan dożi sussegwenti ta' Ocrevus jingħataw bħala infużjoni waħda ta' 600 mg ġol-vini kull 6 xhur (Tabella 1).
English: Newborn offspring of maternal animals exposed to ocrelizumab were noted to have depleted B cell populations during the post natal phase.
Maltese: Fil-provi kliniċi kienu inklużi pazjenti b'indeboliment ħafif tal-fwied.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C and subsequently for 8 hours at room temperature, unless dilution is undertaken in controlled and validated aseptic conditions.
Maltese: Jekk ma tintużax immedjatament, iż-żminijiet u l-kondizzjonijiet ta' ħażna waqt u qabel l-użu huma rresponsabbiltà tal-utent u normalment ma jkunux itwal minn 24 siegħa f'temperatura ta' 2-8°C u sussegwentement għal 8 sigħat f'temperatura tal-kamra, sakemm id-dilwizzjoni ma ssirx f'kondizzjonijiet asettiċi kkontrollati u validati.
English: The diluted infusion solution must be administered using an infusion set with a 0.2 or 0.22 micron in-line filter.
Maltese: Is-soluzzjoni għall-infużjoni dilwita għandha tingħata permezz ta' sett għall-infużjoni b'filtru fil-pajp ta' 0.2 jew 0.22 mikroni.
English: EU (MA) number Invented name
Maltese: Numru tal-MA UE
English: --1 Each dose of 2 ml of vaccine contains one of the following inactivated bluetongue virus strains: Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP* ≥ 1
Maltese: --1 Kull doża ta' 2 ml ta' vaċċin fiha waħda minn dawn l-istrejns inattivati tal-bluetongue virus: Bluetongue virus inattivat, serotip 1, strejn BTV-1/ALG2006/01 E1 RP* ≥ 1
English: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* ≥ 1
Maltese: BTV-8/BEL2006/02 RP* ≥ 1
English: Inactivated bluetongue virus, serotype 4, strain SPA-1/2004 RP** ≥ 0.8
Maltese: Bluetongue virus inattivat, serotip 4, strejn SPA-1/2004
English: *Relative Potency by a mice potency test compared to a reference vaccine efficacious in sheep and cattle **Relative potency by a mice potency test compared to a reference vaccine efficacious in sheep.
Maltese: RP** ≥ 0.8 *Qawwa relattiva skont test ta' qawwa fil-ġrieden imqabbel ma' tilqima ta' referenza li hija effikaċi fin-nagħaġ u l-ifrat ** Qawwa relattiva skont test ta' qawwa fil-ġrieden imqabbel ma' tilqima ta' referenza li hija effikaċi fin-nagħaġ
English: 10 pre-filled syringes + 10 needles
Maltese: 10 siringi mimlijin għallest + 10 labriet
English: 50 pre-filled syringes
Maltese: 50 siringa mimlija għallest mingħajr labar
English: 27 November 2015 EMA/134145/2015
Maltese: EMA/134145/2015
English: More information
Maltese: Aktar informazzjoni
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 ta' Novembru 2015
English: Examples of high-strength insulin formulations are Tresiba (200 units/ml insulin degludec) and Humalog (insulin lispro 200 units/ml).
Maltese: Eżempji ta' formulazzjonijiet ta' insulina ta' qawwa kbira huma Tresiba (200 unità/ml ta' insulina degludec) u Humalog (insulina lispro 200 unita/ml).
English: Toujeo (insulin glargine 300 units/ml), although it is also a high-strength insulin, is not bioequivalent to insulin glargine 100 units/ml (such as Lantus) which means that these insulins are not interchangeable.
Maltese: Toujeo (insulina glargine 300 unità/ml), għalkemm hija insulina ta' qawwa kbira wkoll, mhijiex bijoekwivalenti għall-insulina glargine 100 unità/ml (bħal Lantus) li jfisser li dawn l-insulini ma jinbidlux waħda mal-oħra.
English: Focus on colour differentiation, warning statements on carton/label and other safety design features (such as tactile elements on the pre-filled pen).
Maltese: Iffoka fuq id-differenzjazzjoni tal-kulur, l-istqarrijiet ta' twissija fuq il-kartuna/tikketta u karatteristiċi tas-sigurtà tad-disinn oħra (bħall-elementi tattili fuq il-pinna mimlija għal-lest).
English: Therefore, when switching from insulin glargine 100 units/ml to Toujeo, this can be done on a unit to unit basis, but a higher Toujeo dose (approx. 10-18%) may be needed to achieve target ranges for plasma glucose level.
Maltese: Għaldaqstant, meta teqleb minn insulina glargine 300 unità/ml għal Toujeo, dan jista' jsir fuq bażi ta' unità għal unità, iżda jista' jkun hemm bżonn doża ogħla ta' Toujeo (bejn wieħed u ieħor 10-18%) sabiex jintlaħqu l-firxiet fil-mira għal-livell ta' glukożju fil-plażma.
English: • When switching patients from standard-strength insulin to an insulin formulation that is not bioequivalent (such as Toujeo, insulin glargine 300 units/ml), switching can be done on a unit to unit basis, but the dose may need to be adjusted to achieve target ranges for plasma glucose level.
Maltese: • Meta teqleb il-pazjenti minn insulina ta' qawwa kbira għal formulazzjoni ta' insulina li mhijiex bikoekwivalenti (bħal Toujeo, insulina glargine 300 unità/ml), il-qlib jista' jsir fuq bażi ta' unità għal unità, iżda jista' jkun hemm bżonn li d-doża tiġi aġġustata biex jintlaħqu firxiet fil-mira għallivell ta' glukożju fil-plażma.
English: A high-strength insulin is a medicine that contains insulin at a concentration of more than the standard 100 units/ml, which for many years has been the only strength available across the EU.
Maltese: Insulina ta' qawwa kbira hija mediċina li fiha l-insulina f'konċentrazzjoni ta' aktar mill-100 unità/ml standard, li għal ħafna snin kienet l-unika qawwa disponibbli madwar l-UE.
English: • If the concentration of insulin stated on your medicine pack is higher than 100 units/ml, you are using high-strength insulin.
Maltese: • Jekk il-konċentrazzjoni ta' insulina ddikjarata fuq il-pakkett tal-mediċina tiegħek hija ta' aktar minn 100 unità/ml, inti qed tuża insulina ta' qawwa kbira.
English: Guidance on prevention of medication errors with highstrength insulins
Maltese: Gwida dwar il-prevenzjoni ta' żbalji ta' medikazzjoni b'insulini ta' qawwa kbira
English: • Explain differences in the design of the package and the pre-filled pen for high-strength insulins and standard-strength insulins, especially if the patient has been transferred from standardstrength insulin to high-strength insulin.
Maltese: • Spjega d-differenzi fid-disinn tal-pakkett u l-pinna mimlija għal-lest għal insulini ta' qawwa kbira u insulini ta' qawwa standard, speċjalment jekk il-pazjenti nqalbu minn insulina ta' qawwa standard għal insulina ta' qawwa kbira.
English: • If you are being transferred from standard strength insulin to high-strength insulin, your healthcare professional will highlight any differences in design between your high-strength insulin pen and other standard-strength insulin pens.
Maltese: • Jekk qed tinqaleb minn insulina ta' qawwa standard għal insulina ta' qawwa kbira, il-professjonist fil-kura tas-saħħa tiegħek ser jenfasizza kwalunkwe differenza fid-disinn bejn il-pinna b'insulina ta' qawwa kbira u pinen oħra b'insulina ta' qawwa standard.
English: • If you are being transferred from standard-strength insulin to a high-strength insulin you will usually be using the same number of units that you were when using the standard-strength insulin.1 This also applies if you are being transferred from a high-strength to a standard-strength insulin.
Maltese: • Jekk qed tinqaleb minn insulina ta' qawwa standard għal insulina ta' qawwa kbira normalment ser tkun qed tuża l-istess numru ta' unitajiet li kont qed tuża bl-insulina ta' qawwa standard.1
English: Further information on the safe use of these medicines and other ways to minimise the possible risk of medication errors with these medicines can be found in the guidance on risk minimisation strategies for high-strength and fixed-combination insulin products.
Maltese: Aktar informazzjoni dwar l-użu sikur ta' dawn il-mediċini u modi oħra biex jitnaqqas ir-riskju possibbli ta' żbalji ta' medikazzjoni b'dawn il-mediċini tinstab fil-gwida dwar it-tnaqqis tar-riskju għal prodotti ta' insulina ta' qawwa kbira u kkombinati b'mod fiss.
English: However, there are differences in the way high-strength insulin products are used compared with existing insulin formulations of standardstrength and there is therefore a risk of medication errors and accidental mix-ups.
Maltese: Madankollu, hemm differenzi fil-mod kif prodotti tal-insulina ta' qawwa kbira jintużaw meta mqabbla ma' formulazzjonijiet eżistenti tal-insulina ta' qawwa standard u għaldaqstant hemm riskju ta' żbalji ta' medikazzjoni u bdil aċċidentali ta' prodott ma ieħor.
English: • Always prescribe the insulin dose in units (“units” to be spelled out and stated in lower case) and include the dose frequency.
Maltese: • Dejjem ippreskrivi d-doża tal-insulina f'unitajiet ("unitajiet" għandha tiġi spelluta u miktuba b'ittri żgħar) u inkludi l-frekwenza tad-doża.
English: • Pharmacists are encouraged to check that patients and carers are able to read the strength of insulin and the dose counter of the pen device before dispensing the medicine.
Maltese: • L-ispiżjara huma mħeġġa jiċċekkjaw li l-pazjenti u dawk li jieħdu ħsiebhom huma kapaċi jaqraw ilqawwa tal-insulina u l-kontatur tad-doża tal-apparat tal-pinna qabel jużaw il-mediċina.
English: The active substance is capsaicin.
Maltese: Is-sustanza attiva hi capsaicin.
English: Date of first authorisation: 15 May 2009 Date of latest renewal: 15 May 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 15 ta' Mejju 2009 Data ta l-aħħar tiġdid: 15 ta' Mejju 2014
English: Dermal assessment
Maltese: Evalwazjoni dermali
English: No data are available following 30-minute treatments.
Maltese: M'hemmx informazzjoni disponibbli wara trattamenti ta' 30 minuta.
English: Capsaicin, or 6-nonenamide, N-[(4-hydroxy-3-methoxyphenyl) methyl]-8-methyl, (6E), is a highly selective agonist for the transient receptor potential vanilloid 1 receptor (TRPV1).
Maltese: Capsaicin, jew 6-nonenamide, N-[(4-hydroxy-3-methoxyphenyl) methyl]-8-methyl (6E), huwa agonista selettiv ħafna għar-riċettur temporanju potenzjali vanilloid 1 (transient receptor potential vanilloid 1, TRPV1).
English: EU/1/09/524/001 1 patch EU/1/09/524/002 2 patches
Maltese: EU/1/09/524/001 1 stikk EU/1/09/524/002 2 stikk
English: Sensory function
Maltese: Funzjoni tas-sensi
English: Matrix silicone adhesives diethylene glycol monoethyl ether silicone oil ethylcellulose N50 (E462)
Maltese: Matriċi adeżivi tas-silikon diethylene glycol monoethyl ether żejt tas-silikon ethylcellulose N50 (E462)
English: Eye irritation
Maltese: Irritazzjoni okulari
English: 640 micrograms of capsaicin per cm 2 of patch (8% w/w).
Maltese: 640 mikrogramma capsaicin għal kull cm 2 tal-istikk (8% piż/piż).
English: Table 1: Tabulated list of adverse reactions
Maltese: Tabella 1: Tabella tar- reazzjonijiet avversi
English: Qutenza 179 mg cutaneous patch capsaicin
Maltese: Qutenza 179 mg stikk kutanju capsaicin
English: There is no antidote to capsaicin.
Maltese: M'hemmx antidotu għal capsaicin.
English: In clinical trials, patients were pre-treated with topical lidocaine (4%), lidocaine (2.5%)/prilocaine (2.5%) or with 50 mg of tramadol.
Maltese: Fi provi kliniċi, il-pazjenti ġew ittrattati minn qabel b'4% lidocaine, 2.5% lidocaine/2.5% prilocaine topiku jew b'50 mg tramadol.
English: Qutenza 179 mg cutaneous patch
Maltese: Qutenza 179 mg stikk kutanju
English: Dysgeusia, hypoaesthesia
Maltese: Disġewsija, ipoestesija,
English: Remove anaesthetic.
Maltese: Neħħi l-anestetiku.
English: According to the EC Scientific Committee on Food, the average European oral intake of capsaicin is 1.5 mg/day (0.025 mg/kg/day for a 60 kg person) and the highest dietary exposure is 25 to 200 mg/day (up to 3.3 mg/kg/day for a 60 kg person).
Maltese: Skont il-Kumitat Xjentifiku dwar l-Ikel tal-KE, il-konsum orali medju fl-Ewropa ta' capsaicin huwa 1.5 mg/ġurnata (0.025 mg/kg/ġurnata għal persuna ta' 60 kg) u l-ogħla esponiment dijetetiku huwa 25 sa 200 mg/ġurnata (sa 3.3 mg/kg/ġurnata għal persuna ta' 60 kg).
English: • Periodic Safety update Reports
Maltese: • Rapporti Perjodiċi ta 'Aġġornament tas-Sigurtà
English: Apply topical anaesthetic to treatment area.
Maltese: Applika anestetiku topiku fuq iż-żona tat-trattament.
English: The outer surface of the backing layer is imprinted with ‘capsaicin 8%'.
Maltese: Il-wiċċ ta' barra tas-saff ta' protezzjoni għandu mmarkat fuqu ‘capsaicin 8%'.
English: First degree atrio-ventricular (AV) block, tachycardia, palpitations
Maltese: Imblokk atrijoventrikolari (AV) tal-ewwel grad, takikardija, palpitazzjonijiet
English: Gastrointestinal disorders Uncommon
Maltese: Disturbi gastrointestinali
English: System organ class and frequency
Maltese: Klassifikazzjoni skont sistemi, organi u frekwenza
English: Adverse reactions were transient, self limiting and usually mild to moderate in intensity.
Maltese: Ir-reazzjonijiet avversi kienu temporanji, awtolimitati u ġeneralment ta' intensità minn ħafifa għal moderata.
English: A population pharmacokinetic analysis of patients treated for 60 and 90 minutes indicated that capsaicin levels in plasma peaked around 20 minutes after Qutenza removal and declined very rapidly, with a mean elimination half-life of about 130 minutes.
Maltese: Analiżi farmakokinetika għall-popolazzjoni tal-pazjenti ttrattati għal 60 u 90 minuta indikat li l-livelli ta' capsaicin fil-plażma laħqu l-ogħla livell madwar 20 minuta wara t-tneħħija ta' Qutenza u tbaxxew malajr ħafna, b'half-life medja ta' eliminazzjoni ta' madwar 130 minuta.
English: Infections and infestations Uncommon
Maltese: Infezzjonijiet u infestazzjonijiet
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Maltese: Dan jippermetti l-monitoraġġ kontinwu bejn il benefiċċju u r-riskju tal-prodott mediċinali.
English: In Table 1 below all adverse reactions, which occurred at an incidence greater than control and in more than one patient in controlled clinical trials in patients with postherpetic neuralgia (PHN), painful Human Imunodeficiency Virus - Associated Neuropathy (HIV-AN) and painful diabetic peripheral neuropathy, are listed by system organ class and frequency: very common (≥ 1/10), common (≥ 1/100
Maltese: Fit-Tabella 1 hawn isfel huma elenkati r-reazzjonijiet avversi kollha, li seħħew b'inċidenza akbar milli bis-sustanza ta' kontroll u f'iżjed minn pazjent wieħed fi provi kliniċi kkontrollati f'pazjenti b'nevralġija posterpetika (PHN) ;newropatija bl- uġigħ assoċjata mal- Virus uman ta' immunodefiċjenza (HIV-AN), u newropatija periferali dijabetika bl-uġigħ.skont il-klassifika ta' sistemi u organi u l-frekwenza: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100) u mhux magħrufa (ma jistgħux jiġu stmati mid-dejta disponibbli).
English: Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastiniċi
English: Each 50 g tube of cleansing gel for Qutenza contains 0.2 mg/g butylhydroxyanisole (E320).
Maltese: Kull tubu ta' 50 g ta' ġell għat-tindif għal Qutenza fih 0.2 mg/g butylhydroxyanisole (E320).
English: • to be aware of the risk of reductions in sensory function which are generally minor and temporary (including to thermal and sharp stimuli) following administration of Qutenza
Maltese: • li jkun konxju tar-riskju ta' tnaqqis fil-funzjoni sensorjali li huma ġeneralment minuri u temporanji (inklużi stimuli termali u qawwija) wara l-għoti ta' Qutenza
English: Available pharmacodynamic/toxicological data in animals have shown excretion of capsaicin/metabolites in milk (for details see 5.3).
Maltese: Dejta farmakodinamika / tossikoloġika fl-annimali uriet li kien hemm eliminazzjoni ta' capsaicin/metaboliti fil-ħalib tas-sider (gћad-dettalji ara 5.3).
English: CARTON OF 1 OR 2 PATCHES
Maltese: KARTUNA BI STIKK 1 JEW 2
English: The use of a mask and protective glasses is recommended, see section 4.2.
Maltese: L-użu ta' maskla u nuċċali ta' protezzjoni huwa rakkomandat, ara sezzjoni 4.2.
English: Each patch is 14 cm x 20 cm (280 cm2) and consists of an adhesive side containing the active substance and an outer surface backing layer.
Maltese: Kull stikk huwa 14 cm x 20 cm (280 cm2) u jikkonsisti minn naħa adeżiva li fiha s-sustanza attiva u wiċċ ta' barra ta' saff ta' protezzjoni.
English: Temporary, minor changes in heat detection (1°C to 2°C) and sharp sensations were detected at the Qutenza application site in clinical trials with healthy volunteers.
Maltese: Kienu rilevati bidliet temporanji żgħar fil-perċezzjoni tas-sħana (1°C sa 2°C) u sensazzjonijiet qawwija fis-sit tal-applikazzjoni ta' Qutenza fi provi kliniċi fuq voluntiera b'saħħithom.
English: Pharmacotherapeutic group: Anaesthetics, other local anaesthetics, ATC code: N01BX04
Maltese: Anestetiċi, anestetiċi lokali oħra, Kodiċi ATC: