FrancophonIA/ELRC3.0 huggingface dataset:
English: 30 mg (suspension or capsules) once weekly * Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients; the clearance of oseltamivir carboxylate is expected to be higher when automated peritoneal dialysis (APD) mode is used.
Maltese: 30 mg (suspensjoni jew kapsuli) darba fil-ġimgħa * Dejta miksuba minn studji f'pazjenti fuq dijalisi kontinwa ambulatorja tal-peritonew (CAPD); it-tneħħija ta' oseltamivir carboxylate hija mistennija li tkun ogħla meta tintuża s-sistema ta' dijalisi awtomatizzata talperitonew (APD).
English: > 9 - 10 kg 30 mg twice daily
Maltese: > 9 - 10 kg 30 mg darba kuljum 5.0 ml darba kuljum
English: Excipients with known effect:
Maltese: Kura tal-influwenza:
English: Prevention during an influenza epidemic in the community: The recommended dose for prevention of influenza during a community outbreak is 75 mg oseltamivir once daily for up to 6 weeks.
Maltese: Id-doża rakkomandata għall-prevenzjoni tal influwenza waqt tifqigħa tal-influwenza fil-komunità hija ta' 75 mg oseltamivir darba kuljum għal perijodu sa 6 ġimgħat.
English: A large amount of data on oseltamivir exposure of pregnant women from post-marketing reports and observational studies (more than 1000 exposed outcomes during the first trimester) indicate no malformative nor feto/neonatal toxicity by oseltamivir.
Maltese: Ammont kbir ta' data dwar esponiment għal oseltamivir ta' nisa tqal minn rapporti ta' wara t-tqegħid fis-suq u studji ta' osservazzjoni (aktar minn 1000 riżultat ta' esponiment matul l-ewwel trimestru) ma jindika l-ebda tossiċità malformattiva u lanqas tossiċità fil-fetu/tarbija tat-twelid b'oseltamivir.
English: Tamiflu is indicated in adults and children including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community.
Maltese: Tamiflu huwa indikat f'adulti u tfal inkluż trabi tat-twelid li twieldu meta kien imisshom li jkollhom is-sintomi tipiċi tal-influwenza, meta jkun hemm il-passa tal-virus tal-influwenza fil-komunità.
English: Pharmacy compounding
Maltese: FARMAĊEWTIKU
English: Tamiflu 30 mg hard capsules EU/1/02/222/003
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/02/222/003
English: Treating flu: dose for 5 days
Maltese: Kura tal-influwenza: doża għal 5 ijiem
English: Table 1 Adverse reactions in studies investigating Tamiflu for treatment and prevention of influenza in adults and adolescents or through post-marketing surveillance
Maltese: Tabella 1 Reazzjonijiet avversi fi studji li nvestigaw Tamiflu għall-kura u l-prevenzjoni talinfluwenza fl-adulti u fl-adoloxxenti jew minn sorveljanza ta' wara t-tqegħid fis-suq
English: The following age-adjusted dosing prophylaxis regimen is recommended for infants 0 - 12 months of age (see Section 5.2 for exposure simulation):
Maltese: Il-kors ta' dożaġġ għall-profilassi aġġustat skont l-età li ġej huwa rakkomandat għal trabi b'età ta' 0 - 12-il xahar (ara Sezzjoni 5.2 għal simulazzjoni tal-espożizzjoni):
English: The recommended post-exposure prevention dose of Tamiflu is:
Maltese: Kura u prevenzjoni tal-influwenza fit-tfal:
English: Treatment mode can be switched from APD to CAPD if considered necessary by a nephrologist.
Maltese: Il-metodu tal-kura jista' jinbidel minn APD għal CAPD jekk ikun ikkunsidrat neċessarju minn nefroloġista.
English: Tamiflu 45 mg hard capsules EU/1/02/222/004
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/02/222/004
English: Agitation,
Maltese: Madankollu,
English: No data allowing a dose recommendation for premature children (<36 weeks post-conceptual age) are currently available.
Maltese: Bħalissa m'hemmx dejta disponibbli li tippermetti rakkomandazzjoni ta' doża għal tfal prematuri (età ta' < 36 ġimgħa wara l-konċepiment).
English: Children weighing > 40 kg and who are able to swallow capsules may receive treatment with the adult dosage of 75 mg capsules twice daily for 5 days as an alternative to the recommended dose of Tamiflu suspension.
Maltese: Tfal li jiżnu > 40 kg u li huma kapaċi jibilgħu l-kapsuli jistgħu jingħataw kura bid-dożaġġ tal-adulti ta' 75 mg kapsuli darbtejn kuljum għal ħamest ijiem bħala alternattiva għad-doża rakkomandata ta' suspensjoni Tamiflu.
English: For infants and children1 year of age or older: The recommended dose of Tamiflu 6 mg/ml oral suspension is indicated in the table below.
Maltese: Id-doża rakkomandata tas-suspensjoni orali ta' Tamiflu 6 mg/ml hija indikata fit-tabella taħt.
English: • The bottle, containing Tamiflu powder (in the medicine pack)
Maltese: • Buqar tal-plastik għall-kejl (fil-pakkett tal-mediċina)
English: The hard capsule consists of a grey opaque body bearing the imprint “ROCHE” and a light yellow opaque cap bearing the imprint “75 mg”.
Maltese: Il-kapsula iebsa hija opaka, ta' lewn griż u għandha l-marka “ROCHE” u kappa safra ċara, opaka li għandha l-marka “75 mg”.
English: The appropriate dispenser sizes for taking the correct volume of Tamiflu suspension (6 mg/ml) are shown below.
Maltese: Id-daqsijiet xierqa tad-dispenser biex jittieħed il-volum korrett ta' suspensjoni Tamiflu (6 mg/ml) huma mniżżla isfel.
English: 1.5 ml twice daily 1.5 ml once daily 3 ml
Maltese: 1.5 ml darbtejn kuljum 1.5 ml darba kuljum 3 ml
English: The box also contains 1 plastic measuring jug (55 ml), 1 plastic bottle adapter (to help get the drug into the dispenser),1 plastic 3 ml oral dispenser and 1 plastic 10 ml oral dispenser (to give the correct amount of medicine via the mouth).
Maltese: Il-kaxxa fiha wkoll buqar tal-plastik għall-kejl (55 ml), adapter tal-plastik għall-flixkun (li jgħin sabiex il-mediċina tingħadda għal ġod-dispenser), dispenser orali tal-plastik ta' 3 ml u dispenser orali talplastik ta' 10 ml (biex tagħti l-ammont korrett ta' mediċina mill-ħalq).
English: Dose adjustment is recommended for both treatment and prevention in adolescents (13 to 17 years of age) and adults with severe renal impairment.
Maltese: Għall-adoloxxenti (b'età minn 13 sa 17-il sena) u adulti:
English: 75 mg dose
Maltese: 75 mg darba kuljum
English: Cough, Nasal congestion
Maltese: Livell ta' koxjenza mibdul, Konvulżjoni
English: 60 mg dose
Maltese: 60 mg darba kuljum
English: The MAH shall agree the communication plan for the DHPC letter with the National Competent Authority in the Member States where the letter will be distributed.
Maltese: L-MAH għandu jiftiehem dwar il-pjan ta' komunikazzjoni għall-ittra DHPC mal-Awtorità Kompetenti Nazzjonali fl-Istati Membri fejn l-ittra se tiġi mqassma.
English: Tamiflu 75 mg hard capsules EU/1/02/222/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/02/222/001
English: 45 mg dose
Maltese: 45 mg darba kuljum
English: 12 mg twice daily
Maltese: 12-il mg darbtejn kuljum
English: Tamiflu should be used for the treatment and prevention of influenza only when reliable epidemiological data indicate that influenza virus is circulating in the community.
Maltese: Tamiflu għandu jiġi użat biss għall-kura u l-prevenzjoni tal-influwenza meta dejta epidemjoloġika affidabbli tindika li l-virus tal-influwenza qiegħed jinfirex fil-komunità.
English: 30 mg (suspension or capsules) once daily
Maltese: 30 mg (suspensjoni jew kapsuli) darba fil-ġimgħa
English: A 3 ml oral dispenser (graduated in 0.1 ml steps) should be used for dosing infants less than 1 year old requiring 1 to 3 ml of Tamiflu oral suspension.
Maltese: Dispenser orali ta' 3 ml (immarkat bi gradi f'żidiet ta' 0.1 ml) għandu jintuża għall-għoti ta' dożi lil trabi b'età inqas minn sena li jeħtieġu 1 sa 3 ml ta' Tamiflu suspensjoni orali.
English: What Tamiflu looks like and contents of the pack The 75 mg hard capsule consists of a grey opaque body bearing the imprint “ROCHE” and a light yellow opaque cap bearing the imprint “75 mg”.
Maltese: Il-kapsula iebsa ta' 75 mg hija magħmula minn ġisem griż u opâk li għandu stampat “ROCHE” u għatu isfar ċar u opâk li għandu stampat “75 mg”.
English: 3.0 ml twice daily 3.0 ml once daily 3 ml
Maltese: 2.0 ml darbtejn kuljum 2.0 ml darba kuljum 3.0 ml
English: • Anaphylactic and anaphylactoid reactions: severe allergic reactions, with face and skin swelling, itchy rashes, low blood pressure and breathing difficulties
Maltese: • Reazzjonijiet anafilattiċi u anafilaktojdi: reazzjonijiet allerġiċi severi, b'nefħa fil-wiċċ u lġilda, raxx bil-ħakk, pressjoni baxxa u diffikultajiet fit-teħid tan-nifs
English: Method of administration Swallow the capsules whole with water.
Maltese: Metodu ta' kif għandu jingħata Ibla l-kapsuli sħaħ bl-ilma.
English: • Upper abdominal fullness
Maltese: Doża rakkomandata għall-kura
English: You should use only 75 mg capsules for 75 mg doses.
Maltese: Għad-dożi ta' 75 mg għandek tuża kapsuli ta' 75 mg biss.
English: Tamiflu powder for suspension will appear as an opaque and white to light yellow suspension after reconstitution.
Maltese: Tamiflu trab għal suspensjoni wara li jiġi rikostitwit jidher bħala suspensjoni opaka u bajda sa isfar ċar.
English: > 6 - 7 kg
Maltese: > 7 sa kg
English: See the second set of instructions.
Maltese: Ara it-tieni sett ta' istruzzjonijiet.
English: • Fill the dispenser with the correct dose Unscrew the cap from the bottle.
Maltese: • Imla' d-dispenser bid-doża korretta Neħħi l-għatu mill-flixkun.
English: NAME OF THE MEDICINAL PRODUCT Tamiflu 75 mg capsules Oseltamivir
Maltese: Tamiflu 75 mg kapsuli ibsin Oseltamivir
English: Tamiflu 30 mg hard capsules Capsule core
Maltese: Tamiflu 30 mg kapsuli ibsin Qalba tal-kapsula
English: What Tamiflu looks like and contents of the pack
Maltese: Id-dehra ta' Tamiflu u l-kontenuti tal-pakkett
English: The safety profile reported in subjects who received the recommended dose of Tamiflu for prophylaxis (75 mg once daily for up to 6 weeks) was qualitatively similar to that seen in the treatment studies, despite a longer duration of dosing in the prophylaxis studies.
Maltese: Il-profil ta' sigurtà rrappurtat f'pazjenti li rċevew id-doża rakkomandata ta' Tamiflu għall-profilassi (75 mg darba kuljum għal perijodu sa 6 ġimgħat) kien simili b'mod kwalitattiv għal dak osservat flistudji ta' kura, minkejja tul ta' żmien itwal ta' dożaġġ fl-istudji ta' profilassi.
English: What Tamiflu looks like and contents of the pack The 45 mg hard capsule consists of a grey opaque body bearing the imprint “ROCHE” and a grey opaque cap bearing the imprint “45 mg”.
Maltese: Kapsula iebsa ta' 45 mg hija magħmula minn ġisem griż opâk li għandu stampat “ROCHE” u għatu griż u opâk li għandu stampat “45 mg”.
English: Vomiting
Maltese: Mediċinali
English: 5.0 ml (or 10.0 ml)
Maltese: 5.0 ml (jew 10.
English: In pre- and post-natal rat studies, prolonged parturition was noted at 1,500 mg/kg/day: the safety margin between human exposure and the highest no-effect dose (500 mg/kg/day) in rats is 480-fold for oseltamivir and 44-fold for the active metabolite, respectively.
Maltese: Fi studju li sar kemm qabel kif ukoll wara t-twelid fuq il-firien, ġie nnotat li lproċess tat-twelid ittawwal meta ngħataw 1,500 mg/kg/jum; il-marġni ta' sigurtà bejn l-espożizzjoni umana u l-ogħla doża li ma ħalliet l-ebda effett (500 mg/kg/jum) fil-ġrieden hija ta' 480 darba għal oseltamivir u ta' 44 darba għall-metabolu attiv, rispettivament.
English: This procedure describes the preparation of a 6 mg/ml suspension that will provide one patient with enough medicine for a 5-day course of treatment or a 10-day course of prophylaxis.
Maltese: Din il-proċedura tiddeskrivi l-preparazzjoni ta' suspensjoni ta' 6 mg/ml li ser tipprovdi pazjent wieħed b'medikazzjoni biżżejjed għall-kors ta' kura ta' 5 ijiem jew kors ta' profilassi ta' 10 ijiem.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/222/001
Maltese: EU/1/02/222/001
English: What Tamiflu looks like and contents of the pack The 30 mg hard capsule consists of a light yellow opaque body bearing the imprint “ROCHE” and a light yellow opaque cap bearing the imprint “30 mg”.
Maltese: Il-kapsula iebsa ta' 30 mg hija magħmula minn ġisem safrani ċar u opâk li għandu stampat “ROCHE” u għatu isfar ċar u opâk li għandu stampat “30 mg”.
English: upper abdominal pain), Dyspepsia, Nausea
Maltese: Uġigħ addominali (inkluż uġigħ fladdome ta' fuq), Dispepsja, Tqalligħ
English: • Hepatic disorders (fulminant hepatitis, hepatic function disorder and jaundice): yellowing of the skin and white of the eyes, change in stool color, changes in behaviour
Maltese: • Disturbi tal-fwied (epatite fulminanti, disturb fil-funzjoni tal-fwied u suffejra): sfurija talġilda u tal-abjad tal-għajnejn, bidla fil-kulur tal-ippurgar, bidliet fl-imġiba
English: Resistant strains selected during oseltamivir treatment have been isolated from both immunocompetent and immunocompromised patients.
Maltese: Razez reżistenti magħżula waqt il-kura b'oseltamivir kienu iżolati kemm minn pazjenti immunokompetenti kif ukoll minn dawk immunokompromessi.
English: Tamiflu contains oseltamivir, which belongs to a group of medicines named neuraminidase inhibitors.
Maltese: Dawn il-mediċini jipprevjenu l-virus tal-influwenza milli jinxtered ġol-ġisem.
English: Clinically important drug interactions involving competition for renal tubular secretion are unlikely, due to the known safety margin for most of these substances, the elimination characteristics of the active metabolite (glomerular filtration and anionic tubular secretion) and the excretion capacity of these pathways.
Maltese: Interazzjonijiet klinikament importanti ma' mediċini li jinvolvu kompetizzjoni għas-sekrezzjoni tubulari renali huma improbabbli, minħabba l-marġni ta' sigurtà magħrufa għall-biċċa l-kbira ta' dawn is-sustanzi, il-karatteristiċi ta' kif jiġi eliminat il-metabolu attiv (filtrazzjoni glomerulari u sekrezzjoni anijonika tubulari) u l-kapaċità ta' l-eliminazzjoni ta' dawn il-passaġġi.
English: NAME OF THE MEDICINAL PRODUCT Tamiflu 30 mg capsules Oseltamivir
Maltese: Informazzjoni għall-utent Tamiflu 30 mg kapsuli ibsin oseltamivir
English: NAME OF THE MEDICINAL PRODUCT Tamiflu 45 mg capsules Oseltamivir
Maltese: Tamiflu 45 mg kapsuli ibsin Oseltamivir
English: When Tamiflu powder for oral suspension is not available Commercially manufactured Tamiflu for oral suspension (6 mg/ml) is the preferred product for paediatric and adult patients who have difficulties swallowing capsules or where lower doses are needed.
Maltese: Meta Tamiflu trab għal suspensjoni orali ma jkunx disponibbli Tamiflu għal suspensjoni orali (6 mg/ml) manifatturat b'mod kummerċjali huwa l-prodott preferut għall-pazjenti pedjatriċi u adulti li għandhom diffikultà biex jibilgħu kapsuli jew meta jkunu meħtieġa dożi aktar baxxi.
English: Always use the oral dispenser that is provided in the box and has markings indicating the dose in millilitres (ml).
Maltese: Uża dejjem id-dispenser ipprovdut fil-kaxxa u li għandu marki li jindikaw id-doża f'millilitri (ml).
English: For adolescents (13 to 17 years of age) and adults: The recommended dose for prevention of influenza following close contact with an infected individual is 75 mg oseltamivir once daily for 10 days.
Maltese: Għall-adoloxxenti (b'età minn 13 sa 17-il sena) u l-adulti d-doża rakkomandata għall-prevenzjoni tal-influwenza wara li jkun sar kuntatt mill-qrib ma' individwu infettat hija ta' 75 mg oseltamivir darba kuljum għal għaxart ijiem.
English: Co-administration of probenecid, a potent inhibitor of the anionic pathway of renal tubular secretion, results in an approximate 2-fold increase in exposure to the active metabolite of oseltamivir.
Maltese: Huwa importanti li jiġu rrappurtati effetti sekondarji suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: A potential for skin sensitisation to oseltamivir was observed in a "maximisation" test in guinea pigs.
Maltese: F'test ta' “massimizzazzjoni” fuq il-fniek tal-Indi ġiet osservata l-possibbilta' ta' sensitizzazzjoni filġilda b'oseltamivir.
English: 30 mg dose
Maltese: 30 mg darba kuljum
English: Tamiflu 45 mg hard capsules Capsule core
Maltese: Tamiflu 45 mg kapsuli ibsin Qalba tal-kapsula
English: Dosing table of oseltamivir for children less than 1 year of age : 3 mg/kg twice daily
Maltese: Tabella ta' dożaġġ ta' oseltamivir għal tfal b'età inqas minn sena: 3 mg/kg darba kuljum Piż tal-ġisem* Doża rakkomandata għal għaxart ijiem
English: 30 mg (suspension or capsules) every second day
Maltese: 30 mg (suspensjoni jew kapsuli) darba kuljum
English: More than 40 kg
Maltese: Aktar minn 40 kg
English: 3.5 ml twice daily 3.5 ml once daily 10 ml
Maltese: 2.5 ml darbtejn kuljum 2.5 ml darba kuljum 3.0 ml
English: When only 75 mg capsules are available, and doses of 30 mg or 45 mg are needed, the preparation of Tamiflu suspension involves additional steps.
Maltese: Meta jkun hemm disponibbli kapsuli ta' 75 mg biss u jkunu meħtieġa dożi ta' 30 mg jew 45 mg, ilpreparazzjoni tas-suspensjoni Tamiflu tinvolvi passi addizzjonali.
English: 20 October 2015 EMA/487922/2015
Maltese: EMA/487922/2015
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom week during treatment.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 ta' Ottubru 2015
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Maltese: Dan ifisser li, għalkemm m'hemmx biżżejjed evidenza minn provi kliniċi, l-effikaċja ta' dawn il-mediċini erbali hija plawsibbli u hemm evidenza li ilhom jintużaw b'dan il-mod sigur għal millinqas 30 sena (inkluż mill-inqas 15-il sena fl-UE).
English: Matricaria oil is the common name for the essential oil of the flower heads of the plant Matricaria recutita L. (also known as chamomile).
Maltese: Żejt tal-kamumella huwa l-isem komuni għaż-żejt essenzjali tal-blanzuni tal-fjuri tal-pjanta Matricaria recutita L. (magħrufa wkoll bħala kamumella).
English: Matricaria oil medicines must not be used in patients who are allergic to matricaria oil or other plants of the same family (Asteraceae (Compositae)).
Maltese: Iż-żejt tal-kamumella ma għandux jintuża f'pazjenti li huma allerġiċi għaż-żejt tal-kamumella jew pjanti oħrajn tal-istess familja (Asteraceae (Compositae)).
English: Matricaria oil medicines should only be used in adults and adolescents (above 12 years of age).
Maltese: Il-mediċini li fihom iż-żejt tal-kamumella għandhom jintużaw biss f'adulti u adolexxenti (li għandhom iktar minn 12-il sena).
English: Further information on the HMPC assessment of matricaria oil medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC concluded that, on the basis of its long-standing use, matricaria oil medicines can be used as add-on treatment of irritation of the skin and areas around the anus and genitals, once serious conditions have been excluded by a medical doctor.
Maltese: Għalkemm hija disponibbli dejta ta' osservazzjoni bil-mediċini li fihom iż-żejt tal-kamumella bħala addittiv għal mal-ilma tal-banju għall-irritazzjoni tal-ġilda, din kienet limitata wisq biex tintuża bħala evidenza.
English: Matricaria oil
Maltese: Żejt tal-kamumella
English: Other information about matricaria oil medicines
Maltese: Aktar informazzjoni dwar il-mediċini li fihom iż-żejt tal-kamumella
English: Further information on the risks associated with matricaria oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati mal-mediċini li fihom iż-żejt tal-kamumella, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografu taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku tal-Aġenzija:
English: The HMPC conclusions on the use of matricaria oil medicines for irritation of the skin and areas around anus and genitals are based on their ‘traditional use' in this condition.
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu tal-mediċini li fihom iż-żejt tal-kamumella għall-irritazzjoni talġilda u l-partijiet madwar l-anus u l-ġenitali huma bbażati fuq l-'użu tradizzjonali' tagħhom f'din ilkundizzjoni.
English: Patients with open wounds, extensive skin damage or acute (short-term) skin disease, high fever and severe infections should not have full or partial baths with matricaria oil.
Maltese: Il-pazjenti b'feriti miftuħin, bi ħsara estensiva fil-ġilda jew b'marda tal-ġilda akuta (għal żmien qasir), b'deni għoli u b'infezzjonijiet severi ma għandhomx jieħdu banju sħiħ jew parzjali biż-żejt tal-kamumella.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of matricaria oil.
Maltese: Dan id-dokument huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għallProdotti Mediċinali Erbali (HMPC) dwar l-użu mediċinali taż-żejt tal-kamumella.
English: Any applications for the licensing of medicines containing matricaria oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Maltese: Kwalunkwe applikazzjoni għal-liċenzjar ta' mediċini li fihom iż-żejt tal-kamumella għandha titressaq lillawtoritajiet nazzjonali responsabbli mill-prodotti mediċinali li ser jivvalutaw l-applikazzjoni għallmediċina erbali u jqisu l-konklużjonijiet xjentifiċi tal-HMPC.
English: Tolerance, dependence
Maltese: Tolleranza, dipendenza
English: It may harm them,
Maltese: Frekwentement,
English: OTFC (normalized to 400 mcg)
Maltese: OTFC (normalizzat għal 400 mcg)
English: TEVA B.V. Swensweg 5 2031 GA Haarlem Netherlands
Maltese: TEVA B.V. Swensweg 5 2031 GA Haarlem L-Olanda
English: Tachycardia Bradycardia
Maltese: Takikardija Bradikardija
English: Partial opioid agonists/antagonists
Maltese: Agonisti/antagonisti parzjali ta' opioid
English: Pharmacokinetic parameter (mean)
Maltese: Parametru farmakokinetiku (medja)
English: Rare: may affect up to 1 in 1,000 people
Maltese: Rari: jistgħu jaffetwaw sa persuna waħda minn kull 1,000
English: The active substance of Effentora is fentanyl citrate.
Maltese: Is-sustanza attiva f'Effentora hi fentanyl citrate.
English: Sodium starch glycolate type A Sodium hydrogen carbonate Sodium carbonate anhydrous Citric acid anhydrous Magnesium stearate
Maltese: Sodium starch glycolate tip A Sodium hydrogen carbonate Sodium carbonate anhydrous Citric acid anhydrous Magnesium stearate
English: AUC0-tmax (ng.hr/ml) AUC0-inf (ng.hr/ml)
Maltese: Tmax (minuta) ** Cmax (ng/mL) AUC0-tmax (ng.hr/mL) AUC0-inf (ng.hr/mL)
English: Controlled sodium diet
Maltese: Dieta tas-sodium ikkontrollata
English: The plasma protein binding of fentanyl is 80% to 85%.
Maltese: It-twaħħil mal-proteini fil-plażma ta' fentanyl huwa 80% sa 85%.
English: Pharmacotherapeutic group: analgesics; opioids; ATC code N02AB03.
Maltese: Kategorija farmakoterapewtika: analġeżiċi; opioids; Kodiċi ATC:
English: • You use benzodiazepines (see section 2 under “Other medicines and Effentora”).
Maltese: • Tuża benzodiazepines (ara sezzjoni 2 taħt “Mediċini oħra u Effentora”).
English: Aluminium laminated blister of PVC/Al foil/Polyamide/PVC with paper/polyester lidding.
Maltese: Folja laminata tal-aluminju ta' PVC/folja ta' Al/Polyamide/PVC b'għatu tal-karta/polyester.
English: Biliary dilatation
Maltese: Dilatazzjoni biljari
English: Plasma Fentanyl Concentration (ng/mL)
Maltese: Konċentrazzjoni fil-Plażma ta' Fentanyl (ng/mL)
English: Patients assessed pain intensity on a 11-point scale.
Maltese: Il-pazjenti vvalutaw l-intensità ta' l-uġigħ fuq skala ta' 11-il punt.
English: Respiratory depression
Maltese: depressjoni respiratorja.
English: Contains sodium
Maltese: Fih sodium
English: Very common Common
Maltese: Mhux Komuni Rari
English: Effentora 400 micrograms
Maltese: Effentora 400 mikrogramma