FrancophonIA/ELRC3.0 huggingface dataset:
English: Powder and solvent for prolonged release suspension for injection Powder and solvent for prolonged release suspension for injection Powder and solvent for prolonged release suspension for injection
Maltese: Mnejn jingħata Il-pakkett
English: MA (EU) number (Invented) name Strength
Maltese: Numru ta' l-EU Isem (ivvintat)
English: 5 million cells/ml Suspension for injection
Maltese: 5 miljun ċellola/ml suspensjoni għall-injezzjoni
English: Pharmaceutica l Form
Maltese: Għamla farmaċewtika
English: Intralesional use vial (glass)
Maltese: Użu għal ġol ferita kunjett (ħġieġ) 6 ml
English: EMA/429427/2010 EMEA/H/C/000703
Maltese: EMEA/H/C/000703
English: The full EPAR for Gardasil can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: • genital warts.
Maltese: • felul ġenitali.
English: Gardasil human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
Maltese: Gardasil vaċċin tal-papillomavirus uman [tipi 6, 11, 16, 18] (rikombinanti, assorbit)
English: • precancerous lesions (growths) in the cervix, vulva or vagina and anus;
Maltese: • leżjonijiet prekanċerużi (tkabbir) fiċ-ċerviċi, il-vulva jew il-vaġina u l-anus;
English: HPV types 16 and 18 cause approximately 70% of cervical cancers and between 75 and 80% of anal cancers.
Maltese: It-tipi 16 u 18 talHPV jikkawżaw madwar 70% tal-kanċers taċ-ċerviċi u bejn 75 u 80% tal-kanċers anali.
English: This document is a summary of the European public assessment report (EPAR) for Gardasil.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Gardasil.
English: HPV types 6 and 11 cause approximately 90% of genital warts.
Maltese: It-tipi 6 u 11 tal-HPV jikkawżaw madwar 90% tal-felul ġenitali.
English: • cervical and anal cancers;
Maltese: • kanċer taċ-ċerviċi u kanċer anali;
English: It is a suspension for injection that contains purified proteins for four types of the human papillomavirus (types 6, 11, 16 and 18).
Maltese: Dan huwa sospensjoni għal injezzjoni li fiha proteini purifikati għal erba' tipi ta' papillomavirus uman (tipi 6, 11, 16 u 18).
English: Gardasil contains the purified L1 proteins for HPV types 6, 11, 16 and 18, which are produced by a method known as ‘recombinant DNA technology': they are made by yeast cells into which a gene (DNA) has been introduced that makes them able to produce the L1 proteins.
Maltese: Gardasil fih il-proteini L1 purifikati għat-tipi 6, 11, 16 u 18 tal-HPV, li huma prodotti b'metodu magħruf bħala 'teknoloġija rikombinanti' tad-DNA: dawn isiru minn ċelloli tal-ħmira li fihom tkun ġiet introdotta ġene (DNA) li tagħmilhom kapaċi jipproduċu l-proteini L1.
English: Gardasil is a vaccine.
Maltese: Gardasil huwa vaċċin.
English: When a patient is given the vaccine, the immune system makes antibodies against the L1 proteins.
Maltese: Meta pazjent jingħata l-vaċċin, is-sistema immunitarja tipproduċi antikorpi kontra l-proteini L1.
English: A similar effect of Gardasil was seen when the analysis also included lesions of the cervix due to the other two HPV types (types 6 and 11).
Maltese: Gardasil wera effetti simili meta l-analiżi inkludiet ukoll leżjonijiet taċ-ċerviċi minħabba ż-żewġ tipi l-oħra tal-HPV (tipi 6 u 11).
English: These virus-like particles are not capable of causing infection.
Maltese: Dawn ilpartikuli qishom virus mhumiex kapaċi jikkawżaw infezzjoni.
English: Three studies of Gardasil given as three doses looked at the ability of Gardasil to prevent infection with HPV types 6, 11, 16 and 18 and genital warts caused by these HPV types in almost 4,000 women aged between 24 and 45 years, and at the development of antibodies against these HPV types in around 1,700 girls and boys aged between nine and 15 years.
Maltese: Tliet studji ta' Gardasil mogħti bħala tliet dożi ffokaw fuq l-abbiltà ta' Gardasil li jipprevjeni infezzjoni mit-tipi 6, 11, 16 u 18 tal-HPV u leżjonijiet ġenitali kkawżati minn dawn it-tipi ta' HPV fi kważi 4,000 mara ta' bejn l-24 u l-45 sena, kif ukoll fuq l-iżvilupp ta' antikorpi għal kontra dawn it-tipi ta' HPV f'madwar 1,700 tifel u tifla ta' bejn id-disa' snin u l-15-il sena.
English: All papillomaviruses have a shell, or ‘capsid', that is made up of proteins called ‘L1 proteins'.
Maltese: Il-papillomavirusis kollha għandhom qoxra, jew ‘kapside', magħmula minn proteini msejħin ‘proteini L1'.
English: Gardasil is used in males and females from the age of nine years to protect against the following conditions caused by specific types of human papillomavirus (HPV):
Maltese: Gardasil jintuża f'irġiel u nisa mill-età ta' disa' snin għall-protezzjoni kontra l-kondizzjonijiet li ġejjin ikkawżati minn tipi speċifiċi ta' papillomavirus uman (HPV):
English: After vaccination, the immune system is able to produce antibodies more quickly when it is exposed to the real viruses.
Maltese: Wara lvaċċinazzjoni, is-sistema immunitarja ssir kapaċi tipproduċi antikorpi b'ritmu aktar mgħaġġel meta tkun esposta għall-virusis reali.
English: What is Gardasil?
Maltese: X'inhu Gardasil?
English: In contrast, there was a total of 189 cases of external genital lesions out of almost 8,000 women in the placebo group.
Maltese: Bil-maqlub ta' dan, kien hemm total ta' 189 każ ta' leżjonijiet ġenitali esterni minn kważi 8,000 mara fil-grupp talplaċebo.
English: With regard to precancerous anal lesions, there 5 cases in the vaccinated group (consisting of around 200 patients) compared with 24 cases in the placebo group (which also had around 200 patients).
Maltese: Fir-rigward ta' leżjonijiet anali prekanċerużi, kien hemm 5 każijiet fil-grupp li ngħata l-vaċċin (li kien jikkonsisti f'madwar 200 pazjent) meta mqabbel ma' 24 każ fil-grupp tal-plaċebo (li kien jinkludi wkoll madwar 200 pazjent).
English: The proteins are assembled in ‘virus-like particles' (structures that look like HPV, so that the body can recognise them easily).
Maltese: Il-proteini jinġemgħu f''partikuli qishom virus' (strutturi li jixbhu l-HPV, sabiex il-ġisem ikun jista' jagħrafhom faċilment).
English: In the four studies in 21,000 women, out of the more than 8,000 women vaccinated with Gardasil who had never been infected by HPV types 6, 11, 16 or 18 before, one woman developed a precancerous lesion in the cervix that might have been due to HPV type 16 or 18.
Maltese: Fl-erba' studji f'21,000 mara, minn aktar minn 8,000 mara li ngħataw il-vaċċin ta' Gardasil li qatt ma kienu infettati mit-tipi 6, 11, 16 jew 18 tal-HPV qabel, mara waħda żviluppat leżjonijiet prekanċerużi fiċ-ċerviċi li setgħu kienu kaġun tat-tipi 16 jew 18 tal-HPV.
English: Other information about Gardasil:
Maltese: Tagħrif ieħor dwar Gardasil:
English: Why has Gardasil been approved?
Maltese: Għaliex ġie approvat Gardasil?
English: How has Gardasil been studied?
Maltese: Kif ġie studjat Gardasil?
English: In four main studies of Gardasil given as three dose, Gardasil was compared with placebo (a dummy vaccine) in almost 21,000 women aged between 16 and 26 years.
Maltese: F'erba' studji ewlenin ta' Gardasil mogħti bħala tliet dożi, Gardasil tqabbel ma' plaċebo (vaċċin finta) fi kważi 21,000 mara ta' bejn is-16 u s-26 sena.
English: There were no cases of anal cancer in the study but it is expected that protection against precancerous anal lesions will translate into protection against the cancer.
Maltese: Ma kien hemm l-ebda każ ta' kanċer anali fl-istudju iżda huwa mistenni li l-protezzjoni kontra leżjonijiet anali prekanċerużi tinbidel fi protezzjoni kontra l-kanċer.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Gardasil on 20 September 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Gardasil valida fl-Unjoni Ewropea kollha fl-20 ta' Settembru 2006.
English: What is the risk associated with Gardasil?
Maltese: X'inhu r-riskju assoċjat ma' Gardasil?
English: Human papillomaviruses are viruses that cause warts and abnormal tissue growth.
Maltese: Il-papillomavirusis huma virusis li jikkawżaw felul u tkabbir anormali fit-tessuti.
English: In the study boys and men, there were 3 cases genital lesions among around 1,400 patients given the vaccines compared with 32 cases among around 1,400 given placebo.
Maltese: Fl-istudju tas-subien u l-irġiel, kien hemm 3 każijiet ta' leżjonijiet ġenitali fost madwar 1,400 pazjent li ngħataw il-vaċċini meta mqabbla ma' 32 każ fost madwar 1,400 li ngħataw il-plaċebo.
English: Finally, a main study in around 4,000 boys and men from 16 years of age compared the vaccine with placebo to test the vaccine's effect in preventing genital warts, precancerous anal lesions and anal cancer.
Maltese: Fl-aħħar nett, studju ewlieni f'madwar 4,000 tifel u raġel ta' bejn is-16 u s-26 sena qabbel il-vaċċin mal-plaċebo biex jiġi ttestjat l-effett tal-vaċċin fil-prevenzjoni ta' felul ġenitali, leżjonijiet anali prekanċerużi u kanċer anali.
English: In studies, the most common side effects with Gardasil (seen in more than 1 patient in 10) were headache and reactions at the site of the injection (redness, pain and swelling).
Maltese: Fl-istudji, l-effetti sekondari l-aktar komuni b'Gardasil (li dehru f'iktar minn pazjent 1 minn kull 10) kienu wġigħ ta' ras u reazzjonijiet fis-sit tal-injezzjoni (ħmura, uġigħ u nefħa).
English: The main measure of effectiveness was the development of antibodies against HPV types 6, 11, 16 and 18 one month after the last dose.
Maltese: Il-kejl ewlieni tal-effikaċja kien l-iżvilupp ta' antikorpi kontra t-tipi 6, 11, 16 u 18 tal-HPV xahar wara l-aħħar doża.
English: For the full list of all side effects reported with Gardasil, see the package leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji kollha rrapportati b'Gardasil, ara l-fuljett ta' tagħrif.
English: In contrast, 85 of the more than 8,000 women who received the placebo vaccine developed lesions that were due to these two HPV types.
Maltese: Bil-maqlub ta' dan, 85 minn aktar minn 8,000 mara li ngħataw il-vaċċin plaċebo żviluppaw leżjonijiet li kienu riżultat ta' dawn iż-żewġ tipi talHPV.
English: In the three studies on genital warts, 2 women out of almost 8,000 in the Gardasil group developed genital warts, and there were no cases of precancerous lesions of the vulva or the vagina.
Maltese: Fit-tliet studji dwar felul ġenitali żewġ nisa minn kważi 8,000 fil-grupp ta' Gardasil żviluppaw felul ġenitali, u ma kienx hemm każijiet ta' leżjonijiet prekanċerużi tal-vulva jew il-vaġina.
English: The vaccine is given as an injection into a muscle, preferably in the shoulder or the thigh.
Maltese: Il-vaċċin jingħata bħala injezzjoni f'muskolu, preferibbilment fl-ispalla jew ilkoxxa.
English: A risk management plan has been developed to ensure that Gardasil is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Gardasil jintuża bl-aktar mod sigur possibbli.
English: The vaccine also contains an ‘adjuvant' (a compound containing aluminium) to stimulate a better response.
Maltese: Il-vaċċin fih ukoll ‘adjuvant' (taħlita li fiha l-aluminju) biex jistimola rispons aħjar.
English: The studies also showed that the vaccine stimulates the production of sufficient amounts of antibodies against HPV in girls and boys aged between nine and 15 years.
Maltese: L-istudji wrew ukoll li l-vaċċin jistimula l-produzzjoni ta' ammonti biżżejjed ta' antikorpi kontra l-HPV fil-bniet u s-subien ta' bejn id-disgħa snin u l-15-il sena.
English: The CHMP decided that Gardasil's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Gardasil huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The studies also showed that Gardasil provided some protection against lesions in the cervix linked to other cancer-causing types of HPV, including type 31.
Maltese: Dan jgħin fil-protezzjoni kontra l-mard ikkawżat minn dawn il-virusis.
English: There are more than 100 types of papillomavirus, some of which are associated with genital cancers.
Maltese: Hemm iktar minn 100 tip ta' papillomavirus, li wħud minnhom huma assoċjati ma' kanċers ġenitali.
English: Further information on Pegfilgrastim Mundipharma can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/pegfilgrastim-mundipharma.
Maltese: ema.europa.eu/medicines/human/EPAR/pegfilgrastim-mundipharma.
English: The active substance in Pegfilgrastim Mundipharma, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Maltese: Is-sustanza attiva f'Pegfilgrastim Mundipharma, il-pegfilgrastim, hija forma ta' filgrastim, li hija simili ħafna għal proteina tal-bniedem imsejħa fattur stimolanti tal-kolonja tal-granuloċiti (G-CSF).
English: Laboratory studies comparing Pegfilgrastim Mundipharma with Neulasta have shown that the active substance in Pegfilgrastim Mundipharma is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li qabblu Pegfilgrastim Mundipharma ma' Neulasta wrew li s-sustanza attiva f'Pegfilgrastim Mundipharma hija simili ħafna għal dik f'Neulasta f'termini ta' struttura, purità u attività bijoloġika.
English: Pegfilgrastim Mundipharma contains the active substance pegfilgrastim.
Maltese: Pegfilgrastim Mundipharma fih is-sustanza attiva pegfilgrastim.
English: The reference medicine for Pegfilgrastim Mundipharma is Neulasta.
Maltese: Ilmediċina ta' referenza għal Pegfilgrastim Mundipharma hija Neulasta.
English: Other information about Pegfilgrastim Mundipharma
Maltese: Informazzjoni oħra dwar Pegfilgrastim Mundipharma
English: What are the risks associated with Pegfilgrastim Mundipharma?
Maltese: X'inhuma r-riskji assoċjati ma' Pegfilgrastim Mundipharma?
English: Pegfilgrastim Mundipharma is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy.
Maltese: Pegfilgrastim Mundipharma jingħata bħala doża waħda ta' 6 mg li tiġi injettata taħt il-ġilda mill-inqas 24 siegħa wara t-tmiem ta' kull ċiklu ta' kimoterapija.
English: It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (when neutropenia is accompanied by fever due to an infection).
Maltese: Dan jingħata speċifikament biex jitnaqqas it-tul ta' żmien tan-newtropenija u biex tiġi evitata nnewtropenija bid-deni (meta n-newtropenija tkun akkumpanjata minn deni minħabba infezzjoni).
English: Pegfilgrastim Mundipharma is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia).
Maltese: Pegfilgrastim Mundipharma mhuwiex maħsub biex jintuża f'pazjenti bil-lewkimja majelojde kronika talkanċer tad-demm jew b'sindromi majelodisplastiċi (kundizzjonijiet li fihom jiġi prodott għadd kbir ta' ċelloli tad-demm anormali, li jistgħu jiżviluppaw f'lewkimja).
English: Pegfilgrastim Mundipharma is a ‘biosimilar medicine'.
Maltese: Pegfilgrastim Mundipharma huwa “mediċina bijosimili”.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Pegfilgrastim Mundipharma has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Pegfilgrastim Mundipharma għandu struttura, purità u attività bijoloġika simili ħafna għal Neulasta u jiġi distribwit bl-istess mod fil-ġisem.
English: Pegfilgrastim Mundipharma is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer chemotherapy and can leave patients vulnerable to infections.
Maltese: Pegfilgrastim Mundipharma huwa mediċina li tintuża f'pazjenti bil-kanċer biex tgħin fin-newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm), li hija effett sekondarju komuni talkimoterapija tal-kanċer u tista' twassal biex il-pazjenti jsiru vulnerabbli għall-infezzjonijiet.
English: How is Pegfilgrastim Mundipharma used?
Maltese: Kif jaħdem Pegfilgrastim Mundipharma?
English: As for all medicines, data on the use of Pegfilgrastim Mundipharma are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Pegfilgrastim Mundipharma hija ssorveljata kontinwament.
English: For more information on biosimilar medicines, see here.
Maltese: Għal aktar informazzjoni dwar ilmediċini bijosimili, ara hawn.
English: What measures are being taken to ensure the safe and effective use of Pegfilgrastim Mundipharma?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Pegfilgrastim Mundipharma?
English: All these data were considered sufficient to conclude that Pegfilgrastim Mundipharma will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses.
Maltese: Din id-data kollha ġiet meqjusa biżżejjed sabiex jiġi konkluż li Pegfilgrastim Mundipharma se jaġixxi bl-istess mod bħal Neulasta f'termini ta' effikaċja u sigurtà fl-użijiet approvati tiegħu.
English: Mundipharma, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Maltese: F'Pegfilgrastim Mundipharma, il-filgrastim ġiet “pegilata” (twaħħlet ma' kimika msejħa polietilenglikol).
English: The most common side effect with Pegfilgrastim Mundipharma (which may affect more than 1 in 10 people) is pain in the bones.
Maltese: Leffett sekondarju l-aktar komuni b'Pegfilgrastim Mundipharma (li jista' jaffettwa aktar minn persuna waħda minn kull 10) huwa wġigħ fl-għadam.
English: Side effects reported with Pegfilgrastim Mundipharma are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Pegfilgrastim Mundipharma huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: This means that Pegfilgrastim Mundipharma is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Pegfilgrastim Mundipharma huwa simili ħafna għal mediċina bijoloġika oħra (il-“mediċina ta' referenza”) li diġà hija awtorizzata fl-UE.
English: For the full list of side effects and restrictions with Pegfilgrastim Mundipharma, see the package leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji u r-restrizzjonijiet b'Pegfilgrastim Mundipharma, ara l-fuljett ta' tagħrif.
English: How does Pegfilgrastim Mundipharma work?
Maltese: Kif jintuża Pegfilgrastim Mundipharma?
English: The safety of Pegfilgrastim Mundipharma has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neulasta.
Maltese: Is-sigurtà ta' Pegfilgrastim Mundipharma ġiet evalwata, u abbażi tal-istudji kollha li saru, l-effetti sekondarji tal-mediċina jitqiesu li huma komparabbli ma' dawk tal-mediċina ta' referenza Neulasta.
English: vasodilatation.
Maltese: vasodilatazzjoni.
English: • the possible development of tolerance,
Maltese: • Il-possibilita' li tiġi żviluppata tolleranza,
English: Madrid, Spain transdérmicos EFG
Maltese: Madrid, Spanja transdérmicos EFG
English: Active substance Parenteral (im) Oral
Maltese: Sustanza Attiva Parenterali (im) Orali
English: 10 (rectal)
Maltese: 10 (rettali)
English: Spain ratiopharm España, S.A.
Maltese: Spanja ratiopharm España, S.A.
English: xerostomia, dyspepsia.
Maltese: gżerostomja, dispepsja.
English: Morphine
Maltese: Morfina
English: Uncommon: tachycardia, bradycardia.
Maltese: Mhux komuni: takikardija, bradikardija.
English: Avenida de Burgos 16D, 5º Planta, 28036 Madrid, Spain
Maltese: Avenida de Burgos 16D, 5º Planta, 28036 Madrid, Spanja
English: respiratory depression, apnoea.
Maltese: dipressjoni respiratorja, apneja.
English: {Name and Address} {tel} {fax} {e-mail}
Maltese: {Isem u indirizz} {telefon} {fax} {e-mail}
English: {Name and address} {tel} {fax} {e-mail}
Maltese: {telefon} {fax} {e-mail}
English: amblyopia.
Maltese: ambliopija.
English: For a full list of excipients, see section 6.1.
Maltese: Għal lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: Albert-SchweitzerGasse 3, 1140 WIEN, Austria
Maltese: Albert-SchweitzerGasse 3, 1140 WIEN, L-Awstrija
English: Manufacturer Merckle GmbH Ludwig-Merckle-Str. 3 89143 Blaubeuren Germany
Maltese: Merckle GmbH Ludwig-Merckle-Str. 3 89143 Blaubeuren Il-Ġermanja
English: Distribution The plasma protein binding for fentanyl is 84 %.
Maltese: Distribuzzjoni Il-perċentwal ta' fentanyl li jeħel mal-proteini tad-demm huwa 84 %.
English: The following frequencies are used for the description of the occurrence of adverse reactions: Very common (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1000, <1/100), Rare (≥1/10,000, <1/1000), Very rare (<1/10,000)
Maltese: Reazzjonijiet avversi huma kklassifikati taħt it-titlu tal-frekwenza, l-aktar frekwenti l-ewwel, bil-konvenzjoni li ġejja: komuni ħafna ( ≥ 10 %), komuni ( ≥ 1 % u < 10 %), mhux komuni ( ≥ 0.1 % u < 1 %), rari (≥ 0.01 % u < 0.1 %), rari ħafna ( ≤ 0.01 %).
English: Pharmacotherapeutic group: opioids; Phenylpiperidine derivatives, ATC code: N02AB03
Maltese: Kategorija farmakoterapewtika: opjojdi; derivattivi ta' Phenylpiperidine, Kodiċi ATC:
English: sedation, nervousness, loss of appetite.
Maltese: sedazzjoni, nervożita', nuqqas ta' aptit.
English: arrhythmia.
Maltese: arritmija.
English: If needed, a similar dose can be given every 2 or 3 minutes, or be administered as continued infusion as 2 mg in 500 ml sodium chloride 9 mg/ml (0.9 %) solution for injection or glucose 50 mg/ml (5 %) solution.
Maltese: Jekk ikun hemm il-bżonn, doża simili tista' tingħata kull 2-3 minuti, inkella tista' tiġi amministrata bħala infużjoni kontinwa ta' 2mg ġo 500ml sodium chloride 9mg/ml (0.9 %) soluzzjoni għall-injezzjoni jew ġo soluzzjoni ta' glucose 50mg/ml (5 %).
English: 0.8 (sublingual)
Maltese: 0.8 (taħt l-ilsien)
English: Fentanyl is metabolized primarily in the liver via CYP3A4.
Maltese: Fentanyl jiġi metabolizzat primarjament fil-fwied minn CYP3A4.
English: Fentanyl may produce bradycardia.
Maltese: Fentanyl jista' jipproduċi bradikardja.
English: - Severe impairment of the central nervous system.
Maltese: - Indeboliment sever tas-sistema nervuża ċentrali
English: The CNS depressants mentioned above include: - opioids - anxiolytics and tranquilizers - hypnotics - general anaesthetics - phenothiazines - skeletal muscle relaxants - sedating antihistamines - alcoholic beverages
Maltese: Id-dipressanti tas-CNS imsemmija jinkludu: - opjojdi - ansjolitiċi u trankwillanti - ipnotiċi - anestetiċi generali - phenothiazines - Rilassanti tal-muskoli skeletali - antiistaminiċi b'effetti sedattivi - xorb alkoħoliku
English: A starting dose of 0.4-2 mg naloxone hydrochloride i.v.
Maltese: 4-2 mg naloxone hydrochloride mogħtija minn ġol-vina.
English: The symptoms of fentanyl overdose are an extension of its pharmacological actions, e.g. lethargy, coma, respiratory depression with Cheyne-Stokes respiration and/or cyanosis.
Maltese: Is-sintomi ta' doża eċċessiva ta' fentanyl huma estensjonijiet ta' l-attivita` farmakoloġika ez.letarġija, koma, dipressjoni respiratorja, b'respirazzjoni Cheyne-Stokes, u/jew cyanosis.
English: Finally, regarding the demonstration of bioequivalence, the discussions pertained to the deviations to the guideline “Note for guidance on modified release oral and trans-dermal dosage forms: section II: pharmacokinetic and clinical evaluation- (CPMP/EWP/280/96)”.
Maltese: Fl-aħħarnett, fir-rigward tal-wiri ta' bijoekwivalenza, id-diskussjonijiet kienu fuq id-devjazzjonijiet mil-linja gwida “Nota għal gwida fuq forom ta' dożaġġ b'rilaxx immodifikat orali u transdermali: sezzjoni II: evalwazzjoni farmakokinetika u evalwazzjoni klinika-(CPMP/EWP/280/96)”.