FrancophonIA/ELRC3.0 huggingface dataset:
English: Following widespread use of hepatitis B vaccines, in very rare cases, syncope, paralysis, neuropathy, neuritis (including Guillain-Barré syndrome, optic neuritis and multiple sclerosis), encephalitis, encephalopathy, meningitis and convulsions have been reported.
Maltese: Wara użu estensiv tal-vaċċin ta' l-epatite B, f'każi rari ħafna, ġew irrapurtati, reqqet ir-ruħ, paraliżi, newropatija, newrite (inkluż il-marda ta' Guillain-Barré, newrite ottika u sklerożi multipla), enkefalite, enkefalopatija, meninġite u konvulżjonijiet.
English: Rare: vertigo
Maltese: Rari:sturdament
English: Pharmacotherapeutic group: Vaccines, hepatitis vaccines, ATC code J07BC01.
Maltese: Vaċċini, vaċċini tal-epatite, Kodiċi ATC JO7BC01
English: • problems with the nerves of your eye (optic neuritis)
Maltese: • problemi bin-nervituri ta' għajnejk (newrite ottika)
English: Date of first authorisation: 02 February 2005 Date of latest renewal: 10 December 2009
Maltese: Data tal-aħħar tiġdid: 10 ta' Diċembru 2009
English: Fendrix induces specific humoral antibodies against HBsAg (anti-HBs antibodies).
Maltese: Fendrix tinduċi antikorpi speċifiċi ta' l-umuri kontra l-HbsAg (antikorpi kontra l-HBs).
English: Fendrix is for adults and young people aged 15 years and above.
Maltese: Fendrix qiegħed għal adulti u żgħażagħ mill-età ta' 15-il sena 'l fuq.
English: (≥1/100 to <1/10) Uncommon: (≥1/1,000 to <1/100)
Maltese: (≥1/1,000 sa <1/100)
English: 2adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total) 3produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
Maltese: 2adsorbit fuq aluminium phosphate (total ta' 0.5 milligrammi Al3+) 3manifatturat f'ċelloli tal-ħmira (Saccharomyces cerevisiae) permezz tat-teknoloġija rekombinanti tad
English: Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
Maltese: Fendrix suspensjoni għall-injezzjoni Epatite B (rDNA) vaċċin (supplimentat, adsorbit)
English: Hepatitis B surface antigen 1, 2, 3
Maltese: L-antiġenu ta' barra ta' l-epatite 1, 2, 3
English: Their frequency is defined using the conventions listed below:
Maltese: Il-frekwenza tagħhom hija ddefinita skont il-konvenzjonijiet elenkati hawn taħt:
English: • infection caused by a virus
Maltese: • infezzjoni kkawżata minn virus
English: 2adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total) 3produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
Maltese: 2adsorbit fuq aluminium phosphate (total ta' 0.5 milligramma Al3+) 3manifatturat f'ċelloli tal-ħmira (Saccharomyces cerevisiae) permezz tat-teknoloġija rikombinanti tadDNA.
English: • feeling nervous
Maltese: • tħossok nervuż
English: PREFILLED SYRINGE
Maltese: Twissijiet u prekawzjonijiet
English: GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut - 1330 Rixensart Belgium
Maltese: 89, Rue de l'Institut - 1330 Rixensart Il-Belġju
English: Hepatitis B surface antigen1, 2, 3
Maltese: L-antiġenu ta' barra ta' l-epatite B1, 2, 3
English: Limited data on overdose are available.
Maltese: Hija disponibbli dejta limitata dwar doża eċċessiva..
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 dose (0.5 ml):
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Doża waħda (0.5ml):
English: Gastrointestinal disorders: Common: gastrointestinal disorder
Maltese: Komuni: disturb gastro-intestinali
English: Other medicines and Fendrix
Maltese: Mediċini oħra u Fendrix
English: LIST OF EXCIPIENTS Sodium chloride Water for injections
Maltese: TA' EĊĊIPJENTI Sodium Chloride
English: NAME OF THE MEDICINAL PRODUCT Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
Maltese: Fendrix suspensjoni għall-injezzjoni Epatite B (rDNA) vaċċin (supplimentat, adsorbit).
English: Contents of the pack and other information What Fendrix contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Fendrix:
English: • allergic reactions, including anaphylactoid reactions.
Maltese: • reazzjonijiet allerġiċi, li jinkludu reazzjonijiet anafilaktojd.
English: Fendrix is indicated in adolescents and adults from the age of 15 years onwards for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients).
Maltese: Fendrix huwa indikat fl-adoloxxenti u fl-adulti mill-età ta' 15-il sena 'il fuq għat-tilqim attiv kontra linfezzjoni ikkawżata mis-sub-tipi kollha magħrufa tal-virus ta' l-epatite B (HBV) għall-pazjenti b'insuffiċjenza tal-kliewi (inkluż il-pazjenti qabel jagħmlu d-dialisi tad-demm u l-pazjenti waqt li jagħmlu d-dialisi tad-demm).
English: An anti-HBs antibody titre ≥ 10 mIU/ml correlates with protection to HBV infection.
Maltese: Titre ta' antikorpi ≥ 10mIU/ml jikkorelata ma' protezzjoni mill-infezzjoni bil-HBV.
English: In a comparative clinical study in 165 pre-haemodialysis and haemodialysis patients (15 years and above), protective levels of specific humoral antibodies (anti-HBs titres ≥ 10 mIU/ml) were observed in 74.4% of Fendrix recipients (N = 82) one month after the third dose (i.e at month 3), as compared to 52.4% of patients in the control group who received a double dose of a commercially available hepatitis B vaccine (N = 83) for this population.
Maltese: Fi studju kliniku kumparattiv f'165 pazjent ta' qabel id-dialisi tad-demm u ta' waqt id-dialisi taddemm (minn 15-il sena ‘l fuq), xahar wara t-tielet doża (jiġifieri fit-tielet xahar), kienu osservati livelli protettivi ta' antikorpi speċifiċi ta' l-umuri (titres ta' kontra l-HBs ≥ 10mIU/ml) f'74.4% ta'dawk li ħadu Fendrix (N=82) meta mqabbla ma' 52.4% tal-pazjenti tal-grupp ta' kontroll li rċievew doża doppja ta' vaċċin ta' l-epatite B li hawn fis-suq (N=83).
English: Antibody persistence
Maltese: Persistenza ta' l-antikorp
English: At month 3, Geometric Mean Titres (GMT) were 223.0 mIU/ml and 50.1 mIU/ml in the Fendrix and control groups respectively, with 41.0% and 15.9% of subjects with anti-HBs antibody titres ≥100 mIU/ml respectively.
Maltese: Fit-3 xahar Titres Ġometriċi Medji (TGM) kienu ta' 223.0 mIU/ml u 50.1mIU/ml fil-grupp ta' Fendrix u ta' kontroll rispettivament, b'41% u 15.9% rispettivament tas-suġġetti b'titres ta' antikorpi ta' kontra l-HBs ≥ 100mIU/ml.
English: • Fendrix is available in packs of 1 (with or without a separate needle) and in a pack size of 10 without needles.
Maltese: • Fendrix jinsab f'pakkett ta' 1 (b'labra separata jew mingħajrha) u f'pakkett ta' 10 mingħajr labar.
English: • numbness or weakness of the arms and legs (neuropathy), inflammation of nerves (neuritis), weakness and paralysis in the extremities and often progressing to the chest and face (Guillain-Barré syndrome), swelling or infection of the brain (encephalitis, encephalopathy).
Maltese: • titrix jew dgħufija tad-dirgħajn u r-riġlejn (newropatija), infjammazzjoni tan-nervituri (newrite), dgħufija u paraliżi fl-idejn u fis-saqajn u ħafna drabi tinfirex għas-sider u l-wiċċ (sindrome ta' Guillain-Barré), nefħa jew infezzjoni tal-moħħ (enċefalite, enċefalopatija).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva GlaxoSmithKline Biologicals S.A.
English: What is hepatitis B?
Maltese: X'inhi l-epatite B?
English: United Kingdom GlaxoSmithKline UK Tel: +44 (0)800 221 441 customercontactuk@gsk.com
Maltese: United Kingdom GlaxoSmithKline UK Tel: +44 (0)800 221 441
English: At month 7, GMTs were 3559.2 mIU/ml and 933.0 mIU/ml in the Fendrix and control groups who received the commercially available hepatitis B vaccine respectively, with 83.1% and 67.5% of subjects with anti-HBs antibody titres ≥100 mIU/ml respectively.
Maltese: Fis-7 xahar, it-TGM kienu ta' 3559.2mIU/ml u 933.0mIU/ml rispettivament fil-grupp ta' Fendrix u lgrupp ta' kontroll li ħadu l-vaċċin ta' l-epatite B li hawn fis-suq, b'83.1% u 67.5% rispettivament tassuġġetti b'titres ta' antikorpi kontra l-HBs ≥100mIU/ml.
English: MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ GlaxoSmith Kline Biologicals s.a
English: • Fendrix can only help to protect you against infection with the hepatitis B virus.
Maltese: • Fendrix jista' jgħin biss biex jipproteġik kontra infezzjoni bil-virus tal-epatite B.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains:
Maltese: U KWANTITATTIVA Doża waħda (0.5millilitru) fiha:
English: Non-clinical data reveal no special hazard for humans based on conventional animal studies consisting of acute and repeated dose toxicity, cardiovascular and respiratory safety pharmacology and reproductive toxicity including pregnancy and peri and postnatal development of the pups till weaning (see section 4.6).
Maltese: Tagħrif mhux kliniku magħmul fuq studji konvenzjonali fl-annimali ta' l-effett tossiku minn dożi ripetuti u akuti, sigurtà farmakoloġika kardiovaskulari u respiratorja u ta' l-effett tossiku fuq is-sitema riproduttiva inkluż fit-tqala u fl-iżvilupp ta' qabel u wara t-twelid tal-frieħ sal-ftim ma juru l-ebda periklu speċjali għall-bnedmin (ara sezzjoni 4.6).
English: at.info@gsk.com
Maltese: lv-epasts@gsk.com customercontactuk@gsk.com
English: 10 pre-filled syringes 1 dose (0.5 ml)
Maltese: 10 siringi mimlijin għal-lest Doża waħda (0.5 ml)
English: Fendrix should be injected intramuscularly in the deltoid region.
Maltese: Fendrix għandu jingħata b'injezzjoni fil-muskolu, fil-parti deltoid.
English: • if you have ever had an allergic reaction to any vaccine against hepatitis B
Maltese: • jekk inti qatt kellek reazzjoni allerġika għal kwalunkwe tilqima kontra l-epatite B
English: Muskuloskeletal and connective tissue disorders: Rare: tendinitis, back pain
Maltese: Disturbi muskolu-skeltrali u tal-connective tissue: Rari: infjammazzjoni ta' l-għerq, uġigħ fid-dahar
English: 1 pre-filled syringe 1 dose (0.5 ml)
Maltese: Doża waħda (0.5ml)
English: • The other ingredients in Fendrix are: sodium chloride, water for injections.
Maltese: • Is-sustanzi l-oħra f'Fendrix huma: sodium chloride, ilma għall-injezzjonijiet.
English: After completion of a four dose primary course (i.e at month 7), 90.9% of Fendrix recipients were seroprotected (≥ 10 mIU/ml) against hepatitis B, in comparison with 84.4% in a control group who received the commercially available hepatitis B vaccine.
Maltese: Wara li tlesta l-kors primarju ta' l-ewwel erba' dożi (jiġifieri fis-7 xahar), 90.9% ta' dawk li ħadu Fendrix kellhom seroprotezzjoni (≥ 10mIU/ml) kontra l-epatite B meta mqabbla ma 84.
English: GlaxoSmithKline Latvia SIA Tel: + 371 67312687 lv-epasts@gsk.com
Maltese: GlaxoSmithKline Latvia SIA Tel: + 371 67312687
English: Anti-HBs antibodies have been shown to persist for at least 36 months following a 0, 1, 2, 6 month primary course of Fendrix in pre-haemodialysis and haemodialysis patients.
Maltese: Antikorpi kontra l-HBs intwerew li jippersistu għal ta' l-anqas 36 xhahar wara kors b' Fendrix f' 0,1,2,6 xahar fil-pazjenti ta' qabel id-dialisi tad-demm u ta' waqt id-dialisi tad-demm.
English: • Fendrix may not protect you from being ill if you have already caught the hepatitis B virus.
Maltese: • Fendrix jista' ma jipproteġikx milli timrad jekk ikun diġà qabdek il-virus tal-epatite B.
English: At month 36, 80.4% of these patients retained protective antibody levels (anti-HBs titres ≥ 10mIU/ml), as compared to 51.3% of patients who received a commercially available hepatitis B vaccine.
Maltese: Fis-36 xahar, 80.4% ta' dawn il-pazjenti żammew il-livelli protettivi ta' antikorpi (titres ta' kontra l-HBs ≥ 10mIU/ml) meta mqabbla ma 51.3% tal-pazjenti li rċievew il-vaċċin ta' l-epatite B li hawn fis-suq.
English: How to store Fendrix
Maltese: Kif gћandek tieћu Fendrix
English: Fendrix can also be used as a booster after a course of a different type of hepatitis B vaccine.
Maltese: Fendrix jista' wkoll jingħata bħala booster wara kors ta' tip differenti ta' tilqim tal-epatite B.
English: • Fendrix is a white, milky suspension presented in a glass prefilled syringe (0.5 ml).
Maltese: • Fendrix huwa suspensjoni bajda qisha ħalib, preżentata ġo siringa tal-ħġieġ mimlija għal-lest (0.5
English: Fendrix has moderate influence on the ability to drive and use machine.
Maltese: Fendrix għandu effett moderat fuq il-ħila ta' sewqan u l-użu tal-magni.
English: Booster dose:
Maltese: Doża ta' rinforz:
English: Adverse reactions reported in a clinical trial following primary vaccination with Fendrix and considered as being at least possibly related to vaccination have been categorised by frequency.
Maltese: Reazzjonijiet mhux mixtieqa rrappurtati fi prova klinika wara tilqim primarju b' Fendrix u meqjusa li possibilment għandhom xi ftit x'jaqsmu mat-tilqim ġew ikkategorizzati skond il-frekwenza.
English: At month 36, GMTs were 154.1 mIU/ml and 111.9 mIU/ml in the Fendrix and control groups respectively, with 58.7% and 38.5% of subjects with anti-HBs antibody titres ≥100 mIU/ml respectively.
Maltese: 9mIU/ml rispettivament fil-grupp ta' Fendrix u lgrupp ta' kontroll, b'83.1% u 67.5% rispettivament tas-suġġetti b'titres ta' antikorpi kontra l-HBs ≥100mIU/ml.
English: • Fendrix may need to be given at the same time as an injection of hepatitis B “immuno-globulins”.
Maltese: • Fendrix jista' jkollu bżonn jingħata fl-istess ħin ma' injezzjoni ta' “immunoglobulini” tal-epatite B.
English: Primary immunisation:
Maltese: Tilqim primarju:
English: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 dk-info@gsk.com
Maltese: Tlf: + 45 36 35 91 00 dk-info@gsk.com
English: General disorders and administration site conditions: Very common: fatigue, pain Common: fever, injection site swelling, redness
Maltese: Mhux komuni: reazzjoni oħra fis-sit ta' l-injezzjoni Rari: tertir, fwawar, għatx, astenja
English: • As with all vaccines, a course of Fendrix cannot fully protect all people that are vaccinated.
Maltese: • Bħal b'kull tilqima oħra, kors ta' Fendrix ma jistax jipproteġi kompletament lil persuni kollha li jitlaqqmu.
English: • Experience with hepatitis B vaccine:
Maltese: • Esperjenza bil-vaċċin ta' l-epatite B:
English: • Fendrix helps your body to produce its own protection against the virus (antibodies).
Maltese: • Fendrix jgħin lil ġismek jipproduċi prottezzjoni għalih innifsu kontra l-virus (antikorpi).
English: For adjuvants, see section 2.
Maltese: Għall-awżiljari ara sezzjoni 2
English: • fainting
Maltese: • aċċessjonijiet
English: • stomach and digestion problems.
Maltese: • problemi bl-istonku u bid-diġestjoni.
English: Pregnancy
Maltese: Nervożiżmu
English: 1 pre-filled syringe 1 separate needle 1 dose (0.5 ml)
Maltese: Siringa waħda mimlija għal-lest Labra waħda separata Doża waħda (0.5 ml)
English: EXP
Maltese: GmbH.
English: 0.5 ml of suspension in pre-filled syringe (type I glass) with a plunger stopper (rubber butyl) with or without separate needle in a pack size of 1, or without needles in a pack size of 10.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 0.5 millilitru ta' suspenjoni f'siringa mimlija għall-lest (ħġieġ tat-tip 1) magħluqa bi planġer (lakstu butyl) b'labra jew bla labra f'pakketti ta'1, jew mingħajr labra f'pakketti t'10.
English: • feeling thirsty
Maltese: • tħossok stordut
English: In pre-haemodialysis and haemodialysis patients:
Maltese: Infezzjonijiet u infestazzjonijiet:
English: Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
Maltese: Id-data ta' meta jiskadi tirreferi għall-aħħar ġurnata ta' dak ix-xahar.
English: The most common adverse reactions reported were local reactions at the injection site.
Maltese: Ir-reazzjonijiet avversi l-aktar komuni li ġew irrappurtati kienu reazzjonijiet lokali fis-sit ta' l-injezzjoni.
English: • back pain, swelling of your tendons.
Maltese: • uġigħ fid-dahar, nefha fit-tendini.
English: Turbid white suspension.
Maltese: Suspensjoni bajda mhux ċara.
English: Fendrix is a vaccine which prevents hepatitis B.
Maltese: Fendrix huwa vaċċin li jilqa' kontra l-epatite B.
English: As pre-haemodialysis and haemodialysis patients are particularly exposed to HBV and have a higher risk to become chronically infected, a precautionary attitude should be considered i.e. giving a booster dose in order to ensure a protective antibody level as defined by national recommendations and guidelines.
Maltese: Minħabba li l-pazjenti ta' qabel id-dialisi tad-demm u ta' waqt id-dialisi tad-demm ikunu partikolarment esposti għall-HBV u għandhom riskju akbar li jiġu infettati b'mod kroniku, għanda tiġi kkunsidrata attitudni ta' prekawzjoni jiġifieri li tingħata doża ta' rinforz biex tiżgura livell ta' antikorp protettiv kif mfisser fir-rakkomandazzjonijiet u l-gwidi nazzjonali.
English: Fendrix should not be given to subjects suffering from acute severe febrile illness.
Maltese: Fendrix m'għandha qatt tingħata minn ġol-ġilda jew fil-vina.
English: Data on concomitant administration of Fendrix with specific hepatitis B immunoglobulin (HBIg) have not been generated.
Maltese: Għad ma hemmx tagħrif dwar l-amministrazzjoni ta' Fendrix ma' l-immunoglobulina speċifika ta' lepatite B (HBIg).
English: • feeling dizzy
Maltese: TWISSIJA(IET) SPEĊJALI
English: It is used for patients with kidney problems:
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata:
English: Very rare (these may occur with up to 1 in 10,000 doses of the vaccine)
Maltese: Rari ħafna (dawn jistgħu jseħħu b'sa doża waħda minn kull 10,000 doża tal-vaċċin)
English: Clinical trials involving the administration of 2,476 doses of Fendrix to 82 pre-haemodialysis and haemodialysis patients and to 713 healthy subjects ≥ 15 years of age allowed to document the reactogenicity of the vaccine.
Maltese: Provi kliniċi fejn ingħataw 2476 doża ta' Fendrix lil 82 pazjent xi wħud qabel għamlu d-dialisi taddemm u xi wħud waqt li kienu qed jagħmlu d-dialisi tad-demm u lill-713 suġġetti f'saħħithom ≥ 15-il sena wasslu għad-dokumentazzjoni tal-kapaċità tal-vaċċin li jipproduċi effetti mhux mixtieqa.
English: Hypersensitivity after previous administration of other hepatitis B vaccines.
Maltese: Sensittività eċċessiva wara tilqima preċedenti b'vaċċini oħra ta' l-epatite B.
English: The doctor or nurse will give Fendrix as an injection into your muscle.
Maltese: It-tabib jew l-infermier se jagħtu Fendrix bħala injezzjoni ġol-muskolu.
English: • Carriers of the virus are likely to get serious liver problems, such as “cirrhosis” or liver cancer.
Maltese: • Ġarriera tal-virus x'aktarx ikollhom problemi serji fil-fwied, bħal ”ċirrożi” jew kanċer tal-fwied.
English: Hepatitis B is caused by a virus which makes the liver swollen.
Maltese: L-epatite B hija kkawżata minn virus li jikkawża nefħa fil-fwied
English: Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
Maltese: Rari (dawn jistgħu jseħħu b'sa doża waħda minn kull 1000 doża tal-vaċċin)
English: Abseamed (epoetin alfa)
Maltese: Abseamed (epoetina alfa)
English: Further information on Abseamed 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: Abseamed contains the active substance epoetin alfa and is a ‘biosimilar medicine'.
Maltese: Abseamed fih is-sustanza attiva epoetina alfa u huwa “mediċina bijosimili”.
English: For patients with chronic kidney failure, myelodysplastic syndromes, or receiving chemotherapy, haemoglobin levels should remain within the recommended range (between 10 and 12 grams per decilitre in adults and between 9.5 and 11 g/dl in children).
Maltese: Għal pazjenti b'insuffiċjenza kronika tal-kliewi, b'sindromi majelodisplastiċi, jew li jkunu qed jirċievu kimoterapija, il-livelli tal-emoglobina għandhom jibqgħu fil-medda rakkomandata (bejn 10 grammi u 12-il gramma għal kull deċilitru fl-adulti u bejn 9.5 u 11 g/dl fit-tfal).
English: Other information about Abseamed
Maltese: Informazzjoni oħra dwar Abseamed
English: The reference medicine for Abseamed is Eprex/Erypo.
Maltese: Il-mediċina ta' referenza għal Abseamed hija Eprex/Erypo.
English: Abseamed, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems.
Maltese: Abseamed, injettat f'vina, tqabbel mal-mediċina ta' referenza fi studju ewlieni li fih ħadu sehem 479 pazjent b'anemija kkawżata minn problemi fil-kliewi.
English: Abseamed received a marketing authorisation valid throughout the EU on 28 August 2007.
Maltese: Abseamed irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-28 ta' Awwissu 2007.
English: What are the risks associated with Abseamed?
Maltese: X'inhuma r-riskji assoċjati ma' Abseamed?
English: Laboratory studies comparing Abseamed with the reference medicine Eprex/Erypo have shown that the active substance in Abseamed is highly similar to that in Eprex/Erypo in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li qabblu Abseamed mal-mediċina ta' referenza Eprex/Erypo wrew li s-sustanza attiva f'Abseamed hija simili ħafna għal dik f'Eprex/Erypo f'termini ta' struttura, purità u attività bijoloġika.
English: • to treat anaemia (low red blood cell counts) that is causing symptoms in patients with chronic kidney failure (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems;
Maltese: • għall-kura tal-anemija (għadd baxx ta' ċelluli tad-demm ħomor) li tkun qed tikkawża sintomi f'pazjenti b'insuffiċjenza kronika tal-kliewi (tnaqqis progressiv u fit-tul fil-kapaċità tal-kliewi li jaħdmu sew) jew bi problemi oħra fil-kliewi;
English: • to reduce the need for blood transfusions in adults with moderate anaemia who are about to undergo major orthopaedic (bone) surgery, such as hip surgery.
Maltese: • biex titnaqqas il-ħtieġa għal trasfużjonijiet tad-demm f'adulti b'anemija moderata li dalwaqt ser jagħmlu intervent kirurġiku ortopediku (tal-għadam) maġġuri, bħalma hi operazzjoni tal-ġenb.
English: It is used in patients with normal blood iron levels who could experience complications from a blood transfusion, if they do not donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood;
Maltese: Jintuża wkoll f'pazjenti b'livelli normali ta' ħadid fid-demm li jistgħu jesperjenzaw kumplikazzjonijiet minn trasfużjoni tad-demm, jekk ma jagħtux id-demm tagħhom stess qabel lintervent kirurġiku u huma mistennija jitilfu bejn 900 u 1,800 ml ta' demm;
English: • patients about to undergo major orthopaedic surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.
Maltese: • pazjenti li se jsirilhom intervent kirurġiku ortopediku maġġuri li għandhom problemi kardjovaskulari serji (fil-qalb u fl-arterji u l-vini) inkluż attakk tal-qalb reċenti jew puplesija.
English: As for all medicines, data on the use of Abseamed are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Abseamed hija ssorveljata kontinwament.
English: The most common side effects with Abseamed (which may affect more than 1 in 10 people) are nausea (feeling sick), diarrhoea, vomiting, fever and headache.
Maltese: L-effetti sekondarji l-aktar komuni b'Abseamed (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma dardir (tħossok ma tiflaħx), dijarea, rimettar, deni u uġigħ ta' ras.
English: How is Abseamed used?
Maltese: Kif jaħdem Abseamed?
English: Side effects reported with Abseamed are carefully evaluated and any necessary action taken to protect patients.
Maltese: Leffetti sekondarji rrappurtati b'Abseamed huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Abseamed has a highly similar structure, purity and biological activity to Eprex/Erypo 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, Abseamed għandu struttura, purità u attività bijoloġika simili ħafna għal Eprex/Erypo u jiġi distribwit bl-istess mod fil-ġisem.