FrancophonIA/ELRC3.0 huggingface dataset:
English: PhotoBarr is used to remove high-grade dysplasia (cells with atypical changes that increase the risk of developing cancer) in patients with Barrett's oesophagus (gullet).
Maltese: PhotoBarr huwa użat biex ineħħi displasja ta' grad għoli (ċelluli b'bidliet atipiċi li jżidu r-riskju li jiżviluppa l-kanċer) f'pazjenti li għandhom esofagu ta' Barrett.
English: Tracheo-oesophageal fistula, Gastrointestinal necrosis Skin and subcutaneous tissue disorders Very common: Photosensitivity reaction Common:
Maltese: Biex tikkalkola d-doża tad-dawl, il-formula dożimetrika li ġejja tintuża għal kull diffużur li jaħdem filfibra ottika:
English: Table 3.
Maltese: Tabella 4.
English: In these studies foetotoxicity, but not teratogenicity, occurred in rats and rabbits only at evaluated intravenous doses (greater than of equal to 4 mg/kg) and at greater frequency (daily) compared in the clinical use.
Maltese: Dan sar meta l-annimali ngħataw dożi elevati intravenużi (akbar jew daqs 4 mg/kg) u bi frekwenza akbar (kuljum) meta mqabbla mal-użu fil-klinika.
English: Indoor light:
Maltese: Injezzjoni ta' PhotoBarr:
English: WHAT PHOTOBARR IS AND WHAT IT IS USED FOR PhotoBarr is a light-activated medicine used in photodynamic therapy (PDT) in combination with a non-burning red laser light.
Maltese: X'INHU PHOTOBARR U GĦALXIEX JINTUŻA PhotoBarr hija mediċina attivata bid-dawl f'terapija fotodinamika (PDT), f' kombinazzjoni ma' dawl laser aħmar li ma jaħraqx.
English: The reddish-brown solution is slowly injected, over 3 to 5 minutes, into a vein.
Maltese: L-injezzjoni ngħatat fuq bejn 3 sa 5 minuti.
English: Cardiac disorders Common:
Maltese: Disturbi respiratorji, toraċiċiu medjastinali Komuni:
English: Illumination of the target area with 630 nm wavelength laser light constitutes the second stage of therapy.
Maltese: It-tieni parti tat-terapija tinvolvi l-espożizzjoni għaddawl laser b' 630 nm wavelength, fuq il-parti li jkollha bżonn it-trattament.
English: Table 3 lists appropriate fibre optic power outputs and treatment times using a light intensity of 400 mW/cm.
Maltese: Tabella 3 turi r-rata talenerġija li toħroġ mill-apparat tal-fibra ottika, kif ukoll it-tul ta' żmien ta' trattament meta l-intensità tad-dawl tkun 400 mW/ċm.
English: PhotoBarr PDT plus omeprazole (PDT + OM) treatment was compared to a group treated with omeprazole alone (OM only), in the BO with HGD controlled clinical trial.
Maltese: It-trattament permezz ta' terapija fotodinamika b'PhotoBarr flimkien ma' omeprazole (PDT + OM) ġie mqabbel ma' grupp ittrattat b'omeprazole biss (OM biss), waqt provi kliniċi kkontrollati fuq l-esofagu ta' Barrett (BO) flimkien ma' displasja qawwija (HGD). Fil-grupp ta' PDT + OM, ġew ittrattati 133 pazjenti.
English: Nodules are to be pre-treated at a light doses of 50 J/cm of diffuser length with a short (< 2.5 cm) fibre optic diffuser placed directly against the nodules followed by standard balloon application as described above.
Maltese: Għoqod diskreti jingħataw doża ta' dawl ta' 50 J/ċm (jintuża diffuiżur qasir) fil-bidu qabel l-użu bid-dawl permezz tal-bużżieqa u l-apparat regolari.
English: The serum decay was bi-exponential, with a slow distribution phase and a very long elimination phase that started approximately 24 hours after injection.
Maltese: Ii-taħsir fis-serum kien bi-esponenzjali, b'fażi ta' distribuzzjoni u fażi twila ħafna u fażi ta' eliminazzjoni twila ħafna li tkun bdiet madwar 24 siegħa wara l-injezzjoni.
English: There is no information on overdose of PhotoBarr.
Maltese: M'hemmx informazzjoni fuq każijiet ta' doża eċċessiva b'PhotoBarr.
English: Patient guide − Brief background and introduction to Barrett's oesophagus and high grade
Maltese: − Sfont fil-qosor u introduzzjoni dwar l-esofagu ta' Barrett u displasja ta' grad għoli
English: The majority of the SARs were gastrointestinal disorders (8% - 11 patients), specifically nausea (3% - 4 patients), vomiting (3% - 4 patients) and upper abdominal pain (2% - 2 patients).
Maltese: Fil-biċċa l-kbira, r-reazzjonijiet avversi li kienu serji li effettwaw ħdax il-pazjent, kienu problemi fis-sistema diġestiva (8%), b'mod speċifiku d-dardir (3% - 4 pazjenti), rimettar (3% - 4 pazjenti), u uġigħ fin-naħa ta' fuq tal-addome (2% - 2 pazjenti).
English: Patients may receive a second course of PDT a minimum of 90 days after the initial therapy; up to three courses of PDT (each injection separated by a minimum of 90 days) should be given to a previously treated segment which still shows HGD or to a new segment if the initial Barrett's segment was >7 cm in length.
Maltese: Huma jistgħu jingħataw sa tlett korsijiet ta' terapija fotodinamika (kull injezzjoni tingħata mill-anqas 90 jum wara ta' qabel) fuq l-istess parti li tkun ġiet trattata qabel li tkun għadha turi HGD, kif ukoll meta lparti ta' Barrett tkun oriġinalment >7 ċm fit-tul.
English: − Within 60 days of an important (pharmacovigilance or risk minimisation) milestone
Maltese: − Fi żmien 60 jum li jintlaħaq tragward importanti (farmakoviġilanza dwar
English: An occurrence rate of 12% for oesophageal strictures was observed during the first course of treatment.
Maltese: Fl-ewwel kors tat-trattament ġiet osservata rata ta' 12% ta' kontrazzjonijiet fl-esofagu.
English: − That PhotoBarr o Remains in your body for 60-90 days after receiving the injection o There is an increased risk of photosensitivity (sensitivity to light) o Exposed skin will become red and cause discomfort in most cases but severe o Commercially available sun blocks are not effective in preventing sensitivity o Photosensitivity can only be prevented by avoiding exposure to the sun for 90 days after receiving the PhotoBarr injection
Maltese: Kard ta' alert tal-pazjent Il-bżonn li l-kard tintwera lil kull tabib li jkun qed jikkurah o Jibqa' fil-ġisem għal 60-90 jum wara li tingħata l-injezzjoni o Hemm riskju ogħla ta' fotosensittività (sensittività għad dawl) o Il-ġilda esposta ser issir ħamra u tikkawża skonfort f'ħafna każijiet imma każijiet severi ta' fotosensittività huma possibbli o Sun blocks kummerċjalment disponibbli m'humiex effettivi biex jevitaw is o Fotosensittività tista' tiġi evitata billi ma jkunx hemm espożizzjoni għax-xemx għal 90 jum wara li tirċievi injezzjoni ta' PhotoBarr
English: Short fibre optic diffusers to be used without a centering balloon to deliver 50 J/cm of diffuser length at a light intensity of 400 mW/cm Diffuser length (cm)
Maltese: J/ċm ta' tul tad-diffużur, b'intensità ta' dawl ta' 400 mW/ċm diffużur (ċm)
English: Since PhotoBarr is activated by the red part of light, sunscreens for UV (ultraviolet) light will not protect you against photosensitivity reactions.
Maltese: Peress li PhotoBarr hu attivat mill-parti l-ħamra tad-dawl, kremi tad-dlik kontra x-xemx għaddawl UV (ultravjola) mhux ser jipproteġuk kontra reazzjonijiet ta' fotosensittività.
English: Pruritus, rash, skin fragility, skin discolouration, skin ulcer, dermatitis exfoliative, dry skin, milia, rash maculo-papular, rash papular, scar, skin hyperpigmentation, skin lesion, skin nodule, urticaria
Maltese: sulluzzu, odinofagja, dijarea, dispepsja, ulċera fl-esofagu, uġigħ fin naħa ta' fuq tal-addome*, uġigħ fl-addome, haematemesis, uġigħ fl-esofagu, tifwiq, melaena (ematoċeznija), disturb fl-esofagu, rigurġitazzjoni tal-ikel, spażmu flesofagu, esofaġite.
English: Other information about ProteqFlu:
Maltese: Informazzjoni oħra dwar ProteqFlu:
English: A short lived swelling at the injection site may occur (max. diameter 5 cm) which decreases within 4 days.
Maltese: Jista' jkun hemm nefħa li ma tantx iddum fis-sit tal-injezzjoni (dijametru massimu ta' 5 cm) li tinżel fi żmien 4 ijiem.
English: This means that a gene from two different equine influenza strains (A/eq/Ohio/03 and A/eq/Richmond/1/07) was inserted into the canarypox vector viruses, which do not produce disease in horses, allowing the vector to produce specific proteins from these influenza strains.
Maltese: Dan ifisser li ġene minn żewġ razez differenti tal-influwenza ekwina (A/eq/Ohio/03 u A/eq/Richmond1/07) iddaħħal fil-virusijiet vetturi tal-canarypox, li ma jipproduċux marda fiż-żwiemel, biex b'hekk il-vettur seta' jipproduċi proteini speċifiċi minn dawn ir-razez tal-influwenza.
English: Equine influenza vaccine
Maltese: Vaċċin kontra l-influwenza ekwina
English: In laboratory studies, horses were challenged (infected) with equine influenza virus and the clinical signs and the excretion of the influenza virus after the challenge were compared between vaccinated and control animals (non-vaccinated animals or those vaccinated with a competitor product).
Maltese: Flistudji fil-laboratorju, iż-żwiemel ġew sfidati (infettati) bil-virus tal-influwenza ekwina u s-sinjali kliniċi u l-eskrezzjoni tal-virus tal-influwenza wara l-isfida tqabblu bejn annimali mlaqqma u annimali ta' kontroll (annimali mhux imlaqqma jew annimali mlaqqma bi prodott kompetitur).
English: The European Commission granted a marketing authorisation valid throughout the European Union for ProteqFlu on 6 March 2003.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha, għal ProteqFlu fis-6 ta' Marzu 2003.
English: It contains parts of two equine influenza (flu) strains, which have been inserted into two canarypox vector (carrier) viruses respectively.
Maltese: Fih partijiet minn żewġ razez tal-influwenza (flu) ekwina, li ddaħħlu f'żewġ virusijiet vetturi (ġarriera) tal-canarypox rispettivament.
English: The vaccine reduces the clinical signs of equine influenza and the excretion (shedding) of the virus after infection.
Maltese: Il-vaċċin inaqqas is-sinjali kliniċi tal-influwenza ekwina u l-eskrezzjoni (tixrid) tal-virus wara l-infezzjoni.
English: Why has ProteqFlu been approved?
Maltese: Għaliex ġie approvat ProteqFlu?
English: What is ProteqFlu?
Maltese: X'inhu ProteqFlu?
English: ProteqFlu is available as a suspension for injection.
Maltese: ProteqFlu huwa disponibbli bħala sospensjoni għall-injezzjoni.
English: The studies showed that ProteqFlu was effective in reducing clinical signs and virus excretion after infection with equine influenza, 14 days after primary vaccination.
Maltese: L-istudji wrew li ProteqFlu kien effiċjenti fit-tnaqqis tas-sinjali kliniċi u l-eskrezzjoni tal-virus wara linfezzjoni bl-influwenza ekwina, 14-il jum wara t-tilqima primarja.
English: Information on the prescription status of this product may be found on the label/outer package.
Maltese: Informazzjoni dwar l-istatus tal-preskrizzjoni ta' dan il-prodott tinstab fuq it-tikketta/il-pakkett ta' barra.
English: ProteqFlu is a vaccine which was produced with the use of recombinant DNA technology.
Maltese: ProteqFlu huwa vaċċin li ġie prodott bl-użu ta' teknoloġija rikombinanti tad-DNA.
English: The current formulation of ProteqFlu produced similar antibody responses against the two flu strains included in the vaccine to those seen in the main studies.
Maltese: Il-formulazzjoni attwali ta' ProteqFlu pproduċiet risponsi tal-antikorpi kontra ż-żewġ razez talinfluwenza inklużi fil-vaċċin li huma simili għal dawk li kien hemm fl-istudji ewlenin.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċju u r-riskju jinstab fil-modulu tad-diskussjoni xjentifika f'dan l-EPAR.
English: When ProteqFlu is given to horses, the animals' immune system recognises the specific proteins from the equine influenza strains as ‘foreign' and makes antibodies against them.
Maltese: Meta ProteqFlu jingħata liż-żwiemel, is-sistema immunitarja tal-annimali tagħraf il-proteini speċifiċi mir-razez tal-influwenza ekwina bħala ‘barranin' u tipproduċi antikorpi kontrihom.
English: The immunogenicity of the current formulation of the vaccine was confirmed in 15 foals.
Maltese: L-immunoġeniċità tal-formulazzjoni attwali tal-vaċċin ġiet ikkonfermata fi 15-il moħor.
English: What is the risk associated with ProteqFlu?
Maltese: Għal xiex jintuża ProteqFlu?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ProteqFlu exceed the risks for the approved indication and recommended that ProteqFlu be given a marketing authorisation.
Maltese: ll-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' ProteqFlu huma akbar mir-riskji tiegħu għall-indikazzjonijiet approvati u rrakkomanda li ProteqFlu jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Most of the studies were performed with ProteqFlu-Te, a vaccine that protects against two strains of equine influenza as well as against tetanus.
Maltese: Ħafna mill-istudji saru bi ProteqFlu-Te, vaċċin li jipproteġi kontra żewġ razez ta' influwenza ekwina kif ukoll kontra t-tetnu.
English: This should be followed by revaccination 5 months later and afterwards by yearly booster vaccinations.
Maltese: Din għandha tkun segwita minn tilqima mill-ġdid 5 xhur wara u suċċessivament minn tilqimiet booster kull sena.
English: Horses should receive a primary vaccination, consisting of two injections at 5-6 months of age, given 4-6 weeks apart.
Maltese: Iż-żwiemel għandhom jingħataw tilqima primarja, li tikkonsisti minn żewġ injezzjonijiet meta ż-żiemel ikollu 5-6 xhur, bittieni injezzjoni mogħtija 4-6 ġimgħat wara l-ewwel waħda.
English: ProteqFlu is used to vaccinate horses from 4 months of age against equine influenza.
Maltese: ProteqFlu jintuża sabiex jitlaqqmu żwiemel ta' 4 xhur u aktar kontra l-influwenza ekwina.
English: The vaccine is given as an intramuscular injection (injection into a muscle).
Maltese: Il-vaċċin jingħata bħala injezzjoni intramuskolari (injezzjoni ġewwa muskolu).
English: What is the withdrawal period?
Maltese: Kemm għandu jdum il-perjodu ta' tiżmim?
English: ProteqFlu contains an adjuvant (carbomer) to enhance the immune response.
Maltese: Dan jgħin fil-protezzjoni kontra l-influwenza ekwina.
English: The effectiveness of ProteqFlu was first assessed in several laboratory and field studies.
Maltese: Għall-ewwel, l-effikaċja ta' ProteqFlu ġiet ivvalutata f'diversi studji fil-laboratorju u fuq il-post.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Maltese: Il-vaċċini jaħdmu billi ‘jgħallmu' lis-sistema immunitarja (id-difiżi naturali tal-ġisem) kif tiddefendi ruħha kontra l-mard.
English: The absolute bioavailability is 58% (48-70%
Maltese: Ilbijodisponibilità assoluta hi ta' 58% (48-70%1).
English: Abortion spontaneous
Maltese: Abort spontanju
English: Difference [95% CI]
Maltese: [CI ta' 95%]
English: See Table 1 below.
Maltese: Ara Tabella 1 taħt.
English: Sodium citrate
Maltese: Sodium citrate Sucrose
English: N.V. Organon Veersemeer 4, 5347 JN Oss The Netherlands
Maltese: N.V. Organon Veersemeer 4, 5347 JN Oss
English: (18-36 years of age)
Maltese: (età ta' 18-36 sena)
English: Stimulation day 5 or 6:
Maltese: Stimulazzjoni f'jum 5 jew 6:
English:  Malformations of the reproductive organs incompatible with pregnancy.
Maltese:  Malformazzjonijiet tal-organi riproduttivi inkompatibbli mat-tqala.
English: Stimulation day 8:
Maltese: Stimulazzjoni f'jum 8:
English: Elonva 150 µg recFSH 300 IU n N % n N % n N % n N %
Maltese: IU n N % n N % n N % n N %
English: (35-42 years of age)
Maltese: (età ta' 35-42 sena)
English: Alanine aminotransferase increased, aspartate aminotransferase increased
Maltese: Żieda fl-alanine aminotransferase, żieda flaspartate aminotransferase
English: MSD (Norge) AS Tlf: + 47 32 20 73 00 msdnorge@msd.no
Maltese: MSD (Norge) AS Tlf: + 47 32 20 73 00
English: Box 20 5340 BH Oss The Netherlands
Maltese: P.O.Box 20 5340 BH Oss
English: Elonva contains sodium
Maltese: Elonva fih sodium
English: Magyarország MSD Pharma Hungary Kft. Tel.: + 36 1 888-5300 hungary_msd@merck.com
Maltese: Magyarország MSD Pharma Hungary Kft. Tel.: + 36 1 888-5300
English: Predicted range for 90% of subjects.
Maltese: 1 Firxa mbassra għal 90% tal-individwi.
English: MSD SHARP & DOHME GMBH Tel: 0800 673 673 673 (+49 (0) 89 4561 2612) e-mail@msd.de
Maltese: MSD SHARP & DOHME GMBH Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
English: o A basal antral follicle count > 20.
Maltese: o Għadd tal-follikuli antrali bażali ta' > 20.
English: Kloosterstraat 6 5349 AB Oss P.O.
Maltese: Kloosterstraat 6 5349 AB
English: FTET Cycles of ENGAGE
Maltese: Ċikli ta' FTET ta' ENGAGE
English: Manufacturers N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands.
Maltese: Organon, Kloosterstraat 6, 5349 AB Oss, L-Olanda.
English: België/Belgique/Belgien MSD Belgium BVBA/SPRL Tel/Tél: 0800 38 693 (+32(0)27766211) dpoc_belux@merck.com
Maltese: België/Belgique/Belgien MSD Belgium BVBA/SPRL Tel/Tél: 0800 38 693 (+32(0)27766211)
English: Distribution, metabolism and elimination of corifollitropin alfa are very similar to other gonadotropins, such as FSH, hCG and LH.
Maltese: Id-distribuzzjoni, il-metaboliżmu u l-eliminazzjoni ta' corifollitropin alfa huma simili ħafna għal gonadotropins oħrajn, bħal FSH, hCG u LH.
English: Follow current clinical practice for reducing the risk of OHSS during Assisted Reproductive Technology (ART).
Maltese: Segwi l-prattika klinika attwali għat-tnaqqis fir-riskju ta' OHSS matul it-Teknoloġija ta' Riproduzzjoni Assistita (ART - Assisted Reproductive Technology).
English: Stimulation day 1:
Maltese: Stimulazzjoni f'jum 1:
English: 50 - 60 kg More than 60 kg
Maltese: Inqas minn 50 kg 50 - 60 kg Aktar minn 60 kg
English: Elonva is indicated for use in infertility (see section 4.1).
Maltese: Elonva huwa indikat għal użu f'infertilità (ara sezzjoni 4.1).
English: Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) malta_info@merck.com
Maltese: Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558)
English: The steady state volume of distribution is 9.2 L (6.5-13.1 L
Maltese: Il-volum tad-distribuzzjoni fl-istat fiss huwa ta' 9.2 L (6.5-13.1 L1).
English: Other ingredients: sodium citrate, sucrose, polysorbate 20, methionine, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.
Maltese: Sustanzi oħra: sodium citrate, sucrose, polysorbate 20, methionine, sodium hydroxide (għal aġġustament tal-pH), hydrochloric acid (għal aġġustament tal-pH), ilma għall-injezzjonijiet.
English: Pharmacotherapeutic group: sex hormones and modulators of the genital system, gonadotropins, ATC code: G03GA09
Maltese: Kategorija farmakoterapewtika: ormoni tas-sess u modulatori tas-sistema ġenitali, gonadotropins
English: The maximum number of FTET cycles was 5 and 4 for the follow-up FTET trial for ENGAGE and PURSUE, respectively.
Maltese: In-numru massimu ta' ċikli ta' FTET kien 5 u 4 għall-prova ta' segwitu ta' FTET għal ENGAGE u PURSUE, rispettivament.
English: Corifollitropin alfa does not display any intrinsic LH/hCG activity.
Maltese: Corifollitropin alfa ma juri l-ebda attività LH/hCG intrinsika.
English: Ovarian torsion
Maltese: Torsjoni tal-ovarji
English:  Risk factors for OHSS:
Maltese:  Fatturi ta' riskju għal OHSS:
English: Merck Sharp & Dohme BV Tel: 0800 99 99 000 (+ 31 23 5153153) medicalinfo.nl@merck.com
Maltese: Merck Sharp & Dohme BV Tel: 0800 99 99 000 (+ 31 23 5153153)
English: *corifollitropin alfa is a glycoprotein produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Maltese: *corifollitropin alfa hu glikoproteina magħmul fiċ-ċelluli tal-Ovarji tal-Ħamster Ċiniż (CHO) minn teknoloġija tat-tfassil tad-DNA.
English: Congenital malformations
Maltese: Malformazzjonijiet konġenitali
English: (See also section 4.)
Maltese: (Ara wkoll sezzjoni 4).
English: FTET Cycles of PURSUE
Maltese: Ċikli ta' FTET ta' PURSUE
English: Table 1: Mean Number of Oocytes Retrieved from ENSURE, ENGAGE, and PURSUE Intent-to-Treat Population (ITT)
Maltese: Tabella 1: Medja tan-numru ta' Ooċiti Rkuprati minn ENSURE, ENGAGE, u PURSUE Popolazzjoni bl-Intenzjoni li tiġi Kkurata (ITT - Intent-to-Treat)
English: Exposure to corifollitropin alfa increases proportionally with dose within the range of 60 micrograms to 240 micrograms.
Maltese: Esponiment għal corifollitropin alfa jiżdied fi proporzjon mad-doża fil-firxa minn 60 mikrogramma sa 240 mikrogramma.
English: The pH may have been adjusted with sodium hydroxide and/or hydrochloric acid.
Maltese: Il-pH jista' jkun ġie aġġustat b'sodium hydroxide u/jew hydrochloric acid.
English: ANNEX I
Maltese: NUMRU(I )
English: - The other ingredients are: sodium citrate, sucrose, polysorbate 20, methionine and water for injections.
Maltese: - Is-sustanzi l-oħra huma: sodium citrate, sucrose, polysorbate 20, methionine u ilma għall-injezzjonijiet.
English: Vascular complications
Maltese: Disturbi vaskulari
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Ewropea għall-Mediċini http://www.ema.europa.eu/
English: o Polycystic ovarian syndrome (PCOS).
Maltese: o Sindrome Poliċistiku tal-Ovarji (PCOS - Polycystic ovarian syndrome).
English: Clinical signs and symptoms of severe OHSS are large ovarian cysts, acute abdominal pain, ascites, pleural effusion, hydrothorax, dyspnoea, oliguria, haematological abnormalities and weight gain.
Maltese: Sinjali u sintomi kliniċi ta' OHSS sever huma ċisti kbar tal-ovarji, uġigħ addominali akut, axxite, ħruġ ta' likwidu mill-plewra, idrotoraċi, dispnea, oligurija, abnormalitajiet ematoloġiċi u żieda fil-piż.
English: Elonva is indicated for Controlled Ovarian Stimulation (COS) in combination with a Gonadotropin Releasing Hormone (GnRH) antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program.
Maltese: Elonva hu indikat għal Stimulazzjoni Kkontrollata tal-Ovarji (COS) flimkien ma' antagonist tal-Ormon li Jerħi Gonadotropin (GnRH) għall-iżvilupp ta' follikuli multipli f'nisa li qed jipparteċipaw fi programm ta' Teknoloġija Riproduttiva Assistita (ART).
English: PURSUE (35-42 years of age) (body weight greater than or equal to 50 kg)
Maltese: (età ta' 35-42 sena) (piż tal-ġisem ta' 50 kg jew aktar)
English: EU/1/09/609/001
Maltese: FIS-SUQ EU/1/09/609/001
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Maltese: Sodium hydroxide (għal aġġustament tal-pH) Hydrochloric acid (għal aġġustament tal-pH)
English: Elonva contains the active ingredient corifollitropin alfa and belongs to the group of medicines called gonadotropic hormones.
Maltese: Elonva fih is-sustanza attiva corifollitropin alfa u jagħmel parti mill-grupp ta' mediċini msejħa ormoni gonadotropiċi.
English: Other medicines and Elonva
Maltese: Mediċini oħra u Elonva
English: Since corifollitropin alfa is not a substrate of cytochrome P450 enzymes, no metabolic interactions with other medicinal products are anticipated.
Maltese: Billi corifollitropin alfa mhuwiex substrat tal-enzimi ta' ċitokrom P450, l-ebda interazzjonijiet metaboliċi ma' prodotti mediċinali oħrajn mhuma antiċipati.
English: The GnRH antagonist is used to prevent premature Luteinising Hormone (LH) surges.
Maltese: L-antagonist ta' GnRH jintuża biex jiġu evitati żidiet f'daqqa prematuri ta' Ormon Luteinising (LH).
English: The relevance of these findings for the clinical use of Elonva is limited.
Maltese: Ir-rilevanza klinika ta' dawn is-sejbiet għall-użu kliniku ta' Elonva hi limitata.
English: In normal responders a daily dose of 150 IU (rec)FSH is advised.
Maltese: doża ta' kuljum ta' 150 IU ta' (rec)FSH hi rakkomandata.
English: The long duration of FSH activity was achieved by adding the carboxy-terminal peptide of the β-subunit of human chorionic gonadotropin (hCG) to the β-chain of human FSH.
Maltese: inkisbet biż-żieda tal-carboxy-terminal peptide tal-β-subunit ta' gonadotropin korjoniku uman (hCG) mal-katina-β ta' FSH uman.
English: Store in a refrigerator (2ºC-8°C).
Maltese: Aħżen fi friġġ (2ºC-8°C).
English: Gonadotropic hormones play an important role in human fertility and reproduction.
Maltese: L-ormoni gonadotropiċi għandhom rwol importanti fil-fertilità u r-riproduzzjoni talbniedem.