FrancophonIA/ELRC3.0 huggingface dataset:
English: • OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty in breathing and/or possible fluid accumulation in your stomach or chest.
Maltese: • L-OHSS jista' jsir sever bi tkabbir evidenti tal-ovarji, tnaqqis fil-produzzjoni tal-awrina, żieda fil-piż, diffikultà fit-teħid tan-nifs u/jew akkumulazzjoni possibbli ta' fluwidu fiż-żaqq jew fis sider.
English: ANNEX II
Maltese: NUMRU(I)
English: Miscarriage
Maltese: Investigazzjonijiet
English: Pregnancy loss
Maltese: Disturbi vaskulari
English: • gynaecological haemorrhages of unknown aetiology;
Maltese: • Meta l-Aġenzija Ewropea għall-Mediċini titlob din l-informazzjoni;
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of the solution contains 600 IU (equivalent to 44 micrograms) of follitropin alfa*.
Maltese: IU (ekwivalenti għal 44 mikrogramm) ta' follitropin alfa*.
English: In clinical trials comparing r-hFSH (follitropin alfa) and urinary FSH in ART (see table 1 below) and in ovulation induction, follitropin alfa was more potent than urinary FSH in terms of a lower total dose and a shorter treatment period needed to trigger follicular maturation.
Maltese: Fi provi kliniċi komparattivi bejn r-hFSH (follitropin alfa) u FSH urinarju f'ART (ara t-tabella hawn taħt) u f'induzzjoni ta' ovulazzjoni, follitropin alfa kien iktar qawwi minn FSH urinarju fir-rigward ta' doża totali aktar baxxa u perjodu ta' kura iqsar meħtieġ biex tiskatta l-maturazzjoni follikolari.
English: • The usual dose of Bemfola is 150 IU (0.25 mL) together with hCG.
Maltese: • Id-doża normali ta' Bemfola hi ta' 150 IU (0.25 ml) flimkien ma' hCG.
English: Bemfola 300 IU/0.50 mL pre-filled pen Bemfola 450 IU/0.75 mL pre-filled pen
Maltese: 375 ml soluzzjoni għal injezzjoni f'pinna mimlija għal-lest Bemfola 300 IU/0.50
English: • primary ovarian failure;
Maltese: • insuffiċjenza primarja tal-ovarji
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċjuu rriskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar riskji.
English: PHARMACEUTICAL FORM Solution for injection (injection).
Maltese: Soluzzjoni għall-injezzjoni (injezzjoni).
English: Women with anovulation resulting from severe LH and FSH deficiency In LH and FSH deficient women (hypogonadotropic hypogonadism), the objective of follitropin alfa therapy in association with lutropin alfa is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotropin (hCG).
Maltese: F'nisa b'nuqqas ta' LH u FSH (ipogonadiżmu ipogonadotrofiku), l-għan tat-terapija b'follitroin alfa flimkien ma' lutropin alfa hu li jiġi żviluppat follikulu Graafjan matur wieħed li minnu jinħeles l-ooċit wara l-għoti ta' gonadotropina korjonika umana (hCG).
English: Bemfola 75 IU/0.125 mL solution for injection in pre-filled pen Bemfola 150 IU/0.25 mL solution for injection in pre-filled pen Bemfola 225 IU/0.375 mL solution for injection in pre-filled pen
Maltese: IU/0.125 ml soluzzjoni għal injezzjoni f'pinna mimlija għal-lest Bemfola 150 IU/0.25 ml soluzzjoni għal injezzjoni f'pinna mimlija għal-lest Bemfola 225 IU/0.
English: Pack sizes of 1, 5 and 10 pre-filled pens including one disposable needle and alcohol swab per pen.
Maltese: Daqsijiet tal-pakkett ta' 1, 5 jew 10 pinen mimlija għal-lest inkluża labra li tintrema wara l-użu u swab tal-alkoħol għal kull pinna.
English: • Your asthma may get worse
Maltese: Aggravament jew aggravament ta' ażżma
English: Mild or moderate OHSS usually resolves spontaneously.
Maltese: OHSS ħafif jew moderat, ġeneralment ifieq waħdu.
English: NAME OF THE MEDICINAL PRODUCT Bemfola 75 IU/0.125 mL solution for injection in pre-filled pen follitropin alfa
Maltese: IU/0.125 ml injezzjoni follitropin alfa
English: Breastfeeding
Maltese: Pożoloġija
English: • The numbers on the dose display are measured in International Units or IU.
Maltese: • In-numri fuq id-displej tad-doża huma mkejlin f'Unitajiet Internazzjonali jew IU.
English: 1.5 mL cartridge (type I glass), with a plunger stopper (halobutyl rubber) and an aluminium crimp cap with a rubber inlay, assembled in a pre-filled pen.
Maltese: Skartoċċ ta' 1.5 ml (ħġieġ tip I), b'tapp planġer (gomma halobutyl) u b'kappa tal-aluminju li tgeżwer biex tissiġilla b'saff fuq ġewwa tal-gomma, assemblati f'pinna mimlija għal-lest.
English: • Swelling of the veins above and behind the testicles (varicocele).
Maltese: • Nefħa tal-vini fuq u n-naħa ta' wara tat-testikoli (varikoċele).
English: • ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome;
Maltese: • tkabbir tal-ovarji jew ċista fl-ovarji mhux minħabba sindrome poliċistiku tal-ovarji
English: • Follitropin alfa in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency.
Maltese: • Follitropin alfa flimkien ma' preparazzjoni ta' ormon luteinising (LH) hu rakkomandat biex jistimula l-iżvilupp follikulari ta' nisa li g ħandhom nuqqas qawwi ta' LH u FSH.
English: The prevalence of congenital malformations after ART may be slightly higher than after spontaneous conceptions.
Maltese: ART kienet irrappurtata li hi ogħla meta mqabbla mal-popolazzjoni ġenerali.
English: • Bemfola 75 IU/0.125 mL: Each cartridge contains 75 IU (equivalent to 5.5 micrograms) follitropin alfa in 0.125 mL solution.
Maltese: IU/0.125 ml: Kull skarto ċċ fih 75 IU (ekwivalenti g ħal 5.5 mikrogrammi)
English: In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/L.
Maltese: Fi studji kliniċi dawn il-pazjenti kienu definiti minn livell ta' LH fis-serum endoġenu ta' < 1.2 IU/l.
English: When an optimal response is obtained, a single injection of 250 micrograms r-hCG or 5,000 IU up to 10,000 IU hCG should be administered 24-48 hours after the last follitropin alfa and lutropin alfa injections.
Maltese: 10,000 IU ta' hCG għandha tingħata 24-48 siegħa wara l-aħħar injezzjonijiet ta' follitropin alfa u lutropin alfa.
English: Impaired fertility has been reported in rats exposed to pharmacological doses of follitropin alfa (≥ 40 IU/kg/day) for extended periods, through reduced fecundity.
Maltese: Nuqqas ta' fertilità kien irrappurtat f'firien esposti g ħal dożi farmakoloġiċi ta' follitropin alfa (≥ 40 IU/kg/kuljum) għal perjodi estiżi, minħabba tnaqqis fil-fekondità.
English: No other clinically significant medicinal product interaction has been reported during follitropin alfa therapy.
Maltese: Ma kienet irrappurtata l-ebda interazzjoni klinikament sinifikanti tal-prodott mediċinali waqt it-terapija b'follitropin alfa.
English: • together with another medicine called “human chorionic gonadotropin” (hCG) to help produce sperm in men that are infertile due to a low level of certain hormones.
Maltese: • flimkien ma' mediċina oħra magħrufa bħala ‘Gonadotropin Korjonika umana (hCG)' biex jgħin fil-produzzjoni tal-isperma f'irġiel li mhumiex fertili minħabba livell baxx ta' ċerti ormoni.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/005
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/909/005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/004
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/909/004
English: with unexplained vaginal bleeding.
Maltese: Ilma għall-injezzjonijiet
English: Nevertheless one could expect Ovarian HyperStimulation Syndrome (OHSS) to occur, which is described in section 4.
Maltese: jistenna li jse ħħ is -Sindrome ta' Iperstimulazzjoni tal-Ovarji (OHSS), li hu deskritt f'sezzjoni 4.
English: 6.3 Shelf life
Maltese: Sib post nadif
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/002
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/909/002
English: Each prefilled pen delivers 300 IU (equivalent to 22 micrograms) in 0.5 mL.
Maltese: Kull pinna mimlija għal-lest tagħti 300 IU (ekwivalenti għal 22 mikrogramma) f'0.5 ml.
English: The maximum daily dose is 450 IU (0.75 mL).
Maltese: IU (0.375 ml).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri, essenzjalment ‘ħielsa mis-sodium'.
English: Follitropin alfa is not indicated during breastfeeding.
Maltese: Treddigħ Follitropin alfa mhuwiex indikat waqt it-treddigħ.
English: The following symptomatology may be observed in severe cases of OHSS: abdominal pain, abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea.
Maltese: Is-sintomi li ġejjin jistgħu jkunu osservati f'każi severi ta' OHSS: uġigħ addominali, nefħa addominali, tkabbir sever tal-ovarji, żieda fil-piż, dispneja, oligurja, u sintomi gastrointestinali li jinkludu dardir, rimettar u dijarrea.
English: When an optimal response is obtained, a single injection of 250 micrograms of recombinant human chorionic gonadotropin alfa (r-hCG) or 5,000 IU up to 10,000 IU hCG should be administered 24-48 hours after the last follitropin alfa injection.
Maltese: Meta jintlaħaq l-aħjar effett mixtieq, injezzjoni waħda ta' 250 mikrogramma ta' choriogonadotrofin alfa umana rikombinanti (r-hCG) jew 5,000 IU sa 10,000
English: Men with hypogonadotropic hypogonadism
Maltese: Irġiel b'ipogonadiżmu ipogonadotrofiku
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 225 IU/0.375 mL injection follitropin alfa
Maltese: Bemfola 225 IU/0.375 ml soluzzjoni għal injezzjoni f'pinna mimlija għal-lest follitropin alfa
English: Follitropin alfa should be given at a dose of 150 IU three times a week, concomitantly with hCG, for a minimum of 4 months.
Maltese: Follitropin alfa għandu jingħata f'doża ta' 150 IU tliet darbiet fil-ġimgħa, flimkien ma' hCG, għal minimu ta' 4 xhur.
English: Bemfola treatment seldom causes severe OHSS unless the medicine that is used for final follicular maturation (containing human chorionic gonadotropin, hCG) is administered.
Maltese: ħlief jekk tingħata l mediċina li tintuża għall-maturazzjoni follikulari finali (li fiha Gonadotropin Korjonika umanahCG).
English: Bemfola usually does not work if you have this problem.
Maltese: Bemfola normalment ma ja ħ dimx jekk għandek din il -problema.
English: Each cartridge contains 0.25 mL solution for injection.
Maltese: Kull skartoċċ fih 0.25 mL soluzzjoni għal injezzjoni.
English: Luteal phase support may be considered since lack of substances with luteotrophic activity (LH/hCG) after ovulation may lead to premature failure of the corpus luteum.
Maltese: Jista' jiġi kkunsidrat appoġġ fil-fażi lutejali taċ -ċiklu, minħabba li n-nuqqas ta' sustanzi b'attività lutejatrofika (LH/hCG) wara l-ovulazzjoni tista' tikkawża nuqqas ta' żvilupp fil-corpus luteum.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.375 mL
Maltese: INDIVIDWALI 0.375 ml
English: 5,000 IU to 10,000 IU of hCG, 24 to 48 hours after the last Bemfola injection.
Maltese: IU ta' hCG, 24 sa 48 siegħa wara l-aħħar injezzjoni tiegħek ta' Bemfola.
English: Each prefilled pen delivers 150 IU (equivalent to 11 micrograms) in 0.25 mL.
Maltese: Kull pinna mimlija għal-lest tagħti 150 IU (ekwivalenti għal 11-il mikrogramma) ta' 0.25 ml.
English: Semen analysis is recommended 4 to 6 months after the beginning of treatment as part of the assessment of the response.
Maltese: Hu rakkomandat li ssir analiżi tas-semen bejn 4 u 6 xhur wara li tinbeda l-kura bħala parti mill evalwazzjoni tar-rispons.
English: • If you use Bemfola with other medicines which help ovulation (such as hCG or clomiphene citrate), this may increase the response of your follicles.
Maltese: • Jekk tuża Bemfola ma' mediċini oħrajn li jgħinu l-ovulazzjoni (bħal hCG jew clomiphene citrate), dan jista' jżid ir-rispons tal-follikuli tiegħek.
English: Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting,
Maltese: Uġigħ addominali, nefħa addominali, skumdità addominali, dardir, rimettar,
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 75 IU/0.125 mL injection follitropin alfa
Maltese: IU/0.75 ml injezzjoni follitropin alfa
English: Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilisation or other assisted reproductive technologies A commonly used regimen for superovulation involves the administration of 150-225 IU of follitropin alfa daily commencing on days 2 or 3 of the cycle.
Maltese: Pereżempju, wara ġimagħtejn ta' kura b'a gonist, 150-225 IU ta' follitropin alfa jingħataw għall-ewwel 7 ijiem.
English: INSTRUCTIONS ON USE
Maltese: TQEGĦID FIS-SUQ
English: Women with anovulation (including polycystic ovarian syndrome) Follitropin alfa may be given as a course of daily injections.
Maltese: Nisa li ma jovulawx (inkluż is-sindrome poliċistiku tal-ovarji) Follitropin alfa jista' jingħata bħala kors ta' injezzjonijiet ta' kuljum.
English: Ovarian Hyperstimulation Syndrome (OHSS)
Maltese: Gonadotropin Menopawsali urinarju (hMG).
English: Each cartridge contains 0.75 mL solution for injection.
Maltese: Kull skartoċċ fih 0.75 mL soluzzjoni għal injezzjoni.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/003
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/909/003
English: If you need to develop several eggs for collection prior to any assisted reproductive technology
Maltese: Jekk teħtieġ li tiżviluppa diversi bajd għall-ġbir qabel kwalunkwe teknoloġija ta' riproduzzjoni assistita
English: • together with another medicine called “lutropin alfa” (“luteinising hormone” or LH) to help release an egg from the ovary (ovulation) in women that are not ovulating because their body is producing very little gonadotropins (FSH and LH).
Maltese: • flimkien ma' mediċina oħra magħrufa bħala ‘lutropin alfa' (‘Ormon Luteinising' jew LH) biex jgħin fir-rilaxx ta' bajda mill-ovarji (ovulazzjoni) f'nisa li mhumiex jovulaw minħabba li l ġisem tagħhom jipproduċi ftit li xejn gonadotropins (FSH u LH).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.25 mL
Maltese: INDIVIDWALI 0.25 ml
English: Concomitant use of follitropin alfa with other medicinal products used to stimulate ovulation (e.g. hCG, clomiphene citrate) may potentiate the follicular response, whereas concurrent use of a GnRH agonist or antagonist to induce pituitary desensitisation may increase the dose of follitropin alfa needed to elicit an adequate ovarian response.
Maltese: Fi provi kliniċi komparattivi bejn r-hFSH (follitropin alfa) u FSH urinarju f'ART (ara t-tabella hawn taħt) u f'induzzjoni ta' ovulazzjoni, follitropin alfa kien iktar qawwi minn FSH urinarju fir-rigward ta'
English: If you are a woman, this medicine increases your risk of developing OHSS.
Maltese: Jekk int mara, din il-mediċina żżidlek ir-riskju li tiżviluppa OHSS.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/001
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/909/001
English: • The usual starting dose of Bemfola is 75 to 150 IU (0.12 to 0.25 mL) each day.
Maltese: • Id-doża normali tal-bidu ta' Bemfola hi ta' 75 sa 150 IU (0.
English: FSH is a gonadotropin, a type of hormone that plays an important role in human fertility and reproduction.
Maltese: FSH huwa gonadotropin, tip ta' ormon li għandu rwol importanti fil-fertilità tan-nisa u firriproduzzjoni.
English: • Gallstones
Maltese: • Kalkli
English: Serum creatinine at Day - Y
Maltese: Kreatinina fis-serum f'ġurnata - Y
English: • Unexpected ADRs according to the SPC.
Maltese: • ADRs mhux mistennija skont l-SPC.
English: • Persistent and progressive increase in hepatic enzymes
Maltese: • Żieda persistenti u progressiva fl-enzimi tal-fwied
English: • All serious ADRs
Maltese: • ADRs serji kollha
English: o Patient information leaflet o Information on the need for regular monitoring, and when it should be carried out, of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin o Information that renal biopsy may be considered if significant renal abnormalities occur.
Maltese: o Il-fuljett ta' tagħrif tal-pazjent o Informazzjoni fuq il-bżonn ta' monitoraġġ regolari, u ta' meta għandu jsir, tal kreatinina fis-serum, tneħħija tal-kreatinina, proteinurja, enzimi tal-fwied, ferritina o Informazzjoni li jista' jkun hemm bżonn ta' bijopsija tal-kliewi jekk ikun hemm anomalija sinifikanti fil-kliewi.
English: • The need to monitor serum ferritin monthly
Maltese: • Il-bżonn li ferritina (ferritin) fis-serum ikun monitorat kull xahar
English: • Adults: >33% above baseline and creatinine clearance <LLN (90 ml/min)
Maltese: >33 % fuq il-linja ta' bażi u t-tneħħija tal-kreatinina <LLN (90 ml/min)
English: Before initiating treatment, Serum creatinine at Day - X
Maltese: Qabel jibda t-trattament, Kreatinina fis-serum f'ġurnata - X
English: • The need for a guidance table highlighting pre-treatment measurements of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin, such as:
Maltese: • Il-bżonn għal tabella gwida li turi b'mod ċar iċ-ċifri, qabel ma jinbeda t-trattament, talkreatinina fis-serum, it-tneħħija tal-kreatinina, proteinurja, enzimi tal-fwied, ferritina, bħal:
English: Physician information about Exjade (brochure and pocket card) Patient information pack
Maltese: Informazzjoni għat-tabib dwar Exjade (ktieb żgħir u kartuna li toqgħod fil-but) Pakkett ta' tagħrif għall-pazjent
English: • Adults and paediatrics: >33% above baseline or creatinine clearance <LLN (90 ml/min) o The need to consider renal biopsy:
Maltese: >33 % fuq il-linja ta' bażi u t-tneħħija talkreatinina <LLN (90 ml/min) o Il-bżonn li tikkunsidra bijopsija tal-kliewi:
English: Value 1
Maltese: MILL-ISTATI
English: • That rises in serum transaminases occur in patients treated with Exjade o The need for liver function tests prior to prescription, then at monthly intervals or more often if clinically indicated o Not to prescribe to patients with pre-existing severe hepatic disease o The need to interrupt treatment if persistent or progressive increase in liver enzymes were noted.
Maltese: • Li ż-żidiet fit-transaminażi tas-serum jistgħu jseħħu f'pazjenti ttrattati b'Exjade o Il-bżonn għal testijiet tal-funzjoni tal-fwied qabel ma t-tabib jikteb ir-riċetta, imbagħad f'intervalli ta' xahar jew aktar spissi jekk ikun hemm indikazzjonijiet kliniċi o Biex ma jinkitbux riċetti għall-pazjenti li jkollhom minn qabel mard qawwi tal-fwied o Il-bżonn biex jitwaqqaf it-trattament jekk ikun hemm żidiet persistenti u progressivi tal-enzimi tal-fwied.
English: • Increase in serum creatinine levels (>33% above baseline) or decrease of creatinine clearance (<90 ml/min).
Maltese: • Żieda fil-livelli tal-kreatinina (>33 % fuq il-linja ta' bażi) jew tnaqqis fit tneħħija tal-kreatinina (<90 ml/min).
English: • The need for annual auditory and ophthalmic testing
Maltese: • Tibdil sinifikanti fit-testijiet tas-smigħ jew oftalmiċi
English: • The importance of measuring creatinine clearance
Maltese: • L-importanza li titkejjel it-tneħħija tal-kreatinina
English: • Paediatrics: either > ULN or creatinine clearance falls to <LLN o The need to interrupt treatment if serum creatinine rises:
Maltese: • Pazjenti pedjatriċi: jew > ULN jew it-tneħħija tal-kreatinina taqa' għal <LLN o Il-bżonn li twaqqaf it-trattament jekk il-kreatinina fis-serum titla':
English: Product information
Maltese: MEMBRI
English: • Monthly thereafter o The need to reduce by 10 mg/kg the dose if serum creatinine rises:
Maltese: • Kull xahar minn hemm ‘il quddiem o Il-bżonn li d-doża titnaqqas b'10 mg/kg jekk il-kreatinina fis-serum togħla:
English: The physician information about Exjade should contain the following key elements:
Maltese: L-informazzjoni għat-tabib dwar Exjade għandu jkollha dawn l-elementi kruċjali:
English: o Patient booklet where the physician can record the results of the above along with the dose of Exjade o Reminder card for dates of tests
Maltese: o Ktieb żgħir tal-pazjent fejn it-tabib jista' jniżżel ir-riżultati ta' dawn t'hawn fuq flimkien mad-doża ta' Exjade o Kartuna żgħira biex tfakkar id-dati tat-testijiet
English: The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the conditional marketing authorisation as further explained in the European Public Assessment Report.
Maltese: Is-CHMP wara li kkunsidrat l-applikazzjoni hija tal-fehma li l-bilanċ bejn benefiċċju u riskju huwa favorevoli li jirrakkomanda l-għoti tal-awtorizzazzjoni kondizzjonali kif imfisser aktar fir-Rapport Ewropew ta' Valutazzjoni Pubblika.
English: • Conditional marketing authorisation
Maltese: • Awtorizzjoni għat-tqegħid fis-suq kondizzjonali
English: Conclusions presented by the European Medicines Agency on:
Maltese: Konklużjonijiet ippreżentati mill-Aġenzija Ewropea għall-Mediċini dwar:
English: MA (EU) Number
Maltese: Numru ta' l-EU
English: Intravenous use vial (glass)
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Powder for concentrate for solution for infusion
Maltese: 1 mg Trab għal konċentrat għal soluzzjoni għallinfużjoni
English: MA (EU) number (Invented) name Strength Pharmaceutical form
Maltese: Numru tal-MA (UE) Isem (ivvintat)
English: Route of administration
Maltese: Mnejn għandu jingħata
English: Content (concentration)
Maltese: Kontenut (konċentrazzjoni
English: Strength Pharmaceutical Form Route of Administration
Maltese: Qawwa Għamla Farmaċewtika
English: MA (EU) number
Maltese: Numru tal-MA (EU) Isem (Ivvintat)
English: Member State EU/EEA
Maltese: Stat Membru/EEA
English: Annex I
Maltese: ANNESS I
English: Slovakia
Maltese: Slovakja
English: The application was submitted to the United Kingdom as reference Member State and to Austria, Czech Republic, Estonia, Finland, France, Germany, Greece, Italy, Latvia, the Netherlands, Slovakia and Spain as concerned Member States.
Maltese: Lapplikazzjoni kienet ippreżentata lir-Renju Unit bħala l-Istat Membru ta' referenza u lill-Awstrija, irRepubblika Ċeka, l-Estonja, il-Finlandja, Franza, il-Ġermanja, il-Greċja, l-Italja, il-Latvja, il-Pajjiżi lBaxxi, is-Slovakkja u Spanja bħala Stati Membri kkonċernati.
English: Estonia
Maltese: Estonja
English: The Netherlands
Maltese: Olanda
English: Annex III
Maltese: ANNESS III
English: The type II variation has been subject to a worksharing procedure (UK/V/xxxx/WS/006) by the veterinary Coordination Group for Mutual Recognition and Decentralised Procedures (CMD(v)) according to Article 20 of Commission Regulation (EC) No 1234/2008 involving Soludox 500 mg/g powder for use in drinking water for pigs and chickens (NL/V/0141/001/DC) and Soludox 500 mg/g powder for use in drinking water for pigs and chickens (UK/V/0349/001/DC).
Maltese: Il-varjazzjoni tat-tip II kienet soġġetta għal proċedura ta' kondiviżjoni tax-xogħol (UK/V/xxxx/WS/006) mill-Grupp ta' Koordinazzjoni veterinarju għar-Rikonoxximent Reċiproku u l-Proċeduri Deċentralizzati (CMD(v)) skont l-Artikolu 20 tar-Regolament tal-Kummissjoni (KE) Nru 1234/2008 li jinkludi t-trab ta' 500 mg/g ta' Soludox għall-użu fl-ilma tax-xorb għall-majjali u t-tiġieġ (NL/V/0141/001/DC) u t-trab ta' 500 mg/g ta' Soludox għall-użu fl-ilma tajjeb għax-xorb għall-majjali u t-tiġieġ (UK/V/0349/001/DC).
English: INN Pharmaceutical form
Maltese: INN Għamla Farmaċewtika
English: Latvia
Maltese: Latvja
English: The combined muscle data using the actual values including those below the limit of quantification, a statistically derived meat withdrawal period of 9 days is obtained (F-test: <0.025; Cochran: >0.05; Bartlett: >0.05; Shapiro: >0.10).
Maltese: 025; Cochran: >0.05; Bartlett: