FrancophonIA/ELRC3.0 huggingface dataset:
English: This side effect is common (may affect up to 1 in 10 people).
Slovenian: Ta neželeni učinek je pogost (pojavi se lahko pri največ 1 bolniku od 10).
English: Bemfola 300 IU/0.50 mL solution for injection in pre-filled pen Bemfola 450 IU/0.75 mL solution for injection in pre-filled pen follitropin alfa
Slovenian: Bemfola 300 i.e./0,50 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Bemfola 450 i.e./0,75 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin alfa
English: Each prefilled pen delivers 75 IU (equivalent to 5.5 micrograms) in 0.125 mL.
Slovenian: En napolnjen injekcijski peresnik zagotavlja 75 i.e. (kar ustreza 5,5 mikrograma) v 0,125 ml.
English: However, since follitropin alfa is not indicated in pregnancy, these data are of limited clinical relevance.
Slovenian: Vendar imajo ti podatki le omejen klinični pomen, ker folitropin alfa ni indiciran v nosečnosti.
English: Setting the dose
Slovenian: Nastavitev odmerka
English: Bemfola usually does not work if you have this problem.
Slovenian: V takih primerih zdravilo Bemfola običajno ni učinkovito.
English: SC
Slovenian: LH
English: • Each mL of the solution contains 600 IU (equivalent to 44 micrograms) follitropin alfa.
Slovenian: En mililiter raztopine vsebuje 600 i.e. (kar ustreza 44 mikrogramom) folitropina alfa.
English: Within its shelf-life, the unopened product may be stored at or below 25°C for up to 3 months without being refrigerated again and must be discarded if it has not been used after 3 months.
Slovenian: V času roka uporabnosti se lahko neodprto zdravilo shranjuje pri temperaturi do 25 °C do tri mesece brez ponovnega shranjevanja v hladilniku.
English: Each pre-filled pen delivers 225 IU follitropin alfa, equivalent to 16.5 micrograms per 0.375 mL.
Slovenian: En napolnjen injekcijski peresnik zagotavlja odmerek 225 i.e. folitropina alfa, kar ustreza 16,5 mikrograma, v 0,375 ml.
English: Each pre-filled pen delivers 450 IU follitropin alfa, equivalent to 33 micrograms per 0.75 mL.
Slovenian: En napolnjen injekcijski peresnik zagotavlja odmerek 450 i.e. folitropina alfa, kar ustreza 33 mikrogramom, v 0,75 ml.
English: INFORMATION IN BRAILLE Bemfola 150 IU/0.25 mL
Slovenian: PODATKI V BRAILLOVI PISAVI Bemfola 150 i.e./0,25 ml
English: INFORMATION IN BRAILLE Bemfola 450 IU/0.75 mL
Slovenian: PODATKI V BRAILLOVI PISAVI Bemfola 450 i.e./0,75 ml
English: • Bemfola 450 IU/0.75 mL: Each cartridge contains 450 IU (equivalent to 33 micrograms) follitropin alfa in 0.75 mL solution.
Slovenian: Bemfola 450 i.e./0,75 ml: En vložek vsebuje 450 i.e. (kar ustreza 33 mikrogramom) folitropina alfa v 0,75 ml raztopine.
English: The maximum daily dose is 450 IU (0.75 mL).
Slovenian: 450 i.e. (0,75 ml).
English: Bemfola 450 IU/0.75 mL (33 micrograms/0.75 mL) is not designed to allow the cartridge to be removed.
Slovenian: Zdravilo Bemfola 450 i.e./0,75 ml (33 mikrogramov/0,75 ml) je oblikovano tako, da ne dopušča odstranitve vložka.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.375 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 0,375 ml
English: • Anovulation (including polycystic ovarian syndrome, PCOs) in women who have been unresponsive to treatment with clomiphene citrate.
Slovenian: • Anovulacija (vključno s sindromom policističnih jajčnikov (PCOS-including polycystic ovarian syndrome)) pri ženskah, ki se niso odzvale na zdravljenje s klomifen citratom.
English: For instructions on the administration with the pre-filled pen, see the package leaflet.
Slovenian: Za navodila o uporabi napolnjenega injekcijskega peresnika, glejte navodilo za uporabo.
English: Each prefilled pen delivers 300 IU (equivalent to 22 micrograms) in 0.5 mL.
Slovenian: En napolnjen injekcijski peresnik zagotavlja 300 i.e. (kar ustreza 22 mikrogramom) v 0,5 ml.
English: Each prefilled pen delivers 150 IU (equivalent to 11 micrograms) in 0.25 mL.
Slovenian: En napolnjen injekcijski peresnik zagotavlja 150 i.e. (kar ustreza 11 mikrogramom) v 0,25 ml.
English: Men
Slovenian: Moški
English: Each prefilled pen delivers 225 IU (equivalent to 16.5 micrograms) in 0.375 mL.
Slovenian: En napolnjen injekcijski peresnik zagotavlja 225 i.e. (kar ustreza 16,5 mikrograma) v 0,375 ml.
English: • Anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomiphene citrate.
Slovenian: • Anovulacija (vključno s sindromom policističnih jajčnikov (PCOS-including polycystic ovarian syndrome) pri ženskah, ki se niso odzvale na zdravljenje s klomifen citratom.
English: • Complications of OHSS such as twisting of ovaries or blood clotting may occur rarely (may affect up to 1 in 1,000 people).
Slovenian: • Zapleti OHSS, kot je zasuk (torzija) jajčnikov ali nastajanje krvnih strdkov, se pojavijo redko
English: Bemfola 300 IU/0.50 mL pre-filled pen Bemfola 450 IU/0.75 mL pre-filled pen
Slovenian: Bemfola 300 i.e./0,50 ml napolnjen injekcijski peresnik Bemfola 450 i.e./0,75 ml napolnjen injekcijski peresnik
English: • ovarian, uterine or mammary carcinoma.
Slovenian: • rak na jajčniku, maternici ali dojkah.
English: • When you get the desired response, you will be given a single injection of 250 micrograms of “recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique), or 5,000 to 10,000 IU of hCG, 24 to 48 hours after your last Bemfola injection.
Slovenian: • Ko boste dosegli želeni odziv, boste prejeli eno injekcijo z 250 mikrogrami „rekombinantnega hCG“ (r-hCG, v laboratoriju izdelan hCG s posebno tehnologijo DNK) ali 5.000 do 10.000 i.e.
English: Each pre-filled pen delivers 300 IU follitropin alfa, equivalent to 22 micrograms per 0.5 mL.
Slovenian: En napolnjen injekcijski peresnik zagotavlja odmerek 300 i.e. folitropina alfa, kar ustreza 22 mikrogramom, v 0,5 ml.
English: What Bemfola is used for
Slovenian: Za kaj uporabljamo zdravilo Bemfola
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.
Slovenian: Režim, ki se običajno uporablja za superovulacijo, vključuje dajanje 150-225 i.e. folitropina alfa na dan, s pričetkom na 2. ali 3. dan ciklusa.
English: • Bemfola 300 IU/0.50 mL: Each cartridge contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.50 mL solution.
Slovenian: Bemfola 300 i.e./0,50 ml: En vložek vsebuje 300 i.e. (kar ustreza 22 mikrogramom) folitropina alfa v 0,50 ml raztopine.
English: Each prefilled pen delivers 450 IU (equivalent to 33 micrograms) in 0.75 mL.
Slovenian: En napolnjen injekcijski peresnik zagotavlja 450 i.e. (kar ustreza 33 mikrogramom) v 0,75 ml.
English: Bemfola 300 IU/0.50 mL (22 micrograms/0.5 mL) is not designed to allow the cartridge to be removed.
Slovenian: Zdravilo Bemfola 300 i.e./0,50 ml (22 mikrogramov/0,5 ml) je oblikovano tako, da ne dopušča odstranitve vložka.
English: • Headache
Slovenian: • glavobol;
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of the solution contains 600 IU (equivalent to 44 micrograms) of follitropin alfa*.
Slovenian: En mililiter raztopine vsebuje 600 i.e. (kar ustreza 44 mikrogramom) folitropina alfa*.
English: Before starting treatment, the reason for the couple's infertility must be thoroughly investigated and putative contraindications for pregnancy must be evaluated.
Slovenian: Pred začetkom zdravljenja je potrebno podrobno raziskati razlog za neplodnost para in ovrednotiti domnevne kontraindikacije za nosečnost.
English: Bemfola contains sodium
Slovenian: Zdravilo Bemfola vsebuje natrij.
English: Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Phosphoric acid
Slovenian: 6.1 Seznam pomožnih snovi poloksamer 188 saharoza metionin dinatrijev fosfat dihidrat natrijev dihidrogenfosfat dihidrat fosforjeva kislina voda za injekcije
English: The patients should be advised of the potential risk of multiple births before starting treatment.
Slovenian: Pred pričetkom zdravljenja morajo biti bolnice seznanjene s možnim tveganjem večplodnih porodov.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 225 IU/0.375 mL injection follitropin alfa
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Bemfola 225 i.e./0,375 ml injekcija folitropin alfa s.c.
English: Getting your pre-filled pen ready for injection
Slovenian: Priprava vašega napolnjenega injekcijskega peresnika za injiciranje Različni deli vašega injekcijskega peresnika
English: If your body responds too strongly, your treatment with Bemfola will be stopped and you will not be given any hCG (see section 2, OHSS).
Slovenian: Če pride do pretiranega odziva, je treba zdravljenje z zdravilom Bemfola prekiniti in opustiti uporabo hCG (glejte poglavje 2, OHSS).
English: Each cartridge contains 0.375 mL solution for injection.
Slovenian: Vsak vložek vsebuje 0,375 ml raztopine za injiciranje.
English: Common (may affect up to 1 in 10 people):
Slovenian: Pogosti (pojavijo se lahko pri največ 1 bolniku od 10):
English: NAME OF THE MEDICINAL PRODUCT Bemfola 75 IU/0.125 mL solution for injection in pre-filled pen
Slovenian: IME ZDRAVILA Bemfola 75 i.e./0,125 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: If your body responds too strongly, your treatment will be stopped and you will not be given any hCG (see section 2, OHSS).
Slovenian: Če pride do pretiranega odziva, je treba zdravljenje prekiniti in opustiti uporabo hCG (glejte poglavje 2, OHSS).
English: Nervous system disorders
Slovenian: Odmerek Gumb za nastavitev odmerka
English: There is no relevant use of follitropin alfa in the elderly population.
Slovenian: Folitropin alfa ni primerna za uporabo pri starejših bolnikih.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 75 IU/0.125 mL injection follitropin alfa
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Bemfola 75 i.e./0,125 ml injekcija folitropin alfa s.c.
English: NAME OF THE MEDICINAL PRODUCT Bemfola 225 IU/0.375 mL solution for injection in pre-filled pen
Slovenian: IME ZDRAVILA Bemfola 225 i.e./0,375 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serije
English: How to use the Bemfola pre-filled pen
Slovenian: Uporaba napolnjenega injekcijskega peresnika Bemfola
English: NAME OF THE MEDICINAL PRODUCT Bemfola 300 IU/0.50 mL solution for injection in pre-filled pen
Slovenian: IME ZDRAVILA Bemfola 300 i.e./0,50 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: NAME OF THE MEDICINAL PRODUCT Bemfola 150 IU/0.25 mL solution for injection in pre-filled pen
Slovenian: IME ZDRAVILA Bemfola 150 i.e./0,25 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 150 IU/0.25 mL injection follitropin alfa
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Bemfola 150 i.e./0,25 ml injekcija folitropin alfa s.c.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.25 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 0,25 ml
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.75 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 0,75 ml
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 450 IU/0.75 mL injection follitropin alfa
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Bemfola 450 i.e./0,75 ml injekcija folitropin alfa s.c.
English: Each cartridge contains 0.5 mL solution for injection.
Slovenian: Vsak vložek vsebuje 0,5 ml raztopine za injiciranje.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 300 IU/0.5 mL injection follitropin alfa
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Bemfola 300 i.e./0,5 ml injekcija folitropin alfa s.c.
English: NAME OF THE MEDICINAL PRODUCT Bemfola 450 IU/0.75 mL solution for injection in pre-filled pen
Slovenian: IME ZDRAVILA Bemfola 450 i.e./0,75 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: Complication of severe OHSS General disorders and administration site conditions Very common: Injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection)
Slovenian: reakcije na mestu injiciranja (npr. bolečina, eritem, hematom, oteklina in/ali razdraženost na mestu injiciranja)
English: • If you are a woman: with large ovaries or sacs of fluids within the ovaries (ovarian cysts) of unknown origin.
Slovenian: s povečanjem jajčnika ali vrečkami tekočine znotraj jajčnikov (cistami jajčnikov)
English: Each cartridge contains 0.25 mL solution for injection.
Slovenian: Vsak vložek vsebuje 0,25 ml raztopine za injiciranje.
English: (hMG).
Slovenian: OHSS.
English: NAME OF THE MEDICINAL PRODUCT Bemfola 75 IU/0.125 mL solution for injection in pre-filled pen follitropin alfa
Slovenian: Bemfola 75 i.e./0,125 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin alfa
English: Each cartridge contains 0.75 mL solution for injection.
Slovenian: Vsak vložek vsebuje 0,75 ml raztopine za injiciranje.
English: Thromboembolism(both in association with and separate from OHSS Respiratory, thoracic and mediastinal disorders Very rare:
Slovenian: trombembolizem, tako v povezavi z in ločeno od OHSS Bolezni dihal, prsnega koša in mediastinalnega prostora
English: NAME OF THE MEDICINAL PRODUCT Bemfola 300 IU/0.5 mL solution for injection in pre-filled pen follitropin alfa
Slovenian: Bemfola 300 i.e./0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin alfa
English: If you need to develop several eggs for collection prior to any assisted reproductive technology
Slovenian: Ženske v postopku stimulacije ovarijev za doseganje razvoja več foliklov pred oploditvijo in vitro ali drugimi postopki asistirane reprodukcije
English: How to store Bemfola
Slovenian: Shranjevanje zdravila Bemfola
English: Miscarriage
Slovenian: Odmerjanje
English: with a condition that usually makes normal pregnancy impossible, such as ovarian failure (early menopause), or malformed reproductive organs.
Slovenian: Folitropina alfa ne smete uporabljati, kadar ni mogoče doseči učinkovitega odziva, kot je npr.: primarna odpoved jajčnikov; malformacije spolnih organov, ki niso združljive z nosečnostjo; fibroidni tumorji maternice, ki niso združljivi z nosečnostjo;
English: NAME OF THE MEDICINAL PRODUCT Bemfola 225 IU/0.375 mL solution for injection in pre-filled pen follitropin alfa
Slovenian: Bemfola 225 i.e./0,375 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin alfa
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/005
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/909/005
English: NAME OF THE MEDICINAL PRODUCT Bemfola 150 IU/0.25 mL solution for injection in pre-filled pen follitropin alfa
Slovenian: Bemfola 150 i.e./0,25 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin alfa
English: Remove the peel tab from the injection needle.
Slovenian: Z injekcijske igle odlepite jeziček.
English: NAME OF THE MEDICINAL PRODUCT Bemfola 450 IU/0.75 mL solution for injection in pre-filled pen follitropin alfa
Slovenian: Bemfola 450 i.e./0,75 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin alfa
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/909/002
English: Fertility
Slovenian: driska
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/909/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/909/001
English: Women with anovulation (including polycystic ovarian syndrome) Follitropin alfa may be given as a course of daily injections.
Slovenian: Folitropin alfa se lahko daje kot zaporedje dnevnih injekcij.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/909/003
English: ¾ The Member States shall ensure that in their Member State:
Slovenian: ¾ Država članica naj v svoji državi zagotovi naslednje:
English: Product information
Slovenian: Podatke o zdravilu
English: • On two occasions prior to initiation of treatment
Slovenian: • ob dveh priložnostih pred uvedbo zdravljenja,
English: Serum creatinine at Day - Y
Slovenian: kreatinin v serumu na dan - Y
English: • Every week during the first month of initiation of treatment or after modification of therapy
Slovenian: • vsak teden v prvem mesecu po uvedbi ali spremembi zdravljenja,
English: Value 2 X and Y are the days (to be determined) when pre-treatment measurements should be performed.
Slovenian: X in Y sta dneva (ki ju je treba določiti) za izvedbo meritev pred zdravljenjem;
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: • POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JO MORA IZPOLNITI DRŽAVA ČLANICA
English: Before initiating treatment, Serum creatinine at Day - X
Slovenian: pred uvedbo zdravljenja kreatinin v serumu na dan - X
English: Physician information about Exjade (brochure and pocket card) Patient information pack
Slovenian: Podatke o zdravilu Exjade za zdravnika (knjižico in kartonček) Komplet podatkov o zdravilu za bolnika
English: • Persistent and progressive increase in hepatic enzymes
Slovenian: • persistentno in progresivno zvišanje vrednosti jetrnih encimov,
English: The Patient information pack should include the following information:
Slovenian: Komplet podatkov o zdravilu za bolnika mora vsebovati naslednje informacije:
English: • Gallstones
Slovenian: • žolčni kamni,
English: • The importance of measuring creatinine clearance
Slovenian: • pomembnost merjenja očistka kreatinina;
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: DODATEK POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JO MORA IZPOLNITI DRŽAVA ČLANICA
English: • The educational programme should prompt doctors to report serious ADRs and certain selected ADRs as below:
Slovenian: • izobraževalni program, ki bo zdravnike spodbujal k poročanju o resnih neželenih učinkih in določenih izbranih neželenih učinkih, navedenih spodaj:
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.
Slovenian: • dejstvo, da pri bolnikih, ki se zdravijo z zdravilom Exjade, prihaja do zvišanja vrednosti serumskih transaminaz, o potrebnost izvajanja testov jetrne funkcije preden se predpiše zdravilo, nato pa v mesečnih intervalih ali bolj pogosto, če je klinično indicirano, o opozorilo, da se bolnikom s predhodno hudo boleznijo jeter zdravila ne sme predpisati, o potrebnost prekinitve zdravljenja, če pride do persistentnega in progresivnega zvišanja vrednosti jetrnih encimov;
English: • Brief overview of methods of measuring creatinine clearance
Slovenian: • kratek pregled metod merjenja očistka kreatinina;
English: • Significant changes found in auditory or ophthalmological testing
Slovenian: • pomembne spremembe izvidov pri slušnem ali okulističnem pregledu,
English: • The need to monitor serum ferritin monthly
Slovenian: • potrebnost mesečnega spremljanja feritina v serumu;
English: • That Exjade causes rises in serum creatinine in some patients o The need to monitor serum creatinine
Slovenian: • dejstvo, da Exjade pri nekaterih bolnikih povzroča zvišanje kreatinina v serumu, o potrebnost spremljanja kreatinina v serumu,
English: • Monthly thereafter o The need to reduce by 10 mg/kg the dose if serum creatinine rises:
Slovenian: o potrebnost zmanjšanja odmerka za 10 mg/kg, če se kreatinin v serumu zviša:
English: The physician information about Exjade should contain the following key elements:
Slovenian: Podatki o zdravilu Exjade za zdravnika morajo navajati naslednje ključne vsebine:
English: The MAH must ensure that, at launch, all physicians who are expected to prescribe Exjade are provided with a physician information pack containing the following:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo ob prihodu zdravila na tržišče vsi zdravniki, ki bodo lahko predpisovali zdravilo Exjade, prejeli obvestilo za zdravnike, ki bo vsebovalo sledeče:
English: • The need for a guidance table highlighting pre-treatment measurements of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin, such as:
Slovenian: • potrebnost vodenja in upoštevanja preglednice, ki opozarja na naslednje meritve pred zdravljenjem: kreatinina v serumu, očistka kreatinina, proteinurije, jetrnih encimov in feritina, kot je prikazano:
English: • The need for annual auditory and ophthalmic testing
Slovenian: • potrebnost enkrat letnega slušnega in okulističnega pregleda;
English: • Increase in serum creatinine levels (>33% above baseline) or decrease of creatinine clearance (<90 ml/min).
Slovenian: • zvišanje vrednosti kretainina v serumu (>33% nad izhodiščno vrednostjo) ali padec očistka kreatinina (<90 ml/min),
English: • All serious ADRs
Slovenian: • vsi resni neželeni učinki,
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.
Slovenian: o navodilo za uporabo zdravila za bolnika, o podatke o potrebnosti rednega spremljanja in časovni razpored preiskav kreatinina v serumu, očistka kreatinina, proteinurije, jetrnih encimov in feritina, o obvestilo o možnosti, da je v primeru pojava pomembnih ledvičnih nepravilnosti treba razmisliti o ledvični biopsiji, o bolnikovo knjižico, v katero lahko zdravnik beleži izvide navedenih preiskav skupaj z odmerki zdravila Exjade, o kartonček za načrtovane datume preiskav.
English: proteinuria, signs of Fanconi's Syndrome).
Slovenian: • kadar je kreatinin v serumu zvišan in se pokaže še druga nepravilnost (kot je proteinurija, znaki Fanconijevega sindroma);
English: • Unexpected ADRs according to the SPC.
Slovenian: • ne-pričakovani neželeni učinki zdravila glede na Povzetek glavnih značilnosti zdravila.
English: • Adults: >33% above baseline and creatinine clearance <LLN (90 ml/min)
Slovenian: • pri odraslih: >33% od izhodiščne vrednosti, očistek kreatinina pa pade pod SMN (spodnjo mejo normale: 90 ml/min)
English: • Adults and paediatrics: >33% above baseline or creatinine clearance <LLN (90 ml/min) o The need to consider renal biopsy:
Slovenian: • pri odraslih in pediatričnih bolnikih: ostane >33% nad izhodiščno vrednostjo ali pa očistek kreatinina ostane pod SMN (90 ml/min);
English: • Paediatrics: either > ULN or creatinine clearance falls to <LLN o The need to interrupt treatment if serum creatinine rises:
Slovenian: • pri pediatričnih bolnikih: nad ZMN (zgornjo mejo normale) ali pa očistek kreatinina pade pod SMN;
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.
Slovenian: • pogojnem dovoljenju za promet z zdravilom Odbor CHMP je obravnaval vlogo in meni, da je razmerje med tveganji in koristmi ugodno za priporočilo za odobritev pogojnega dovoljenja za promet z zdravilom, kot je dodatno pojasnjeno v Evropskem javnem poročilu o oceni zdravila.
English: Conclusions presented by the European Medicines Agency on:
Slovenian: Zaključki, ki jih je predstavila Evropska agencija za zdravila, o: