FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 2: Galafold (migalastat) amenability table
Croatian: Tablica 2.: Tablica mutacija koje omogućuju odgovili na lijek Galafold (migalastat) Promjena nukleotida
English: PULL out card on the right 3.
Croatian: 1. PRITISNITE i držite jezičak s lijeve strane 2. IZVUCITE karticu s desne strane 3. GURNITE kapsulu kroz foliju 4. GURNITE karticu natrag u držač
English: The change from baseline to Month 18 in LVMi (g/m 2) in patients with left ventricular hypertrophy (females with baseline LVMi > 95 g/m and males with baseline LVMi > 115 g/m2) was -8.4 (95% CI: -15.7, 2.6; n=13) for migalastat and 4.5 (95% CI: -10.7, 18.4; n=5) for ERT. After 30 months treatment with Galafold, the mean change from baseline in LVMi was -3.8 (95% CI: -8.9, 1.3; n=28) and the mean change from baseline in LVMi in patients with left ventricular hypertrophy at baseline was -10.0 (95% CI: -16.6, -3.3; n=10).
Croatian: Nakon 30 mjeseci liječenja lijekom Galafold, srednja vrijednost promjene od početne vrijednosti u LVMi bila je -3,8 (95 % CI: -8,9; 1,3; n = 28), a srednja vrijednost promjene od početne vrijednosti u LVMi u bolesnika s hipertrofijom lijevog ventrikula na početku bila je -10,0 (95 % CI: -16,6; -3,3; n = 10).
English: Protein Sequence change c.290delC
Croatian: Promjena slijeda u proteinu c.1208delT
English: Do not take Galafold if you:
Croatian: Što morate znati prije nego počnete uzimati Galafold Nemojte uzimati Galafold:
English: Further information on Halimatoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Halimatoz možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The proportion of patients who had at least a 75% reduction in symptoms after 16 weeks of treatment was 68% with Halimatoz and 63% with Humira.
Croatian: Udio bolesnika u kojih je nakon 16 tjedana liječenja zabilježeno smanjenje simptoma od najmanje 75 % iznosio je 68 % za lijek Halimatoz i 63 % za lijek Humira.
English: This means that Halimatoz is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Croatian: Drugim riječima, Halimatoz je vrlo sličan drugom biološkom lijeku („referentni lijek”) koji je već odobren u EU-u.
English: The dose and frequency of injection depends on the condition to be treated and the dose for a child is usually calculated according to the child's weight; because Halimatoz is only available in doses of 40 mg, it is not suitable for children who need less than a 40-mg dose.
Croatian: Doza i učestalost injekcije ovisi o stanju koje je potrebno liječiti, a doza za djecu uglavnom se izračunava u skladu s tjelesnom težinom djeteta; budući da je Halimatoz dostupan samo u dozama od 40 mg, nije prikladan za djecu kojoj je potrebna niža doza.
English: After training, patients or their carers may inject Halimatoz if their doctor considers it appropriate.
Croatian: Nakon obuke bolesnici ili njihovi njegovatelji mogu ubrizgati lijek Halimatoz ako to njihov liječnik smatra primjerenim.
English: What measures are being taken to ensure the safe and effective use of Halimatoz?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Halimatoz?
English: The company that markets Halimatoz must provide educational packs for doctors who prescribe the medicine.
Croatian: Tvrtka koja stavlja na tržište lijek Halimatoz mora dostaviti edukacijske pakete za liječnike koji propisuju taj lijek.
English: Like other medicines of its class, Halimatoz may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
Croatian: Kao i drugi lijekovi u tom razredu, Halimatoz može utjecati na sposobnost imunosnog sustava da se bori protiv infekcija i raka, pa su zabilježeni slučajevi ozbiljnih infekcija i raka krvi u bolesnika koji su liječeni adalimumabom.
English: Halimatoz is a medicine that acts on the immune system and is used to treat the following conditions:
Croatian: Halimatoz je lijek koji djeluje na imunosni sustav te se primjenjuje za liječenje sljedećih stanja:
English: The reference medicine for Halimatoz is Humira.
Croatian: Referentni lijek za lijek Halimatoz je Humira.
English: Halimatoz must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Croatian: Halimatoz se ne smije primjenjivati u bolesnika s aktivnom tuberkulozom ili drugim teškim infekcijama ni u bolesnika s umjerenim do teškim zatajenjem srca (nesposobnost srca da pumpa dovoljne količine krvi u tijelu).
English: Side effects reported with Halimatoz are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Halimatoz pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Halimatoz is available as a solution for injection under the skin in a pre-filled syringe or pen and is usually given every 2 weeks.
Croatian: Halimatoz je dostupan kao otopina za potkožnu injekciju u napunjenoj štrcaljki ili brizgalici te se obično primjenjuje svaka dva tjedna.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Halimatoz has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Croatian: Europska agencija za lijekove zaključila je da, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Halimatoz ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i lijek Humira te se u tijelu raspoređuje na isti način.
English: Because Halimatoz is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Halimatoz.
Croatian: Budući da je lijek Halimatoz biosličan lijek, ispitivanja učinkovitosti i sigurnosti adalimumaba provedena za lijek Humira nije potrebno ponavljati za lijek Halimatoz.
English: An overview of Halimatoz and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Halimatoz i zašto je odobren u EU-u
English: What is Halimatoz and what is it used for?
Croatian: Što je Halimatoz i za što se primjenjuje?
English: The active substance in Halimatoz, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF).
Croatian: Djelatna tvar u lijeku Halimatoz, adalimumab, monoklonsko je protutijelo (vrsta proteina) namijenjeno prepoznavanju i vezivanju za tvar u tijelu zvanu faktor tumorske nekroze (TNF).
English: Other information about Halimatoz
Croatian: Ostale informacije o lijeku Halimatoz
English: Halimatoz is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments.
Croatian: Halimatoz se prvenstveno koristi u odraslih osoba kod ozbiljnog, umjereno ozbiljnog stanja bolesti ili onog koje se pogoršava, odnosno kad bolesnici ne mogu primiti drugu terapiju.
English: Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a serious skin condition).
Croatian: Druge rijetke ozbiljne nuspojave (koje se mogu javiti u manje od 1 na 1 000 osoba) uključuju poremećaj u kojemu koštana srž više ne proizvodi krvne stanice, poremećaje živaca, lupus i poremećaje slične lupusu (pri čemu imunosni sustav bolesnika napada tkiva u vlastitom organizmu, uzrokujući upalu i oštećenja organa) i Stevens-Johnsonov sindrom (ozbiljna bolest kože).
English: Halimatoz contains the active substance adalimumab and is a ‘biosimilar medicine'.
Croatian: Halimatoz sadrži djelatnu tvar adalimumab te je „biosličan lijek”.
English: The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Croatian: Najčešće nuspojave povezane s adalimumabom (zabilježene u više od 1 na 10 bolesnika) su infekcije (uključujući infekcije nosa, grla i sinusa), reakcije na mjestu primjene injekcije (crvenilo, svrbež, krvarenje, bol ili oticanje), glavobolja i bol u mišićno-koštanom sustavu.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Halimatoz have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Halimatoz nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: (collections of pus) and scarring on the skin;
Croatian: (nakupljanje gnoja) i ožiljke na koži;
English: What are the risks associated with Halimatoz?
Croatian: Koji su rizici povezani s lijekom Halimatoz?
English: Why is Halimatoz authorised in the EU?
Croatian: Zašto je lijek Halimatoz odobren u EU-u?
English: • polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases causing inflammation in the joints);
Croatian: • poliartikularnog juvenilnog idiopatskog artritisa i aktivnog artritisa povezanog s entezitisom (obje su rijetke bolesti koje uzrokuju upalu zglobova);
English: • axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation;
Croatian: • aksijalnog spondiloartritisa (upale kralježnice koja uzrokuje bolove u leđima), uključujući i ankilozantni spondilitis, te kad rendgenska snimka ne pokazuje bolest, no postoje jasni znaci upale;
English: For more information on the use of Halimatoz in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Halimatoz za sva stanja, kao i kada se može primjenjivati u djece, pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: As for all medicines, data on the use of Halimatoz are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Halimatoz kontinuirano se prate.
English: Halimatoz can only be obtained by prescription and treatment must be started and supervised by a doctor who has experience in the treatment of the diseases for which Halimatoz is used.
Croatian: Halimatoz se izdaje samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju bolesti za koje se Halimatoz koristi.
English: Therefore, the Agency's view was that, as for Humira, the benefits of Halimatoz outweigh the identified risks and it can be authorised.
Croatian: Stoga je stav Agencije da korist kod lijeka Halimatoz, kao i kod lijeka Humira, nadmašuje identificirane rizike te da lijek može biti odobren.
English: TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Halimatoz is used to treat.
Croatian: TNF pridonosi nastanku upale i pronađen je u visokim koncentracijama u bolesnika s bolestima koje se liječe lijekom Halimatoz.
English: Eye specialists treating uveitis should also take advice from doctors who have experience of using Halimatoz.
Croatian: Očni specijalisti koji liječe uveitis trebali bi također poslušati savjete liječnika s iskustvom u primjeni lijeka Halimatoz.
English: For more information about using Halimatoz, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Halimatoz pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Laboratory studies comparing Halimatoz with Humira have shown that the active substance in Halimatoz is highly similar to that in Humira in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojima su uspoređivani lijekovi Halimatoz i Humira pokazala su da je djelatna tvar u lijeku Halimatoz vrlo slična djelatnoj tvari u lijeku Humira u pogledu strukture, čistoće i biološke aktivnosti.
English: All these data were considered sufficient to conclude that Halimatoz will behave in the same way as Humira in terms of effectiveness and safety in its approved uses.
Croatian: Svi ti podatci smatraju se dovoljnima za donošenje zaključka da će lijek Halimatoz za odobrene indikacije djelovati na isti način kao lijek Humira u pogledu djelotvornosti i sigurnosti.
English: How is Halimatoz used?
Croatian: Kako se Halimatoz koristi?
English: • hidradenitis suppurativa (acne inversa), a long-term skin disease that causes lumps, abscesses
Croatian: • gnojnog hidradenitisa (acne inversa), kronične bolesti kože koja uzrokuje kvržice, apscese
English: What benefits of Halimatoz have been shown in studies?
Croatian: Koje su koristi lijeka Halimatoz dokazane u ispitivanjima?
English: How does Halimatoz work?
Croatian: Kako djeluje Halimatoz?
English: In addition, a study in psoriasis has shown that the effects of the medicine are equivalent to those of Humira in this condition.
Croatian: Nadalje, u ispitivanju psorijaze utvrđeno je da je djelotvornost tog lijeka jednaka djelotvornosti lijeka Humira pri liječenju tog stanja.
English: Studies have also shown that giving Halimatoz produces similar levels of the active substance in the body to giving Humira.
Croatian: Ispitivanja su dokazala i da primjena lijeka Halimatoz dovodi do slične razine djelatne tvari u tijelu kao i primjena lijeka Humira.
English: For the full list of side effects and restrictions with Halimatoz, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Halimatoz potražite u uputi o lijeku.
English: In addition, Halimatoz was as effective as Humira in a study involving 465 patients with moderate or severe plaque psoriasis.
Croatian: Osim toga, u ispitivanju u kojem je sudjelovalo 465 bolesnika s umjerenom do teškom plak psorijazom, lijek Halimatoz bio je jednako djelotvoran kao lijek Humira.
English: It is therefore difficult to recommend an optimal method.
Croatian: Stoga je teško preporučiti optimalnu metodu.
English: The significance of these changes is unknown.
Croatian: Značajnost ovih promjena nije poznata.
English: Although this interaction has not been formally investigated, there is no evidence that such an interaction is harmful.
Croatian: Iako ova interakcija nije službeno ispitana, nema dokaza da je takva interakcija štetna.
English: These can be taken from you or from a donor.
Croatian: Stanice se mogu uzeti od Vas ili od darivatelja.
English: Do not warm Grastofil in any other way (for example, do not warm it in a microwave or in hot water).
Croatian: Nemojte zagrijavati Grastofil ni na koji drugi način (na primjer, nemojte ga zagrijavati u mikrovalnoj pećnici ili vrućoj vodi).
English: Some of the information you require is given at the end of this leaflet, but proper treatment of your disease requires close and constant co-operation with your doctor.
Croatian: Neke od informacija koje su Vam potrebne nalaze se na kraju ove upute, ali pravilno liječenje Vaše bolesti zahtijeva blisku i stalnu suradnju s liječnikom.
English: This will make the injection more comfortable.
Croatian: Tako će injekcija biti ugodnija.
English: Before you inject Grastofil you must do the following:
Croatian: Prije nego što si ubrizgate Grastofil morate učiniti sljedeće:
English: These changes all reversed after discontinuation of treatment.
Croatian: Sve su se promjene povukle nakon prekida liječenja.
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Croatian: Kao i kod svih terapijskih proteina, postoji mogućnost izazivanja imunogenosti.
English: Sarkhej Bavla Highway Moraiya; Taluka: Sanand, Ahmedabad - 382213 Gujarat, India
Croatian: Sarkhej Bavla Highway Moraiya; Taluka: Sanand, Ahmedabad - 382213 Gujarat, Indija
English: If you use more Grastofil than you should
Croatian: Ako primijenite više Grastofila nego što ste trebali
English: The volume of distribution in blood is approximately 150 mL/kg.
Croatian: Volumen distribucije u krvi je približno 150 ml/kg.
English: In some disease types, however, longer treatment lasting up to about one month may be required.
Croatian: Međutim, u nekim oblicima bolesti može biti potrebno duže liječenje u trajanju i do približno mjesec dana.
English: The timing of leukapheresis: one or two leukaphereses on days 5 and 6 which is often sufficient.
Croatian: Planiranje leukafereze: jedna ili dvije leukafereze 5. i 6. dan, što je često dovoljno.
English: These symptoms generally develop in a rapid fashion.
Croatian: Ovi simptomi obično nastupaju naglo.
English: To give yourself a subcutaneous injection you will need:
Croatian: Da biste sami sebi dali supkutanu injekciju, trebat će Vam:
English: Equipment that you need
Croatian: Potrebna oprema
English: Thereafter, it is recommended that the ANC is measured at least twice weekly for the first two weeks and subsequently once per week or once every other week during maintenance therapy.
Croatian: Nakon toga, preporučuje se mjeriti ABN najmanje dvaput tjedno tijekom prva dva tjedna, a potom jedanput tjedno ili jedanput svaki drugi tjedan tijekom terapije održavanja.
English: Your doctor or nurse will give you instructions on how to do this (see information below on instructions for injecting Grastofil).
Croatian: Vaš liječnik ili medicinska sestra će Vam dati upute kako to učiniti (pogledajte u nastavku upute za ubrizgavanje Grastofila).
English: Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
Croatian: Pronađite ugodno, dobro osvijetljeno mjesto i odložite svu opremu na dohvat ruke.
English: How long will I have to take Grastofil?
Croatian: Koliko ću dugo morati primjenjivati Grastofil?
English: Important: do not try to give yourself an injection unless you have received training from your doctor or nurse.
Croatian: Važno: nemojte pokušavati sami sebi dati injekciju ako Vas tome nisu podučili liječnik ili medicinska sestra.
English: This should be considered when interpreting boneimaging results.
Croatian: To treba uzeti u obzir kad se tumače rezultati radioloških pretraga.
English: This section contains information on how to give yourself an injection of Grastofil.
Croatian: Ovaj dio sadrži informacije o tome kako da sami sebi date injekciju Grastofila.
English: The clinical relevance of this finding to multiple dose administration is not clear.
Croatian: Klinička važnost ovog nalaza za primjenu višestrukih doza nije jasna.
English: cells mean that direct comparison between different studies is difficult.
Croatian: stanica znači da je teško napraviti izravnu usporedbu između različitih ispitivanja.
English: If needed, you may cover the injection site with a plaster.
Croatian: Po potrebi, mjesto injekcije možete prekriti flasterom.
English: If you are receiving this medicine by subcutaneous injection, your doctor may suggest that you learn how to give yourself the injections.
Croatian: Ako dobivate ovaj lijek supkutanom injekcijom, Vaš liječnik može predložiti da naučite kako da si sami dajete injekcije.
English: The choice of mobilisation method should be considered in relation to the overall objectives of treatment for an individual patient.
Croatian: Izbor metode mobilizacije potrebno je razmatrati u odnosu na ukupne ciljeve liječenja u pojedinog bolesnika.
English: • increase of certain enzymes in the blood
Croatian: • povišenje određenih enzima u krvi
English: You should talk to your doctor about your risks of developing cancers of the blood and what testing should be done.
Croatian: Trebate razgovarati s Vašim liječnikom o rizicima od razvoja raka krvi i pretragama koje bi trebalo napraviti.
English: Put the needle fully into the skin as shown by your nurse or doctor.
Croatian: Uvedite iglu do kraja pod kožu kako su Vam pokazali medicinska sestra ili liječnik.
English: Other medicines and Grastofil
Croatian: Drugi lijekovi i Grastofil
English: Date of first authorisation: 18 October 2013 Date of latest renewal: 4 October 2018
Croatian: Datum posljednje obnove odobrenja: 4. listopada 2018
English: The usual dose of Grastofil varies depending on your illness and weight.
Croatian: Uobičajena doza lijeka Grastofil razlikuje se ovisno o Vašoj bolesti i tjelesnoj težini.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER
Croatian: Uputa o lijeku: informacije za korisnika
English: If you see blood in the syringe, pull the needle out and re-insert it in another place.
Croatian: Ako ugledate krv u štrcaljki, izvucite iglu i ubodite na drugo mjesto.
English: Your healthcare professional should always record the exact medicine you are using.
Croatian: Zdravstveni radnik uvijek treba zabilježiti točno koji lijek uzimate.
English: In other circumstances, additional leukaphereses may be necessary.
Croatian: U drugim okolnostima mogu biti potrebne dodatne leukafereze.
English: See section 2 “What you need to know before you use Grastofil”.
Croatian: Pogledajte dio 2 „Što morate znati prije nego primijenite Grastofil“.
English: Growth factors are proteins that are produced naturally in the body but they can also be made using biotechnology for use as a medicine.
Croatian: Faktori rasta su proteini koji se prirodnim putem stvaraju u tijelu, no moguće ih je stvoriti i biotehnološkim postupkom te koristiti kao lijek.
English: Dose adjustment is not required in these circumstances.
Croatian: U takvim okolnostima nije potrebna prilagodba doze.
English: cell numbers vary depending on the precise methodology used and therefore, recommendations of numbers based on studies in other laboratories need to be interpreted with caution.
Croatian: stanica protočnim citometrom razlikuju se ovisno o tome koja se točno metodologija koristila pa se stoga preporučeni brojevi na temelju ispitivanja u drugim laboratorijima trebaju tumačiti s oprezom.
English: What Grastofil looks like and contents of the pack
Croatian: Kako Grastofil izgleda i sadržaj pakiranja
English: After one to two weeks of therapy, the initial dose may be doubled or halved depending upon the patient's response.
Croatian: Nakon jednog do dva tjedna liječenja, početnu dozu moguće je udvostručiti ili smanjiti na pola ovisno o odgovoru bolesnika.
English: Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present.
Croatian: Vezujuća protutijela pojavljuju se kao što se očekuje kod svih bioloških lijekova, međutim do sada nisu povezana s neutralizirajućom aktivnošću.
English: No undesirable effects directly attributable to this degree of leukocytosis have been reported.
Croatian: Nisu zabilježeni nikakvi neželjeni učinci koji se mogu izravno pripisati ovom stupnju leukocitoze.
English: The only consistently reported adverse event was musculoskeletal pain which is no different from the experience in the adult population.
Croatian: Jedina dosljedno prijavljivana nuspojava bila je mišićno-koštana bol, što se ne razlikuje od iskustva u odrasle populacije.
English: • transfusion reaction
Croatian: • transfuzijska reakcija
English: Accidental one-time exposure to freezing temperatures does not adversely affect the stability of Grastofil.
Croatian: Nehotično jednokratno izlaganje temperaturama zamrzavanja ne utječe štetno na stabilnost Grastofila.
English: If you have missed an injection, contact your doctor as soon as possible.
Croatian: Ako ste propustili injekciju, obratite se liječniku čim je prije moguće.
English: You do not need to remove the air bubble before injecting.
Croatian: Ne morate istisnuti mjehurić zraka prije ubrizgavanja.
English: Grastofil treatment will last for 4 to 5 days.
Croatian: Liječenje Grastofilom će trajati 4 do 5 dana.