FrancophonIA/ELRC3.0 huggingface dataset:
English: For 15mg prolonged release oral formulations
Croatian: Za oralne formulacije s produljenim oslobađanjem od 15 mg
English: Adult population
Croatian: Stariji ljudi
English: The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to 3 times daily, taken by mouth (oral route).
Croatian: Preporučena doza je 0,1 do 0,15 mg/kg tjelesne težine, koja se ponavlja do 3 puta na dan, na usta (putem primjene kroz usta).
English: The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to 3 times daily, given by slow injection into a vein.
Croatian: Preporučena doza je 0,1 do 0,15 mg/kg tjelesne težine, koja se ponavlja do 3 puta na dan, i koja se primjenjuje polaganom injekcijom u venu.
English: The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to three times daily by intravenous route.
Croatian: Preporučena doza je 0,1 do 0,15 mg/kg tjelesne težine, koja se ponavlja do tri puta na dan intravenskim putem primjene.
English: For formulations which cannot be used to administer a 5mg dose Tablets/capsules/granules are not suitable for use in children weighing less than 61 kg. Other pharmaceutical forms/strengths may be more appropriate for administration to this population.
Croatian: Za formulacije koje se ne mogu koristiti za primjenu doze od 5 mg Tablete/kapsule/granule nisu prikladne za primjenu u djece težine manje od 61 kg.
English: Adult population {Tradename} is indicated in adults for: - Prevention of delayed chemotherapy induced nausea and vomiting (CINV) - Prevention of radiotherapy induced nausea and vomiting (RINV).
Croatian: Odrasla populacija {Zaštićeno ime} je indiciran/a u odraslih za: - prevenciju odgođenog nastupa mučnine i povraćanja induciranih kemoterapijom - prevenciju mučnine i povraćanja induciranih radioterapijom.
English: For formulations which can be used to administer a 5mg dose Tablets/capsules/granules are not suitable for use in children weighing less than 30 kg. Other pharmaceutical forms/strengths may be more appropriate for administration to this population
Croatian: Za formulacije koje se mogu koristiti za primjenu doze od 5 mg Tablete/kapsule/granule nisu prikladne za primjenu u djece težine manje od 30 kg.
English: Appropriate additional information regarding posologies adaptation should be implemented in the SmPC depending on the strength of the formulations
Croatian: Odgovarajuće dodatne informacije o prilagodbi doze potrebno je implementirati u Sažetak opisa svojstava lijeka ovisno o dozi formulacija
English: For the 30 mg strengh prolonged release preparations
Croatian: Za pripravke s produljenim oslobađanjem doze od 30 mg
English: The time interval of at least 24 hours specified in the section 4.2 should be respected between each metoclopramide administration, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Croatian: Potrebno je pridržavati se vremenskog razmaka od najmanje 24 sata navedenog u dijelu 4.2 između svake primjene metoklopramida, čak i u slučaju povraćanja ili neprihvaćanja doze, kako bi se izbjeglo predoziranje.
English: You must wait at least 24 hours between each metoclopramide dose, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Croatian: Morate pričekati najmanje 24 sata između svake primjene doze metoklopramida, čak i u slučaju povraćanja i neprihvaćanja doze, kako biste izbjegli predoziranje.
English: Contact your doctor or pharmacist straight away.
Croatian: Ako uzmete više {Zaštićeno ime} nego što ste trebali Odmah se obratite svom liječniku ili ljekarniku.
English: You must wait at least 6 hours between each metoclopramide dose, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Croatian: Morate pričekati najmanje 6 sati između svake doze metoklopramida, čak i u slučaju povraćanja i neprihvaćanja doze, kako biste izbjegli predoziranje.
English: The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to three times daily by oral route.
Croatian: Preporučena doza je 0,1 do 0,15 mg/kg tjelesne težine, koja se ponavlja do tri puta na dan peroralnim putem primjene.
English: - you are taking levodopa (a medicine for Parkinson's disease) or dopaminergic agonists (see below “Other medicines and Tradename”) - you have ever had an abnormal blood pigment levels (methaemoglobinemia) or NADH cytochromeb5 deficiency
Croatian: ako ste ikad imali poremećaj razine pigmenta u krvi (methemoglobinemija) ili nedostatak NADH citokroma-b5
English: - you are allergic to metoclopramide or any of the other ingredients of this medicine (listed in section 6).
Croatian: Za sve formulacije - Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenu u dijelu 6.1.
English: The time interval of at least 12 hours specified in the section 4.2 should be respected between each metoclopramide administration, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Croatian: Potrebno je pridržavati se vremenskog razmaka od najmanje 12 sati navedenog u dijelu 4.2 između svake primjene metoklopramida, čak i u slučaju povraćanja ili neprihvaćanja doze, kako bi se izbjeglo predoziranje.
English: You must wait at least 12 hours between each metoclopramide dose, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Croatian: Morate pričekati najmanje 12 sati između svake primjene doze metoklopramida, čak i u slučaju povraćanja i neprihvaćanja doze, kako biste izbjegli predoziranje.
English: Frequency Adverse reactions
Croatian: Kontraindicirana kombinacija
English: The time interval of at least 6 hours specified in the section 4.2 should be respected between each metoclopramide administration, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Croatian: Potrebno je pridržavati se vremenskog razmaka od najmanje 6 sati navedenog u dijelu 4.2 između svake primjene metoklopramida, čak i u slučaju povraćanja ili neprihvaćanja doze, kako bi se izbjeglo predoziranje.
English: deficiency.
Croatian: Depresija
English: For the 15 mg strengh prolonged release preparations
Croatian: Za pripravke s produljenim oslobađanjem Doza od 15 mg
English: 30 mg strength prolonged release preparations
Croatian: Pripravci s produljenim oslobađanjem doze od 30 mg
English: Adult population {Tradename} is indicated in adults for: - Prevention of delayed chemotherapy induced nausea and vomiting (CINV) - Prevention of radiotherapy induced nausea and vomiting (RINV) 4.2 Posology and method of administration
Croatian: Odrasla populacija {Zaštićeno ime} je indiciran/a u odraslih za: - prevenciju odgođenog nastupa mučnine i povraćanja induciranih kemoterapijom - prevenciju mučnine i povraćanja induciranih radioterapijom - simptomatsko liječenje mučnine i povraćanja, uključujući mučnine i povraćanja induciranih akutnom migrenom.
English: - to prevent delayed nausea and vomiting that may occur after chemotherapy - to prevent nausea and vomiting caused by radiotherapy - to treat nausea and vomiting including nausea and vomiting which may occur with a migraine.
Croatian: Odrasla populacija {Zaštićeno ime} koristi se u odraslih za: - sprječavanje odgođenog nastupa mučine i povraćanja koji se mogu javiti nakon kemoterapije - sprječavanje mučine i povraćanja uzrokovanih radioterapijom - liječenje mučine i povraćanja, uključujući mučnine i povraćanja koji se mogu javiti kod migrene.
English: Age
Croatian: Dob
English: Immune system disorders
Croatian: Poremećaji probavnog sustava Često
English: Oral route
Croatian: Peroralni put primjene
English: improvement in lameness was considered relevant and positive effects lasted over a period of one year.
Croatian: Smanjenje hromosti smatralo se relevantnim, a pozitivni učinci trajali su godinu dana.
English: Further information on Arti-Cell Forte can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Više informacija o VMP-u Arti-Cell Forte nalazi se na internetskim stranicama Agencije ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.:
English: Arti-Cell Forte received a marketing authorisation valid throughout the EU on 29 March 2019.
Croatian: Za VMP Arti-Cell Forte izdano je odobrenje za stavljanje u promet koje je na snazi u EU-u od 29. ožujka 2019.
English: This overview was last updated in June 2018.
Croatian: Pregled informacija posljednji je put ažuriran u 6. 2018.
English: Accidental self-injection can cause pain, local inflammatory reactions and swelling at the injection site which may last for several weeks and possibly cause fever.
Croatian: Nehotično samoinjiciranje može uzrokovati bol, lokalne upalne reakcije i oticanje na mjestu primjene injekcije koji mogu trajati nekoliko tjedana te mogu izazvati vrućicu.
English: The stem cells have been prepared by being taken from blood from donor horses and grown in the laboratory to increase their numbers; they are treated so that they develop into cartilage cells which help to protect cartilage.
Croatian: Matične se stanice pripremaju iz krvi konja donora i uzgajaju se u laboratoriju kako bi se povećao njihov broj; tretiraju se kako bi se razvile u stanice hrskavice koje pomažu u zaštiti hrskavice.
English: The side effects were seen in the first week after use of the medicine.
Croatian: Nuspojave su zabilježene u prvom tjednu nakon primjene VMP-a.
English: It consists of two vials which are supplied frozen: one vial contains the active substance and a second vial contains equine allogeneic plasma (EAP) which is the liquid part of blood.
Croatian: Sastoji se od dvije bočice koje se isporučuju zamrznute: jedna bočica sadrži djelatnu tvar, a druga bočica alogeničnu plazmu konja (EAP) koja je tekući dio krvi.
English: Other information about Arti-Cell Forte
Croatian: Ostale informacije o VMP-u Arti-Cell Forte
English: The withdrawal period for meat from horses treated with Arti-Cell Forte is ‘zero' days, which means that there is no mandatory waiting time.
Croatian: Razdoblje karencije za meso konja liječenih VMP-om Arti-Cell Forte iznosi „nula” dana, odnosno nema obveznog razdoblja čekanja.
English: Before withdrawing the vials from the liquid nitrogen canister, protective equipment consisting of gloves, long sleeves and a facemask or goggles should be worn.
Croatian: Prije uzimanja bočice iz spremnika s tekućim dušikom, potrebno je opremiti se zaštitnom opremom koja se sastoji od rukavica, dugih rukava i maske za lice ili naočala.
English: In order to prepare the injection, the content of both vials, once thawed, are mixed and then injected only by a veterinarian directly into the affected joint.
Croatian: Kako bi se pripremila injekcija, nakon odmrzavanja sadržaj obje bočice se miješa, a zatim ga isključivo veterinar ubrizgava izravno u zahvaćeni zglob.
English: Liquid nitrogen containers should be handled by properly trained personnel only.
Croatian: Spremnicima tekućeg dušika smije rukovati samo prikladno obučeno osoblje.
English: In a field study involving horses with a history of lameness lasting 2 to 6 months, 50 horses were treated with Arti-Cell Forte and 25 received a placebo (dummy injection) of saline in one fetlock joint.
Croatian: U terenskom ispitivanju koje je obuhvatilo konje koji su prethodno patili od hromosti u trajanju od 2 mjeseca do 6 mjeseci, 50 konja bilo je liječeno VMP-om Arti-Cell Forte, a 25 je primilo injekciju placeba (prividno liječenje) u obliku fiziološke otopine u jedan krunski zglob.
English: The most common side effects with Arti-Cell Forte (which may affect more than 1 in 10 horses) are mild increases in lameness, injection site reactions such as swelling and mild increases in temperature at the injection site.
Croatian: Najčešće nuspojave VMP-a Arti-Cell Forte (mogu se javiti u više od 1 na 10 konja) su blago pogoršanje hromosti, reakcije na mjestu primjene injekcije, kao što su oticanje i blago povećanje temperature na mjestu primjene injekcije.
English: The addition of the EAP to the stem cells after thawing and just before injection of the medicine increases the viability (ability to live) of the stem cells.
Croatian: Dodatak EAP-a matičnim stanicama nakon odmrzavanja te neposredno prije primjene VMP-a injekcijom povećava održivost (sposobnost preživljavanja) matičnih stanica.
English: The European Medicines Agency decided that Arti-Cell Forte's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od VMP-a Arti-Cell Forte nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: The vials containing equine mesenchymal stem cells and equine allogeneic plasma can be stored and transported either frozen or in liquid nitrogen containers.
Croatian: Bočice koje sadrže mezenhimske matične stanice konja i alogeničnu plazmu konja mogu se čuvati i prevoziti zamrznute ili u spremnicima s tekućim dušikom.
English: The medicine is available as an injection and can only be obtained with a prescription.
Croatian: VMP je dostupan kao injekcija i izdaje se samo na veterinarski recept.
English: An overview of Arti-Cell Forte and why it is authorised in the EU
Croatian: Pregled informacija o VMP-u Arti-Cell Forte i zašto je odobren u EU-u
English: What is Arti-Cell Forte and what is it used for?
Croatian: Što je Arti-Cell Forte i za što se primjenjuje?
English: It contains stem cells which are obtained from equine blood.
Croatian: Sadrži matične stanice dobivene iz krvi konja.
English: All horses received intravenous ketoprofen, a medicine to relieve pain and inflammation, at the time of treatment.
Croatian: Svi su konji u vrijeme liječenja intravenski primili ketoprofen, lijek za ublažavanje bola i upale.
English: What are the risks associated with Arti-Cell Forte?
Croatian: Koji su rizici povezani s VMP-om Arti-Cell Forte?
English: Arti-Cell Forte is a veterinary medicine used to treat mild to moderate lameness linked to non-infective joint inflammation in horses.
Croatian: Arti-Cell Forte je veterinarsko-medicinski proizvod (VMP) koji se primjenjuje za liječenje blage do umjerene hromosti povezane s neinfektivnom upalom zglobova u konja.
English: The handling of liquid nitrogen should take place in a wellventilated area.
Croatian: Rukovanje tekućim dušikom potrebno je provesti u dobro prozračenom prostoru.
English: Why is Arti-Cell Forte authorised in the EU?
Croatian: Zašto je Arti-Cell Forte odobren u EU-u?
English: Six weeks after treatment 68% of the horses treated with Arti-Cell Forte had a lameness score reduction by 2 or 3 lameness grades compared to none of the horses in the control group.
Croatian: 68 % konja liječenih VMP-om Arti-Cell Forte rezultat hromosti smanjio se za 2 ili 3 stupnja hromosti u usporedbi s konjima iz kontrolne skupina kod kojih uopće nije došlo do poboljšanja rezultata.
English: For more information about using Arti-Cell Forte, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Za dodatne informacije o primjeni VMP-a Arti-Cell Forte pogledajte uputu o VMP-u, odnosno obratite se veterinaru ili ljekarniku.
English: How does Arti-Cell Forte work?
Croatian: Kako djeluje Arti-Cell Forte?
English: This product contains chondrogenic induced equine mesenchymal stem cells and EAP.
Croatian: Ovaj proizvod sadrži hondrogeno inducirane, mezenhimske matične stanice konja i alogeničnu plazmu konja (EAP).
English: The stem cells in the active substance (mesenchymal stem cells) are treated so that they develop into cartilage cells.
Croatian: Matične stanice u djelatnoj tvari (mezenhimske matične stanice) tretiraju se tako da se razviju u stanice hrskavice.
English: What benefits of Arti-Cell Forte have been shown in studies?
Croatian: Koje su koristi od VMP-a Arti-Cell Forte utvrđene u ispitivanjima?
English: EMA/410964/2018
Croatian: Arti-Cell Forte (hondrogeno inducirane, alogenične mezenhimske matične stanice izvedene iz periferne krvi konja) EMA/410964/2018
English: Further information on Hyrimoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Hyrimoz 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 Hyrimoz 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 Hyrimoz i 63 % za lijek Humira.
English: What measures are being taken to ensure the safe and effective use of Hyrimoz?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Hyrimoz?
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 Hyrimoz 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 Hyrimoz dostupan samo u dozama od 40 mg, nije prikladan za djecu kojoj je potrebna niža doza.
English: What is Hyrimoz and what is it used for?
Croatian: Što je Hyrimoz i za što se koristi?
English: This means that Hyrimoz is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Croatian: Drugim riječima, Hyrimoz je vrlo sličan drugom biološkom lijeku („referentni lijek”) koji je već odobren u EU-u.
English: After training, patients or their carers may inject Hyrimoz if their doctor considers it appropriate.
Croatian: Nakon obuke bolesnici ili njihovi njegovatelji mogu ubrizgati lijek Hyrimoz ako to njihov liječnik smatra primjerenim.
English: The company that markets Hyrimoz must provide educational packs for doctors who prescribe the medicine.
Croatian: Tvrtka koja stavlja na tržište lijek Hyrimoz mora dostaviti edukacijske pakete za liječnike koji propisuju taj lijek.
English: Hyrimoz is a medicine that acts on the immune system and is used to treat the following conditions:
Croatian: Hyrimoz je lijek koji djeluje na imunosni sustav te se koristi za liječenje sljedećih stanja:
English: Like other medicines of its class, Hyrimoz 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, Hyrimoz 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: Other information about Hyrimoz
Croatian: Ostale informacije o lijeku Hyrimoz
English: Hyrimoz 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: Hyrimoz je dostupan kao otopina za potkožnu injekciju u napunjenoj štrcaljki ili brizgalici te se obično primjenjuje svaka dva tjedna.
English: An overview of Hyrimoz and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Hyrimoz i zašto je odobren u EU-u
English: Why is Hyrimoz authorised in the EU?
Croatian: Zašto je lijek Hyrimoz odobren u EU-u?
English: Side effects reported with Hyrimoz are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Hyrimoz pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Hyrimoz 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: Hyrimoz 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: Because Hyrimoz is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Hyrimoz.
Croatian: Budući da je lijek Hyrimoz biosličan lijek, ispitivanja učinkovitosti i sigurnosti adalimumaba provedena za lijek Humira nije potrebno ponavljati za lijek Hyrimoz.
English: The reference medicine for Hyrimoz is Humira.
Croatian: Referentni lijek za lijek Hyrimoz je Humira.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Hyrimoz 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 Hyrimoz ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i lijek Humira te se u tijelu raspoređuje na isti način.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hyrimoz 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 Hyrimoz nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: What are the risks associated with Hyrimoz?
Croatian: Koji su rizici povezani s lijekom Hyrimoz?
English: Hyrimoz is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments.
Croatian: Hyrimoz 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: The active substance in Hyrimoz, 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 Hyrimoz, adalimumab, monoklonsko je protutijelo (vrsta proteina) namijenjeno prepoznavanju i vezivanju za tvar u tijelu zvanu faktor tumorske nekroze (TNF).
English: For more information on the use of Hyrimoz 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 Hyrimoz za sva stanja, kao i kada se može primjenjivati u djece, pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Hyrimoz contains the active substance adalimumab and is a ‘biosimilar medicine'.
Croatian: Hyrimoz 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, ždrijela i sinusa), reakcije na mjestu primjene injekcije (crvenilo, svrbež, krvarenje, bol ili oticanje), glavobolja i bol u mišićno-koštanom sustavu.
English: As for all medicines, data on the use of Hyrimoz are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Hyrimoz kontinuirano se prate.
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 ankilozantni spondilitis te kad rendgenska snimka ne pokazuje bolest, no postoje jasni znaci upale;