FrancophonIA/ELRC3.0 huggingface dataset:
English: The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia (salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal antiinflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim).
Croatian: Rizik od hiperkalijemije se povećava u slučaju kombinacije s drugim lijekovima koji također mogu izazvati hiperkalijemiju (nadomjesci soli koji sadrže kalij, diuretici koji štede kalij, ACE-inhibitori, antagonisti receptora angiotenzina II, nesteroidni protuupalni lijekovi (NSAIL, uključujući selektivne COX-2 inhibitore), heparin, imunosupresivi (ciklosporin ili takrolimus) i trimetoprim).
English: What Kinzalmono looks like and contents of the pack Kinzalmono 40 mg tablets are white, oblong-shaped and engraved with the code number '51H' on one side.
Croatian: Kako Kinzalmono izgleda i sadržaj pakiranja Kinzalmono 40 mg tablete su bijele, duguljastog oblika, s utisnutom oznakom „51H“ na jednoj strani.
English: Kinzalmono 80 mg tablets
Croatian: Kinzalmono 80 mg tablete
English: Kinzalmono 20 mg tablets
Croatian: Kinzalmono 20 mg tablete
English: What Kinzalmono looks like and contents of the pack Kinzalmono 80 mg tablets are white, oblong-shaped and engraved with the code number '52H' on one side.
Croatian: Kako Kinzalmono izgleda i sadržaj pakiranja Kinzalmono 80 mg tablete su bijele, duguljastog oblika, s utisnutom oznakom „52H“ na jednoj strani.
English: Kinzalmono is available in blister packs containing 14, 28, 56 or 98 tablets, or unit dose blister packs containing 28 x 1 tablets.
Croatian: Kinzalmono je dostupan u blister pakiranjima od 14, 28, 56 ili 98 tableta, ili blisterima djeljivim na jedinične doze s 28 x 1 tabletom.
English: Kinzalmono 20 mg tablets EU/1/98/091/009 (14 tablets) EU/1/98/091/010 (28 tablets) EU/1/98/091/011 (56 tablets) EU/1/98/091/012 (98 tablets)
Croatian: Kinzalmono 20 mg tablete EU/1/98/091/009 (14 tableta) EU/1/98/091/010 (28 tableta) EU/1/98/091/011 (56 tableta) EU/1/98/091/012 (98 tableta)
English: Kinzalmono 40 mg tablets EU/1/98/091/001 (14 tablets) EU/1/98/091/002 (28 tablets) EU/1/98/091/003 (56 tablets) EU/1/98/091/004 (98 tablets) EU/1/98/091/013 (28 x 1 tablets)
Croatian: Kinzalmono 40 mg tablete EU/1/98/091/001 (14 tableta) EU/1/98/091/002 (28 tableta) EU/1/98/091/003 (56 tableta) EU/1/98/091/004 (98 tableta) EU/1/98/091/013 (28 x 1 tableta)
English: In the "Prevention Regimen For Effectively avoiding Second Strokes" (PRoFESS) trial in patients 50 years and older, who recently experienced stroke, an increased incidence of sepsis was noted for telmisartan compared with placebo, 0.70 % vs. 0.49 % [RR 1.43 (95 % confidence interval 1.002.06)]; the incidence of fatal sepsis cases was increased for patients taking telmisartan (0.33 %) vs. patients taking placebo (0.16 %) [RR 2.07 (95 % confidence interval 1.14 - 3.76)].
Croatian: godina i starijih, koji su nedavno imali moždani udar, zabilježena je povećana incidencija sepse za telmisartan u usporedbi s placebom, 0,70 % u odnosu na 0,49 % RR 1,43 (95 % interval pouzdanosti 1,00 - 2,06).
English: Haemoglobin decreased, blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased
Croatian: Sniženi hemoglobin, povišene vrijednosti mokraćne kiseline u krvi, povišeni jetreni enzimi, povišena kreatin-fosfokinaza u krvi za daljnje opise, molimo vidjeti pod “Opis odabranih nuspojava”.
English: Kinzalmono 80 mg tablets EU/1/98/091/005 (14 tablets) EU/1/98/091/006 (28 tablets) EU/1/98/091/007 (56 tablets) EU/1/98/091/008 (98 tablets) EU/1/98/091/014 (28 x 1 tablets)
Croatian: Kinzalmono 80 mg tablete EU/1/98/091/005 (14 tableta) EU/1/98/091/006 (28 tableta) EU/1/98/091/007 (56 tableta) EU/1/98/091/008 (98 tableta) EU/1/98/091/014 (28 x 1 tableta)
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), severe allergic reaction (anaphylactic reaction), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), upset stomach, dry mouth, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Croatian: Sepsa* (često nazvana „trovanje krvi“ je teška infekcija s upalnim odgovorom cijelog organizma što može dovesti do smrtnog ishoda), povećanje određenih bijelih krvnih stanica (eozinofilija), nizak broj krvnih pločica (trombocitopenija), teška alergijska reakcija (anafilaktička reakcija), alergijska reakcija (npr. osip, svrbež, otežano disanje, piskanje, oticanje lica ili nizak krvni tlak), niske razine šećera u krvi (u bolesnika sa šećernom bolesti), osjećaj tjeskobe, izrazita pospanost, oštećen vid, ubrzani otkucaji srca (tahikardija), suhoća usta, nadražaj želuca, poremećaj osjeta okusa (disgeuzija), abnormalna funkcija jetre (vjerojatnost da će iskusiti ovu nuspojavu, veća je za bolesnike iz Japana), brzo oticanje kože i sluznice koji mogu dovesti do smrtnog ishoda (angioedem također sa smrtnim ishodom), ekcem (poremećaj kože), crvenilo kože, koprivnjača (urtikarija), težak osip od lijeka, bol u zglobovima (artralgija), bol u udovima, bol tetiva, simptomi nalik gripi, snižen hemoglobin (krvni protein), povišena razina mokraćne kiseline, povišeni jetreni enzimi ili kreatin fosfokinaza u krvi.
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Croatian: Sepsa* (često nazvana „trovanje krvi“ je teška infekcija s upalnim odgovorom cijelog organizma što može dovesti do smrtnog ishoda), povećanje određenih bijelih krvnih stanica (eozinofilija), nizak broj krvnih pločica (trombocitopenija), teška alergijska reakcija (anafilaktička reakcija), alergijska reakcija (npr. osip, svrbež, otežano disanje, piskanje, oticanje lica ili nizak krvni tlak), niske razine šećera u krvi (u bolesnika sa šećernom bolesti), osjećaj tjeskobe, izrazita pospanost, oštećen vid, ubrzani otkucaji srca (tahikardija), suhoća usta, nadražaj želuca, poremećaj osjeta okusa (digeuzija), abnormalna funkcija jetre (vjerojatnost da će iskusiti ovu nuspojavu, veća je za bolesnike iz Japana), brzo oticanje kože i sluznice koji mogu dovesti do smrtnog ishoda (angioedem također sa smrtnim ishodom), ekcem (poremećaj kože), crvenilo kože, koprivnjača (urtikarija), težak osip od lijeka, bol u zglobovima (artralgija), bol u udovima, bol tetiva, simptomi nalik gripi, snižen hemoglobin (krvni protein), povišena razina mokraćne kiseline, povišeni jetreni enzimi ili kreatin fosfokinaza u krvi.
English: Package leaflet: Information for the user Kinzalmono 20 mg tablets Telmisartan
Croatian: Uputa o lijeku: Informacije za korisnika Kinzalmono 20 mg tablete telmisartan
English: Package leaflet: Information for the user Kinzalmono 40 mg tablets Telmisartan
Croatian: Uputa o lijeku: Informacije za korisnika Kinzalmono 40 mg tablete telmisartan
English: Package leaflet: Information for the user Kinzalmono 80 mg tablets Telmisartan
Croatian: Uputa o lijeku: Informacije za korisnika Kinzalmono 80 mg tablete telmisartan
English: NAME OF THE MEDICINAL PRODUCT Kinzalmono 40 mg tablets telmisartan
Croatian: NAZIV LIJEKA Kinzalmono 40 mg tablete telmisartan
English: NAME OF THE MEDICINAL PRODUCT Kinzalmono 80 mg tablets telmisartan
Croatian: NAZIV LIJEKA Kinzalmono 80 mg tablete telmisartan
English: NAME OF THE MEDICINAL PRODUCT Kinzalmono 20 mg tablets telmisartan
Croatian: NAZIV LIJEKA Kinzalmono 20 mg tablete telmisartan
English: Kinzalmono 40 mg and 80 mg tablets Pack sizes: Blister with 14, 28, 56 or 98 tablets or perforated unit dose blisters with 28 x 1 tablets.
Croatian: Veličine pakiranja: blister s 14, 28, 56 ili 98 tableta ili perforirani blisteri djeljivi na jedinične doze s 28 x 1 tabletom.
English: What Kinzalmono looks like and contents of the pack Kinzalmono 20 mg tablets are white, round and engraved with the code number '50H' on one side and the company logo on the other side.
Croatian: Kinzalmono 20 mg tablete su bijele, okrugle s utisnutom oznakom „50H“ na jednoj i logom tvrtke na drugoj strani.
English: This treatment course is repeated one year later.
Croatian: Ovakav raspored liječenja ponavlja se nakon godinu dana.
English: It must not be given to patients with active cancers.
Croatian: Ne smije se primjenjivati u bolesnika s aktivnim rakom.
English: The full EPAR for Mavenclad can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Mavenclad nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The first year, patients take one to two tablets a day for 4 or 5 days; after one month, they again take one to two tablets a day for 4 or 5 days, adding up to a total dose of 1.75 mg per kg body weight over the two periods.
Croatian: Prve godine bolesnici uzimaju jednu do dvije tablete dnevno 4 ili 5 dana; nakon mjesec dana ponovno uzimaju jednu do dvije tablete dnevno 4 ili 5 dana, čime ukupna doza iznosi 1,75 mg po kilogramu tjelesne težine tijekom tih dvaju razdoblja.
English: Mavenclad cladribine
Croatian: Mavenclad kladribin
English: No other medicines should be taken within 3 hours of a Mavenclad tablet.
Croatian: Ne smiju se uzimati nikakvi drugi lijekovi u razdoblju od 3 sata nakon što se uzme tableta Mavenclad.
English: The immune cells called lymphocytes play a key role in this process.
Croatian: Imunosne stanice koje se nazivaju limfociti imaju ključnu ulogu u tom procesu.
English: Cladribine is already approved in the EU for the treatment of certain leukaemias (cancers affecting lymphocytes).
Croatian: Lijek Cladribine već je odobren u EU-a za liječenje određenih oblika leukemije (rak koji djeluje na limfocite).
English: This is a summary of the European public assessment report (EPAR) for Mavenclad.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Mavenclad.
English: The dose depends on patients' body weight and treatment consists of two courses spread over 2 years.
Croatian: Doziranje ovisi o tjelesnoj težini bolesnika, a liječenje se sastoji od dva ciklusa liječenja u ukupnom trajanju od 2 godine.
English: Mavenclad is used in patients whose disease is highly active.
Croatian: Mavenclad se primjenjuje u bolesnika kod kojih je bolest vrlo aktivna.
English: The European Medicines Agency therefore decided that Mavenclad's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Stoga je Europska agencija za lijekove zaključila da koristi lijeka Mavenclad nadmašuju s njim povezane rizike i preporučila davanje odobrenja za njegovu primjenu u EU-u.
English: What measures are being taken to ensure the safe and effective use of Mavenclad?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Mavenclad?
English: What is Mavenclad and what is it used for?
Croatian: Što je Mavenclad i za što se koristi?
English: In a follow-up study for up to a further 2 years, benefit of the original treatment was maintained but there seemed no additional benefit from giving more than 2 courses of Mavenclad treatment.
Croatian: U naknadnom ispitivanju koje je trajalo sljedeće dvije godine korist izvornog liječenja i dalje je bila vidljiva, ali nisu zabilježene nikakve dodatne koristi od primjene lijeka Mavenclad u više od 2 ciklusa liječenja.
English: The company that markets Mavenclad will provide information on the medicine for healthcare professionals and patients, including advice on the side effects and safety concerns, the need for monitoring before and during treatment, and on pregnancy prevention and effective contraception in both female and male patients.
Croatian: Tvrtka koje lijek Mavenclad stavlja u promet objavit će informacije o lijeku za zdravstvene djelatnike i bolesnike, uključujući savjete o nuspojavama i razlozima za zabrinutost za zdravlje, o potrebama nadzora prije i tijekom liječenja te o sprečavanju trudnoće i djelotvornoj kontracepciji u ženskih i muških bolesnika.
English: In multiple sclerosis, the body's immune (defence) system attacks and damages the protective sheath around the nerve cells in the central nervous system (the brain and spinal cord).
Croatian: Kod multiple skleroze imunosni (obrambeni) sustav tijela napada i oštećuje zaštitnu ovojnicu oko živčanih stanica u središnjem živčanom sustavu (mozak i leđna moždina).
English: This appeared to be most marked in patients with highly active disease, in whom the clinical benefits were considered to outweigh the risks of a severe long-term lowering in lymphocyte numbers, which increases the risk of infection and possibly of cancer.
Croatian: Ovo djelovanje bilo je najizraženije u bolesnika kod kojih je bolest bila vrlo aktivna i kod kojih se smatralo da kliničke koristi nadmašuju rizike od ozbiljnog i dugoročnog smanjenja broja limfocita, što povećava rizik od infekcije i mogućeg raka.
English: Rashes, hair loss and lowered counts of another type of white blood cell, neutrophils, may also affect up to 1 patient in 10.
Croatian: Osip, gubitak kose i smanjeni broj još jedne vrste bijelih krvnih stanica, neutrofila, isto se tako mogu javiti u najviše 1 od 10 bolesnika.
English: The active substance in Mavenclad, cladribine, has a similar chemical structure to purine, one of the substances needed to make up the DNA.
Croatian: Djelatna tvar u lijeku Mavenclad, kladribin, ima sličan kemijski sastav kao purin, jedna od tvari potrebna za stvaranje DNK.
English: Other information about Mavenclad
Croatian: Ostale informacije o lijeku Mavenclad
English: Effects on lymphocytes reduce the body's immune defence against infections and cancer: Mavenclad must not be given to patients with active long-term infections such as tuberculosis or hepatitis, nor to patients with HIV infection or whose immune defences are weakened for other reasons such as treatment with medicines that suppress the immune system.
Croatian: Djelovanjem na limfocite smanjuje se imunološka obrana tijela od infekcija i raka: Mavenclad se ne smije primjenjivati u bolesnika s aktivnim dugotrajnim infekcijama kao što su tuberkuloza ili hepatitis ni u bolesnika s infekcijom virusom HIV-a ili bolesnika čiji je imunosni obrambeni sustav oslabljen zbog drugih razloga, kao što je liječenje lijekovima za potiskivanje imunosnog sustava.
English: The study compared the effect of Mavenclad and placebo (a dummy treatment) in reducing the relapse rate 96 weeks after the start of treatment.
Croatian: U ispitivanju je uspoređeno djelovanje lijeka Mavenclad i placeba (prividnog liječenja) na smanjenje stope relapsa bolesti 96 tjedana nakon početka liječenja.
English: Patients treated with Mavenclad had a relapse rate of 0.14 per year on average, compared with 0.33 for patients given placebo; at the end of 96 weeks, around 8 out 10 patients given standard doses of Mavenclad and 6 out of 10 given placebo had not had a relapse.
Croatian: Kod bolesnika koji su liječeni lijekom Mavenclad stopa relapsa bolesti iznosila je u prosjeku 0,14 godišnje u usporedbi sa stopom od 0,33 kod bolesnika koji su primili placebo; na kraju 96 tjedana relaps bolesti nije zabilježen kod oko 8 od 10 bolesnika kojima su dane standardne doze lijeka Mavenclad i kod 6 od 10 bolesnika koji su primili placebo.
English: Treatment must also be avoided in patients whose kidney function is moderately or severely reduced, and in women who are pregnant or breast feeding.
Croatian: Mora se izbjegavati i njegova primjena za liječenje bolesnika s umjereno ili znatno smanjenom funkcijom bubrega i liječenje žena u trudnoći ili žena koje doje.
English: It is not intended to provide practical advice on how to use Mavenclad.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Mavenclad.
English: Mavenclad can only be obtained with a prescription and treatment must be started and supervised by a doctor experienced in treating multiple sclerosis.
Croatian: Mavenclad se izdaje samo na recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju multiple skleroze.
English: The results suggested that the effects were greatest in patients with highly active disease and that benefit might be expected in other relapsing forms of multiple sclerosis.
Croatian: Iz rezultata se može zaključiti da je djelovanje lijeka najveće u bolesnika kod kojih je bolest vrlo aktivna i da se mogu očekivati koristi i kod ostalih relapsnih oblika multiple skleroze.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mavenclad 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 Mavenclad nalaze se i u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: What are the risks associated with Mavenclad?
Croatian: Koji su rizici povezani s lijekom Mavenclad?
English: For more information about treatment with Mavenclad, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Mavenclad pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: In addition, patients given Mavenclad were nearly 50% less likely to have disease progression (indicated as an increase in disability that lasted for at least 6 months).
Croatian: Osim toga, kod bolesnika koji su primili lijek Mavenclad vjerojatnost napredovanja bolesti (koja se izražava povećanjem nesposobnosti u trajanju od najmanje 6 mjeseci) bila je 50 % manja.
English: Why is Mavenclad approved?
Croatian: Zašto je lijek Mavenclad odobren?
English: The most common side effects with Mavenclad are lymphopenia (reduction in lymphocytes, which may affect more than 1 in 10 people) and infections with herpes zoster virus, in up to 1 patient in 10.
Croatian: Najčešća nuspojava lijeka Mavenclad jesu limfopenija (smanjenje broja limfocita, koja se može javiti u više od 1 od 10 bolesnika) i infekcije virusom herpes zoster, koje se mogu javiti u najviše 1 od 10 bolesnika.
English: Mavenclad has been shown to be effective in one main study involving 1,326 patients with relapsingremitting multiple sclerosis.
Croatian: Djelotvornost lijeka Mavenclad dokazana je u jednom glavnom ispitivanju koje je obuhvatilo 1 326 bolesnika s relapsno-remitirajućom multiplom sklerozom.
English: It contains the active substance cladribine.
Croatian: Sadržava djelatnu tvar kladribin.
English: Mavenclad has been shown to reduce relapse rates and delay disease progression in patients with relapsing multiple sclerosis.
Croatian: Dokazano je da Mavenclad smanjuje stope relapsa bolesti i odgađa napredovanje bolesti u bolesnika s relapsom multiple skleroze.
English: For practical information about using Mavenclad, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Mavenclad bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: In addition, the fact that Mavenclad is given by mouth, and requires only 2 short courses 12 months apart, offers an advantage to patients.
Croatian: Osim toga, činjenica da se Mavenclad primjenjuje kroz usta i da su potrebna samo 2 kratka ciklusa liječenja u razmaku od
English: This brings about the death of the lymphocytes, slowing down the progression of multiple sclerosis.
Croatian: Limfociti zbog toga odumiru, što usporava napredovanje multiple skleroze.
English: For the full list of all side effects reported with Mavenclad, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih za lijek Mavenclad potražite u uputi o lijeku.
English: What benefits of Mavenclad have been shown in studies?
Croatian: Koje su koristi lijeka Mavenclad dokazane u ispitivanjima?
English: Mavenclad is a medicine used to treat adults with the relapsing forms of multiple sclerosis, a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord.
Croatian: Mavenclad je lijek koji se koristi za liječenje odraslih osoba s relapsnim oblicima multiple skleroze, bolesti u kojoj upala oštećuje zaštitne ovojnice oko živčanih stanica u mozgu i leđnoj moždini. „Relaps” znači da dolazi do razbuktavanja simptoma koji se ponavljaju.
English: In the body, cladribine is taken up by cells such as lymphocytes and interferes with the production of new DNA.
Croatian: Kladribin u tijelu iskorištavaju stanice poput limfocita te on ometa proces stvaranja novog DNK.
English: How does Mavenclad work?
Croatian: Kako djeluje Mavenclad?
English: How is Mavenclad used?
Croatian: Kako se lijek Mavenclad koristi?
English: The company also provided information from a variety of supportive studies.
Croatian: Tvrtka je dostavila i informacije iz različitih potpornih ispitivanja.
English: Further information on Xromi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/xromi .
Croatian: Više informacija o lijeku Xromi dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/xromi.
English: It must not be used in pregnancy, and breast-feeding must be stopped while taking the medicine.
Croatian: Ne smije se primjenjivati u trudnoći, a dojenje se treba prekinuti tijekom uzimanja lijeka.
English: Patients are usually started at a daily dose of 15 mg for each kg of body weight, and increased if necessary every 8 weeks to a maximum of 35 mg per kg.
Croatian: Bolesnicima se obično daje početna dnevna doza od 15 mg po kilogramu tjelesne težine, a prema potrebi se povećava svakih osam tjedana do najviše 35 mg po kilogramu.
English: What is Xromi and what is it used for?
Croatian: Što je Xromi i za što se koristi?
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but is given as a liquid to be swallowed rather than as capsules and is authorised for different uses.
Croatian: To znači da je sličan „referentnom lijeku” koji sadrži istu djelatnu tvar, ali se radije daje u obliku tekućine za piće nego u obliku kapsula i odobren je za druge primjene.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Croatian: Dva su lijeka bioekvivalentna ako u tijelu postižu iste razine djelatne tvari.