FrancophonIA/ELRC3.0 huggingface dataset:
English: The pH and osmolarity of ready-to-use solutions for infusion: pH 4.0 to 5.0 and 385-397 mOsm/l (if diluted in glucose 50 mg/ml [5%] solution for injection) and pH 4.0 to 6.8 and 370-378 mOsm/l (if diluted in sodium chloride 9 mg/ml [0.9%] solution for injection).
Croatian: pH i osmolarnost otopina spremnih za infuziju su: pH 4,0 do 5,0 i 385-397 mOsm/l (ako je razrijeđeno u 5 %-tnoj otopini glukoze za injekciju [50 mg/ml]) i pH 4,0 do 6,8 i 370-378 mOsm/l (ako je razrijeđeno u 0,9 %-tnoj otopini natrijeva klorida za injekciju [9 mg/ml]).
English: Bone marrow toxicity is a common and severe toxic adverse reaction of carmustine.
Croatian: Toksičnost za koštanu srž je česta i teška nuspojava toksičnosti kod karmustina.
English: Renal toxicity.
Croatian: Bubrežna toksičnost.
English: Description of selected adverse reactions
Croatian: Opis odabranih nuspojava Mijelosupresija
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku ili medicinskoj sestri.
English: Carmustine is embryotoxic in rats and rabbits and teratogenic in rats when given in doses equivalent to the human dose.
Croatian: Karmustin je embriotoksičan u štakora i kunića te teratogen u štakora kada se daje u dozama koje odgovaraju dozama u ljudu.
English: Further, the ready-to-use solutions needs to be protected from light (e.g. using alu-foil wrapped around the container of the Ready-to-Use solution) and preferably kept at temperatures below 20-22°C as carmustine degrades faster at higher temperatures.
Croatian: Nadalje, otopine spremne za uporabu treba zaštiti od svjetlosti (npr. zamatanjem aluminijskom folijom spremnika otopine spremne za infuziju) i po mogućnosti čuvati na temperaturama ispod 20 do
English: Common (may affect up to 1 in 10 people) - Acute leukaemias and bone marrow dysplasias (abnormal development of the bone marrow).Symptoms may include bleeding from the gums, bone pain, fever, frequent infections, frequent or severe nosebleed, lumps caused by swollen lymph nodes in and around the neck, underarm, abdomen or groin, pale skin, shortness of breath, weakness, fatigue or a general decrease in energy; - Anaemia (decrease in the amount of red blood cells in the blood); - Encephalopathy (disorder of brain).
Croatian: Simptomi mogu uključivati krvarenje iz desni, bol u kostima, vrućicu, česte infekcije, česta ili teška krvarenja iz nosa, kvržice uzrokovane otečenim limfnim čvorovima u vratu i oko vrata, u pazusima, abdomenu ili preponama, blijedu kožu, otežano disanje, slabost, umor ili opće smanjenje energije; - Anemija (pad u broju crvenih krvnih stanica);
English: The pH and osmolarity of ready-to-use solutions for infusion are: pH 4.0 to 5.0 and 385-397mOsm/l (if diluted in glucose 50 mg/ml [5%] solution for injection), and pH 4.0 to 6.8 and 370-378mOsm/l (if diluted in sodium chloride 9 mg/ml [0.9%] solution for injection).
Croatian: pH i osmolarnost otopina spremnih za infuziju su: pH 4,0 do 5,0 i 385-397 mOsm/l (ako je razrijeđeno u 5%-tnoj otopini glukoze za injekciju [50 mg/ml]) i pH 4,0 do 6,8 i 370-378 mOsm/l (ako se razrijedi u 0,9%-tnoj otopini natrijeva klorida za injekciju [9 mg/ml]).
English: Phlebitis.
Croatian: Flebitis.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete također prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: The injected area should be monitored during the administration.
Croatian: Mjesto primjene infuzije treba nadzirati tijekom primjene.
English: Further, the ready-to-use solution solution needs to be protected from light (e.g. using alu-foil wrapped around the container of the ready-to-use solution) and preferably kept at temperatures below 20-22°C as Carmustine degrades faster at higher temperatures.
Croatian: Nadalje, otopinu spremnu za uporabu treba zaštiti od svjetlosti (npr. zamatanjem aluminijskom folijom spremnika otopine spremne za infuziju) i po mogućnosti čuvati na temperaturama ispod 20 do
English: The Carmustine Obvius powder for concentrate for solution for infusion contains no preservative and is not intended as multiple dose vial.
Croatian: Carmustine Obvius prašak za koncentrat za otopinu za infuziju ne sadrži konzervans i ne služi kao višedozna bočica.
English: Carmustine Obvius is a powder and solvent for concentrate for solution for infusion.
Croatian: Carmustine Obvius je prašak i otapalo za koncentrat za otopinu za infuziju.
English: Each vial of powder for concentrate for solution for infusion contains 100 mg carmustine.
Croatian: Jedna bočica praška za koncentrat za otopinu za infuziju sadrži 100 mg karmustina.
English: On one hand, their carbamoylating activity was reported to contribute to the cytotoxic properties of their parent drugs by inhibiting DNA repair enzymes.
Croatian: S jedne je strane zabilježeno da karbamilirajuća aktivnost pridonosi citotoksičnim svojstvima njihovih ishodišnih molekula inhibicijom enzima koji popravljaju
English: All patients younger than 5 years of age at the time of treatment died from pulmonary fibrosis; neither the carmustine dose nor an additional vincristine dose or spinal radiation had any influence on the fatal outcome.
Croatian: Medijan dobi bolesnika koji su umrli tijekom liječenja iznosio je 2,5 godine (od 1 do 12 godina), medijan dobi bolesnika koji su dugoročno preživjeli na terapiji iznosio je 10 godina (od 5 do 16 godina) Svi bolesnici mlađi od 5 godina u vrijeme terapije umrli su od plućne fibroze; ni doza karmustina ni dodatna doza vinkristina ili zračenje kralježnice nisu imale nikakav utjecaj na smrtni ishod.
English: Reconstitution and dilution, as recommended, results in a clear, colourless to light yellow stock solution which has to be further diluted with 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection, or glucose 50 mg/ml (5%) solution for injection.
Croatian: Rekonstitucija i razrjeđenje prema ovoj uputi rezultiraju bistrom, bezbojnom do žutom koncentriranom otopinom koju treba dalje razrijediti s 500 ml 0,9 %-tne otopine natrijeva klorida za injekciju (9 mg/ml) ili 5%-tnom otopinom glukoze za injekciju (50 mg/ml).
English: Solvent Ethanol, anhydrous.
Croatian: Otapalo etanol, bezvodni.
English: Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body), and feeling you are going to faint.
Croatian: Odmah razgovarajte sa svojim liječnikom ili medicinskom sestrom ako primijetite bilo što od sljedećeg: bilo koje iznenadno piskanje, otežano disanje, oticanje očnih kapaka, lica ili usana, osip ili svrbež (posebice onaj koji zahvaća cijelo tijelo) te osjećaj da ćete se onesvijestiti.
English: Package leaflet: Information for the user Carmustine Obvius 100 mg powder and solvent for concentrate for solution for infusion carmustine
Croatian: Uputa o lijeku: Informacije za korisnika Carmustine Obvius 100 mg prašak i otapalo za koncentrat za otopinu za infuziju karmustin
English: The solvent is a colourless clear liquid supplied in a clear glass ampule.
Croatian: Otapalo je bezbojna prozirna tekućina koja dolazi u ampuli od prozirnog stakla.
English: - Excipients: - Powder: No excipients.
Croatian: - Pomoćne tvari: - Prašak: Nema pomoćnih tvari.
English: This medicine contains 0.57 vol% ethanol (alcohol), which means 7.62 g per dose.
Croatian: Ovaj lijek sadrži 0,57 vol % etanola (alkohol), tj. do 7,62 g po dozi, što odgovara 11,2 ml piva ili 4,65 ml vina po dozi.
English: Reconstitution and dilution of the powder for concentrate for solution for infusion Dissolve the Carmustine (100 mg powder) with 3 ml of the supplied sterile refrigerated ethanol solvent in the primary packaging (brown glass vial).
Croatian: Otopite 100 mg praška karmustina za koncentrat za otopinu za infuziju s 3 ml priloženog sterilnog, na hladnom čuvanog otapala etanola u primarnom pakiranju (smeđa staklena bočica).
English: Nausea and vomiting - severe
Croatian: Teška mučnina i povraćanje
English: The injected area will be monitored during the administration.
Croatian: Mjesto primjene infuzije pratit će se tijekom primjene.
English: After reconstitution and dilution, the solution should be administered within 3 hours after reconstitution and dilution of the product.
Croatian: Nakon rekonstitucije i razrjeđivanja, otopinu treba primijeniti u roku od 3 sata nakon rekonstitucije i razrjeđivanja lijeka.
English: After reconstitution and dilution, one mL of solution contains 3.3 mg carmustine.
Croatian: Nakon rekonstitucije i razrjeđivanja jedan ml otopine sadrži 3,3 mg karmustina.
English: Carmustine may impair male fertility.
Croatian: Karmustin može poremetiti plodnost kod muškaraca.
English: Powder and solvent for concentrate for solution for infusion.
Croatian: Prašak i otapalo za koncentrat za otopinu za infuziju.
English: After reconstitution and dilution, one mL of solution contains contains 3.3 mg carmustine.
Croatian: Nakon rekonstitucije i razrjeđivanja jedan mL otopine sadrži 3,3 mg karmustina.
English: Common Anaemia.
Croatian: Anemija.
English: After reconstitution and dilutionthe solution should be administered within 3 hours after reconstitution and dilution of the product.
Croatian: Nakon rekonstitucije i razrjeđivanja otopinu treba primijeniti unutar 3 sata nakon rekonstitucije i razrjeđivanja lijeka.
English: The 30 ml stock solution is to be diluted immediately by adding the 30 ml stock solution to either 500 ml 5% glucose or 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection in glass containers.
Croatian: Dobivenih 30 ml koncentrirane otopine treba odmah razrijediti dodavanjem 30 ml koncentrirane otopine ili u 500 ml 5 %-tne glukoze ili u 500 ml 0,9 %-tne otopine natrijeva klorida za injekciju (9 mg/ml) u staklenim spremnicima.
English: EXP After reconstitution/dilution: See package leaflet for the shelf life of the reconstituted medicine.
Croatian: Nakon rekonstitucije/razrjeđivanja: Za rok valjanosti rekonstituiranog lijeka pogledajte uputu o lijeku.
English: Common Hepatotoxicity, reversible, delayed up to 60 days after administration (high-dose therapy and dose-limiting), manifested by: - bilirubin, reversible increase - alkaline phosphatase, reversible increase - SGOT, reversible increase.
Croatian: koja se manifestira kao: - bilirubin, reverzibilni porast - alkalna fosfataza, reverzibilni porast - AST, reverzibilni porast
English: By reconstituting the powder with the solvent provided, a solution has to be prepared by adding additional 27 ml water for injections.
Croatian: Otapanjem praška pomoću priloženog otapala otopinu treba prirediti dodavanjem dodatnih
English: if you suffer from higher-grade kidney dysfunction.
Croatian: ako imate poremećaj bubrežne funkcije koji je višeg stupnja. primjena u djece i adolescenata ako dojite.
English: The 30 ml stock solution is to be diluted immediately by adding the 30 ml stock solution to either 500 ml glucose 50 mg/ml (5%) solution for injection or 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection in glass containers.
Croatian: Dobivenih 30 ml koncentrirane otopine treba odmah razrijediti dodavanjem 30 ml koncentrirane otopine ili u 500 ml 5 % otopine glukoze za injekciju jačine (50 mg/ml) ili 500 ml 0,9 %-tne otopine natrijeva klorida za injekciju (9 mg/ml) u staklenim spremnicima.
English: Hepatic and renal function should also be checked prior to treatment and regularly monitored during therapy (see section 4.8).
Croatian: Funkciju jetre i bubrega također treba provjeriti prije liječenja te redovito pratiti tijekom terapije
English: Carmustine Obvius 100 mg powder and solvent for concentrate for solution for infusion
Croatian: Carmustine Obvius 100 mg prašak i otapalo za koncentrat za otopinu za infuziju
English: - Severe nausea and vomiting - When used on the skin, inflammation of the skin (dermatitis); - Accidental contact with skin may cause transient hyperpigmentation (darkening of an area of skin or nails)
Croatian: - Slučajni doticaj s kožom može uzrokovati prolaznu hiperpigmentaciju (tamnjenje područja kože ili noktiju).
English: Carmustine Obvius 100 mg powder and solvent for concentrate for solution for infusion carmustine
Croatian: Carmustine Obvius 100 mg prašak i otapalo za koncentrat za otopinu za infuziju karmustin
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING POWDER VIAL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU
English: Symptoms may include: fluid accumulation in the abdomen, enlargement of spleen, severe bleeding of the oesophgus, yellow-coulouring of skin and whites of the eyes; - Breathing problems caused by interstitial fibrosis (with lower doses); - Kidney problems; - Gynecomastia (breast growth in males)
Croatian: Simptomi mogu uključiti sljedeće: Nakupljanje tekućine u abdomenu, povećanje slezene, teško krvarenje ezofagusa, žutilo kože i bjeloočnica;
English: SOLVENT AMPOULE
Croatian: AMPULA S OTAPALOM
English: If Carmustine Obvius is used during pregnancy, or if the patient becomes pregnant while taking (receiving) Carmustine Obvius, the patient should be apprised of the potential hazard to the foetus.
Croatian: Ako se lijek primjenjuje tijekom trudnoće ili ako bolesnica zatrudni dok uzima
English: Reconstitution, as recommended, results in a clear, colourless to light yellow stock solution.
Croatian: Rekonstitucija provedena prema ovoj uputi, rezultira bistrom, bezbojnom do svijetložutom koncentriranom otopinom.
English: Very common (may affect more than 1 in 10 people) - Delayed myelosuppression (decrease in blood cells in bone marrow) which can increase the chance of infections if white blood cells are decreased - Ataxia (lack of voluntary coordination of muscle movements); - Dizziness; - Headache; - Transient redness in the eye, blurred vision due to retinal bleeding; - Hypotension (fall in blood pressure); - Phlebitis (inflammation of the veins) associated with pain, swelling, redness, tenderness; - Respiratory disorders (lung related disorders) with breathing problems;
Croatian: - Odgođena mijelosupresija (pad broja krvnih stanica u koštanoj srži) koja može povećati mogućnost infekcija ako se broj bijelih krvnih stanica smanji; - Ataksija (manjak voljne koordinacije pokreta mišića);
English: Powder and solvent for concentrate for solution for infusion 1 vial of 100 mg powder
Croatian: Prašak i otapalo za koncentrat za otopinu za infuziju 1 bočica sa 100 mg praška 1 ampula s 3 ml otapala
English: Women of childbearing potential/contraception in males and females Women should use effective contraception to avoid becoming pregnant while on treatment and for at least 6 months after treatment.
Croatian: Žene moraju koristiti učinkovitu kontracepciju kako bi izbjegle trudnoću tijekom liječenja i najmanje 6 mjeseci nakon liječenja.
English: Then aseptically add 27 ml of sterile water for injections to the alcohol solution.
Croatian: 27 ml vode za injekciju.
English: Myelosuppression
Croatian: Prijavljivanje nuspojava
English: - If you get any side effects, talk to your doctor or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili medicinsku sestru.
English: EXP
Croatian: Otapalo
English: The infusion should last around 1 to 2 hours.
Croatian: Infuzija traje otprilike 1 do 2 sata.
English: Growth improvements were also observed in all 6 surviving infants.
Croatian: Poboljšanja u rastu su također uočena u svih 6 preživjele djece.
English: However, further data are needed on the long-term benefits and safety of the medicine.
Croatian: No, potrebni su daljnji podaci o dugoročnim koristima i sigurnosti lijeka.
English: If antibodies develop, Kanuma may not work effectively.
Croatian: Ako se razviju protutijela, Kanuma ne može djelotvorno funkcionirati.
English: Regarding safety, no major issues have been identified and serious side effects were rare or manageable.
Croatian: Vezano uz sigurnost, veći problemi nisu identificirani, a ozbiljne nuspojave su rijetke ili upravljive.
English: What is Kanuma and what is it used for?
Croatian: Što je Kanuma i za što se koristi?
English: Development of antibodies against the medicine has also been reported especially in infants.
Croatian: Razvoj protutijela protiv lijeka također je prijavljen naročito u djece.
English: What measures are being taken to ensure the safe and effective use of Kanuma?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Kanuma?
English: The most serious side effects with Kanuma (seen in around 3 patients in 100) are signs and symptoms of severe allergic reactions.
Croatian: Najozbiljnije nuspojave lijek Kanuma (uočene kod otprilike 3 bolesnika na 100) su znakovi i simptomi ozbiljnih alergijskih reakcija.
English: In patients who have rapidly progressing disease before 6 months of age, a dose of 1 mg/kg is given once a week instead of once every other week; in these patients the dose can be increased to 3 mg/kg once a week depending on the response to treatment.
Croatian: U bolesnika koji boluju od bolesti koja brzo napreduje prije dobi od 6 mjeseci, doza od 1 mg/kg primjenjuje se jednom na tjedan umjesto jednom svaki drugi tjedan; u ovih se bolesnika doza može povećati na 3 mg/kg jednom na tjedan ovisno o odgovoru na terapiju.
English: Treatment should be given by a trained healthcare professional who can manage medical emergencies (such as a severe allergy).
Croatian: Terapiju treba primjenjivati samo obučeno liječničko osoblje koje može upravljati medicinskom hitnim slučajevima (poput ozbiljne alergije).
English: What are the risks associated with Kanuma?
Croatian: Koji su rizici povezani s lijekom Kanuma?
English: The first study involved 9 infants with growth failure or other evidence of rapidly progressing disease in their first 6 months of life.
Croatian: Prvo je ispitivanje obuhvatilo 9 djece s izostankom rasta ili drugim dokazom brzo napredovane bolesti u prvih 6 mjeseci njihova života.
English: Other information about Kanuma
Croatian: Ostale informacije o lijeku Kanuma
English: These include chest discomfort, red eyes, eyelid swelling, difficulty breathing, itchy rash, hives, flushing, runny nose, rapid heartbeat and rapid breathing.
Croatian: Ove reakcije uključuju nelagodu u prsima, crvenilo očiju, oticanje kapaka, otežano disanje, svrbljivi osip, osip, crvenjenje, curenje nosa, ubrzano kucanje srca i ubrzano disanje.
English: In this study, 31% of the patients given Kanuma (11 out of 36) achieved normal levels of ALT enzymes, compared with 7% of the patients given placebo (2 out of 30).
Croatian: U ovom ispitivanju, 31% bolesnika koji su primali lijek Kanuma (11 od 36) postiglo je normalne koncentracije enzima ALT, u usporedbi sa 7% bolesnika koji su primili placebo (2 od 30).
English: Kanuma sebelipase alfa
Croatian: Kanuma sebelipaz alfa
English: The CHMP considered that Kanuma led to significant improvements in survival in infants, and was effective at improving symptoms of the disease in patients of all ages.
Croatian: CHMP je zaključio da Kanuma rezultira značajnim poboljšanjima u preživljenju djece i da je djelotvorna u poboljšanju simptoma bolesti u bolesnika svih dobi.
English: Kanuma is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Croatian: Kanuma je dostupan kao koncentrat za suspenziju za infuziju (drip u venu).
English: Why is Kanuma approved?
Croatian: Zašto je lijek Kanuma odobren?
English: Kanuma should be started as early as possible after diagnosis and is intended for long-term use.
Croatian: Terapiju lijekom Kanuma treba započeti što je ranije moguće nakon postavljanje dijagnoze i predviđena je samo za dugotrajnu primjenu.
English: The second study involved 66 patients (children and adults) and compared Kanuma with placebo (a dummy treatment).
Croatian: Drugo je ispitivanje obuhvatilo 66 bolesnika (djece i odraslih) i usporedilo je lijek Kanuma s placebom (prividnim liječenjem).
English: This is a summary of the European public assessment report (EPAR) for Kanuma.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Kanuma.
English: The recommended dose is 1 mg per kilogram body weight given once every other week.
Croatian: Preporučena doza lijeka Kanuma iznosi 1 mg po kilogramu tjelesne težine primijenjena jednom svaka dva tjedna u obliku infuzije.
English: The main measure of effectiveness was the proportion of patients who achieved normal levels of a liver enzyme called ALT after 5 months of treatment.
Croatian: Glavna mjera djelotvornosti bio je razmjer bolesnika koji su postigli normalne razine jetrenih enzima naziva ALT nakon 5 mjeseci terapije.
English: It is not intended to provide practical advice on how to use Kanuma.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Kanuma.
English: The study showed that 6 out of the 9 infants given Kanuma survived to 1 year of age.
Croatian: Ispitivanjem je utvrđeno da je 6 od 9 djece koja su primila lijek Kanuma preživjelo do 1. godine života.
English: When the enzyme is absent or present only in low levels, fats accumulate in the body's cells, causing symptoms such as growth failure and liver damage.
Croatian: Ako je enzim odsutan ili je dostupan samo u malim koncentracijama, masti se akumuliraju u stanicama tijela, uzrokujući simptome poput izostanka rasta i oštećenja jetre.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Kanuma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Kanuma dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
English: A risk management plan has been developed to ensure that Kanuma is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Kanuma.
English: Because the number of patients with lysosomal acid lipase deficiency is low, the disease is considered ‘rare', and Kanuma was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 December 2010.
Croatian: Budući da je broj bolesnika s diferenciranim karcinomom štitnjače nizak, ta se bolest smatra „rijetkom” te je lijek Kanuma 17. prosinca 2010. uvršten u skupinu lijekova za rijetke bolesti.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Kanuma's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Kanuma nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: Kanuma must not be used in patients who have had a life-threatening allergic reaction to the active substance which re-occurred after stopping and starting treatment again.
Croatian: Kanuma se ne smije koristiti u bolesnika koji su imali alergijske reakcije opasne po život na djelatnu tvar, a koje su nastupile nakon prekida i ponovnog početka terapije.
English: High levels of ALT enzymes are a sign of liver damage.
Croatian: Visoke koncentracije enzima ALT znak su oštećenja jetre.
English: In addition, the company that markets Kanuma is carrying out a study in infants with rapidly progressing disease and will set-up a registry of patients of all ages to obtain further information on the long-term benefits and safety of Kanuma, in particular on the risk of allergic reactions and the development of antibodies against the medicine.
Croatian: Nadalje, tvrtka koja stavlja lijek Kanuma u promet provodi ispitivanje u djece s brzo napredujućom bolesti i uspostavit će registar bolesnika svih dobi kako bi prikupila daljnje informacije o dugoročnim koristima i sigurnoj primjeni lijeka Kanuma, posebice o riziku alergijskih reakcija i razvoju protutijela protiv lijeka.