FrancophonIA/ELRC3.0 huggingface dataset:
English: Push the plastic adapter firmly into the neck of the bottle as far as you can (figure C) and close the bottle with the child resistant screw cap.
Croatian: Plastični nastavak čvrsto gurnite u grlo boce što dublje možete (Slika C) te bocu zatvorite navojnim zatvaračem sigurnim za djecu.
English: If any air bubbles are observed inside the filled oral syringe, the plunger should be pushed back up until the air bubbles are expelled.
Croatian: Ako u napunjenoj štrcaljki za usta primijetite mjehuriće zraka, klip treba ponovno potisnuti prema gore dok se mjehurići ne istisnu.
English: Dose conversion tables respectively for the three oral syringe sizes:
Croatian: Tablice za konverziju doza za tri veličine štrcaljki za usta:
English: Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in pre-term and full-term jaundiced neonates and develop into kernicterus (brain damage due to deposits of bilirubin in the brain).
Croatian: Natrijev benzoat može pojačati žuticu (žuta boja kože i očiju) u nedonoščadi i donošene novorođenčadi sa žuticom te dovesti do kernikterusa (oštećenja mozga zbog odlaganja bilirubina u mozgu).
English: It is used for measuring doses of less than or up to 1 ml.
Croatian: Upotrebljava se za mjerenje doza manjih ili jednakih 1 ml.
English: The open bottle should be placed upright on a table, and the plastic adapter pushed firmly into the neck of the bottle as far as possible (Figure C).
Croatian: Otvorenu bocu treba odložiti na stol u uspravnom položaju te plastični nastavak čvrsto gurnuti u grlo boce što je dublje moguće (Slika C).
English: Sodium Each ml contains 0.7 mg (0.03 mmol).
Croatian: Natrij Jedan ml sadrži 0,7 mg (0,03 mmol).
English: The medicine can be stored for a single period of 2 months (for 2 mg capsules) or 3 months (for 5 mg, 10 mg and 20 mg capsules) at a temperature not above 25°C, after which it must be discarded.
Croatian: Lijek se može čuvati na temperaturi ispod 25°C jednokratno u razdoblju od 2 mjeseca (za kapsule od 2 mg) ili 3 mjeseca (za kapsule od 5 mg, 10 mg i 20 mg), nakon čega se mora baciti.
English: The child-resistant screw cap should be replaced directly after use.
Croatian: Navojni zatvarač siguran za djecu treba vratiti odmah nakon uporabe.
English: Figure A.
Croatian: Slika A.
English: During the shelf life, the patient may store the capsules for a single period of 2 months (for 2 mg capsules) or 3 months (for 5 mg, 10 mg and 20 mg capsules) at a temperature not above 25°C, after which the medicinal product must be discarded.
Croatian: Unutar roka valjanosti bolesnici mogu čuvati kapsule na temperaturi ispod 25°C jednokratno u razdoblju od 2 mjeseca (za kapsule od 2 mg) i 3 mjeseca (za kapsule od 5 mg, 10 mg i 20 mg), nakon čega se lijek mora baciti.
English: Other uncommon side effects - increased number of white blood cells (leucocytosis), - itching (pruritus), skin inflammation (exfoliative dermatitis), rash.
Croatian: - povećan broj bijelih krvnih stanica (leukocitoza), - svrbež (pruritus), upala kože (eksfolijativni dermatitis), osip.
English: Figure C.
Croatian: Slika C.
English: Age at start of treatment 2 years 4 years 6 years
Croatian: Dob na početku liječenja 2 godine 4 godine 6 godina ≤ 2 mjeseca ≤ 6 mjeseci > 6 mjeseci
English: All patients Start age months Start age months
Croatian: Dob na početku mjeseca Dob na početku mjeseca
English: Orfadin 4 mg/ml oral suspension Nitisinone
Croatian: Orfadin 4 mg/ml oralna suspenzija nitizinon
English: Bilirubin levels should be measured before start of treatment: in case of markedly elevated plasma levels of bilirubin, especially in premature patients with risk factors as acidosis and low albumin level, treatment with an appropriately weighed portion of an Orfadin capsule should be considered instead of the oral suspension until the unconjugated bilirubin plasma levels are normalised.
Croatian: U slučaju izrazito povišenih razina bilirubina u plazmi, osobito u bolesne nedonoščadi s rizičnim čimbenicima kao što su acidoza i niska razina albumina, potrebno je razmotriti liječenje odgovarajućim dozama Orfadin kapsula umjesto oralnom suspenzijom sve dok se razine nekonjugiranog bilirubina u plazmi ne normaliziraju.
English: If any air bubbles are observed inside the filled oral syringe, push the plunger back up until the air bubbles are expelled.
Croatian: Ako u napunjenoj štrcaljki za usta primijetite mjehuriće zraka, klip ponovno potisnite prema gore dok ne istisnete mjehuriće.
English: Each pack contains one bottle, one LDPE bottle adapter and 3 polypropylene (PP) oral syringes (1 ml, 3 ml and 5 ml).
Croatian: Jedno pakiranje sadrži jednu bocu, jedan LDPE nastavak za bocu i 3 polipropilenske (PP) štrcaljke za usta (1 ml, 3 ml i 5 ml).
English: The suspension is administered in the patient's mouth with an oral syringe without dilution.
Croatian: Način primjene Suspenzija se daje bolesniku u usta pomoću štrcaljke za usta, bez razrjeđivanja.
English: The bottle should be shaken vigourously for at least 20 seconds until the solid cake at the bottom of the bottle is completely dispersed (Figure A).
Croatian: 2. Bocu treba snažno tresti najmanje 20 sekundi dok se čvrsti talog na dnu boce potpuno ne rasprši (Slika A).
English: A 1 ml, 3 ml and 5 ml oral syringes are included in the pack to measure the dose in ml in accordance with the prescribed posology.
Croatian: U pakiranju su priložene štrcaljke za usta od 1 ml, 3 ml i 5 ml za mjerenje doze u ml u skladu s propisanim doziranjem.
English: Re-dispersing is required before each use by vigorous shaking.
Croatian: Važne informacije o uputama za uporabu: Prije svake uporabe lijek je potrebno redispergirati snažnim protresanjem.
English: The bottle should be turned to an upright position again, and the oral syringe disconnected by gently twisting it out of the bottle.
Croatian: Bocu treba vratiti u uspravni položaj te izvući štrcaljku za usta iz boce, nježno je okrećući.
English: Cleaning
Croatian: Čišćenje
English: In order to withdraw the prescribed dose (ml), pull the plunger slowly down until the top edge of the black ring is exactly level with the line marking the dose (Figure F).
Croatian: Kako biste izvukli propisanu dozu (ml), klip polako povucite prema dolje dok gornji rub crnog prstena ne bude točno u ravnini s oznakom doze (Slika F).
English: 100 ml brown glass bottle (type III) with a white child-resistant HDPE screw cap with sealing and tamper evidence.
Croatian: Boca od smeđeg stakla (tipa III) od 100 ml s bijelim navojnim HDPE zatvaračem sigurnim za djecu, sa sigurnosnim prstenom i evidencijom otvaranja.
English: Each ml contains 1 mg. Increase in bilirubin following its displacement from albumin, caused by benzoic acid and its salts, may increase jaundice in pre-term and full-term jaundiced neonates and develop into kernicterus (unconjugated bilirubin deposits in the brain tissue).
Croatian: Porast bilirubina zbog njegovog istiskivanja s albumina uzrokovanog benzoatnom kiselinom i njezinim solima može pojačati žuticu u nedonoščadi i donešene novorođenčadi sa žuticom te dovesti do kernikterusa (depozita nekonjugiranog bilirubina u moždanom tkivu).
English: Immediately thereafter, open the bottle by removing the child resistant screw cap. 3.
Croatian: Odmah potom otvorite bocu uklanjanjem navojnog zatvarača sigurnog za djecu.
English: Immediately thereafter, the bottle should be opened by removing the child-resistant screw cap. 3.
Croatian: Odmah potom, bocu treba otvoriti uklanjanjem navojnog zatvarača sigurnog za djecu.
English: It is provided in a 100 ml brown glass bottle with a white, child resistant screw cap. Each bottle contains 90 ml supension.
Croatian: Isporučuje se u smeđoj staklenoj boci od 100 ml s bijelim navojnim zatvaračem sigurnim za djecu.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Croatian: POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI
English: The oral syringes are graduated in 0.01 ml, 0.1 ml and 0.2 ml steps respectively.
Croatian: Štrcaljke za usta obilježene su svakih 0,01 ml, 0,1 ml odnosno 0,2 ml.
English: The bottle should be removed from the refrigerator, and the date when the bottle is removed from the refrigerator should be noted on the bottle label.
Croatian: 1. Bocu treba izvaditi iz hladnjaka te na naljepnici boce zabilježiti datum vađenja iz hladnjaka.
English: In order to withdraw the prescribed dose (ml), the plunger should be pulled down slowly until the top edge of the black ring is exactly level with the line marking the dose (Figure F).
Croatian: 6. Da biste izvukli propisanu dozu (ml), trebate polako povlačiti klip prema dolje dok gornji rub crnog prstena ne bude točno u ravnini s oznakom doze (Slika F).
English: Figure B.
Croatian: Slika B.
English: Based on data from a clinical interaction study with 80 mg nitisinone at steady-state, nitisinone is a moderate inhibitor of CYP2C9 (2.3-fold increase in tolbutamide AUC), therefore nitisinone treatment may result in increased plasma concentrations of co-administered medicinal products metabolized primarily via CYP2C9 (see section 4.4).
Croatian: nitizinon je umjereno jak inhibitor CYP 2C9 (povećanje AUC-a tolbutamida 2,3 puta) pa stoga liječenje nitizinonom može rezultirati povišenim plazmatskim koncentracijama istodobno primijenjenih lijekova koji se primarno metaboliziraju putem CYP 2C9 (vidjeti dio 4.4).
English: The bottle should be closed with the child resistant screw cap.
Croatian: Bocu treba zatvoriti navojnim zatvaračem sigurnim za djecu.
English: Carefully turn the bottle upside down with the oral syringe in place (Figure F).
Croatian: Bocu oprezno okrenite naopako s umetnutom štrcaljkom (slika F).
English: Remove the child resistant screw cap by pushing it down firmly and turning it anti-clockwise (figure B).
Croatian: Uklonite navojni zatvarač siguran za djecu tako da ga čvrsto pritisnete prema dolje i okrenete u smjeru suprotnome od kazaljke na satu (Slika B).
English: The child-resistant screw cap should be removed by pushing it down firmly and turning it anticlockwise (Figure B).
Croatian: Navojni zatvarač siguran za djecu treba ukloniti tako da ga čvrsto pritisnete prema dolje i okrenete u smjeru suprotnome od kazaljke na satu (Slika B).
English: HDPE bottle with a tamper-proof closure of LDPE, containing 60 capsules.
Croatian: Boca od polietilena visoke gustoće sa zaštitnim zatvaračem s evidencijom otvaranja od polietilena niske gustoće, koja sadrži 60 kapsula.
English: The bottle should be turned carefully upside down with the oral syringe in place (Figure F).
Croatian: Bocu treba oprezno okrenuti naopako s umetnutom štrcaljkom (slika F).
English: • The 5 ml oral syringe (the largest oral syringe), is marked from 1 ml to 5 ml with minor 0.2-ml graduations.
Croatian: • Štrcaljka za usta od 5 ml (najveća štrcaljka) obilježena je od 1 do 5 ml u koracima od 0,2 ml.
English: Then the plunger should be pulled down again until the top edge of the black ring is exactly level with the line marking the dose.
Croatian: Zatim klip ponovno treba povlačiti prema dolje dok gornji rub crnog prstena ne bude točno u ravnini s oznakom doze.
English: Printing ink black iron oxide (E 172) shellac propylene glycol ammonium hydroxide
Croatian: Tinta za označavanje željezov oksid, crni (E 172) šelak propilenglikol amonijev hidroksid.
English: Keep the bottle in an upright position and insert the oral syringe firmly into the hole at the top of the bottle (figure E).
Croatian: 4. Bocu držite u uspravnom položaju i čvrsto umetnite štrcaljku za usta u otvor nastavka na vrhu boce (Slika E).
English: Figur E.
Croatian: Slika E.
English: Orfadin 4 mg/ml oral suspension
Croatian: Orfadin 4 mg/ml oralna suspenzija
English: The pack contains a bottle of medicine with a cap, a bottle adaptor and three oral syringes (1 ml, 3 ml and 5 ml).
Croatian: Pakiranje sadrži bocu s lijekom i zatvaračem, nastavak za bocu i tri štrcaljke za usta (1 ml, 3 ml i 5 ml).
English: Follow the instructions given below for dose preparation and administration carefully, in order to ensure that the correct dose is administered.
Croatian: Pažljivo slijedite niže navedene upute za pripremu i primjenu doze, kako biste osigurali primjenu točne doze.
English: It is used for measuring doses of more than 1 ml and up to 3 ml.
Croatian: Upotrebljava se za mjerenje doza većih od 1 ml, a manjih ili jednakih 3 ml.
English: How to prepare the dose to be administered
Croatian: Kako pripremiti dozu za uzimanje
English: - The other ingredients are Capsule content: starch, pregelatinised (maize).
Croatian: Sadržaj kapsule: škrob, prethodno geliran (kukuruzni).
English: Adverse reactions affecting the MedDRA system organ class ‘Blood and lymphatic system disorders' subsided during continued nitisinone treatment.
Croatian: Nuspojave koje zahvaćaju organski sustav "Poremećaji krvi i limfnog sustava" prema
English: Then pull the plunger down again until the top edge of the black ring is exactly level with the line marking the dose.
Croatian: Zatim klip ponovno povlačite prema dolje dok gornji rub crnog prstena ne bude točno u ravnini s oznakom doze.
English: Disconnect the oral syringe by gently twisting it out of the bottle.
Croatian: Štrcaljku za usta izvucite iz boce, nježno je okrećući.
English: Printing ink: iron oxide (E 172) shellac propylene glycol ammonium hydroxide
Croatian: željezov oksid (E 172) šelak propilenglikol amonijev hidroksid.
English: Figure D.
Croatian: Slika D.
English: 5-ml oral syringe (0.2 ml graduation)
Croatian: Štrcaljka za usta od 5 ml (graduirana po 0,2 ml)
English: Replace the child resistant screw cap directly after use.
Croatian: Navojni zatvarač siguran za djecu vratite odmah nakon uporabe.
English: The oral syringe must be emptied slowly to allow swallowing; rapid squirting of the medicine may cause choking.
Croatian: Štrcaljku za usta treba prazniti polako kako bi se bolesniku omogućilo gutanje.
English: • The 3 ml oral syringe (the middle sized oral syringe), is marked from 1 ml to 3 ml with minor 0.1-ml graduations.
Croatian: • Štrcaljka za usta od 3 ml (srednja štrcaljka) obilježena je od 1 ml do 3 ml u koracima od 0,1 ml.
English: The biochemical defect in hereditary tyrosinemia type 1 (HT-1) is a deficiency of fumarylacetoacetate hydrolase, which is the final enzyme of the tyrosine catabolic pathway.
Croatian: Mehanizam djelovanja Biokemijski defekt u nasljednoj tirozinemiji tipa 1 (HT-1) je nedostatak fumarilacetoacetat hidrolaze,
English: The bottle should be kept in an upright position and the oral syringe inserted firmly into the hole of the adaptor, at the top of the bottle (Figure E).
Croatian: Bocu treba držati u uspravnom položaju i čvrsto umetnuti štrcaljku za usta u otvor nastavka na vrhu boce (Slika E).
English: • The 1-ml oral syringe (the smallest oral syringe) is marked from 0.1 ml to 1 ml with minor 0.01-ml graduations.
Croatian: • Štrcaljka za usta od 1 ml (najmanja štrcaljka) obilježena je od 0,1 ml do 1 ml u koracima od 0,01 ml.
English: A more restricted tyrosine and phenylalanine diet should be implemented in case the plasma tyrosine level is above 500 micromol/l.
Croatian: U slučaju razina tirozina u plazmi iznad 500 mikromola/l mora se uvesti restriktivna dijeta bez tirozina i fenilalanina.
English: 1 ml contains 4 mg nitisinone.
Croatian: 1 ml sadrži 4 mg nitizinona.
English: Probability of no HCC (95% confidence interval) at start
Croatian: Vjerojatnost da se HCC neće pojaviti
English: Orfadin 5 mg: Each capsule contains 5 mg nitisinone.
Croatian: Orfadin 5 mg: svaka kapsula sadrži 5 mg nitizinona.
English: Always use one of the oral syringes provided to take the medicine.
Croatian: Lijek uvijek uzimajte jednom od priloženih štrcaljki za usta.
English: Orfadin 20 mg: Each capsule contains 20 mg nitisinone.
Croatian: Orfadin 20 mg: svaka kapsula sadrži 20 mg nitizinona.
English: After first opening, the in-use stability is a single period of 2 months at a temperature not above 25°C, after which it must be discarded.
Croatian: Nakon prvog otvaranja, lijek u primjeni stabilan je na temperaturi ispod 25°C jednokratno u razdoblju od 2 mjeseca, nakon čega se mora baciti.
English: After first opening, the medicine can be stored for a single period of 2 months at a temperature not above 25°C, after which it must be discarded.
Croatian: Nakon prvog otvaranja, lijek se može čuvati na temperaturi ispod 25°C jednokratno u razdoblju od 2 mjeseca, nakon čega se mora baciti.
English: 3-ml oral syringe (0.1 ml graduation)
Croatian: Štrcaljka za usta od 3 ml (graduirana po 0,1 ml)
English: The plunger inside the oral syringe should be pushed fully down.
Croatian: 3. Klip unutar štrcaljke za usta treba biti pritisnut do kraja prema dolje.
English: Based on data from a clinical interaction study with 80 mg nitisinone at steady-state, nitisinone caused a 2.3-fold increase in AUC∞ of the CYP2C9 substrate tolbutamide, which is indicative of a moderate inhibition of CYP2C9.
Croatian: nitizinon je uzrokovao povećanje AUC∞ supstrata CYP 2C9 tolbutamida 2,3 puta, što ukazuje na umjerenu inhibiciju CYP 2C9.
English: 1-ml oral syringe (0.01 ml graduation)
Croatian: Štrcaljka za usta od 1 ml (graduirana po 0,01 ml)
English: Push the plunger inside the oral syringe fully down.
Croatian: 3. Klip unutar štrcaljke za usta pritisnite do kraja prema dolje.
English: Orfadin 2 mg hard capsules Orfadin 5 mg hard capsules Orfadin 10 mg hard capsules Orfadin 20 mg hard capsules nitisinone
Croatian: Orfadin 2 mg tvrde kapsule Orfadin 5 mg tvrde kapsule Orfadin 10 mg tvrde kapsule Orfadin 20 mg tvrde kapsule nitizinon
English: Orfadin 2 mg: Each capsule contains 2 mg nitisinone.
Croatian: Orfadin 2 mg: svaka kapsula sadrži 2 mg nitizinona.
English: The dose that your doctor prescribes you should be given in ml of suspension and not in mg.
Croatian: Doza koju Vam liječnik propiše treba biti u ml suspenzije, a ne u mg jer je štrcaljka za usta koja se koristi za izvlačenje ispravne doze iz boce obilježena u ml. Ako Vam je lijek propisan u mg, upitajte ljekarnika ili liječnika za savjet.
English: 1 ml contains 4 mg of nitisinone.
Croatian: Jedan ml sadrži 4 mg nitizinona.
English: Orfadin 10 mg: Each capsule contains 10 mg nitisinone.
Croatian: Orfadin 10 mg: svaka kapsula sadrži 10 mg nitizinona.
English: Sodium benzoate (E211) Citric acid monohydrate Sodium citrate
Croatian: 6.1 Popis pomoćnih tvari hidroksipropilmetilceluloza glicerol polisorbat 80 natrijev benzoat (E211) citratna kiselina hidrat natrijev citrat aroma jagode (umjetna)
English: How to store Orfadin
Croatian: Moguće nuspojave Kako čuvati Orfadin
English: Orfadin 2 mg hard capsules Orfadin 5 mg hard capsules Orfadin 10 mg hard capsules Orfadin 20 mg hard capsules
Croatian: Orfadin 2 mg tvrde kapsule Orfadin 5 mg tvrde kapsule Orfadin 10 mg tvrde kapsule Orfadin 20 mg tvrde kapsule
English: An updated RMP should be submitted:
Croatian: Jedan ml sadrži:
English: Therefore, it is recommended that if nitisinone treatment with Orfadin hard capsules is initiated with food, this should be maintained on a routine basis, see section 4.2.
Croatian: Stoga se preporučuje da se, ako se liječenje nitizinonom (Orfadin tvrdim kapsulama) započne s hranom,
English: Each capsule contains 5 mg nitisinone.
Croatian: Svaka kapsula sadrži 5 mg nitizinona.
English: Each capsule contains 20 mg nitisinone.
Croatian: Svaka kapsula sadrži 20 mg nitizinona.
English: Note the date when the bottle is removed from the refrigerator on the bottle label.
Croatian: Na naljepnici boce zabilježite datum vađenja iz hladnjaka.
English: Each capsule contains 2 mg nitisinone.
Croatian: Svaka kapsula sadrži 2 mg nitizinona.
English: Each capsule contains 10 mg nitisinone.
Croatian: Svaka kapsula sadrži 10 mg nitizinona.
English: The product can be stored for a single period of 2 months at a temperature not above 25°C, after which it must be discarded.
Croatian: Lijek se može čuvati na temperaturi ispod 25 °C jednokratno u razdoblju od 2 mjeseca, nakon čega se mora baciti.
English: The product can be stored for a single period of 3 months at a temperature not above 25°C, after which it must be discarded.
Croatian: Lijek se može čuvati na temperaturi ispod 25°C jednokratno u razdoblju od 3 mjeseca, nakon čega se mora baciti.
English: White, opaque capsules (6x16 mm) imprinted “NTBC 5mg” in black on the body of the capsule.
Croatian: Bijele, neprozirne kapsule (6x16 mm) s utisnutom crnom oznakom "NTBC 5mg" na tijelu kapsule.
English: White, opaque capsules (6x16 mm) imprinted “NTBC 20mg” in black on the body of the capsule.
Croatian: Bijele, neprozirne kapsule (6x16 mm) s utisnutom crnom oznakom "NTBC 20mg" na tijelu kapsule.
English: White, opaque capsules (6x16 mm) imprinted “NTBC 2mg” in black on the body of the capsule.
Croatian: Bijele, neprozirne kapsule (6x16 mm) s utisnutom crnom oznakom "NTBC 2mg" na tijelu kapsule.
English: LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS
Croatian: SADRŽAJ PO DOZNOJ JEDINICI LIJEKA
English: - Your eyes will be checked by an ophthalmologist before and regularly during nitisinone treatment.
Croatian: - Prije početka liječenja te redovito tijekom liječenja nitizinonom oči će Vam pregledati oftalmolog.
English: White, opaque capsules (6x16 mm) imprinted “NTBC 10mg” in black on the body of the capsule.
Croatian: Bijele, neprozirne kapsule (6x16 mm) s utisnutom crnom oznakom "NTBC 10mg" na tijelu kapsule.
English: Important information about instructions for use:
Croatian: Tinta za označavanje:
English: > 6 months Overall
Croatian: 6.3 Rok valjanosti
English: 4 x 1 capsules (unit dose)
Croatian: 4 x 1 kapsula (jedinična doza)
English: This overview was last updated in 08-2018.
Croatian: Ovaj sažetak je posljednji put ažuriran u 08. 2018.
English: Further information on Lumark can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Lumark možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Lumark?
Croatian: Koje se mjere poduzimaju da bi se osigurala sigurna i učinkovita primjena lijeka Lumark?
English: These tumours affect hormone-secreting cells in many parts of the body, including the pancreas, intestine, stomach and lungs.
Croatian: Ti tumori utječu na stanice koje luče hormone u mnogim dijelovima tijela, uključujući gušteraču, crijeva, želudac i pluća.
English: However, the quantity of Lumark to be used is very small and therefore these risks are considered low.
Croatian: No količina lijeka Lumark koja će se koristiti vrlo je mala te se stoga i rizici smatraju malima.
English: The most common side effects with Lumark (which may affect more than 1 in 10 people) are anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts), leucopenia (low white blood cell counts), lymphopenia (low levels of lymphocytes, a particular type of white blood cell), nausea (feeling sick), vomiting and mild and temporary hair loss.
Croatian: Najčešće su nuspojave lijeka Lumark (koje se mogu pojaviti u više od 1 na 10 osoba) anemija (mali broj crvenih krvnih stanica), trombocitopenija (mali broj trombocita), leukopenija (mali broj bijelih krvnih stanica), limfopenija (mali broj limfocita, posebne vrste bijelih krvnih stanica), mučnina, povraćanje te blago i privremeno opadanje kose.
English: Other information about Lumark
Croatian: Ostale informacije o lijeku Lumark
English: Lumark received a marketing authorisation valid throughout the EU on 19 June 2015.
Croatian: Lijek Lumark dobio je odobrenje za stavljanje lijeka u promet koje vrijedi na prostoru EU-a od 19. lipnja 2015.
English: Medicines radiolabelled with Lumark must not be used in women unless pregnancy has been ruled out.
Croatian: Lijekovi označeni lijekom Lumark ne smiju se primjenjivati u žena dok nije isključena trudnoća.
English: What is Lumark and what is it used for?
Croatian: Što je Lumark i za što se primjenjuje?
English: Side effects reported with Lumark are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Lumark pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.