FrancophonIA/ELRC3.0 huggingface dataset:
English: Very common: Injection site hypertrophy, injection site bruising
Croatian: Vrlo često: hipertrofija na mjestu injiciranja, modrice na mjestu injiciranja
English: Date of latest renewal: 03 August 2017
Croatian: Završno izvješće do 2023. godine
English: A negative pregnancy test is recommended for all women of child bearing potential prior to treatment with mecasermin.
Croatian: Negativan test na trudnoću preporučuje se svim ženama u generativnoj dobi prije liječenja mekaserminom.
English: INCRELEX should be administered using sterile disposable syringes and injection needles.
Croatian: INCRELEX se treba primjenjivati korištenjem jednokratnih, sterilnih štrcaljki i igala.
English: One ml contains 10 mg of mecasermin.
Croatian: Jedan ml sadrži 10 mg mekasermina.
English: INCRELEX may have a major influence on the ability to drive or use machines in case of a hypoglycaemic episode.
Croatian: U slučaju epizoda hipoglikemije INCRELEX može značajno utjecati na sposobnost upravljanja vozilima ili rada sa strojevima.
English: How to store INCRELEX
Croatian: Kako primjenjivati INCRELEX
English: *Mecasermin is a recombinant DNA-derived human insulin-like growth factor-1(IGF-1) produced in Escherichia coli.
Croatian: *Mekasermin je ljudski inzulinu sličan faktor rasta 1 (IGF-1) dobiven tehnologijom rekombinantne DNK u bakteriji Escherichia coli.
English: Lymphoid tissue (e.g., tonsillar) hypertrophy associated with complications, such as snoring, sleep apnoea, and chronic middle-ear effusions have been reported with the use of this medicinal product.
Croatian: Za vrijeme korištenja ovog lijeka prijavljena je hipertrofija limfoidnog tkiva (npr. tonzilarnog) povezana s komplikacijama, kao što su hrkanje, apneja za vrijeme spavanja i kronični izljevi u srednjem uhu.
English: • Product information
Croatian: • Informacije o lijeku
English: Weight increase Weight increase has been observed with mecasermin treatment.
Croatian: Porast tjelesne težine uočen je kod liječenja mekaserminom.
English: • To report any onset of a limp or complaint of hip or knee pain to their physician so it can be evaluated.
Croatian: • Izvijestiti svog liječnika o početku šepanja ili o boli u kuku ili koljenu kako bi se stanje pregledalo.
English: Mecasermin, like insulin, may lower blood sugar levels (see hypoglycaemia in section 4).
Croatian: Ako primijenite više INCRELEXA nego što ste trebali Mekasermin, kao inzulin, može sniziti razine šećera u krvi (pogledajte „hipoglikemija“ u dijelu 4.).
English: Injection site reactions can be avoided by changing the injection site at each injection (injection site rotation).
Croatian: Reakcije na mjestu ubrizgavanja mogu se izbjeći promjenom mjesta ubrizgavanja kod svakog ubrizgavanja (rotacija mjesta ubrizgavanja).
English: Very common: Vomiting, upper abdominal pain
Croatian: Poremećaji probavnog sustava Vrlo često: povraćanje, bol u gornjem dijelu abdomena
English: Studies have not been conducted with mecasermin in breast-feeding mothers.
Croatian: Studije s mekaserminom nisu provedene u dojilja.
English: If you get any side effects, talk to your doctor or pharmacist.
Croatian: Ako dobijete bilo kakve nuspojave, obratite se svom liječniku ili ljekarniku.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja vezanih uz primjenu ovog lijeka, obratite se svom liječniku ili ljekarniku.
English: - if you have finished growing (the bone growth plates are closed).
Croatian: nesvjesticu ili kolaps i ako se općenito ne osjećate dobro), - ako ste prestali rasti (ploče rasta kostiju su zatvorene).
English: Instructions on the administration of glucagon should severe hypoglycaemia occur.
Croatian: Upute o primjeni glukagona ako dođe do teške hipoglikemije.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml contains 10 mg of mecasermin.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedan ml sadrži 10 mg mekasermina.
English: Each vial of 4 ml contains 40 mg of mecasermin*.
Croatian: Jedna bočica od 4 ml sadrži 40 mg mekasermina*.
English: Each ml contains 10 mg of mecasermin*.
Croatian: Jedan ml sadrži 10 mg mekasermina*.
English: Very common: Headache Common: Convulsions, dizziness, tremor
Croatian: Manje često: depresija, nervoza Poremećaji živčanog sustava Vrlo često: glavobolja Često: konvulzije, omaglica, tremor
English: Reproductive system Breast enlargement has been observed with mecasermin treatment.
Croatian: Reproduktivni sustav Primijećeno je povećanje dojki kod liječenja mekaserminom.
English: Common: Thymus hypertrophy
Croatian: Često: hipertrofija timusa
English: Post-marketing reports
Croatian: Prijave nakon stavljanja lijeka u promet
English: IGFBP-3 is reduced in subjects with severe Primary IGFD, resulting in increased clearance of IGF-1 in these subjects relative to healthy subjects.
Croatian: IGFBP-3 je smanjen kod ispitanika s teškom primarnom deficijencijom IGF,
English: Injection site hypertrophy
Croatian: Hipertrofija na mjestu injiciranja
English: Reactions observed from the post-marketing environment
Croatian: Nuspojave primijećene nakon stavljanja lijeka u promet
English: 40mg/4ml
Croatian: Jedna bočica za višestruku primjenu od 4 ml. 40 mg/4 ml
English: Mecasermin should not be administered to a breast-feeding mother.
Croatian: Mekasermin se ne smije primjenjivati kod dojilja.
English: Digestive system Pain in the belly has occurred with mecasermin treatment.
Croatian: Probavni sustav Bol u trbuhu javlja se kod liječenja mekaserminom.
English: The vial contains 4 ml of solution.
Croatian: Bočica sadrži 4 ml otopine.
English: Common: Cardiac murmur, tachycardia
Croatian: Često: skolioza, mijalgija
English: Clearance of total IGF-1 is inversely proportional to serum IGFBP-3 levels and total IGF-1 systemic clearance (CL/F) is estimated to be 0.04 l/hr/kg at 3 mg/l IGFBP-3 in 12 subjects.
Croatian: (CL/F) procjenjuje se da je 0,04 l/h/kg pri 3 mg/l IGFBP-3 u 12 ispitanika.
English: Common: Melanocytic naevus
Croatian: Često: melanocitni nevus
English: Benzyl alcohol Sodium chloride Polysorbate 20
Croatian: 6.1 Popis pomoćnih tvari benzilni alkohol natrijev klorid polisorbat 20 ledena acetatna kiselina natrijev acetat voda za injekcije
English: These conditions and other symptoms and signs known to be associated with GH treatment in general should be monitored during mecasermin treatment.
Croatian: Za vrijeme liječenja mekaserminom treba pratiti pojavu navedenih stanja i drugih simptoma i znakova za koje se zna da su povezani s liječenjem hormonom rasta.
English: Remove the needle from the vial and replace the protective cap. Do not let the needle touch anything.
Croatian: Izvadite iglu iz bočice i ponovno stavite zaštitnu kapicu.
English: Uncommon: Cardiomegaly, ventricular hypertrophy, mitral valve incompetence, tricuspid valve incompetence
Croatian: Često: šum na srcu, tahikardija Manje često: kardiomegalija, hipertrofija klijetki, insuficijencija mitralnog zaliska, insuficijencija trikuspidalnog zaliska
English: NAME OF THE MEDICINAL PRODUCT INCRELEX 10 mg/ml solution for injection
Croatian: INCRELEX 10 mg/ml otopina za injekciju
English: - if you have a localised reaction at the injection site or generalised allergic reaction with INCRELEX.
Croatian: glavobolja, mučnina i/ili povraćanje, obratite se liječniku za savjet, - ako imate lokaliziranu reakciju na mjestu injiciranja ili generaliziranu alergijsku reakciju na
English: Nervous system Headache has occurred with mecasermin treatment.
Croatian: Živčani sustav Kod liječenja mekaserminom zabilježena je glavobolja.
English: Women of childbearing potential / Contraception in males and females A negative pregnancy test is recommended for all women of child bearing potential prior to treatment with mecasermin.
Croatian: Negativan test na trudnoću preporučuje se svim ženama u reproduktivnoj dobi prije liječenja mekaserminom.
English: Seizures (fits) have been observed with mecasermin treatment.
Croatian: Napadaji su primijećeni kod liječenja mekaserminom.
English: Circulating IGF-1 plays an important role in the acquisition and maintenance of bone mass. IGF-1 increases bone density.
Croatian: Metabolizam kostiju/minerala Cirkulirajući IGF-1 igra važnu ulogu u stjecanju i održavanju koštane mase.
English: Each vial contains 40 mg of mecasermin.
Croatian: Jedna bočica sadrži 40 mg mekasermina.
English: Thigh
Croatian: Lonzastrasse
English: Five clinical studies (4 open-label and 1 double-blind, placebo-controlled) were conducted with INCRELEX.
Croatian: Provedeno je pet kliničkih ispitivanja (4 otvorena ispitivanja i 1 dvostruko-slijepo, placebom kontrolirano) s INCRELEXOM. 92 pedijatrijskih ispitanika s teškom primarnom deficijencijom IGF-a dobivalo je supkutane doze mekasermina, općenito u rasponu od 60 do 120 g/kg, davano dva puta dnevno.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Datum posljednje obnove odobrenja: 03. kolovoz 2017. 10. DATUM REVIZIJE TEKSTA Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Thyroid and nutritional deficiencies should be corrected before initiating mecasermin treatment.
Croatian: Prije započinjanja liječenja mekaserminom treba korigirati poremećaje štitnjače i nedostatke u prehrani.
English: Injection sites should be rotated to a different site with each injection.
Croatian: Mjesta injiciranja treba mijenjati prilikom svakog davanja.
English: Musculoskeletal system Joint pains and pains in the limbs have occurred with mecasermin treatment.
Croatian: Koštano-mišićni sustav Kod liječenja mekaserminom zabilježeni su bolovi u zglobovima i udovima.
English: Each vial contains 4 ml of solution.
Croatian: Jedna bočica sadrži 4 ml otopine.
English: Persons with a history of severe hypoglycemia should have glucagon available.
Croatian: Glukagon treba biti dostupan osobama s anamnezom teške hipoglikemije.
English: Injection site hypertrophy (tissue at injection site increases in size) and bruising These can be avoided by changing the injection site at each injection (injection site rotation).
Croatian: Hipertrofija (tkivo na mjestu ubrizgavanja se veličinom povećava) i modrice na mjestu ubrizgavanja
English: • GH sufficiency.
Croatian: • dovoljne količine hormona rasta.
English: Height Velocity SDS
Croatian: SDS brzine rasta
English: Digestive system Vomiting and pain in the upper belly have occurred with mecasermin treatment.
Croatian: Probavni sustav Za vrijeme liječenja mekaserminom javljalo se povraćanje i bol u gornjem dijelu trbuha.
English: Mecasermin has no effects on fertility in rats using intravenous doses 0.25, 1, and 4 mg/day (up to 4 times the clinical exposure with the MRHD based on AUC).
Croatian: Pri primjeni intravenskih doza od 0,25, 1 i 4 mg/dan (do 4 puta većih od kliničke izloženosti kod maksimalne dozvoljene doze kod ljudi temeljeno na AUC), mekasermin nije imao učinaka na plodnost štakora.
English: Rilutek riluzole
Croatian: Rilutek riluzol
English: The main measure of effectiveness was the average survival time.
Croatian: Glavno mjerilo djelotvornosti bilo je prosječno vrijeme produljenja preživljavanja.
English: The full EPAR for Rilutek can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Rilutek nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This summary was last updated in 04-2016.
Croatian: Ovaj sažetak je posljednji put ažuriran u 04. 2016.
English: It is available as 50 mg tablets.
Croatian: Dostupan je u obliku tableta od 50 mg.
English: EMEA/H/C/000109
Croatian: EMA/234576/2016 EMEA/H/C/000109
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rilutek on 10 June 1996.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Rilutek na snazi u Europskoj uniji od 10. lipnja 1996.
English: The recommended dose is 100 mg per day (given as one 50 mg tablet every 12 hours).
Croatian: Preporučena doza je 100 mg na dan (uzima se jedna tableta od 50 mg svakih 12 sati).
English: One of these studies was in older patients (over 75) and in patients with advanced disease.
Croatian: Jedno od tih ispitivanja provedeno je na bolesnicima starije dobi (starijima od 75 godina) i bolesnicima kod kojih je bolest uznapredovala.
English: Rilutek must also not be given to women who are pregnant or breastfeeding.
Croatian: Rilutek se također ne smije davati ženama koje su trudne ili doje.
English: For more information about treatment with Rilutek, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Rilutek pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Riluzole stops the release of glutamate and this may help in preventing the nerve cells being damaged.
Croatian: Riluzol zaustavlja otpuštanje glutamata, a to može pomoći u sprječavanju oštećivanja živčanih stanica.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rilutek.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Rilutek.
English: Rilutek has been compared with placebo (a dummy treatment) in three studies involving a total of 1,282 patients.
Croatian: Rilutek je uspoređen s placebom (prividnim liječenjem) u trima ispitivanjima koja su uključivala ukupno 1282 bolesnika.
English: Other information about Rilutek
Croatian: Ostale informacije o lijeku Rilutek
English: This is a summary of the European public assessment report (EPAR) for Rilutek.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Rilutek.
English: The average survival time was significantly longer for patients who received Rilutek compared with patients who received placebo.
Croatian: Prosječno vrijeme produljenja preživljavanja bilo je znatno dulje u bolesnika koji su primali lijek Rilutek u odnosu na bolesnike koji su primali placebo.
English: ALS is a form of motor neuron disease where the nerve cells responsible for sending instructions to the muscles gradually deteriorate, leading to weakness, muscle wasting and paralysis.
Croatian: Amiotrofična lateralna skleroza oblik je bolesti motoričkih neurona pri kojoj živčane stanice odgovorne za slanje signala mišićima postupno propadaju što dovodi do slabosti, propadanja mišića i paralize.
English: Across the studies, Rilutek was given as 50, 100 or 200 mg per day, and for up to 18 months.
Croatian: U okviru ispitivanja, Rilutek se davao u dozama od 50, 100 ili 200 mg na dan do najviše 18 mjeseci.
English: Rilutek is used to extend the patient's life or to delay the need for mechanical ventilation.
Croatian: Rilutek se koristi kako bi se u bolesnika produljilo preživljavanje ili radi odlaganja potrebe za mehaničkom ventilacijom.
English: Rilutek 50 mg/day was no more effective than placebo and 200 mg/day was no more effective than 100 mg/day.
Croatian: Doza lijeka Rilutek od 50 mg na dan nije se pokazala djelotvornijom od placeba, a doza od 200 mg na dan nije bila djelotvornija od doze od 100 mg na dan.
English: It is thought that the destruction of nerve cells in motor neuron disease may be caused by too much of the neurotransmitter glutamate.
Croatian: Smatra se da je odumiranje živčanih stanica u bolesnika s bolesti motoričkih neurona možda posljedica prevelike količine neurotransmitera glutamata.
English: The most common side effects seen with Rilutek (in more than 1 patient in 10) are nausea (feeling sick), asthenia (weakness) and abnormal liver tests.
Croatian: Najčešće su nuspojave lijeka Rilutek (mogu se javiti u više od 1 na 10 bolesnika) mučnina (osjećaj slabosti), astenija (slabost) i abnormalni rezultati pretrage jetre.
English: Treatment with Rilutek should only be started by a specialist doctor with experience in the management of motor neuron diseases.
Croatian: Liječenje lijekom Rilutek mora započeti isključivo liječnik specijalist s iskustvom u liječenju bolesti motoričkih neurona.
English: Rilutek is used in patients with amyotrophic lateral sclerosis (ALS).
Croatian: Rilutek se koristi u bolesnika s amiotrofičnom lateralnom sklerozom (ALS).
English: The medicine was not more effective than placebo in the late stages of ALS.
Croatian: Lijek se nije pokazao djelotvornijim od placeba u kasnijim fazama amiotrofične lateralne skleroze.
English: What is the risk associated with Rilutek?
Croatian: Koji su rizici povezani s lijekom Rilutek?
English: Rilutek is a medicine containing the active substance riluzole.
Croatian: Rilutek je lijek koji sadrži djelatnu tvar riluzol.
English: What is Rilutek?
Croatian: Što je Rilutek?
English: Looking at the results of the three studies together, over 18 months, patients who received Rilutek 100 mg/day had an average survival time that was about 2 months longer than the survival time for patients who received placebo.
Croatian: Ukupni rezultati svih triju ispitivanja provedenih kroz 18 mjeseci pokazuju da je prosječno vrijeme produljenja preživljavanja u bolesnika koji su primali lijek Rilutek u dozi od 100 mg na dan otprilike dva mjeseca dulje u odnosu na prosjek u bolesnika koji su primali placebo.
English: The active substance in Rilutek, riluzole, acts on the nervous system.
Croatian: Djelatna tvar u lijeku Rilutek, riluzol, djeluje na živčani sustav.
English: Rilutek should not be used in patients with any other form of motor neuron disease.
Croatian: Rilutek se ne smije primjenjivati u bolesnika koji boluju od bilo kakvog drugog oblika bolesti motoričkih neurona.
English: The CHMP decided that Rilutek's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Rilutek nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Rilutek must not be used in patients who have liver disease or who have abnormally high levels of liver enzymes.
Croatian: Rilutek se ne smije primjenjivati u bolesnika s bolesti jetre ili u bolesnika s abnormalno visokim razinama jetrenih enzima.
English: Why has Rilutek been approved?
Croatian: Zašto je lijek Rilutek odobren?
English: For the full list of all side effects reported with Rilutek, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Rilutek potražite u uputi o lijeku.
English: What benefit has Rilutek shown during the studies?
Croatian: Koje su koristi lijeka Rilutek utvrđene u ispitivanjima?
English: What is Rilutek used for?
Croatian: Za što se Rilutek koristi?
English: How is Rilutek used?
Croatian: Kako se Rilutek koristi?
English: How has Rilutek been studied?
Croatian: Kako je Rilutek ispitivan?
English: How does Rilutek work?
Croatian: Kako djeluje Rilutek?
English: The exact way in which it works in ALS is not known.
Croatian: Nije poznato na koji točno način djeluje na amiotrofičnu lateralnu sklerozu.
English: What happens
Croatian: Što se dešava
English: All other bleeding events were nonserious.
Croatian: Svi ostali događaji krvarenja nisu bili ozbiljni.
English: All reactions resolved.
Croatian: Sve reakcije su se povukle.
English: You will remain in the hospital for approximately 3-6 weeks
Croatian: Ostat ćete u bolnici približno 36 tjedana
English: *Patients who have not received transfusions in the prior 60 days.
Croatian: *Bolesnici koji nisu primili transfuzije u proteklih 60 dana.
English: o The importance of annual check-ups.
Croatian: o Važnost godišnjih kontrola.
English: • trouble sleeping
Croatian: • problemi sa spavanjem
English: NA*** 4/5
Croatian: NP*** 4/5
English: Study Total number (adolescents)
Croatian: Ispitivanje Ukupan broj (adolescenti)
English: NR = Not reached.
Croatian: ND = nije dosegnuto.
English: When 20 patients have been treated with 6 months follow-up
Croatian: Nakon liječenja 20 bolesnika uz 6 mjeseci praćenja
English: Date of first authorisation: 29 May 2019
Croatian: Datum prvog odobrenja: 29. svibnja 2019.
English: This reduces or eliminates the need for blood transfusions.
Croatian: Time se smanjuje ili eliminira potreba za transfuzijom krvi.
English: To recover and be monitored until your doctor is satisfied that it is safe for you to leave the hospital.
Croatian: Kako bi se oporavili i bili nadzirani sve dok vaš liječnik ne bude uvjeren da je sigurno da napustite bolnicu.
English: Patient ID: COI ID:
Croatian: ID bolesnika: COI ID:
English: • bump your head or have a head injury
Croatian: • udarite glavom ili imate ozljedu glave.
English: Do not use an in-line blood filter or an infusion pump.
Croatian: Nemojte koristiti linijski krvni filtar ili infuzijsku pumpu.
English: A chemotherapy medicine is given for 4 days in a hospital
Croatian: Kemoterapijski lijek daje se tijekom 4 dana u bolnici
English: • increase in female hormones
Croatian: • povećanje razine ženskih hormona
English: The minimum recommended dose is the same for adults and adolescents 12 years of age and older.
Croatian: Minimalna preporučena doza jednaka je za odrasle i za adolescente u dobi od 12 godina i više.
English: Risks associated with TDT and iron overload
Croatian: Rizici povezani s TDT-om i preopterećenjem željezom
English: This leaflet was last revised in <{MM/YYYY}>
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG}.
English: You must get medical attention if you:
Croatian: Morate dobiti liječničku pomoć ako
English: This will take place in a hospital and will take less than 30 minutes for each infusion bag.
Croatian: To će se provoditi u bolnici i trajat će manje od 30 minuta za svaku infuzijsku vrećicu.
English: Frequencies are defined as: very common (≥1/10), and common (≥1/100 and <1/10).
Croatian: Učestalosti su definirane kao: vrlo često (≥ 1/10) i često (≥ 1/100 i < 1/10).
English: Irradiation could lead to inactivation of the product.
Croatian: Zračenje može dovesti do inaktivacije lijeka.
English: Risk of insertional oncogenesis
Croatian: Rizik od insercijske onkogeneze
English: • low level of red and white blood cells, sometimes with a fever
Croatian: • niska razina crvenih i bijelih krvnih stanica, ponekad s vrućicom
English: • excess water in the body
Croatian: • višak vode u tijelu
English: See section 2, Sodium content.
Croatian: Vidjeti dio 2, Sadržaj natrija.
English: Overall results
Croatian: Ukupni rezultati
English: This means that your blood may not be able to clot as well as normal and you may be prone to bleeding.
Croatian: To znači da se vaša krv možda neće moći dobro zgrušavati kao što može normalna krv i da ćete možda biti skloni krvarenju.
English: It may no longer be possible for you to become pregnant or father a child after receiving chemotherapy medicine.
Croatian: Možda više nećete moći zatrudnjeti ili postati otac djeteta nakon primanja kemoterapijskih lijekova.
English: As this medicine will be given by a qualified doctor, they are responsible for the correct storage of the medicine before and during its use, as well as for its correct disposal.
Croatian: Budući da će ovaj lijek primjenjivati kvalificirani liječnik, on je odgovoran za pravilno čuvanje lijeka prije i tijekom primjene, kao i za ispravno zbrinjavanje.
English: If you are concerned about having children, you should discuss this with your doctor before treatment.
Croatian: Ako ste zabrinuti zbog ovoga, trebali biste o tome razgovarati sa svojim liječnikom prije liječenja.
English: Do not thaw the product until it is ready to be used.
Croatian: Nemojte odmrzavati lijek dok ne bude spreman za korištenje.