FrancophonIA/ELRC3.0 huggingface dataset:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40mg/4ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 40 mg/4 ml
English: Figure 1: Wipe top with alcohol
Croatian: Slika 1: Obrišite vrh alkoholom
English: The dose of 120 μg/kg given subcutaneously (SC) and twice daily (BID) was associated with the greatest growth responses.
Croatian: Doza od 120 μg/kg primjenjivana supkutano (s.c.) i dva puta dnevno bila je povezana s najvećim odgovorima rasta.
English: For severe hypoglycaemia, if you are not responsive and cannot drink sugar-containing fluids, you should give an injection of glucagon.
Croatian: Za teške hipoglikemije, ako ne reagirate i ne možete piti tekućinu koja sadrži šećer, trebate dobiti injekciju glukagona.
English: Some patients may develop antibodies to mecasermin.
Croatian: Kod nekih bolesnika mogu se razviti antitijela na mekasermin.
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Croatian: Budući da je ovo odobrenje za stavljanje lijeka u promet u iznimnim okolnostima, sukladno članku 14. stavku 8. Uredbe (EZ) br. 726/2004, nositelj odobrenja dužan je unutar navedenog vremenskog roka provesti sljedeće mjere:
English: Mecasermin was administered subcutaneously to Sprague Dawley rats at doses of 0, 0.25, 1, 4, and 10 mg/kg/day for up to 2 years.
Croatian: Mekasermin je primijenjen supkutano na štakore Sprague Dawley u dozama 0, 0,25, 1, 4 i 10 mg/kg/dan tijekom 2 godine.
English: Your doctor may perform an echocardiogram before, during and after mecasermin treatment.
Croatian: Vaš liječnik može napraviti ultrazvučni pregled srca prije, za vrijeme i nakon liječenja mekaserminom.
English: Skeletal growth is accomplished at the epiphyseal plates at the ends of a growing bone.
Croatian: Rast kostura ostvaruje se na epifiznim pločama na krajevima kosti koja raste.
English: Placental transfer of mecasermin was not studied.
Croatian: Placentalni prijenos mekasermina nije ispitivan.
English: Uncommon: Benign intracranial hypertension
Croatian: Manje često: benigna intrakranijalna hipertenzija
English: During clinical trials in other indications (totaling approximately 300 patients) 8% of patients reported a local and/or systemic hypersensitivity reactions.
Croatian: Za vrijeme kliničkih ispitivanja drugih indikacija (ukupno u približno 300 bolesnika), 8% bolesnika prijavilo je lokalne i/ili sistemske reakcije preosjetljivosti.
English: Instructions on the treatment of hypoglycaemia.
Croatian: Upute o liječenju hipoglikemije.
English: For subjects with bone age available for at least 6 years after treatment initiation, the mean increase in bone age was comparable to the mean increase in chronological age; for these subjects, there does not appear to be any clinically significant advance of bone age relative to chronological age.
Croatian: Za ispitanike s koštanom dobi dostupnom najmanje 6 godina nakon početka liječenja, srednje povećanje koštane dobi uspoređeno je sa srednjim povećanjem kronološke dobi; za ove se ispitanike to ne čini kao klinički značajan napredak koštane dobi u odnosu na kronološku dob.
English: The bioavailability of mecasermin after subcutaneous administration in healthy subjects has been reported to be approximately 100%.
Croatian: Bioraspoloživost mekasermina, nakon supkutane primjene u zdravih ispitanika, bila je prema izvješćima približno 100%.
English: Doses greater than 0.12 mg/kg given twice daily have not been evaluated in children with severe Primary IGFD.
Croatian: Doze veće od 0,12 mg/kg koje se daju dva puta dnevno nisu procijenjene kod djece s teškom primarnom deficijencijom IGF.
English: Uncommon (may affect up to 1 in 100 people)
Croatian: Manje česte (mogu se javiti do 1 na 100 osoba)
English: If the overdose results in loss of consciousness, intravenous glucose or parenteral glucagon may be required to reverse the hypoglycaemic effects.
Croatian: Ako predoziranje rezultira gubitkom svijesti, može biti potrebno intravensko davanje glukoze ili parenteralni glukagon kako bi se poništio hipoglikemijski učinak.
English: Stop INCRELEX immediately and seek urgent medical advice if you develop a serious allergic reaction.
Croatian: Prekinite odmah uzimanje INCRELEXA i zatražite hitni medicinski savjet ako vam se pojavi ozbiljna alergijska reakcija.
English: Make sure the tip of the needle is in the liquid (see Figure 4).
Croatian: Uvjerite se da je vrh igle u tekućini (pogledajte Sliku 4).
English: Therapy should be discontinued if evidence of neoplasia develops.
Croatian: Terapiju treba prekinuti ako se pojave dokazi novotvorine.
English: In target tissues the Type 1 IGF-1 receptor, which is homologous to the insulin receptor, is activated by IGF-1, leading to intracellular signaling which stimulates multiple processes leading to statural growth.
Croatian: U ciljnim tkivima, tip 1 receptora za IGF-1, koji odgovara receptoru inzulina, aktivira se pomoću IGF-1, dovodeći do međustaničnog signaliziranja koje stimulira višestruke procese, koji dalje vode do staturalnog rasta.
English: The metabolic actions of IGF-1 are in part directed at stimulating the uptake of glucose, fatty acids, and amino acids so that metabolism supports growing tissues.
Croatian: Metabolička djelovanja IGF-1 su dijelom usmjerene na stimuliranje preuzimanja glukoze, masnih kiselina i aminokiselina tako da metabolizam podržava rastuća tkiva.
English: • To inform parents and patients that systemic allergic reactions are possible and that if this occurs treatment should be interrupted and prompt medical attention should be sought.
Croatian: • Informiranje roditelja i bolesnika da su moguće sistemske alergijske reakcije i ako se ovo dogodi liječenje treba biti prekinuto i treba se potražiti brza medicinska pomoć.
English: Acute overdose could lead to hypoglycaemia (low blood sugar).
Croatian: Akutno predoziranje moglo bi dovesti do hipoglikemije (nizak šećer u krvi).
English: Other uncommon side effects seen with mecasermin treatment include depression, nervousness.
Croatian: Druge manje česte nuspojave uočene kod liječenja mekaserminom uključuju depresiju i nervozu.
English: • Immunogenicity sampling information.
Croatian: • Informacije o uzorkovanju radi imunogenosti.
English: The syringes should be of small enough volume that the prescribed dose can be withdrawn from the vial with reasonable accuracy.
Croatian: Štrcaljke trebaju biti dovoljno malog volumena kako bi se propisana doza mogla izvući iz bočice s razumnom preciznošću.
English: IGF-1 has inhibitory effects on insulin secretion.
Croatian: IGF-1 ima inhibitorni učinak na lučenje inzulina.
English: If no significant adverse reactions occur for at least one week, the dose may be raised in increments of 0.04 mg/kg to the maximum dose of 0.12 mg/kg given twice daily.
Croatian: Ako ne dođe do značajnih nuspojava tijekom najmanje tjedan dana, doza se može povećavati za po 0,04 mg/kg do maksimalne doze od 0,12 mg/kg koja se daje dva puta dnevno.
English: INFORMATION IN BRAILLE INCRELEX
Croatian: 16. PODACI NA BRAILLEOVOM PISMU INCRELEX
English: Symptomatic hypoglycaemia was generally avoided when a meal or snack was consumed either shortly before or after the administration of INCRELEX.
Croatian: Simptomatska hipoglikemija općenito je izbjegnuta kada su obrok ili užina konzumirani ili neposredno prije ili nakon primjene lijeka INCRELEX.
English: The dose of mecasermin should never be increased to make up for one or more omitted doses.
Croatian: Doza mekasermina ne smije se nikad povećavati kako bi se nadoknadile jedna ili više propuštenih doza.
English: • To educate parents on the signs, symptoms and treatment of hypoglycaemia, including injection of glucagon.
Croatian: • Educiranje roditelja o znakovima, simptomima i liječenju hipoglikemije, uključujući injiciranje glukagona.
English: Patients were enrolled in the studies on the basis of extreme short stature, slow growth rates, low IGF-1 serum concentrations, and normal GH secretion.
Croatian: Bolesnici su bili uključeni u ispitivanja na temelju iznimno niskog stasa, sporog rasta, niskih koncentracija serumskog IGF-1 i normalnog lučenja hormona rasta.
English: Your doctor or nurse will instruct you how to give the injection of glucagon.
Croatian: Vaš liječnik ili medicinska sestra uputit će Vas kako dati injekciju glukagona.
English: Before putting the needle into the vial, pull back on plunger to draw air into the syringe equal to the prescribed dose.
Croatian: Prije stavljanja igle u bočicu, povucite klip unatrag kako biste uvukli zrak u štrcaljku jednak propisanoj dozi.
English: No studies have been conducted to determine the effect of hepatic impairment on the pharmacokinetics of mecasermin.
Croatian: Nisu provođena ispitivanja za ustanovljenje utjecaja oštećenja jetre na farmakokinetiku mekasermina.
English: Mean (SD) for change from pre-Tx
Croatian: Srednja vrijednost (SD) za promjenu u odnosu na pre-Tx
English: A disruption or early ending of treatment with mecasermin may impair the success of the growth therapy.
Croatian: Prekid ili rani prestanak liječenja mekaserminom može umanjiti uspjeh terapije rasta.
English: The patient information about INCRELEX should contain the following information:
Croatian: Informacije za bolesnika o INCRELEXU trebaju sadržavati sljedeće informacije:
English: If the patient is not awake or alert enough to drink sugarcontaining fluids, an injection of glucagon into the muscle may be necessary to reverse the low blood sugar.
Croatian: Ako bolesnik nije budan ili dovoljno svjestan kako bi pio tekućinu sa šećerom, možda će biti potrebna injekcija glukagona u mišić kako bi podignuo razinu šećera u krvi.
English: Not known: Systemic hypersensitivity (anaphylaxis, generalized urticaria, angioedema, dyspnoea), local allergic reactions at the injection site (pruritus, urticaria)
Croatian: Nepoznato: sistemska preosjetljivost (anafilaksija, generalizirana urtikarija, angioedem, dispneja), lokalne alergijske reakcije na mjestu injiciranja (svrbež, urtikarija)
English: IGF-1 suppresses hepatic glucose production, stimulates peripheral glucose utilization, and can reduce blood glucose and cause hypoglycaemia.
Croatian: IGF-1 potiskuje jetreno stvaranje glukoze, stimulira perifernu utilizaciju glukoze i može sniziti razinu glukoze u krvi i izazvati hipoglikemiju.
English: At the time of initial prescription, physicians should educate parents on the signs, symptoms and treatment of hypoglycaemia, including injection of glucagon.
Croatian: U vrijeme izdavanja prvog recepta, liječnici trebaju obučiti roditelje o znakovima, simptomima i liječenju hipoglikemije, uključujući i davanje injekcije glukagona.
English: Intracranial hypertension/increased intracranial pressure This occurred in 4 subjects (0.96%); in two subjects INCRELEX was discontinued and not restarted; in two subjects the event did not recur after restarting INCRELEX at a reduced dose.
Croatian: Intrakranijalna hipertenzija/povišen intrakranijalni tlak Pojavila se kod 4 ispitanika (0,96%): u dva ispitanika uzimanje INCRELEXA bilo je prekinuto i nije kasnije nastavljano; u dva se ispitanika događaj nije ponovno pojavio nakon ponovne uporabe INCRELEXA u smanjenoj dozi.
English: The recommended starting dose of mecasermin is 0.04 mg/kg of body weight twice daily by subcutaneous injection.
Croatian: Preporučena početna doza mekasermina je 0,04 mg/kg tjelesne težine dva puta dnevno putem supkutane injekcije.
English: If a person with severe hypoglycemia is unconscious or otherwise unable to ingest food normally, an injection of glucagon may be required.
Croatian: Ako je osoba s teškom hipoglikemijom bez svijesti ili zbog bilo kojeg drugog razloga ne može normalno uzimati hranu, može biti potrebna injekcija glukagona.
English: Doses of insulin and/or other hypoglycaemic medicinal products may need to be reduced for diabetic subjects using this medicinal product.
Croatian: Možda će biti potrebno smanjiti doze inzulina i/ili drugih hipoglikemijskih lijekova osobama s dijabetesom koje uzimaju ovaj lijek.
English: INCRELEX should be administered by subcutaneous injection shortly before or after a meal or snack.
Croatian: INCRELEX treba primjenjivati putem supkutane injekcije neposredno prije ili nakon obroka ili užine.
English: Via del Bosco Rinnovato n. 6 Milanofiori Nord Palazzo U7 20090 Assago (Mi) Tel: + 39 - 02 - 39 22 41
Croatian: 6 Milanofiori Nord Palazzo U7 20090 Assago (Mi) Tel: + 39 - 02 - 39 22 41
English: Patients should have examinations periodically and at the occurrence of clinical symptoms to rule out such potential complications or to initiate appropriate treatment.
Croatian: Bolesnici trebaju obavljati povremene preglede, a pri pojavi kliničkih simptoma, radi isključenja tih mogućih komplikacija ili zbog započinjanja odgovarajućeg liječenja.
English: Tonsillar hypertrophy
Croatian: Tonzilarna hipertrofija
English: Treatment with mecasermin should be directed by physicians who are experienced in the diagnosis and management of patients with growth disorders.
Croatian: Liječenje mekaserminom trebaju provoditi liječnici koji su iskusni u dijagnozi i zbrinjavanju bolesnika s poremećajima rasta.
English: What you need to know before you use INCRELEX
Croatian: Što morate znati prije nego počnete primjenjivati INCRELEX
English: Increased blood sugar (hyperglycaemia) Increased blood sugar has also been observed with mecasermin treatment.
Croatian: Povišena razina šećera u krvi (hiperglikemija) Povišena razina šećera u krvi također je uočena kod liječenja mekaserminom.
English: Intracranial hypertension/increased intracranial pressure occurred in 4 (0.96%) of patients from the clinical trials and occurred in 7 - 9 year old treatment naïve subjects.
Croatian: Intrakranijalna hipertenzija/povišen intrakranijalni tlak javila se kod 4 (0,96%) bolesnika iz kliničkih ispitivanja te kod ispitanika u dobi od 7 do 9 godina koji nisu prethodno liječeni.
English: For the long-term treatment of growth failure in children and adolescents from 2 to 18 years with severe primary insulin-like growth factor-1 deficiency (Primary IGFD).
Croatian: Za dugotrajno liječenje zatajenja rasta kod djece i adolescenata od 2 do 18 godina s teškom primarnom deficijencijom inzulinu sličnog faktora rasta 1 (primarna deficijencija IGF-a).
English: IH-associated signs and symptoms resolved after interruption of dosing.
Croatian: Znakovi i simptomi povezani s intrakranijskom hipertenzijom riješili su se nakon prekida doziranja.
English: An enlarged thymus (a specialized organ of the immune system) has been observed with mecasermin treatment.
Croatian: Povećani timus Povećani timus (specijalizirani organ imunološkog sustava) uočen je kod liječenja mekaserminom.
English: For further information ask the doctor.
Croatian: Pitajte liječnika za daljnje informacije.
English: • That patients should have examinations of the ears, nose and throat periodically and at the occurrence of clinical symptoms to rule out such potential complications or to initiate appropriate treatment.
Croatian: • Da bolesnici trebaju periodično otići na preglede ušiju, nosa i grla te pri pojavi kliničkih simptoma kako bi isključili potencijalne komplikacije ili radi započinjanja odgovarajućeg liječenja.
English: Elderly The pharmacokinetics of INCRELEX have not been studied in subjects greater than 65 years of age.
Croatian: Farmakokinetika INCRELEXA nije ispitivana kod ispitanika starijih od 65 godina.
English: Carbohydrate Metabolism
Croatian: Metabolizam ugljikohidrata
English: Some signs of enlarged tonsils/adenoids include: snoring, difficulty breathing or swallowing, sleep apnoea (a condition where breathing stops briefly during sleep), or fluid in the middle ear, as well as infections of the ear.
Croatian: Neki znakovi povećanih krajnika uključuju: hrkanje, otežano disanje ili gutanje, apneju u snu (stanje u kojem disanje nakratko prestaje za vrijeme spavanja) ili tekućinu u srednjem uhu, kao i infekcije uha.
English: Postmarketing reports of local allergic reactions were also received.
Croatian: Nakon stavljanja lijeka u promet primljene su i prijave o lokalnim alergijskim reakcijama.
English: Signs of low blood sugar are: dizziness, tiredness, restlessness, hunger, irritability, trouble concentrating, sweating, nausea and fast or irregular heartbeats.
Croatian: Znakovi niskog šećera u krvi su: omaglica, umor, nemir, glad, razdražljivost, otežana koncentracija, znojenje, mučnina i brzi ili nepravilni otkucaji srca.
English: The doctor should regularly examine your tonsils/adenoids.
Croatian: Liječnik treba redovito pregledavati Vaše krajnike.
English: Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment.
Croatian: Teška primarna deficijencija IGF obuhvaća bolesnike s mutacijama receptora hormona rasta (GH receptor; GHR), post-GHR signalnog puta i defektima gena IGF-1; oni nemaju nedostatak hormona rasta, te se stoga, od njih ne može očekivati da adekvatno odgovore na egzogeno liječenje hormonom rasta.
English: Cell growth: IGF-1 receptors are present on most types of cells and tissues.
Croatian: Rast stanica: receptori IGF-1 postoje u većini tipova stanica i tkiva.
English: Hold the syringe and vial firmly (see Figure
Croatian: Držite čvrsto štrcaljku i bočicu (pogledajte Sliku
English: Before you take the needle out of the vial, check the syringe for air bubbles.
Croatian: Prije nego izvučete iglu iz bočice, provjerite ima li u štrcaljki mjehurića zraka.
English: Push the bubbles out with the plunger and draw liquid back in until you have the correct dose (see Figure 6).
Croatian: Izgurajte van mjehuriće pomoću klipa i uvucite tekućinu natrag dok ne budete imali točnu dozu (pogledajte Sliku 6).
English: Inject INCRELEX just under your skin shortly before or after a meal or snack because it may have insulinlike hypoglycaemic effects and so it may decrease blood sugar levels (see hypoglycaemia in section 4).
Croatian: Ubrizgajte INCRELEX pod samu kožu neposredno prije ili nakon obroka ili užine jer može imati hipoglikemijske učinke slične inzulinu i tako smanjiti razine šećera u krvi (pogledajte „hipoglikemija“ u dijelu 4.).
English: The most frequently occurring side effects with mecasermin are: low blood sugar (hypoglycemia), vomiting, injection site reactions, headache and middle ear infections.
Croatian: Nuspojave koje se najčešće javljaju s mekaserminom su: nizak šećer u krvi (hipoglikemija), povraćanje, reakcije na mjestu ubrizgavanja, glavobolja i infekcija srednjeg uha.
English: From a microbiological point of view, once opened, the medicinal product may be stored for a maximum of 30 days at 2C to 8C.
Croatian: S mikrobiološkog stajališta, jednom otvoreni lijek može se čuvati najviše 30 dana pri 2C do 8C.
English: Growth and metabolism of epiphyseal plate cells are directly stimulated by GH and IGF-1.
Croatian: Rast i metabolizam stanica epifiznih ploča izravno su stimulirani hormonom rasta i IGF-1.
English: Wipe the rubber stopper of the vial with an alcohol swab to prevent contamination of the vial by germs that may be introduced by repeated needle insertions (see Figure 1).
Croatian: Obrišite gumeni čep bočice vaticom natopljenom alkoholom radi sprječavanja kontaminacije bočice bacilima koji mogu biti uneseni ponavljanim umetanjem igala (pogledajte Sliku 1).
English: The symptoms of intracranial hypertension can include visual changes, headache, nausea and/or vomiting.
Croatian: Simptomi intrakranijalne hipertenzije mogu uključivati poremećaje vida, glavobolju, mučninu i/ili povraćanje.
English: Do not use this medicine after the expiry date which is stated on the carton and label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici iza oznake „Rok valjanosti“ ili EXP.
English: This may be through the production of anti-IGF-1 IgEs, sustaining antibodies or neutralizing antibodies respectively.
Croatian: To može biti posljedica proizvodnje anti-IGF-1 IgE antitijela, održavajućih antitijela odnosno neutralizirajućih antitijela.
English: Throw them away properly in a sharps container (such as a biohazard container), hard plastic container (such as a detergent bottle), or metal container (such as an empty coffee can).
Croatian: Bacite ih u spremnik za oštre predmete (kao što je spremnik za biološki opasan otpad), spremnik od tvrde plastike (kao što je boca od deterdženta) ili metalni spremnik (kao što je prazna limenka za kavu).
English: If you are using a new vial, remove the protective cap. Do not remove the rubber stopper.
Croatian: Ako koristite novu bočicu, skinite zaštitnu kapicu.
English: Any patient with the onset of a limp or complaint of hip or knee pain should be evaluated.
Croatian: Svakog bolesnika kod kojeg se pojavi šepanje ili se žali na bol u kuku ili koljenu treba pregledati.
English: Persons who have allergic reactions to injected IGF-1, who have unexpectedly high blood values of IGF-1 after injection, or who fail to show a growth response without any identified cause may be having an antibody response to injected IGF-1.
Croatian: Bolesnici koji imaju alergijske reakcije na injicirani IGF-1, koji imaju neočekivano visoke vrijednosti IGF-1 u krvi nakon injiciranja, ili kod kojih ne dolazi do rasta, a nema utvrđenog razloga za to, možda stvaraju antitijela na IGF-1.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po bočici, tj. sadrži zanemarive količine natrija.
English: Mecasermin is not a substitute for GH treatment.
Croatian: Mekasermin nije zamjena za liječenje hormonom rasta.
English: Inject INCRELEX as instructed by the doctor.
Croatian: Ubrizgajte INCRELEX prema uputama liječnika.
English: Slipped capital femoral epiphysis (with the potential to lead to avascular necrosis) and progression of scoliosis can occur in patients who experience rapid growth.
Croatian: Iskliznuće epifize glave femura (koje može dovesti do avaskularne nekroze) i napredovanje skolioze mogu se dogoditi kod bolesnika koji iskuse brzi rast.
English: One ml contains 9 mg of benzyl alcohol.
Croatian: Jedan ml sadrži 9 mg benzilnog alkohola.
English: INCRELEX should not be administered intravenously.
Croatian: INCRELEX se ne smije primjenjivati intravenski.
English: - The other ingredients are: benzyl alcohol, sodium chloride, polysorbate 20, glacial acetic acid, sodium acetate and water for injections (see section 2 "INCRELEX contains benzyl alcohol and sodium").
Croatian: - Drugi sastojci su: benzilni alkohol, natrijev klorid, polisorbat 20, ledena acetatna kiselina, natrijev acetat i voda za injekcije (pogledajte dio 2. „INCRELEX sadrži benzilni alkohol i natrij“).
English: Used needle and syringe should be placed in a sharps container (such as a biohazard container), hard plastic container (such as a detergent bottle), or metal container (such as an empty coffee can).
Croatian: Upotrijebljene igle i štrcaljke treba staviti u spremnik za oštre predmete (kao što je spremnik za biološki opasan otpad), spremnik od tvrde plastike (kao što je boca od deterdženta) ili metalni spremnik (kao što je prazna limenka za kavu).
English: Biotransformation Both the liver and the kidney have been shown to metabolise IGF-1.
Croatian: Biotransformacija Pokazalo se da i jetra i bubrezi metaboliziraju IGF-1.
English: 5 ml vial (type I glass) closed with a stopper (bromobutyl/isoprene polymer) and a seal (lacquered plastic).
Croatian: Bočica od 5 ml (staklo tipa I) zatvorena čepom (polimer bromobutil/izoprena) i zaštitnim poklopcem (lakirana plastika).
English: It is recommended that the dose be individualised for each patient as described under posology
Croatian: Preporučuje se dozu prilagoditi svakom pojedinom bolesniku kako je opisano u dijelu koji se odnosi na doziranje.