FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, there was a significantly higher incidence of hyperkalaemia, renal failure, hypotension and syncope in the combination arm.
Croatian: Nadalje, u skupini koja je primala kombinaciju postojala je znatno veća učestalost pojave hiperkalijemije, zatajenja bubrega, hipotenzije i sinkope.
English: Renal impairment and kidney transplantation
Croatian: Oštećenje bubrega i transplantacija bubrega
English: If your liver is not working properly, the usual dose should not exceed 40 mg once daily.
Croatian: U bolesnika s oštećenom jetrom, uobičajena doza ne smije prelaziti 40 mg jednom dnevno.
English: These pharmacologicallymediated undesirable effects, known from preclinical studies with both angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists, were prevented by oral saline supplementation.
Croatian: Ove farmakološki posredovane nuspojave, poznate iz nekliničkih ispitivanja s inhibitorima angiotenzin konvertirajućeg enzima i antagonistima receptora angiotenzina II, bile su spriječene oralnim nadomjeskom soli.
English: There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Croatian: Postoje dokazi da istodobna primjena ACE inhibitora, blokatora angiotenzin II receptora ili aliskirena povećava rizik od hipotenzije, hiperkalemije i smanjene bubrežne funkcije (uključujući akutno zatajenje bubrega).
English: Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure.
Croatian: Angiotenzin II je tvar koja se stvara u Vašem tijelu i dovodi do sužavanja krvnih žila, čime se povisuje krvni tlak.Tolura blokira učinak angiotenzina II, tako da se krvne žile šire, a krvni tlak snižava.
English: Anaemia Eosinophilia, thrombocytopenia
Croatian: Anemija Eozinofilija, trombocitopenija
English: Tolura tablets contain sorbitol (E420).
Croatian: Tolura tablete sadrže sorbitol (E420).
English: 80 mg: white to almost white, biconvex, capsule shape tablets
Croatian: 80 mg: bijele do gotovo bijele, bikonveksne, tablete oblika kapsule
English: When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and
Croatian: Kada se utvrdi trudnoća, liječenje antagonistima receptora angiotenzina II mora se trenutno prekinuti te, ako je potrebno, započeti s primjenom drugog lijeka (vidjeti dijelove 4.3 i
English: Excipients with known effect: Each tablet contains 299.7 mg sorbitol (E420) and 114 mg lactose.
Croatian: Pomoćne tvari s poznatim učinkom: Svaka tableta sadrži 299,7 mg sorbitola (E420) i 114 mg laktoze.
English: 40 mg: white to almost white, biconvex, oval tablets
Croatian: 40 mg: bijele do gotovo bijele, bikonveksne, ovalne tablete
English: The safety and efficacy of Tolura in children and adolescents aged below 18 years have not been established.
Croatian: Sigurnost i djelotvornost Tolure nije utvrđena u djece i adolescenata mlađih od 18 godina.
English: No statistically significant difference in the incidence of the primary composite endpoint (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for congestive heart failure) was found [15.7 % in the telmisartan and 17.0 % in the placebo groups with a hazard ratio of 0.92 (95 % CI 0.81 - 1.05, p = 0.22)].
Croatian: Nije pronađena statistički značajna razlika u učestalosti primarnog složenog ishoda (kardiovaskularna smrt, nefatalni infarkt miokarda, nefatalni moždani udar ili hospitalizacija zbog kongestivnog zatajenja srca) [15,7 % u skupini na telmisartanu i 17,0 % u skupini na placebu s omjerom rizika od 0,92 (95 % CI 0,81 - 1,05, p = 0,22)].
English: - Diabetes.
Croatian: - Šećerna bolest.
English: Tolura contains lactose and sorbitol (E420).
Croatian: Tolura sadrži laktozu i sorbitol (E420).
English: Excipients with known effect: Each tablet contains 149.8 mg sorbitol (E420) and 57 mg lactose.
Croatian: Pomoćne tvari s poznatim učinkom: Svaka tableta sadrži 149,8 mg sorbitola (E420) i 57 mg laktoze.
English: (It is also better to avoid Tolura in early pregnancy see pregnancy section.)
Croatian: - Ako ste dulje od 3 mjeseca trudni (također je bolje izbjegavati Toluru u ranoj trudnoći - vidjeti dio o trudnoći).
English: - If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Tolura” and “Warnings and precautions”).
Croatian: - Ako uzimate ACE inhibitor ili aliskiren (vidjeti također informacije pod naslovima
English: Excipients with known effect: Each tablet contains 74.9 mg sorbitol (E420) and 28.5 mg lactose.
Croatian: Pomoćne tvari s poznatim učinkom: Svaka tableta sadrži 74,9 mg sorbitola (E420) i 28,5 mg laktoze.
English: Telmisartan selectively binds the AT1receptor.
Croatian: Telmisartan se selektivno veže na AT1receptor.
English: ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Croatian: ACE inhibitori i blokatori angiotentin II receptora ne smiju se primjenjivati istodobno u bolesnika s dijabetičkom nefropatijom.”
English: What Tolura looks like and contents of the pack Tolura 20 mg tablets are white to almost white, round tablets.
Croatian: Kako Tolura izgleda i sadržaj pakiranja Tolura 20 mg tablete su bijele do gotovo bijele, okrugle tablete.
English: You should see your doctor immediately if you experience any of the following symptoms:
Croatian: Ako Vam se pojave bilo koji od sljedećih simptoma, trebate odmah posjetiti svog liječnika:
English: Back pain (e.g. sciatica), muscle spasms, myalgia, Arthralgia, pain in extremity, tendon pain (tendinitis like symptoms)
Croatian: Bol u leđima (npr. išijas), grčevi mišića, mijalgija, Artralgija, bol u ekstremitetima, bol tetiva (simptomi poput tendinitisa)
English: ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) compared the effects of telmisartan, ramipril and the combination of telmisartan and ramipril on cardiovascular outcomes in 25620 patients aged 55 years or older with a history of coronary artery disease, stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria), which is a population at risk for cardiovascular events.
Croatian: Trial) uspoređivalo je učinke telmisartana, ramiprila i kombinacije telmisartana i ramiprila na kardiovaskularne ishode u 25 620 bolesnika u dobi od 55 godina ili starijim, s anamnezom koronarne arterijske bolesti, moždanog udara, TIA-e, periferne arterijske bolesti ili dijabetes melitusom tipa 2 s dokazanim oštećenjima ciljnih organa (npr.retinopatija, hipertrofija lijeve klijetke, makro- ili mikroalbuminurija), koja je populacija s rizikom pojave kardiovaskularnih događaja.
English: Telmisartan was found to be similarly effective to ramipril in the pre-specified secondary endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.99 (97.5 % CI 0.901.08), p (non-inferiority) = 0.0004], the primary endpoint in the reference study HOPE (The Heart Outcomes Prevention Evaluation Study), which had investigated the effect of ramipril vs. placebo.
Croatian: Pokazalo se da je telmisartan slično učinkovit kao i ramipril u prethodno određenom sekundarnom ishodu uključujući kardiovaskularnu smrt, nefatalni infarkt miokarda i nefatalni moždani udar [0,99 (97,5 % CI 0,90 - 1,08), p (neinferiornost) = 0,0004], u primarnom ishodu referentnog ispitivanja HOPE (The Heart Outcomes
English: Dyspnoea, cough Interstitial lung disease
Croatian: Dispneja, kašalj Bolest plućnog intersticija
English: Marketing Authorisation Holder KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet KRKA, d.d, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija
English: Contains lactose monohydrate and sorbitol (E420).
Croatian: Sadrži laktozu hidrat i sorbitol (E420).
English: Telmisartan does not exhibit any partial agonist activity at the AT1 receptor.
Croatian: Telmisartan ne pokazuje parcijalno agonističko djelovanje na AT1 receptor.
English: What Tolura looks like and contents of the pack Tolura 80 mg tablets are white to almost white, biconvex, capsule shape tablets.
Croatian: Kako Tolura izgleda i sadržaj pakiranja Tolura 80 mg tablete su bijele do gotovo bijele, bikonveksne, tablete oblika kapsule.
English: What Tolura looks like and contents of the pack Tolura 40 mg tablets are white to almost white, biconvex, oval tablets.
Croatian: Kako Tolura izgleda i sadržaj pakiranja Tolura 40 mg tablete su bijele do gotovo bijele, bikonveksne, ovalne tablete.
English: Telmisartan does not exhibit any partial agonist activity at the AT1receptor.
Croatian: Telmisartan ne pokazuje parcijalno agonističko djelovanje na AT1receptor.
English: Very rare side effects (may affect up to 1 in 10,000 people): Progressive scarring of lung tissue (interstitial lung disease)**.
Croatian: Progresivno (napredujuće) stvaranje ožiljka u tkivu pluća (intersticijalna bolest pluća)**.
English: No posology adjustment is required for patients with mild to moderate renal impairment.
Croatian: Nije potrebno prilagođavati doziranje u bolesnika s blagim do umjerenim oštećenjem bubrega.
English: - The other ingredients are povidone, meglumine, sodium hydroxide, lactose monohydrate,
Croatian: - Drugi sastojci su: povidon, meglumin, natrijev hidroksid, laktoza hidrat, sorbitol (E420) i magnezijev stearat.
English: - Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
Croatian: - Stenoza bubrežne arterije (suženje krvnih žila jednog ili oba bubrega).
English: - Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain 'water tablets'), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
Croatian: - Lijekovi koji mogu povisiti razine kalija u krvi kao što su nadomjesci soli koje sadrže kalij, diuretici koji štede kalij (određene tablete za mokrenje), ACE-inhibitori, antagonisti receptora angiotenzina II, NSAIL (nesteroidni protuupalni lijekovi, npr. aspirin ili ibuprofen), heparin, imunosupresivi (npr. ciklosporin ili takrolimus) te antibiotik trimetoprim.
English: Each tablet contains 40 mg telmisartan.
Croatian: Svaka tableta sadrži 40 mg telmisartana.
English: Tolura 40 mg tablets
Croatian: Tolura 40 mg tablete
English: Równoległa 5
Croatian: Sp. z o.o. Ul. Równoległa 5
English: Reduction of cardiovascular morbidity in adults with: - manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or - type 2 diabetes mellitus with documented target organ damage.
Croatian: moždanog udara ili periferne arterijske bolesti) ili - dijabetes melitus tip 2 s dokazanim oštećenjem ciljnih organa.
English: The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia (salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal antiinflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim).
Croatian: Rizik od hiperkalijemije se povećava u slučaju kombinacije s drugim lijekovima koji također mogu izazvati hiperkalijemiju (nadomjesci soli koji sadrže kalij, diuretici koji štede kalij, ACE-inhibitori, antagonisti receptora angiotenzina II, nesteroidni protuupalni lijekovi (NSAIL, uključujući selektivne COX-2 inhibitore), heparin, imunosupresivi (ciklosporin ili takrolimus) i trimetoprim).
English: Each tablet contains 20 mg telmisartan.
Croatian: Svaka tableta sadrži 20 mg telmisartana.
English: Muscoloskeletal and connective tissue disorders Uncommon:
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Manje često:
English: Each tablet contains 80 mg telmisartan.
Croatian: Svaka tableta sadrži 80 mg telmisartana.
English: Renal impairment including acute renal failure
Croatian: Oštećenje bubrega uključujući akutno zatajenje bubrega
English: 14 tablets: EU/1/10/632/015 28 tablets: EU/1/10/632/016 30 tablets: EU/1/10/632/017 56 tablets: EU/1/10/632/018 84 tablets: EU/1/10/632/019 90 tablets: EU/1/10/632/020 98 tablets: EU/1/10/632/021 100 tablets: EU/1/10/632/024
Croatian: 14 tableta: EU/1/10/632/015 28 tableta: EU/1/10/632/016 30 tableta: EU/1/10/632/017 56 tableta: EU/1/10/632/018 84 tableta: EU/1/10/632/019 90 tableta: EU/1/10/632/020 98 tableta: EU/1/10/632/021 100 tableta: EU/1/10/632/024
English: 14 tablets: EU/1/10/632/001 28 tablets: EU/1/10/632/002 30 tablets: EU/1/10/632/003 56 tablets: EU/1/10/632/004 84 tablets: EU/1/10/632/005 90 tablets: EU/1/10/632/006 98 tablets: EU/1/10/632/007 100 tablets: EU/1/10/632/022
Croatian: 14 tableta: EU/1/10/632/001 28 tableta: EU/1/10/632/002 30 tableta: EU/1/10/632/003 56 tableta: EU/1/10/632/004 84 tablete: EU/1/10/632/005 90 tableta: EU/1/10/632/006 98 tableta: EU/1/10/632/007 100 tableta: EU/1/10/632/022
English: 14 tablets: EU/1/10/632/008 28 tablets: EU/1/10/632/009 30 tablets: EU/1/10/632/010 56 tablets: EU/1/10/632/011 84 tablets: EU/1/10/632/012 90 tablets: EU/1/10/632/013 98 tablets: EU/1/10/632/014 100 tablets: EU/1/10/632/023
Croatian: 14 tableta: EU/1/10/632/008 28 tableta: EU/1/10/632/009 30 tableta: EU/1/10/632/010 56 tableta: EU/1/10/632/011 84 tableta: EU/1/10/632/012 90 tableta: EU/1/10/632/013 98 tableta: EU/1/10/632/014 100 tableta: EU/1/10/632/023
English: Tolura 20 mg tablets
Croatian: Tolura 20 mg tablete
English: ul.
Croatian: C.
English: Tolura 80 mg tablets
Croatian: Tolura 80 mg tablete
English: Tolura 40 mg tablets telmisartan
Croatian: Tolura 40 mg tablete telmisartan
English: United Kingdom Consilient Health (UK) Ltd. Tel: + 44(0)203 751 1888
Croatian: Tel: + 44(0)203 751 1888
English: Tolura 80 mg tablets Telmisartan
Croatian: Tolura 80 mg tablete telmisartan
English: Tolura 20 mg tablets telmisartan
Croatian: Tolura 20 mg tablete telmisartan
English: FRI
Croatian: TVARI
English: THU
Croatian: ČET
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Second and third trimester of pregnancy (see sections 4.4 and 4.6) - Biliary obstructive disorders - Severe hepatic impairment
Croatian: - Drugo i treće tromjesečje trudnoće (vidjeti dijelove 4.4 i 4.6).
English: Deutschland TAD Pharma GmbH Tel: + 49 (0) 4721 606-0
Croatian: Tel: + 49 (0) 4721 606-0
English: Haemoglobin decreased, blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased
Croatian: Sniženi hemoglobin, povišene vrijednosti mokraćne kiseline u krvi, povišeni jetreni enzimi, povišena kreatin-fosfokinaza u krvi 1, 2, 3, 4: za daljnje opise, molimo vidjeti pod “Opis odabranih nuspojava”.
English: 3 years.
Croatian: 3 godine
English: ATC code: A16AB15.
Croatian: ATK oznaka: A16AB15.
English: Patients n=33
Croatian: Bolesnici n=33
English: The following information is intended for healthcare professionals only.
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima:
English: Date of first authorisation: 23/03/2018
Croatian: Datum prvog odobrenja: 23/03/2018
English: This may improve the symptoms of the disease.
Croatian: To može poboljšati simptome bolesti.
English: Annual reports to be submitted as part of the annual reassessment
Croatian: Godišnja izvješća podnose se kao dio godišnje ponovne procjene
English: This is known as an infusion-related reaction and can sometimes be severe.
Croatian: To se naziva reakcija povezana s infuzijom i ponekad može biti teška.
English: Example:
Croatian: Primjer:
English: Lamzede Last Observation
Croatian: Lamzede zadnje opažanje
English: Quality of Life
Croatian: Kvaliteta života
English: Other medicines and Lamzede
Croatian: Drugi lijekovi i Lamzede
English: The reconstituted vials should stand on the table for about 5-10 minutes.
Croatian: Bočice s rekonstituiranim sadržajem moraju stajati na stolu oko 5-10 minuta.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before this medicine is used.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: No treatment was administered.
Croatian: Nije provedeno nikakvo liječenje.
English: Lamzede 12 months
Croatian: Lamzede 12 mjeseci
English: The infusion time can be calculated from the following table:
Croatian: Trajanje infuzije može se izračunati iz sljedeće tablice:
English: See sections 4.4 and 5.1.
Croatian: Vidjeti dijelove 4.4 i 5.1.
English: (1) MCID: minimal clinically important difference
Croatian: (1) MCID: minimalna klinički važna razlika (engl. minimal clinically important difference)
English: Thereafter each vial should be tilted and rolled gently for 15-20 seconds to enhance the dissolution process.
Croatian: Nakon toga, svaku bočicu treba nagnuti i lagano kotrljati tijekom 15-20 sekundi da bi se olakšao proces otapanja.
English: a) The number of vials to be used should be calculated based on the individual patient's weight.
Croatian: a) Broj bočica koje će biti upotrijebljene treba izračunati na temelju tjelesne težine pojedinog bolesnika.
English: While under treatment with Lamzede, you may experience some of the following reactions:
Croatian: Dok se liječite lijekom Lamzede, možete imati neke od sljedećih reakcija:
English: Contents of the pack and other information What Lamzede contains
Croatian: Sadržaj pakiranja i druge informacije Što Lamzede sadrži
English: Filter needles must not be used during preparation.
Croatian: Tijekom pripreme se ne smiju koristiti igle s filtrom.
English: Loss of consciousness
Croatian: Gubitak svijesti
English: Rentschler Biopharma SE Erwin-Rentschler-Strasse 21 88471 Laupheim Germany
Croatian: Rentschler Biopharma SE Erwin-Rentschler-Strasse 21 88471 Laupheim
English: Only the volume corresponding to the recommended dose should be administered.
Croatian: Treba se primijeniti samo volumen koji odgovara preporučenoj dozi.
English: As no patients older than 41 years have been identified across Europe, no relevant use in elderly patients is expected.
Croatian: Budući da u Europi nema identificiranih bolesnika starijih od 41 godinu, ne očekuje se relevantna primjena u starijih bolesnika.
English: Pre-treatment with antihistamines and/or corticosteroids may prevent subsequent reactions in those cases where symptomatic treatment was required.
Croatian: Premedikacija antihistaminicima i/ili kortikosteroidima može spriječiti kasnije reakcije u onim slučajevima u kojima je bilo potrebno simptomatsko liječenje.
English: When this enzyme is missing or does not work properly, these sugar compounds build up inside cells and cause the signs and symptoms of the disease.
Croatian: Kada taj enzim nedostaje ili ne radi pravilno, ova se vrsta šećera nakuplja u stanicama i uzrokuje znakove i simptome bolesti.
English: In patients over 18 years old a stabilisation has been demonstrated.
Croatian: U bolesnika starijih od 18 godina dokazana je stabilizacija.
English: - Most of the time you can still be given Lamzede even if you experience an infusion-related reaction.
Croatian: - Većinu vremena i dalje možete primati Lamzede, čak i ako razvijete reakciju povezanu s infuzijom.
English: The results observed in patients below 18 years of age showed an improvement.
Croatian: Rezultati opaženi u bolesnika mlađih od 18 godina pokazali su poboljšanje.
English: Dose (mL)
Croatian: Doza (ml)
English: Lamzede may be given to children and adolescents at the same dose and frequency as in adults.
Croatian: Lamzede se može davati djeci i adolescentima u istoj dozi i jednakom učestalošću kao i u odraslih.
English: Talk to your doctor before Lamzede is used.
Croatian: Obratite se svom liječniku prije nego primijenite Lamzede.
English: All were mild or moderate in severity and none were reported as a serious adverse event.
Croatian: Sve su bile blage do umjerene težine i nijedna nije bila zabilježena kao ozbiljan štetni događaj.
English: What Lamzede is and what it is used for
Croatian: Što je Lamzede i za što se koristi
English: Placebo 12 months
Croatian: Placebo 12 mjeseci
English: Lamzede should be used during pregnancy only when medically necessary.
Croatian: Lamzede se treba primjenjivati tijekom trudnoće samo kad je to medicinski neophodno.
English: Patients were diagnosed based on alpha-mannosidase activity <10% of normal activity in blood leukocytes.
Croatian: Dijagnoza je u bolesnika bila postavljena na temelju aktivnosti alfa-manozidaze < 10% normalne aktivnosti u leukocitima u krvi.
English: These reactions were non-serious and mild to moderate in intensity.
Croatian: Te reakcije nisu bile ozbiljne i bile su blagog do umjerenog intenziteta.
English: Reflux gastritis
Croatian: refluksni gastritis
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na trudnoću, embrionalni/fetalni razvoj, okot ili postnatalni razvoj (vidjeti dio 5.3).
English: (<1/10,000) or not known (cannot be estimated from the available data).
Croatian: (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) ili nepoznato (ne može se procijeniti iz dostupnih podataka).
English: No clinical data are available in children below the age of 6 years.
Croatian: Nema dostupnih kliničkih podataka u djece mlađe od 6 godina.
English: The vial should not be inverted, swirled, or shaken.
Croatian: Bočicu se ne smije preokretati, mućkati ili tresti.
English: Store and transport refrigerated (2°C - 8°C).
Croatian: Čuvati i prevoziti na hladnom (2°C - 8°C).
English: From the total reconstituted volume, only 22 mL (corresponding to 44 mg) should be administered.
Croatian: Od ukupnog rekonstituiranog volumena treba primijeniti samo 22 ml (što odgovara 44 mg).
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije proceduralna glavobolja
English: Lamzede has no or negligible influence on the ability to drive and use machines.
Croatian: Lamzede ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Patients with the most severe rapidly progressing phenotype (with a deterioration within one year and central nervous system involvement) were excluded.
Croatian: Bolesnici s najtežim, brzo progresivnim fenotipom (uz pogoršanje unutar jedne godine i zahvaćenost središnjeg živčanog sustava) bili su isključeni.
English: Paediatric population No dose adjustment is necessary for the paediatric population.
Croatian: Pedijatrijska populacija Nije potrebna prilagodba doze u pedijatrijske populacije.
English: Functional
Croatian: Funkcionalna
English: Elderly No data are available and no relevant use in elderly patients is described.
Croatian: Starije osobe Nema dostupnih podataka i nije opisana relevantna primjena u starijih bolesnika.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, juvenile toxicity and toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, juvenilne toksičnosti te reproduktivne i razvojne toksičnosti.
English: All of these adverse reactions were non-serious.
Croatian: Nijedna od ovih nuspojava nije bila ozbiljna.