FrancophonIA/ELRC3.0 huggingface dataset:
English: No hepatitis B reinfection was reported and no patient was tested HBsAg positive during the treatment period of 48 weeks.
Croatian: Tijekom razdoblja liječenja od 48 tjedana nije prijavljena nijedna ponovna infekcija hepatitisom B te nijedan ispitanik nije imao pozitivne rezultate ispitivanja HBsAg-a.
English: The dose can be individually established and adapted from 500 IU up to 1,000 IU (in exceptional cases up to 1,500 IU) subcutaneous injections on a weekly or fortnightly basis, according to the serum antiHBs concentrations and at the discretion of the physician in charge.
Croatian: Doza lijeka može se odrediti za pojedinog bolesnika i prilagoditi od 500 IU do 1000 IU (u iznimnim slučajevima i do 1500 IU) u supkutanim injekcijama koje se, u skladu s koncentracijama anti-HBs-a u serumu i prema procjeni nadležnog liječnika, daju jednom tjedno ili jednom u dva tjedna.
English: What Zutectra is used for
Croatian: Za što se Zutectra koristi
English: Biotest Austria GmbH Einsiedlergasse 58
Croatian: Österreich Biotest Austria GmbH
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
English: Local reactions at injection sites Swelling, soreness, redness, induration, local heat, itching, bruising and rash.
Croatian: Reakcije na mjestu ubrizgavanja: oticanje, bol, crvenilo, otvrdnjavanje kože, lokalna toplina, svrbež, masnice i osip.
English: 6.6 Special precautions for disposal and other handling This medicinal product should be brought to room temperature (approx. 23°C-27°C) before use.
Croatian: Ovaj lijek treba ostaviti da postigne sobnu temperaturu (oko 23 °C - 27 °C) prije uporabe.
English: With normal immunoglobulins adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.
Croatian: omaglica, vrućica, povraćanje, alergijske reakcije, mučnina, artralgija, nizak krvni tlak i umjerena bol u donjem dijelu leđa.
English: 5.1 Pharmacodynamic properties
Croatian: FARMAKOLOŠKA SVOJSTVA 5.1 Farmakodinamička svojstva
English: Antibody levels >100 IU/l should be maintained in HBsAg and HBV-DNA negative patients.
Croatian: U HBsAg i HBV-DNA negativnih bolesnika moraju se održavati razine antitijela > 100 IU/l.
English: The solution must be brought to room temperature before use.
Croatian: Otopina prije uporabe mora postići sobnu temperaturu.
English: One pre-filled syringe of 1 ml contains Human hepatitis B immunoglobulin 500 IU.
Croatian: Jedna napunjena štrcaljka od 1 ml sadrži 500 IU ljudskog imunoglobulina protiv hepatitisa B.
English: How to store Zutectra
Croatian: Kako čuvati lijek Zutectra
English: 5 pre-filled syringes
Croatian: Otopina za injekciju 5 napunjenih štrcaljki
English: Most adverse drug reactions (ADRs) were mild to moderate in nature.
Croatian: Većina nuspojava na lijek bile su blage do umjerene naravi.
English: The patient or caregiver will be instructed in injection techniques, the keeping of a treatment diary and measures to be taken in case of severe adverse events.
Croatian: vođenju dnevnika liječenja i mjerama koje treba poduzeti u slučaju teških nuspojava.
English: Precautions to be taken before handling or administering the medicinal product Injection of the medicinal product by the patient or by caregiver in a home treatment requires training by a physician experienced in the guidance of patients for home treatment.
Croatian: Ako lijek injicira sam bolesnik ili njegovatelj kod kuće, te osobe dodatno mora obučiti liječnik koji ima iskustva s bolesnicima u kućnoj njezi.
English: EXP The solution should be administered immediately after opening the syringe.
Croatian: Otopinu treba primijeniti odmah nakon otvaranja štrcaljke.
English: There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
Croatian: B19 s imunoglobulinima, a pretpostavlja se i da sadržaj antitijela znatno pridonosi sigurnosti od virusa.
English: It is much easier for someone else to use this site if you do need help.
Croatian: Ako Vam je potrebna pomoć, bit će puno lakše da Vam na tom mjestu lijek primjeni druga osoba.
English: In particular, patients naive to human normal immunoglobulin, patients switched from an alternative product or when there has been a long interval since the previous injection should be monitored during the first injection and for the first hour after the first injection, in order to detect potential adverse signs.
Croatian: Tijekom davanja prve injekcije i u prvom satu nakon prve injekcije posebno se moraju pratiti bolesnici koji prije nisu primali ljudski normalni imunoglobulin, bolesnici koji se prebacuju sa zamjenskog lijeka ili oni u kojih je od prethodne injekcije prošlo dulje razdoblje, radi uočavanja mogućih znakova nuspojava.
English: * single case reports Adverse reactions observed with other human immunoglobulin preparations
Croatian: Nuspojave uočene kod drugih pripravaka ljudskog imunoglobulina
English: Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure.
Croatian: Prevencija ponovne infekcije virusom hepatitisa B (HBV) u HBsAg i HBV-DNA negativnih odraslih bolesnika najranije tjedan dana nakon transplantacije jetre zbog zatajenja jetre uzrokovanog hepatitisom B. Potrebno je potvrditi HBV-DNA negativan status unutar zadnja tri mjeseca prije ortotopne transplantacije jetre.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Biotest Pharma GmbH
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Biotest Pharma GmbH
English: The active substance is human hepatitis B immunoglobulin 500 IU/ml.
Croatian: Djelatna tvar je ljudski imunoglobulin protiv hepatitisa B 500 IU/ml.
English: Triq ir-Russett MT-Kappara SGN 4432 Tel: + 356 27 386221
Croatian: Triq ir-Russett MT-Kappara SGN 4432
English: 49 patients received subcutaneous injections of Zutectra of 500 IU (1 mL) or 1,000 IU (2 mL) (dose adaptation in exceptional cases up to 1,500 IU) per week or fortnightly according to serum anti-HBs trough levels.
Croatian: 500 IU (1 ml) ili 1000 IU (2 ml) (u iznimnim slučajevima doza se može prilagoditi na do 1500 IU) tjedno ili svaka dva tjedna u skladu s najnižim razinama anti-HBs-a u serumu.
English: If you get any side effects, talk to your doctor, healthcare professional or pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, zdravstvenog djelatnika ili ljekarnika.
English: NAME OF THE MEDICINAL PRODUCT Zutectra 500 IU solution for injection in pre-filled syringe
Croatian: Zutectra 500 IU otopina za injekciju u napunjenoj štrcaljki
English: Biotest Pharma GmbH Landsteinerstrasse 5 D-63303 Dreieich Germany
Croatian: Biotest AG Landsteinerstrasse 5 D-63303 Dreieich
English: Furthermore the following reactions have been reported once only: tiredness (fatigue) high blood pressure (hypertension) inflammation of the nose and throat (nasopharyngitis) muscle spasm allergic reactions (hypersensitivity) abnormal heartbeat (palpitations), cardiac discomfort itching (pruritus), rash pain in the mouth and throat
Croatian: mišićni grčevi alergijske reakcije (preosjetljivost) neuobičajeni otkucaji srca (palpitacije), nelagoda u prsnom košu svrbež (pruritus), osip bol u ustima i grlu
English: Zutectra is for subcutaneous (under the skin) injection only.
Croatian: Zutectra se primjenjuje samo potkožnom injekcijom.
English: Reporting of side effects
Croatian: * prijave pojedinačnih slučajeva
English: D-63303 Dreieich Tél/Tel: + 49 6103 801-0
Croatian: Tél/Tel: + 49 6103 801-0
English: The solution should be administered immediately after opening the syringe.
Croatian: Otopinu je potrebno primijeniti odmah nakon otvaranja štrcaljke.
English: Compliance according to anti-HBs serum levels could be shown for 57 (of 61) patients (93%), with no values below 100 IU/l and a mean anti-HBs serum level of 254.3 IU/l at the final visit.
Croatian: Prema razini anti-HBs-a u serumu suradljivost se može dokazati za 57 (od 61) bolesnika (93%) koji nisu imali vrijednosti ispod
English: Zutectra 500 IU solution for injection in pre-filled syringe Human hepatitis B immunoglobulin
Croatian: Zutectra 500 IU otopina za injekciju u napunjenoj štrcaljki ljudski imunoglobulin protiv hepatitisa B
English: The colour of the solution can vary from clear to pale yellow up to light brown.
Croatian: Boja otopine može biti od bezbojne preko svijetložute do svijetlosmeđe.
English: SE-102 34 Stockholm Puh/Tel: + 46 10 130 99 80
Croatian: Puh/Tel: + 46 10 130 99 80
English: ES-08960 Sant Just Desvern Barcelona Tel: + 34 935 952 661
Croatian: ES-08960 Sant Just Desvern
English: How to use Zutectra
Croatian: Kako primjenjivati lijek Zutectra
English: What Zutectra is and what it is used for What you need to know before you use Zutectra How to use Zutectra
Croatian: Što je Zutectra i za što se koristi Što je Zutectra
English: Wipe the intended area with an alcohol swab.
Croatian: Obrišite mjesto davanja lijeka gazom natopljenom alkoholom.
English: SE-102 34 Stockholm Tlf:+ 46 10 130 99 80
Croatian: Tlf:+ 46 10 130 99 80
English: Musculosceletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva mišićni spazmi rijetko*
English: The open, prospective, single-arm clinical trial enrolled 23 liver transplant recipients, who had been receiving intravenous hepatitis B immunoglobulin prophylaxis and subsequently switched to subcutaneous Zutectra.
Croatian: primatelja transplantirane jetre koji su profilaktički dobivali intravenski imunoglobulin protiv hepatitisa B i nakon toga su prebačeni na supkutanu primjenu lijeka Zutectra.
English: Immunoglobulins like Zutectra have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.
Croatian: A ili parvovirusom B19 zbog zaštite antitijelima protiv tih infekcija koje sadrži lijek.
English: 61A Drumul Plaiul Sarului Street, Room 5 013982 Bucharest, District 1 - RO Tel: + 40 743 207 205
Croatian: 013982 Bucharest, District 1 - RO
English: You will be carefully observed during and shortly after the 1st injection with Zutectra to make sure that you do not suffer from a reaction.
Croatian: Tijekom primanja prve injekcije lijeka Zutectra i odmah nakon toga bit ćete pod pažljivim nadzorom zbog moguće reakcije.
English: Tel.: +49 6103 801-0 Fax: +49 6103 801-150 Email: mail@biotest.com
Croatian: Tel.: + 49 6103 801-0 Fax: + 49 6103 801-150
English: Headache
Croatian: Nuspojave
English: It may be helpful to keep a record of where you had the last injection to avoid problems.
Croatian: Kako biste izbjegli probleme, korisno je bilježiti mjesta injiciranja.
English: If you use more Zutectra than you should
Croatian: Ako primijenite više lijeka Zutectra nego što ste trebali Posljedice predoziranja nisu poznate.
English: Muscle spams
Croatian: A ili parvovirusa
English: Tel.: + 49 6103 801-0 Fax: + 49 6103 801-150 Email: mail@biotest.com
Croatian: Tel.: +49 6103 801-0 Faks: +49 6103 801-150
English: The solution can vary from colourless to pale yellow up to light brown.
Croatian: Otopina može varirati od bezbojne preko blijedožute do svijetlosmeđe.
English: If you notice any of the following effects stop the injection and tell your doctor immediately: rash, itching, wheezing, difficulty in breathing, swelling of the eyelids, face, lips, throat or tongue, low blood pressure, fast pulse
Croatian: oticanje kapaka, lica, usnica, grla ili jezika, nizak krvni tlak, brz puls
English: Please tell your doctor about your treatment with Zutectra prior to any vaccination.
Croatian: Prije bilo kakvog cijepljenja obavijestite liječnika o tome da uzimate lijek Zutectra.
English: Glycine
Croatian: Hrvatska
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja orofaringealna bol rijetko*
English: Live attenuated virus vaccines
Croatian: NAČIN PRIMJENE LIJEKA Potkožno
English: NAME OF THE MEDICINAL PRODUCT Zutectra 500 IU solution for injection in pre-filled syringe Human hepatitis B immunoglobulin
Croatian: Uputa o lijeku: Informacije za korisnika Zutectra 500 IU otopina za injekciju u napunjenoj štrcaljki ljudski imunoglobulin protiv hepatitisa B
English: Please tell your doctor about your treatment with Zutectra prior to any blood test.
Croatian: Prije bilo kakvih krvnih pretraga obavijestite liječnika o tome da uzimate lijek Zutectra.
English: The non-interventional post authorization safety study (PASS 978) enrolled 61 adult patients ≥ 6 months after liver transplantation for hepatitis B induced liver failure.
Croatian: Neintervencijsko ispitivanje sigurnosti primjene nakon dobivanja odobrenja lijeka (PASS 978, eng.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Croatian: Lijek se izdaje na recept.
English: PL-01-793 Warszawa Tel.: + 48 22 8322638
Croatian: Tel.: + 48 22 8322638
English: Injection site reactions like pain, urticaria at injection site, haematoma and erythema
Croatian: Opći poremećaji i reakcije na mjestu primjene reakcije na mjestu injiciranja, poput boli, urtikarija na mjestu injiciranja, hematom i eritem često umor, zamaranje rijetko*
English: België/Belgique/Belgien Infarama BVBA Stationsstraat 27
Croatian: België/Belgique/Belgien
English: Hypertension
Croatian: Cijepljenja
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection
Croatian: NAZIV LIJEKA I PUTEVI PRIMJENE LIJEKA
English: Oropharyngeal pain
Croatian: cm oko pupka.
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava glavobolja manje često
English: EXP
Croatian: osip,
English: NAME OF THE MEDICINAL PRODUCT Zutectra 500 IU injection Human hepatitis B immunoglobulin Subcutaneous use
Croatian: Zutectra 500 IU injekcija ljudski imunoglobulin protiv hepatitisa B
English: INFORMATION IN BRAILLE Zutectra 500 IU
Croatian: Zutectra 500 IU
English: Zutectra is supplied in a pack size containing 5 pre-filled syringes each in a blister pack.
Croatian: Zutectra se isporučuje u pakiranju od 5
English: Contents of the pack and other information How to inject Zutectra by yourself or by caregiver
Croatian: Sadržaj pakiranja i druge informacije Što Zutectra sadrži
English: SE-102 34 Stockholm Tel: + 46 10 130 99 80
Croatian: Tel: + 46 10 130 99 80
English: Posology
Croatian: Serija
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava preosjetljivost rijetko*
English: Official batch release
Croatian: Službeno puštanje serije lijeka u promet
English: The withdrawal letter is available here.
Croatian: Dopis o povlačenju dostupan je ovdje.
English: What is Arikayce?
Croatian: Što je Arikayce?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 June 2016
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24. lipnja 2016.
English: It was to be available as a suspension for inhalation.
Croatian: Trebao je biti dostupan kao suspenzija za inhalaciju.
English: What was the recommendation of the CHMP at that time?
Croatian: Koja je bila preporuka CHMP-a u tom trenutku?
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is treating you.
Croatian: Ako sudjelujete u kliničkom ispitivanju te vam je potrebno više informacija o svom liječenju, obratite se liječniku koji vas liječi.
English: What consequences does this withdrawal have for patients in clinical trials?
Croatian: Koje su posljedice ovog povlačenja za bolesnike u kliničkim ispitivanjima?
English: It was to be used in patients whose infection has persisted despite previous treatment.
Croatian: Trebao se upotrebljavati u bolesnika čija se infekcija nastavila unatoč prethodnom liječenju.
English: These liposomes help reduce the rate at which the active substance is broken down, allowing it to remain in the body for longer.
Croatian: Ti liposomi pomažu pri smanjivanju brzine razgradnje djelatne tvari, zbog čega se ona dulje zadržava u tijelu.
English: Because the medicine is breathed in, it also reaches the lungs more directly than amikacin given by injection.
Croatian: Osim toga, s obzirom na to da se lijek udiše, on dolazi do pluća izravnije nego amikacin koji se daje injekcijom.
English: On 8 June 2016, Insmed Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Arikayce intended for the treatment of Mycobacterium avium complex (MAC) lung disease.
Croatian: Dana 8. lipnja 2016. tvrtka Insmed Limited službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Arikayce namijenjenog za liječenje bolesti pluća Mycobacterium avium kompleks (MAK).
English: What was Arikayce expected to be used for?
Croatian: Za što se Arikayce trebao koristiti?
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Croatian: Zahtjev je povučen nakon što je CHMP ocijenio dokumentaciju koju je tvrtka dostavila i sastavio popis pitanja.
English: After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Croatian: Nakon što je CHMP ocijenio odgovore tvrtke na posljednji popis pitanja, još su postojale neke nedoumice.
English: How is Arikayce expected to work?
Croatian: Kako je Arikayce trebao djelovati?
English: Arikayce is an antibiotic containing the active substance amikacin.
Croatian: Arikayce je antibiotik koji sadrži djelatnu tvar amikacin.
English: In its letter notifying the Agency of the withdrawal, the company stated that its decision is based on the understanding that CHMP was not going to recommend approval of the medicine on the basis of current data.
Croatian: U dopisu kojim obavještava Agenciju o povlačenju tvrtka je navela da je odluka o povlačenju utemeljena na prihvaćanju činjenice da CHMP neće preporučiti odobrenje lijeka na temelju postojećih podataka.
English: The company submitted results of an early (phase 2) study in 89 adult patients with lung infections caused by MAC or similar bacteria.
Croatian: Tvrtka je dostavila rezultate ranog ispitivanja (2. faza) u 89 odraslih bolesnika s infekcijom pluća kojoj je uzročnik bio MAK ili slična bakterija.
English: Withdrawal of the marketing authorisation application for Arikayce (amikacin)
Croatian: Povlačenje zahtjeva za davanje odobrenja za stavljanje u promet lijeka Arikayce (amikacin)
English: What were the reasons given by the company for withdrawing the application?
Croatian: Koje je razloge za povlačenje zahtjeva navela tvrtka?
English: The Committee's main concern was that the study submitted in the application did not provide enough evidence that Arikayce can permanently clear the bacteria from patients' sputum.
Croatian: Glavna zabrinutost Odbora bila je da ispitivanje podneseno sa zahtjevom nije pružilo dostatne dokaze da lijek Arikayce može trajno ukloniti bakterije iz sputuma bolesnika.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials for Arikayce.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja u kojima se koristi lijek Arikayce.
English: How far into the evaluation was the application when it was withdrawn?
Croatian: U kojoj je fazi bila ocjena zahtjeva kada je povučen?
English: This study compared Arikayce with placebo (a dummy treatment) and looked mainly at how effectively the medicine cleared bacteria from patients' sputum (phlegm) after about 3 months of treatment.
Croatian: U tom je ispitivanju lijek Arikayce uspoređen s placebom (prividno liječenje), a uglavnom se istraživala učinkovitost lijeka u uklanjanju bakterija iz sputuma (ispljuvka) bolesnika nakon tri mjeseca liječenja.
English: Arikayce was expected to be used to treat adults with a lung infection caused by Mycobacterium avium complex (MAC), a group of bacteria commonly found in the environment, such as in soil and water.
Croatian: Lijek Arikayce trebao se koristiti za liječenje odraslih osoba s infekcijom pluća kojoj je uzročnik Mycobacterium avium kompleks (MAK), skupina bakterija koja se najčešće nalazi u okolišu, primjerice u tlu i vodi.
English: In this medicine, amikacin is contained within microscopic fat capsules known as liposomes.
Croatian: Amikacin se u ovom lijeku nalazi u mikroskopskim mjehurićima masti koji se nazivaju liposomi.
English: Further information on the orphan designation can be found here.
Croatian: Dodatne informacije o odobrenjima za lijekove za rijetke bolesti možete pronaći ovdje.
English: What did the company present to support its application?
Croatian: Što je tvrtka dostavila u prilog zahtjevu?
English: Arikayce was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 8 April 2014 for treating infections caused by MAC and similar bacteria.
Croatian: Lijek Arikayce bio je označen kao lijek za liječenje rijetkih bolesti dana 8. travnja 2014. za liječenje infekcija uzrokovanih MAK-om i sličnim bakterijama.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Arikayce did not outweigh its risks.
Croatian: U skladu s navedenim, CHMP je u vrijeme povlačenja smatrao kako koristi od lijeka Arikayce ne nadmašuju s njim povezane rizike.
English: Based on the review of the data and the company's response to the CHMP lists of questions, the CHMP was of the provisional opinion that Arikayce could not be approved for the treatment of MAC lung infection.
Croatian: Na temelju pregleda podataka i odgovora tvrtke na popise pitanja CHMP-a, u trenutku povlačenja privremeno mišljenje CHMP-a bilo je da nije moguće dati odobrenje za lijek Arikayce za liječenje infekcije pluća kojoj je uzročnik MAK.
English: The active substance in Arikayce, amikacin, is a well-established antibiotic of the group ‘aminoglycosides' that works by disrupting bacterial production of vital proteins.
Croatian: Djelatna tvar u lijeku Arikayce, amikacin, poznati je antibiotik koji pripada skupini „aminoglikozoida”, a djeluje tako da ometa bakterije u stvaranju vitalnih bjelančevina.
English: Withdrawal of the marketing authorisation application for Arikayce (amikacin) EMA/430267/2016
Croatian: (amikacin) EMA/430267/2016
English: It may harm them,
Croatian: NAVOĐENJE DJELATNE(IH) TVARI
English: No special requirements.
Croatian: Nema posebnih zahtjeva.
English: 8501 Novo mesto Slovenia
Croatian: 8501 Novo mesto Slovenija
English: The clinical relevance of these differences is unknown.
Croatian: Klinička važnost tih razlika nije poznata.
English: • Risk management plan (RMP)
Croatian: • Plan upravljanja rizikom (RMP)
English: FBAL is a metabolite without antiproliferative activity.
Croatian: FBAL je metabolit koji nema antiproliferativnu aktivnost.
English: - Vomiting: if you vomit more than once in a 24-hour time period.
Croatian: - povraćanje: ako povratite više od jednom u 24 sata.
English: Median survival was 384 and 373 days.
Croatian: Medijan preživljenja iznosio je 384 i 373 dana.
English: Do not store above 30°C.
Croatian: Ne čuvati na temperaturi iznad 30C.
English: This is extremely important, as taking more than one medicine at the same time can strengthen or weaken the effect of the medicines.
Croatian: To je vrlo važno jer istovremeno uzimanje više lijekova može pojačati ili oslabiti njihov učinak.
English: The consequences of a reduced dose for efficacy are currently uncertain.
Croatian: Posljedice smanjene doze na djelotvornost trenutno nisu jasne.
English: - Take the tablets morning and evening as prescribed by your doctor.
Croatian: - Tablete uzimajte ujutro i navečer, kako Vam je propisao liječnik.
English: OTHER SPECIAL WARNING (S), IF NECESSARY
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO