FrancophonIA/ELRC3.0 huggingface dataset:
English: TESAVEL 100 mg tablets Sitagliptin
Croatian: TESAVEL 100 mg tablete sitagliptin
English: EU/1/07/435/007 EU/1/07/435/008 EU/1/07/435/009 EU/1/07/435/010 EU/1/07/435/011 EU/1/07/435/012 EU/1/07/435/021 EU/1/07/435/022
Croatian: EU/1/07/435/009 EU/1/07/435/010 EU/1/07/435/011 EU/1/07/435/012 EU/1/07/435/021 EU/1/07/435/022
English: TESAVEL 50 mg tablets Sitagliptin
Croatian: TESAVEL 50 mg tablete sitagliptin
English: The Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) included 7,332 patients treated with sitagliptin, 100 mg daily (or 50 mg daily if the baseline eGFR was ≥ 30 and < 50 mL/min/1.73 m2), and 7,339 patients treated with placebo in the intention-to-treat population.
Croatian: Trial Evaluating Cardiovascular Outcomes with Sitagliptin, TECOS) uključivalo je 7332 bolesnika liječena sitagliptinom u dozi od 100 mg na dan (ili 50 mg na dan ako je početni eGFR bio ≥ 30 i < 50 ml/min/1,73 m2) i 7339 bolesnika koji su primali placebo u populaciji predviđenoj za liječenje.
English: EU/1/07/435/013 14 film-coated tablets EU/1/07/435/014 28 film-coated tablets EU/1/07/435/023 30 film-coated tablets EU/1/07/435/015 56 film-coated tablets EU/1/07/435/016 84 film-coated tablets EU/1/07/435/024 90 film-coated tablets EU/1/07/435/017 98 film-coated tablets EU/1/07/435/018 50 x 1 film-coated tablets
Croatian: EU/1/07/435/013 14 filmom obloženih tableta EU/1/07/435/014 28 filmom obloženih tableta EU/1/07/435/023 30 filmom obloženih tableta EU/1/07/435/015 56 filmom obloženih tableta EU/1/07/435/016 84 filmom obloženih tableta EU/1/07/435/024 90 filmom obloženih tableta EU/1/07/435/017 98 filmom obloženih tableta EU/1/07/435/018 50 x 1 filmom obložena tableta
English: To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with GFR < 45 mL/min, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis.
Croatian: Kako bi se postigle koncentracije sitagliptina u plazmi slične onima u bolesnika s normalnom funkcijom bubrega, preporučuju se niže doze u bolesnika s GFR-om < 45 ml/min, kao i u bolesnika u završnoj fazi bubrežne bolesti kojima je potrebna hemodijaliza ili peritonealna dijaliza (vidjeti dio 4.2 i 5.2).
English: EU/1/07/435/007 14 film-coated tablets EU/1/07/435/008 28 film-coated tablets EU/1/07/435/021 30 film-coated tablets EU/1/07/435/009 56 film-coated tablets EU/1/07/435/010 84 film-coated tablets EU/1/07/435/022 90 film-coated tablets EU/1/07/435/011 98 film-coated tablets EU/1/07/435/012 50 x 1 film-coated tablets
Croatian: EU/1/07/435/007 14 filmom obloženih tableta EU/1/07/435/008 28 filmom obloženih tableta EU/1/07/435/021 30 filmom obloženih tableta EU/1/07/435/009 56 filmom obloženih tableta EU/1/07/435/010 84 filmom obloženih tableta EU/1/07/435/022 90 filmom obloženih tableta EU/1/07/435/011 98 filmom obloženih tableta EU/1/07/435/012 50 x 1 filmom obložena tableta
English: The TECOS was a randomised study in 14,671 patients in the intention-to-treat population with an HbA1c of ≥ 6.5 to 8.0 % with established CV disease who received sitagliptin (7,332) 100 mg daily (or 50 mg daily if the baseline eGFR was ≥ 30 and < 50 mL/min/1.73 m2) or placebo (7,339) added to usual care targeting regional standards for HbA1c and CV risk factors.
Croatian: Ispitivanje TECOS bilo je randomizirano ispitivanje provedeno u 14 671 bolesnika, koji pripadaju populaciji za koju je namijenjeno liječenje, s vrijednostima HbA1c od ≥ 6,5 do 8,0% i potvrđenom KV bolesti te su primali sitagliptin (7332) u dozi od 100 mg na dan (ili 50 mg na dan ako je početni eGFR bio ≥ 30 i < 50 ml/min/1,73 m2) ili placebo (7339) kao dodatak standardnom liječenju usmjerenom na regionalne standardne vrijednosti HbA1c i faktore KV rizika.
English: EU/1/07/435/001 14 film-coated tablets EU/1/07/435/002 28 film-coated tablets EU/1/07/435/019 30 film-coated tablets EU/1/07/435/003 56 film-coated tablets EU/1/07/435/004 84 film-coated tablets EU/1/07/435/020 90 film-coated tablets EU/1/07/435/005 98 film-coated tablets EU/1/07/435/006 50 x 1 film-coated tablets
Croatian: EU/1/07/435/001 14 filmom obloženih tableta EU/1/07/435/002 28 filmom obloženih tableta EU/1/07/435/019 30 filmom obloženih tableta EU/1/07/435/003 56 filmom obloženih tableta EU/1/07/435/004 84 filmom obloženih tableta EU/1/07/435/020 90 filmom obloženih tableta EU/1/07/435/005 98 filmom obloženih tableta EU/1/07/435/006 50 x 1 filmom obložena tableta
English: TESAVEL 25 mg film-coated tablets
Croatian: TESAVEL 25 mg filmom obložene tablete
English: TESAVEL 100 mg film-coated tablets
Croatian: TESAVEL 100 mg filmom obložene tablete
English: TESAVEL 25 mg film-coated tablets Sitagliptin
Croatian: TESAVEL 25 mg filmom obložene tablete sitagliptin
English: TESAVEL 50 mg film-coated tablets
Croatian: TESAVEL 50 mg filmom obložene tablete
English: TESAVEL 100 mg film-coated tablets Sitagliptin
Croatian: TESAVEL 100 mg filmom obložene tablete sitagliptin
English: TESAVEL 50 mg film-coated tablets Sitagliptin
Croatian: TESAVEL 50 mg filmom obložene tablete sitagliptin
English: - If you get any side effects gets talk to your doctor, pharmacist, or nurse.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: 23 times the clinical exposure level.
Croatian: 800 mg u kliničkim ispitivanjima.
English: 12 vials + 72 injection syringes + 72 injection needles +
Croatian: + 72 štrcaljke za injekciju +
English: 1 vial + 1 injection syringe + 1 injection needle + 1 cleansing swab vial (glass) 3.0 mL (6 million IU/mL) 1 vial vial (glass) 3.0 mL (6 million IU/mL) 1 vial + 6 injection syringes + 6 injection needles + 12 cleansing swabs vial (glass) 3.0 mL (6 million IU/mL) 2 vials vial (glass) 3.0 mL (6 million IU/mL) 12 vials
Croatian: Veličina pakovanja bočica (staklo) 3,0 ml (6 milijuna IU/ml) 2 bočice bočica (staklo) 2,5 ml (10 milijuna IU/ml) 2 bočice bočica (staklo) 3,0 ml (6 milijuna IU/ml) 2 bočice + 12 štrcaljki za injekciju + 12 igala za injekciju + 24 tupfera za čišćenje bočica (staklo) 3,0 ml (6 milijuna IU/ml) 12 bočica
English: 12 vials + 72 injection syringes with attached needle and needle protection device + 144 cleansing swabs
Croatian: + 72 štrcaljke za injekciju s pričvršćenom iglom i uređajem za zaštitu igle + 144 tupfera za čišćenje bočica (staklo) 2,5 ml (10 milijuna IU/ml) 1 bočica + 6 štrcaljki za injekciju s pričvršćenom iglom
English: 12 vials vial (glass) 3.0 mL (6 million IU/mL) 12 vials + 72 injection syringes + 72 injection needles +
Croatian: bočica (staklo) 2,5 ml (10 milijuna IU/ml) 2 bočice + 12 štrcaljki za injekciju + 12 igala za injekciju + 24 tupfera za čišćenje bočica (staklo) 2,5 ml (10 milijuna IU/ml) 12 bočica + 72 štrcaljke za injekciju +
English: 12 vials + 72 injection syringes with attached needle + 144 cleansing swabs
Croatian: + 72 štrcaljke za injekciju s pričvršćenom iglom
English: vial (glass) 3.0 mL (6 million IU/mL) 2 vials + 12 injection syringes with attached needle and needle protection device +
Croatian: bočica (staklo) 2,5 ml (10 milijuna IU/ml) 2 bočice + 12 štrcaljki za injekciju s pričvršćenom iglom
English: vial (glass) 3.0 mL (6 million IU/mL) 1 vial + 6 injection syringes with attached needle and needle protection device +
Croatian: bočica (staklo) 3,0 ml (6 milijuna IU/ml) 1 bočica + 6 štrcaljki za injekciju s pričvršćenom iglom i uređajem za zaštitu igle + 12 tupfera za čišćenje bočica (staklo) 3,0 ml (6 milijuna IU/ml) 2 bočice + 12 štrcaljki za injekciju s pričvršćenom iglom i uređajem za zaštitu igle + 24 tupfera za čišćenje bočica (staklo) 3,0 ml (6 milijuna IU/ml) 12 bočica
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)* , inactivated, of the following strains: A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Idaho/07/2018) 15 micrograms HA** A/Kansas/14/2017 (H3N2) - like strain (A/Indiana/08/2018) 15 micrograms HA** B/Colorado/06/2017 - like strain (B/Iowa/06/2017) 15 micrograms HA** B/Phuket/3073/2013 - like strain (B/Singapore/INFTT-16-0610/2016) 15 micrograms HA**
Croatian: Jedna doza od 0,5 ml sadrži: soju A/Brisbane/02/2018 (H1N1)pdm09 sličan- poput kojeg je korišten soj (A/Idaho/07/2018) 15 mikrograma HA** soju A/Kansas/14/2017 (H3N2) sličan- poput kojeg je korišten soj (A/Indiana/08/2018) 15 mikrograma HA** soju B/Colorado/06/2017 sličan- poput kojeg je korišten soj (B/Iowa/06/2017) 15 mikrograma HA** soju B/Phuket/3073/2013 sličan- poput kojeg je korišten soj (B/Singapore/INFTT-16-0610/2016) 15 mikrograma HA**po dozi od 0,5 ml
English: * propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin
Croatian: Madin Darby Canine Kidney, MDCK) ** hemaglutinin
English: Intramuscular use Pre-filled syringe (glass) without needle
Croatian: Intramuskularno Napunjena štrcaljka (staklo) bez igle
English: Aripiprazole Zentiva aripiprazole
Croatian: Aripiprazole Zentiva aripiprazol
English: Its exact mechanism of action is unknown, but it attaches to several different receptors on the surface of nerve cells in the brain.
Croatian: Njegov točan mehanizam djelovanja nije poznat, ali poznato je da se veže na nekoliko različitih receptora na površini živčanih stanica u mozgu.
English: • schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Croatian: • shizofrenijom, mentalnom bolesti koja se očituje nizom simptoma, uključujući neorganizirano razmišljanje i govor, halucinacije (bolesnici čuju ili vide nešto čega nema), sumnje i iluzije (pogrešna vjerovanja).
English: The orodispersible tablets can be used in patients who have difficulty swallowing tablets.
Croatian: Orodisperzibilne tablete se mogu koristiti u bolesnika koji imaju poteškoća s gutanjem tableta.
English: Aripiprazole Zentiva is available as tablets (5, 10, 15 and 30 mg) and orodispersible tablets (tablets that dissolve in the mouth; 10, 15 and 30 mg).
Croatian: Zentiva je dostupan kao tablete od (5, 10, 15 i 30 mg) i orodisperzivne tablete (tablete koje se otapaju u ustima; 10, 15 i 30 mg).
English: The Committee recommended that Aripiprazole Zentiva be approved for use in the EU.
Croatian: Odbor je preporučio odobrenje lijeka Aripiprazole Zentiva za korištenje u EU-u.
English: This means that aripiprazole acts like dopamine and 5hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters.
Croatian: To znači da aripiprazol djeluje kao dopamin i 5hidroksitriptamin aktivacijom ovih receptora, ali manje snažno od neurotransmitera.
English: • bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood.
Croatian: • bipolarnom poremećaju tipa I, mentalnom bolesti u slučaju koje bolesnici imaju manične epizode (razdoblja abnormalno visokog raspoloženja), koje se izmjenjuju s razdobljima normalnog raspoloženja.
English: Aripiprazole is thought to act mainly by being a ‘partial agonist' for the receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin).
Croatian: Smatra se da aripiprazol djeluje uglavnom kao „parcijalni agonist” za receptore neurotransmitera dopamina i 5hidroksitriptamina (također zvani serotonin).
English: The dose should be adjusted in patients who are taking other medicines that affect the way Aripiprazole Zentiva is broken down in the body.
Croatian: Dozu treba prilagoditi u bolesnika koji uzimaju druge lijekove, koji mogu utjecati na način razgradnje lijeka Aripiprazole Zentiva u tijelu.
English: This means that Aripiprazole Zentiva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify.
Croatian: Zentiva sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Abilify.
English: Aripiprazole Zentiva is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults who have responded to the medicine in the past.
Croatian: Aripiprazole Zentiva se koristi u odraslih osoba za liječenje umjerenih do ozbiljnih maničnih epizoda i za sprječavanje novih maničnih epizoda u odraslih osoba koje su odgovorile na lijek u prošlosti.
English: Aripiprazole Zentiva is used in patients with the following mental illnesses:
Croatian: Aripiprazole Zentiva koristi se u bolesnika sa sljedećim mentalnim bolestima:
English: Other information about Aripiprazole Zentiva
Croatian: Ostale informacije o lijeku Aripiprazole Zentiva
English: A risk management plan has been developed to ensure that Aripiprazole Zentiva is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Aripiprazole Zentiva
English: Aripiprazole Zentiva is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.
Croatian: Aripiprazole Zentiva se također koristi u razdoblju do 12 tjedana za liječenje umjerenih do ozbiljnih maničnih epizoda u bolesnika u dobi od 13 godina i starijih.
English: In addition, the company that markets Aripiprazole Zentiva will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.
Croatian: Zentiva dostavit će edukacijske materijale koji će se uručiti bolesnicima ili njihovim skrbnicima i liječnicima kako bi se pojasnila sigurna primjena lijeka u bolesnika u dobi između 13 i 17 godina.
English: Aripiprazole Zentiva is used in patients aged 15 years or over;
Croatian: Aripiprazole Zentiva se koristi u bolesnika u dobi od 15 godina ili starijih;
English: Because Aripiprazole Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Zentiva generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i kod referentnog lijeka.
English: For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg by mouth once a day, either on its own or in combination with other medicines.
Croatian: Za terapiju maničnih epizoda u slučaju bipolarnog poremećaja, preporučena početna doza u odraslih osoba iznosi 15 mg peroralno jednom na dan, bilo samostalno ili u kombinaciji s drugim lijekovima.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aripiprazole Zentiva on 25 June 2015.
Croatian: Zentiva na snazi u Europskoj uniji od 25. lipnja 2015.
English: For schizophrenia, the recommended starting dose is 10 or 15 mg by mouth per day in adults, followed by a ‘maintenance' dose of 15 mg once a day.
Croatian: U slučaju shizofrenije, preporučena početna doza iznosi 10 ili 15 mg peroralno na dan za odrasle osobe, nakon čega slijedi doza "održavanja" od 15 mg jednom na dan.
English: Because Aripiprazole Zentiva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Abilify.
Croatian: Zentiva generički lijek, ispitivanja na bolesnicima bila su ograničena na ispitivanja za utvrđivanje da je lijek bioekvivalentan referentnom lijeku Abilify.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Zentiva has been shown to have comparable quality and to be bioequivalent to Abilify.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno kako Aripiprazole
English: In patients aged between 15 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Croatian: U bolesnika u dobi između 15 i 17 godina, početna doza iznosi 2 mg na dan (primjenom lijeka koji sadrži aripiprazol dostupnog u tekućem obliku), koji se postepeno povećava do preporučene doze od 10 mg jednom na dan.
English: Aripiprazole Zentiva contains the active substance aripiprazole and is a ‘generic medicine'.
Croatian: Zentiva sadrži djelatnu tvar aripiprazol i "generički je lijek".
English: The active substance in Aripiprazole Zentiva, aripiprazole, is an antipsychotic medicine.
Croatian: Aripiprazol, djelatna tvar u lijeku Aripiprazole Zentiva, je antipsihotik.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Zentiva, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Zentiva nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: For treating manic episodes in patients aged between 13 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Croatian: Za potrebe liječenja maničnih epizoda u bolesnika u dobi između 13 i 17 godina, početna doza iznosi 2 mg na dan (primjenom lijeka koji sadrži aripiprazol dostupnog u tekućem obliku), koji se postepeno povećava do preporučene doze od 10 mg jednom na dan..
English: The full EPAR and risk management plan summary for Aripiprazole Zentiva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Zentiva nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o liječenju lijekom Aripiprazole Zentiva pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Therefore, the CHMP's view was that, as for Abilify, the benefit outweighs the identified risk.
Croatian: Zentiva koristi nadmašuju utvrđene rizike.
English: This is a summary of the European public assessment report (EPAR) for Aripiprazole Zentiva.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Aripiprazole
English: < PC: {number} SN: {number} NN: {number}>
Croatian: < PC: {broj} SN: {broj} NN: {broj} >
English: Date of first authorisation: 14 January 2016
Croatian: Datum prvog odobrenja: 14. siječnja 2016.
English: Additional standard treatment may be required (see section 4.5).
Croatian: Može se zahtijevati dodatno standardno liječenje (vidjeti dio 4.5).
English: Email: info.de@amrytpharma.com
Croatian: E-pošta: info.de@amrytpharma.com
English: Your doctor or nurse will tell you for how long you should use the gel.
Croatian: Vaš liječnik ili medicinska sestra reći će Vam koliko dugo biste trebali primjenjivati gel.
English: 23.4 g
Croatian: Gel. 23,4 g
English: Duration of use
Croatian: Trajanje uporabe
English: The safety and efficacy of Episalvan in children and adolescents under 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost Episalvana u djece i adolescenata u dobi do 18 godina nisu još ustanovljene.
English: Always use this medicine exactly as your doctor or nurse has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako Vam je rekao Vaš liječnik ili medicinska sestra.
English: This makes overdose very unlikely, even if applied to large skin areas and for a long period of time.
Croatian: Stoga je predoziranje vrlo malo vjerojatno, čak i ako se nanosi na velika područja na koži i u duljem vremenskom razdoblju.
English: Discard the tube after first use.
Croatian: Tubu bacite nakon prve uporabe.
English: Warnings and precautions Talk to your doctor or nurse before using Episalvan.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili medicinskoj sestri prije nego primijenite Episalvan.
English: Rash pruritic Purpura
Croatian: Pruritički osip Purpura
English: Do not use Episalvan - if you are allergic to birch bark or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Episalvan - ako ste alergični na brezovu koru ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Pharmacotherapeutic group: Preparation for treatment of wounds and ulcers; ATC code: D03AX13 .
Croatian: Farmakoterapijska skupina: Zdravila za oskrbo ran in razjed; ATK oznaka: D03AX13.
English: 'Very conservative calculation' means that the first observation of wound closure was taken as time of wound closure.
Croatian: „Vrlo konzervativan izračun” znači da je prvo opažanje zatvaranja rane uzeto kao vrijeme zatvaranja rane.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, local tolerance, and phototoxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, lokalne tolerancije i fototoksičnosti.
English: Since no biologically relevant levels of betulin were found in patients, no further studies related to distribution, biotransformation and elimination were performed.
Croatian: Budući da u bolesnika nisu pronađeni biološki relevantne razine betulina, nisu provedena daljnja ispitivanja povezana s distribucijom, biotransformacijom i eliminacijom.
English: Repeated dose toxicity and local tolerance have been studied for up to 4 weeks.
Croatian: Toksičnost ponovljenih doza i lokalna tolerancija ispitivane su do 4 tjedna.
English: Apply Episalvan at the next planned change of the wound dressing, continuing with your normal routine.
Croatian: Nanesite Episalvan kod sljedeće planirane promjene komprese i nastavite s Vašom uobičajenom rutinom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1069/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1069/001
English: Episalvan gel is sterile.
Croatian: Episalvan gel je sterilan.
English: If you have an infection in the wound additional treatment may be required.
Croatian: Ako imate infekciju rane možda će biti potrebno dodatno liječenje.
English: Do not stop using it without consulting your doctor or nurse.
Croatian: Nemojte ga prestati primjenjivati bez savjetovanja sa svojim liječnikom ili medicinskom sestrom.
English: Pregnancy No studies in pregnant women have been conducted.
Croatian: Trudnoća Nisu provedena ispitivanja u trudnica.
English: The single-use tube is packed in a cardboard box.
Croatian: Tuba za jednokratnu uporabu zapakirana je u kartonskoj kutiji.
English: Patients with deeper burn wounds (Grade 2b) were not included.
Croatian: Bolesnici s dubljim ranama izazvanim opeklinama (2.b stupanj) nisu bili uključeni.
English: Carcinogenicity and reproductive and developmental toxicity studies have not been performed.
Croatian: Nisu provedena ispitivanja kancerogenosti te reproduktivne i razvojne toksičnosti.
English: Episalvan can be used during pregnancy.
Croatian: Episalvan se može koristiti u trudnoći.
English: Episalvan is for single use only.
Croatian: Episalvan je namijenjen samo za jednokratnu uporabu.
English: Table 2: Overview of Efficacy Results: Intra-patient difference in time to wound closure
Croatian: Tablica 2.: Pregled rezultata djelotvornosti: Intraindividualne razlike u vremenu zatvaranja rane
English: The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalost nuspojava određuje se kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nije poznato (ne može se procijeniti iz dostupnih podataka).
English: Sunflower oil, refined.
Croatian: Suncokretovo ulje, rafinirano.
English: Difference in time to wound closure was set to 0 for photo series rated as ‘not evaluable'.
Croatian: Razlika u vremenu zatvaranja rane postavljena je na 0 za seriju fotografija ocijenjenih kao „nepogodna za procjenu”.