FrancophonIA/ELRC3.0 huggingface dataset:
English: Hold the tray securely in the palm of the hand, ensuring that the side with the holes is facing upwards, and use the tabs on the side of the tray to remove the top of the tray with the other hand.
Croatian: Držite pliticu čvrstu na dlanu ruke vodeći računa da je strana s otvorima okrenuta prema gore i upotrijebite jezičke sa strane plitice kako biste drugom rukom skinuli vrh plitice.
English: EVARREST will remain in place and adhere to the tissue, and is absorbable.
Croatian: EVARREST će ostati na mjestu postavljanja i prionuti uz tkivo te će se resorbirati.
English: In total, no more than the equivalent of two 10.2 cm x 10.2 cm units or four 5.1 cm x 10.2 cm units should remain in the body as there is only limited long-term experience with larger quantities.
Croatian: Ukupno, u tijelu ne smije ostati količina matriksa veća od ekvivalentne količine dviju jedinica dimenzija 10,2 cm x 10,2 cm ili četiriju jedinica dimenzija 5,1 cm x 10,2 cm jer postoji samo ograničeno dugoročno iskustvo s većim količinama.
English: ● To open the product, remove the foil sachet from the carton, carefully peel open the foil sachet avoiding contact with the inside of the foil or the white sterile tray containing EVARREST.
Croatian: Otvorite proizvod tako da izvadite folijsku vrećicu iz kutije, pažljivo je odlijepite vodeći računa da izbjegnete kontakt s unutarnjom stranom folije ili bijelom, sterilnom pliticom koja sadrži EVARREST.
English: Three subjects out of 145 (~2%) in the group treated with EVARREST showed an increase in the titre of anti-thrombin antibodies after treatment.
Croatian: Tri ispitanika od 145 (približno 2 %) u skupini s primijenjenim EVARREST-om imala su porast titra antitrombinskih protutijela nakon primjene EVARREST-a.
English: Up to the equivalent of two 10.2 cm x 10.2 cm units or four 5.1 cm x 10.2 cm units should be used if needed to cover the entire bleeding area, with an overlap of approximately 1 to 2 cm.
Croatian: Ako je potrebno, mora se koristiti količinu matrice jednaku dvije jedinice dimenzija 10,2 cm x 10,2 cm ili četiri jedinice dimenzija 5,1 cm x 10,2 cm, kako bi se pokrilo cijelo područje krvarenja s preklapanjem od približno 1 do 2 cm.
English: The EVARREST sealant matrix can remain in the sterile field to be available for use throughout the procedure.
Croatian: Matrica za tkivno ljepilo EVARREST može ostati u sterilnom polju kako bi bio dostupan za uporabu tijekom postupka.
English: Table 1 Summary of Adverse Reactions to EVARREST MedDRA System Organ Class Preferred Term
Croatian: Tablica 1 Sažetak nuspojava uz EVARREST MedDRA klasifikacija organskih sustava
English: Blood clot (thromboembolism)
Croatian: Krvni ugrušak (tromboembolija)
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKEIH DJELATNIH TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Omrix Biopharmaceuticals Ltd
Croatian: Omrix Biopharmaceuticals
English: How to store EVARREST
Croatian: Kako čuvati EVARREST
English: EVARREST should be applied so it extends approximately 1 to 2 cm beyond the margins of the target bleeding area.
Croatian: EVARREST se mora primijeniti tako da približno 1 do 2 cm prelazi preko rubova ciljnog područja krvarenja.
English: ● If bleeding is due to incomplete adherence to the tissue (where bleeding persists from under the dressing), remove EVARREST sealant matrix and use a new one.
Croatian: • Ako se krvarenje nastavi zbog nepotpunog prianjanja na tkivo (kada se krvarenje nastavlja ispod zavoja), uklonite matricu za tkivno ljepilo EVARREST i primijenite novu.
English: Signs of hypersensitivity reactions include hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Croatian: Znakovi reakcija preosjetljivosti uključuju koprivnjaču, generaliziranu urtikariju, stezanje u prsima, piskanje, hipotenziju i anafilaksiju.
English: Unintentional fluid intake into the airway (aspiration), build up of excess fluid in the cavity surrounding the lungs; the frequency was uncommon (may affect up to 1 in 100 people).
Croatian: Nehotični unos tekućine u dišne puteve (aspiracija), stvaranje viška tekućine u prostoru oko pluća; učestalost je bila manje česta (može se javiti u do 1 na 100 osoba).
English: Apply in a single layer; ensure that the edges overlap (by approximately 1 to 2 cm) with the existing EVARREST sealant matrix.
Croatian: Primijenite ih u jednom sloju; vodite računa da se rubovi preklapaju (za približno 1 do 2 cm) s postojećom matricom za tkivno ljepilo EVARREST.
English: Increase in the levels of fibrinogen in the blood: the frequency was uncommon (may affect up to 1 in 100 people).
Croatian: Porast razina fibrinogena u krvi: učestalost je bila manje česta (može se javiti u do 1 na 100 osoba).
English: The application site should be monitored intraoperatively to verify that haemostasis is maintained.
Croatian: Mjesto primjene se tijekom kirurškog zahvata mora nadzirati radi provjere održavanja hemostaze.
English: PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Foil Sachet (5.1 cm x 10.2 cm)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Folijska vrećica (5,1 cm x 10,2 cm)
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno lokalnim propisima.
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja P
English: Omrix Biopharmaceuticals Ltd.
Croatian: Omrix Biopharmaceuticals N.V.
English: Using sterile scissors, carefully cut EVARREST to the size and shape as necessary to fit and maintain contact with the bleeding area with an overlap of approximately 1 to 2 cm. Keep the powdery white-to-yellow colour active side of EVARREST facing down while in the tray.
Croatian: Sterilnim škarama pažljivo izrežite EVARREST na veličinu i oblik potreban da bi pristajala uz područje krvarenja i zadržala kontakt s područjem krvarenja tako da približno 1 do 2 cm prelazi njegove rubove.
English: If not satisfied with the placement, remove EVARREST and use a new EVARREST sealant matrix.
Croatian: Ako niste zadovoljni s položajem, uklonite EVARREST i stavite novi EVARREST matrica za tkivno ljepilo.
English: How EVARREST is used
Croatian: Kako se EVARREST primjenjuje
English: NAME OF THE MEDICINAL PRODUCT EVARREST Sealant Matrix
Croatian: NAZIV LIJEKA EVARREST matrica za tkivno ljepilo
English: Apply an appropriately sized piece of EVARREST to adequately cover the entire bleeding area, with an overlap of approximately 1 to 2 cm onto non-bleeding tissue, to assist with adherence to the wound site.
Croatian: Primijenite komad lijeka EVARREST odgovarajuće veličine kako bi se njime pokrilo cijelo područje krvarenja tako da rubovi prelaze 1 do 2 cm na tkivo koje ne krvari, te biste na taj način pripomogli prianjanju na mjesto rane.
English: EVARREST is to be applied with approximately 3 minutes of firm manual compression.
Croatian: EVARREST se primjenjuje čvrstom manualnom kompresijom trajanja približno 3 minute.
English: The measures taken in the manufacture of fibrinogen and thrombin are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped virus, hepatitis A. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Croatian: Mjere poduzete tijekom proizvodnje fibrinogena i trombina smatraju se djelotvornima za viruse s ovojnicom poput virusa humane imunodeficijencije (HIV), virusa hepatitisa B, virusa hepatitisa C, i virusa hepatitisa
English: Antibodies against components of fibrin sealant/haemostatic products may occur rarely.
Croatian: Rijetko se mogu javiti protutijela na komponente fibrinskog tkivnog ljepila/hemostatike.
English: ● If bleeding is due to incomplete adherence to the tissue (where bleeding persists from under the dressing), remove EVARREST sealant matrix and use a new EVARREST sealant matrix.
Croatian: U slučaju krvarenja zbog nepotpunog prianjanja na tkivo (kada se krvarenje nastavlja ispod pokrova), uklonite EVARREST matrica za tkivno ljepilo i upotrijebite novi EVARREST.
English: Leonardo Da Vincilaan 15
Croatian: Leonardo Da Vincilaan 15 1831 Diegem
English: Accumulation of fluid in the stomach, swelling of the stomach; the frequency was uncommon (may affect up to 1 in 100 people).
Croatian: Nakupljanje tekućine u trbuhu, oticanje trbuha, učestalost je bila manje česta (može se javiti u do 1 na 100 osoba).
English: If not satisfied with the placement of EVARREST, remove the used EVARREST sealant matrix and repeat the application procedure above with a new EVARREST sealant matrix.
Croatian: Ako niste zadovoljni s položajem lijeka EVARREST, uklonite iskorišteni EVARREST matrica za tkivno ljepilo i ponovite prethodno opisani postupak primjene s novim EVARREST matrica za tkivno ljepilo.
English: It was a prospective, randomised, controlled single-centre study observing the clinical utility of EVARREST against Standard of Care (SoC) in soft tissue bleeding during intra-abdominal, retroperitoneal, pelvic and non-cardiac thoracic surgery.
Croatian: Standard of Care - SoC) kod krvarenja iz mekih tkiva tijekom intraabdominalnih, retroperitonealnih te kirurških zahvata na zdjelici i nekardijalnih torakalnih kirurških zahvata.
English: EVARREST should only be used in a single layer, with an overlap of approximately 1 to 2 cm onto non-bleeding tissue or an adjacent EVARREST sealant matrix.
Croatian: EVARREST se mora koristiti samo u jednom sloju s preklapanjem od približno 1 do 2 cm preko tkiva koje ne krvari ili na susjedni EVARREST matrica za tkivno ljepilo.
English: Composite Matrix (Polyglactin 910 and oxidised regenerated cellulose) 20 mg/cm2 Arginine hydrochloride
Croatian: 6.1 Popis pomoćnih tvari kompozitni matrica (poliglaktin 910 i oksidirana regenerirana celuloza) 20 mg/cm2 argininklorid glicin natrijev klorid natrijev citrat kalcijev klorid ljudski albumin manitol natrijev acetat
English: 40 IU Contains one sealant matrix (5.1 cm x 10.2 cm)
Croatian: Sadrži jedan matrica za tkivno ljepilo (5,1 cm x 10,2 cm)
English: After surgery (post-procedural haemorrhage); the frequency was uncommon (may affect up to 1 in 100 people).
Croatian: - Nakon kirurškog zahvata (postproceduralno krvarenje); učestalost je bila manje česta (može se javiti u do 1 na 100 osoba).
English: Mannitol
Croatian: Ltd
English: EVARREST should only be used in a single layer with an overlap of approximately 1 to 2 cm onto non-bleeding tissue to help it stick to the bleeding area.
Croatian: EVARREST se smije koristiti samo u jednom sloju s preklapanjem od približno 1 do 2 cm na tkivo koje ne krvari kako bi se pripomoglo lijepljenju pripravka na područje krvarenja.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: I izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
English: 8.1 mg
Croatian: 8,1 mg ljudski trombin
English: Application of EVARREST
Croatian: Primjena lijeka EVARREST
English: EVARREST should only be used in a single layer, with an overlap of approximately 1 to 2 cm onto non-bleeding tissue, to assist with adherence to the wound site.
Croatian: EVARREST se smije koristiti samo u jednom sloju s preklapanjem od približno 1 do 2 cm na tkivo koje ne krvari kako bi se pripomoglo prianjanju na ranu.
English: Multiple bleeding sites may be treated simultaneously.
Croatian: Istovremeno se EVARREST može primijeniti na više mjesta krvarenja.
English: Aspiration
Croatian: Doziranje
English: Pleural effusion Pulmonary embolism
Croatian: U arterijama koje opskrbljuju pluća (plućna embolija)
English: Accumulation of fluid in the pancreas: the frequency was uncommon (may affect up to 1 in 100 people).
Croatian: Nakupljanje tekućine u gušterači: učestalost je bila manje česta (može se javiti u do 1 na 100 osoba).
English: Contains two sealant matrices (5.1 cm x 10.2 cm) 2 units
Croatian: Sadrži jedan matrica za tkivno ljepilo (10,2 cm x 10,2 cm) Sadrži dva matriksa za tkivno ljepilo (5,1 cm x 10,2 cm) 2 jedinice
English: - surgery to the brain or spinal cord - controlling bleeding in the stomach or intestines by applying the product through an endoscope
Croatian: Primjena lijeka EVARREST nije ispitivana u sljedećim postupcima te stoga nema informacija koje bi potvrdile njegovu učinkovitost: - kirurški zahvati na mozgu ili na kralježničkoj moždini - kontrola krvarenja u želucu ili crijevima primjenom lijeka kroz endoskop (endoskopsku cijev) - kirurškom zbrinjavanju crijeva lijepljenjem.
English: - careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded.
Croatian: - pažljivi odabir darivatelja krvi i plazme kako bi se osiguralo da su darivatelji s rizikom za prijenos infekcija isključeni. - testiranje svake donacije i pulova plazme (plasma pools) na prisutnost virusa/znakove infekcija. - uključivanje postupaka koji mogu inaktivirati ili ukloniti viruse tijekom procesa obrade krvi i plazme.
English: Composite Matrix (Polyglactin 910 and oxidised regenerated cellulose) Arginine hydrochloride
Croatian: Pomoćne tvari: kompozitni matrica (poliglaktin 910 i oksidirana regenerirana celuloza) argininklorid glicin natrijev klorid natrijev citrat kalcijev klorid ljudski albumin manitol natrijev acetat
English: ● Gastrointestinal haemorrhage
Croatian: Prijavljivanje nuspojava
English: Pack size of 1 and as sealant matrices which are 5.1 cm x 10.2 cm in size, Pack size of 2.
Croatian: EVARREST se isporučuje kao matrica za tkivno ljepilo veličine 10,2 cm x 10,2 cm u pakiranju s 1 matriksom, te kao matrica za tkivno ljepilo veličine 5,1 cm x 10,2 cm u pakiranju s 2 matriksa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) EVARREST contains per cm2
Croatian: NAVOĐENJE DJELATNE(IH) TVARI EVARREST sadrži po cm2 ljudski fibrinogen ljudski trombin
English: What you need to know before you are treated with EVARREST:
Croatian: Što morate znati prije nego
English: Abdominal distension
Croatian: Poremećaji probavnog sustava Distenzija abdomena
English: Uncommon Uncommon Uncommon
Croatian: Manje često Manje često
English: Pack size of 1, 10.2 cm x 10.2 cm sealant matrix.
Croatian: Matrica za tkivno ljepilo dimenzija 10,2 cm x 10,2 cm na plitici (poliester).
English: 5.1 cm x 10.2 cm sealant matrix in a tray (polyester).
Croatian: Matrica za tkivno ljepilo dimenzija 5,1 cm x 10,2 cm na plitici (poliester).
English: Name and address of the manufacturer(s) of the biological active substance(s)
Croatian: Naziv(i) i adresa(e) proizvođača biološke(ih) djelatne(ih) tvari ljudski fibrinogen i ljudski trombin:
English: Sealant Matrix
Croatian: Pakiranje s 1 matrica.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Croatian: • Plan upravljanja rizikom (RMP)
English: Dog and cats Dogs: intravenous or subcutaneous Cats: subcutaneous
Croatian: Goveda: supkutana ili intravenska Svinje:
English: EU (MA) Number Invented Name
Croatian: Izmišljeno ime
English: Bottle (HDPE)
Croatian: Oralnu uporabu HDPE boca polipropilen mjerenje šprice
English: 1.5 g 20 sachets Meat and offal: 3 days
Croatian: 1 bočica Meso i jestive iznutrice: 15 dana (Goveda), Meso i jestive iznutrice offal: 5 dana (Svinje)
English: Strength Pharmaceutical Form Route of Administration Packaging
Croatian: Aneks A - alli 60 mg Tvrde Kapsule / alli 27 mg Tablete za žvakanje
English: Outcome of a procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/123)
Croatian: Ishod postupka u skladu s člankom 34. Direktive 2001/82/EZ (EMEA/V/A/123)
English: What is Lincocin?
Croatian: Što je Lincocin?
English: The European Commission issued a decision on 5 October 2017.
Croatian: Europska komisija donijela je odluku 5. listopada 2017.
English: Why was Lincocin reviewed?
Croatian: Zašto je Lincocin ponovno ocjenjivan?
English: Questions and answers on Lincocin and its associated names EMA/585749/2017
Croatian: Pitanja i odgovori o VMP-u Lincocin i pridruženim imenima EMA/585749/2017
English: 5 October 2017
Croatian: 5. listopada 2017.
English: Questions and answers on Lincocin and its associated names
Croatian: Pitanja i odgovori o VMP-u Lincocin i pridruženim imenima
English: The amended product information is available on the 'All documents' tab.
Croatian: Izmijenjene informacije o VMP-u dostupne su u kartici „All documents”.
English: Lincocin is authorised in the EU via national procedures.
Croatian: VMP Lincocin odobren je u EU-u u okviru nacionalnih postupaka.
English: The European Commission noted that there are divergences across Member States in the way the veterinary medicinal product can be used, as seen in the differences in the product information in the countries where Lincocin is marketed.
Croatian: Europska komisija primijetila je da u državama članicama postoje odstupanja u načinu na koji se veterinarsko-medicinski proizvod može primjenjivati, kao što je uočeno u razlikama u informacijama o VMP-u u zemljama u kojima je Lincocin stavljen u promet.
English: Lincocin (and associated names, such as Lincocine poudre soluble and Albiotic Pulver 400 mg/g) is marketed in Belgium, Denmark, France, Germany, Hungary, Ireland, Poland and United Kingdom.
Croatian: Pulver 400 mg/g) stavljen je u promet u Belgiji, Danskoj, Francuskoj, Njemačkoj, Mađarskoj, Irskoj, Poljskoj i Ujedinjenoj Kraljevini.
English: Lincocin is a veterinary medicinal product available as powder for oral solution and contains 400 mg lincomycin per gram of product.
Croatian: Lincocin je veterinarsko-medicinski proizvod koji je dostupan u obliku praška za oralnu otopinu, a sadržava 400 mg linkomicina po gramu proizvoda.
English: Lincocin is indicated for the treatment and metaphylaxis of enzootic pneumonia caused by Mycoplasma hyopneumoniae in pigs and treatment and metaphylaxis of necrotic enteritis caused by Clostridium perfringens in chickens.
Croatian: VMP Lincocin indiciran je za liječenje i metafilaksu enzootske pneumonije u svinja koju uzrokuje bakterija Mycoplasma hyopneumoniae, te za liječenje i metafilaksu nekrotičnog enteritisa u kokoši koji uzrokuje bakterija Clostridium perfringens.
English: Lincomycin is a lincosamide antibiotic which is produced by Streptomyces lincolnensis.
Croatian: Linkomicin je linkozamidni antibiotik, a proizvodi ga bakterija Streptomyces lincolnensis.
English: On 5 July 2016, the European Commission referred the matter to the CVMP in order to harmonise the product information for Lincocin (and associated names) in the EU.
Croatian: Europska komisija je 5. srpnja 2016. uputila predmet CVMP-u radi usklađivanja informacija o VMP-u za VMP Lincocin (i pridružena imena) u EU-u.
English: Based on the evaluation of the currently-available data, the CVMP concluded that the product information for Lincocin and its associated names should be harmonised across the EU.
Croatian: CVMP je na temelju evaluacije trenutačno dostupnih podataka zaključio da se informacije o VMP-u za Lincocin i pridružena imena moraju uskladiti na razini EU-a.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that there is a need to harmonise the product information [summary of product characteristics (SPC), labelling and package leaflet] for Lincocin in the European Union (EU).
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji zaključio je da postoji potreba za usklađivanjem informacija o VMP-u (sažetka opisa svojstava VMP-a, označivanja i uputa o VMP-u) za VMP Lincocin u Europskoj uniji (EU).
English: On 13 July 2017, the European Medicines Agency (the Agency) completed a review of Lincocin.
Croatian: Europska agencija za lijekove (Agencija) dovršila je ponovno ocjenjivanje VMPa Lincocin.
English: Consequently, the CVMP recommended that variations to the terms of the marketing authorisations for the aforementioned product are required in order to amend the product information accordingly.
Croatian: uvjeta odobrenja za stavljanje VMP-a u promet za navedeni proizvod kako bi se na odgovarajući način izmijenile informacije o VMP-u.
English: Date of first authorisation: 17 May 2002 Date of latest renewal: 22 May 2007
Croatian: Datum prvog odobrenja: 17. svibnja 2002 Datum zadnje obnove odobrenja: 22. svibnja 2007
English: Now turn over.
Croatian: Sada okrenite
English: • Tilt your head back.
Croatian: • Zabacite glavu prema natrag.
English: How much to use see side 1
Croatian: Koliko primjeniti pogledajte stranicu 1
English: Treatment may be maintained for up to four months, if considered necessary.
Croatian: Kapi se mogu uzimati do četiri mjeseca, ako se smatra potrebnim.
English: The recommended dose is one drop in the eye or eyes, twice a day, morning and evening.
Croatian: Preporučena doza je jedna kap u oko ili oči, dva puta na dan - ujutro i navečer.
English: It could infect the drops left in the bottle.
Croatian: To bi moglo inficirati preostale kapi u bočici.
English: • Risk Management Plan (RMP)
Croatian: • Plan upravljanja rizikom (RMP) Nije primjenjivo
English: You should throw away the bottle four weeks after you first opened it to prevent infections, and use a new bottle.
Croatian: Bočicu trebate baciti četiri tjedna nakon prvog otvaranja da spriječite infekcije te uzmite novu bočicu.
English: Keep the bottle tightly closed when not in use.
Croatian: Čuvati bočicu dobro zatvorenom kada nije u uporabi.
English: Not known (frequency cannot be estimated from the available data) Effects in the eye
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) Nuspojave na oku
English: • Hold the bottle, pointing down, between your thumb and middle finger.
Croatian: • Bočicu držite okrenuto naopako, između palca i srednjeg prsta.
English: Do not put in any more drops until it's time for your next regular dose.
Croatian: Ne ukapavajte više kapi sve dok ne bude vrijeme za sljedeću redovnu dozu.
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kao Vam je rekao liječnik ili ljekarnik.
English: • If you use drops in both eyes, repeat the steps for your other eye.
Croatian: • Ako primjenjujete kapljice na oba oka, ponovite ove korake na drugom oku.
English: BOX OF 1 BOTTLE + BOX OF 3 BOTTLES
Croatian: KUTIJA S 1 BOČICOM + KUTIJA S 3 BOČICE
English: • If you are allergic (hypersensitive) to olopatadine or any of the other ingredients of this medicine (listed in section 6).
Croatian: • Ako ste alergični (preosjetljivi) na olopatadin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Do not give this medicine to children under the ages of 3 years because there is no data to indicate that it is safe and work in children under 3 years.
Croatian: Opatanol nemojte davati djeci mlađoj od 3 godine jer nema podataka koji bi naveli da je siguran i djeluje kod djece ispod 3 godine.
English: • Get the Opatanol bottle and a mirror.
Croatian: • Uzmite bočicu lijeka Opatanol i ogledalo.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A) (AKO JE POTREBNO
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala i reproduktivne toksičnosti.
English: • Don't squeeze the bottle, it is designed so that just a gentle press on the bottom is needed
Croatian: • Ne stiskajte bočicu, napravljena je tako da je dovoljan samo lagani pritisak na njeno dno
English: Pharmacotherapeutic group: ophthalmologicals; decongestant and antiallergics; other antiallergics, ATC code: S01GX 09
Croatian: Farmakoterapijska skupina: oftalmici; dekongestivi i antialergici; ostali antialergici, ATK oznaka: S01GX 09
English: TURN THE PAGE FOR MORE ADVICE.
Croatian: OKRENITE STRANICU ZA DODATNE INFORMACIJE
English: What OPATANOL is and what it is used for
Croatian: Što je Opatanol i za što se koristi