FrancophonIA/ELRC3.0 huggingface dataset:
English: This treatment effect was still evident after the additional year of follow-up at which stage the risk reduction was 41% (Hazard Ratio = 0.59, 95% confidence interval (0.42, 0.83), p=0.0011).
Croatian: Taj terapijski učinak bio je još uvijek vidljiv nakon dodatne godine naknadnog praćenja u kojoj fazi je smanjenje rizika iznosilo 41% (omjer hazarda = 0,59, interval pouzdanosti 95% (0,42, 0,83), p=0,0011).
English: Thrombocytopenia Thrombotic microangiopathy including thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome#
Croatian: Trombotička mikroangiopatija uključujući trombotičku trombocitopeničku purpuru/hemolitički uremički sindrom#
English: What Extavia contains The active substance is interferon beta-1b.
Croatian: Što Extavia sadrži Djelatna tvar je interferon beta-1b.
English: - Pack containing 5 vials with powder and 5 pre-filled syringes with solvent - Pack containing 14 vials with powder and 14 pre-filled syringes with solvent - Pack containing 15 vials with powder and 15 pre-filled syringes with solvent - Pack containing 14 vials with powder and 15 pre-filled syringes with solvent
Croatian: - Pakiranje koje sadrži 5 bočica s praškom i 5 napunjenih štrcaljki s otapalom - Pakiranje koje sadrži 14 bočica s praškom i 14 napunjenih štrcaljki s otapalom - Pakiranje koje sadrži 15 bočica s praškom i 15 napunjenih štrcaljki s otapalom - Pakiranje koje sadrži 14 bočica s praškom i 15 napunjenih štrcaljki s otapalom
English: In the placebo-controlled phase, Extavia delayed the progression from the first clinical event to clinically definite multiple sclerosis (CDMS) in a statistically significant and clinically meaningful manner, corresponding to a risk reduction of 47% (Hazard Ratio = 0.53, 95% confidence interval (0.39, 0.73), p<0.0001).
Croatian: U placebom kontroliranoj fazi, Extavija je odgodila progresiju od prvog kliničkog događaja do klinički definitivne multiple skleroze (KDMS) na statistički i klinički značajan način, što odgovara smanjenju rizika za 47% (omjer hazarda = 0,53, interval pouzdanosti 95% (0,39, 0,73), p<0,0001).
English: Periodic monitoring of early signs or symptoms, e.g. oedema, proteinuria and impaired renal function, is recommended, especially in patients at higher risk of renal disease.
Croatian: Preporučuje se periodičko praćenje ranih znakova ili simptoma, npr. edema, proteinurije i oštećenja bubrežne funkcije, pogotovo u bolesnika s visokim rizikom od razvoja bolesti bubrega.
English: At the beginning of treatment side effects are common but in general they decrease with further treatment.
Croatian: Na početku liječenja nuspojave su česte, ali općenito se smanjuju uz nastavak liječenja.
English: If your depression and/or suicidal thoughts are severe, you will not be prescribed Extavia (see also “Do not use Extavia”).
Croatian: Ako su Vaša depresija i/ili misli o samoubojstvu jako izraženi, nećete se liječiti Extavijom (pogledajte također „Nemojte primjenjivati Extaviju“).
English: 10 - 15 cm from groin
Croatian: 10-15 cm od koljena knee
English: Single clinical event suggestive of multiple sclerosis One controlled clinical trial with Extavia was performed in patients with a single clinical event and Magnetic Resonance Imaging (MRI) features suggestive of multiple sclerosis (at least two clinically silent lesions on the T2-weighted MRI).
Croatian: Jednokratan klinički događaj koji upućuje na multiplu sklerozu Jedno je kontrolirano kliničko ispitivanje s Extavijom provedeno u bolesnika s jednim kliničkim događajem i karakteristikama na snimci napravljenoj magnetskom rezonancijom (MR) koje upućuju na multiplu sklerozu (najmanje dvije klinički tihe lezije na T2 mjerenoj snimci MR-om).
English: Treatment with Extavia should be started under the supervision of a doctor who is experienced in the treatment of multiple sclerosis.
Croatian: Liječenje Extavijom treba započeti pod nadzorom liječnika koji ima iskustva u liječenju multiple skleroze.
English: The absolute bioavailability of subcutaneously administered interferon beta-1b was approximately
Croatian: Apsolutna bioraspoloživost supkutano primijenjenog interferona beta-1b bila je otprilike 50%.
English: In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential white blood cell counts, platelet counts, and blood chemistries, including liver function tests (e.g. aspartate aminotransferase serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase serum glutamate pyruvate transaminase (SGPT) and gamma glutamyltransferase), are recommended prior to initiation and at regular intervals following introduction of Extavia therapy, and then periodically thereafter in the absence of clinical symptoms.
Croatian: Uz laboratorijske pretrage koje su uobičajeno potrebne za praćenje bolesnika s multiplom sklerozom, preporučuje se izrada kompletne krvne slike i diferencijalne krvne slike, određivanje broja trombocita i biokemijskih parametara u krvi, što uključuje testove jetrene funkcije (npr. aspartat aminotransferaze, serumske glutamat-oksaloacetat transaminaze (SGOT), alanin aminotransferaze serumske glutamat piruvat transaminaze (SGPT) i gama glutamiltransferaze), prije započinjanja te u redovnim intervalima nakon uvođenja terapije Extavijom, a nakon toga periodički ako nema kliničkih simptoma.
English: The following side effects listing is based on reports from clinical trials with Extavia (List 1) and from side effects reported on the marketed product (List 2).
Croatian: Popis nuspojava u nastavku temelji se na izvješćima iz kliničkih ispitivanja s Extavijom (Popis 1) te iz nuspojava prijavljenih za lijek nakon stavljanja u promet (Popis 2).
English: 2.25 ml graduated (with dose marks of: 0.25 ml, 0.5 ml, 0.75 ml, 1.0 ml) pre-filled syringe (type I glass) with 1.2 ml solvent.
Croatian: Graduirana (s odmjernim oznakama za: 0,25 ml, 0,5 ml, 0,75 ml, 1,0 ml) napunjena štrcaljka od 2,25 ml (staklo tipa I) s 1,2 ml otapala.
English: Regular thyroid function tests are recommended in patients with a history of thyroid dysfunction or as clinically indicated.
Croatian: Redoviti testovi funkcije štitnjače preporučuju se u bolesnika s disfunkcijom štitnjače u anamnezi ili kako je klinički indicirano.
English: PART II: ROTATING INJECTION SITES
Croatian: DIO II: PROMJENA MJESTA INJICIRANJA
English: Caution should be used and close monitoring considered when administering interferon beta to patients with severe renal failure.
Croatian: Potreban je oprez i pomno praćenje prilikom primjene interferona beta u bolesnika s teškim zatajenjem bubrega.
English: Before injection, the Extavia solution has to be prepared from a vial of Extavia powder and 1.2 ml of liquid from the pre-filled solvent syringe.
Croatian: Prije injiciranja otopinu Extavije treba pripremiti iz bočice praška Extavia i 1,2 ml tekućine iz otapalom napunjene štrcaljke.
English: ► Tell your doctor immediately: - if you get some or all of these symptoms: foamy urine, fatigue, swelling, particularly and the ankles and eyelids, and weight gain, as they may be signs of a possible kidney problem.
Croatian: Odmah se obratite svom liječniku: - ako dobijete neke ili sve od navedenih simptoma: pjenasta mokraća, umor, oticanje, posebice gležnjeva i kapaka te porast tjelesne težine, budući da to mogu biti znakovi problema s bubrezima.
English: There are follow-up data under controlled clinical conditions for patients with relapsing-remitting multiple sclerosis for up to 5 years and for patients with secondary progressive multiple sclerosis for up to 3 years.
Croatian: Postoje podaci dobiveni praćenjem bolesnika s relapsno-remitirajućom multiplom sklerozom u kontroliranim kliničkim uvjetima u razdoblju do 5 godina te bolesnika sa sekundarno progresivnom multiplom sklerozom do 3 godine.
English: Blood and lymphatic system disorders Lymphocyte count decreased (<1500/mm³)
Croatian: Poremećaji krvi i limfnog sustava Smanjeni broj limfocita (<1500/mm³)
English: The activities of interferon beta-1b are species-restricted and therefore, the most pertinent pharmacological information on interferon beta-1b is derived from studies of human cells in culture or human in vivo studies.
Croatian: Djelovanja interferona beta-1b ovisna su o vrstama te stoga najvažnije farmakološke informacije o interferonu beta-1b potječu iz ispitivanja na kulturama ljudskih stanica ili ljudskim stanicama u in vivo ispitivanjima.
English: Sodium chloride Water for injection
Croatian: Otapalo natrijev klorid voda za injekciju
English: Hyperthyroidism, Thyroid disorders
Croatian: Hipertiroidizam, poremećaji štitnjače
English: if you feel noticeably more sad or hopeless than before the treatment with Extavia, or if you develop thoughts of suicide.
Croatian: ako se osjećate zamjetno tužnije ili beznadnije nego prije liječenja Extavijom, ili ako počnete razmišljati o samoubojstvu.
English: EU/1/08/454/008 15 vials with powder and 15 pre-filled syringes with solvent EU/1/08/454/010 5 vials with powder and 5 pre-filled syringes with solvent EU/1/08/454/011 14 vials with powder and 14 pre-filled syringes with solvent EU/1/08/454/013 14 vials with powder and 15 pre-filled syringes with solvent
Croatian: EU/1/08/454/008 15 bočica s praškom i 15 napunjenih štrcaljki s otapalom EU/1/08/454/010 5 bočica s praškom i 5 napunjenih štrcaljki s otapalom EU/1/08/454/011 14 bočica s praškom i 14 napunjenih štrcaljki s otapalom EU/1/08/454/013 14 bočica s praškom i 15 napunjenih štrcaljki s otapalom
English: Extavia 250 microgram/ml powder and solvent for solution for injection.
Croatian: Extavia 250 mikrograma/ml prašak i otapalo za otopinu za injekciju.
English: Inspection prior to use
Croatian: Provjera prije primjene
English: If, for some reason, you are not able to inject Extavia immediately, you can refrigerate the reconstituted solution for up to 3 hours before using it. Do not freeze the solution, and do not wait longer than 3 hours to inject it.
Croatian: Ako iz nekog razloga ne možete odmah injicirati Extaviju, pripremljenu otopinu možete držati u hladnjaku do 3 sata prije primjene.
English: • Patients with relapsing remitting multiple sclerosis and two or more relapses within the last two years.
Croatian: • Bolesnika s relapsno remitirajućom multiplom sklerozom koji su doživjeli dva ili više relapsa unutar posljednje dvije godine.
English: The optimal dose has not been fully clarified.
Croatian: Nije još poznato koja je optimalna doza.
English: In addition, the following side effects have been identified during post-marketing experience.
Croatian: K tome, sljedeće su nuspojave identificirane u razdoblju nakon stavljanja lijeka u promet.
English: Table 2 Adverse drug reactions (ADRs) identified during post-marketing surveillance (frequencies - where known - calculated based on pooled clinical trial data N = 1,093)
Croatian: Tablica 2 Nuspojave na lijek identificirane tijekom praćenja nakon stavljanja lijeka u promet (učestalosti - ako su poznate - izračunate na temelju objedinjenih podataka iz kliničkih ispitivanja N = 1093)
English: - serious allergic (anaphylactic) reactions, - the thyroid gland does not work properly(thyroid disorders), too much hormone is produced (hyperthyroidism), - inflammation of the pancreas (pancreatitis), see section 2 “Warnings and precautions”, - blood clots in the small blood vessels that can affect your kidneys (thrombotic thrombocytopenic purpura or haemolytic uraemic syndrome).
Croatian: - ozbiljne alergijske (anafilaktičke) reakcije, - štitna žlijezda ne funkcionira pravilno (poremećaji štitnjače), stvara se previše hormona (hipertireoidizam), - upala gušterače (pankreatitis), pogledajte dio 2 „Upozorenja i mjere opreza“, - krvni ugrušci u malim krvnim žilama koji mogu utjecati na Vaše bubrege (trombotička trombocitopenička purpura ili hemolitički uremički sindrom).
English: Retrospective analyses in subgroups showed that a treatment effect on disability progression is most likely in patients with active disease before treatment commences (Hazard Ratio 0.72, 95% confidence interval (0.59, 0.88), p=0.0011, corresponding to a 28% risk reduction due to Extavia in patients with relapses or pronounced EDSS progression, 8.0 million IU Extavia versus all placebo patients).
Croatian: Retrospektivne analize u podskupinama pokazale su da je učinak liječenja na napredak invalidnosti najvjerojatniji u bolesnika s aktivnom bolešću prije početka liječenja (omjer hazarda 0,72, interval pouzdanosti 95% (0,59; 0,88), p=0,0011, odgovara 28%-tnoj redukciji rizika zbog Extavije u bolesnika s relapsima ili izraženom progresijom na EDSS ljestvici, 8,0 milijuna IU Extavije naspram svih bolesnika koji su primali placebo).
English: D) Making the injection manually (to make an injection with the ExtaviPro 30G autoinjector, refer to the instructions for use provided with the auto-injector)
Croatian: D) Ručno davanje injekcije (za davanje injekcije pomoću autoinjektora ExtaviPro 30G, pročitajte upute za uporabu priložene uz autoinjektor)
English: Swirl the syringevial assembly gently until the powder is completely dissolved.
Croatian: Lagano vrtite sklop štrcaljke i bočice dok se prašak u potpunosti ne otopi.
English: Solvent: Sodium chloride, water for injection.
Croatian: Otapalo: natrijev klorid, voda za injekciju.
English: Drug-induced lupus erythematosus
Croatian: Lupus eritematosus uzrokovan lijekom
English: Flu-like symptoms may also be reduced by administration of non-steroidal anti-inflammatory medicinal products.
Croatian: Simptomi nalik gripi mogu se smanjiti i primjenom nesteroidnih protuupalnih lijekova.
English: 13 - Turn the syringe-vial-assembly so that the vial is at the top.
Croatian: 13 - Okrenite sklop štrcaljke i bočice tako da bočica bude na vrhu.
English: Use the packaging to handle the vial adapter.
Croatian: Upotrijebite pakovanje da biste rukovali nastavkom za bočicu.
English: Single Event suggestive of Multiple Sclerosis (BENEFIT)
Croatian: Pojedinačni poremećaj koji ukazuje na multiplu sklerozu (BENEFIT)
English: - problems with your small blood vessels (capillaries) may develop when using medicines like Extavia (systemic capillary leak syndrome), (frequency unknown).
Croatian: Mogu se razviti problemi s malim krvnim žilama (kapilarama) kada se koriste lijekovi poput Extavije (sindrom povećane propusnosti sistemskih kapilara).
English: - During treatment with Extavia, kidney problems that may reduce your kidney function, including scarring (glomerulosclerosis), may occur.
Croatian: - Tijekom liječenja Extavijom može doći do problema s bubrezima koji smanjuju funkciju Vaših bubrega, uključujući stvaranje ožiljaka (glomeruloskleroza).
English: After 3 years, a pre-planned interim analysis showed EDSS progression (confirmed increase in EDSS of greater than or equal to 1.0 compared to baseline) occurred in 24% of the patients in the delayed treatment group compared to 16% in the immediate treatment group [Hazard Ratio = 0.6, 95% confidence interval (0.39, 0.92), p=0.022].
Croatian: Nakon 3 godine unaprijed planirana privremena analiza pokazala je da se progresija na EDSS-u (potvrđeno povećanje EDSS-a veće ili jednako 1,0 u usporedbi s početnom vrijednošću) javila u 24% bolesnika u skupini s odgođenim početkom liječenja, u odnosu na 16% u skupini s neposredno započetim liječenjem [omjer hazarda = 0,6, interval pouzdanosti 95% (0,39, 0,92), p=0,022].
English: 1.2 ml sodium chloride solution 5.4 mg/ml
Croatian: 1,2 ml otopine natrijevog klorida 5,4 mg/ml
English: Hepatobiliary disorders Alanine aminotransferase increased (SGPT >5 times baseline)
Croatian: Povišena alanin aminotransferaza (SGPT >5 puta početna vrijednost)
English: Abnormal vision Ear and labyrinth disorders Ear pain
Croatian: Poremećaji uha i labirinta Bol u uhu
English: To reduce the risk of getting injection site reaction you must: use a sterile (aseptic) injection technique, rotate the injection sites with each injection (see Annex Self-Injection procedure).
Croatian: koristiti sterilnu (aseptičnu) tehniku injiciranja, - mijenjati mjesto injiciranja sa svakom injekcijom (pogledajte Prilog Postupak samoinjiciranja).
English: Nervous system disorders Headache 
Croatian: Poremećaji živčanog sustava Glavobolja
English: The incidence of injection site reactions may be reduced by the use of an auto-injector.
Croatian: Incidencija reakcija na mjestu injiciranja može se smanjiti uporabom autoinjektora.
English: Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
Croatian: Bolesnici s postojećom teškom depresijom i/ili mislima o samoubojstvu (vidjeti dijelove 4.4 i
English: Side effects derived only during post marketing:
Croatian: Nuspojave zabilježene samo nakon stavljanja lijeka u promet:
English: To reconstitute the powder, the pre-filled syringe with solvent should be used with a needle or a vial adapter to inject the 1.2 ml of the solvent (sodium chloride 5.4 mg/ml (0.54%) solution for injection) into the Extavia vial.
Croatian: Za rekonstituciju praška treba koristiti napunjenu štrcaljku s otapalom s iglom ili nastavkom za bočicu kako bi se ubrizgalo 1,2 ml otapala (otopina natrijevog klorida 5,4 mg/ml (0,54%) za injekciju) u bočicu Extavije.
English: You should rotate the injection site at every injection.
Croatian: Kod svake injekcije mijenjajte mjesto injiciranja.
English: This may suggest an inflammation of the pancreas (pancreatitis), which has been reported with Extavia use.
Croatian: To bi moglo upućivati na upalu gušterače (pankreatitis) koja je zabilježena uz primjenu Extavije.
English: 11 - Examine the solution carefully.
Croatian: 11 - Pažljivo pregledajte otopinu.
English: One of the two studies demonstrated a statistically significant delay in the time to disability progression (Hazard Ratio = 0.69, 95% confidence interval (0.55, 0.86), p=0.0010, corresponding to a 31% risk reduction due to Extavia) and in the time to becoming wheelchair-bound (Hazard Ratio = 0.61, 95% confidence interval (0.44, 0.85), p=0.0036, corresponding to a 39% risk reduction due to Extavia) in patients who received Extavia.
Croatian: Jedno od dva ispitivanja pokazalo je statistički značajnu odgodu u vremenu do napretka invalidnosti (omjer hazarda = 0,69, interval pouzdanosti 95 % (0,55; 0,86), p = 0,0010 odgovara smanjenju rizika od 31 % zbog primjene Extavije) te vremena koje je potrebno da bolesnik postane vezan za invalidska kolica (omjer hazarda = 0,61; interval pouzdanosti 95 % (0,44; 0,85), p = 0,0036, odgovara smanjenju rizika od 39 % zbog primjene Extavije) u bolesnika koji su liječeni Extaviju.
English: For subcutaneous use after reconstitution with 1.2 ml of solvent.
Croatian: Za supkutanu primjenu nakon pripreme otopine s 1,2 ml otapala.
English: * Significantly associated with Extavia treatment for RRMS, p <0.05 ° Significantly associated with Extavia treatment for SPMS, p <0.05 § Injection site reaction (various kinds) comprises all adverse events occurring at the injection site, i.e. the following terms: injection site haemorrhage, injection site hypersensitivity, injection site inflammation, injection site mass, injection site necrosis, injection site pain, injection site reaction, injection site oedema, and injection site atrophy & “Flu-like symptom complex” denotes flu syndrome and/or a combination of at least two adverse events from fever, chills, myalgia, malaise, sweating.
Croatian: Laboratorijska abnormalnost Značajna povezanost s liječenjem Extavijom za bolesnike s prvim događajem koji ukazuje na MS, p <0,05 * Značajna povezanost s liječenjem Extavijom za RR-MS, p <0,05 ° Značajna povezanost s liječenjem Extavijom za SP-MS, p <0,05 § Reakcija na mjestu injiciranja (različite vrste) obuhvaća sve nuspojave koje se javljaju na mjestu injiciranja, tj. sljedeće termine: krvarenje na mjestu injiciranja, preosjetljivost na mjestu injiciranja, upala na mjestu injiciranja, izraslina na mjestu injiciranja, nekroza na mjestu injiciranja, bol na mjestu injiciranja, reakcija na mjestu injiciranja, edem na mjestu injiciranja i atrofija na mjestu injiciranja & „Kompleks simptoma nalik gripi“ označava sindrom gripe i/ili kombinaciju najmanje dva štetna događaja od vrućice, zimice, bolova u mišićima, malaksalosti, znojenja.
English: - Set up a permanent storage area in a convenient location out of the sight and reach of children so that your Extavia and other supplies are always easy to find.
Croatian: Nađite prikladno stalno mjesto za čuvanje Extavije i ostalog potrebnog pribora izvan pogleda i dohvata djece na mjestu gdje ćete ih lako naći.
English: Injection site necrosis has been reported in patients using Extavia (see section 4.8).
Croatian: U bolesnika koji koriste Extaviju zabilježena je nekroza na mjestu primjene injekcije (vidjeti dio 4.8).
English: • Vial adapters for use when reconstituting your medicine
Croatian: • Nastavke za bočicu za korištenje tijekom pripreme Vašeg lijeka
English: Therefore, the tip cap may contain natural rubber latex.
Croatian: Stoga, zatvarač vrha može sadržavati prirodnu lateks gumu.
English: Transfer all the solvent to the vial.
Croatian: Premjestite svo otapalo u bočicu.
English: Slowly pull the plunger back to draw all of the solution into the syringe.
Croatian: Polako povucite klip kako biste uvukli svu otopinu u štrcaljku.
English: Extavia should be used with caution with: - medicines which need a certain liver enzyme system (known as cytochrome P450 system) for their removal from the body, for example medicines used to treat epilepsy (such as phenytoin).
Croatian: Extaviju treba upotrebljavati s oprezom s: - lijekovima koji trebaju određeni sustav jetrenih enzima (poznat kao sustav citokroma P450)
English: Solvent - clear/colourless solution.
Croatian: Otapalo - bistra/bezbojna otopina.
English: The medicinal product should be discarded before use if it contains particulate matter or is discoloured.
Croatian: Lijek treba zbrinuti prije primjene ako sadrži čestice ili je promijenio boju.
English: if you experience loss of appetite, tiredness, feeling sick (nausea), repeated vomiting, especially if you notice widespread itching, yellowing of the skin, or of the whites of the eyes or easy bruising.
Croatian: Ako osjetite gubitak apetita, umor, osjećaj mučnine, opetovano povraćanje te posebno ako primijetite rašireni svrbež, žutilo kože ili bjeloočnica, ili lako stvaranje modrica.
English: - If you experience symptoms such as itching all over your body, swelling of your face and/or your tongue or sudden shortness of breath.
Croatian: Ako osjetite simptome poput svrbeža po cijelom tijelu, oticanja lica i/ili jezika ili iznenadni nedostatak zraka.
English: Treatment day
Croatian: Dan liječenja
English: AREA 1
Croatian: PODRUČJE 1
English: Giving many times the dose of Extavia recommended for the treatment of multiple sclerosis has not led to life-threatening situations.
Croatian: Ako primijenite više Extavije nego što ste trebali Primjena Extavije u dozi više puta većoj od preporučene doze za liječenje multiple skleroze nije uzrokovala po život opasne situacije.
English: Blood bilirubin increased
Croatian: Povišenje bilirubina u krvi
English: The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Croatian: * º Znojenje * Malaksalost * Koristi se najprimjereniji MedDRA-in naziv za opisivanje određene reakcije i njegovi sinonimi i povezana stanja.
English: - 3-month multipack containing 42 (3x14) vials with powder and 42 (3x14) pre-filled syringes with solvent - 3-month multipack containing 45 (3x15) vials with powder and 45 (3x15) pre-filled syringes with solvent - 3-month multipack containing 42 (3x14) vials with powder and 45 (3x15) pre-filled syringes with solvent
Croatian: - 3-mjesečno višestruko pakiranje koje sadrži 42 (3x14) bočice s praškom i 42 (3x14) napunjene štrcaljke s otapalom - 3-mjesečno višestruko pakiranje koje sadrži 45 (3x15) bočica s praškom i 45 (3x15) napunjenih štrcaljki s otapalom - 3-mjesečno višestruko pakiranje koje sadrži 42 (3x14) bočice s praškom i 45 (3x15) napunjenih štrcaljki s otapalom
English: Snap off and discard the tip of the syringe.
Croatian: Odlomite i bacite vrh štrcaljke.
English: Respiratory, thoracic and mediastinal disorders Upper respiratory infection
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Infekcija gornjeg dijela dišnog sustava