FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of injection site reactions may be reduced by the use of an autoinjector.
Croatian: Incidencija reakcija na mjestu injiciranja može se smanjiti uporabom autoinjektora.
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. AST (SGOT), ALT (SGPT) and γ-GT), are recommended prior to initiation and at regular intervals following introduction of Betaferon therapy, and then periodically thereafter in the absence of clinical symptoms.
Croatian: preporučuje se napraviti kompletnu krvnu sliku i diferencijalnu krvnu sliku, odrediti broj trombocita te provesti biokemijske pretrage krvi uključujući testove jetrene funkcije (primjerice, AST (SGOT), ALT (SGPT) i γ -GT) prije početka terapije te u redovnim razmacima nakon uvođenja terapije lijekom Betaferon, a nakon toga periodički u odsustvu kliničkih simptoma.
English: 4 - Open the blister pack containing the vial adapter, but leave the vial adapter inside.
Croatian: 4 - Otvorite blister-pakiranje koje sadrži nastavak za bočicu, ali ne vadite nastavak van.
English: Be sure that the orange tip cap is firmly attached to the solvent syringe!
Croatian: Provjerite da je zatvarač s narančastim vrhom čvrsto pričvršćen na štrcaljku s otapalom.
English: Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) and membranous glomerulopathy (MGN) have been reported during treatment with interferon beta products.
Croatian: Tijekom liječenja lijekovima koji sadrže interferon beta zabilježeni su slučajevi nefrotskog sindroma s različitim nefropatijama u podlozi, uključujući kolabirajuću fokalnu segmentalnu glomerulosklerozu (FSGS), bolest minimalnih promjena (engl. minimal change disease, MCD), membranoproliferativni glomerulonefritis (MPGN) i membransku glomerulopatiju (MGN).
English: ► Checking the content of the pack
Croatian: Provjera sadržaja pakiranja
English: MARKETING AUTHORISATION NUMBER EU/1/95/003/008
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/003/008
English: Ear and labyrinth disorders Ear pain
Croatian: Poremećaji uha i labirinta Bol u uhu
English: − Blood clots in the small blood vessels may occur during your treatment.
Croatian: Tijekom liječenja mogu se pojaviti krvni ugrušci u malim krvnim žilama.
English: Thyroid function tests are recommended regularly in patients with a history of thyroid dysfunction or as clinically indicated.
Croatian: Preporučuje se redovito testiranje funkcije štitnjače u bolesnika s anamnezom poremećaja u radu štitnjače ili kako je klinički indicirano.
English: − During treatment with Betaferon, kidney problems that may reduce your kidney function, including scarring (glomerulosclerosis), may occur.
Croatian: Tijekom liječenja lijekom Betaferon, mogu se javiti problemi s bubrezima koji mogu smanjiti funkciju bubrega, uključujući stvaranje ožiljaka (glomeruloskleroza).
English: At the beginning of treatment side effects are common but in general they become less with further treatment.
Croatian: Na početku liječenja nuspojave su češće, ali obično nestaju s daljnjim liječenjem.
English: Secondary progressive multiple sclerosis: In some cases people with relapsing-remitting MS find that their symptoms increase and they progress to another form of MS called secondary progressive MS. With this, people find themselves becoming increasingly impaired, whether or not they have relapses.
Croatian: Sekundarno progresivna multipla skleroza: U nekim slučajevima osobe s relapsno-remitirajućom multiplom sklerozom primjećuju da su im se simptomi pojačali te da njihova bolest prelazi u drugi oblik, tzv. sekundarno progresivnu multiplu sklerozu.
English: 51368 Leverkusen Germany
Croatian: Bayer AG 51368 Leverkusen Njemačka
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA VIŠESTRUKOG PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)
English: It is a good idea to know where you plan to inject before you prepare your syringe.
Croatian: Dobro je odabrati mjesto injiciranja prije same priprave injekcije.
English: Talk to your doctor, pharmacist or nurse for further information.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri da biste saznali više o toj mogućnosti.
English: AREA 1
Croatian: Tablica 1.
English: Then draw up solution as far as the mark on the syringe:
Croatian: Potom uvucite otopinu sve do oznake na štrcaljki:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bayer AG
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Bayer AG
English: Hepatic injury (including hepatitis), Hepatic failure2
Croatian: hepatitis oštećenje jetre (uključujući hepatitis),
English: Fever Λ * °
Croatian: Λ * °
English: - if you currently suffer from severe depression and/or suicidal thoughts (see ‘Warnings and precautions' and section 4 ‘Possible side effects').
Croatian: - ako trenutačno patite od teške depresije i/ili mislite o samoubojstvu (pogledajte „Upozorenja i mjere opreza“ i dio 4. „Moguće nuspojave“.) - ako imate tešku bolest jetre (pogledajte „Upozorenja i mjere opreza“, „Drugi lijekovi i Betaferon“ i dio
English: It contains specially marked syringes with 0.50 ml marking.
Croatian: Sadrži posebno označene štrcaljke s oznakom za 0,50 ml.
English: As for other beta interferons, severe liver damage, including cases of liver failure, have been reported rarely in patients taking Betaferon.
Croatian: Što se tiče drugih interferona beta, postoje rijetka izvješća o teškim oštećenjima jetre uključujući slučajeve zatajenja jetre u bolesnika koji uzimaju Betaferon.
English: The active substance is interferon beta-1b, 250 microgram per millilitre when reconstituted.
Croatian: Djelatna tvar je interferon beta-1b, 250 mikrograma po mililitru nakon pripreme otopine za primjenu.
English: You should rotate the injection site at every injection.
Croatian: Kod svake injekcije rotirajte mjesto injiciranja.
English: LIST OF EXCIPIENTS Excipients: Human albumin, mannitol
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: ljudski albumin, manitol
English: This first triple pack should be used for treatment days 1, 3 and 5.
Croatian: Prvo trostruko pakiranje treba upotrijebiti za dane liječenja 1, 3 i 5.
English: Before injection, the Betaferon solution has to be prepared from a vial of Betaferon powder and 1.2 ml of liquid from the pre-filled solvent syringe.
Croatian: Prije injiciranja otopinu lijeka Betaferon treba pripremiti iz bočice praška lijeka Betaferon i 1,2 ml tekućine iz napunjene štrcaljke s otapalom.
English: Betaferon should be administered with caution to patients with a history of seizures and to those receiving treatment with anti-epileptics, particularly if their epilepsy is not adequately controlled with anti-epileptics (see sections 4.5 and 4.8).
Croatian: Betaferon treba primjenjivati oprezno u bolesnika s anamnezom epileptičkih napadaja te u onih koji su na terapiji antiepilepticima, posebice ako njihova epilepsija nije odgovarajuće kontrolirana s antiepilepticima
English: p < 0.05 * Significantly associated with Betaferon treatment for RRMS, p < 0.05 ° Significantly associated with Betaferon treatment for SPMS, p < 0.05 § Injection site reaction (various kinds) comprises all adverse events occurring at the injection site,
Croatian: Značajna povezanost s liječenjem lijekom Betaferon za bolesnike s prvim događajem koji ukazuje na MS, p < 0,05 * Značajna povezanost s liječenjem lijekom Betaferon za RRMS, p < 0,05 º Značajna povezanost s liječenjem lijekom Betaferon za SPMS, p < 0,05
English: Betaferon 250 mcg n=292
Croatian: 250 µg n = 292
English: Contents of the pack and other information
Croatian: Sadržaj pakiranja i druge informacije Što Betaferon sadrži
English: Slowly pull the plunger back to withdraw all the solution out of the vial and into the syringe.
Croatian: Polako povucite klip nazad da biste izvukli svu otopinu iz bočice u štrcaljku.
English: Risk reduction Hazard ratio with 95% confidence interval log-rank test
Croatian: Omjer hazarda s intervalom pouzdanosti od 95 %
English: Preparing the injection
Croatian: Priprava injekcije
English: - kidney problems including scarring (glomerulosclerosis) that may reduce your kidney function, uncommon severe loss of appetite leading to weight loss (anorexia), rare disease of the heart muscle (cardiomyopathy), rare sudden shortness of breath (bronchospasm), rare the liver does not work properly (hepatic injury (including hepatitis), hepatic failure), rare problems with your small blood vessels may develop when using medicines like Betaferon (systemic capillary leak syndrome), frequency unknown rash, redness of the skin in the face, joint pain, fever, weakness and others caused by the medicine (drug-induced lupus erythematosus), frequency unknown severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs (pulmonary arterial hypertension), frequency unknown.
Croatian: Vaših bubrega, manje često - jaki gubitak apetita koji vodi do gubitka težine (anoreksija), rijetko - bolest srčanog mišića (kardiomiopatija), rijetko - iznenadan nedostatak zraka (bronhospazam), rijetko - jetra ne radi pravilno (ozljeda jetre (uključujući hepatitis), zatajenje jetre), rijetko - problemi s malim krvnim žilama mogu nastati prilikom primjene lijekova kao što je Betaferon (sindrom povećane propusnosti sistemskih kapilara), učestalost nepoznata - osip, crvenilo kože lica, bol u zglobovima, vrućica, slabost i ostale nuspojave uzrokovane lijekom (lupus eritematosus uzrokovan lijekom), učestalost nepoznata
English: 0.5 ml for the injections at day 7, 9 and 11 of therapy.
Croatian: 0,5 ml za injekcije na dane liječenja 7, 9 i 11.
English: ► Rare (may affect up to 1 in 1,000 users):
Croatian: - promjena boje kože ► Rijetko (mogu se javiti u do 1 na 1000 korisnika):
English: The damage to the CNS can occur within an MS attack (relapse).
Croatian: Oštećenje središnjeg živčanog sustava može se dogoditi tijekom napada multiple skleroze (relaps).
English: Your doctor has prescribed Betaferon to treat your MS. You will best tolerate Betaferon in the beginning if you start with a low dose and gradually increase to the full standard dose (see first part of this leaflet, section 3.
Croatian: Najbolje ćete podnijeti Betaferon u početku terapije ako krenete s malom dozom lijeka koju postupno povećavate do pune standardne doze (pogledajte prvi dio ove upute, dio 3. „Kako primjenjivati Betaferon“).
English: 0.75 ml for the injections at day 13, 15 and 17 of therapy.
Croatian: 0,75 ml za injekcije na dane liječenja 13, 15 i 17.
English: Within this period, the development of neutralising activity was associated with a significant increase in newly active lesions and T2 lesion volume on magnetic resonance imaging.
Croatian: Unutar tog razdoblja, razvoj neutralizirajuće aktivnosti bio je povezan sa značajnim porastom u novo aktiviranim lezijama te volumenu
English: It contains specially marked syringes with 0.25 ml marking.
Croatian: Sadrži posebno označene štrcaljke s oznakom za 0,25 ml.
English: Events were reported at various time points during treatment and may occur several weeks to several years after starting treatment with interferon beta.
Croatian: Događaji su prijavljeni u različito vrijeme tijekom liječenja i mogu se pojaviti nekoliko tjedana do nekoliko godina nakon početka liječenja interferonom beta.
English: 1.0 ml * The titration period may be adjusted, if any significant adverse reaction occurs.
Croatian: * Razdoblje titracije može se prilagoditi u slučaju pojave značajnih nuspojava.
English: MARKETING AUTHORISATION NUMBER EU/1/95/003/007
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/95/003/007
English: SN
Croatian: SN NN
English: System Organ Class Adverse Event and Laboratory Abnormalities
Croatian: Štetni događaji i laboratorijske abnormalnosti
English: One controlled clinical trial with Betaferon in patients with relapsing-remitting multiple sclerosis and able to walk unaided (baseline EDSS 0 to 5.5) was performed.
Croatian: Provedeno je jedno kontrolirano kliničko ispitivanje s lijekom Betaferon u bolesnika s relapsno- remitirajućom multiplom sklerozom koji hodaju samostalno (početne vrijednosti na EDSS ljestvici od 0 do 5,5).
English: − if you notice pain in your belly which is radiating to your back, and/or you feel sick or have a fever.
Croatian: Ako ste osjetili bol u trbuhu koja se širi prema leđima i/ili osjećate mučninu ili imate povišenu tjelesnu temperaturu.
English: Betaferon contains 300 microgram (9.6 million IU) of recombinant interferon beta-1b per vial.
Croatian: Betaferon sadrži 300 mikrograma (9,6 milijuna IU) rekombinantnog interferona beta-1b po bočici.
English: • 3 Betaferon vials (with powder for solution for injection)
Croatian: • 3 bočice lijeka Betaferon (s praškom za otopinu i injekciju):
English: - painful joints (arthralgia)
Croatian: bolnost zglobova (artralgija)
English: The following adverse event listing is based on reports from clinical trials (Table 1, adverse events and laboratory abnormalities) and from the post-marketing surveillance (Table 2, frequencies - where known- based on pooled clinical trials (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)) of Betaferon use.
Croatian: Poremećaji reproduktivnog sustava i dojki menoragija učestalosti temeljene na objedinjenim kliničkim ispitivanjima (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).
English: The solvent for Betaferon is provided in a 2.25-millilitre pre-filled syringe and contains 1.2 ml sodium chloride solution 5.4 mg/ml (0.54% w/v).
Croatian: Otapalo za Betaferon dostupno je u napunjenoj štrcaljki od 2,25 ml i sadrži 1,2 ml otopine natrijevog klorida 5,4 mg/ml (0,54 % m/V).
English: The Betaferon powder is provided in a 3-millilitre vial, containing 300 microgram (9.6 million IU) interferon beta-1b per vial.
Croatian: Betaferon prašak dostupan je u bočici od 3 ml koja sadrži 300 mikrograma (9,6 milijuna IU) interferona beta-1b po bočici.
English: However, the in-use stability has been demonstrated for 3 hours at 2-8 °C.
Croatian: Ipak, dokazana je stabilnost prilikom primjene tijekom 3 sata pri temperaturi 2-8°C.
English: − if you have loss of appetite, fatigue, feeling sick , repeated vomiting, especially if you notice widespread itching, yellowing of the skin or of the whites of the eyes, or easy bruising.
Croatian: − ako ste izgubili apetit, osjećate se umorno, imate mučninu, opetovano povraćate, a osobito ako imate svrbež po cijelom tijelu, žutu boju kože ili bjeloočnica ili Vam lako nastaju modrice.
English: Τηλ: +357 22 48 38 58
Croatian: NOVAGEM Limited Τηλ: +357 22 48 38 58
English: The schedule shown in the diagram below will help you to vary the sites appropriately.
Croatian: Raspored prikazan na donjem dijagramu pomoći će
English: If the patient has multiple lesions Betaferon should be discontinued until healing has occurred.
Croatian: Ako bolesnik ima višestruke lezije potrebno je prekinuti terapiju lijekom Betaferon dok lezije na zacijele.
English: Cases of thrombotic microangiopathy, manifested as thrombotic thrombocytopenic purpura (TTP) or haemolytic uraemic syndrome (HUS), including fatal cases, have been reported with interferon beta products.
Croatian: Tijekom liječenja lijekovima koji sadrže interferon beta prijavljeni su slučajevi trombotičke mikroangiopatije, koja se očituje kao trombotička trombocitopenička purpura (TTP) ili hemolitički uremički sindrom (HUS), uključujući smrtne slučajeve.
English: Slowly push the plunger of the syringe in all the way to transfer all of the solvent into the vial.
Croatian: Lagano pogurajte klip štrcaljke cijelu duljinu da biste prebacili svo otapalo u bočicu.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Betaferon Lijek čuvajte izvan pogleda i dohvata djece.
English: ► Flu-like symptoms such as fever, chills, painful joints, malaise, sweating, headache, or muscular pain.
Croatian: Najčešće primijećene nuspojave su: ► Simptomi nalik gripi kao što su vrućica, zimica, bolni zglobovi, malaksalost, znojenje, glavobolja ili bolovi u mišićima.
English: Rotation Cycle 6: Middle right section of each area
Croatian: Rotacijski ciklus 1: Gornji lijevi dio svakog područja Rotacijski ciklus 2: Donji desni dio svakog područja Rotacijski ciklus 3: Srednji lijevi dio svakog područja Rotacijski ciklus 4: Gornji desni dio svakog područja Rotacijski ciklus 5: Donji lijevi dio svakog područja Rotacijski ciklus 6: Srednji desni dio svakog područja
English: Events were reported at various time points during treatment and may occur after several years of treatment with interferon beta.
Croatian: Događaji su zabilježeni u različitim stadijima tijekom liječenja i mogu se javiti nakon nekoliko godina liječenja interferonom beta.
English: Symptoms include redness, swelling, change in the skin colour, inflammation, pain and hypersensitivity.
Croatian: Simptomi uključuju crvenilo, oticanje, promjenu boje kože, upalu, bol i preosjetljivost.
English: In addition, the following side effects have been identified during post-marketing experience
Croatian: Nadalje, sljedeće nuspojave su identificirane nakon stavljanja lijeka na tržište:
English: Do not use Betaferon
Croatian: Nemojte primjenjivati Betaferon
English: Betaferon microgram (Placebo) n=124 (n=123)
Croatian: Betaferon mikrograma (placebo) n = 124 (n =
English: Now you are ready to attach the pre-filled solvent syringe to the vial adapter.
Croatian: Sad ste spremni pričvrstiti napunjenu štrcaljku s otapalom na nastavak za bočicu.
English: 12 - Examine the solution carefully.
Croatian: 12 - Pažljivo pregledajte otopinu.
English: − If you have ever had seizures or if you are taking medicines to treat epilepsy (antiepileptics), your doctor will monitor your treatment carefully (see also ‘Other medicines and Betaferon' and section 4.
Croatian: (antiepileptike), Vaš će liječnik pomno nadzirati Vaše liječenje (pogledajte također „Drugi lijekovi i
English: Flu-like symptoms & Λ *°
Croatian: Simptomi nalik gripi & Λ *° 44 % (18 %)
English: Giving many times the dose of Betaferon recommended for the treatment of multiple sclerosis has not led to life-threatening situations.
Croatian: Ako primijenite više lijeka Betaferon nego što ste trebali Primjena lijeka Betaferon u dozi više puta većoj od preporučene doze za liječenje multiple skleroze nije uzrokovala po život opasne situacije.
English: 3 Vials with powder for solution for injection, each containing 300 microgram (9.6 million IU).
Croatian: 3 bočice s praškom za otopinu za injekciju, svaka sadrži 300 mikrograma (9,6 milijuna IU).
English: In-use stability demonstrated for 3 hours at 2-8 °C.
Croatian: Dokazana stabilnost otopine u primjeni je 3 sata na temperaturi od 2 do 8 °C.
English: If too much solution enters the vial along with the air bubbles, get back into the horizontal position (see pict.
Croatian: Ako previše otopine ulazi u bočicu skupa s mjehurićima zraka, položite štrcaljku u vodoravni položaj (pogledajte sliku 13) te povucite klip malo nazad da biste uvukli otopinu nazad u bočicu.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL OF VIAL (BETAFERON)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI (BETAFERON)
English: − Set up a permanent storage area in a convenient location out of the sight and reach of children so your Betaferon and other supplies are always easy to find.
Croatian: Nađite prikladno stalno mjesto za čuvanje injekcija lijeka Betaferon i ostalog potrebnog pribora izvan pogleda i dohvata djece na mjestu gdje ćete ih lako naći.
English: Solvent (with sodium chloride solution 5.4 mg/ml (0.54% w/v)): 2.25 ml pre-filled syringe (type I glass) with 1.2 ml solvent.
Croatian: Otapalo (otopina natrijevog klorida od 5,4 mg/ml (0,54 % m/V)): napunjena štrcaljka od 2,25 ml (staklo tip I) s 1,2 ml otapala.
English: Injection site reactions may occur less frequently, if you use an auto-injector device.
Croatian: Reakcije na mjestu injiciranja rjeđe se događaju ako upotrebljavate autoinjektor.
English: m. b. H. Tel: +43-(0)1-711 46-0
Croatian: Tel: +43-(0)1-711 46-0
English: If you have a Betaferon titration pack you will find 4 differently coloured and numbered triple packs, each containing:
Croatian: Ako imate titracijsko pakiranje lijeka Betaferon u njemu ćete naći četiri različito obojana i numerirana pakiranja od kojih svako sadrži:
English: Luxembourg / Luxemburg Bayer SA-NV
Croatian: Bayer SA-NV
English: Thrombocytopenia Thrombotic microangiopathy including thrombotic thrombocytopenic purpura/ haemolytic uraemic syndrome3
Croatian: uključujući trombotičku trombocitopeničku purpuru/ hemolitički uremički sindrom
English: White blood cell count decreased (<3,000/mm³) × Λ * °
Croatian: Smanjeni broj leukocita (< 3000/mm³) × Λ * °
English: As for other beta interferons, severe hepatic injury, including cases of hepatic failure, has been reported rarely in patients treated with Betaferon.
Croatian: Što se tiče drugih interferona beta, postoje rijetka izvješća o teškim oštećenjima jetre uključujući slučajeve zatajenja jetre u bolesnika koji se liječe lijekom Betaferon.
English: Start by using the yellow triple pack which is clearly marked with a “1” on the top right hand side of the box.
Croatian: Počnite sa žutim trostrukim pakiranjem koje je jasno označeno s „1“ na gornjoj desnoj strani kutije.
English: - infection, abscess
Croatian: - infekcija, apsces
English: Year 5 results Open-label follow-up
Croatian: Rezultati iz pete godine Praćenje u fazi otvorenog liječenja
English: Caution should be used and close monitoring considered when administering interferon beta to patients with severe renal failure.
Croatian: Poremećaji bubrega i mokraćnog sustava Potreban je oprez i pomno praćenje prilikom primjene interferona beta u bolesnika s teškim zatajenjem bubrega.
English: In the open-label follow-up phase, the treatment effect on CDMS was still evident after 3 and 5 years (Table 3) even though the majority of patients from the placebo-group were treated with Betaferon at least from the second year onwards.
Croatian: (Tablica 3), iako je većina bolesnika iz placebo skupine liječena s lijekom Betaferon najmanje od druge godine nadalje.
English: Clinical efficacy and safety
Croatian: Klinička djelotvornost i sigurnost: RR-MS
English: Triple pack 4 is designed to help you prepare the next 3 injections (days 19, 21 and 23).
Croatian: Trostruko pakiranje br. 4 osmišljeno je da Vam pomogne u pripremi sljedeće tri injekcije (dani 19, 21 i 23).
English: Symptoms can be redness, swelling, discolouration, inflammation, pain, hypersensitivity, tissue damage (necrosis).
Croatian: Simptomi mogu biti crvenilo, oticanje, promjena boje, upala, bol, preosjetljivost, oštećenje tkiva (nekroza).
English: Do not use Betaferon if you notice it contains particles or is discoloured.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da otopina sadrži čestice ili je promijenila boju.
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 kao što su svrbež po cijelom tijelu, oticanje lica i/ili jezika ili iznenadni nedostatak zraka.
English: Pack comprising 15 single packs, part of a 3-month pack containing 45 (3 x 15) single packs.
Croatian: Pakiranje se sastoji od 15 pojedinačnih pakiranja te je dio tromjesečnog pakiranja koje sadrži 45 pojedinačnih pakiranja (3x15).
English: ► Uncommon (may affect up to 1 in 100 users):
Croatian: - menstrualni poremećaji (menoragija) ► Manje često (mogu se javiti u do 1 na 100 korisnika):