FrancophonIA/ELRC3.0 huggingface dataset:
English: • Gently swirl the liquid, sliding the vial in a circular motion on a flat surface.
Croatian: • Lagano promiješajte tekućinu, klizeći bočicom kružnim pokretom po ravnoj površini.
English: However, monitor LTs monthly to determine if further increases occur.
Croatian: Međutim, potrebno je pratiti testove jetrene funkcije svaki mjesec kako bi se ustanovilo dolazi li do daljnjih povećanja.
English: Psychiatric disorders abnormal dreams panic attack, short term memory loss, apathy, confusion, sleep disorder, libido increased anger
Croatian: Psihijatrijski poremećaji neobični snovi napadaji panike, kratkoročni gubitak pamćenja, apatija, konfuzija, poremećaj spavanja, povećanje libida ljutnja
English: Meniere's disease
Croatian: Meniereova bolest
English: The mean total body systemic clearance of pegvisomant following multiple doses is estimated to be 28 ml/h for subcutaneous doses ranging from 10 to 20 mg/day.
Croatian: Prosječni ukupni tjelesni sistemski klirens pegvisomanta nakon višekratnih doza procijenjen je na 28 ml/h kod supkutane primjene doza od 10 do 20 mg na dan.
English: Before withdrawing the dissolved Somavert invert the vial with the syringe still inserted into it and ensure the gap in the stopper can be seen as shown in the diagram below:
Croatian: Prije izvlačenja otopljenog lijeka Somavert, okrenite naopako bočicu sa štrcaljkom još uvijek umetnutom u bočicu i pazite da vidite otvor u čepu kako je to prikazano na donjoj slici:
English: Solvent for SOMAVERT SC
Croatian: Otapalo za SOMAVERT s.c.
English: At least 5 times ULN, or transaminase elevations at least 3 times ULN associated with any increase in serum TBIL (with or without signs/symptoms of hepatitis or other liver injury)
Croatian: Povišene najmanje 5 puta od GGN ili transaminaze povišene najmanje 3 puta od GGN, povezano s bilo kojim povećanjem ukupnog bilirubina u serumu (sa znakovima/simptomima hepatitisa ili drugih oštećenja jetre ili bez njih)
English: Inhibition of growth hormone action with pegvisomant leads to decreased serum concentrations of insulin-like growth factor-I (IGF-I), as well as other growth hormone-responsive serum proteins such as free IGF-I, the acid-labile subunit of IGF-I (ALS), and insulin-like growth factor binding protein-3 (IGFBP-3).
Croatian: Inhibicija djelovanja hormona rasta pomoću pegvisomanta dovodi do smanjenja koncentracije inzulinu sličnog čimbenika rasta 1 (IGF-1) u serumu, kao i drugih serumskih proteina koji reagiraju na hormon rasta, kao što su slobodni IGF-I, podjedinice IGF-1 osjetljive na kiselinu (ALS) i protein koji veže inzulinu sličan čimbenik rasta 3 (IGFBP-3).
English: Very common may affect more than 1 in 10 people:
Croatian: Vrlo često: može se javiti u više od 1 na 10 osoba
English: Note: If you see air in the syringe, tap the barrel to float the bubbles to the top,and then gently push the bubbles out into the vial.
Croatian: Napomena: Ako uočite zrak u štrcaljki tapkajte po tijelu štrcaljke kako biste potjerali mjehuriće na vrh i potom lagano pogurajte mjehuriće van u bočicu.
English: or several days after administration.
Croatian: Mogu se pojaviti odmah ili nekoliko dana nakon primjene.
English: SOMAVERT contains sodium
Croatian: SOMAVERT sadrži natrij
English: • Slowly pull back the plunger rod to withdraw as much medicine as possible from the vial.
Croatian: • Polako povucite klip kako biste povukli što je više moguće lijeka iz bočice.
English: Do not use this medicine after the expiry date which is stated on the vial and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza oznake „Rok valjanosti” ili „EXP”.
English: About 17% of patients will develop antibodies to growth hormone during treatment.
Croatian: Oko 17% bolesnika razvit će antitijela na hormon rasta tijekom liječenja za koje se ne čini da utječu na učinkovitost ovog lijeka.
English: Effects on ability to drive and use machines
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima
English: In cases of overdose, administration of this medicine should be discontinued and not resumed until IGF-I levels return to within or above the normal range.
Croatian: U slučaju predoziranja potrebno je prekinuti primjenu pegvisomanta i nastaviti s primjenom tek nakon što se razine IGF-1 vrate unutar ili iznad raspona normalnih vrijednosti.
English: • Push the needle through the centre of vial stopper, as shown.
Croatian: • Pogurajte iglu kroz središte čepa bočice kako je prikazano.
English: Serum IGF-I concentrations should be measured every four to six weeks and appropriate dose adjustments made in increments of 5 mg/day in order to maintain the serum IGF-I concentration within the age-adjusted normal range and to maintain an optimal therapeutic response.
Croatian: Koncentracije IGF-1 u serumu potrebno je mjeriti svakih četiri do šest tjedana i odgovarajuće povećavati dozu za po 5 mg na dan do kako bi se koncentracija IGF-1 u serumu održala unutar normalnog raspona prilagođenog za dob i kako bi se zadržao optimalni terapijski odgovor.
English: 10 vials of powder
Croatian: 10 bočica s praškom
English: A loading dose of 80 mg pegvisomant should be administered subcutaneously under medical supervision.
Croatian: Udarna doza od 80 mg pegvisomanta primjenjuje se supkutano pod liječničkim nadzorom.
English: For pegvisomant no clinical data on exposed pregnancies are available.
Croatian: Nema dostupnih kliničkih podataka o izloženosti pegvisomantu tijekom trudnoće.
English: Greater than 3 but less than 5 times ULN (without signs/symptoms of hepatitis or other liver injury, or increase in serum TBIL)
Croatian: Povišene >3 puta, ali <5 puta od GGN (bez znakova/simptoma hepatitisa ili drugih oštećenja jetre, odnosno povećanja ukupnog bilirubina u serumu)
English: • Immediately perform a comprehensive hepatic workup.
Croatian: • Odmah provesti sveobuhvatan pregled jetre.
English: Foam makes the medicine unusable.
Croatian: Pjena čini lijek neupotrebljivim.
English: • Lack of interest, feeling confused, increased sex drive, panic attack, loss of memory, problems sleeping.
Croatian: • nezainteresiranost, osjećaj smetenosti, pojačan spolni nagon, napadi panike, gubitak pamćenja,
English: The metabolism of pegvisomant has not been studied.
Croatian: Metabolizam pegvisomanta nije ispitivan.
English: Dose adjustments should be based on serum IGF-I levels.
Croatian: Dozu treba prilagoditi na temelju razine IGF-1 u serumu.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using SOMAVERT.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite SOMAVERT.
English: • Support the syringe while the needle is in the vial stopper to prevent bending the needle.
Croatian: • Držite štrcaljku dok je igla u čepu bočice kako biste spriječili savijanje igle.
English: Serum IGF-I concentrations should be monitored and maintained within the age-adjusted normal range by adjustment of the pegvisomant dose.
Croatian: Potrebno je pratiti koncentracije IGF-1 u serumu i održavati ih unutar normalnog raspona prilagođenog za dob prilagođavanjem doze pegvisomanta.
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Croatian: Nakon rekonstitucije: Uvjete čuvanja nakon rekonstitucije lijeka vidjeti u dijelu 6.3.
English: Dose-dependent, statistically significant reductions in mean IGF-I (p<0.0001), free IGF-I (p<0.05), IGFBP-3 (p<0.05) and ALS (p<0.05) were observed at all post-baseline visits in the pegvisomant treatment groups.
Croatian: Na svim kontrolnim pregledima bolesnika iz skupina koje su primale pegvisomant opažena su statistički značajna, o dozi ovisna sniženja prosječnih vrijednosti IGF-1 (p<0,0001), slobodnog IGF-1 (p<0,05), IGFBP-3 (p<0,05) i ALS (p<0,05).
English: • Dizziness, sleepiness, uncontrolled trembling, decreased sense of touch.
Croatian: • omaglica, pospanost, nekontrolirano drhtanje, smanjen osjet dodira
English: • Muscle pain, arthritis.
Croatian: • bol u mišićima, artritis
English: Incompatibilities
Croatian: 6.2 Inkompatibilnosti
English: • Dry mouth, increased saliva, tooth problems, haemorrhoids.
Croatian: • suha usta, pojačano izlučivanje sline, problemi sa zubima, hemoroidi.
English: This medicine must be dissolved before use.
Croatian: Ovaj lijek se prije primjene mora otopiti.
English: When adding the solvent from the syringe the vial and syringe should held at an angle as shown in the diagram below.
Croatian: Prilikom dodavanja otapala iz štrcaljke, bočicu i štrcaljku treba držati pod kutom prikazanim na donjoj slici.
English: Note: Make sure you keep the needle in at full depth.
Croatian: Napomena: Pazite da je igla u potpunosti ubodena u kožu.
English: The effects of SOMAVERT in pregnant women are not known, and so the use of this medicine in pregnant women is not recommended.
Croatian: Budući da nisu poznati učinci ovog lijeka u trudnica, njegova se primjena ne preporučuje.
English: • Support both the syringe and vial in one hand, as shown.
Croatian: • Držite i štrcaljku i bočicu jednom rukom kako je prikazano.
English: • Decreased platelets in the blood, increased or decreased white cells in the blood, tendency to bleed.
Croatian: • smanjen broj krvnih pločica u krvi, povećan ili smanjen broj bijelih krvnih stanica u krvi,
English: Signs or symptoms suggestive of hepatitis or other liver injury (e.g., jaundice, bilirubinuria, fatigue, nausea, vomiting, right upper quadrant pain, ascites, unexplained edema, easy bruisability)
Croatian: Znakovi ili simptomi koji ukazuju na hepatitis ili druga oštećenja jetre (npr. žutica, bilirubinurija, umor, mučnina, povraćanje, bol u gornjem desnom kvadrantu, ascites, edem koji se ne može objasniti, lako dobivanje modrica)
English: After preparing the SOMAVERT solution it must be used immediately.
Croatian: Nakon pripreme lijeka, SOMAVERT otopina se mora odmah primijeniti.
English: The active substance in SOMAVERT, pegvisomant is known as a growth hormone receptor antagonist.
Croatian: Djelatna tvar u lijeku SOMAVERT, pegvisomant, poznata je kao antagonist receptora hormona rasta.
English: Special precautions for disposal and other handling The syringe and safety needle used to administer the injection are provided with the medicinal product.
Croatian: Štrcaljka i sigurnosna igla koje se koriste za primjenu injekcije isporučuju se s lijekom.
English: Every four to six weeks your doctor will make appropriate dose adjustments, made in increments of 5 mg pegvisomant/day, based on your so-called serum IGF-I levels to maintain an optimal therapeutic response.
Croatian: Vaš će liječnik napraviti odgovarajuću prilagodbu doze pegvisomanta povisujući je za 5 mg na dan na temelju razine takozvanog IGF-1 u serumu, da bi se održao optimalan terapijski odgovor.
English: Pegvisomant has significant structural similarity to growth hormone which causes it to cross-react in commercially available growth hormone assays.
Croatian: Pegvisomant ima značajnu sličnost u strukturi s hormonom rasta, što uzrokuje križnu reakciju pri primjeni komercijalno dostupnih testova za hormon rasta.
English: In the week following discontinuation of treatment the adverse reactions noted were: insomnia, increased fatigue, oedema peripheral, tremor, and weight gain.
Croatian: U tjednu nakon prekida liječenja zabilježene nuspojave bile su nesanica, pojačan umor, periferni edemi, tremor i porast tjelesne težine.
English: Check medicine
Croatian: Provjerite lijek
English: 10 mg or 15 mg or 20 mg or 25 mg or 30 mg of pegvisomant in powder in a vial (type I flint glass) with a stopper (chlorobutyl rubber) and 1 ml solvent (water for injections) in a pre-filled syringe (type I borosilicate glass) with a plunger stopper (bromobutyl rubber) and a tip cap (bromobutyl rubber).
Croatian: 10 mg ili 15 mg ili 20 mg ili 25 mg ili 30 mg pegvisomanta u prašku u bočici (silikatno staklo tipa I) s čepom (klorobutilna guma) i 1 ml otapala (voda za injekcije) u napunjenoj štrcaljki (borosilikatno staklo tipa I) sa čepom klipa (brombutilna guma) i zatvaračem vrha (brombutilna guma).
English: • Gently pinch the skin at the site of injection.
Croatian: • Nježno uhvatite kožni nabor na mjestu injiciranja.
English: • Increased blood cholesterol, weight gain, increased blood glucose, decreased blood glucose.
Croatian: • povišen kolesterol u krvi, porast tjelesne težine, povišena razina šećera u krvi, snižena razina šećera u krvi
English: Pull the needle down so that the needle tip is at its lowest point in the liquid.
Croatian: Povucite iglu prema dolje tako da se vrh igle nalazi na najnižoj točki u tekućini.
English: Nervous system disorders headache somnolence, tremor, dizziness, hypoaesthesia narcolepsy, migraine, dysgeusia
Croatian: Poremećaji živčanog sustava glavobolja somnolencija, tremor, omaglica, hipoestezija narkolepsija, migrena, disgeuzija
English: SOMAVERT 10 mg and 15 mg Pack size of 30 vials, pre-filled syringes and safety needles.
Croatian: SOMAVERT 10 mg i 15 mg Veličina pakiranja od 30 bočica, napunjenih štrcaljki i sigurnosnih igala.
English: There is limited experience of overdose with pegvisomant.
Croatian: Iskustvo s predoziranjem pegvisomantom je ograničeno.
English: • Bruising or bleeding at injection site, soreness or swelling at injection site, build up of fat below the surface of the skin at injection site, swelling of the extremities, weakness, fever.
Croatian: • modrica ili krvarenje na mjestu primjene injekcije, bolnost ili oteknuće na mjestu primjene injekcije, nakupljanje masnog tkiva ispod površine kože na mjestu injekcije, oticanje udova,
English: • Abnormal dreams.
Croatian: • neobični snovi
English: QUESTIONS & ANSWERS What should I do if anything has accidentally touched the vial stopper?
Croatian: Što moram učiniti ako je nešto slučajno dotaknulo čep bočice?
English: Before attaching the supplied safety needle the syringe cap will need to be removed from the pre-filled syringe.
Croatian: Prije pričvršćivanja isporučene sigurnosne igle potrebno je skinuti zatvarač štrcaljke s napunjene štrcaljke.
English: • Turn the vial so that you can see the stopper gap, as shown.
Croatian: • Okrenite bočicu tako da vidite otvor u čepu kako je prikazano.
English: Pegvisomant is an analogue of human growth hormone that has been genetically modified to be a growth hormone receptor antagonist.
Croatian: Pegvisomant je analog ljudskog hormona rasta koji je genetski modificiran tako da djeluje kao antagonist receptora hormona rasta.
English: • Pull the needle down so that the needle tip is at the lowest point in the liquid.
Croatian: • Povucite iglu prema dolje tako da se vrh igle nalazi na najnižoj točki u tekućini.
English: in acromegalic patients with diabetes mellitus, doses of insulin or hypoglycaemic medicinal products may need to be decreased (see section 4.5).
Croatian: Stoga može biti potrebno smanjiti doze inzulina ili hipoglikemijskih lijekova akromegaličnim bolesnicima s dijabetesom melitusom (vidjeti dio 4.5).
English: The powder is white to slightly off-white.
Croatian: Prašak je bijele do blago bjelkaste boje.
English: Do not use SOMAVERT:
Croatian: Nemojte primjenjivati SOMAVERT
English: Elevated, but less than or equal to 3 times ULN
Croatian: Povišene, ali ≤3 puta od GGN
English: Caution: Do not let the end of the syringe touch anything when the syringe cap is off.
Croatian: Oprez: Pazite da kraj štrcaljke ne dođe ni sa čim u doticaj nakon što je skinut zatvarač štrcaljke.
English: The serum IGF-1 was normalised at the end of the study (week 12) in 9.7%, 38.5%, 75% and 82% of subjects treated with placebo, 10 mg/day, 15 mg/day or 20 mg/day pegvisomant respectively.
Croatian: Serumski IGF-1 imao je normalne vrijednosti na kraju ispitivanja (12. tjedan) u 9,7% ispitanika liječenih placebom, 38,5% ispitanika liječenih dozom pegvisomanta od 10 mg na dan, 75% ispitanika liječenih dozom pegvisomanta od 15 mg na dan i 82% ispitanika liječenih dozom pegvisomanta od 20 mg na dan.
English: • Anger
Croatian: • bijes
English: To avoid this, use a slightly different place for your injection each time, as described in Step 2 of the ‘instructions for preparing and giving an injection of Somavert' section of this leaflet.
Croatian: Da bi se to izbjeglo, svaki put primijenite injekciju na malo drugačije mjesto, kako je opisano u 2. koraku
English: How to use SOMAVERT
Croatian: Kako primjenjivati SOMAVERT
English: If air is seen in the syringe, tap the barrel to float the bubbles to the top, and then gently push the bubbles out into the vial.
Croatian: Ako uočite zrak u štrcaljki, prstom tapkajte po tijelu štrcaljke kako biste potjerali mjehuriće na vrh, a potom lagano istisnite mjehuriće van u bočicu.
English: If you inject more SOMAVERT than you should If you accidentally inject more SOMAVERT than told to by your doctor it is unlikely to be serious, but you should contact your doctor, pharmacist or nurse immediately.
Croatian: Ako ste slučajno ubrizgali više lijeka SOMAVERT nego što Vam je odredio liječnik, odmah se obratite svom liječniku, ljekarniku ili medicinskoj sestri iako nije vjerojatno da ćete imati ozbiljnih posljedica.
English: Remove needle cover
Croatian: Skinite poklopac igle
English: Metabolism and nutrition disorders hypercholesterol aemia, hyperglycaemia, hypoglycaemia, weight increased hypertriglyceridemia
Croatian: Poremećaji metabolizma i prehrane hiperkolesterolemija, hiperglikemija, hipoglikemija, povećanje tjelesne težine hipertrigliceridemija
English: Assessment of baseline levels of liver enzymes prior to initiation of SOMAVERT Prior to the start of SOMAVERT, patients should have an assessment of baseline levels of liver tests (LTs) [serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin (TBIL), and alkaline phosphatase (ALP)].
Croatian: Procjena početnih vrijednosti jetrenih enzima prije početka liječenja lijekom SOMAVERT Prije početka primjene lijeka SOMAVERT potrebno je procijeniti početne vrijednosti testova jetrene funkcije bolesnika [alanin aminotransferaze (ALT) i aspartat aminotransferaze (AST) u serumu, ukupnog bilirubina u serumu i alkalne fosfataze].
English: Пфайзер Люксембург САРЛ, Клон България Pfizer Kft.
Croatian: Пфайзер Люксембург САРЛ, Клон България
English: • Keep the syringe upright to avoid leakage.
Croatian: • Držite štrcaljku u uspravnom položaju kako biste izbjegli curenje.
English: General disorders and administration site conditions injection site reaction (including injection site hypersensitivity), injection site bruising or bleeding, injection site hypertrophy (e.g. lipohypertro phy)
Croatian: Opći poremećaji i reakcije na mjestu primjene reakcija na mjestu primjene injekcije (uključujući preosjetljivost na mjestu primjene injekcije), modrica ili krvarenje na mjestu primjene, hipertrofija na mjestu primjene injekcije (npr. lipohipertrofija)
English: • Throw the needle cover away; it is not needed again.
Croatian: • Bacite poklopac za iglu; nećete ga više trebati.
English: A growth hormone deficient state may result from administration of this medicinal product, despite the presence of elevated serum growth hormone levels.
Croatian: Primjena ovog lijeka može dovesti do simptoma nedostatka hormona rasta unatoč povišenim vrijednostima hormona rasta u serumu.
English: influenza-like illness, fatigue,
Croatian: • bolest slična gripi, umor
English: You should continue to inject this medicine for as long as instructed by your doctor.
Croatian: Ovaj lijek trebate primjenjivati onoliko dugo koliko Vam je to rekao liječnik.
English: • Pull the needle out of the vial.
Croatian: • Izvucite iglu iz bočice.
English: • Press the plunger very slowly so that the liquid gently runs down the inside of the vial.
Croatian: • Pritišćite klip vrlo polako tako da tekućina lagano curi niz stijenku bočice.
English: For pegvisomant no data on fertility are available.
Croatian: Nisu dostupni podaci o utjecaju pegvisomanta na plodnost.
English: • Protein in the urine, increased urine, kidney problems.
Croatian: • proteini u mokraći, pojačano mokrenje, problemi sa bubrezima.
English: • Rapid swelling of skin and underlying tissue and inner lining (mucosa) of organs
Croatian: • ubrzano oticanje kože i potkožnog tkiva te sluznice organa (angioedem)
English: Gastrointestinal disorders diarrhoea vomiting, constipation, nausea, abdominal distension, dyspepsia, flatulence haemorrhoids, salivary hypersecretion, dry mouth, tooth disorder
Croatian: Poremećaji probavnog sustava proljev povraćanje, konstipacija, mučnina, distenzija abdomena, dispepsija, flatulencija hemoroidi, hipersekrecija sline, suha usta, poremećaj zuba
English: Caution: Do not let the needle touch anything.
Croatian: Oprez: Pazite da igla ne dođe ni sa čim u doticaj.
English: • May continue therapy with SOMAVERT.
Croatian: • Moguće je nastaviti terapiju lijekom SOMAVERT.
English: Somavert powder in vial with solvent in a pre-filled syringe pegvisomant for injection For Subcutaneous Injection Only single dose vial
Croatian: Somavert prašak u bočici s otapalom u napunjenoj štrcaljki pegvisomant za injekciju Samo za supkutanu injekciju jednodozna bočica
English: PHARMACOLOGICAL PROPERTIES 5.1.
Croatian: 5.1 Farmakodinamička svojstva
English: Blood and lymphatic system disorders thrombocytopenia, leukopenia, leukocytosis, haemorrhagic diathesis
Croatian: Poremećaji krvi i limfnog sustava trombocitopenija, leukopenija, leukocitoza, hemoragijska dijateza
English: In the event of either being observed, discard the medicinal product..
Croatian: U slučaju da uočite bilo što od navedenog, bacite lijek.
English: A starting dose of 80 mg of pegvisomant will be given subcutaneously (just under the skin) by your doctor.
Croatian: Početnu dozu od 80 mg pegvisomanta u obliku potkožne injekcije (ispod kože) dat će Vam liječnik.
English: Store the powder vial(s) in a refrigerator (2C - 8C) in their outer carton in order to protect from light.
Croatian: Bočica (e) sa praškom čuvati u hladnjaku (2°C-8°C) u vanjskom pakiranju radi zaštite od svjetlosti.
English: Inject medicine
Croatian: Injicirajte lijek
English: Swirl vial
Croatian: Zatvarač štrcaljke
English: Add the solvent to the vial of powder.
Croatian: Dodajte otapalo u bočicu s praškom.
English: • Fold the needle guard out of the way of the needle cover.
Croatian: • Presavijte štitnik za iglu dalje od poklopca za iglu.
English: Store the pre-filled syringe(s) below 30C or store in a refrigerator.
Croatian: Napunjena štrcaljka(e) se može čuvati ispod 30C ili u frižideru.
English: • An alcohol swab.
Croatian: • Vatica natopljena alkoholom.
English: PHARMACEUTICAL FORM Powder and solvent for solution for injection (powder for injection).
Croatian: Prašak i otapalo za otopinu za injekciju (prašak za injekciju).
English: Musculoskeletal and connective tissue disorders arthralgia myalgia, arthritis
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva artralgija mialgija, artritis
English: • Throw the syringe cap away; it is not needed again.
Croatian: • Bacite zatvarač štrcaljke; nećete ga više trebati.
English: • Fold the needle guard over the needle.
Croatian: • Presavijte štitnik za iglu preko igle.
English: Systemic hypersensitivity reactions including anaphylactic/anaphylactoid reactions, laryngospasm, angioedema, generalized skin reactions (rash, erythema, pruritus, urticaria).have been reported in post marketing use.
Croatian: Kod primjene nakon stavljanja lijeka u promet zabilježene su sistemske reakcije preosjetljivosti uključujući anafilaktičke/anafilaktoidne reakcije, laringospazam, angioedem i generalizirane kožne reakcije (osip, eritem, svrbež, urtikarija).
English: • Facial swelling, dry skin, night sweats, redness of the skin (erythema), raised itchy bumps on the skin (urticaria).
Croatian: • oticanje lica, suha koža, noćno znojenje, crvenilo kože (eritema), izdignute natekline na koži koje svrbe (urtikarija).
English: Immune system disorders hypersensitivity reactionsb anaphylactic reactionb, anaphylactoid reactionb
Croatian: Poremećaji imunološkog sustava reakcije preosjetljivosti anafilaktička reakcija b,, anafilaktoidna reakcija
English: Respiratory, thoracic and mediastinal disorders dyspnoea laryngospasmb
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja dispneja laringospazam