FrancophonIA/ELRC3.0 huggingface dataset:
English: The most commonly reported adverse reactions occurring in  10% of patients with acromegaly treated with pegvisomant during the clinical trials were headache 25%, arthralgia 16% and diarrhoea
Croatian: Najčešće zabilježene nuspojave nastale u ≥10% bolesnika s akromegalijom liječenom pegvisomantom tijekom kliničkih ispitivanja bile su glavobolja u 25%, artralgija u 16% i proljev u 13%.
English: The powder should be reconstituted with 1 ml solvent.
Croatian: Prašak se mora rekonstituirati s 1 ml otapala.
English: • A suitable sharps container.
Croatian: • Odgovarajući spremnik za oštre predmete.
English: Pegvisomant should be administered by subcutaneous injection.
Croatian: Pegvisomant se treba primijeniti supkutanom injekcijom.
English: It is important to keep using all your medicines as well as SOMAVERT unless you are told otherwise by your doctor, pharmacist or nurse.
Croatian: Važno je da nastavite uzimati sve lijekove, kao i SOMAVERT, osim ako Vam liječnik, ljekarnik ili medicinska sestra nisu savjetovali drugačije.
English: Serum IGF-1 monitoring
Croatian: Praćenje IGF-1 u serumu
English: • Check that the plunger rod has not moved-if it has, then push it back all the way into the syringe.
Croatian: • Provjerite da se klip nije pomaknuo - ako se pomaknuo, pogurajte ga skroz nazad u štrcaljku.
English: The syringe should be kept upright to avoid leakage and the end of the syringe should not be allowed to contact anything.
Croatian: Štrcaljku treba držati u uspravnom položaju kako bi se izbjeglo curenje, a kraj štrcaljke ne smije biti u doticaju ni sa čim.
English: Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).The potential risk for humans is unknown.
Croatian: Ispitivanja provedena na životinjama vezana uz učinke na trudnoću, embrionalni ili fetalni razvoj, porod ili postnatalni razvoj su nedostatna (vidjeti dio 5.3).
English: • Abnormal sense of taste, migraine.
Croatian: • promijenjeni osjet okusa, migrena.
English: In the one reported incident of acute overdose, where 80 mg/day was administered for 7 days, the patient experienced a slight increase in fatigue and dry mouth.
Croatian: U jednom zabilježenom incidentu akutnog predoziranja u kojem se primjenjivala doza od 80 mg na dan tijekom 7 dana, bolesnik je osjetio blago pojačan umor i suhoću usta.
English: Bubbles or air gaps that float to the top of the liquid should be pushed back out into the vial.
Croatian: Mjehuriće ili zračne džepove koji plutaju na površini tekućine treba istisnuti natrag u bočicu.
English: • Peel open the packaging of the syringe and safety needle to make it easier to pick up each item as you prepare for your injection.
Croatian: • Otvorite pakiranja štrcaljke i sigurnosne igle kako biste olakšali uzimanje svakog predmeta dok pripremate svoju injekciju.
English: Cardiac disorders oedema peripheral
Croatian: Srčani poremećaji periferni edemi
English: The colour of the protective plastic cap is specific to the strength of the product.
Croatian: Boja zaštitnog plastičnog zatvarača ovisi o jačini lijeka.
English: Pegvisomant treatment should therefore not be monitored or adjusted based on serum growth hormone concentrations reported from these assays.
Croatian: Stoga liječenje pegvisomantom ne treba pratiti niti prilagođavati na temelju serumskih koncentracija hormona rasta iskazanih u tim testovima.
English: The pharmacokinetics of pegvisomant are similar in normal healthy volunteers and acromegaly patients, although heavier individuals tend to have a higher total body clearance of pegvisomant than lighter individuals, and may thus require greater doses of pegvisomant.
Croatian: Farmakokinetika pegvisomanta u zdravih dobrovoljaca slična je onoj u bolesnika s akromegalijom, iako pojedinci s većom tjelesnom težinom pokazuju veći ukupni tjelesni klirens pegvisomanta nego oni s manjom tjelesnom težinom pa njima mogu trebati veće doze pegvisomanta.
English: Abbreviations: ALT = alanine aminotransferase; AST = aspartate transaminase; LT = liver test; ULN = upper limit of normal.
Croatian: Kratice: ALT = alanin aminotransferaza; AST = aspartat aminotransferaza; GGN = gornja granica normale.
English: After single subcutaneous pegvisomant administration no linearity is observed with rising doses of 10, 15 or 20 mg.
Croatian: Nakon jednokratne supkutane primjene pegvisomanta nije opažena linearnost s povećanjem doza od 10, 15 do 20 mg.
English: • The syringe and needle should NEVER be reused.
Croatian: • Štrcaljka i igla NIKADA se ne smiju ponovno upotrijebiti.
English: • Do not use if: o the medicine is cloudy or hazy; o the medicine has any colour at all; o there are any particles or there is a layer of foam in the vial.
Croatian: • Nemojte koristiti ako: o je lijek zamućen ili neproziran; o je lijek obojen; o postoje čestice ili sloj pjene u bočici.
English: - Your doctor or nurse will monitor the levels of IGF-I (Insulin-like growth factors) circulating in the blood and adjust the dose of SOMAVERT if necessary.
Croatian: • Vaš liječnik ili medicinska sestra pratit će razine IGF-1 (inzulinu sličnog faktora rasta) u cirkulaciji i po potrebi Vam prilagoditi dozu lijeka SOMAVERT.
English: Two weeks after stopping treatment, leukocytosis and moderate bleeding from injection and vein puncture sites was observed which were considered possibly related to pegvisomant.
Croatian: Dva tjedna nakon prekida terapije zabilježena je leukocitoza i umjereno krvarenje iz mjesta punkcije vene i primjene injekcije, koji su se smatrali moguće povezani s pegvisomantom.
English: What SOMAVERT is and what it is used for What you need to know before you use SOMAVERT How to use SOMAVERT
Croatian: Što je SOMAVERT i za što se koristi Što morate znati prije nego počnete primjenjivati SOMAVERT Kako primjenjivati SOMAVERT Moguće nuspojave
English: Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize IGF-I concentrations or was not tolerated.
Croatian: Liječenje odraslih bolesnika s akromegalijom koji nisu imali odgovarajući odgovor na kirurško liječenje i/ili radioterapiju i u kojih odgovarajuće liječenje analozima somatostatina nije normaliziralo koncentracije IGF-1 ili ga nisu podnosili.
English: Administration of SOMAVERT should be discontinued if signs of liver disease persist.
Croatian: Primjenu lijeka SOMAVERT treba prekinuti ako znakovi bolesti jetre uporno traju.
English: The data from 145 patients in two long-term studies who received daily doses of 10, 15, or 20 mg, demonstrate pegvisomant mean serum concentrations (± SD) of approximately 8800 ± 6300, 13200 ± 8000 and 15600 ± 10300 ng/ml, respectively.
Croatian: Podaci prikupljeni tijekom dva dugoročna ispitivanja u 145 bolesnika koji su primali dnevne doze od 10 mg, 15 mg odnosno 20 mg pokazali su da su srednje vrijednosti (± SD) koncentracije pegvisomanta u serumu bile približno 8800 ± 6300, 13200 ± 8000 odnosno 15600 ± 10300 ng/ml.
English: * Excipient with known effect
Croatian: Pomoćna tvar s poznatim učinkom
English: The list below contains adverse reactions seen in clinical trials or that were spontaneously reported, classified by system organ class and frequency.
Croatian: Na sljedećem se popisu nalaze nuspojave opažene u kliničkim ispitivanjima ili spontano prijavljene, a raspoređene su prema klasama organskih sustava i učestalosti.
English: To ensure that only a trace of medicine remains, make sure the needle tip is as low as it can be in the vial when drawing off your dose.
Croatian: Kako biste osigurali da u bočici preostane samo vrlo mala količina lijeka, pazite da je vrh igle što je niže moguće u bočici kada izvlačite svoju dozu.
English: You should not breast-feed while taking SOMAVERT unless your doctor has discussed this with you.
Croatian: Tijekom uzimanja lijeka SOMAVERT ne smijete dojiti, osim ako niste o tome razgovarali sa svojim liječnikom.
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Choose injection area
Croatian: Odaberite područje injiciranja
English: What you need to know before you use SOMAVERT
Croatian: Što morate znati prije nego počnete primjenjivati SOMAVERT
English: Before disposing of the syringe and needle fold the needle guard over the needle and ensure it clicks into place.
Croatian: Prije zbrinjavanja štrcaljke i igle, presavinite štitnik za iglu preko igle i pazite da klikne na mjestu.
English: • Do not withdraw the needle yet.
Croatian: • Nemojte još izvući iglu.
English: Tell your doctor or pharmacist if you are using or have recently used any other medicines.
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate ili ste nedavno uzeli bilo koje druge lijekove, uključujući i one koje se izdaju bez recepta.
English: The excretion of pegvisomant in breast milk has not been studied in animals.
Croatian: Izlučivanje pegvisomanta u mlijeko nije ispitano u životinja.
English: After reconstitution, the reconstituted solution should be inspected visually for extraneous (or for any foreign) particulate matter or any variation in physical appearance prior to administration.
Croatian: Nakon rekonstitucije, rekonstituiranu otopinu prije primjene treba vizualno pregledati sadrži li strane čestice ili bilo kakvu promjenu u fizičkom izgledu.
English: The study conducted with pegvisomant in diabetic patients treated either by insulin or by oral hypoglycaemic medicinal products revealed the risk of hypoglycaemia in this population.
Croatian: Ispitivanje provedeno s pegvisomantom u dijabetičkih bolesnika koji su bili liječeni ili inzulinom ili oralnim hipoglikemijskim lijekovima pokazalo je rizik od hipoglikemije u ovoj populaciji.
English: Foam looks like a mass of small bubbles that float as a layer to the top of the liquid.
Croatian: • Pjena izgleda poput mnoštva malih mjehurića koji plutaju kao sloj na površini tekućine.
English: • Increased fatty substances in the blood, increased appetite.
Croatian: • povišene vrijednost masnoća u krvi, pojačan apetit.
English: • Clean the injection area with the alcohol swab as instructed by your healthcare provider.
Croatian: • Očistite područje injiciranja alkoholom natopljenom vaticom prema uputama svog liječnika.
English: After reconstitution, the product should be used immediately.
Croatian: Nakon rekonstitucije, lijek treba odmah primijeniti.
English: Draw off dose
Croatian: Izvucite dozu
English: In clinical studies, for patients treated with pegvisomant (n=550), the majority of adverse reactions to pegvisomant were of mild to moderate intensity, of limited duration and did not require discontinuation of treatment.
Croatian: U kliničkim je ispitivanjima većina nuspojava u bolesnika liječenih pegvisomantom (n=550) bila blage do umjerene jačine i ograničenog trajanja i nije zahtijevala prekid liječenja.
English: The site of injection should be rotated daily to help prevent lipohypertrophy.
Croatian: Mjesto injiciranja treba svakodnevno mijenjati kako bi se spriječio nastanak lipohipertrofije.
English: SOMAVERT should not be used during pregnancy unless clearly necessary (see section 4.4).
Croatian: SOMAVERT se ne smije primjenjivati tijekom trudnoće osim ako je to nužno potrebno (vidjeti dio
English: Acromegalic patients (n=112) have been treated in a 12-week, randomised, double-blind, multicentre study comparing placebo and pegvisomant.
Croatian: Bolesnici s akromegalijom (n=112) bili su uključeni u randomizirano, dvostruko slijepo, multicentrično ispitivanje u trajanju od 12 tjedana u kojem su se uspoređivali placebo i pegvisomant.
English: • Serum concentrations of ALT and AST should be monitored at 4- to 6-week intervals for the first 6 months of treatment with SOMAVERT, or at any time in patients exhibiting symptoms suggestive of hepatitis.
Croatian: • Potrebno je pratiti serumske koncentracije ALT-a i AST-a u razmacima od 4 do 6 tjedana tijekom prvih 6 mjeseci liječenja lijekom SOMAVERT, odnosno u bilo koje vrijeme u bolesnika sa simptomima koji ukazuju na hepatitis.
English: It is not known if pegvisomant passes into breast milk.
Croatian: Nije poznato prelazi li pegvisomant u majčino mlijeko.
English: • Gently apply pressure using a hard surface to lock the needle guard in place.
Croatian: • Lagano pritisnite o tvrdu površinu kako biste zaključali štitnik za iglu na mjestu.
English: The mean IGF-I concentration in this cohort fell from 917 ng/ml to 299 ng/ml on pegvisomant, with 92% achieving a normal (age-adjusted) IGF-I concentration.
Croatian: Prosječna koncentracija IGF-1 u toj kohorti smanjila se sa 917 ng/ml na 299 ng/ml uz pegvisomant, a u 92% bolesnika postigla se normalna (prilagođena za dob) koncentracija IGF-1.
English: Pfizer Luxembourg SARL filiāle Latvijā Tel: +371 670 35 775
Croatian: Pfizer Luxembourg SARL filiāle Latvijā Pfizer Limited Tel: +371 670 35 775
English: The injection must not be mixed in the same syringe or vial as any other medicine.
Croatian: Injekcija se ne smije miješati s drugim lijekovima u istoj štrcaljki ili bočici.
English: Absorption of pegvisomant following subcutaneous administration is slow and prolonged, and peak serum pegvisomant concentrations are not generally attained until 33-77 hours after administration.
Croatian: Apsorpcija pegvisomanta nakon supkutane primjene je polagana i produljena, te se vršne serumske koncentracije pegvisomanta obično ne postižu sve do 33-77 sati nakon primjene.
English: This medicine contains less than 1 mg of sodium per dose i.e. essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mg natrija po dozi, tj. zanemarive količine natrija.
English: ALT or AST elevations
Croatian: Povišeni ALT ili AST
English: Malignant fibrous histiocytomas associated with fibrosis and histiocytic inflammation were observed at injection sites in males in the rat carcinogenicity study at exposure levels equivalent to three times the human exposure based on mean plasma concentrations in two long-term studies at a daily dose of 30 mg.
Croatian: Maligni fibrozni histiocitomi povezani s fibrozom i histiocitoznom upalom opaženi su na mjestima injekcije u mužjaka u ispitivanju karcinogenosti kod štakora pri razinama izloženosti ekvivalentnima trostukoj izloženosti kod ljudi, temeljeno na prosječnim koncentracijama u plazmi u dvije dugoročne studije pri dnevnoj dozi od 30 mg.
English: • Release the pinched skin and pull the needle straight out.
Croatian: • Pustite kožni nabor i izvucite iglu ravno iz kože.
English: If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor, pharmacist or nurse.
Croatian: Ako imate dojam da je učinak ovog lijeka prejak ili preslab, razgovarajte s Vašim liječnikom, ljekarnikom ili medicinskom sestrom
English: • If liver injury is confirmed, the drug should be discontinued.
Croatian: • Ako se potvrdi oštećenje jetre, potrebno je prekinuti primjenu lijeka.
English: The solvent should be emptied into the vial slowly to avoid the possibility of a foam forming.
Croatian: Otapalo treba polako isprazniti u bočicu kako bi se izbjegla mogućnost stvaranja pjene.
English: For the different dose regimens the following strengths are available: SOMAVERT 10 mg, SOMAVERT 15 mg, SOMAVERT 20 mg, SOMAVERT 25 mg and SOMAVERT 30 mg.
Croatian: Za različite režime doziranja dostupne su sljedeće jačine: SOMAVERT 10 mg, SOMAVERT 15 mg, SOMAVERT 20 mg, SOMAVERT 25 mg i SOMAVERT 30 mg.
English: Occurrence of injection site hypertrophy has been observed, including lipohypertrophy.
Croatian: Opažen je nastanak hipertrofije na mjestu primjene injekcije, uključujući lipohipertrofiju.
English: • Perform a comprehensive hepatic workup to discern if an alternative cause of liver dysfunction is present.
Croatian: • Provesti sveobuhvatni pregled jetre kako bi se otkrilo postoji li neki drugi uzrok disfunkcije jetre.
English: Symptoms of a serious allergic reaction may include one or more of the following: swelling of the face, tongue, lips, or throat; wheezing or trouble breathing (spasm of the larynx); generalized skin rash, nettle rash (urticaria) or itching; or dizziness.
Croatian: Simptomi ozbiljne alergijske reakcije mogu uključivati jedno ili više od sljedećeg: oticanje lica, jezika, usana ili grla; piskanje ili otežano disanje (grč grkljana); generalizirani kožni osip; koprivnjača (urtikarija) ili svrbež; ili omaglica.
English: • Clean the vial stopper with a fresh alcohol wipe, and leave it to dry completely.
Croatian: • Očistite čep bočice novom vaticom natopljenom alkoholom i ostavite ga da se osuši do kraja.
English: Most injection site reactions characterised as localised erythemas and soreness, spontaneously resolved with local symptomatic treatment, while pegvisomant therapy continued.
Croatian: Većina reakcija na mjestu primjene injekcije poput lokaliziranih eritema i bolnosti spontano se povukla uz lokalno simptomatsko liječenje uz nastavak terapije pegvisomantom.
English: The list below contains adverse reactions seen in clinical trials with SOMAVERT.
Croatian: Sljedeći popis sadrži nuspojave zabilježene u kliničkim ispitivanjima s lijekom SOMAVERT.
English: If you forget to use SOMAVERT
Croatian: Ako ste zaboravili primijeniti SOMAVERT
English: The liquid comes in a pre-filled syringe labeled ‘Solvent for SOMAVERT'.
Croatian: Tekućina se isporučuje u napunjenoj štrcaljki označenoj s „Otapalo za SOMAVERT“.
English: Patients receiving insulin or oral hypoglycaemic medicinal products may require dose reduction of these active substances due to the effect of pegvisomant on insulin sensitivity (see section 4.4).
Croatian: U bolesnika koji primaju inzulin ili oralne hipoglikemike može biti potrebno smanjiti dozu tih djelatnih tvari zbog učinka pegvisomanta na inzulinsku osjetljivost (vidjeti dio 4.4).
English: Pegvisomant is slowly eliminated from serum, with mean estimates of half-life generally ranging from 74 to 172 hours following either single or multiple-doses.
Croatian: Pegvisomant se sporo eliminira iz seruma, uz uobičajeni prosječni poluvijek eliminacije u rasponu od približno 74 do 172 sata nakon jednokratne ili višekratnih doza.
English: • If the decision is to treat, LTs and clinical symptoms should be monitored very closely.
Croatian: • Ako je donesena odluka da se provede liječenje, potrebno je pomno pratiti testove jetrene funkcije i kliničke simptome.
English: PFIZER ΕΛΛΑΣ Α.Ε.
Croatian: Ελλάδα PFIZER ΕΛΛΑΣ Α.Ε
English: - If you experience disturbed vision or headaches while using SOMAVERT you must contact your doctor immediately.
Croatian: • Ako tijekom uzimanja lijeka SOMAVERT primijetite poremećaj vida ili glavobolje, morate se odmah obratiti liječniku.
English: Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Following this, the usual daily dose of pegvisomant is 10 mg, which is given by subcutaneous injection (just under the skin).
Croatian: Nakon toga, uobičajena dnevna doza pegvisomanta je 10 mg i daje se potkožnom injekcijom (ispod kože).
English: • No-never shake the vial.
Croatian: • Ne - nikada ne tresite bočicu.
English: • Blood in the urine.
Croatian: • krv u mokraći
English: A cohort of 38 acromegalic subjects has been followed in a long-term, open-label, dose-titration study for at least 12 consecutive months of daily dosing with pegvisomant (mean = 55 weeks).
Croatian: Kohorta od 38 bolesnika s akromegalijom praćena je u sklopu dugotrajnog otvorenog ispitivanja titracije doze tijekom najmanje 12 uzastopnih mjeseci svakodnevnog doziranja pegvisomanta (prosječno 55 tjedana).
English: A single Somavert pack containing:
Croatian: Pojedinačno pakiranje lijeka Somavert sadrži:
English: Pegvisomant is highly selective for the GH receptor, and does not cross-react with other cytokine receptors, including prolactin.
Croatian: Pegvisomant je visoko selektivan za receptore hormona rasta i ne ulazi u križne reakcije s drugim citokinskim receptorima, uključujući prolaktinske.
English: • If LTs normalize (regardless of whether an alternative cause of the liver dysfunction is discovered), consider cautious reinitiation of therapy with SOMAVERT, with frequent LT monitoring.
Croatian: • Ako se vrijednosti testova jetrene funkcije normaliziraju (bez obzira je li otkriven neki drugi uzrok disfunkcije jetre ili ne), razmotriti ponovno oprezno uvođenje terapije lijekom SOMAVERT uz često praćenje testova jetrene funkcije.
English: It should be considered whether to continue treatment with somatostatin analogues.
Croatian: Potrebno je razmotriti nastavak liječenja analozima somatostatina.
English: • Perform a comprehensive hepatic workup, including serial LTs, to determine if and when serum levels return to normal.
Croatian: • Provesti sveobuhvatni pregled jetre, uključujući uzastopne testove jetrene funkcije, kako bi se ustanovilo vraćaju li se serumske razine na normalne vrijednosti i kada se to događa.
English: If a patient develops LT elevations, or any other signs or symptoms of liver dysfunction while receiving SOMAVERT, the following patient management is recommended (Table B).
Croatian: Ako se u bolesnika pojave povišene vrijednosti testova jetrene funkcije ili bilo koji drugi znakovi ili simptomi disfunkcije jetre dok prima lijek SOMAVERT, preporučuje se liječenje bolesnika kako slijedi u nastavku (tablica B).
English: • All questions should be handled by a doctor, nurse or pharmacist familiar with SOMAVERT.
Croatian: • Za sva pitanja obratite se liječniku, medicinskoj sestri ili ljekarniku koji su upoznati s lijekom SOMAVERT.
English: • Continue swirling the liquid until all the powder has fully dissolved.
Croatian: • Nastavite miješati tekućinu dok se sav prašak ne otopi.
English: Hepatobiliary disorders abnormal liver function tests (e.g. transaminase elevation) (see section 4.4)
Croatian: Poremećaji jetre i žuči poremećeni testovi funkcije jetre (npr. povišene transaminaze) (vidjeti dio 4.4)
English: SOMAVERT is used for the treatment of acromegaly, a hormonal disorder resulting from the increased secretion of growth hormone (GH) and IGF-I (Insulin-like growth factors), which is characterised by overgrowth of bone, soft tissue swelling, heart disease and related disorders.
Croatian: SOMAVERT se koristi za liječenje akromegalije, hormonskog poremećaja koji nastaje zbog pojačanog lučenja hormona rasta i IGF-1 (inzulinu sličnog faktora rasta) koji se očituje prekomjernim rastom kostiju, oticanjem mekog tkiva, bolešću srca i povezanim poremećajima.
English: • Determine if cholelithiasis or choledocholithiasis is present, particularly in patients with a history of prior therapy with somatostatin analogs.
Croatian: • Ustanoviti je li prisutna kolelitijaza ili koledokolitijaza, osobito u bolesnika s anamnezom prethodne terapije analozima somatostatina.
English: Slowly withdraw the plunger in the syringe to withdraw the medicine from the vial.
Croatian: Polako povucite klip štrcaljke kako biste povukli lijek iz bočice.
English: • Based on the workup, consider initiation of therapy with SOMAVERT.
Croatian: • Na temelju pregleda razmotriti uvođenje terapije lijekom SOMAVERT.
English: Following this, SOMAVERT 10 mg reconstituted in 1 ml of solvent should be administered once daily as a subcutaneous injection.
Croatian: Nakon toga se SOMAVERT 10 mg rekonstituiran u 1 ml otapala primjenjuje jedanput na dan supkutanom injekcijom.
English: Pegvisomant is a potent antagonist of growth hormone action.
Croatian: Pegvisomant je snažni antagonist djelovanja hormona rasta.
English: The safety and efficacy of SOMAVERT in patients with renal or hepatic insufficiency has not been established.
Croatian: Sigurnost i djelotvornost lijeka SOMAVERT u bolesnika s insuficijencijom bubrega ili jetre nije ustanovljena.
English: Add liquid
Croatian: Dodajte tekućinu
English: • Carefully pull the needle cover straight off.
Croatian: • Pažljivo ravno povucite poklopac za iglu.