FrancophonIA/ELRC3.0 huggingface dataset:
English: The list below contains adverse reactions seen in clinical trials with SOMAVERT.
Slovenian: Spodnji seznam vsebuje neželene učinke, zabeležene v kliničnih preskušanjih zdravila SOMAVERT.
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.
Slovenian: Če ste uporabili večji odmerek zdravila SOMAVERT, kot bi smeli Če si pomotoma injicirate več zdravila SOMAVERT, kot vam je naročil zdravnik, to praviloma sicer ni nič resnega, kljub temu pa se morate takoj posvetovati z zdravnikom, farmacevtom ali medicinsko sestro.
English: Greater than 3 but less than 5 times ULN (without signs/symptoms of hepatitis or other liver injury, or increase in serum TBIL)
Slovenian: Večje od 3-kratnika ZMN, vendar manjše od 5-kratnika ZMN (brez znakov/simptomov hepatitisa ali druge poškodbe jeter oz. brez zvečanja vrednosti TBIL v serumu)
English: Once treatment begins, your doctor or nurse will monitor the level of liver enzymes in the blood every 4-6 weeks for the first 6 months of treatment with SOMAVERT.
Slovenian: Po začetku zdravljenja z zdravilom SOMAVERT bosta zdravnik ali medicinska sestra v prvih 6 mesecih zdravljenja na 4 do 6 tednov preverila raven jetrnih encimov v vaši krvi.
English: Cardiac disorders oedema peripheral
Slovenian: Srčne bolezni periferni edem
English: You should continue to inject this medicine for as long as instructed by your doctor.
Slovenian: Injiciranje tega zdravilamorate nadaljevati toliko časa, kot vam naroči zdravnik.
English: • Perform a comprehensive hepatic workup to discern if an alternative cause of liver dysfunction is present.
Slovenian: • Opravite celosten diagnostični pregled jeter, da ugotovite, ali obstaja drug vzrok motnje delovanja jeter.
English: Pegvisomant is highly selective for the GH receptor, and does not cross-react with other cytokine receptors, including prolactin.
Slovenian: Pegvisomant je zelo selektiven za receptorje za rastni hormon, zato nima navzkrižnih reakcij z drugimi citokinskimi receptorji, vključno s prolaktinom.
English: Pegvisomant should be administered by subcutaneous injection.
Slovenian: Pegvisomant se daje s subkutano injekcijo.
English: • An alcohol swab.
Slovenian: • alkoholni zloženec,
English: Effects on ability to drive and use machines
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev
English: - The solvent is water for injections.
Slovenian: Vehikel je voda za injekcije.
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.
Slovenian: Simptomi hude alergijske reakcije lahko vključujejo enega ali več naslednjih simptomov: oteklost obraza, jezika, ustnic ali žrela; piskajoče ali oteženo dihanje (krč grla); kožni izpuščaj po celem telesu; koprivnica (urtikarija) ali srbenje; omotica.
English: However, it is possible to accidently draw air into the syringe, which should be removed before injecting.
Slovenian: Če se zgodi, da v brizgo pomotoma izvlečete zrak, ga je treba pred injiciranjem odstraniti.
English: Hepatobiliary disorders abnormal liver function tests (e.g. transaminase elevation) (see section 4.4)
Slovenian: Bolezni jeter, žolčnika in žolčevodov nenormalni testi jetrne funkcije (npr. zvišanje transaminaz) (glejte poglavje 4.4)
English: This medicine must be dissolved before use.
Slovenian: Pred uporabo je treba to zdraviloraztopiti.
English: Following this, the usual daily dose of pegvisomant is 10 mg, which is given by subcutaneous injection (just under the skin).
Slovenian: Nato je običajni dnevni odmerek 10 mg pegvisomanta; uporablja se kot subkutana injekcija (injekcija tik pod kožo).
English: Check medicine
Slovenian: Preverite zdravilo
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.
Slovenian: Koncentracijo IGF-I v serumu je treba meriti na štiri do šest tednov in odmerek ustrezno prilagajati z zvečevanjem po 5 mg/dan za vzdrževanje koncentracije IGF-I v serumu v normalnem območju za starost ter vzdrževanje optimalnega terapevtskega odziva.
English: This is achieved by snapping it off.
Slovenian: Odstranite ga tako, da ga odlomite.
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.
Slovenian: Za različne odmerne sheme so na voljo jakosti SOMAVERT 10 mg, SOMAVERT 15 mg. SOMAVERT 20 mg, SOMAVERT 25 mg in SOMAVERT 30 mg.
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.
Slovenian: Po rekonstituciji je treba pripravljeno raztopino pred uporabo vizualno pregledati, da ne vsebuje tujih delcev oz. se njen fizični izgled ni spremenil.
English: Occurrence of injection site hypertrophy has been observed, including lipohypertrophy.
Slovenian: Opažali so pojav hipertrofije (vključno z lipohipertrofijo) na mestu injiciranja.
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:
Slovenian: Preden raztopljeno zdravilo Somavert izvlečete, zasukajte vialo s še vedno vstavljeno injekcijsko brizgo in se prepričajte, da je prazen prostor v zamašku viden, kot kaže spodnja slika:
English: A growth hormone deficient state may result from administration of this medicinal product, despite the presence of elevated serum growth hormone levels.
Slovenian: Uporaba tega zdravila lahko povzroči pomanjkanje rastnega hormona kljub zvišani ravni rastnega hormona v serumu.
English: Psychiatric disorders abnormal dreams panic attack, short term memory loss, apathy, confusion, sleep disorder, libido increased anger
Slovenian: Psihiatrične motnje nenormalne sanje napadi panike, kratkoročna izguba spomina, apatičnost, zmedenost, motnje spanja, zvečanje libida jeza
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).
Slovenian: Pri bolnikih, ki prejemajo insulin ali peroralne antidiabetike, utegne biti potrebno zmanjšanje odmerka teh učinkovin, ker pegvisomant spremeni občutljivost za insulin (glejte poglavje 4.4).
English: Somavert comes in a vial as a white block of powder.
Slovenian: Zdravilo Somavert je na voljo v viali kot bel prašek.
English: A loading dose of 80 mg pegvisomant should be administered subcutaneously under medical supervision.
Slovenian: Začetni odmerek 80 mg pegvisomanta je treba aplicirati subkutano pod zdravniškim nadzorom.
English: For pegvisomant no data on fertility are available.
Slovenian: Podatkov o vplivu pegvisomanta na plodnost ni na voljo.
English: • Push the plunger rod down slowly until the barrel is empty.
Slovenian: • Bat počasi potiskajte navzdol, dokler brizga ni prazna.
English: Not all pack sizes are marketed.
Slovenian: Na trgu morda ni vseh navedenih pakiranj.
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).
Slovenian: Če se pri bolniku med zdravljenjem z zdravilom SOMATOVERT pojavijo zvečane vrednosti jetrnih testov ali kakršnikoli drugi znaki ali simptomi motnje delovanja jeter, je bolnika priporočljivo obravnavati, kot sledi v nadaljevanju (preglednica B).
English: Add the solvent to the vial of powder.
Slovenian: V vialo s praškom dodajte vehikel.
English: • Based on the workup, consider initiation of therapy with SOMAVERT.
Slovenian: • Na podlagi diagnostičnega pregleda razmislite o možnosti uvedbe zdravljenja z zdravilom SOMAVERT.
English: • Anger
Slovenian: • jeza
English: Pull the needle down so that the needle tip is at its lowest point in the liquid.
Slovenian: Iglo povlecite navzdol tako, da je njena konica na najnižji točki v tekočini.
English: Meniere's disease
Slovenian: Ménièrova bolezen
English: • If you are allergic to pegvisomant or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila SOMAVERT: če ste alergični na pegvisomant ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: Before disposing of the syringe and needle fold the needle guard over the needle and ensure it clicks into place.
Slovenian: Preden brizgo in iglo zavržete, upognite varovalni nastavek čez iglo, tako da se zaskoči čez iglo.
English: Since serum concentrations of therapeutically-effective doses of this medicine are generally 100 to 1000 times higher than the actual serum growth hormone concentrations seen in acromegalics, measurements of serum growth hormone concentrations will be spuriously reported in commercially available growth hormone assays.
Slovenian: Koncentracije v serumu so pri terapevtsko učinkovitih odmerkih tega zdravila praviloma od 100- do 1.000-krat večje kot dejanska serumska koncentracija rastnega hormona pri bolnikih z akromegalijo.
English: For pegvisomant no clinical data on exposed pregnancies are available.
Slovenian: Kliničnih podatkov o izpostavljenosti pegvisomantu med nosečnostjo ni.
English: Pegvisomant is a potent antagonist of growth hormone action.
Slovenian: Pegvisomant je močan antagonist delovanja rastnega hormona.
English: Approximately linear pharmacokinetics is observed at steady state in the population pharmacokinetic studies.
Slovenian: V populacijskih študijah farmakokinetike so v stanju dinamičnega ravnovesja ugotavljali približno linearno farmakokinetiko.
English: Store the powder vial(s) in a refrigerator (2C - 8C) in their outer carton in order to protect from light.
Slovenian: Viale s praškom shranjujte v hladilniku (2 C - 8 C) v njihovi zunanji ovojnini za zagotovitev zaščite pred svetlobo.
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.
Slovenian: IGF-I v serumu je bil na koncu študije (12. teden) normalen pri 9,7 % preskušancev, ki so prejemali placebo, med prejemniki pegvisomanta pa pri 38,5 % tistih, ki so ga prejemali 10 mg/dan, pri 75 % tistih, ki so ga prejemali 15 mg/dan, in pri 82 % tistih, ki so ga prejemali 20 mg/dan.
English: • Dry mouth, increased saliva, tooth problems, haemorrhoids.
Slovenian: • suha usta, povečano slinjenje, težave z zobmi, hemoroidi
English: Foam looks like a mass of small bubbles that float as a layer to the top of the liquid.
Slovenian: • Pene izgledajo kot gmota majhnih mehurčkov, ki se v plasti dvigujejo na gladino.
English: Dispose of the syringe in the same way as a used syringe.
Slovenian: Zavrzite jo na enak način, kot bi zavrgli uporabljeno injekcijsko brizgo.
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.
Slovenian: Če menite, da je učinek tega zdravila premočan ali prešibak, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: in acromegalic patients with diabetes mellitus, doses of insulin or hypoglycaemic medicinal products may need to be decreased (see section 4.5).
Slovenian: Zato utegne biti pri bolnikih z akromegalijo in sladkorno boleznijo potrebno zmanjšanje odmerka insulina ali peroralnih antidiabetikov (glejte poglavje 4.5).
English: How to use SOMAVERT
Slovenian: Kako uporabljati zdravilo SOMAVERT
English: Gently dissolve the powder with a slow, swirling motion.
Slovenian: Prašek previdno raztopite s počasnim obračanjem.
English: • A safety needle.
Slovenian: • iglo z varovalom.
English: Following this, SOMAVERT 10 mg reconstituted in 1 ml of solvent should be administered once daily as a subcutaneous injection.
Slovenian: Potem je treba aplicirati 10 mg zdravila SOMAVERT, pripravljenega v 1 ml vehikla, enkrat na dan kot subkutano injekcijo.
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)
Slovenian: Znaki ali simptomi, ki kažejo na hepatitis ali drugo poškodbo jeter (npr. zlatenica, bilirubinurija, utrujenost, navzea, bruhanje, bolečina v zgornjem desnem kvadrantu, ascites, nepojasnjen edem, hitro pojavljanje podplutb)
English: Slowly withdraw the plunger in the syringe to withdraw the medicine from the vial.
Slovenian: Počasi izvlecite bat in izvlecite zdravilo iz viale.
English: Pegvisomant is an analogue of human growth hormone that has been genetically modified to be a growth hormone receptor antagonist.
Slovenian: Pegvisomant je analog človeškega rastnega hormona, genetsko spremenjen tako, da je antagonist receptorja za rastni hormon.
English: • Slowly pull back the plunger rod to withdraw as much medicine as possible from the vial.
Slovenian: • Bat počasi izvlecite iz brizge, da boste iz viale lahko izvlekli kar največ zdravila.
English: • Caution: Do not squirt the liquid directly onto the powder, as this creates foam.
Slovenian: • Pozor: Tekočine ne brizgnite neposredno na prašek, saj tako nastanejo pene, kar naredi zdravilo neuporabno.
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.
Slovenian: Zdravnik ali medicinska sestra bostaspremljalaraven IGF-1 (insulinu podobnih rastnih dejavnikov) v krvi in, če bo treba, ustrezno prilagodilaodmerek zdravila SOMAVERT.
English: • Keep the syringe upright to avoid leakage.
Slovenian: • Injekcijsko brizgo držite pokonci, da se izognete iztekanju.
English: Serum IGF-I concentrations should be monitored and maintained within the age-adjusted normal range by adjustment of the pegvisomant dose.
Slovenian: Spremljati je treba koncentracijo IGF-I v serumu in jo s prilagajanjem odmerka pegvisomanta vzdrževati v normalnem območju za starost.
English: The powder should be reconstituted with 1 ml solvent.
Slovenian: Prašek je treba raztopiti z 1 ml vehikla.
English: • Avoid bony areas or areas that are bruised, red, sore or hard, or areas that have scars or skin conditions.
Slovenian: • Izogibajte se kostnim predelom ali predelom s podplutbami, rdečinami, ranami, trdo kožo ali brazgotinami ali predelom, prizadetim zaradi kožnih bolezni.
English: This medicine contains less than 1 mg of sodium per dose i.e. essentially ‘sodium-free'.
Slovenian: Zdravilo SOMAVERT vsebuje natrij To zdravilo vsebuje manj kot 1 mg natrija na odmerek, kar v bistvu pomeni 'brez natrija'.
English: • Increased levels of substances that measure the function of the liver.
Slovenian: • zvišane ravni snovi, ki so merilo delovanja jeter; to se lahko vidi v rezultatih preiskav krvi
English: • Press the plunger very slowly so that the liquid gently runs down the inside of the vial.
Slovenian: • Bat zelo previdno potiskajte navzdol, da tekočina počasi teče po notranji steni viale.
English: Draw off dose
Slovenian: Izvlecite odmerek
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)].
Slovenian: Ocena izhodiščnih ravni jetrnih encimov pred uvedbo zdravljenja z zdravilom SOMAVERT Pred začetkom zdravljenja z zdravilom SOMAVERT je treba pri bolnikih oceniti izhodiščne vrednosti jetrnih testov (alanin-aminotransferaza (ALT) v serumu, aspartat-aminotransferaza (AST) v serumu, celokupni bilirubin (TBIL - total bilirubin) v serumu in alkalna fosfataza (ALP - alkaline phosphatase) v serumu).
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.
Slovenian: Zdravnik bo na štiri do šest tednov ustrezno prilagodil odmerek s povečanji po 5 mg pegvisomanta/dan; pri tem bo upošteval vaš izvid t. i. koncentracije IGF-I v serumu, da bo ohranil najboljši odziv na zdravljenje.
English: Table B. Clinical recommendations based on abnormal liver test results while on SOMAVERT
Slovenian: Preglednica B. Klinična priporočila na podlagi nenormalnih vrednosti jetrnih testov med zdravljenjem z zdravilom SOMAVERT
English: Somavert powder in vial with solvent in a pre-filled syringe pegvisomant for injection For Subcutaneous Injection Only single dose vial
Slovenian: Somavert prašek v viali z vehiklom v napolnjeni injekcijski brizgi pegvisomant za injiciranje samo za subkutano injiciranje viala z enkratnim odmerkom
English: Special warnings and precautions for use
Slovenian: Opozorila in previdnostni ukrepi
English: When adding the solvent from the syringe the vial and syringe should held at an angle as shown in the diagram below.
Slovenian: Med dodajanjem vehikla iz injekcijske brizge držite vialo in brizgo pod kotom, kot kaže spodnja slika.
English: Caution: Do not let anything touch the vial stopper.
Slovenian: Pozor: Z zamaškom viale se ne dotikajte ničesar.
English: Prior to the start of SOMAVERT, patients should have an assessment of baseline levels of liver tests [serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin (TBIL), and alkaline phosphatase (ALP)].
Slovenian: Pred začetkom zdravljenja z zdravilom SOMAVERT je treba pri bolnikih oceniti izhodiščne vrednosti jetrnih testov (alanin-aminotransferaza (ALT) v serumu, aspartat-aminotransferaza (AST) v serumu, celokupni bilirubin (TBIL) v serumu in alkalna fosfataza (ALP) v serumu).
English: There is limited experience of overdose with pegvisomant.
Slovenian: Izkušnje s prevelikim odmerjanjem pegvisomanta so omejene.
English: Therefore, pegvisomant should not be used in breast-feeding women.
Slovenian: Pegvisomanta se zato ne sme uporabljati pri doječih materah.
English: Swirl vial
Slovenian: Zasukajte vialo
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).
Slovenian: 10 mg, 15 mg, 20 mg, 25 mg ali 30 mg pegvisomanta v obliki praška v viali (kremenčevo steklo tipa I) z zamaškom (iz klorobutilne gume) in 1 ml vehikla (voda za injekcije) v napolnjeni injekcijski brizgi (borosilikatno steklo tipa I) z zamaškom (iz bromobutilne gume) in zaporko (iz bromobutilne gume).
English: Caution: Do not let the needle touch anything.
Slovenian: Pozor: Z iglo se ne dotikajte ničesar.
English: For recommendations regarding initiation of SOMAVERT based on baseline LTs and recommendations for monitoring of LTs while on SOMAVERT, refer to Table A in Special warnings and precautions for use (4.4).
Slovenian: Za priporočila glede uvedbe zdravljenja z zdravilom SOMAVERT na podlagi izhodiščnih vrednosti jetrnih testov in priporočila za spremljanje jetrnih testov med zdravljenjem z zdravilom SOMAVERT glejte preglednico A v poglavju Posebna opozorila in previdnostni ukrepi (4.4).
English: • Turn the vial so that you can see the stopper gap, as shown.
Slovenian: • Vialo obrnite tako, da vidite prazen prostor v zamašku, kot kaže slika.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede priprave zdravila pred uporabo glejte poglavje 6.6.
English: • Insert the needle to its full depth into the pinched skin.
Slovenian: • Zabodite iglo do konca v stisnjeno kožo.
English: However, due to the marked pharmacological response in monkey, systemic exposures higher than those achieved in patients at therapeutic doses have not been studied.
Slovenian: Vendar pa sistemska izpostavljenost, ki presega izpostavljenost, doseženo pri bolnikih v terapevtskih odmerkih, zaradi izrazitega farmakološkega odziva pri opicah ni bila raziskana.
English: Very common may affect more than 1 in 10 people:
Slovenian: Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov
English: Acromegalic patients (n=112) have been treated in a 12-week, randomised, double-blind, multicentre study comparing placebo and pegvisomant.
Slovenian: V 12-tedenski randomizirani, dvojno slepi, multicentrični študiji so placebo in pegvisomant primerjali pri 112 bolnikih z akromegalijo.
English: • Increased blood cholesterol, weight gain, increased blood glucose, decreased blood glucose.
Slovenian: • zvišana raven holesterola v krvi, povečanje telesne mase, zvišana raven glukoze v krvi, znižana raven glukoze v krvi
English: The liquid comes in a pre-filled syringe labeled ‘Solvent for SOMAVERT'.
Slovenian: Tekočina je na voljo v napolnjeni injekcijski brizgi z oznako 'Vehikel za zdravilo SOMAVERT'.
English: or several days after administration.
Slovenian: lahko se pojavi takoj ali več dni po uporabi
English: What SOMAVERT looks like and contents of the pack SOMAVERT is presented as a powder and a solvent for injection (either 10 mg, 15 mg, 20 mg, 25 mg or 30 mg pegvisomant in a vial and 1 ml of solvent in a pre-filled syringe).
Slovenian: Izgled zdravila SOMAVERT in vsebina pakiranja Zdravilo SOMAVERT je na voljo kot prašek in vehikel za raztopino za injiciranje (10 mg, 15 mg, 20 mg, 25 mg oziroma 30 mg pegvisomanta v viali in 1 ml vehikla v napolnjeni injekcijski brizgi).
English: • Facial swelling, dry skin, night sweats, redness of the skin (erythema), raised itchy bumps on the skin (urticaria).
Slovenian: • otekanje obraza, suha koža, nočno znojenje, rdečina na koži (eritem), srbeče izbokline na koži (koprivnica)
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.
Slovenian: Zagotovite, da v viali ostane le sled zdravila in preden izvlečete zdravilo, se prepričajte, da je konica igle kar se da nizko v viali.
English: Except for one segment II test in the rabbit, no other reproductive toxicity studies were conducted.
Slovenian: segmenta pri kuncih druge študije reprodukcijske toksičnosti niso bile opravljene.
English: Special precautions for disposal and other handling The syringe and safety needle used to administer the injection are provided with the medicinal product.
Slovenian: Zdravilu sta priloženi injekcijska brizga in igla z varovalom, ki se uporabljata za injiciranje zdravila.
English: Store the carton(s) of powder vials in the refrigerator at 2°C to 8°C and away from direct sunlight.
Slovenian: Viale s praškom shranjujte v hladilniku pri temperaturi od 2 °C do 8 °C ter zaščitene pred neposredno sončno svetlobo.
English: Withdrawing and reinserting greatly increases the risk of needle damage, and will blunt the needle.
Slovenian: Če iglo izvlečete in jo ponovno zabodete, se tveganje za poškodbe igle močno poveča, konica igle pa postane topa.
English: Non-clinical data revealed no special hazard for humans based on studies of repeated dose toxicity in rat and monkey.
Slovenian: Predklinični podatki na osnovi študij toksičnosti pri ponavljajočih se odmerkih pri podganah in opicah ne kažejo posebnega tveganja za človeka.
English: For recommendations regarding initiation of SOMAVERT, based on baseline liver tests (LTs) and recommendations for monitoring of liver tests while on SOMAVERT, refer to Table A.
Slovenian: Za priporočila glede uvedbe zdravljenja z zdravilom SOMAVERT na podlagi izhodiščnih vrednosti jetrnih testov in priporočila za spremljanje jetrnih testov med zdravljenjem z zdravilom SOMAVERT glejte preglednico A.