natgillin/translations-raw huggingface dataset:
• 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.
• Če se jetrni testi normalizirajo (ne glede na to, ali odkrijete drug vzrok motnje delovanja jeter), razmislite o previdni ponovni uvedbi zdravljenja z zdravilom SOMAVERT s pogostim spremljanjem jetrnih testov.
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.
Da bi to preprečili, zdravilo vsakič injicirajte nekoliko drugam, tako kot je opisano v 2. koraku poglavja "Navodila za pripravo in injiciranje zdravila Somavert" tega navodila.
Most injection site reactions characterised as localised erythemas and soreness, spontaneously resolved with local symptomatic treatment, while pegvisomant therapy continued.
Večina reakcij na mestu injiciranja, opisanih kot lokaliziran eritem in bolečina, je z lokalnim simptomatskim zdravljenjem spontano minila, medtem ko se je zdravljenje s pegvisomantom nadaljevalo.
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.
V kliničnih študijah je bila pri bolnikih, zdravljenih s pegvisomantom (n = 550), večina neželenih učinkov blagih do zmernih, omejenega trajanja in ni zahtevala prekinitve zdravljenja.
Abbreviations: ALT = alanine aminotransferase; AST = aspartate transaminase; LT = liver test; ULN = upper limit of normal.
Okrajšave: ALT = alanin-aminotransferaza; AST = aspartat-aminotransferaza; ZMN = zgornja meja normale.
However, monitor LTs weekly to determine if further increases occur (see below).
Vendar pa tedensko spremljajte jetrne teste glede nadaljnjih zvečanj (glejte spodaj).
• Allergic reaction after administration (fever, rash, pruritus and, in severe cases, difficulty to breathe, rapid swelling of skin, requiring urgent medical attention).
• alergijska reakcija po uporabi (vročina, izpuščaj, srbenje in v hudih primerih težave z dihanjem, hitro otekanje kože, zaradi katerih so potrebni nujni zdravstveni ukrepi);
It is important to keep using all your medicines as well as SOMAVERT unless you are told otherwise by your doctor, pharmacist or nurse.
Pomembno je, da še naprej jemljete vsa svoja zdravila in tudi zdravilo SOMAVERT, razen če vam zdravnik, farmacevt ali medicinska sestra naročijo drugače.
If you forget to give yourself an injection you should inject the next dose as soon as you remember and then continue to inject SOMAVERT as prescribed by your doctor.
Če si pozabite dati injekcijo, si naslednji odmerek injicirajte, čim se spomnite, potem pa z injiciranjem zdravila SOMAVERT nadaljujte tako, kot vam je predpisal zdravnik.
Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1.
Pharmacotherapeutic group: Other anterior pituitary lobe hormones and analogues, ATC code: H01AX01.
Farmakoterapevtska skupina: drugi hormoni prednjega režnja hipofize in sorodne učinkovine, oznaka ATC: H01AX01.
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
Najpogosteje opisani neželeni učinki, ki so se v kliničnih preskušanjih pojavili pri  10 % bolnikov z akromegalijo, zdravljenih s pegvisomantom, so bili glavobol (25 %), artralgija (16 %) in diareja
How can I tell if there is any foam in the vial?
Kako vem, da so v viali pene?
What SOMAVERT is and what it is used for
Kaj je zdravilo SOMAVERT in za kaj ga uporabljamo
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.
Pegvisomant se iz seruma odstranjuje počasi; povprečne ocene razpolovnega časa na splošno so od 74 do 172 ur po posamičnem ali večkratnih odmerkih.
• The syringe and needle should NEVER be reused.
• Brizge in igle ne smete NIKOLI ponovno uporabiti.
• Determine if cholelithiasis or choledocholithiasis is present, particularly in patients with a history of prior therapy with somatostatin analogs.
• Ugotovite, ali je prisotna holelitiaza ali holedoholitiaza, še zlasti pri bolnikih, ki so se v preteklosti že zdravili z analogi somatostatina.
Do not spray the liquid directly onto the powder, as this creates foam.
Ne brizgajte tekočine neposredno na prašek, saj tako nastanejo pene.
• Rapid swelling of skin and underlying tissue and inner lining (mucosa) of organs
• hitro otekanje kože in podkožnega tkiva ter notranje obloge (sluznice) organov
Frequency Not Known (Cannot Be Estimated From Available Data)
Neznana (ni mogoče oceniti iz razpoložljivih podatkov)
Do not use this medicine after the expiry date which is stated on the vial and the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli.
This ensures that all air is removed from the syringe before you draw off the dose.
Tako boste zagotovo odstranili ves zrak iz brizge, preden izvlečete odmerek.
• If liver injury is confirmed, the drug should be discontinued.
• V primeru potrditve poškodbe jeter je treba zdravljenje z zdravilom prekiniti.
• Severe breathlessness (laryngospasm)
• huda zasoplost (laringospazem)
• Clean the injection area with the alcohol swab as instructed by your healthcare provider.
• Mesto injiciranja očistite z alkoholnim zložencem, kot vam je naročil zdravstveni delavec.
The pre-filled solvent syringe may be stored at room temperature.
Napolnjene injekcijske brizge lahko shranjujete pri sobni temperaturi.
Uncommon (≥1/1,000 to <
Občasni (≥ 1/1.000 in
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).
Kohorto 38 preskušancev z akromegalijo so spremljali v dolgoročni, odprti študiji s titriranjem odmerka vsaj 12 zaporednih mesecev vsakodnevne uporabe pegvisomanta (povprečje = 55 tednov).
Do not inject a double dose to make up for forgotten individual doses.
Ne injicirajte dvojnega odmerka, če ste pozabili uporabiti prejšnjega.
• Continue swirling the liquid until all the powder has fully dissolved.
• Nadaljujte z mešanjem tekočine, dokler se ves prašek ne raztopi.
A single Somavert pack containing:
Eno pakiranje zdravila Somavert vsebuje:
• Clean the vial stopper with a fresh alcohol wipe, and leave it to dry completely.
• Očistite zamašek viale s svežim alkoholnim zložencem in pustite, da se posuši.
• Decreased platelets in the blood, increased or decreased white cells in the blood, tendency to bleed.
• zmanjšano število krvnih ploščic v krvi, zvečano ali zmanjšano število belih krvnih celic v krvi, nagnjenost h krvavitvam
• Only mix Somavert and the solvent when you are ready to inject your dose.
• Zdravilo Somavert in vehikel zmešajte šele, ko ste pripravljeni na injiciranje odmerka.
The excretion of pegvisomant in breast milk has not been studied in animals.
Izločanje pegvisomanta v materino mleko ni bilo preučeno na živalih.
• Do not treat with SOMAVERT until a comprehensive workup establishes the cause of the patient's liver dysfunction.
• Ne zdravite z zdravilom SOMAVERT, dokler s celostnim diagnostičnim pregledom ne ugotovite vzroka motnje delovanja jeter pri bolniku.
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.
Študij na živalih o učinkih na nosečnost, razvoj zarodka/ploda, porod ali poporodni razvoj ni dovolj (glejte poglavje 5.3).
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.
Opisan je en primer akutnega prevelikega odmerjanja pri uporabi 80 mg/dan 7 dni; bolnik je bil nekoliko bolj utrujen in je imel suha usta.
Statistically significant differences from placebo (p<0.05) were observed for improvements in the total signs and symptoms score for all dose groups compared to placebo.
V vseh odmernih skupinah so ugotovili statistično pomembno (p < 0,05) razliko izboljšanja celotne ocene simptomov in znakov v primerjavi s placebom.
If you forget to use SOMAVERT
Če ste pozabili uporabiti zdravilo SOMAVERT
* Excipient with known effect
Pomožna snov z znanim učinkom
1/100 to <1/10
 1/100 in < 1/10
Growth hormone-secreting pituitary tumours may sometimes expand, causing serious complications (for example, visual field defects).
Hipofizni tumorji, ki izločajo rastni hormon, se včasih lahko zvečajo in povzročijo resne zaplete (npr. izpade v vidnem polju).
• Check that the plunger rod has not moved-if it has, then push it back all the way into the syringe.
• Preverite, da se bat ni premaknil - če se je, ga do konca potisnite nazaj v injekcijsko brizgo.
Bubbles or air gaps that float to the top of the liquid should be pushed back out into the vial.
Mehurčke ali zračne vrzeli, ki se dvigujejo na gladino, potisnite nazaj v vialo.
How to store SOMAVERT Contents of the pack and other information
Shranjevanje zdravila SOMAVERT Vsebina pakiranja in dodatne informacije
• Release the pinched skin and pull the needle straight out.
• Izpustite stisnjeno kožo in iglo izvlecite naravnost iz kože.
The injection must not be mixed in the same syringe or vial as any other medicine.
Zdravila se v isti brizgi ali viali ne sme mešati z nobenim drugim zdravilom.
• Tiny air bubbles in the liquid are normal and are safe to inject.
• Majhni zračni mehurčki v tekočini so običajni.
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.
Zdravljenje odraslih bolnikov z akromegalijo, ki se na operacijo in/ali obsevanje niso ustrezno odzvali in pri katerih ustrezna farmakoterapija z analogi somatostatina ni normalizirala koncentracije IGF-I oz. takšne farmakoterapije niso prenašali.
Pegvisomant is not recommended during pregnancy (see section 4.6).
Pegvisomanta ni priporočljivo uporabljati med nosečnostjo (glejte poglavje
The injection can be self-administered or given by another person, for example your doctor or his/her assistant.
Injekcijo si lahko daste sami ali vam jo da kdo drug, npr. zdravnik ali medicinska sestra.
• Choose a different location within an area for each injection.
• Za vsako injiciranje izberite drugo mesto znotraj predela injiciranja.
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.
Absorpcija pegvisomanta po subkutani aplikaciji je počasna in podaljšana; največja koncentracija pegvisomanta v serumu je praviloma dosežena šele od 33 do 77 ur po uporabi.
What you need to know before you use SOMAVERT
Kaj morate vedeti, preden boste uporabili zdravilo SOMAVERT
Do not use any other liquid to mix with Somavert.
Za mešanje z zdravilom Somavert ne uporabljajte drugih tekočin.
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).
Zavrtje delovanja rastnega hormona s pegvisomantom povzroči zmanjšanje koncentracije insulinu podobnega rastnega faktorja I (IGF-I) v serumu, pa tudi drugih serumskih beljakovin, odzivnih na rastni hormon, npr. prostega IGF-I, kislinsko labilne podenote IGF-I (ALS) in beljakovine 3, ki veže insulinu podobni rastni faktor (IGFBP-3).
However, monitor LTs monthly to determine if further increases occur.
Vendar pa mesečno spremljajte jetrne teste glede nadaljnjih zvečanj.
Is it OK to shake the vial if the powder is not dissolving?
Ali lahko vialo stresem, če se prašek ni raztopil?
• If necessary, use a clean cotton ball and press lightly on the injection area.
• Če je treba, uporabite čist kos vate in ga rahlo pritisnite na mesto injiciranja.
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.
V skupini, ki je prejemala pegvisomant, so na vseh poizhodiščnih pregledih ugotavljali od odmerka odvisno, statistično pomembno zmanjšanje povprečnega IGF-I (p < 0,0001), prostega IGF-I (p < 0,05), IGFBP-3 (p < 0,05) in ALS (p < 0,05).
Choose injection area
Izberite mesto injiciranja
For storage conditions after reconstitution of the medicinal product, see section 6.3.
Po pripravi: Za pogoje shranjevanja po pripravi zdravila glejte poglavje 6.3.
Other medicines and SOMAVERT
Druga zdravila in zdravilo SOMAVERT
• Protein in the urine, increased urine, kidney problems.
• beljakovine v urinu, večje izločanje urina, težave z ledvicami
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.
Podatki dveh dolgoročnih študij s skupno 145 bolniki, ki so prejemali dnevne odmerke 10, 15 ali 20 mg, kažejo naslednje povprečne koncentracije (± SD) pegvisomanta v serumu: približno 8.800 ± 6.300 ng/ml (10 mg), 13.200 ± 8.000 ng/ml (15 mg) in 15.600 ± 10.300 ng/ml (20 mg).
*produced in Escherichia coli cells by recombinant DNA technology.
*pridobljen s tehnologijo rekombinantne DNA iz bakterije Escherichia coli.
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.
Študija pegvisomanta pri diabetikih, zdravljenih z insulinom ali peroralnimi antidiabetiki, je pokazala veliko tveganje za hipoglikemijo v tej populaciji.
• Remove a single Somavert pack from the refrigerator and allow it to come to room temperature naturally in a safe place.
• Eno pakiranje zdravila Somavert vzemite iz hladilnika in pustite, da se na varnem mestu segreje na sobno temperaturo.
What SOMAVERT is and what it is used for What you need to know before you use SOMAVERT How to use SOMAVERT
Kaj je zdravilo SOMAVERT in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo SOMAVERT Kako uporabljati zdravilo SOMAVERT Možni neželeni učinki
• Immediately perform a comprehensive hepatic workup.
• Takoj opravite celosten diagnostični pregled jeter.
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.
Ocenjeni povprečni celotni telesni sistemski očistek pegvisomanta po večkratnem odmerjanju je 28 ml/uro pri subkutanih odmerkih od 10 do 20 mg/dan.
• Lack of interest, feeling confused, increased sex drive, panic attack, loss of memory, problems sleeping.
• pomanjkanje zanimanja, občutek zmedenosti, zvišan libido, napad panike, izguba spomina, težave s spanjem
• Pull the needle out of the vial.
• Iglo izvlecite iz viale.
- If you experience disturbed vision or headaches while using SOMAVERT you must contact your doctor immediately.
Če se vam med uporabo zdravila SOMAVERT pojavijo motnje vida ali glavoboli, se morate nemudomaposvetovati z zdravnikom.
Two weeks after stopping treatment, leukocytosis and moderate bleeding from injection and vein puncture sites was observed which were considered possibly related to pegvisomant.
Dva tedna po prekinitvi zdravljenja so opazili levkocitozo in zmerno krvavitev z injekcijskih in venepunkcijskih mest; ocenili so, da so te spremembe lahko povezane s pegvisomantom.
In the week following discontinuation of treatment the adverse reactions noted were: insomnia, increased fatigue, oedema peripheral, tremor, and weight gain.
V tednu po prekinitvi zdravljenja so zabeležili naslednje neželene učinke: nespečnost, večjo utrujenost, periferni edem, tremor in zvečanje telesne mase.
• Do not withdraw the needle yet.
• Igle še ne izvlecite.
• Increased fatty substances in the blood, increased appetite.
• zvišana raven maščob v krvi, povečan apetit
These substances decrease the action of GH and levels of IGF-I circulating in the blood.
Ta snov zmanjšuje delovanje rastnega hormona in raven IGF-I v krvnem obtoku.
Dose adjustments should be based on serum IGF-I levels.
Odmerek je treba prilagajati na podlagi vrednosti IGF-I v serumu.
Add liquid
Dodajte tekočino
The syringe and needle should never be reused.
Brizge in igle ne smete ponovno uporabiti.
• No-never shake the vial.
• Ne, viale nikoli ne stresajte.
• 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.
• Zdravila ne uporabljajte, če: o je motno ali megleno; o je obarvano; o so v njem delci ali je v viali plast pene.
You should not breast-feed while taking SOMAVERT unless your doctor has discussed this with you.
Med uporabo zdravila SOMAVERT ne smete dojiti, razen če ste se o tem posvetovali z zdravnikom.
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)
Vsaj 5-kratnik ZMN oz. zvečanja vrednosti transaminaz za vsaj 3-kratnik ZMN, povezana s kakršnimkoli povečanjem vrednosti TBIL v serumu (z znaki/simptomi hepatitisa ali druge poškodbe jeter ali brez njih)
• Flu-like illness, fatigue.
• gripi podobni simptomi, utrujenost
The list below contains adverse reactions seen in clinical trials with SOMAVERT.
Spodnji seznam vsebuje neželene učinke, zabeležene v kliničnih preskušanjih zdravila SOMAVERT.
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.
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.
Greater than 3 but less than 5 times ULN (without signs/symptoms of hepatitis or other liver injury, or increase in serum TBIL)
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)
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.
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.
Cardiac disorders oedema peripheral
Srčne bolezni periferni edem
You should continue to inject this medicine for as long as instructed by your doctor.
Injiciranje tega zdravilamorate nadaljevati toliko časa, kot vam naroči zdravnik.
• Perform a comprehensive hepatic workup to discern if an alternative cause of liver dysfunction is present.
• Opravite celosten diagnostični pregled jeter, da ugotovite, ali obstaja drug vzrok motnje delovanja jeter.
Pegvisomant is highly selective for the GH receptor, and does not cross-react with other cytokine receptors, including prolactin.
Pegvisomant je zelo selektiven za receptorje za rastni hormon, zato nima navzkrižnih reakcij z drugimi citokinskimi receptorji, vključno s prolaktinom.
Pegvisomant should be administered by subcutaneous injection.
Pegvisomant se daje s subkutano injekcijo.
• An alcohol swab.
• alkoholni zloženec,
Effects on ability to drive and use machines
4.7 Vpliv na sposobnost vožnje in upravljanja strojev
- The solvent is water for injections.
Vehikel je voda za injekcije.
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.
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.
However, it is possible to accidently draw air into the syringe, which should be removed before injecting.
Če se zgodi, da v brizgo pomotoma izvlečete zrak, ga je treba pred injiciranjem odstraniti.
Hepatobiliary disorders abnormal liver function tests (e.g. transaminase elevation) (see section 4.4)
Bolezni jeter, žolčnika in žolčevodov nenormalni testi jetrne funkcije (npr. zvišanje transaminaz) (glejte poglavje 4.4)
This medicine must be dissolved before use.
Pred uporabo je treba to zdraviloraztopiti.
Following this, the usual daily dose of pegvisomant is 10 mg, which is given by subcutaneous injection (just under the skin).
Nato je običajni dnevni odmerek 10 mg pegvisomanta; uporablja se kot subkutana injekcija (injekcija tik pod kožo).
Check medicine
Preverite zdravilo
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.
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.
This is achieved by snapping it off.
Odstranite ga tako, da ga odlomite.
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.
Za različne odmerne sheme so na voljo jakosti SOMAVERT 10 mg, SOMAVERT 15 mg. SOMAVERT 20 mg, SOMAVERT 25 mg in SOMAVERT 30 mg.
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.
Po rekonstituciji je treba pripravljeno raztopino pred uporabo vizualno pregledati, da ne vsebuje tujih delcev oz. se njen fizični izgled ni spremenil.
Occurrence of injection site hypertrophy has been observed, including lipohypertrophy.
Opažali so pojav hipertrofije (vključno z lipohipertrofijo) na mestu injiciranja.
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:
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:
A growth hormone deficient state may result from administration of this medicinal product, despite the presence of elevated serum growth hormone levels.
Uporaba tega zdravila lahko povzroči pomanjkanje rastnega hormona kljub zvišani ravni rastnega hormona v serumu.
Psychiatric disorders abnormal dreams panic attack, short term memory loss, apathy, confusion, sleep disorder, libido increased anger
Psihiatrične motnje nenormalne sanje napadi panike, kratkoročna izguba spomina, apatičnost, zmedenost, motnje spanja, zvečanje libida jeza
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).
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).