FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cosentyx, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: For the full list of all side effects and restrictions with Cosentyx, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Cosentyx glejte navodilo za uporabo.
English: It is not intended to provide practical advice on how to use Cosentyx.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: • ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine) when conventional treatments do not work well enough.
Slovenian: • z ankilozirajočim spondilitisom (boleznijo, ki povzroča vnetje in bolečine v vretencih), kadar konvencionalno zdravljenje ni dovolj učinkovito.
English: What are the risks associated with Cosentyx?
Slovenian: Kakšna tveganja so povezana z zdravilom Cosentyx?
English: The doctor should consider stopping treatment if no improvement has been seen during this time.
Slovenian: Če v tem času ne pride do izboljšanja, mora zdravnik razmisliti o prekinitvi zdravljenja.
English: The medicine is available as a powder used to make a solution for injection, or as a ready-to-use solution in a pre-filled syringe or pen injector.
Slovenian: Zdravilo je na voljo v obliki praška za pripravo raztopine za injiciranje ali v obliki pripravljene raztopine v napolnjeni injekcijski brizgi ali injekcijskem peresniku.
English: Studies showed that Cosentyx is effective in treating psoriasis, psoriatic arthritis and ankylosing spondylitis, with patients showing greater improvements with Cosentyx than with placebo (a dummy treatment) or with a comparator medicine, etanercept.
Slovenian: Študije so pokazale, da je zdravilo Cosentyx učinkovito pri zdravljenju psoriaze, psoriatičnega artritisa in ankilozirajočega spondilitisa, pri čemer je pri bolnikih prišlo do večjega izboljšanja z zdravilom Cosentix kot s placebom (zdravilom brez zdravilne učinkovine) ali kot s primerjalnim zdravilom, etanerceptom.
English: The active substance in Cosentyx, secukinumab, is a monoclonal antibody, a type of protein, designed to recognise and attach to a messenger molecule in the immune system called interleukin 17A.
Slovenian: Zdravilna učinkovina zdravila Cosentyx, sekukinumab, je monoklonsko protitelo, vrsta beljakovine, ki je bilo zasnovano tako, da prepozna signalno molekulo imunskega sistema, imenovano interlevkin 17A, in se veže nanjo.
English: For more information about treatment with Cosentyx, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Cosentyx preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What is Cosentyx and what is it used for?
Slovenian: Kaj je zdravilo Cosentyx in za kaj se uporablja?
English: In addition, 65% of patients given Cosentyx had clear or nearly clear skin, compared with 27% of patients given etanercept and 2% of those given placebo.
Slovenian: Poleg tega je imelo 65 % bolnikov, ki so prejemali zdravilo Cosentyx, kožo brez znakov ali skoraj brez znakov, v primerjavi s 27 % bolnikov, ki so prejemali etanercept, in 2 % bolnikov, ki so prejemali placebo.
English: What benefits of Cosentyx have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Cosentyx izkazalo v študijah?
English: Why is Cosentyx approved?
Slovenian: Zakaj je bilo zdravilo Cosentyx odobreno?
English: For practical information about using Cosentyx, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Cosentyx naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: This compares with 44% of those on a comparator medicine etanercept and 4% of those on placebo.
Slovenian: Do podobnega rezultata je prišlo pri 44 % bolnikov, ki so prejemali primerjalno zdravilo etanercept, in 4 % bolnikov, ki so prejemali placebo.
English: • psoriatic arthritis (inflammation of the joints associated with psoriasis) when disease-modifying anti-rheumatic drugs (DMARDs) do not work well enough;
Slovenian: • s psoriatičnim artritisom (vnetjem sklepov, povezanim s psoriazo), kadar imunomodulirajoča antirevmatska zdravila (DMARD) niso dovolj učinkovita;
English: Cosentyx is given by injection under the skin as four weekly injections followed by monthly maintenance injections.
Slovenian: Zdravilo Cosentyx se daje v obliki podkožnih injekcij, najprej štiri injekcije enkrat na teden, nato pa kot vzdrževalno zdravljenje enkrat na mesec.
English: It contains the active substance secukinumab.
Slovenian: Vsebuje zdravilno učinkovino sekukinumab.
English: In a study of 397 patients with psoriatic arthritis, between 51% and 54% of patients on the approved doses of Cosentyx achieved a 20% reduction in ACR scores (painful, swollen joints and other symptoms) after 24 weeks.
Slovenian: V študiji s 397 bolniki s psoriatičnim artritisom je od 51 % do 54 % bolnikov, ki so prejemali odobrene odmerke zdravila Cosentyx, po 24 tednih doseglo 20-odstotno zmanjšanje indeksa ACR (boleči, otekli sklepi in drugi simptomi).
English: Finally, in a study of 219 patients with ankylosing spondylitis, 61% of patients given the approved dose of Cosentyx achieved a 20% reduction in ASAS scores (back pain, morning stiffness and other symptoms) after 16 weeks, compared with 28% of patients on with placebo.
Slovenian: V študiji pri 219 bolnikih z ankilozirajočim spondilitisom je 61 % bolnikov, ki so prejeli odobreni odmerek zdravila Cosentyx, po 16 tednih doseglo 20-odstotno zmanjšanje indeksa ASAS (bolečine v hrbtu, jutranja okorelost in drugi simptomi), v primerjavi z 28 % bolnikov, ki so prejemali placebo.
English: The medicine has been shown to be of substantial clinical benefit in patients with psoriasis, psoriatic arthritis and ankylosing spondylitis.
Slovenian: Dokazali so, da ima zdravilo pri bolnikih s psoriazo, psoriatičnim artritisom in ankilozirajočim spondilitisom bistvene klinične koristi.
English: How does Cosentyx work?
Slovenian: Kako zdravilo Cosentyx deluje?
English: In 4 psoriasis studies involving 2,403 patients, 79% of those on Cosentyx achieved a 75% reduction in their PASI scores (a measure of disease severity and area of skin affected) after 12 weeks of treatment.
Slovenian: V štirih študijah pri psoriazi, ki so vključevale 2 403 bolnike, je po 12 tednih zdravljenja 79 % bolnikov, ki so prejemali zdravilo Cosentyx, doseglo 75-odstotno zmanjšanje vrednosti indeksa PASI (indeks jakosti bolezni in prizadete površine kože).
English: How is Cosentyx used?
Slovenian: Kako se zdravilo Cosentyx uporablja?
English: Adolescents and adults 12-65 years
Slovenian: Mladostniki in odrasli 12 do 65 let
English: Limited data are available.
Slovenian: Na voljo so omejeni podatki.
English: Q1 first quartile; Q3 third quartile
Slovenian: Q1 prvi kvartil; Q3 tretji kvartil
English: How much Iblias you should use and how often you should use it depends on many factors such as:
Slovenian: Koliko zdravila Iblias morate uporabiti in kako pogosto ga morate uporabiti je odvisno od več dejavnikov, kot so:
English: • allergic reactions including severe sudden allergic reaction
Slovenian: • alergijske reakcije, tudi hude nenadne alergijske reakcije
English: Success rate*
Slovenian: Stopnja uspešnosti*
English: • the factor VIII level that is needed.
Slovenian: • vrednost faktorja VIII, ki jo želimo doseči.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 February 2016
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 18. februar 2016
English: These complications have not been associated with the product itself.
Slovenian: Ti zapleti niso bili povezani s samim zdravilom.
English: • Administer your next dose immediately and continue at regular intervals as advised by your doctor.
Slovenian: • Takoj uporabite vaš naslednji odmerek in zdravljenje nadaljujte v rednih presledkih, kot vam je predpisal zdravnik.
English: Each package of Iblias contains:
Slovenian: Vsako pakiranje zdravila Iblias vsebuje:
English: A safety and efficacy study has been performed in children of 0-12 years (see section 5.1); limited data are available for children below 1 year.
Slovenian: Študija varnosti in učinkovitosti je bila izvedena pri otrocih, starih od 0 do 12 let (glejte poglavje 5.1); za otroke, mlajše od 1 leta, so na voljo omejeni podatki.
English: There was no relevant change over the 6-12 months treatment period.
Slovenian: V 6- do 12-mesečnem obdobju zdravljenja ni bilo pomembnih sprememb.
English: Annex IV Scientific conclusions
Slovenian: Priloga IV Znanstveni zaključki
English: • dysgeusia (strange taste)
Slovenian: • disgevzija (nenavaden okus)
English: Such studies are not considered meaningful due to the production of antibodies against the heterologous human protein in animals.
Slovenian: Ocenjuje se, da te študije nimajo pomena zaradi nastajanja protiteles proti heterologni humani beljakovini pri živalih.
English: Speak to your doctor if you would like further information on this.
Slovenian: Posvetujte se z zdravnikom, če v zvezi s tem potrebujete še dodatne informacije.
English: For paediatric patients above the age of 12, the dose recommendations are the same as for adults.
Slovenian: Za pediatrične bolnike, starejše od 12 let, so priporočeni odmerki enaki kot za odrasle.
English: The specific activity of Iblias is approximately 4000 IU/mg protein.
Slovenian: Specifična aktivnost zdravila Iblias je približno 4000 i.e./mg beljakovine.
English: The excretion in animals has not been studied.
Slovenian: Izločanja pri živalih niso preučevali.
English: Factor VIII level required (%) (IU/dL)
Slovenian: Potrebna raven faktorja VIII (%) (i.e./dl)
English: EXP (End of the 12 month period, if stored up to 25 °C): ........... Do not use after this date.
Slovenian: EXP (konec 12 mesečnega obdobja, če zdravilo shranjujete pri temperaturi do 25 °C): ............ Ne uporabljajte po tem datumu.
English: ABR - all bleeds (median, Q1,Q3)
Slovenian: LSK - vse krvavitve (mediana, Q1,Q3)
English: Consequently, patients should be evaluated for cardiac risk factors.
Slovenian: Pri bolnikih je treba oceniti dejavnike tveganja za srčnožilne bolezni.
English: 140 subjects were treated for at least 12 months, and 55 of these subjects for a median of 24 months.
Slovenian: 140 oseb je bilo zdravljenih vsaj 12 mesecev; 55 med njimi z mediano 24 mesecev.
English: EU/1/15/1077/001 - Iblias 250 IU EU/1/15/1077/002 - Iblias 500 IU EU/1/15/1077/003 - Iblias 1000 IU EU/1/15/1077/004 - Iblias 2000 IU EU/1/15/1077/005 - Iblias 3000 IU
Slovenian: EU/1/15/1077/001 - Iblias 250 i.e. EU/1/15/1077/002 - Iblias 500 i.e. EU/1/15/1077/003 - Iblias 1000 i.e. EU/1/15/1077/004 - Iblias 2000 i.e. EU/1/15/1077/005 - Iblias 3000 i.e.
English: Warm both unopened vials in your hands to a comfortable temperature (do not exceed 37 °C).
Slovenian: Z rokami ogrejte obe neodprti viali do primerne temperature (na ne več kot 37 °C).
English: Pharmacotherapeutic group: antihemorrhagics: blood coagulation factor VIII, ATC code: B02BD02
Slovenian: Farmakoterapevtska skupina: antihemoragiki, koagulacijski faktor VIII, oznaka ATC: B02BD02
English: Repeat infusion every 8 - 24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dL).
Slovenian: Ponavljajte vsakih 8 do 24 ur, dokler se rana ustrezno ne zaceli; nato nadaljujte zdravljenje vsaj še naslednjih 7 dni za vzdrževanje aktivnosti faktorja VIII na 30 do 60 % (i.e./dl).
English: • Do not use a double dose to make up for a forgotten dose.
Slovenian: • Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Frequencies have been evaluated according to the following convention: common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Slovenian: Pogostnosti so opredeljene kot sledi: pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100).
English: Your doctor will tell you how often and at what intervals this medicine is to be administered.
Slovenian: Zdravnik vam bo razložil, kako pogosto in v kakšnih presledkih morate uporabljati to zdravilo.
English: Use only the items that are provided with each package of this medicine.
Slovenian: Uporabite lahko samo pribor, ki je priložen v vsakem pakiranju zdravila.
English: Study 1 Study 2 2 x/week dosing
Slovenian: Študija 1 Študija 2 Odmerja nje 2 x/teden
English: • if you are allergic to mouse or hamster proteins.
Slovenian: • če ste alergični na beljakovine miši ali hrčkov.
English: The activated partial thromboplastin time (aPTT) is prolonged in people with haemophilia.
Slovenian: Aktivirani parcialni tromboplastinski čas (APTČ) je pri ljudeh s hemofilijo podaljšan.
English: Consistent results were determined for both products.
Slovenian: Izsledki so bili skladni za obe zdravili.
English: A total of 204 subjects have been included in the clinical trial program, 153 subjects ≥ 12 years and 51 subjects < 12 years.
Slovenian: V program kliničnega preskušanja je bilo skupaj vključenih 204 oseb, 153 oseb ≥ 12 let in 51 oseb < 12 let.
English: T1/2 (h) AUC (IU.h/dL)** CL (dL/h/kg) Vss (dL/kg) * Based on population PK estimates **AUC calculated for a dose of 50 IU/kg
Slovenian: T1/2 (h) AUC (i.e.·h/dl)** očistek (dl/h/kg) Vss (dl/kg) * Na podlagi ocen populacijske farmakokinetike **AUC izračunana za odmerek 50 i.e./kg
English: Any of the following symptoms during injection/infusion can be an early warning for allergic and anaphylactic reactions:
Slovenian: Kateri koli od naslednjih simptomov med injiciranjem/infundiranjem je lahko zgodnje opozorilo za alergijsko in anafilaktično reakcijo:
English: BW: Body weight *Success rate defined as % of bleeds treated successfully with =/< 2 infusions
Slovenian: TM: telesna masa *Stopnja uspešnosti je opredeljena kot % uspešno zdravljenih krvavitev z =/< 2 infuzijama
English: Children and adolescents The listed warnings and precautions apply to patients of all ages, adults and children.
Slovenian: Otroci in mladostniki Navedena opozorila in previdnostni ukrepi veljajo za bolnike vseh starosti, za odrasle in otroke.
English: In completed clinical studies with 71 paediatric previously treated patients, the frequency, type and severity of adverse reactions in children were found to be similar to those in adults.
Slovenian: V zaključenih kliničnih študijah pri 71 pediatričnih predhodno zdravljenih bolnikih so ugotovili, da so bili pogostnost, vrsta in resnost neželenih učinkov pri otrocih podobni kot pri odraslih.
English: Control and Prevention of Bleeding
Slovenian: Nadzor in preprečevanje krvavitve
English: The recommended prophylaxis doses are 20-50 IU/kg twice weekly, three times weekly or every other day according to individual requirements.
Slovenian: Priporočeni profilaktični odmerki so 20 do 50 i.e./kg dvakrat na teden, trikrat na teden ali vsak drugi dan, glede na potrebe posameznika.
English: Factor VIII is a protein naturally found in the blood that helps to clot it.
Slovenian: Faktor VIII je beljakovina, ki je naravno prisotna v krvi in sodeluje pri strjevanju krvi.
English: The most serious side effects are allergic reactions or anaphylactic shock (an uncommon, severe allergic reaction affecting blood pressure and breathing).
Slovenian: Najbolj resni neželeni učinki so alergijske reakcije ali anafilaktični šok (občasna, huda alergijska reakcija, ki vpliva na krvni tlak in dihanje).
English: Repeat infusion every 8 to 24 hours until threat is resolved
Slovenian: Ponavljajte vsakih 8 do 24 ur, dokler ogroženost ne mine.
English: Since Iblias is a replacement protein of endogenous factor VIII, no adverse effects on fertility are expected.
Slovenian: Ker je zdravilo Iblias nadomestna beljakovina endogenega faktorja VIII, neželeni učinki na plodnost niso pričakovani.
English: Therefore, factor VIII should be used during pregnancy only if clearly indicated.
Slovenian: Zato se sme faktor VIII med nosečnostjo uporabljati le, če je to jasno indicirano.
English: No animal fertility studies have been conducted with Iblias and its effect on human fertility has not been established in controlled clinical trials.
Slovenian: Študij na živalih o vplivu zdravila Iblias na plodnost niso izvedli in njegovih učinkov na plodnost pri ljudeh niso ugotavljali v nadzorovanih kliničnih preskušanjih.
English: The speed of injection should be based on your comfort, but should not be faster than 2.0 mL per minute.
Slovenian: Hitrost injiciranja naj bo prilagojena vašemu počutju, vendar ne injicirajte hitreje kot 2 ml na minuto.
English: The doctor should always adjust the dose and the frequency of administration according to your individual needs.
Slovenian: Zdravnik mora odmerek in pogostost aplikacije odmerka prilagoditi glede na vaše individualne potrebe.
English: Other medicines and Iblias
Slovenian: Druga zdravila in zdravilo Iblias
English: Determine the point of injection and clean the skin with an alcohol swab.
Slovenian: Določite mesto injiciranja in kožo očistite z alkoholnim zložencem.
English: Iblias is prepared by recombinant technology without addition of any human- or animal-derived components in the manufacturing process.
Slovenian: Zdravilo Iblias je pridobljen z rekombinantno tehnologijo brez dodane kakršne koli komponente humanega ali živalskega izvora v postopku izdelave.
English: If you are using Iblias to prevent bleeding (prophylaxis), your doctor will calculate the dose for you.
Slovenian: Če zdravilo Iblias uporabljate za preprečevanje krvavitev (profilakso), bo velikost odmerka za vas izračunal zdravnik.
English: It is unknown whether Iblias is excreted in human milk.
Slovenian: Ni znano, ali se zdravilo Iblias izloča v materino mleko.
English: Iblias can be used for all age groups.
Slovenian: Zdravilo Iblias se lahko uporablja za vse starostne skupine.
English: Iblias can be used in children of all ages.
Slovenian: Zdravilo Iblias se lahko uporablja pri otrocih vseh starosti.
English: For 250/500/1000 IU strength:
Slovenian: Za jakost 250/500/1000 i.e.:
English: Treatment of bleeding Your doctor will calculate the dose of this medicine and how frequently you should use it to get the necessary level of factor VIII activity in your blood.
Slovenian: Zdravnik bo izračunal odmerek tega zdravila in kako pogosto ga morate uporabiti, da se pri vas doseže želena aktivnost faktorja VIII v krvi.
English: Components for reconstitution and administration are provided with each package of this medicine.
Slovenian: Sestavni deli za rekonstitucijo in uporabo so priloženi v vsakem pakiranju tega zdravila.
English: In children below the age of 12 higher doses or more frequent injections than in adults may be needed.
Slovenian: Pri otrocih, mlajših od 12 let, bodo morda potrebni večji odmerki ali pogostejše injiciranje kot pri odraslih.
English: Repeat infusion every 12 - 24 hours for 3 - 4 days or more until pain and acute disability are resolved.
Slovenian: Ponavljajte vsakih 12 do 24 ur, 3 do 4 dni ali več, dokler ne mineta bolečina in akutna onesposobljenost.
English: This will usually be in the range of 20 to 40 IU of octocog alfa per kg of body weight, injected two or three times per week.
Slovenian: Velikost odmerka bo običajno od 20 do 40 i.e. oktokoga alfa na kilogram telesne mase, injiciranega dva- ali trikrat na teden.
English: Repeated PK measurements after 6 to 12 months of prophylaxis treatment with Iblias did not indicate any relevant changes in PK characteristics after long-term treatment.
Slovenian: Ponavljajoče farmakokinetične meritve po 6 do 12 mesecih profilaktičnega zdravljenja z zdravilom Iblias niso pokazale pomembnih sprememb farmakokinetičnih parametrov po dolgotrajnem zdravljenju.
English: No interactions of human coagulation factor VIII (rDNA) products with other medicinal products have been reported.
Slovenian: O medsebojnem delovanju zdravil s humanim koagulacijskim faktorjem VIII (rDNK) z drugimi zdravili niso poročali.
English: Iblias should be injected intravenously over 2 to 5 minutes depending on the total volume.
Slovenian: Zdravilo Iblias je treba injicirati intravensko 2 do 5 minut, odvisno od skupne količine.
English: The analysis of all recorded incremental recoveries in previously treated patients demonstrated a median rise of > 2% (> 2 IU/dL) per IU/kg body weight for Iblias.
Slovenian: Analiza vseh zabeleženih postopnih izboljšanj pri predhodno zdravljenih bolnikih je pokazala mediano povečanja za > 2 % (> 2 i.e./dl) na i.e./kg telesne mase za zdravilo Iblias.
English: For 2000/3000 IU strength:
Slovenian: Za jakost 2000/3000 i.e.:
English: Do not increase the dose of Iblias to control your bleeding without checking with your doctor.
Slovenian: Ne povečajte odmerka zdravila Iblias za nadzor krvavitev, ne da bi se posvetovali z zdravnikom.
English: If these components cannot be used, please contact your doctor.
Slovenian: Če se teh sestavnih delov ne da uporabiti, se posvetujte z zdravnikom.
English: Dose/injection for bleed treatment Median (min; max)
Slovenian: Odmerek / injekcije za zdravljenje krvavitve mediana (min; max)
English: This medicine must not be mixed with other infusion solutions.
Slovenian: Tega zdravila ne smete mešati z drugimi raztopinami za injiciranje.
English: Make sure that no blood enters the syringe.
Slovenian: Preverite, da v injekcijski brizgi ni krvi.
English: These may be signs of a rare severe sudden allergic reaction (an anaphylactic reaction) to Iblias.
Slovenian: To so lahko znaki redke, hude nenadne alergijske reakcije (anafilaktična reakcija) na zdravilo Iblias.
English: In the case of the following haemorrhagic events, the factor VIII activity should not fall below the given level (in % of normal) in the corresponding period.
Slovenian: V primeru spodaj navedenih krvavitev aktivnost faktorja VIII ne sme pasti pod navedeno raven aktivnosti (% normalne aktivnosti) v ustreznem obdobju.
English: Take special care with Iblias and talk to your doctor or pharmacist if:
Slovenian: Opozorila in previdnostni ukrepi Bodite posebno pozorni pri uporabi zdravila Iblias in se posvetujte z zdravnikom ali farmacevtom, če:
English: Eligible patients (<6 years, male, severe haemophilia A, no previous treatment with any FVIII concentrate or only minimal treatment with blood components) were included from 42 sites.
Slovenian: Vključeni so bili primerni bolniki (< 6 let, moški, huda hemofilija A, brez predhodnega zdravljenja s katerim koli koncentratom FVIII ali le minimalno zdravljeni s krvnimi komponentami) iz 42 ustanov.
English: Follow the directions given by your doctor closely and use the detailed instructions for reconstitution and administration provided at the end of this leaflet.
Slovenian: Pri uporabi zdravila natančno upoštevajte navodila zdravnika in podrobnejša navodila za rekonstitucijo in uporabo, ki jih najdete na koncu tega navodila.
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Slovenian: Trombin pretvori fibrinogen v fibrin, ki omogoča nastanek krvnega strdka.
English: • heart palpitations (feeling your heart beating hard, rapidly, or irregularly)
Slovenian: • palpitacije srca (občutite močno, hitro ali neredno utripanje srca)
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Slovenian: Če se zdravila ne uporabi takoj po rekonstituciji, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik.
English: What you need to know before you use Iblias
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Iblias