FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials oral aripiprazole has not been shown to induce clinically relevant weight gain.
Slovenian: Zvečanje telesne mase Klinična preskušanja niso pokazale, da bi peroralni aripiprazol povzročil klinično pomembno zvečanje telesne mase.
English: Crospovidone
Slovenian: Distonija
English: ABILIFY 30 mg orodispersible tablets are round and pink, marked with ‘"A" over "643"' on one side and ‘30' on the other.
Slovenian: Okrogle oblike in roza barve, označene z "A" nad "643" na eni strani in 30 na drugi.
English: ABILIFY 15 mg tablets Yellow iron oxide (E 172)
Slovenian: ABILIFY 15 mg tablete rumeni železov oksid (E 172)
English: Talk to your doctor before taking ABILIFY.
Slovenian: Pred začetkom uporabe zdravila ABILIFY se posvetujte z zdravnikom.
English: Sulfobutylether β-cyclodextrin (SBECD) Tartaric acid
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi sulfobutileter betaciklodekstrin (SBECD) vinska kislina natrijev hidroksid voda za injekcije
English: ABILIFY contains sodium
Slovenian: Zdravilo ABILIFY vsebuje natrij
English: Tell the doctor or nurse if you feel dizzy or faint after the injection.
Slovenian: Če ste po prejemu injekcije omotični ali omedlite, o tem obvestite zdravnika ali medicinsko sestro.
English: ABILIFY 30 mg tablets Each tablet contains 30 mg of aripiprazole.
Slovenian: 57 mg laktoze (v obliki monohidrata) na tableto ABILIFY 30 mg tablete Ena tableta vsebuje 30 mg aripiprazola.
English: The occurrence of suicidal behaviour is inherent in psychotic illnesses and mood disorders and in some cases has been reported early after initiation or switch of antipsychotic treatment, including treatment with aripiprazole (see section 4.8).
Slovenian: V nekaterih primerih so o njegovem pojavu poročali zgodaj po uvedbi ali zamenjavi antipsihotičnega zdravljenja,
English: This can lead to symptoms such as:
Slovenian: To lahko privede do simptomov, kot so:
English: Overall Response Rate, %
Slovenian: Celokupni delež odgovora, %
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 December 2018
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 12. december 2018
English: Children and adolescents Ogivri is not recommended for anyone under the age of 18 years.
Slovenian: Otroci in mladostniki Zdravilo Ogivri ni priporočljivo za mlajše od 18 let.
English: This medicinal product must not be mixed or diluted with other medicinal products except those mentioned in section 6.6.
Slovenian: Zdravila ne smemo mešati ali redčiti z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
English: • Your doctor will advise you of the risks and benefits of taking Ogivri during pregnancy.
Slovenian: • Zdravnik vam bo svetoval glede tveganja in koristi uporabe zdravila Ogivri v času nosečnosti.
English: The bioactivity of D7D and the clinical impact of the elevation of this metabolite were unclear.
Slovenian: Biološka aktivnost D7D in klinični vpliv zaradi dviga ravni tega metabolita nista bila jasna.
English: Therefore, your doctor may decide to continue to check your heart functions, even after you finish treatment.
Slovenian: Zato se bo vaš zdravnik morda odločil za nadaljevanje spremljanja delovanja vašega srca tudi po končanem zdravljenju.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba ime in številko serije uporabljenega zdravila jasno zabeležiti.
English: Side effects of not known frequency: frequency cannot be estimated from the available data
Slovenian: Neželeni učinki z neznano pogostnostjo - pogostnosti ni mogoče oceniti iz podatkov, ki so na voljo:
English: • increased muscle tone or tension (hypertonia)
Slovenian: • povečan mišični tonus ali napetost (hipertonija)
English: Ogivri should only be given by a doctor or nurse.
Slovenian: Zdravilo Ogivri lahko daje le zdravnik ali medicinska sestra.
English: In this section, the following categories of frequency have been used: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: V tem poglavju so neželeni učinki navedeni po pogostnosti na naslednji način: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznano (ni mogoče oceniti iz razpoložljivih podatkov).
English: • breathlessness (including breathlessness at night),
Slovenian: • težave z dihanjem (vključno s težavami z dihanjem ponoči),
English: Ogivri can cause breathing difficulties, especially when it is first given.
Slovenian: Zdravilo Ogivri lahko povzroči težave z dihanjem, še zlasti, ko ga prejmete prvič.
English: Patients with HFI cannot break down fructose, which may cause serious side effects.
Slovenian: Bolniki s HFI ne morejo razgraditi fruktoze, kar lahko privede do resnih neželenih učinkov.
English: Therefore, these patients should not be treated with trastuzumab (see section 4.3).
Slovenian: Zato takih bolnikov ne smemo zdraviti s trastuzumabom (glejte poglavje 4.3).
English: Infusion reactions, allergic-like reactions and hypersensitivity It is estimated that approximately 40 % of patients who are treated with trastuzumab will experience some form of infusion-related reaction.
Slovenian: Infuzijske reakcije, alergiji podobne reakcije in preobčutljivost Ocenjujejo, da se pri približno 40 % bolnikov, ki prejemajo trastuzumab, pojavi neka oblika reakcij, povezanih z infuzijo.
English: If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not receive this medicine.
Slovenian: Če imate dedno intoleranco za fruktozo (HFI), kar je redka genetska bolezen, tega zdravila ne smete jemati.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Slovenian: Če se zdravilo ne uporabi takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik.
English: * defined as absence of any invasive cancer both in the breast and axillary nodes
Slovenian: * Definiran kot odsotnost kakršnega koli invazivnega raka v dojkah in aksilarnih bezgavkah
English: The reconstituted solution should not be frozen.
Slovenian: Pripravljene raztopine se ne sme zamrzniti.
English: Approximately 17 % of cardiac dysfunction related events occurred after completion of trastuzumab.
Slovenian: Približno 17 % dogodkov, povezanih z motnjo delovanja srca, je nastopilo po zaključku zdravljenja s trastuzumabom.
English: Serious reactions have been treated successfully with supportive therapy such as oxygen, beta agonists, and corticosteroids.
Slovenian: Resne reakcije so uspešno zdravili s podpornim zdravljenjem, kot so kisik, beta agonisti in kortikosteroidi.
English: 47.3 (32-ne)
Slovenian: 47,3 (32-no)
English: See section 4.8 for how to report adverse reactions
Slovenian: Glejte poglavje 4.8 o tem, kako poročati o neželenih učinkih.
English: Duration of Response, Median months
Slovenian: Trajanje odgovora, mediana mesecev
English: Some of these symptoms can be serious and some patients have died (see section 2 under “Warnings and precautions”).
Slovenian: Nekateri od teh simptomov so lahko resni in opisani so primeri smrti (glejte poglavje 2, “Opozorila in previdnostni ukrepi”).
English: The dose of Ogivri depends on your body weight.
Slovenian: Odmerek zdravila Ogivri je odvisen od vaše telesne mase.
English: These effects mainly occur with the first intravenous infusion (“drip” into your vein) and during the first few hours after the start of the infusion.
Slovenian: Ti učinki se pojavijo predvsem med prvo intravensko infuzijo (“kapljanjem” zdravila v žilo) in prvih nekaj ur po pričetku infuzije.
English: The results of these simulations indicate that at least 95 % of patients will reach concentrations that are < 1 mcg/mL (approximately 3 % of the population predicted Cmin,ss, or about 97 % washout) by 7 months.
Slovenian: Rezultati teh simulacij kažejo, da bo najmanj 95 % bolnikov do 7. meseca doseglo koncentracije < 1 μg/ml (približno 3 % Cmin, ss predvidene za populacijo ali približno 97-% izpiranje).
English: 12 weeks.
Slovenian: 24 mesecih.
English: As human IgG1 is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during trastuzumab therapy and for 7 months after the last dose.
Slovenian: Ker se humani IgG1 izloča v materino mleko, potencialni škodljivi vpliv na otroka pa ni znan, naj ženske ne dojijo med zdravljenjem s trastuzumabom in še 7 mesecev po zadnjem odmerku.
English: 4.7 Effects on ability to drive and use machines Ogivri may have a minor influence on the ability to drive and use machines (see section 4.8).
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Ogivri ima lahko blag vpliv na sposobnost vožnje in upravljanje strojev (glejte poglavje 4.8).
English: Trastuzumab loading dose should be administered as a 90-minute intravenous infusion.
Slovenian: Uvajalni odmerek trastuzumaba se daje kot 90-minutna intravenska infuzija.
English: These medicines (or any other anthracyclines) can damage heart muscle and increase the risk of heart problems with Ogivri.
Slovenian: Ta zdravila (ali kateri koli antraciklin) lahko poškodujejo srčno mišico in zvečajo tveganje za nastanek težav s srcem ob uporabi zdravila Ogivri;
English: FP + H: Fluoropyrimidine/cisplatin + Trastuzumab FP: Fluoropyrimidine/cisplatin a Odds ratio
Slovenian: FP + H: fluoropirimidin/cisplatin + trastuzumab FP: fluoropirimidin/cisplatin a Razmerje obetov
English: Trastuzumab 1 Year N = 1702***
Slovenian: Trastuzumab 1 leto n = 1702***
English: If you develop any signs of heart failure (inadequate pumping of blood by the heart), your heart function may be checked more frequently (every six to eight weeks), you may receive treatment for heart failure or you may have to stop Ogivri treatment.
Slovenian: Če bodo pri vas nastopili kakršni koli znaki srčnega popuščanja (to je, da vaše srce ne črpa krvi v zadostni meri), bo zdravnik delovanje vašega srca preveril pogosteje (vsakih šest do osem tednov); lahko prejmete zdravila proti srčnemu popuščanju ali pa boste morda morali prenehati z zdravljenjem z zdravilom Ogivri.
English: What Ogivri is and what it is used for
Slovenian: Kaj je zdravilo Ogivri in za kaj ga uporabljamo
English: Time to Disease Progression, Median months
Slovenian: Čas do napredovanja bolezni, mediana mesecev
English: If the first dose is well tolerated the next doses may be given over 30 minutes (see section 2 under “Warnings and precautions”).
Slovenian: Če boste začetni odmerek dobro prenašali, boste nadaljnje odmerke prejeli v 30 minutah (glejte poglavje 2, “Opozorila in previdnostni ukrepi”).
English: • if you have severe breathing problems at rest due to your cancer or if you need oxygen treatment.
Slovenian: • imate hude težave z dihanjem v mirovanju zaradi raka ali če potrebujete zdravljenje s kisikom.
English: When Ogivri binds to HER2 it stops the growth of such cells and causes them to die.
Slovenian: Ko se zdravilo Ogivri veže na HER2, zaustavi rast teh celic in povzroči njihovo smrt.
English: Chemo + Trastuzumab (n = 115)
Slovenian: Kemoterapija + trastuzumab (n = 115)
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden boste prejeli to zdravilo.
English: Women of childbearing potential should be advised to use effective contraception during treatment with trastuzumab and for 7 months after treatment has concluded (see section 5.2).
Slovenian: Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem s trastuzumabom ter še 7 mesecev po zaključku zdravljenja uporabljajo učinkovito kontracepcijo (glejte poglavje 5.2).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreeed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: • Hypersensitivity to the active substance, murine proteins, or to any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost na učinkovino, murine beljakovine ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing trastuzumab in all subsets of the paediatric population for breast and gastric cancer (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z referenčnim zdravilom, ki vsebuje trastuzumab, za vse skupine pediatrične populacije pri raku dojk in raku želodca (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Table 6 Efficacy results from study BO16348
Slovenian: Preglednica 6 Rezultati učinkovitosti študije BO16348
English: If diluted aseptically, it may be stored for 24 hours (do not store above 30°C).
Slovenian: Če je redčenje potekalo aseptično, se lahko raztopino hrani do 24 ur (ne shranjujte pri temperaturi nad 30 °C).
English: Heart problems can sometimes occur during treatment and occasionally after treatment has stopped and can be serious.
Slovenian: Včasih se lahko med zdravljenjem ali občasno tudi po končanem zdravljenju pojavijo težave s srcem, ki so lahko resne.
English: If an alternate route of administration is required, other trastuzumab products offering such an option should be used
Slovenian: Če je potrebna drugačna pot uporabe, je treba uporabiti druga zdravila, ki vsebujejo trastuzumab in omogočajo to možnost.
English: Observation N = 1697***
Slovenian: Opazovanje n = 1697***
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC03
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa, oznaka ATC: L01XC03
English: Only patients with a large amount of HER2 will be treated with Ogivri.
Slovenian: Le bolniki z velikim številom HER2 bodo zdravljeni z zdravilom Ogivri.
English: In this trial, 87 % of patients entered had disease that was IHC3+, and 95 % of patients entered had disease that was IHC3+ and/or FISH-positive.
Slovenian: V tem preskušanju je 87 % vključenih bolnikov imelo bolezen, ki je bila IHC 3+, 95 % vključenih bolnikov pa je imelo bolezen, ki je bila IHC 3+ in/ali FISH-pozitivna.
English: In all patients cardiac function should be monitored during treatment (e.g. every 12 weeks).
Slovenian: Med zdravljenjem je treba nadzorovati delovanje srca pri vseh bolnikih (npr. vsakih 12 tednov).
English: 21 (mg/mL, concentration of reconstituted solution)
Slovenian: 21 (mg/ml, koncentracija pripravljene raztopine)
English: Your doctor may prescribe Ogivri for the treatment of breast and gastric cancer when:
Slovenian: Vaš zdravnik vam lahko zdravilo Ogivri predpiše za zdravljenje raka dojk in raka želodca, če:
English: • You should use effective contraception during treatment with Ogivri and for at least 7 months after treatment has ended.
Slovenian: • Med zdravljenjem z zdravilom Ogivri in vsaj še 7 mesecev po zaključku zdravljenja morate uporabljati učinkovito kontracepcijo.
English: The product is not intended to be stored after reconstitution and dilution unless this has taken place under controlled and validated aseptic conditions.
Slovenian: Zdravila po rekonstituciji ali redčenju ni dovoljeno shranjevati, razen če sta rekonstitucija in redčenje potekala v kontroliranih in validiranih aseptičnih pogojih.
English: The rate was highest in patients who were administered trastuzumab concurrently with a taxane (2.0 %).
Slovenian: Delež je bil najvišji pri bolnikih, ki so trastuzumab prejeli sočasno s taksanom (2,0 %).
English: Very rarely, patients with severe breathing difficulties before treatment have died when they were given Ogivri.
Slovenian: Zelo redko je pri bolnikih, ki so imeli hude težave z dihanjem pred začetkom zdravljenja, pri uporabi zdravila Ogivri prišlo do smrtnih primerov;
English: An absolute benefit of 13 percentage points in favour of the trastuzumab arm was estimated in terms of 3-year event-free survival rate (65 % versus 52 %).
Slovenian: Absolutna korist 13 odstotnih točk v prid skupini, ki je prejemala trastuzumab, je bila ocenjena v smislu 3-letnega preživetja brez bolezni (65 % proti 52 %).
English: The efficacy results from the BO16348 trial following 12 months* and 8 years** median follow-up are summarized in Table 6:
Slovenian: Rezultati učinkovitosti študije BO16348 po medianem času spremljanja 12 mesecev* in 8 let** so povzeti v preglednici 6:
English: 150 mg vial
Slovenian: 150-mg viala
English: Study M77001: Full analysis set (intent-to-treat), 24 months results
Slovenian: 3 Študija M77001: celotna skupina bolnikov (bolniki, ki so jih nameravali zdraviti, intent-to-treat), rezultati po
English: Trastuzumab 1 Year N = 1693
Slovenian: Trastuzumab 1 leto n = 1693
English: For intravenous use only after reconstitution and dilution
Slovenian: Za intravensko uporabo le po rekonstituciji in razredčitvi.
English: AC→PH (vs. AC→P) (NSABP B-31 and NCCTG N9831)*
Slovenian: AC→PH (v primerjavi z AC→P) (NSABP B-31 in NCCTG N9831)*
English: Treatment with Ogivri alone or with a taxane may affect the heart, especially if you have ever used an anthracycline (taxanes and anthracyclines are two other kinds of medicine used to treat cancer).
Slovenian: Samostojno zdravljenje z zdravilom Ogivri ali v kombinaciji s taksanom lahko vpliva na srce, še posebno, če ste se kdaj zdravili z antraciklinom (taksani in antraciklini sta dve drugi vrsti zdravil, ki se uporabljata za zdravljenje raka).
English: Switching treatment between trastuzumab intravenous and trastuzumab subcutaneous formulation and vice versa.
Slovenian: Prehod z zdravljenja s trastuzumabom v intravenski obliki na subkutano obliko in obratno
English: *Cmin,ss - Cmin at steady state **Cmax,ss = Cmax at steady state *** time to 90% of steady-state
Slovenian: * Cmin, ss - Cmin v stanju dinamičnega ravnovesja ** Cmax, ss = Cmax v stanju dinamičnega ravnovesja *** čas do 90 % stanja dinamičnega ravnovesja
English: Patients were either naïve to trastuzumab intravenous treatment (20.3 %) or pre-exposed to trastuzumab intravenous (79.7 %).
Slovenian: Bolniki še niso prejemali trastuzumaba v intravenski obliki (20,3 %) ali pa so bili predhodno izpostavljeni trastuzumabu v intravenski obliki (79,7 %).
English: In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1 % (30/296) of patients treated with trastuzumab intravenous developed antibodies against trastuzumab.
Slovenian: V študiji neoadjuvantnega-adjuvantnega zgodnjega raka dojk (BO22227) z mediano spremljanja, ki je presegla 70 mesecev, so se pri 10,1 % bolnikov (30/296), zdravljenih z intravensko obliko trastuzumaba, razvila protitelesa proti trastuzumabu.
English: The non-linear elimination parameter values were 8.81 mg/day for the maximum elimination rate (Vmax) and 8.92 mcg/mL for the Michaelis-Menten constant (Km) for the MBC, EBC, and AGC patients.
Slovenian: Vrednosti parametrov nelinearnega izločanja so bile 8,81 mg/dan za največjo hitrost izločanja (Vmax) in 8,92 µg/ml za Michaelis-Mentenovo konstanto (Km) za bolnike z MBC, EBC in AGC.
English: - The active substance is trastuzumab.
Slovenian: - Učinkovina je trastuzumab.
English: Should an infusion reaction occur the infusion should be discontinued or the rate of infusion slowed and the patient should be monitored until resolution of all observed symptoms (see section 4.2).
Slovenian: Če se pojavi infuzijska reakcija, je potrebno infundiranje zdravila Ogivri prekiniti ali upočasniti njegovo hitrost in bolnika nadzorovati, dokler vsi simptomi ne izzvenijo (glejte poglavje 4.2).
English: Any remaining reconstituted solution should be discarded.
Slovenian: Ostanke rekonstituirane raztopine je treba zavreči.
English: For early breast cancer, metastatic breast cancer and metastatic gastric cancer, Ogivri is given every 3 weeks.
Slovenian: Pri zgodnji obliki raka dojk, metastatskem raku dojk in metastatskem raku želodca se zdravilo Ogivri daje vsake 3 tedne.
English: L-histidine hydrochloride
Slovenian: L-histidinijev klorid hidrat
English: • fluid retention (swelling) in the legs or arms,
Slovenian: • zadrževanje tekočine (otekanje) v nogah ali rokah,
English: In patients who receive anthracycline-containing chemotherapy further monitoring is recommended, and should occur yearly up to 5 years from the last administration of trastuzumab, or longer if a continuous decrease of LVEF is observed.
Slovenian: Pri bolnikih, ki prejemajo kemoterapijo z antraciklini, je priporočljivo nadaljnje spremljanje, ki ga je treba izvajati letno do 5 let po zadnjem dajanju trastuzumaba ali dlje, če iztisni delež levega prekata (LVEF) stalno pada.
English: After reconstitution with sterile water for injections, the reconstituted solution is physically and chemically stable for 48 hours at 2°C-8°C.
Slovenian: Po rekonstituciji s sterilno vodo za injekcije je rekonstituirana raztopina fizikalno in kemijsko stabilna 48 ur pri temperaturi od 2 °C-8 °C.
English: Glucose solutions must not be used for dilution since these cause aggregation of the protein.
Slovenian: Za redčenje ne uporabljajte raztopin glukoze, ker le-te povzročajo agregacijo beljakovin.
English: Paediatric population There is no relevant use of trastuzumab in the paediatric population.
Slovenian: Pediatrična populacija Trastuzamab ni namenjen za uporabo pri pediatrični populaciji.
English: Other side effects can occur at any time during treatment with Ogivri, not just related to an infusion.
Slovenian: Drugi neželeni učinki se lahko pojavijo kadar koli med zdravljenjem z zdravilom Ogivri in niso povezani le z infuzijo.
English: If you stop using Ogivri
Slovenian: Če ste prenehali uporabljati zdravilo Ogivri
English: 6.6 Special precautions for disposal and other handling Ogivri should be carefully handled during reconstitution.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Med rekonstitucijo se mora z zdravilom Ogivri pazljivo ravnati.
English: If you receive Ogivri with any other medicine to treat cancer, such as paclitaxel, docetaxel, an aromatase inhibitor, capecitabine, 5-fluorouracil, or cisplatin you should also read the patient information leaflets for these products.
Slovenian: Če prejemate zdravilo Ogivri z drugimi zdravili za zdravljenje raka, kot so paklitaksel, docetaksel, zaviralec aromataze, kapecitabin, 5-fluorouracil ali cisplatin, preberite tudi navodila za uporabo teh zdravil.
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: Ogivri is a biosimilar medicinal product.
Slovenian: Zdravilo Ogivri je podobno biološko zdravilo.
English: You must tell your doctor before receiving this medicine if you have HFI or if you can no longer take sweet foods or drinks because you feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.
Slovenian: Preden prejmete to zdravilo, morate zdravnika obvestiti o svoji intoleranci za fruktozo, prav tako mu morate povedati, če ne morete več uživati sladke hrane ali sladkih napitkov, ker vam je slabo, bruhate ali se neprijetno počutite (npr. napenjanje, krči v trebuhu, driska).
English: Sorbitol content
Slovenian: Vsebnost sorbitola
English: 420 mg vial
Slovenian: 420-mg viala