FrancophonIA/ELRC3.0 huggingface dataset:
English: Niraparib is eliminated primarily through the hepatobiliary and renal routes.
Slovenian: Niraparib se primarno izloča prek jeter, žolčnika in žolčevodov ter ledvic.
English: Clinic visits occurred each cycle (4 weeks ± 3 days).
Slovenian: Obiski na kliniki so se odvijali v vsakem ciklu
English: • Withhold Zejula for a maximum of 28 days and monitor blood counts weekly until platelet counts return to ≥ 100,000/µL.
Slovenian: Prekinite zdravljenje z zdravilom Zejula za največ 28 dni in tedensko spremljajte število krvnih celic, dokler se število trombocitov ne povrne na ≥ 100.000/µl.
English: The study met its primary objective of statistically significantly improved PFS for niraparib maintenance monotherapy compared with placebo in the gBRCAmut cohort (HR 0.27; 95 % CI* 0.173, 0.410; p < 0.0001) as well as in the overall non-gBRCAmut cohort (HR 0.45; 95 % CI* 0.338, 0.607; p < 0.0001).
Slovenian: Študija je dosegla svoj primarni cilj statistično značilnega izboljšanja PFS za vzdrževalno monoterapijo z niraparibom v primerjavi s placebom v kohorti gBRCAmut (HR 0,27; 95-% IZ* 0,173,
English: Hazard ratio (95 % CI) *CI denotes confidence interval, gBRCAmut germline BRCA mutation, and NR not reached
Slovenian: *IZ pomeni interval zaupanja, gBRCAmut pomeni zarodno mutacijo BRCA, ND pomeni »ni doseženo«.
English: Dyspnea
Slovenian: dispepsija
English: placebo (N = 65)
Slovenian: (N = 65)
English: Nausea, vomiting, abdominal pain
Slovenian: Pogosti navzea, bruhanje, bolečina v trebuhu
English: Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML), including cases with fatal outcome, have been reported in a small number of patients who received Zejula or placebo.
Slovenian: Pri majhnem številu bolnic, ki so prejele zdravilo Zejula ali placebo, so poročali o mielodisplastičnem sindromu/akutni mieloični levkemiji (MDS/AML), vključno s primeri s smrtnim izidom.
English: Haematologic adverse reactions have been observed during the treatment with Zejula especially during the initial phase of the treatment.
Slovenian: Preglednica 2: Prilagajanje odmerka zaradi hematoloških neželenih učinkov Med zdravljenjem z zdravilom Zejula so opazili hematološke neželene učinke, zlasti v začetni fazi zdravljenja.
English: Common (may affect up to 1 in 10 people) Reduction in the number of white cells in the blood (leukopenia) Talk to your doctor if you get any other side effects.
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnic): • Znižanje števila belih krvničk v krvi (levkopenija).
English: Inhibition of hepatic uptake transporters (OATP1B1, OATP1B3, and OCT1) Neither niraparib nor M1 is an inhibitor of organic anion transport polypeptide 1B1 (OATP1B1) or 1B3 (OATP1B3).
Slovenian: Zaviranje prenašalcev jetrnega privzema (OATP1B1, OATP1B3 in OCT1) Niraparib in M1 nista zaviralca organskega anionskega prenašalnega polipeptida 1B3 (OATP1B1) ali 1B3 (OATP1B3).
English: Patients began treatment on Cycle 1/Day 1 (C1/D1) with niraparib 300 mg or matched placebo administered QD in continuous 28-day cycles.
Slovenian: dnevu s 300 mg nirapariba ali ujemajočim se placebom, danim enkrat dnevno v kontinuiranih 28-dnevnih ciklih.
English: No dose adjustment is necessary for patients with mild to moderate renal impairment.
Slovenian: Pri bolnicah z blago do zmerno okvaro ledvic prilagoditev odmerka ni potrebna.
English: placebo (N = 116)
Slovenian: (N = 116)
English: Each hard capsule contains niraparib tosylate monohydrate equivalent to 100 mg of niraparib.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje niraparibijev tosilat monohidrat v količini, ki ustreza 100 mg nirapariba.
English: Insomnia, anxiety, depression
Slovenian: Zelo pogosti nespečnost Pogosti anksioznost, depresija
English: Back pain, arthralgia
Slovenian: Občasni bolečina v hrbtu, artralgija,
English: No effect on behavioural and/or neurological parameters have been observed in repeat-dose toxicity studies in rats and dogs at estimated CNS exposure levels similar to or below expected therapeutic exposure levels.
Slovenian: podobnih pričakovanim terapevtskim ravnem izpostavljenosti ali nižjih, niso opazili vpliva na vedenjske in/ali nevrološke parametre.
English: In the clinical programme, thrombocytopenia was managed with laboratory monitoring, dose modification and platelet transfusion where appropriate (see section 4.2).
Slovenian: V kliničnem programu so trombocitopenijo obvladovali z laboratorijskim spremljanjem, prilagajanjem odmerka in, če je bilo to primerno, s transfuzijo trombocitov (glejte poglavje 4.2).
English: Thrombocytopenia, anaemia, neutropenia
Slovenian: Zelo pogosti trombocitopenija, anemija, nevtropenija
English: • 56 × 1 hard capsules
Slovenian: • 56 × 1 trdo kapsulo • 28 × 1 trdo kapsulo
English: Niraparib as a substrate of renal uptake transporters (OAT1, OAT3, and OCT2) Neither niraparib nor M1 is a substrate of organic anion transporter 1 (OAT1), 3 (OAT3), and organic cation transporter 2 (OCT2).
Slovenian: Niraparib kot substrat ledvičnih privzemnih prenašalcev (OAT1, OAT3 in OCT2) Niraparib in M1 nista substrata organskega anionskega prenašalca 1 (OAT1), 3 (OAT3) in organskega kationskega prenašalca 2 (OCT2).
English: Non-gBRCAmut cohort niraparib (N = 138)
Slovenian: (n = 203) in ne-gBRCAmut (n = 350).
English: Haematologic adverse reactions (thrombocytopenia, anaemia, neutropenia) have been reported in patients treated with Zejula.
Slovenian: Pri bolnicah, zdravljenih z zdravilom Zejula, so poročali o hematoloških neželenih učinkih (trombocitopeniji, anemiji, nevtropeniji).
English: • Stomach pain
Slovenian: • bolečina v trebuhu,
English: Hypertension, including hypertensive crisis, has been reported with Zejula therapy.
Slovenian: Pri zdravljenju z zdravilom Zejula so poročali o hipertenziji, vključno s hipertenzivno krizo.
English: Hypertension, including hypertensive crisis, has been reported with the use of Zejula.
Slovenian: Pri uporabi zdravila Zejula so poročali o hipertenziji, vključno s hipertenzivno krizo.
English: Headache, dizziness, dysgeusia
Slovenian: Zelo pogosti glavobol, omotičnost, disgevzija
English: Inhibition of renal uptake transporters (OAT1, OAT3, and OCT2) Neither niraparib nor M1 inhibits organic anion transporter 1 (OAT1), 3 (OAT3), and organic cation transporter 2 (OCT2).
Slovenian: Zaviranje prenašalcev ledvičnega privzema (OAT1, OAT3 in OCT2) Niraparib in M1 ne zavirata organskega anionskega prenašalca 1 (OAT1), 3 (OAT3) in organskega kationskega prenašalca 2 (OCT2).
English: The safety and efficacy of niraparib as maintenance therapy was studied in a Phase 3 randomised, double-blind, placebo-controlled international trial (ENGOT-OV16 / NOVA) in patients with relapsed predominantly high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who were platinum sensitive, defined by complete response (CR) or partial response (PR) for more than six months to their penultimate (next to last) platinum-based therapy.
Slovenian: jajcevoda ali primarnega peritonealnega raka visoke stopnje, ki je bil občutljiv na platino, kar je bilo opredeljeno kot popoln odziv (PO) ali delni odziv (DO) na njihovo predzadnje zdravljenje na osnovi platine, ki je trajal več kot šest mesecev.
English: • Indigestion
Slovenian: • omotičnost,
English: No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit (e.g. itraconazole, ritonavir, and clarithromycin) or induce CYP enzymes (e.g. rifampin, carbamazepine, and phenytoin).
Slovenian: Pri sočasnem dajanju zdravila Zejula z zdravili, za katera je znano, da zavirajo (npr. itrakonazol, ritonavir in klaritromicin) ali spodbujajo
English: Your doctor may recommend a lower dose if you experience side effects (such as nausea, tiredness, abnormal bleeding/bruising, anaemia).
Slovenian: Če se pri vas pojavijo neželeni učinki (kot so siljenje na bruhanje (navzea), utrujenost, nenormalna krvavitev/modrice, anemija), bo zdravnik morda priporočil manjši odmerek.
English: Niraparib as a substrate of CYPs (CYP1A2 and CYP3A4) Niraparib is a substrate of carboxylesterases (CEs) and UDP-glucuronosyltransferases (UGTs) in vivo.
Slovenian: Niraparib je in vivo substrat karboksilesteraz (CE, carboxylesterases) in UDP-glukuronoziltransferaz (UGT).
English: Low blood-cell counts
Slovenian: Nizka števila krvnih celic
English: Tachycardia
Slovenian: CTCAE
English: Capsule content Magnesium stearate
Slovenian: Občasni fotosenzitivnost, izpuščaj
English: What Zejula is and what it is used for What you need to know before you take Zejula How to take Zejula
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Zejula
English: There are limited clinical data in patients aged 75 or over.
Slovenian: 75 let, so omejeni.
English: niraparib (N = 234)
Slovenian: (N = 234)
English: In patients with baseline platelet count less than 180 × 109/L, thrombocytopenia of any grade and Grade 3/4 occurred in 76 % and 45 % of the patients, respectively.
Slovenian: Pri bolnicah z izhodiščnim številom trombocitov manj kot 180 × 109/l se je trombocitopenija katere koli stopnje oziroma 3. ali
English: Gamma-glutamyl transferase increased * Frequencies are based on percent of patients using all-causality adverse events.
Slovenian: * Pogostnosti temeljijo na odstotku bolnic ob upoštevanju neželenih dogodkov vseh vzrokov.
English: Estimated Survival Function
Slovenian: - Navodilo shranite.
English: Very common
Slovenian: Pogosti dispneja
English: Urinary tract infection, bronchitis
Slovenian: Infekcijske in parazitske bolezni Zelo pogosti okužba sečil Pogosti bronhitis, konjunktivitis
English: Name and address of the manufacturer(s) responsible for batch release Manufacturing Packaging Farmaca (MPF) B.V. Appelhof 13
Slovenian: Ime in naslov proizvajalca (proizvajalcev), odgovornega (odgovornih) za sproščanje serij
English: A.
Slovenian: IZ)
English: How to store Zejula
Slovenian: Shranjevanje zdravila Zejula
English: Back pain, arthralgia, myalgia
Slovenian: Zelo pogosti bolečina v hrbtu, artralgija Pogosti mialgija
English: Lactose
Slovenian: stomatitis
English: Lactose monohydrate
Slovenian: Pogosti hipertenzija
English: The median duration of anaemia of any grade was 63 days, and 8 days for Grade 3/4 events.
Slovenian: Mediani čas trajanja anemije katere koli stopnje je bil 63 dni, dogodkov
English: Reproductive toxicology
Slovenian: Toksikologija vpliva na sposobnost razmnoževanja
English: Nervous system disorders
Slovenian: • prebavne motnje,
English: Neither niraparib nor M1 is a substrate of organic anion transport polypeptide 1B1 (OATP1B1), 1B3 (OATP1B3), or organic cation transporter 1 (OCT1).
Slovenian: Niraparib kot substrat jetrnih privzemnih prenašalcev (OATP1B1, OATP1B3 in OCT1) Niraparib in M1 nista substrata organskega anionskega prenašalnega polipeptida 1B1 (OATP1B1), 1B3 (OATP1B3) ali organskega kationskega prenašalca 1 (OCT1).
English: • Abdominal bloating
Slovenian: • siljenje na bruhanje,
English: Ελλάδα
Slovenian: • izpuščaj,
English: 10 June 2016
Slovenian: 10. junij 2016
English: The European Commission issued a decision on 10 June 2016.
Slovenian: Evropska komisija je sklep izdala 10. junija 2016.
English: The company requested the authorisation to be recognised in Bulgaria, Croatia, France, Germany, Ireland, Italy, the Netherlands, Poland, Portugal, Romania, Slovenia, Spain and the United Kingdom (the ‘concerned Member States').
Slovenian: Želela je priznanje dovoljenja za promet v Bolgariji, na Hrvaškem, v Franciji, Nemčiji, na Irskem, v Italiji, na Nizozemskem, Poljskem, Portugalskem, v Romuniji, Sloveniji, Španiji in Združenem kraljestvu („zadevne države članice“).
English: However, the Member States could not reach an agreement and the Belgian Federal Agency for Medicines and Health Products referred the matter to the CVMP for arbitration on 29 September 2015.
Slovenian: Vendar države članice niso mogle doseči soglasja, zato je belgijska zvezna agencija za zdravila in zdravstvene izdelke 29. septembra 2015 zadevo napotila na odbor CVMP v arbitražo.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that subject to the conduct of additional studies and the implementation of further measures specified in a Risk Management Plan the marketing authorisation for CattleMarker IBR Inactivated should be granted in all concerned Member States.
Slovenian: Na osnovi vrednotenja trenutno razpoložljivih podatkov in znanstvene razprave znotraj odbora je odbor CVMP zaključil, da se pod pogojem, da bodo opravljene dodatne študije in izvedeni nadaljnji ukrepi, opredeljeni v načrtu za obvladovanje tveganj, dovoljenje za promet s cepivom CattleMarker IBR Inactivated izda v vseh zadevnih državah članicah.
English: On 17 March 2016, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine CattleMarker IBR Inactivated emulsion for injection for cattle (thereafter called CattleMarker IBR Inactivated).
Slovenian: Evropska agencija za zdravila je 17. marca 2016 zaključila postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede izdaje dovoljenja za promet s cepivom CattleMarker IBR Inactivated emulzija za injiciranje za govedo (v nadaljnjem besedilu: CattleMarker IBR Inactivated).
English: Why was CattleMarker IBR Inactivated reviewed?
Slovenian: Zakaj je bilo cepivo CattleMarker IBR Inactivated pregledano?
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, subject to conditions relating to risk mitigation and surveillance measures, the marketing authorisation granted in Belgium for CattleMarker IBR Inactivated can be recognised in other Member States of the EU.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da se pod pogoji glede ukrepov za zmanjšanje tveganja in nadzornih ukrepov dovoljenje za promet z zdravilom, izdano v Belgiji za cepivo CattleMarker IBR Inactivated, lahko prizna v drugih državah članicah EU.
English: What is CattleMarker IBR Inactivated?
Slovenian: Kaj je cepivo CattleMarker IBR Inactivated?
English: Zoetis Belgium SA submitted an application for CattleMarker IBR Inactivated for mutual recognition on the basis of the initial authorisation granted by Belgium.
Slovenian: Družba Zoetis Belgium SA je predložila vlogo za medsebojno priznavanje cepiva CattleMarker IBR Inactivated na podlagi začetne odobritve, izdane v Belgiji.
English: The potential risk of recurrence of Bovine Neonatal Pancytopenia linked to the use of this vaccine in pregnant cows had been addressed by Zoetis; however Germany considered that the proposed handling of the risks was inadequate and that a large scale post authorisation study should be initiated by Zoetis.
Slovenian: Družba Zoetis je obravnavala možno tveganje za ponovitev pancitopenije novorojenega goveda v povezavi z uporabo tega cepiva pri brejih kravah, vendar pa je bilo po mnenju Nemčije predlagano obvladovanje tveganja neustrezno in bi morala družba Zoetis začeti obsežno študijo o varnosti zdravila po pridobitvi dovoljenja za promet.
English: The grounds for the referral were concerns raised by Germany regarding the immunological safety of CattleMarker IBR Inactivated, as the composition and manufacture of this product are similar to PregSure BVD, a vaccine from Zoetis which has been shown to induce a long-lasting allogeneic antibody response that has been associated with Bovine Neonatal Pancytopenia, a neonatal alloimmune disease, in the progeny of vaccinated dams.
Slovenian: Podlaga za napotitev so bili pomisleki, ki jih je izrazila Nemčija glede imunološke varnosti cepiva CattleMarker IBR Inactivated, ker sta sestava in izdelava tega cepiva podobni kot pri cepivu PregSure BVD družbe Zoetis, za katerega je bilo dokazano, da pri potomcih cepljenih samic sproža dolgotrajen alogenski odziv protiteles, povezan s pancitopenijo novorojenega goveda, ki je aloimunska bolezen novorojenega goveda.
English: Questions and answers on CattleMarker IBR Inactivated emulsion for injection for cattle (inactivated gE Bovine Herpes Virus type 1 (BoHv-1), strain Difivac) EMA/290855/2016
Slovenian: Vprašanja in odgovori o cepivu CattleMarker IBR Inactivated emulzija za injiciranje za govedo (inaktiviran gE goveji herpes virus tipa 1 (BoHV-1), sev Difivac) EMA/290855/2016
English: CattleMarker IBR Inactivated is produced on the same bovine cell line and is adjuvanted with the same highly potent adjuvant as PregSure BVD.
Slovenian: Cepivo CattleMarker IBR Inactivated se proizvaja na enaki celični liniji goveda kot cepivo PregSure BVD in dodan mu je enak zelo močan adjuvans.
English: The product is indicated for active immunisation of seronegative cattle from 2 weeks of age to reduce the clinical signs (pyrexia and depression) of IBR and the duration of virus shedding caused by BoHV-1 infection.
Slovenian: Cepivo je indicirano za aktivno imunizacijo seronegativnega goveda, starejšega od dveh tednov, za zmanjšanje kliničnih znakov (pireksija in depresija) infekcioznega bovinega rinotraheitisa in skrajšanje trajanja izločanja virusa, ki ga povzroča okužba z virusom BoHV-1.
English: CattleMarker IBR Inactivated is an inactivated infectious bovine rhinotracheitis (IBR) vaccine which contains inactivated glycoprotein E (gE) negative bovine herpes virus 1 (BoHV-1), strain Difivac.
Slovenian: CattleMarker IBR Inactivated je inaktivirano cepivo proti infekcioznemu bovinemu rinotraheitisu (IBR), ki vsebuje inaktiviran glikoprotein E (gE)-negativen goveji herpes virus tipa 1 (BoHV-1), sev Difivac.
English: Active immunisation of female cattle from 6 months of age is also indicated to reduce the clinical signs (pyrexia and duration of dyspnoea) of IBR and virus shedding caused by BoHV-1 infection and to reduce the incidence of abortions associated with BoHV-1 infections as demonstrated during the second trimester of gestation following challenge.
Slovenian: Indicirano je tudi za aktivno imunizacijo goveda ženskega spola, starejšega od šest mesecev, zaradi zmanjšanja kliničnih znakov (pireksija in trajanje dispneje) infekcioznega bovinega rinotraheitisa in skrajšanja trajanja izločanja virusa, ki ga povzroča okužba z virusom BoHV-1, ter zmanjšanja pojavov zvrgavanja, povezanih z okužbami z virusom BoHV-1, kot je bilo dokazano v drugem trimesečju brejosti po provokaciji.
English: Questions and answers on CattleMarker IBR Inactivated emulsion for injection for cattle (inactivated gE Bovine Herpes Virus type 1 (BoHv-1), strain Difivac)
Slovenian: Vprašanja in odgovori o cepivu CattleMarker IBR Inactivated emulzija za injiciranje za govedo (inaktiviran gE goveji herpes virus tipa 1 (BoHV-1), sev Difivac)
English: Strength Pharmaceutical Form
Slovenian: ime jakost farmacevtska oblika pot uporabe ovojnina
English: Invented name
Slovenian: EMA številka Izmišljeno ime
English: These reactions can sometimes be serious.
Slovenian: Včasih so lahko te reakcije resne.
English: • It is important that your hands and the items you use be as clean as possible.
Slovenian: • Pomembno je, da so vaše roke in predmeti, ki jih uporabljate, kolikor je le mogoče čisti.
English: Tell your doctor straight away if:
Slovenian: Takoj povejte zdravniku, če:
English: You may need it again.
Slovenian: Morda jo boste ponovno potrebovali.
English: The larger the dose, the longer it will take to inject.
Slovenian: Večji ko je odmerek, dlje traja injiciranje.
English: For immediate and single use following first opening and reconstitution.
Slovenian: Za takojšnjo in enkratno uporabo po prvem odprtju in rekonstituciji.
English: Follow the procedure exactly, as it may differ from your past experience.
Slovenian: Postopek natančno upoštevajte, saj se morda razlikuje od tistega, ki ga poznate iz preteklosti.
English: Need to increase the dose (%)
Slovenian: Potreba po povečanju odmerka (%)
English: Not provided in the pack:
Slovenian: Ni priloženo v pakiranju:
English: Complete a partial injection (only when needed).
Slovenian: Dokončajte z delno injekcijo (le po potrebi)
English: E - 28760 Tres Cantos (Madrid) Spain
Slovenian: E - 28760 Tres Cantos (Madrid) Španija
English: This usually takes about 10 days but can take any time between 5 and 20 days.
Slovenian: To običajno traja približno 10 dni, vendar je razpon kadarkoli med 5 in 20 dni.
English: EXP Shelf-life after first use: 28 days
Slovenian: EXP Rok uporabnosti po prvi uporabi: 28 dni
English: Put it aside for later use.
Slovenian: Shranite ga za kasnejšo uporabo.
English: Your doctor will decide how much medicine you will take and how often.
Slovenian: Vaš zdravnik bo določil, koliko zdravila boste uporabili in kako pogosto.
English: Wash your hands and find a clean area
Slovenian: Umijte si roke in poiščite čisto površino
English: It most often occurs after hormonal treatment has been discontinued and reaches its maximum at about seven to ten days following treatment.
Slovenian: Najpogosteje se pojavi po prekinitvi hormonskega zdravljenja in doseže maksimum približno sedem do deset dni po zdravljenju.
English: • A good place is a clean table or kitchen surface.
Slovenian: • Primerna površina je čista miza ali kuhinjska površina.
English: See the “Instructions for Use”.
Slovenian: Glejte „Navodilo za uporabo“.
English: Due to a local reactivity to benzyl alcohol, the same site of injection should not be used on consecutive days.
Slovenian: Zaradi lokalnih reakcij na benzilalkohol se isto mesto injiciranja ne sme uporabiti več dni zaporedoma.
English: Gonadotropins are involved in reproduction and fertility.
Slovenian: Gonadotropini sodelujejo pri razmnoževanju in plodnosti.
English: • malformations of sexual organs incompatible with pregnancy
Slovenian: • malformacije spolnih organov, ki niso združljive z nosečnostjo
English: Volume to be injected (mL)
Slovenian: Volumen, ki ga je treba injicirati (ml)
English: A treatment diary is included on the last page.
Slovenian: Dnevnik zdravljenja je vključen na zadnji strani.
English: Do not touch the needle and do not allow the needle to touch any surface.
Slovenian: Igle se ne dotikajte in pazite, da se tudi igla ne dotakne nobene površine.
English: • Record the treatment day number (1), date (2) and time (3) of your injection.
Slovenian: • Za datum zdravljenja zabeležite številko (1), datum (2) in čas (3) injekcije.
English: The next injection should be done at the same time the next day.
Slovenian: Naslednjo injekcijo je treba aplicirati naslednji dan, ob istem času.
English: Do not inject directly into a vein.
Slovenian: Ne injicirajte direktno v žilo.
English: Any unused solution must be discarded not later than 28 days after first opening.
Slovenian: Vso neuporabljeno raztopino morate zavreči najkasneje 28 dni po prvem odprtju.
English: •Wash your hands with soap and water.
Slovenian: •Umijte si roke z milom in vodo.
English: An example of a treatment diary:
Slovenian: Primer dnevnika zdravljenja:
English: • Before starting the preparation, please read these instructions the whole way through first.
Slovenian: • Preden začnete s pripravo, najprej v celoti preberite spodnja navodila.
English: • Slowly push the needle into the skin entirely (1).
Slovenian: • Počasi zabodite celo iglo v kožo (1).
English: The following definitions apply to the frequency terminology used hereafter: 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).
Slovenian: V nadaljevanju se uporabljajo naslednje navedbe pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000).
English: Warning: Do not attach the needle too tightly; the needle could be difficult to remove after the injection.
Slovenian: Opozorilo: Igle ne pritrdite preveč tesno; morda jo bo po injiciranju težko odstraniti.
English: Studies have shown that these two medicines can be mixed and injected together, without either product being adversely affected.
Slovenian: Študije so pokazale, da se ti dve zdravili lahko mešata in injicirata skupaj, ker to ne vpliva na nobeno od teh dveh zdravil.