FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Restaysis, ciclosporin, reduces the activity of cells of the immune system (the body's natural defences) that are involved in the processes that cause inflammation.
Slovenian: Učinkovina v zdravilu Restaysis, ciklosporin, zmanjša delovanje celic imunskega sistema (naravnega obrambnega mehanizma telesa), ki sodelujejo pri procesih, ki povzročajo vnetje.
English: Withdrawal of the marketing authorisation application for Restaysis (ciclosporin) EMA/275525/2018
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Restaysis (ciklosporin) EMA/275525/2018
English: Withdrawal of the marketing authorisation application for Restaysis (ciclosporin)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Restaysis (ciklosporin)
English: It was to be available as eye drops.
Slovenian: Na voljo naj bi bilo v obliki kapljic za oči.
English: On 25 April 2018, Allergan Pharmaceuticals International Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Restaysis, for the treatment of moderate dry eye disease.
Slovenian: Podjetje Allergan Pharmaceuticals International Limited je 25. aprila 2018 uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Restaysis, namenjenim zdravljenju zmerne bolezni suhega očesa.
English: After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Slovenian: Potem ko je odbor CHMP ocenil odgovore podjetja na zadnji sklop vprašanj, so nekatera vprašanja še vedno ostala nerešena.
English: The main measures of effectiveness were the number of patients with damaged eye surface and with blurred vision, after 6 months of treatment.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov s poškodovano površino očesa in zamegljenim vidom po šestih mesecih zdravljenja.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Slovenian: Vlogo so umaknili po tem, ko je odbor CHMP že ocenil dokumentacijo, ki jo je predložilo podjetje, in oblikoval seznam vprašanj.
English: The company presented an analysis of the results from three studies with ciclosporin conducted in the 1990s in patients with moderate to severe dry eye disease, where Restaysis was compared with placebo (a dummy treatment).
Slovenian: Družba je predstavila analizo rezultatov treh študij ciklosporina, ki so jih opravili v 90. letih 20. stoletja pri bolnikih z zmerno do hudo boleznijo suhega očesa in v katerih so zdravilo Restaysis primerjali s placebom (zdravilom brez učinkovine).
English: The company informed the CHMP that the withdrawal will have no consequences on ongoing clinical trials.
Slovenian: Podjetje je odbor CHMP obvestilo, da umik ne bo imel posledic za klinična preskušanja, ki trenutno potekajo.
English: What was Restaysis expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Restaysis uporabljalo?
English: Restaysis is a medicine that contains the active substance ciclosporin.
Slovenian: Zdravilo Restaysis vsebuje učinkovino ciklosporin.
English: Inflammation seems to have an important role in the development of dry eye disease, regardless of the cause of the disease.
Slovenian: Pri razvoju bolezni suhega očesa ima verjetno pomembno vlogo vnetje, ne glede na vzrok bolezni.
English: The analysis focused on a subgroup of patients with moderate dry eye disease.
Slovenian: Analiza se je osredotočila na podskupino bolnikov z zmerno boleznijo suhega očesa.
English: The CHMP concluded that the results presented by the company were not robust enough to demonstrate that Restaysis is effective.
Slovenian: Odbor CHMP je zaključil, da rezultati, ki jih je predstavila družba, niso bili dovolj zanesljivi za dokaz o učinkovitosti zdravila Restaysis.
English: Restaysis was expected to be used in adults with moderate dry eye disease that was inadequately controlled despite treatment with tear substitutes or eye lubricants.
Slovenian: Zdravilo Restaysis naj bi se uporabljalo pri odraslih z zmerno boleznijo suhega očesa, ki kljub uporabi nadomestkov solz ali mazil za oči ni zadostno uravnavana.
English: Applying it directly to the eye was expected to reduce inflammation and the symptoms of the disease.
Slovenian: Z nanosom neposredno v oko naj bi se zmanjšali vnetje in simptomi bolezni.
English: In particular, the way the results were analysed in patients with moderate dry eye disease could have introduced a bias in favour of Restaysis.
Slovenian: Predvsem bi lahko način analize rezultatov pri bolnikih z zmerno boleznijo suhega očesa nakazoval na pristranskost rezultatov v korist zdravilu Restaysis.
English: How does Restaysis work?
Slovenian: Kako zdravilo Restaysis deluje?
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Restaysis could not have been approved for the treatment of moderate dry eye disease.
Slovenian: Odbor CHMP je na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil, ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Restaysis ni mogoče odobriti za zdravljenje zmerne bolezni suhega očesa.
English: What is Restaysis?
Slovenian: Kaj je zdravilo Restaysis?
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it withdrew its application because of the CHMP's view that the data provided did not allow concluding on a positive benefit-risk balance in the intended patient population.
Slovenian: Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da umik temelji na mnenju CHMP, da predstavljeni podatki odboru ne dovoljujejo, da bi pozitivno ocenil razmerje med tveganji in koristmi zdravila Restaysis pri ciljni populaciji bolnikov.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that, because of lack of proven effectiveness, the benefits of Restaysis did not outweigh its risks.
Slovenian: Zato je odbor CHMP ob umiku vloge menil, da koristi zdravila Restaysis zaradi pomanjkanja dokazov o učinkovitosti ne odtehtajo z njim povezanih tveganj.
English: However, this difference was not statistically significant.
Slovenian: Vendar ta razlika ni bila statistično značilna.
English: Wait 1 to 3 minutes.
Slovenian: Počakajte 1 do 3 minute.
English: Twice daily.
Slovenian: Dvakrat na dan.
English: • If you have severe heart problems.
Slovenian: • če imate resne težave s srcem.
English: The dose reductions can be temporary or permanent.
Slovenian: Zmanjšanje odmerkov je lahko začasno ali trajno.
English: 08757 Corbera de Llobregat (Barcelona) Spain
Slovenian: 08757 Corbera de Llobregat (Barcelona) Španija
English: >50 to ≤60 >60 to ≤70 >70 to ≤80 >80 to ≤90 >90 to ≤100
Slovenian: >50 do ≤60 >60 do ≤70 >70 do ≤80 >80 do ≤90 >90 do ≤100
English: Read the following instructions carefully.
Slovenian: Pozorno preberite naslednja navodila.
English: Wash your hands thoroughly with soap and water.
Slovenian: Roke temeljito operite z milom in vodo.
English: Never inject Ceplene any faster or all at once.
Slovenian: Zdravila Ceplene nikoli ne injicirajte hitreje ali vsega naenkrat.
English: Noventia Pharma srl Via Carlo PISACANE 31 I-47121 Forli (FC) Italy
Slovenian: Noventia Pharma srl Via Carlo PISACANE 31 I-47121 Forli (FC) Italija
English: • If you are pregnant.
Slovenian: • če ste noseči.
English: Each carton contains 14 vials.
Slovenian: Vsak karton vsebuje 14 vial.
English: If you have an infection, your doctor will closely monitor you.
Slovenian: Če imate okužbo, vas bo zdravnik pozorno spremljal.
English: The recommended dosing regimen is presented in Tables 1 and 2.
Slovenian: Priporočen režim odmerjanja je predstavljen v preglednicah 1 in 2.
English: Other oncology (advanced tumour) studies
Slovenian: Druge onkološke študije (napredovalih tumorjev)
English: The metabolites are mainly excreted in urine.
Slovenian: Metaboliti se v glavnem izločajo z urinom.
English: Each dose is calculated from your body weight.
Slovenian: Vsak odmerek se izračuna na podlagi vaše telesne mase.
English: This table also provides the volume required if a 20% dose reduction is prescribed.
Slovenian: V tej preglednici je naveden tudi volumen, potreben v primeru, ko je predpisano 20-odstotno zmanjšanje odmerka.
English: Results of this pilot study were used to design and implement a multi-national phase 3 trial.
Slovenian: Rezultati te pilotne študije so bili osnova za načrtovanje in izvedbo multinacionalnega preskušanja faze 3.
English: Biotransformation/Elimination
Slovenian: Biotransformacija/Izločanje
English: Frequencies are defined as 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), or not known (cannot be estimated from the available data).
Slovenian: Pogostnost je opredeljena kot zelo pogosto ( 1/10), pogosto ( 1/100 do < 1/10), občasno ( 1/1.000 do < 1/100), redko ( 1/10.000 do < 1/1.000), zelo redko (< 1/10.000), ali neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: They are used to treat depression.
Slovenian: Uporabljajo se za zdravljenje depresije.
English: Maximum plasma concentration is reached approximately 10 minutes after end of subcutaneous infusion.
Slovenian: Največja plazemska koncentracija je dosežena približno 10 minut po koncu subkutane infuzije.
English: Notice the numbered marks on each syringe.
Slovenian: Poglejte številčne oznake na vsaki brizgi.
English: Do not touch the stopper with your hands.
Slovenian: Zaporke se ne dotikajte z rokami.
English: • narrowing of the arteries (systemic peripheral arterial disease),
Slovenian: • zožanje arterij (sistemska periferna arterijska bolezen),
English: These medicines help the body's immune system fight diseases like cancer by improving the immune system's natural role in fighting disease.
Slovenian: Ta zdravila pomagajo imunskemu sistemu telesa v boju proti boleznim, kot je rak, z izboljševanjem naravne vloge imunskega sistema v boju proti bolezni.
English: It is used to maintain the remission (the period during which the disease is less severe or not detectable).
Slovenian: Uporablja se za vzdrževanje faze remisije (obdobja, v katerem je bolezen manj huda ali je ni mogoče zaznati).
English: Monitoring of laboratory test results is recommended including standard haematological and blood chemistry tests.
Slovenian: Priporočljivo je spremljanje rezultatov laboratorijskih preiskav, vključno s standardnimi hematološkimi preiskavami in kemijskimi preiskavami krvi.
English: The efficacy of Ceplene has not been fully demonstrated in patients older than age 60.
Slovenian: Učinkovitost zdravila Ceplene ni bila popolnoma dokazana pri bolnikih, starejših od 60 let.
English: • Difficulty in sleeping (insomnia)
Slovenian: • težave pri spanju (nespečnost)
English: When the syringe is empty, remove the needle from your skin.
Slovenian: Ko je brizga prazna, odstranite iglo iz kože.
English: Find a comfortable, well-lit place to sit and where you can lie back.
Slovenian: Izberite udoben, dobro osvetljen prostor, kjer se lahko usedete in uležete.
English: Ceplene use is not recommended in children and adolescents, as there is no information available about using this medicine in this age group.
Slovenian: Zdravila Ceplene se ne priporoča za uporabo pri otrocih in mladostnikih, ker ni na voljo podatkov o uporabi zdravila v tej starostni skupini.
English: For example, if you inject IL-2 in the left arm, you could inject Ceplene into the left or right thigh, the stomach, or the right arm.
Slovenian: Na primer, če boste IL-2 injicirali v levo roko, potem lahko zdravilo Ceplene injicirate v levo ali desno stegno, trebuh ali desno roko.
English: The mean half-life was 0.75 to 1.5 hours in patients.
Slovenian: Povprečna razpolovna doba pri bolnikih je bila 0,75 do 1,5 ure.
English: Do not use if the date has passed the last day of the month shown.
Slovenian: Ne uporabljajte, če je rok uporabnosti že pretekel zadnji dan navedenega meseca.
English: NOTE: Dispensing of aldesleukin must be carried out under controlled aseptic conditions.
Slovenian: OPOMBA: Odmerjanje aldeslevkina se mora izvajati v kontroliranih aseptičnih pogojih.
English: Patients should be monitored for the expected symptomatic adverse reactions and laboratory changes associated with this treatment.
Slovenian: Bolnike je treba opazovati zaradi pričakovanih simptomatskih neželenih učinkov in laboratorijskih sprememb, povezanih s tem zdravljenjem.
English: Your doctor or nurse will show you how to inject yourself.
Slovenian: Zdravnik ali medicinska sestra vam bosta pokazala, kako si zdravilo injicirate sami.
English: • If you are allergic (hypersensitive) to histamine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični (preobčutljivi) na histamin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Week number (w)*
Slovenian: Številka tedna (t)*
English: • Anti-malarial or medicines used to treat infections responsible for sleeping sickness.
Slovenian: • Zdravila proti malariji ali zdravila za zdravljenje okužb, ki povzročajo spalno bolezen.
English: Treatment-free (6 weeks)
Slovenian: Obdobje brez zdravljenja (6 tednov)
English: Please inform your doctor immediately if you have stopped taking Ceplene by your own decision.
Slovenian: Nemudoma obvestite zdravnika, če ste prenehali jemati zdravilo Ceplene na podlagi svoje odločitve.
English: Your doctor may change your dose.
Slovenian: Zdravnik lahko spremeni odmerek zdravila.
English: Injection volume* (mL)
Slovenian: Volumen injiciranja* (mL)
English: The following adverse reactions, not listed above, were at least possibly related to the study medicine:
Slovenian: Naslednji neželeni učinki, ki niso navedeni zgoraj, so vsaj verjetno povezani z uporabo preiskovanega zdravila:
English: This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicine.
Slovenian: To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh podatkov o zdravilu.
English: The safety and efficacy of Ceplene in children below 18 years of age have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Ceplene pri otrocih, mlajših od 18 let, še nista bili dokazani.
English: (hypothyroidism)
Slovenian: (hipotiroidizem)
English: • heart disease (for severe heart problems see above “Do not use Ceplene”),
Slovenian: • bolezni srca (za resne težave s srcem glejte zgoraj „Ne uporabljajte zdravila Ceplene“),
English: Your doctor will also carry out some blood tests during treatment.
Slovenian: Med zdravljenjem bo zdravnik izvedel tudi nekaj krvnih preiskav.
English: The dispensing and storage directions in the section 6.6 are specific to aldesleukin.
Slovenian: Navodila za odmerjanje in shranjevanje v poglavju 6.6 so specifična za aldeslevkin.
English: 20% dose reduction injection volume (mL)**
Slovenian: 20-odstotno zmanjšanje odmerka volumen injiciranja (mL)**
English: • Antihistamines used to treat allergy.
Slovenian: • Antihistaminiki za zdravljenje alergij.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Slovenian: DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 14(8) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet v določenem časovnem okvirju izvesti naslednje ukrepe:
English: They are used to treat mental conditions.
Slovenian: Ti se uporabljajo za zdravljenje psihičnih težav.
English: Patients should be monitored during treatment for possible clinical complications due to hypotension or hypovolaemia.
Slovenian: Bolnike je med zdravljenjem treba spremljati zaradi možnih kliničnih zapletov zaradi hipotenzije in hipovolemije.
English: Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
English: The treatment with IL-2 and Ceplene lasts for 81 weeks and is cyclic.
Slovenian: Zdravljenje z IL-2 in zdravilom Ceplene traja 81 tednov in je ciklično.
English: A decrease of blood pressure may occur.
Slovenian: Pojavi se lahko znižanje krvnega tlaka.
English: Do not try to inject yourself unless a qualified professional has trained you.
Slovenian: Ne poskušajte si zdravila injicirati sami, preden vas usposobljen strokovnjak o tem ustrezno ne pouči.
English: • During pregnancy.
Slovenian: • Med nosečnostjo.
English: 0.5 mL solution is sufficient for a single dose (see section 6.6).
Slovenian: 0,5 mL raztopine zadostuje za enkraten odmerek (glejte poglavje 6.6).
English: • Loss of appetite (anorexia)
Slovenian: • izguba apetita (anoreksija)
English: Treatment periods and treatment breaks
Slovenian: Obdobja zdravljenja in obdobja premora med zdravljenji
English: • Your body does not make enough thyroxine, a body chemical called a hormone
Slovenian: • vaše telo ne proizvaja zadostne količine tiroksina, kemične snovi v telesu, imenovane hormon
English: Inject slowly over a period of 5-15 minutes.
Slovenian: Injicirajte počasi v času 5-15 minut.
English: What Ceplene is and what is used for
Slovenian: Kaj je zdravilo Ceplene in za kaj ga uporabljamo
English: Check the expiry date (EXP) on the vial label.
Slovenian: Na nalepki na viali preverite rok uporabnosti (EXP).
English: For possible injection sites, see Figure 4.
Slovenian: Možna mesta injiciranja so prikazana na sliki 4.
English: Your doctor will check your blood pressure, pulse rate and lung function.
Slovenian: Zdravnik bo preveril vaš krvni tlak, srčni utrip in delovanje pljuč.
English: What you need to know before you use Ceplene
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Ceplene
English: • Patients with significantly compromised cardiac function, e.g., NYHA Class III/IV.
Slovenian: • Bolniki z izrazito kompromitirano srčno funkcijo, na primer stopnja III/IV po NYHA
English: You must use this medicine exactly as it has been prescribed for you.
Slovenian: Zdravilo uporabljajte natančno tako, kot vam je bilo predpisano.
English: Clearance of Ceplene is almost twice as high in females resulting in considerably lower systemic exposure than in males.
Slovenian: Očistek zdravila Ceplene je pri ženskah skoraj dvakrat višji, kar pomeni bistveno nižjo sistemsko izpostavljenost kot pri moških.
English: • Depression
Slovenian: • depresija
English: Localised toxic dermatitis - treatment should be discontinued until symptoms resolved.
Slovenian: Lokaliziran toksični dermatitis - zdravljenje prekinite, dokler simptomi ne izginejo.
English: *Injection volume rounded up to the nearest 0.05 mL ** Injection volumes based on 20% reductions are rounded thus actual dose reductions vary from 15%-25%
Slovenian: * Volumen injiciranja, zaokrožen na najbližjih 0,05 mL ** Volumni injiciranja, ki temeljijo na 20-odstotnem zmanjšanju odmerka, so zaokroženi, zato dejanska znižanja odmerka nihajo od 15-25 %.
English: Standard dosage (µg)
Slovenian: Standardni odmerek (µg)
English: Your doctor will explain to you how to prepare and inject IL-2.
Slovenian: Zdravnik vam bo pojasnil način priprave in injiciranja IL-2.
English: Histamine is rapidly absorbed after subcutaneous injection.
Slovenian: Histamin se po subkutanem injiciranju hitro absorbira.
English: Treatment*
Slovenian: Zdravljenje*
English: w.4 to w.6 w.10 to w.12 w.16 to w.18
Slovenian: t. 4 do t. 6 t. 10 do t. 12 t. 16 do t. 18
English: There were no clinically significant differences in safety parameters or in pharmacodynamics.
Slovenian: V varnostnih parametrih ali farmakodinamiki ni bilo klinično značilnih razlik.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europe.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: *see dose modification for provisions for the modification to dose and dosage schedule
Slovenian: * glejte prilagajanje odmerkov za pogoje glede prilagajanja odmerkov in časovnega razporeda odmerjanja
English: Ceplene is indicated for use in adults.
Slovenian: Zdravilo Ceplene je indicirano za uporabo pri odraslih.
English: Pharmacotherapeutic group: Immunostimulants, other immunostimulants, ATC code: L03AX14.
Slovenian: Farmakoterapevtska skupina: Zdravila za spodbujanje imunske odzivnosti, druga zdravila za spodbujanje imunske odzivnosti, oznaka ATC: L03AX14.
English: Patient monitoring on day 1 should include vital signs, including pulse, blood pressure and respiratory rate.
Slovenian: Nadzorovanje bolnika v prvem dnevu cikla naj vključuje spremljanje življenjskih znakov, vključno s srčnim utripom, krvnim tlakom in hitrostjo dihanja.
English: If you use more Ceplene than you should
Slovenian: Če ste uporabili večji odmerek zdravila Ceplene, kot bi smeli
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Slovenian: SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
English: Take the syringe and follow the “INSTRUCTIONS FOR INJECTION” information below.
Slovenian: Vzemite brizgo in sledite „NAVODILOM ZA INJICIRANJE“ v nadaljevanju.
English: Treatment-free (3 weeks) *see dose modification for provisions for the modification to dose and dosage schedule
Slovenian: Obdobje brez zdravljenja (3 tedni) * glejte prilagajanje odmerkov za pogoje glede prilagajanja odmerkov in časovnega razporeda odmerjanja
English: Ceplene belongs to a group of medicines called immunomodulatory medicines.
Slovenian: Zdravilo Ceplene sodi v skupino t.i. imunomodulatornih zdravil.
English: In the absence of compatibility studies this medicinal product should not be mixed with other medicinal products, diluents or infusion solutions.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili, sredstvi za razredčevanje ali raztopinami za infuzije.
English: Push down the syringe plunger and inject one-tenth of a millilitre (0.1 mL) every minute, or more slowly if instructed to do so by your doctor.
Slovenian: Bat brizge potisnite navzdol in injicirajte eno desetino mililitra (0,1 ml) vsako minuto ali še počasneje, če vam je tako naročil zdravnik.
English: Allow the area to dry for 10 seconds.
Slovenian: Počakajte 10 sekund, da se posuši.
English: Each mark (0.1, 0.2, 0.3, etc.) represents one-tenth of a millilitre (0.1 mL).
Slovenian: Vsaka označba (0,1; 0,2; 0,3 itd.) predstavlja eno desetino mililitra (0,1 mL).
English: • Pain and formation of extra tissue in the skin around the injection site
Slovenian: • bolečina in nastanek novih tkiv v koži okoli mesta injiciranja
English: If blood appears, do not inject Ceplene because the needle has entered a blood vessel.
Slovenian: Če se pojavi kri, ne injicirajte zdravila Ceplene, saj je v tem primeru igla v žili.
English: You will usually inject two doses of 0.5 mL in a day, unless your doctor has prescribed a lower dose for you.
Slovenian: Po navadi boste uporabili dva odmerka po 0,5 mL na dan, razen če vam zdravnik predpiše manjše odmerke.
English: Patient weight (kg)
Slovenian: Telesna masa bolnika (kg)
English: To reduce potential adverse reactions, the administration time may be lengthened to a maximum of 15 minutes, see below.
Slovenian: Za zmanjšanje možnosti pojava neželenih učinkov se lahko čas injiciranja podaljša na največ 15 minut, glejte spodaj.
English: Do not lay the syringe down or let the needle touch anything.
Slovenian: Brizge ne odlagajte in pazite, da se igla ne bo ničesar dotaknila.