FrancophonIA/ELRC3.0 huggingface dataset:
English: For revaccination, a single dose of Versican Plus DHPPi is required every three years for distemper, canine adenovirus (type 1 and type 2) and parvovirus.
Slovenian: Za zaščito pred pasjo kugo, pasjim adenovirusom (tipa 1 in 2) ter pasjim parvovirusom je vsaka tri leta potrebno ponovno cepljenje z enkratnim odmerkom cepiva Versican Plus DHPPi.
English: Canine distemper, canine adenovirus, canine parvovirosis and canine parainfluenza virus vaccine (live attenuated)
Slovenian: Versican Plus DHPPi cepivo proti pasji kugi, pasjemu adenovirusu, pasji parvovirozi in virusu pasje parainfluence (živo, atenuirano)
English: How has Versican Plus DHPPi been studied?
Slovenian: Kako je bilo zdravilo Versican Plus DHPPi raziskano?
English: How does Versican Plus DHPPi work?
Slovenian: Kako zdravilo Versican Plus DHPPi deluje?
English: This medicine is the same as Eucreas, which is already authorised in the European Union (EU).
Slovenian: To zdravilo je enako zdravilu Eucreas, ki je že odobreno v Evropski uniji (EU).
English: Vildagliptin on its own was approved by the EU in September 2007 under the name Galvus, and metformin has been available in the EU since 1959.
Slovenian: Vildagliptin, uporabljen samostojno, je bil v EU odobren septembra 2007 pod imenom Galvus, metformin pa je v EU na voljo od leta 1959.
English: The recommended dose of Zomarist is one tablet twice a day, with one tablet taken in the morning and one in the evening.
Slovenian: Priporočeni odmerek zdravila Zomarist je ena tableta dvakrat na dan, pri čemer se ena tableta vzame zjutraj, druga pa zvečer.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zomarist on 1 December 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Zomarist, veljavno po vsej Evropski uniji, odobrila dne 1. decembra 2008.
English: The full EPAR for Zomarist can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zomarist je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Zomarist
Slovenian: Druge informacije o zdravilu Zomarist
English: For more information about treatment with Zomarist, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Zomarist preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Vildagliptin / metformin hydrochloride
Slovenian: Zomarist vildagliptin/metforminijev klorid
English: This is a summary of the European public assessment report (EPAR) for Zomarist.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zomarist.
English: What benefit has Zomarist shown during the studies?
Slovenian: Kakšne koristi je zdravilo Zomarist izkazalo med študijami?
English: What is the risk associated with Zomarist?
Slovenian: Kakšna tveganja so povezana z zdravilom Zomarist?
English: The company that makes Eucreas has agreed that its scientific data can be used for Zomarist.
Slovenian: Družba, ki proizvaja zdravilo Eucreas, se strinja, da se lahko znanstveni podatki tega zdravila uporabijo za zdravilo Zomarist.
English: It must not be used in patients who have diabetic ketoacidosis (high levels of ketones and acids in the blood), diabetic pre-coma, problems with their kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack.
Slovenian: Prav tako se ne sme uporabljati pri bolnikih, ki imajo diabetično ketoacidozo (visoke koncentracije ketonov in kislin v krvi), diabetično predkomo, težave z ledvicami in jetri, bolezni, ki lahko vplivajo na ledvice, ali bolezen, ki povzroči zmanjšanje pretoka kisika v tkiva, kot je srčno popuščanje ali oteženo delovanje pljuč ali nedavni srčni napad.
English: It must also not be used in patients with alcohol intoxication (excessive alcohol consumption) or alcoholism, or during breastfeeding.
Slovenian: Prav tako se ne sme uporabljati pri bolnikih z akutno zastrupitvijo z alkoholom (prekomerno uživanje alkohola) ali v primeru alkoholizma oziroma med dojenjem.
English: The most common side effects with Zomarist (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite.
Slovenian: Najpogostejši neželeni učinki zdravila Zomarist (opaženi pri več kot 1 bolniku od 10) so slabost, bruhanje, driska, bolečina v trebuhu in izguba teka.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zomarist.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Zomarist, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Therefore, the Committee decided that the benefits of Zomarist are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor je zaključil, da so koristi zdravila Zomarist večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: The choice of tablet strength to start with depends on the patient's current treatment and the expected effects of Zomarist, but it is recommended to provide a dose of metformin similar to the dose already being taken.
Slovenian: Izbira začetne jakosti tablete je odvisna od bolnikovega dotedanjega zdravljenja in pričakovanega učinka zdravila Zomarist, vendar je priporočljivo, da je odmerek metformina podoben odmerku, ki ga bolnik že jemlje.
English: The applicant also presented the results of two studies showing that the active substances in the two strengths of Zomarist were absorbed in the body in the same way as when they were taken as separate tablets.
Slovenian: Predlagatelj je tudi predstavil rezultate dveh študij, ki kažeta, da je telo zdravilni učinkovini v obeh jakostih zdravila Zomarist absorbiralo enako, kot pri njunem jemanju v obliki ločenih tablet.
English: Elderly patients taking Zomarist should have their kidney function monitored regularly.
Slovenian: Pri starejših bolnikih, ki jemljejo zdravilo Zomarist, je treba redno spremljati delovanje ledvic.
English: Zomarist should not be used in people who may be hypersensitive (allergic) to vildagliptin, metformin or any of the other ingredients.
Slovenian: Zdravila Zomarist ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) vildagliptin, metformin ali katero koli drugo sestavino zdravila.
English: Patients adding vildagliptin had a fall in HbA1c levels of 0.88 percentage points after 24 weeks from a starting level of 8.38%.
Slovenian: Bolnikom, ki so kot dodatek prejemali vildagliptin, so se koncentracije HbA1c po 24 tednih zmanjšale za 0,88 odstotne točke glede na izhodiščno vrednost 8,38 %.
English: Zomarist should not be used in patients who have moderate or severe problems with their kidneys or who have problems with their liver.
Slovenian: Zdravilo Zomarist se ne sme uporabljati pri bolnikih, ki imajo zmerne ali hude težave z ledvicami ali težave z jetri.
English: Zomarist is a medicine that contains the active substances vildagliptin and metformin hydrochloride.
Slovenian: Zomarist je zdravilo, ki vsebuje zdravilni učinkovini vildagliptin in metforminijev klorid.
English: Vildagliptin can be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Slovenian: Vildagliptin se lahko uporablja z metforminom pri bolnikih s sladkorno boleznijo tipa 2, pri katerih samo z metforminom ni mogoče doseči zadovoljivega nadzora.
English: The studies with Galvus as an add-on to metformin, metformin and a sulphonylurea, or metformin and insulin have been used to support the use of Zomarist in the same indications.
Slovenian: Študije zdravila Galvus kot dodatnega zdravila metforminu, metforminu in sulfonilsečnini ali metforminu, sulfonilsečnini in insulinu, so bile uporabljene v podporo zdravilu Zomarist za iste indikacije.
English: Zomarist is used to treat type 2 diabetes.
Slovenian: Zdravilo Zomarist se uporablja za zdravljenje sladkorne bolezni tipa 2.
English: Zomarist contains two active substances, which each have a different mode of action.
Slovenian: Zdravilo Zomarist vsebuje dve zdravilni učinkovini, ki imata različen način delovanja.
English: Taking Zomarist with or just after food may reduce any stomach problems caused by metformin.
Slovenian: Jemanje zdravila Zomarist sočasno s hrano ali neposredno po obroku lahko ublaži želodčne težave, ki jih povzroča metformin.
English: Why has Zomarist been approved?
Slovenian: Zakaj je bilo zdravilo Zomarist odobreno?
English: For the full list of all side effects reported with Zomarist, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Zomarist, glejte navodilo za uporabo.
English: • in patients whose disease is insufficiently controlled with the maximum tolerated dose of metformin taken alone;
Slovenian: • pri bolnikih, pri katerih bolezen ni zadostno nadzorovana z največjim odmerkom metformina,
English: It is used in the following ways:
Slovenian: Zdravilo Zomarist se uporablja:
English: Patients already taking vildagliptin and metformin should switch to Zomarist containing the same amounts of each active substance.
Slovenian: Bolniki, ki že jemljejo vildagliptin in metformin, naj preidejo na zdravilo Zomarist, v katerem sta ti dve zdravilni učinkovini zastopani v enaki količini.
English: What is Zomarist used for?
Slovenian: Za kaj se zdravilo Zomarist uporablja?
English: How has Zomarist been studied?
Slovenian: Kako je bilo zdravilo Zomarist raziskano?
English: What is Zomarist?
Slovenian: Kaj je zdravilo Zomarist?
English: How does Zomarist work?
Slovenian: Kako zdravilo Zomarist deluje?
English: How is Zomarist used?
Slovenian: Kako se zdravilo Zomarist uporablja?
English: List of antiretrovirals: abacavir; abacavir, dolutegravir, lamivudine; abacavir; abacavir, lamivudine, zidovudine; atazanavir; atazanavir, cobicistat; bictegravir, emtricitabine, tenofovir alafenamide; darunavir; darunavir, cobicistat; darunavir, cobicistat, emtricitabine, tenofovir alafenamide; didanosine; dolutegravir; dolutegravir, rilpivirine; efavirenz ; efavirenz, emtricitabine, tenofovir disoproxil; elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide; elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil; emtricitabine; emtricitabine, rilpivirine, tenofovir alafenamide; emtricitabine, rilpivirine, tenofovir disoproxil; emtricitabine, tenofovir alafenamide; emtricitabine, tenofovir disoproxil; enfuvirtide; etravirine; fosamprenavir; indinavir; lamivudine; lamivudine, tenofovir; lamivudine, zidovudine; lopinavir, ritonavir; maraviroc; nevirapine; raltegravir; rilpivirine; ritonavir; saquinavir; stavudine; tenofovir disoproxil; tipranavir; zidovudine
Slovenian: Seznam protiretrovirusnih zdravil: abakavir; abakavir, dolutegravir, lamivudin; abakavir; abakavir, lamivudin, zidovudin; atazanavir; atazanavir, kobicistat; biktegravir, emtricitabin, tenofoviralafenamid; darunavir; darunavir, kobicistat; darunavir, kobicistat, emtricitabin, tenofoviralafenamid; didanozin; dolutegravir; dolutegravir, rilpivirin; efavirenz; efavirenz, emtricitabin, dizoproksiltenofovirat; elvitegravir, kobicistat, emtricitabin, tenofoviralafenamid; elvitegravir, kobicistat, emtricitabin, dizoproksiltenofovirat; emtricitabin; emtricitabin, rilpivirin, tenofoviralafenamid; emtricitabin, rilpivirin, dizoproksiltenofovirat; emtricitabin, tenofoviralafenamid; emtricitabin, dizoproksiltenofovirat; enfuvirtid; etravirin; fosamprenavir; indinavir; lamivudin; lamivudin, tenofovir; lamivudin, zidovudin; lopinavir, ritonavir; maravirok; nevirapin; raltegravir; rilpivirin; ritonavir; sakvinavir; stavudin; dizoproksiltenofovirat; tipranavir; zidovudin
English: Adopted at the 9-12 July 2018 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 9. in 12. julijem 2018
English: Antiretrovirals - Autoimmune hepatitis (EPITT no 18956)
Slovenian: Protiretrovirusna zdravila - avtoimunski hepatitis (EPITT št. 18956)
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Slovenian: Kakršne koli vnetne simptome je treba obravnavati in po potrebi uvesti zdravljenje.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/414649/2018
Slovenian: Novo besedilo informacij o zdravilu - izvlečki iz priporočil odbora PRAC o signalih EMA/PRAC/496941/2018
English: Special warnings and precautions for use
Slovenian: Posebna opozorila in previdnostni ukrepi Sindrom imunske reaktivacije
English: Cases of reversible aseptic meningitis and rare cases of transient cutaneous reactions (including cutaneous lupus erythematosus - frequency unknown) have been observed with human normal immunoglobulin.
Slovenian: Pri humanem polispecifičnem imunoglobulinu so opazili primere reverzibilnega aseptičnega meningitisa in redke primere prehodnih kožnih reakcij (vključno s kožnim eritematoznim lupusom - neznana pogostnost).
English: Human normal immunoglobulin for intravenous administration (IVIg) - Lupus-like syndrome and related terms (EPITT no 19098)
Slovenian: Ig) - sindrom, podoben lupusu, in podobni izrazi (EPITT št. 19098)
English: In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic
Slovenian: Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART - "combination antiretroviral therapy") nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične patogene in povzroči resna klinična stanja ali poslabšanje simptomov.
English: Foxes
Slovenian: Lisice
English: This summary was last updated in May 2008.
Slovenian: Povzetek je bil nazadnje posodobljen 05-2008.
English: The viruses have been selected because of their ‘low virulence' (limited ability to cause the disease).
Slovenian: Virusi so bili izbrani zaradi njihove „nizke virulence“ (omejena zmožnost povzročiti bolezen).
English: The baits are distributed by land or by air.
Slovenian: Vabe se razdeljujejo po tleh ali zraku.
English: The vaccine confers 6-month protection against rabies.
Slovenian: Cepivo zagotavlja 6-mesečno zaščito pred steklino.
English: It is recommended to wear rubber gloves when handling the bait.
Slovenian: Priporoča se uporaba gumijastih rokavic pri rokovanju z vabo.
English: The distribution of almost four million baits of the product during the field trials over four years have been followed by an intensive surveillance of the vaccination areas.
Slovenian: Razdelitvi skoraj štirih milijonov vab z izdelkom med preskušanji na terenu v štirih letih je sledilo intenzivno nadzorovanje območij cepljenja.
English: The number of baits distributed depends on the number of foxes or raccoon dogs and varies between 13 and 20 per square kilometre.
Slovenian: Število razdeljenih vab je odvisno od števila lisic ali rakunastih psov ter znaša med 13 in 20 na kvadratni kilometer.
English: As a result, rabies decreased significantly in the vaccinated areas until its complete elimination.
Slovenian: Posledično se je prisotnost stekline na območjih cepljenja močno zmanjšala, dokler ni bila popolnoma odpravljena.
English: The marketing authorisation was subsequently renewed in 2005 and varied in April 2008 to include raccoon dogs as a new target species.
Slovenian: Dovoljenje za promet z zdravilom je bilo nato podaljšano leta 2005 in spremenjeno aprila 2008, da vključuje rakunaste pse kot novo ciljno vrsto.
English: Efficacy was based on the efficacy results from laboratory studies and the extensive use of the vaccine in the field for foxes.
Slovenian: Učinkovitost je temeljila na rezultatih učinkovitosti iz laboratorijskih študij in obsežne uporabe cepiva na terenu za lisice.
English: People whose immune system is weakened must not be allowed to handle this vaccine.
Slovenian: Osebe z oslabljenim imunskim sistemom ne smejo rokovati s tem cepivom.
English: As raccoon dogs are considered a minor species, no field trials were carried out.
Slovenian: Ker se rakunasti psi štejejo za manj pomembne vrste, niso bila opravljena nobena preskušanja na terenu.
English: Moreover, the use of this vaccine has been efficiently preventing the vaccinated area from re-infection from still contaminated neighbouring areas.
Slovenian: Poleg tega uporaba tega cepiva uspešno preprečuje, da se na območja cepljenja ponovno ne razširi steklina iz še vedno okuženih sosednjih območij.
English: No case of vaccine induced rabies was reported, confirming the safety of the vaccine in the field.
Slovenian: Poročali niso o nobeni okužbi s steklino, ki bi jo sprožilo cepivo, kar potrjuje varnost cepiva na terenu.
English: Raccoon dogs
Slovenian: Rakunasti psi
English: People handling and distributing this vaccine should be vaccinated against rabies.
Slovenian: Osebe, ki rokujejo s tem cepivom in ga razdeljujejo, morajo biti cepljene proti steklini.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Rabigen SAG2 to Virbac S.A. on 6 April 2000.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Rabigen SAG2, veljavno po vsej Evropski uniji, odobrila družbi Virbac S.A. dne 6. aprila 2000.
English: The viruses are contained in a sachet within a bait matrix.
Slovenian: Viruse vsebuje vrečka v matrici vabe.
English: In the event of human exposure to the active substance of the vaccine, seek medical advice immediately and show the package leaflet or the label to the doctor.
Slovenian: V primeru izpostavljenosti ljudi zdravilni učinkovini cepiva se nemudoma posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
English: If the foxes or racoon dogs are then exposed to the rabies virus later in life, they do not become infected.
Slovenian: Če so lisice ali rakunasti psi nato pozneje v življenju izpostavljeni virusom stekline, se ne okužijo.
English: As the foxes or raccoon dogs eat the bait, they get exposed to the viruses and make antibodies against them.
Slovenian: Ko lisice ali rakunasti psi pojedo vabo, so izpostavljeni virusom in proti njim izdelajo protitelesa.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) RABIGEN SAG2 EPAR summary for the public
Slovenian: EMEA/V/C/043 EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) RABIGEN SAG2 Povzetek EPAR za javnost
English: Other information about Rabigen SAG2:
Slovenian: Druge informacije o zdravilu Rabigen SAG2:
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Rabigen SAG2 exceed the risks for its use in red foxes and raccoon dogs to prevent infection by rabies virus and recommended that Rabigen SAG2 be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi cepiva Rabigen SAG2 za uporabo pri rdečih lisicah in rakunastih psih za preprečevanje okužb z virusom stekline večje od z njim povezanih tveganj, in priporočil, da se za cepivo Rabigen SAG2 odobri dovoljenje za promet.
English: Rabigen SAG2 is used for the active immunisation of red foxes (Vulpes vulpes) and raccoon dogs (Nyctereutes procyonoides) to prevent infection by rabies virus.
Slovenian: Cepivo Rabigen SAG2 se uporablja za aktivno imunizacijo rdečih lisic (Vulpes vulpes) in rakunastih psov (Nyctereutes procyonoides), da se prepreči okužba z virusom stekline.
English: Rabigen contains live rabies viruses.
Slovenian: Cepivo Rabigen vsebuje žive viruse stekline.
English: Rabigen SAG2 can only be used by authorised personnel within the framework of vaccination campaigns against rabies.
Slovenian: Cepivo Rabigen SAG2 lahko uporablja samo pooblaščeno osebje v okviru akcij cepljenja proti steklini.
English: No undesirable effects have been shown for Rabigen SAG2.
Slovenian: Za cepivo Rabigen SAG2 niso bili dokazani nobeni neželeni učinki.
English: What benefit has Rabigen SAG2 shown during the studies?
Slovenian: Kakšne koristi je zdravilo Rabigen SAG2 izkazalo med študijami?
English: Rabigen SAG2 is a vaccine.
Slovenian: Rabigen SAG2 je cepivo.
English: It is presented as baits.
Slovenian: Na voljo je v obliki vab.
English: What is the risk associated with Rabigen SAG2?
Slovenian: Kakšna tveganja so povezana z zdravilom Rabigen SAG2?
English: Why has Rabigen SAG2 been approved?
Slovenian: Zakaj je bilo zdravilo Rabigen SAG2 odobreno?
English: Following bait uptake, adult and fox cubs and raccoon dogs showed significant antibody response.
Slovenian: Po zaužitju vabe je bilo pri odraslih lisicah in njihovih mladičih ter rakunastih psih mogoče opaziti velik odziv protiteles.
English: When distributed in the wild, the SAG2 rabies vaccine bait was readily taken by free ranging foxes and raccoon dogs.
Slovenian: Vabo s cepivom proti steklini SAG2, razdeljeno v divjini, so prosto živeče lisice in rakunasti psi takoj zaužili.
English: Rabigen SAG2 is a vaccine againts rabies.
Slovenian: Rabigen SAG2 je cepivo proti steklini.
English: How has Rabigen SAG2 been studied?
Slovenian: Kako je bilo zdravilo Rabigen SAG2 raziskano?
English: What is Rabigen SAG2 used for?
Slovenian: Za kaj se zdravilo Rabigen SAG2 uporablja?
English: What is Rabigen SAG2?
Slovenian: Kaj je zdravilo Rabigen SAG2?
English: How does Rabigen SAG2 work?
Slovenian: Kako zdravilo Rabigen SAG2 deluje?
English: Do not use after this date.
Slovenian: Ne uporabljajte po tem datumu.
English: Repeat every 12 to 24 hours.
Slovenian: 12 do 24 ur.
English: A safety and efficacy study has been performed in children of 012 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: In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Z namenom izboljšanja sledljivosti bioloških zdravil, je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
English: Of note, annualised bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Slovenian: Opomba: Letna stopnja krvavitev (ABR - Annualized Bleeding Rate) ni primerljiva med različnimi koncentrati faktorja in različnimi kliničnimi študijami.
English: T1/2 (h) AUC (IU.h/dL)**
Slovenian: T1/2 (h) AUC (i.e.·h/dl)**
English: To treat a bleed, your doctor will calculate and adjust your dose and how often it should be given, depending on factors such as:
Slovenian: Za zdravljenje krvavitev vam bo zdravnik izračunal in prilagodil odmerek zdravila ter določil kako pogosto ga morate prejeti glede na dejavnike, kot so:
English: Frequencies have been evaluated according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Slovenian: Pogostnosti so opredeljene v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100).
English: Date of first authorisation: 18 February 2016
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 18. februar 2016
English: Administer your next dose immediately and continue at regular intervals as advised by your doctor.
Slovenian: Takoj si injicirajte naslednji odmerek in zdravljenje nadaljujte v rednih presledkih, kot vam je predpisal zdravnik.
English: CA 94710
Slovenian: Berkeley CA 94710