FrancophonIA/ELRC3.0 huggingface dataset:
English: Pack size of 1.
Slovenian: Velikost pakiranja 1 viala.
English: • 1 infusion set with 35 cm tubing and 25G needle
Slovenian: • 1 komplet za infundiranje s 35 cm cevko in iglo 25 G
English: • The potential risk of an immune complex-mediated type III hypersensitivity reaction due to the formation of antibodies directed against Host Related Impurities (HRI).
Slovenian: • Morebitno tveganje preobčutljivostne reakcije tipa III, povzročene z imunskimi kompleksi, zaradi tvorbe protiteles proti nečistotam, povezanim z gostiteljem (HRI).
English: If you experience allergic reactions e.g. hives, rash, itching, dizziness, wheezing, difficulty breathing or your tongue swells up following the administration of Ruconest, you should seek emergency medical assistance so that symptoms of your allergic reaction can be treated urgently.
Slovenian: Če imate alergijske reakcije, tj. koprivnico, izpuščaje, srbenje, vrtoglavico, hropenje, težave pri dihanju ali vaš jezik oteče po dajanju zdravila Ruconest, morate poiskati nujno medicinsko pomoč, da se lahko simptome vaše alergijske reakcije nemudoma zdravi.
English: • Leave the remainder of the solvent in the vial and discard the vial.
Slovenian: • Preostali vehikel pustite v viali in jo zavrzite.
English: Before Ruconest can be administered, the powder needs to be dissolved in the solvent included in the package (see section 3).
Slovenian: Pred injiciranjem zdravila Ruconest se mora prašek popolnoma raztopiti v vehiklu, priloženem v pakiranju (glejte poglavje 3).
English: Gently inject the solution of the second syringe.
Slovenian: Nežno injicirajte raztopino druge brizge.
English: However headache or vertigo have been reported following the use of Ruconest, but may also occur as a result of an attack of HAE.
Slovenian: Vendar pa so po uporabi zdravila Ruconest poročali o glavobolu ali vrtoglavici, ki pa se lahko pojavita tudi zaradi napada HAE.
English: The plasma protein C1INH is the main regulator of activation of the contact and complement systems in vivo.
Slovenian: Plazemska beljakovina C1INH je glavni uravnalec aktivacije sistemov kontakta in komplementa in vivo.
English: Ruconest is intended for intravenous administration after reconstitution with water for injections.
Slovenian: Zdravilo Ruconest je namenjeno za intravenozno uporabo po rekonstituciji z vodo za injekcije.
English: • After the powder has dissolved, the solution should be clear and colourless.
Slovenian: • Ko se prašek raztopi, mora biti raztopina bistra in brezbarvna.
English: Do not remove the adapter packaging.
Slovenian: Ne odstranite embalaže adapterja.
English: Emergency medical treatment should be available immediately to be administered in case of anaphylactic reactions or shock.
Slovenian: Na voljo mora biti takojšnja nujna medicinska pomoč za primer anafilaktične reakcije ali šoka.
English: • That patients with clinical evidence of cow's milk allergy may have antibodies cross reacting with the rabbit milk impurities in Ruconest.
Slovenian: • Da imajo lahko bolniki s klinično dokazano alergijo na kravje mleko protitelesa, ki povzročijo navzkrižno reakcijo z nečistotami kunčjega mleka v zdravilu Ruconest.
English: • Disinfect the injection site thoroughly with an alcohol pad and let the skin dry.
Slovenian: • Mesto injiciranja dobro razkužite z alkoholno blazinico in pustite, da se koža osuši.
English: Embryofetal studies in rat and rabbit; Daily single doses of vehicle or 625 U/kg/administration of rhC1INH were administered intravenously to mated rats and rabbits.
Slovenian: Študije razvoja zarodka/plodu pri podganah in kuncih; enkratni dnevni odmerek vehikla ali 625 e./kg rhC1INH sta bila dana intravensko podganam in kuncem v obdobju parjenja.
English: In HAE patients, Ruconest at a dose of 50 U/kg increases plasma C1INH activity level to greater than 0.7 U/ml for approximately 2 hours (see section 5.2).
Slovenian: Pri bolnikih s HAE zdravilo Ruconest v odmerku 50 e/kg poveča raven aktivnosti C1INH v plazmi na raven, višjo od 0,7 e/ml, za približno 2 uri (glejte poglavje 5.2).
English: Ruconest is supplied in a carton box containing one vial.
Slovenian: Zdravilo Ruconest je na voljo v kartonski škatli, ki vsebuje eno vialo.
English: • 1 vial of 20 ml solvent
Slovenian: • 1 vialo z 20 ml vehikla
English: Do not remove the syringe packaging.
Slovenian: Ne odstranite embalaže brizge.
English: • Hold the adapter with one hand.
Slovenian: • Z eno roko držite adapter.
English: Disinfect the injection site with an alcohol pad.
Slovenian: Mesto injiciranja razkužite z alkoholno blazinico.
English: Fertility There are no data on the effects of Ruconest on male or female fertility.
Slovenian: O učinkih zdravila Ruconest na moško ali žensko plodnost ni podatkov.
English: How to use Ruconest
Slovenian: Kako uporabljati zdravilo Ruconest
English: Ruconest is indicated for treatment of acute angioedema attacks in adults and adolescents with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency.
Slovenian: Zdravilo Ruconest je indicirano za zdravljenje akutnih napadov angioedema pri odraslih in mladostnikih s hereditarnim (dednim) angioedemom (HAE: Hereditary Angioedema) zaradi pomanjkanja zaviralca esteraze C1.
English: The amino acid sequence of conestat alfa is identical to that of endogenous C1INH.
Slovenian: Aminokislinsko zaporedje konestata alfa je identično zaporedju endogenega C1INH.
English: HAE patients have a heterozygous deficiency of the plasma protein C1INH.
Slovenian: Bolniki s HAE imajo heterozigotno pomanjkanje plazemske beljakovine C1INH.
English: • Put the vial adapters on the work surface.
Slovenian: • Adapterje za viale položite na delovno površino.
English: This should be taken into consideration by patients on a controlled sodium diet.
Slovenian: To morajo upoštevati bolniki, ki so na dieti za nadzorovanim vnosom natrija.
English: Tabulated lists of adverse reactions
Slovenian: Tabelarični seznam neželenih učinkov
English: Never use any kit component after the expiry date stated on the big outer carton.
Slovenian: Nobene komponente v kompletu ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini (veliki škatli).
English: • Put the powder and solvent vials required on a flat and clean surface.
Slovenian: • Potrebne viale s praškom in vehiklom položite na ravno in čisto površino.
English: The educational material for the Healthcare Professional should include information on the following key elements:
Slovenian: Izobraževalno gradivo za zdravstvene delavce mora vsebovati informacije o naslednjih ključnih elementih:
English: • Leave the syringe on the adapter and gently swirl the vial for approximately half a minute.
Slovenian: • Brizgo pustite pritrjeno na adapter in nato približno pol minute nežno vrtite vialo.
English: 1 Unit of conestat alfa activity is defined as the equivalent of C1 esterase inhibiting activity present in 1 ml of pooled normal plasma.
Slovenian: 1 enota konestata alfa je opredeljena kot enakovredna zaviralni aktivnosti esteraze C1 v 1 ml zlitja normalne plazme.
English: Pharming Technologies B.V. Darwinweg 24
Slovenian: Pharming Technologies B.V.
English: • Feel, with your other hand, for an appropriate vein.
Slovenian: • Z drugo roko zatipajte ustrezno žilo.
English: • Ensure the kit package is complete and contains all components listed in section 6 of this leaflet.
Slovenian: Preden začnete • Prepričajte se, da je ovojnina celovita in vsebuje vse komponente, navedene v 6. poglavju teh navodil za uporabo.
English: Continue to fill the syringe with 14 ml solvent.
Slovenian: Nadaljujte s polnjenjem brizge s 14 ml vehikla.
English: The reconstituted solution in each vial should be visually inspected for particulate matter and discoloration.
Slovenian: Rekonstituirano raztopino v vsaki viali je treba vizualno pregledati glede trdnih delcev in spremembe barve.
English: • The need to inform patients about the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis, and that they should alert their physician if these symptoms occur.
Slovenian: • Obveznost informiranja bolnika o zgodnjih znakih preobčutljivostnih reakcij, ki vključujejo koprivnico, splošno urtikarijo, stiskanje v prsih, hropenje, hipotenzijo in anafilakso, in da morajo na te simptome opozoriti svojega zdravnika, če se pojavijo.
English: • Check that no air is present in the syringe, infusion tube or the needle.
Slovenian: • Preverite, da v brizgi, cevki za infundiranje ali igli ni zraka.
English: • In addition to the kit, the following is required: - a tourniquet - plaster for securing the needle
Slovenian: • Poleg kompleta potrebujete še: - žilno prevezo - obliž za pritrditev igle
English: Ruconest is administered into a vein over about 5 minutes.
Slovenian: Zdravilo Ruconest se injicira v veno približno 5 minut.
English: Ruconest must be administered by a healthcare professional until the patient (or caregiver) is competent to administer after having been properly trained and in agreement with the healthcare professional.
Slovenian: Zdravilo Ruconest mora dajati zdravstveni delavec, dokler bolnik (ali skrbnik) po ustreznem usposabljanju in v dogovoru z zdravstvenim delavcem ni zadostno usposobljen za samostojno dajanje.
English: • Draw in the volume of prepared solution, while keeping the syringe in the vertical position.
Slovenian: • Izsesajte količino pripravljene raztopine, pri čemer naj bo brizga v navpičnem položaju.
English: Preclinical data do not indicate any safety concern for the use of conestat alfa in humans based on studies of safety pharmacology, single-dose toxicity, two-week sub-chronic toxicity and local tolerance in various animal species including rats, dogs, rabbits and cynomolgus monkeys.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti enkratnega odmerka, dvotedenske subkronične toksičnosti in lokalne tolerance pri različnih živalskih vrstah, vključno s podganami, psi, kunci in javanskimi makaki, ne kažejo posebnega tveganja za človeka.
English: • Carefully pull back the syringe plunger slightly until you see blood being drawn into the tubing, to ensure that the needle is in the vein.
Slovenian: • Previdno rahlo povlecite bat brizge, dokler v cevki ne zagledate krvi, s tem se boste prepričali, da je igla v žili.
English: • Abdominal pain, diarrhoea, nausea
Slovenian: • Bolečine v trebuhu, diareja, slabost
English: The patient card should contain the following key elements:
Slovenian: Opozorilna kartica za bolnika mora vsebovati naslednje ključne elemente:
English: For patients of 84 kg or above the volume required to be administered is 28 ml, corresponding to 4200 U (2 vials).
Slovenian: Za bolnike s telesno maso 84 kg ali več je potrebni volumen za dajanje 28 ml, kar ustreza 4200 e. (2 viali).
English: If you plan becoming pregnant, discuss with your doctor before starting to use Ruconest.
Slovenian: Če načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: No dose adjustment is necessary in patients with renal impairment since conestat alfa does not undergo renal clearance.
Slovenian: Pri bolnikih z ledvično okvaro ni potrebna prilagoditev odmerka, saj se konestat alfa ne izloča prek ledvic.
English: - Body weight up to 84 kg
Slovenian: - Telesna masa do 84 kg
English: The medicinal product should be used immediately.
Slovenian: Zdravilo je treba takoj uporabiti.
English: • The fact that Ruconest is derived from milk of transgenic rabbits and contains trace of rabbit proteins (Host Related Impurities, HRI).
Slovenian: • Dejstva, da se zdravilo Ruconest pridobiva iz mleka transgenskih kuncev in vsebuje sledove kunčjih beljakovin (nečistote, povezane z gostiteljem: HRI - Host Related Impurities).
English: • There are limited data on the use of this medicinal product in home or self-administration.
Slovenian: • Podatkov o uporabi tega zdravila pri zdravljenju doma ali samostojnem dajanju je malo.
English: Some side effects may occur during treatment with Ruconest: Common: may affect up to 1 in 10 people
Slovenian: Med zdravljenjem z zdravilom Ruconest se lahko pojavijo nekateri neželeni učinki: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov):
English: Step 11: Preparing the injection site
Slovenian: 11. korak: Priprava mesta za injiciranje
English: Do not use this medicine after the expiry date which is stated on the carton and on the label of the vial after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na oznaki viale poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: The administration of Ruconest is to resolve the shortage of C1 inhibitor and will lead to reduction of symptoms of an acute attack of HAE.
Slovenian: Z dajanjem zdravila Ruconest odpravimo pomanjkanje zaviralca C1 in zmanjšamo simptome akutnega napada angioedema.
English: Do not drive or use machinery if you feel dizzy or suffer from headache after using Ruconest.
Slovenian: Ne vozite avtomobila ali upravljajte z orodji ali stroji, če imate po uporabi zdravila Ruconest vrtoglavico ali glavobol.
English: • the batch number written on the label of the powder vial
Slovenian: • številko serije na nalepki viale s praškom
English: Inject the Ruconest solution immediately after preparation, preferably while seated.
Slovenian: Raztopino zdravila Ruconest injicirajte nemudoma po pripravi, če je mogoče, v sedečem položaju.
English: Conestat alfa is derived from milk of transgenic rabbits and contains traces of rabbit protein.
Slovenian: Konestat alfa je pridobljen iz mleka transgenskih kuncev in vsebuje sledove kunčjih beljakovin.
English: • Hives and swelling of the skin.
Slovenian: • Koprivnica in otekanje kože.
English: • Carefully remove the plaster for securing the needle and withdraw the needle from the vein.
Slovenian: • Previdno odstranite obliž za pritrditev igle in jo odstranite iz žile.
English: Ruconest must be administered by a healthcare professional until you or your caregiver are properly trained and capable to administer Ruconest.
Slovenian: Zdravilo Ruconest mora dajati zdravstveni delavec, dokler vi ali vaš skrbnik niste zadostno usposobljeni in zmožni za dajanje zdravila Ruconest.
English: 1 powder vial 1 solvent vial 2 vial adapters 1 syringe
Slovenian: 1 vialo s praškom 1 vialo z vehiklom 2 adapterja za viale 1 brizgo
English: In the majority of cases a single dose of Ruconest is sufficient to treat an acute angioedema attack.
Slovenian: V večini primerov za zdravljenje akutnega napada angioedema zadostuje en odmerek zdravila
English: 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),
Slovenian: Pogostnost neželenih učinkov v nadaljevanju je opredeljena v skladu z naslednjo klasifikacijo: 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),
English: Based on animal data, conestat alfa is cleared from the circulation by the liver via receptor-mediated endocytosis followed by complete hydrolysis/degradation.
Slovenian: Na podlagi podatkov študij na živalih se konestat alfa očisti iz krvnega obtoka s presnovo v jetrih z od receptorja odvisno endocitozo, ki ji sledi popolna hidroliza/razgradnja.
English: Home-treatment and self-administration
Slovenian: Zdravljenje doma in samostojno dajanje
English: If air bubbles appear, minimise as far as possible by gently tapping the syringe and applying gentle pressure by pushing the plunger into the syringe.
Slovenian: Če se pojavijo mehurčki, jih poskusite čim bolj omejiti z nežnim trepljanjem brizge in nežnim pritiskanjem bata v brizgo.
English: • That patients treated with Ruconest should be monitored for clinical signs and symptoms of hypersensitivity during administration.
Slovenian: • Da je treba bolnike, zdravljene z zdravilom Ruconest, med dajanjem spremljati glede preobčutljivostnih kliničnih znakov in simptomov.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Slovenian: Bolnike je treba poučiti o zgodnjih znakih preobčutljivostnih reakcij, ki vključujejo koprivnico, generalizirano urtikarijo, stiskanje v prsih, hropenje, hipotenzijo in anafilakso.
English: - Body weight up to 84 kg For patients up to 84 kg calculate the volume required to be administered according to the formula below:
Slovenian: - Telesna masa do 84 kg Za bolnike s telesno maso do 84 kg izračunajte potrebni volumen v skladu s spodnjo preglednico:
English: • It is the responsibility of the physician to provide the patient or a caregiver with instructions and training on administration outside of a clinic setting.
Slovenian: • Zdravnik mora bolnika ali njegovega skrbnika poučiti in usposobiti za dajanje zdravila zunaj bolnišnične ustanove.
English: • Turn the whole - solvent vial with adapter and syringe - upside down.
Slovenian: • Celotni sestav - vialo z vehiklom, adapter in brizgo - obrnite na glavo.
English: Ruconest should be administered by a healthcare professional.
Slovenian: Zdravilo Ruconest mora dati zdravstveni delavec.
English: It is not recommended to use Ruconest during pregnancy or breast-feeding.
Slovenian: Uporaba zdravila Ruconest med nosečnostjo ali dojenjem ni priporočena.
English: • Immediately after removing the needle, press the sterile pad on the injection site for a few minutes to reduce bleeding.
Slovenian: • Takoj po odstranitvi igle na mesto injiciranja pritisnite sterilni tampon in ga držite nekaj minut,
English: 1 infusion set with needle 2 alcohol pads 1 sterile non-woven pad 1 adhesive plaster
Slovenian: 1 komplet za infundiranje z iglo 2 alkoholni blazinici 1 sterilni netkani tampon 1 obliž
English: After administration of Ruconest (50 U/kg) to asymptomatic HAE patients, a Cmax of 1.36 U/ml was observed.
Slovenian: Po dajanju zdravila Ruconest (50 e./kg) asimptomatičnim bolnikom s HAE so izmerili Cmaks 1,36 e./ml.
English: - bodyweight 42 kg or less: 1 powder and 1 solvent vial - bodyweight over 42 kg: 2 powder and 2 solvent vials
Slovenian: - telesna masa do 42 kg: 1 viala s praškom in 1 viala z vehiklom - telesna masa nad 42 kg: 2 viali s praškom in 2 viali z vehiklom
English: • It is the responsibility of the physician to verify that all the necessary skills have been acquired by the non-Healthcare Professional and that Ruconest may be safely and effectively administered outside of a Healthcare Professional setting.
Slovenian: • Zdravnik je dolžan preveriti, da je nezdravstveni delavec razvil vse potrebne spretnosti ter da je omogočeno varno in učinkovito dajanje zdravila Ruconest zunaj zdravstvene ambulante.
English: Step 3: Mounting of adapters on vials
Slovenian: 3. korak: Namestitev adapterjev na viale
English: Conestat alfa, recombinant human complement component 1 (C1) esterase inhibitor (rhC1INH), is an analogue of human C1INH and is obtained from the milk of rabbits expressing the gene encoding for human C1INH.
Slovenian: Konestat alfa, rekombinantna humana sestavina komplementa 1 (C1) zaviralca esteraze (rhC1INH), je analog humanega C1INH in se ga pridobiva iz mleka kuncev, ki izražajo kodiranje gena za humani
English: • 1 vial of 2100 U powder
Slovenian: • 1 vialo z 2100 e. praška
English: Solvent vial: Water for injections
Slovenian: Viala z vehiklom: voda za injekcije
English: Millilitres of prepared solution to be injected below 84 kg bodyweight in kg divided by three
Slovenian: Število mililitrov, ki jih je treba injicirati do 84 kg telesna masa v kg deljeno s tri več kot 84 kg
English: - Body weight of 84 kg or greater
Slovenian: - Telesna masa 84 kg ali več
English: The efficacy and safety of Ruconest as a treatment of acute angioedema attacks in patients with HAE has been evaluated in two double blind randomized placebo controlled and four open label clinical studies.
Slovenian: HAE so ocenili v dveh dvojno slepih, randomiziranih, s placebom nadzorovanih študijah in štirih odprtih kliničnih študijah.
English: Water for injections should be added slowly to avoid forceful impact on the powder and mixed gently to minimise foaming of the solution.
Slovenian: Vodo za injekcije je treba dodati počasi, da se izognete močnemu curku na prašek, in rahlo premešati, da v največji možni meri omejite penjenje raztopine.
English: • Dizziness, throat irritation
Slovenian: • Vrtoglavica, draženje v grlu
English: Leave the syringe on the adapter.
Slovenian: Brizgo pustite pritrjeno na adapter.
English: Powder for solution for injection 1 vial
Slovenian: prašek za raztopino za injiciranje 1 viala
English: Conestat alfa is a recombinant (not blood-derived) form of human C1 inhibitor (rhC1INH).
Slovenian: Konestat alfa je rekombinantna (ni proizvedena iz krvi) oblika humanega zaviralca C1 (rhC1INH).
English: Remove the needle cap from the needle of the infusion set and carefully insert the needle into the vein.
Slovenian: Odstranite pokrovček igle s kompleta za infundiranje in jo previdno vstavite v žilo.
English: • Safely dispose of the used infusion set with needle, any unused solution, the syringe and the empty vial in an appropriate medical waste container as these materials may hurt others if not disposed of properly.
Slovenian: • Uporabljeni komplet za infundiranje skupaj z iglo, vso neporabljeno raztopino, brizgo in prazno vialo varno odstranite v ustrezni zabojnik za medicinske odpadke, saj lahko ti pripomočki poškodujejo druge, če niso primerno odstranjeni.
English: Conestat alfa is the recombinant analogue of the human C1 esterase inhibitor (rhC1INH) produced by recombinant DNA technology in the milk of transgenic rabbits.
Slovenian: Konestat alfa je rekombinantni analog humanega zaviralca esteraze C1 (rhC1INH), pridobljen s tehnologijo rekombinantne DNA v mleku transgenskih kuncev.
English: • Hold the adapter with the other hand and attach the syringe.
Slovenian: • Z drugo roko primite adapter in namestite brizgo.
English: Ruconest is to be used by adults and adolescents with a rare inherited blood disorder, called Hereditary Angioedema (HAE).
Slovenian: Zdravilo Ruconest lahko uporabljajo odrasli in mladostniki z redko dedno krvno boleznijo, imenovano dedni (hereditarni) angioedem.
English: • Use of Ruconest is only approved in acute attacks of hereditary angioedema.
Slovenian: • Zdravilo Ruconest se lahko uporablja samo pri akutnih napadih hereditarnega (dednega) angioedema.
English: Please safely dispose of the used infusion set with needle, any unused solution, the syringe and the empty vial in an appropriate medical waste container as these materials may hurt others if not disposed of properly.
Slovenian: Odstranjevanje Prosimo, da uporabljeni komplet za infundiranje skupaj z iglo, vso neporabljeno raztopino, brizgo in prazno vialo varno odstranite v ustrezni zabojnik za medicinske odpadke, saj lahko ti pripomočki poškodujejo druge, če niso primerno odstranjeni.
English: Inhibition kinetics were found to be comparable with those observed for plasma-derived human C1INH.
Slovenian: Ugotovili so, da je kinetika zaviranja primerljiva s tisto, ugotovljeno za humani C1INH, pridobljen iz plazme.
English: • Batch number and dose
Slovenian: • Številko serije in odmerek zdravila
English: Ruconest is presented as a single glass vial containing a white to off-white powder for solution for injection together with one glass vial containg a clear, colourless solvent to dissolve the powder.
Slovenian: Zdravilo Ruconest je pakirano kot ena steklena viala z belim do belkastim praškom za raztopino za injiciranje skupaj s stekleno vialo, ki vsebuje bistro, brezbarvno tekočino za raztopitev praška.
English: One case of hypersensitivity was observed in clinical trials with Ruconest.
Slovenian: V kliničnih preizkušanjih z zdravilom Ruconest so opazili en primer preobčutljivosti.
English: 100 U/kg n =16
Slovenian: 100 e/kg n =16
English: While keeping it vertical, slowly draw in 14 ml solvent.
Slovenian: Držite ga v navpičnem položaju in počasi izsesajte 14 ml vehikla.
English: Name and address of the manufacturers of the biological active substance
Slovenian: SPROŠČANJE SERIJ Ime in naslov izdelovalcev biološke zdravilne učinkovine