FrancophonIA/ELRC3.0 huggingface dataset:
English: Edible green ink contains: Black iron oxide - synthetic (E172) Yellow iron oxide - synthetic (E172) Propylene glycol
Slovenian: užitno zeleno črnilo Užitno zeleno črnilo vsebuje: črni železov oksid - sintetični (E172)
English: Caution is advisable if Duloxetine Lilly is used concomitantly with serotonergic agents like SSRIs, SNRIs, tricyclic antidepressants like clomipramine or amitriptyline, MAOIs like moclobemide or linezolid, St John's wort (Hypericum perforatum) or triptans, tramadol, pethidine and tryptophan (see section 4.4).
Slovenian: denimo, klomipraminom ali amitriptilinom, z MAOI, denimo moklobemidom ali linezolidom, s šentjanževko (Hypericum perforatum), triptani, tramadolom, petidinom in triptofanom, priporočamo previdnost (glejte poglavje 4.4).
English: Adverse reactions may be more common during concomitant use of Duloxetine Lilly and herbal preparations containing St John's wort (Hypericum perforatum).
Slovenian: Ob sočasni uporabi zdravila Duloksetin Lilly in pripravkov rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), so lahko neželeni učinki pogostejši.
English: Titanium dioxide (E171) Triethyl citrate
Slovenian: titanov dioksid (E171) propilenglikol šelak povidon
English: Duloxetine Lilly demonstrated statistical superiority over placebo as measured by improvement in the 17-item Hamilton Depression Rating Scale (HAM-D) total score (including both the emotional and somatic symptoms of depression).
Slovenian: Zdravilo Duloksetin Lilly se je izkazalo za statistično boljše kot placebo, kar so izmerili z izboljšanjem skupnega števila točk po Hamiltonovi lestvici za ocenjevanje depresije s 17 postavkami
English: Duloxetine Lilly 30 mg hard gastro-resistant capsules Duloxetine Lilly 60 mg hard gastro-resistant capsules
Slovenian: Duloksetin Lilly 30 mg trde gastrorezistentne kapsule Duloksetin Lilly 60 mg trde gastrorezistentne kapsule
English: 7 hard gastro-resistant capsules 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 7 trdih gastrorezistentnih kapsul 28 trdih gastrorezstentnih kapsul 98 trdih gastrorezistentnih kapsul
English: General disorders and administration site conditions Falls8
Slovenian: Splošne težave in spremembe na mestu aplikacije padci8 utrujenost bolečina v prsnem košu7
English: Treatment of major depressive disorder.
Slovenian: 4.1 Terapevtske indikacije Zdravljenje velikih depresivnih motenj.
English: Feeling abnormal Feeling cold Thirst
Slovenian: neobičajno počutje občutek mraza žeja mrzlica bolehnost občutek vročine motnja hoje
English: Cutaneous vasculitis
Slovenian: kožni vaskulitis
English: Syncope2
Slovenian: rdečica sinkopa2
English: Duloxetine is very weakly excreted into human milk based on a study of 6 lactating patients, who did not breast feed their children.
Slovenian: Na osnovi študije 6 doječih bolnic, ki niso dojile svojih otrok, se duloksetin zelo slabo izloča v materino mleko.
English: Duloxetine Lilly 30 mg hard gastro-resistant capsules Duloxetine Lilly 60 mg hard gastro-resistant capsules duloxetine (as hydrochloride)
Slovenian: NAVODILO ZA UPORABO Duloksetin Lilly 30 mg trde gastrorezistentne kapsule Duloksetin Lilly 60 mg trde gastrorezistentne kapsule duloksetin (v obliki duloksetinijevega klorida)
English: Mechanism of action
Slovenian: NAVODILA ZA UPORABO
English: Dizziness, sensory disturbances (including paraesthesia or electric shock-like sensations, particularly in the head), sleep disturbances (including insomnia and intense dreams), fatigue, somnolence,
Slovenian: Reakcije, o katerih najpogosteje poročajo so omotica, senzorične motnje (vključno s parestezijo ali občutki, podobnimi električnemu šoku, predvsem v glavi), motnje spanja (vključno z nespečnostjo in intenzivnimi sanjami), utrujenost, zaspanost, agitacija ali tesnobnost, slabost in/ali bruhanje, tresenje, glavobol, mialgija, razdražljivost, driska, hiperhidroza in vrtoglavica.
English: Dysgeusia Dyskinesia Restless legs syndrome Poor quality sleep
Slovenian: živčnost motnje pozornosti disgevzija diskinezija sindrom nemirnih nog slaba kvaliteta spanja serotoninski sindrom6 konvulzije1
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Capsule content:
Slovenian: 6.1 Seznam drugih sestavin zdravila
English: Rare side effects (may affect up to 1 in 1000 people)
Slovenian: Redki neželeni učinki (se lahko pojavijo pri največ 1 od 1.000 bolnikov)
English: • feeling of dizziness or “spinning” (vertigo), ear pain
Slovenian: • večje zenice (temni osrednji del očesa), motnja vida • omotica ali vrtoglavica (vertigo), ušesna bolečina
English: - If you get any of the side effects talk to your doctor or pharmacist.
Slovenian: - Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Ejaculation disorder
Slovenian: Okvarjeno delovanje jeter
English: Duloxetine Lilly 30 mg hard gastro-resistant capsules duloxetine
Slovenian: Duloksetin Lilly 30 mg trde gastrorezistentne kapsule duloksetin
English: Medicinal product subject to medical prescription
Slovenian: FARMACEVTSKI PODATKI
English: Povidone
Slovenian: SERIJE
English: Duloxetine Lilly is a hard gastro-resistant capsule.
Slovenian: Izgled zdravila Duloksetin Lilly in vsebina pakiranja Zdravilo Duloksetin Lilly je trda gastrorezistentna kapsula.
English: Blurred vision Mydriasis Visual impairment
Slovenian: Očesne bolezni zamegljen vid midriaza okvara vida glavkom
English: Somnolence
Slovenian: Midriaza
English: Duloxetine Lilly 60 mg hard gastro-resistant capsules duloxetine
Slovenian: Duloksetin Lilly 60 mg trde gastrorezistentne kapsule duloksetin
English: Aggression and anger4
Slovenian: manija halucinacije agresija in jeza5
English: Close supervision of patients and in particular those at high risk should accompany medicinal product therapy especially in early treatment and following dose changes.
Slovenian: Med zdravljenjem, še posebej po uvedbi zdravljenja in pri vsaki spremembi odmerka, je treba bolnike skrbno nadzirati.
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Edible green ink
Slovenian: Duloksetin Lilly 30 mg želatina natrijev lavrilsulfat titanov dioksid (E171) indigotin (E132)
English: Duloxetine Lilly is for oral use.
Slovenian: Zdravilo Duloksetin Lilly jemljemo peroralno.
English: • contraction of the jaw muscle
Slovenian: • krčenje čeljustne mišice
English: Elevated liver enzymes (ALT, AST, alkaline phosphatase) Acute liver injury
Slovenian: Bolezni jeter, žolčnika in žolčevodov hepatitis3 zvišani jetrni encimi (ALT, AST, alkalna fosfataza) akutna okvara jeter odpoved jeter6 zlatenica6
English: • throat tightness, nose bleeds
Slovenian: • občutek slabosti (navzea), suha usta
English: Duloxetine should be used with caution in patients whose conditions could be compromised by an increased heart rate or by an increase in blood pressure.
Slovenian: Pri bolnikih, pri katerih bi povišana srčna frekvenca ali povišanje krvnega tlaka lahko vplivala na njihovo stanje, je pri uporabi duloksetina potrebna previdnost.
English: Each capsule contains 60 mg of duloxetine (as hydrochloride).
Slovenian: Ena kapsula vsebuje 60 mg duloksetina (v obliki klorida).
English: Reproductive system and breast disorders Erectile dysfunction
Slovenian: Infekcijske in parazitske bolezni laringitis
English: − are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and Duloxetine Lilly')
Slovenian: - ste alergični (preobčutljivi) na duloksetin ali katerokoli drugo sestavino tega zdravila (navedeno v poglavju 6) - imate obolenje jeter - imate hudo obolenje ledvic - jemljete ali ste v zadnjih 14 dneh jemali drugo antidepresivno zdravilo, imenovano zaviralec monoaminooksidaze (MAOI) (glejte »Druga zdravila in zdravilo Duloksetin Lilly«)
English: Each capsule contains 30 mg of duloxetine (as hydrochloride).
Slovenian: Ena kapsula vsebuje 30 mg duloksetina (v obliki klorida).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Duloxetine Lilly in all subsets of the paediatric population in the treatment of major depressive disorder, diabetic neuropathic pain and generalised anxiety disorder.
Slovenian: Duloksetin Lilly za vse skupine pediatrične populacije pri zdravljenju velike depresivne motnje,
English: There was no statistically significant difference in discontinuation due to adverse events between duloxetine and placebo groups during the 10 week acute treatment phase.
Slovenian: tedenski fazi akutnega zdravljenja ni bilo statistično pomembne razlike v prekinitvi zdravljenja zaradi neželenih učinkov.
English: Duloxetine Lilly contains sucrose.
Slovenian: Zdravilo Duloksetin Lilly vsebuje saharozo.
English: Call your doctor or pharmacist immediately if you take more than the amount of Duloxetine Lilly prescribed by your doctor.
Slovenian: Če vzamete večjo količino zdravila Duloksetin Lilly, kot vam je predpisal zdravnik, nemudoma pokličite zdravnika ali farmacevta.
English: Metabolism and nutrition disorders Decreased
Slovenian: Presnovne in prehranske motnje zmanjšanje hiperglikemija dehidracija apetita
English: You must wait at least 14 days after you have stopped taking an MAOI before you can take Duloxetine Lilly.
Slovenian: Po prenehanju jemanja MAOI morate počakati vsaj 14
English: Blood cholesterol increased
Slovenian: Žilne bolezni zvišan krvni tlak3
English: However,
Slovenian: Zato svetujemo,
English: Paraesthesia
Slovenian: Dojenje
English: You should tell your doctor if this happens to you.
Slovenian: Če se pri vas pojavijo taki občutki, o tem obvestite zdravnika.
English: Duloxetine should be used with caution in patients treated with other medicinal products associated with hepatic injury.
Slovenian: Pri bolnikih, ki jemljejo zdravila, ki lahko povzročijo okvaro jeter, je pri uporabi duloksetina potrebna previdnost.
English: Nervous system disorders Headache
Slovenian: Bolezni živčevja glavobol zaspanost omotica letargija tremor parestezija
English: Talk to your doctor before you take Duloxetine Lilly if you: - are taking other medicines to treat depression (see ‘Other medicines and Duloxetine Lilly') - are taking St. John's Wort, a herbal treatment (Hypericum perforatum) - have kidney disease - have had seizures (fits) - have had mania - suffer from bipolar disorder - have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) - have a history of bleeding disorders (tendency to develop bruises) - are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly) - are currently being treated with another medicine which may cause liver damage - are taking other medicines containing duloxetine (see ‘Other medicines and Duloxetine Lilly')
Slovenian: - imate tveganje za nizek nivo natrija (če na primer jemljete diuretike, sploh če ste starejši) - se trenutno zdravite z drugimi zdravili, ki lahko povzročijo poškodbo jeter
English: Shellac
Slovenian: Šentjanževka
English: Contents of the pack and other information What Duloxetine Lilly contains
Slovenian: Kaj je zdravilo Duloksetin Lilly in za kaj ga uporabljamo Zdravilo Duloksetin Lilly vsebuje učinkovino duloksetin.
English: Dermatitis contact Cold sweat Photo-sensitivity reactions
Slovenian: Bolezni imunskega sistema anafilaktična reakcija preobčutljivost
English: Common side effects (may affect up to 1 in 10 people)
Slovenian: Pogosti neželeni učinki (se lahko pojavijo pri največ 1 od 10 bolnikov)
English: Obizur susoctocog alfa
Slovenian: Obizur susoktokog alfa
English: What measures are being taken to ensure the safe and effective use of Obizur?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Obizur?
English: Obizur has been authorised under ‘exceptional circumstances'.
Slovenian: Zdravilo Obizur je pridobilo dovoljenje za promet „v izjemnih okoliščinah“.
English: Factor VIII is one of the proteins needed for normal clotting of the blood.
Slovenian: Faktor VIII je ena od beljakovin, ki so potrebne za normalno strjevanje krvi.
English: Obizur was not compared with any other medicine.
Slovenian: Zdravila Obizur niso primerjali z nobenim drugim zdravilom.
English: All 28 patients showed a positive response within 24 hours of starting treatment with Obizur; in 24 out of 28 patients, the bleeding stopped completely.
Slovenian: Pri vseh 28 bolnikih so opazili pozitiven odziv v 24 urah od začetka zdravljenja z zdravilom Obizur: pri 24 od 28 bolnikov se je krvavitev v celoti ustavila.
English: The response to Obizur was considered positive if bleeding stopped or was reduced, while a negative response meant that the bleeding continued or worsened.
Slovenian: Odziv na zdravilo Obizur so šteli za pozitiven, če se je krvavitev ustavila ali zmanjšala, negativen odziv pa je pomenil, da se je krvavitev nadaljevala ali poslabšala.
English: The dose, and how often it is given, as well as the length of treatment, are adjusted depending on the patient's condition and requirements, and the degree of danger posed by the bleeding.
Slovenian: Odmerek, pogostnost dajanja in trajanje zdravljenja se prilagodijo glede na bolnikovo stanje in potrebe ter stopnjo nevarnosti, ki jo krvavitev zanj pomeni.
English: In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure.
Slovenian: V nekaterih primerih lahko reakcije postanejo hude (anafilaksa) in so lahko povezane z nevarno strmimi padci krvnega tlaka.
English: Hypersensitivity (allergic) reactions may occur with Obizur, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations.
Slovenian: Pri uporabi zdravila Obizur se lahko pojavijo preobčutljivostne (alergijske) reakcije, ki lahko vključujejo angioedem (otekanje tkiva pod kožo), pekoč in zbadajoč občutek na mestu injiciranja, mrzlico, rdečico, srbeč izpuščaj, glavobol, koprivnico, hipotenzijo (nizek krvni tlak), občutek utrujenosti ali nemira, navzejo (slabost) ali bruhanje, tahikardijo (hiter srčni utrip), stiskanje v prsih, sopenje in občutek ščemenja.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Obizur are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Obizur večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The full EPAR and risk management plan summary for Obizur 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) in povzetek načrta obvladovanja tveganj za zdravilo Obizur sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What benefits of Obizur have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Obizur izkazalo v študijah?
English: Why is Obizur approved?
Slovenian: Zakaj je bilo zdravilo Obizur odobreno?
English: With regard to safety, the Committee considered that the potential for allergic reactions and the development of antibodies against the medicine is expected, and is outweighed by the beneficial effects.
Slovenian: Glede varnosti je menil, da sta možnost alergijskih reakcij in razvoj protiteles proti zdravilu pričakovana, a ju koristni učinki zdravila odtehtajo.
English: As a result, it will not be as easily recognised by the antibodies and it can replace the human factor VIII that has been inactivated, thereby helping the blood to clot and controlling the bleeding.
Slovenian: Posledično jo protitelesa ne prepoznajo tako zlahka, zato lahko nadomesti humani faktor VIII, ki je bil deaktiviran, ter tako pomaga pri strjevanju krvi in nadzoru nad krvavitvijo.
English: This is because it has not been possible to obtain complete information about Obizur due to the rarity of the disease.
Slovenian: Do tega je prišlo zato, ker zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o njem.
English: Since Obizur has been approved under exceptional circumstances, the company that markets the medicine will establish and maintain a patient registry to collect and analyse short- and long-term data on the effectiveness and safety of Obizur in patients with acquired haemophilia caused by antibodies against factor VIII.
Slovenian: Ker je zdravilo Obizur pridobilo dovoljenje za promet v izjemnih okoliščinah, bo družba, ki ga trži, vzpostavila in vzdrževala register bolnikov, v katerem bo zbirala in analizirala kratkoročne in dolgoročne podatke o učinkovitosti in varnosti zdravila Obizur pri bolnikih s pridobljeno hemofilijo, ki jo povzročajo protitelesa proti faktorju VIII.
English: It is not intended to provide practical advice on how to use Obizur.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: A risk management plan has been developed to ensure that Obizur is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Obizur je bil pripravljen načrt obvladovanja tveganj.
English: susoctocog alfa, works in the body in the same way as human factor VIII, but has a slightly different shape.
Slovenian: Zdravilna učinkovina v zdravilu Obizur, susoktokog alfa, deluje v telesu enako kot humani faktor VIII, vendar ima nekoliko drugačno obliko.
English: What are the risks associated with Obizur?
Slovenian: Kakšna tveganja so povezana z zdravilom Obizur ?
English: What is Obizur and what is it used for?
Slovenian: Kaj je zdravilo Obizur in za kaj se uporablja?
English: The results of the main study showed that Obizur was effective in treating serious bleeding episodes in adults with the disorder.
Slovenian: Rezultati glavne študije so pokazali, da je bilo zdravilo Obizur učinkovito pri zdravljenju resnih epizod krvavitev pri odraslih s to motnjo.
English: This is a summary of the European public assessment report (EPAR) for Obizur.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Obizur.
English: Additionally, the company that markets Obizur will provide healthcare professionals who are expected to use Obizur with educational material containing information on how to calculate the dose.
Slovenian: Poleg tega bo družba, ki trži zdravilo Obizur, zdravstvenim delavcem, za katere se pričakuje, da ga bodo uporabljali, priskrbela izobraževalno gradivo, ki bo vsebovalo informacije o izračunu odmerkov.
English: Obizur must not be used in patients who have had a severe allergic reaction to susoctocog alfa, any of its other ingredients, or hamster protein.
Slovenian: Zdravila Obizur ne smejo uporabljati bolniki, ki so imeli hudo alergijsko reakcijo na susoktokog alfa ali katero koli drugo sestavino zdravila ali na beljakovine hrčka.
English: Obizur can only be obtained with a prescription and treatment should be supervised by a doctor with experience in the treatment of haemophilia.
Slovenian: Izdaja zdravila Obizur je le na recept, zdravljenje pa mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem hemofilije.
English: Patients with acquired haemophilia caused by antibodies against factor VIII have blood clotting problems, such as bleeding in the joints, muscles or internal organs.
Slovenian: Bolniki s pridobljeno hemofilijo, ki jo povzročajo protitelesa proti faktorju VIII, imajo zaplete s strjevanjem krvi, kot so krvavitve v sklepe, mišice ali notranje organe.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Obizur, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: For more information about treatment with Obizur, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Obizur preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What information is still awaited for Obizur?
Slovenian: Katere informacije o zdravilu Obizur še pričakujemo?
English: Obizur is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Slovenian: Zdravilo Obizur je na voljo v obliki praška in vehikla, ki se zmešata za pripravo raztopine za injiciranje v veno.
English: Obizur contains the active substance susoctocog alfa.
Slovenian: Zdravilo Obizur vsebuje zdravilno učinkovino susoktokog alfa.
English: For practical information about using Obizur, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Obizur naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Other information about Obizur
Slovenian: Druge informacije o zdravilu Obizur
English: How is Obizur used?
Slovenian: Kako se zdravilo Obizur uporablja?
English: Obizur has been investigated in one main study involving 28 adult patients with acquired haemophilia caused by antibodies against factor VIII who were experiencing a serious bleeding episode.
Slovenian: Zdravilo Obizur so proučevali v eni glavni študiji, ki je vključevala 28 odraslih bolnikov s pridobljeno hemofilijo, ki so jo povzročila protitelesa proti faktorju VIII, ter z resno epizodo krvavitve.
English: Patients with acquired haemophilia caused by antibodies against factor VIII may develop antibodies against susoctocog alfa.
Slovenian: Pri bolnikih s pridobljeno hemofilijo, ki jo povzročajo protitelesa proti faktorju VIII, se lahko razvijejo protitelesa proti susoktokogu alfa.
English: For the full list of all side effects and restrictions with Obizur, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Obizur glejte navodilo za uporabo.
English: The CHMP noted the lack of specific treatments for acquired haemophilia caused by antibodies against factor VIII.
Slovenian: Odbor je upošteval pomanjkanje določenih zdravil za zdravljenje pridobljene hemofilije, ki jo povzročajo protitelesa proti faktorju VIII.
English: Obizur is a medicine used for the treatment of bleeding episodes in adults with acquired haemophilia, a bleeding disorder caused by the spontaneous development of antibodies that inactivate factor VIII.
Slovenian: Obizur je zdravilo, ki se uporablja za zdravljenje epizod krvavitev pri odraslih s pridobljeno hemofilijo, tj. motnjo strjevanja krvi, ki jo povzroča spontani razvoj protiteles, ki deaktivirajo faktor VIII.
English: How does Obizur work?
Slovenian: Kako zdravilo Obizur deluje?
English: --1 Recombinant Protein Q from Leishmania infantum MON-1 ≥ 36.7 ELISA Units (EU)* * Antigen content determined in an ELISA against an internal standard.
Slovenian: Rekombinantni protein Q iz parazita Leishmania infantum MON-1 ≥ 36,7 enot ELISA (EU)* * Vsebnost antigena je določena s testom ELISA v primerjavi z internim standardom.
English: EU (MA) Number Invented name
Slovenian: EU (MA) številka Izmišljeno ime
English: Lyophilisate: 1 vial; solvent:
Slovenian: Karenca liofilizat: 1 viala; vehikel: 1 viala liofilizat: 4 viale; vehikel: 4 viale liofilizat: 100 vial; vehikel:
English: Packaging Content
Slovenian: Pakiranje Vsebina
English: Subcutaneous use Vial (glass)
Slovenian: Subkutana uporaba viala (steklo)
English: 10 mg/ ml Solution for injection.
Slovenian: INCRELEX 10 mg/ml Raztopina za injiciranje
English: 1 Vial
Slovenian: 1 viala
English: Strength Pharmaceutical Form
Slovenian: Izmišljeno ime Jakost farmacevtska oblika pot uporabe
English: Package size
Slovenian: Ovojnina vsebina velikost pakiranja