FrancophonIA/ELRC3.0 huggingface dataset:
English: General disorders and administration site conditions Very Common:
Slovenian: Splošne težave in spremembe na mestu aplikacije Zelo pogosti:
English: Hyperglycaemia, weight decreased Weight decreased
Slovenian: hiperglikemija, zmanjšanje telesne mase zmanjšanje telesne mase
English: TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ
Slovenian: Prekinitev ali opustitev odmerjanja temozolomida v obdobju sočasnega zdravljenja z obsevanjem toksičnost prekinitev zdravljenja s TMZa opustitev zdravljenja s TMZ
English: Temozolomide Teva 250 mg hard capsules
Slovenian: Temozolomide Teva 250 mg trde kapsule
English: Recurrent or progressive malignant glioma
Slovenian: Bolniki s ponavljajočim se ali napredujočim malignim gliomom
English: Dose during Cycles 2-6 in absence of toxicity
Slovenian: opombe zmanjšanje zaradi predhodne toksičnosti odmerek v prvem ciklu odmerek v drugem in šestem ciklu, brez toksičnosti
English: In some cases, your Temozolomide Teva dose will be reduced or treatment stopped.
Slovenian: Naslednje odmerke zdravila Temozolomide Teva boste morda vzeli z zamikom ali pa boste zdravilo prenehali jemati.
English: Stomatitis, diarrhoea, dyspepsia, dysphagia, mouth dry
Slovenian: stomatitis, diareja, bolečine v trebuhu, dispepsija, disfagija stomatitis, diareja, dispepsija, disfagija, suha usta
English: Temozolomide Teva 140 mg hard capsules
Slovenian: Temozolomide Teva 140 mg trde kapsule
English: Vomiting, nausea, constipation
Slovenian: bruhanje, navzeja, zaprtost
English: This is because Temozolomide Teva could cause hepatitis B to become active again, which can be fatal in some cases.
Slovenian: V tem primeru vam bo zdravnik predpisal tudi zdravilo za preprečevanje te vrste pljučnice (PCP); - če ste kdaj bili ali ste okuženi s hepatitisom B. Zdravilo Temozolomide Teva lahko povzroči ponovno aktivacijo hepatitisa B, kar se lahko v nekaterih primerih konča s smrtnim izidom.
English: Visual field defect, vision blurred, diplopia
Slovenian: meglen vid nepravilnost vidnega polja, meglen vid, diplopija
English: Very rare cases of lung side effects have been observed with Temozolomide Teva.
Slovenian: Med bolniki, ki so se zdravili z zdravilom Temozolomide Teva, so opazili zelo redke primere neželenih učinkov na pljuča.
English: Temozolomide Teva 20 mg hard capsules
Slovenian: Temozolomide Teva 20 mg trde kapsule
English: How to store Temozolomide Teva
Slovenian: Shranjevanje zdravila Temozolomide Teva
English: Temozolomide Teva 250 mg hard capsules Each hard capsule contains 250 mg temozolomide.
Slovenian: Temozolomide Teva 250 mg trde kapsule Ena trda kapsula vsebuje 250 mg temozolomida.
English: Temozolomide Teva 250 mg hard capsules Temozolomide
Slovenian: Temozolomide Teva 250 mg trde kapsule temozolomid
English: Temozolomide Teva 140 mg hard capsules Temozolomide
Slovenian: Temozolomide Teva 140 mg trde kapsule temozolomid
English: < 0.5 x 109/l
Slovenian: < 0,5 x 109/l število trombocitov
English: Excipient with known effect Each hard capsule contains 87 mg of lactose.
Slovenian: Ena trda kapsula vsebuje 87 mg laktoze.
English: The pharmacokinetics of TMZ were comparable in patients with normal hepatic function and in those with mild or moderate hepatic impairment.
Slovenian: Pri bolnikih z normalnim delovanjem jeter in pri tistih z blago ali zmerno okvaro jeter je bila farmakokinetika TMZ primerljiva.
English: Temozolomide Teva 250 mg hard capsules have a white opaque body and cap with two stripes in black ink on the cap and with “T 250 mg” in black ink on the body.
Slovenian: Temozolomide Teva 250 mg trde kapsule imajo belo neprosojno telo s črnim natisnjenim napisom »T 250 mg« in belo neprosojno kapico z dvema črnima progama.
English: Temozolomide Teva 5 mg hard capsules Temozolomide
Slovenian: Temozolomide Teva 5 mg trde kapsule temozolomid
English: Temozolomide Teva 20 mg hard capsules have a white opaque body and cap with two stripes in orange ink on the cap and with “T 20 mg” in orange ink on the body.
Slovenian: Temozolomide Teva 20 mg trde kapsule imajo belo neprosojno telo z oranžnim natisnjenim napisom »T 20 mg« in belo neprosojno kapico z dvema oranžnima progama.
English: Febril neutropenia, thrombocytopenia, anaemia, leukopenia
Slovenian: nevtropenija, trombocitopenija, limfopenija, levkopenija febrilna nevtropenija, trombocitopenija, anemija, levkopenija
English: Temozolomide Teva 100 mg hard capsules
Slovenian: Temozolomide Teva 100 mg trde kapsule
English: Temozolomide Teva 250 mg hard capsules: Each capsule contains 250 mg temozolomide.
Slovenian: Temozolomide Teva 250 mg trde kapsule: Ena kapsula vsebuje 250 mg temozolomida.
English: Take the missed dose as soon as possible during the same day.
Slovenian: Če ste pozabili vzeti zdravilo Temozolomide Teva Vzemite izpuščeni odmerek čim prej, še istega dne.
English: Temozolomide Teva 5 mg hard capsules have a white opaque body and cap with two stripes in green ink on the cap and with “T 5 mg” in green ink on the body.
Slovenian: Temozolomide Teva 5 mg trde kapsule imajo belo neprosojno telo z zelenim natisnjenim napisom »T 5 mg« in belo neprosojno kapico z dvema zelenima progama.
English: Temozolomide Teva 20 mg hard capsules Temozolomide
Slovenian: Temozolomide Teva 20 mg trde kapsule temozolomid
English: Temozolomide Teva 5 mg hard capsules Each hard capsule contains 5 mg temozolomide.
Slovenian: Temozolomide Teva 5 mg trde kapsule Ena trda kapsula vsebuje 5 mg temozolomida.
English: Reproductive system and breast disorders Uncommon:
Slovenian: Infekcijske in parazitske bolezni Redki:
English: Excipient with known effect Each hard capsule contains 84 mg of lactose.
Slovenian: Ena trda kapsula vsebuje 84 mg laktoze.
English: Temozolomide Teva 5 mg hard capsules: Each capsule contains 5 mg temozolomide.
Slovenian: Temozolomide Teva 5 mg trde kapsule: Ena kapsula vsebuje 5 mg temozolomida.
English: Treatment with concomitant TMZ can be continued when all of the following conditions are met:
Slovenian: stopnja 2 po splošnih merilih toksičnosti stopnja 3 ali 4 po splošnih merilih toksičnosti a: Sočasno zdravljenje s TMZ lahko nadaljujete, če so izpolnjeni vsi od naslednjih pogojev: absolutno število nevtrofilcev
English: Temozolomide Teva 140 mg hard capsules have a white opaque body and cap with two stripes in blue ink on the cap and with “T 140 mg” in blue ink on the body.
Slovenian: Temozolomide Teva 140 mg trde kapsule imajo belo neprosojno telo z modrim natisnjenim napisom »T 140 mg« in belo neprosojno kapico z dvema modrima progama.
English: Temozolomide Teva 20 mg hard capsules Each hard capsule contains 20 mg temozolomide.
Slovenian: Temozolomide Teva 20 mg trde kapsule Ena trda kapsula vsebuje 20 mg temozolomida.
English: Asthenia, face oedema, pain, condition aggravated, rigors, tooth disorder,
Slovenian: poslabšanje zdravstvenega stanja, rigor, težave z zobmi
English: Following oral administration, approximately 5% to 10% of the dose is recovered unchanged in the urine over 24 hours, and the remainder excreted as temozolomide acid, 5-aminoimidazole-4carboxamide (AIC) or unidentified polar metabolites.
Slovenian: Po peroralnem vnosu se v 24 urah približno 5 do 10 % odmerka pojavi v urinu v nespremenjeni obliki.
English: Temozolomide Teva 180 mg hard capsules Each hard capsule contains 180 mg temozolomide.
Slovenian: Temozolomide Teva 180 mg trde kapsule Ena trda kapsula vsebuje 180 mg temozolomida.
English: You will again take Temozolomide Teva once daily for 5 days followed by 23 days without Temozolomide Teva.
Slovenian: Znova boste pet dni jemali Temozolomide Teva enkrat dnevno,
English: In patients previously untreated with chemotherapy, TMZ is administered orally at a dose of 200 mg/m² once daily for the first 5 days followed by a 23 day treatment interruption (total of 28 days).
Slovenian: Pri bolnikih, ki se še niso zdravili s kemoterapijo, se TMZ prvih pet dni daje peroralno v odmerku 200 mg/m² enkrat dnevno.
English: Temozolomide Teva 140 mg hard capsules Each hard capsule contains 140 mg temozolomide.
Slovenian: Temozolomide Teva 140 mg trde kapsule Ena trda kapsula vsebuje 140 mg temozolomida.
English: Hepatic enzymes increased, Gamma GT increased, AST increased
Slovenian: povišanje ravni jetrnih encimov, povišanje ravni gamaglutamiltransferaze, povišanje ravni aspartat-aminotransferaze
English: Temozolomide Teva 140 mg hard capsules: Each capsule contains 140 mg temozolomide.
Slovenian: Temozolomide Teva 140 mg trde kapsule: Ena kapsula vsebuje 140 mg temozolomida.
English: Malignancies
Slovenian: mialgija
English: Temozolomide Teva 180 mg hard capsules Temozolomide
Slovenian: Temozolomide Teva 180 mg trde kapsule temozolomid
English: Temozolomide Teva 180 mg hard capsules: Each capsule contains 180 mg temozolomide.
Slovenian: Temozolomide Teva 180 mg trde kapsule: Ena kapsula vsebuje 180 mg temozolomida.
English: Temozolomide Teva 180 mg hard capsules
Slovenian: Temozolomide Teva 180 mg trde kapsule
English: Fever, asthenia, rigors, malaise, pain, taste perversion
Slovenian: vročina, astenija, rigor, slabo počutje, bolečina,
English: Temozolomide Teva 20 mg hard capsules: Each capsule contains 20 mg temozolomide.
Slovenian: Temozolomide Teva 20 mg trde kapsule: Ena kapsula vsebuje 20 mg temozolomida.
English: Temozolomide Teva 100 mg hard capsules: Each capsule contains 100 mg temozolomide.
Slovenian: Temozolomide Teva 100 mg trde kapsule: Ena kapsula vsebuje 100 mg temozolomida.
English: Temozolomide Teva 100 mg hard capsules Each hard capsule contains 100 mg temozolomide.
Slovenian: Temozolomide Teva 100 mg trde kapsule Ena trda kapsula vsebuje 100 mg temozolomida.
English: Patients in the TMZ + RT arm received concomitant TMZ (75 mg/m²) once daily, starting the first day of RT until the last day of RT, for 42 days (with a maximum of 49 days).
Slovenian: Bolniki v kraku s TMZ in obsevanjem so se sočasno zdravili s TMZ (75 mg/m²) enkrat dnevno.
English: Uncommon (may affect up to 1 in 100 people): flu-like symptoms, red spots under the skin, low potassium level in the blood, weight gain, mood swings, hallucination and memory impairment, partial paralysis, impaired coordination, impaired sensations, partial loss of vision, dry or painful eyes, deafness, infection of the middle ear, ringing in the ears, earache, palpitations (when you can feel your heart beat), blood clot in the lung, high blood pressure, pneumonia, inflammation of your sinuses, bronchitis, a cold or the flu, swollen stomach, difficulty controlling your bowel movements, haemorrhoids, peeling skin, increased skin sensitivity to sunlight, change in skin colour, increased sweating, muscle damage, back pain, difficulty in urinating, vaginal bleeding, sexual impotence,
Slovenian: suhe ali boleče oči, naglušnost, vnetje srednjega ušesa, zvonjenje v ušesih, bolečina v ušesu, palpitacije (ko lahko čutite svoj srčni utrip), krvni strdek v pljučih, visok krvni tlak, pljučnica, vnetje sinusov, bronhitis, prehlad ali gripa, otekel želodec, nezmožnost nadzora nad odvajanjem blata,
English: (difficulty passing stools), nausea (feeling sick in your stomach), vomiting, rash, hair loss, tiredness.
Slovenian: (nevtropenija ali limfopenija, trombocitopenija), izguba apetita, glavobol, bruhanje, slabost, zaprtost.
English: Temozolomide Teva 100 mg hard capsules Temozolomide
Slovenian: Temozolomide Teva 100 mg trde kapsule temozolomid
English: Adult patients with newly-diagnosed glioblastoma multiforme Anti-emetic prophylaxis is recommended prior to the initial dose of concomitant phase and it is strongly recommended during the monotherapy phase.
Slovenian: Pred začetnim odmerkom v obdobju sočasnega zdravljenja, še zlasti pa v obdobju samostojnega zdravljenja, se priporoča antiemetična profilaksa.
English: Temozolomide Teva 100 mg hard capsules have a white opaque body and cap with two stripes in pink ink on the cap and with “T 100 mg” in pink ink on the body.
Slovenian: Temozolomide Teva 100 mg trde kapsule imajo belo neprosojno telo z rožnatim natisnjenim napisom »T 100 mg« in belo neprosojno kapico z dvema rožnatima progama.
English: CTC Non-haematological Toxicity (except for alopecia, nausea, vomiting)
Slovenian: < 10 x 109/l nehematološka toksičnost po splošnih merilih toksičnosti (razen za alopecijo, navzejo, bruhanje)
English: EU/1/09/606/011 5 capsules EU/1/09/606/012 20 capsules
Slovenian: EU/1/09/606/011 5 kapsul EU/1/09/606/012 20 kapsul
English: 4.8 Undesirable effects
Slovenian: 4.8 Neželeni učinki Izkušnje iz kliničnih preskušanj
English: A variety of neoplasms, including mammary carcinomas, keratocanthoma of the skin and basal cell adenoma were observed in the 6-cycle rat study while no tumours or pre-neoplastic changes were evident in dog studies.
Slovenian: V študiji na podganah, ki je obsegala šest ciklov, so opazili različne neoplazme, vključno s karcinomom mlečnih žlez, keratoakantomom in adenomom bazalnih celic,
English: The hard capsules have a white opaque body and cap with two stripes in black ink on the cap and with “T 250 mg” in black ink on the body.
Slovenian: Trde kapsule imajo belo neprosojno telo s črnim natisnjenim napisom »T 250 mg« in belo neprosojno kapico z dvema črnima natisnjenima progama.
English: - as you may have a small risk of other changes in blood cells, including leukaemia.
Slovenian: - ker morda obstaja majhno tveganje za druge spremembe krvnih celic, vključno z levkemijo; - če vam je slabo, vas sili na bruhanje ali bruhate, kar so zelo pogosti neželeni učinki zdravila
English: The hard capsules have a white opaque body and cap with two stripes in orange ink on the cap and with “T 20 mg” in orange ink on the body.
Slovenian: Trde kapsule imajo belo neprosojno telo z oranžnim natisnjenim napisom »T 20 mg« in belo neprosojno kapico z dvema oranžnima natisnjenima progama.
English: Psychiatric disorders Common:
Slovenian: Žilne bolezni Pogosti:
English: Excipient with known effect Each hard capsule contains 150 mg of lactose.
Slovenian: Ena trda kapsula vsebuje 150 mg laktoze.
English: Very common (may affect more than 1 in 10 people): reduced number of blood cells (neutropenia or lymphopenia, thrombocytopenia), loss of appetite, headache, vomiting, nausea (feeling sick in your stomach), constipation (difficulty passing stools).
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): okužbe v ustih, okužba rane, zmanjšano število krvnih celic (nevtropenija, trombocitopenija, limfopenija, levkopenija), povišana raven sladkorja v krvi, zmanjšanje telesne mase, spremembe duševnega stanja ali zbranosti, anksioznost oziroma depresija, zaspanost, težave pri govoru, poslabšano ravnotežje, omotica, zmedenost,
English: Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97007-0
Slovenian: Österreich ratiopharm Arzneimittel Vertriebs-GmbH
English: The hard capsules have a white opaque body and cap with two stripes in green ink on the cap and with “T 5 mg” in green ink on the body.
Slovenian: Trde kapsule imajo belo neprosojno telo z zelenim natisnjenim napisom »T 5 mg« in belo neprosojno kapico z dvema zelenima natisnjenima progama.
English: TMZ is to be discontinued if: dose level -1 (100 mg/m²) still results in unacceptable toxicity the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
Slovenian: Uporabo TMZ je treba opustiti: če toksičnost pri ravni odmerka -1 (100 mg/m²) še vedno ni sprejemljiva,
English: Temozolomide Teva contains lactose
Slovenian: Zdravilo Temozolomide Teva vsebuje laktozo
English: Titanium dioxide (E171) Yellow iron oxide (E172) Indigo carmine (E132) aluminium lake
Slovenian: Črnilo šelak, propilenglikol, titanov dioksid (E171), rumeni železov oksid (E172), indigotin (E132).
English: After oral administration to adult patients, TMZ is absorbed rapidly, with peak concentrations reached as early as 20 minutes post-administration (mean time between 0.5 and 1.5 hours).
Slovenian: 20 minut po vnosu (srednji čas med 0,5 in 1,5 ure).
English: Each hard capsule contains 100 mg temozolomide
Slovenian: Ena trda kapsula vsebuje 100 mg temozolomida.
English: The hard capsules have a white body and cap with two stripes in blue ink on the cap and with “T 140 mg” in blue ink on the body.
Slovenian: Trde kapsule imajo belo telo z modrim natisnjenim napisom »T 140 mg« in belo kapico z dvema modrima natisnjenima progama.
English: The hard capsules have a white opaque body and cap with two stripes in red ink on the cap and with “T 180 mg” in red ink on the body.
Slovenian: Trde kapsule imajo belo neprosojno telo z rdečim natisnjenim napisom »T 180 mg« in belo neprosojno kapico z dvema rdečima natisnjenima progama.
English: Allergic reaction, fever, radiation injury, face oedema, pain, taste perversion
Slovenian: poškodba zaradi obsevanja, edem obraza, bolečina, spremenjeno okušanje alergijska reakcija, vročina,
English: Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14% of the patients who received TMZ.
Slovenian: Nepravilnosti trombocitov stopnje 3 ali 4, vključno s trombocitopeničnimi dogodki, so opazili pri
English: Temozolomide Teva 140 mg hard capsules: (including printing ink): gelatin, titanium dioxide (E171), shellac, propylene glycol, Indigo carmine (E132) aluminium lake Temozolomide Teva 180 mg hard capsules: (including printing ink): gelatin, titanium dioxide (E171), shellac, propylene glycol, red iron oxide (E172)
Slovenian: Temozolomide Teva 100 mg trde kapsule: (vključno s tiskarskim črnilom): želatina, titanov dioksid (E171), rdeči železov oksid (E172), šelak, propilenglikol in rumeni železov oksid (E172).
English: Propylene glycol
Slovenian: Črnilo šelak, propilenglikol,
English: Shellac
Slovenian: dizurija
English: The Temozolomide Teva dose may be delayed or stopped, depending on your blood counts and how you tolerate your medicine during the concomitant phase.
Slovenian: To bo odvisno od vaše krvne slike in od tega, kako dobro boste prenašali zdravilo v obdobju sočasnega zdravljenja.
English: CTC Non-haematological toxicity (except for alopecia, nausea, vomiting)
Slovenian: če se po zmanjšanju odmerka ponovi ista stopnja 3 nehematološke toksičnosti (razen za alopecijo, navzejo, bruhanje).
English: EU/1/09/606/007 5 capsules EU/1/09/606/008 20 capsules
Slovenian: EU/1/09/606/007 5 kapsul EU/1/09/606/008 20 kapsul
English: EU/1/09/606/003 5 capsules EU/1/09/606/004 20 capsules
Slovenian: EU/1/09/606/003 5 kapsul EU/1/09/606/004 20 kapsul
English: EU/1/09/606/009 5 capsules EU/1/09/606/010 20 capsules
Slovenian: EU/1/09/606/009 5 kapsul EU/1/09/606/010 20 kapsul
English: Temozolomide Teva 250 mg two stripes in black ink on the cap and “T 250 mg” in black ink on the body
Slovenian: Temozolomide Teva 250 mg dve črni progi na kapici in črn napis
English: The hard capsules have a white opaque body and cap with two stripes in pink ink on the cap and with “T 100 mg” in pink ink on the body.
Slovenian: Trde kapsule imajo belo neprosojno telo z rožnatim natisnjenim napisom »T 100 mg« in belo neprosojno kapico z dvema rožnatima natisnjenima progama.
English: absent or heavy menstrual periods, vaginal irritation, breast pain, hot flushes, shivering, discolouration of your tongue, change in your sense of smell, thirst, tooth disorder.
Slovenian: drgetanje, sprememba barve jezika, sprememba zaznave vonja, žeja, težave z zobmi.
English: EU/1/09/606/005 5 capsules EU/1/09/606/006 20 capsules
Slovenian: EU/1/09/606/005 5 kapsul EU/1/09/606/006 20 kapsul
English: EU/1/09/606/001 5 capsules EU/1/09/606/002 20 capsules
Slovenian: EU/1/09/606/001 5 kapsul EU/1/09/606/002 20 kapsul
English: You should stop breast-feeding while receiving treatment with Temozolomide Teva.
Slovenian: Ko se zdravite z zdravilom Temozolomide Teva, morate prenehati dojiti.
English: Uncommon (may affect up to 1 in 100 people): reduced number of blood cell counts (pancytopenia, anaemia, leukopenia).
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): zmanjšano število krvnih celic
English: Temozolomide Teva 5 mg hard capsules: (including printing ink): gelatin, titanium dioxide (E171), shellac, propylene glycol, Indigo carmine (E132) aluminium lake, yellow iron oxide (E172) Temozolomide Teva 20 mg hard capsules: (including printing ink): gelatine, titanium dioxide (E171), shellac, propylene glycol, Sunset yellow FCF Aluminium Lake (E110) Temozolomide Teva 100 mg hard capsules: (including printing ink): gelatin, titanium dioxide (E171), red iron oxide (E172), shellac, propylene glycol and yellow iron oxide (E172).
Slovenian: o ovoj kapsul: Temozolomide Teva 5 mg trde kapsule: (vključno s tiskarskim črnilom): želatina, titanov dioksid (E171), šelak, propilenglikol, indigotin (E132), rumeni železov oksid (E172).
English: Febrile neutropenia, anaemia
Slovenian: febrilna nevtropenija, anemija limfopenija, petehije
English: Talk to your doctor, pharmacist or nurse before taking Temozolomide Teva.
Slovenian: Pred začetkom jemanja zdravila Temozolomide Teva se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: Dysuria
Slovenian: Dojenje
English: condition aggravated, rigors, tongue discolouration, parosmia, thirst
Slovenian: poslabšanje zdravstvenega stanja, rigor, sprememba barve jezika, parozmija, žeja astenija, edem obraza, bolečina,
English: EU/2/00/018/001 Incurin 1 mg Tablet
Slovenian: EU/2/00/018/001 Incurin
English: EU Number Name Strength Pharmaceutical form
Slovenian: Izmišljeno ime Jakost Farmacevtska oblika
English: 30 tablets
Slovenian: 30 tabletami Zloženka z 1 pretisnim omotom
English: Package size Withdrawal period
Slovenian: Ovojnina Vsebina Velikost pakiranja
English: Blister
Slovenian: Karenca
English: Content
Slovenian: EU številka
English: Oral use
Slovenian: Način uporabe zdravila
English: Box containing 1 blister
Slovenian: 1 mg tableta psi peroralno pretisni
English: 10 U 10 ml (1 U/ml)
Slovenian: 10 enot 10 ml (1 enota/ml)
English: EU Number Invented name Strength Pharmaceutical form Route of administration Packaging
Slovenian: Številka EU Zaščiteno ime Jakost Farmacevtska oblika Pot uporabe
English: 2 prefilled syringes 2 reconstitution devices and 2 needles 19 G l
Slovenian: 2 viali 2 napolnjeni injekcijski brizgi 2 pripomočka za rekonstitucijo in 2 igli 19 G 1
English: Powder: vial (glass) Solvent: prefilled syringe (glass)
Slovenian: Intravenska uporaba Prašek: viala (steklo) Vehikel: napolnjena injekcijska brizga (steklo)
English: 10 U Powder and solvent for solution for injection
Slovenian: 10 enot prašek in vehikel za raztopino za injiciranje
English: Hungary Teva Gyógyszergyár Zrt.
Slovenian: Teva Gyógyszergyár Zrt.
English: Luxembourg Qualiphar Laboratoire Rijksweg 9
Slovenian: Luksemburg Qualiphar Laboratoire Rijksweg 9
English: Hungary Pharma-Regist Kft., Október 6. u. 7.
Slovenian: Pharma-Regist Kft., Október 6. u. 7.
English: Belgium Laboratoria Qualiphar N.V/S.A
Slovenian: Laboratoria Qualiphar N.V/S.A
English: 1-10 Constantinoupoleos Street, 3011, P.O.
Slovenian: 1-10 Constantinoupoleos Street, 3011, P.O. Box
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Slovenian: Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, predlagateljev, imetnikov dovoljenja za promet z zdravilom v državah članicah
English: Hungary Meditop Gyógyszeripari Kft. Ady Endre u. 1
Slovenian: Meditop Gyógyszeripari Kft. Ady Endre u. 1
English: Hungary PannonPharma Kft. Pannonpharma út 1.
Slovenian: PannonPharma Kft. Pannonpharma út 1.
English: Romania MAGISTRA C & C, Bd. Aurel Vlaicu nr. 82A, 900055
Slovenian: MAGISTRA C & C, Bd. Aurel Vlaicu nr. 82A, 900055
English: Luxembourg Biocodex Avenue Gallieni 7
Slovenian: Luksemburg Biocodex Avenue Gallieni 7
English: Slovenia KRKA, d.d., Novo mesto Šmarješka cesta 6
Slovenian: KRKA, d.d., Novo mesto Šmarješka cesta 6
English: Luxembourg D.J.VAN TINTELEN BEHEER B.V.
Slovenian: Luksemburg D.J.VAN TINTELEN BEHEER B.V.
English: Romania VIM SPECTRUM SRL, ROMANIA
Slovenian: VIM SPECTRUM SRL, ROMANIA
English: Romania BIO EEL SRL, str. Bega nr. 4, Targu-Mures,
Slovenian: BIO EEL SRL, str. Bega nr. 4, Targu-Mures,
English: Germany Hexal Aktiengesellschaft Industriestr.25
Slovenian: Hexal Aktiengesellschaft Industriestr.25