FrancophonIA/ELRC3.0 huggingface dataset:
English: A risk management plan has been developed to ensure that Sutent is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Sutent je bil pripravljen načrt obvladovanja tveganj.
English: Sutent is used to treat adults with the following types of cancer:
Slovenian: Zdravilo Sutent se uporablja za zdravljenje odraslih z naslednjimi vrstami raka:
English: For more information about treatment with Sutent, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Sutent preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The CHMP decided that Sutent's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Sutent večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: The main measure of effectiveness in all of the studies was how long the patients lived without their tumours getting worse.
Slovenian: V vseh študijah je bilo glavno merilo učinkovitosti čas, v katerem se stanje bolnikovih tumorjev ni poslabšalo.
English: Sutent is used if the disease is getting worse and the tumour cells are well-differentiated (similar to normal cells in the pancreas).
Slovenian: Zdravilo Sutent se uporablja, kadar se bolezensko stanje poslabšuje in so tumorske celice dobro diferencirane (podobne normalnim celicam trebušne slinavke).
English: What is the risk associated with Sutent?
Slovenian: Kakšna tveganja so povezana z zdravilom Sutent?
English: Sutent was originally given ‘conditional approval' because there was more evidence to come about the medicine, in particular in the treatment of renal cell carcinoma.
Slovenian: Zdravilo Sutent je prvotno pridobilo „pogojno dovoljenje za promet“, ker so pričakovali še več dokazov o zdravilu, zlasti o njegovi uporabi pri zdravljenju karcinoma ledvičnih celic.
English: It is used after treatment with imatinib (another cancer medicine) has failed;
Slovenian: Uporablja se po neuspelem zdravljenju z imatinibom (drugim zdravilom za zdravljenje raka);
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Sutent, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: For the full list of all side effects and restrictions with Sutent, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Sutent glejte navodilo za uporabo.
English: Sutent is a medicine that contains the active substance sunitinib.
Slovenian: Sutent je zdravilo, ki vsebuje zdravilno učinkovino sunitinib.
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 Sutent.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The active substance in Sutent, sunitinib, is a protein kinase inhibitor.
Slovenian: Zdravilna učinkovina v zdravilu Sutent, sunitinib, je zaviralec proteinske kinaze.
English: Sutent is used in patients with GISTs that cannot be removed with surgery or have spread to other parts of the body.
Slovenian: Zdravilo Sutent se uporablja pri bolnikih z gastrointestinalnim stromalnim tumorjem, ki ga ni mogoče odstraniti s kirurškim posegom ali pa se je ta razširil v druge dele telesa.
English: Why has Sutent been approved?
Slovenian: Zakaj je bilo zdravilo Sutent odobreno?
English: • metastatic renal cell carcinoma, a type of kidney cancer, that has spread to other parts of the body;
Slovenian: • metastatskega karcinoma ledvičnih celic, tj. vrste ledvičnega raka, ki se je razširil v druge dele telesa;
English: Sutent was also compared with another cancer medicine, interferon alfa, in 750 patients with metastatic renal cell carcinoma whose cancer had not been treated before.
Slovenian: Zdravilo Sutent so primerjali tudi z drugim zdravilom za zdravljenje raka, interferonom alfa, pri 750 bolnikih z metastatskim karcinomom ledvičnih celic, pri katerih zdravljenje raka še ni bilo izvedeno.
English: These enzymes can be found in some receptors at the surface of cancer cells, where they are involved in the growth and spread of cancer cells and in the blood vessels that supply the tumours, where they are involved in the development of new blood vessels.
Slovenian: Ti encimi se nahajajo na nekaterih receptorjih na površini rakavih celic, kjer sodelujejo pri rasti in širjenju rakavih celic, ter v krvnih žilah, ki oskrbujejo tumor in kjer sodelujejo pri nastanku novih krvnih žil.
English: By blocking these enzymes, Sutent can reduce the growth and spread of the cancer and cut off the blood supply that keeps cancer cells growing.
Slovenian: Zdravilo Sutent lahko z zaviranjem teh encimov zavre rast in širjenje raka ter prekine dotok krvi, ki omogoča rast rakavih celic.
English: For GIST and metastatic renal cell carcinoma, Sutent is given in six-week cycles, at a dose of 50 mg once a day for four weeks, followed by a two-week ‘rest period'.
Slovenian: Pri gastrointestinalnem stromalnem tumorju in metastatskem karcinomu ledvičnih celic se zdravilo Sutent daje v šesttedenskih ciklih, in sicer štiri tedne v odmerku 50 mg enkrat dnevno, čemur sledi dvotedenski premor.
English: Treatment with Sutent should be started by doctors who have experience in administering cancer medicines.
Slovenian: Zdravljenje z zdravilom Sutent lahko uvede samo zdravnik, ki ima izkušnje z dajanjem zdravil za zdravljenje raka.
English: • gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel where there is uncontrolled growth of cells in the supporting tissues of these organs.
Slovenian: • gastrointestinalnega stromalnega tumorja (GIST), tj. vrste raka želodca in črevesja, pri katerem celice v opornem tkivu teh organov nenadzorovano rastejo.
English: Sutent was compared with placebo (a dummy treatment) in 312 patients with GIST whose previous treatment with imatinib had failed and in 171 patients with worsening pancreatic neuroendocrine tumours that could not be removed with surgery.
Slovenian: Zdravilo Sutent so primerjali s placebom (zdravilom brez zdravilne učinkovine) pri 312 bolnikih z gastrointestinalnim stromalnim tumorjem, pri katerih je bilo predhodno zdravljenje z imatinibom neuspešno, in pri 171 bolnikih z nevroendokrinim tumorjem trebušne slinavke, ki se slabša in ki ga ni bilo mogoče odstraniti s kirurškim posegom.
English: The most common side effects with Sutent (seen in more than 1 in 10 patients) include fatigue (tiredness), gastrointestinal disorders (such as diarrhoea, feeling sick, inflammation of the lining of the mouth, indigestion and vomiting), respiratory (such as shortness of breath and cough) and skin disorders (such as skin discoloration, dryness of the skin and rash), hair color changes, dysgeusia (taste disturbances), epistaxis (nosebleeds), loss of appetite, hypertension (high blood pressure), palmar-plantar erythrodysaesthesia syndrome (rash and numbness on the palms and soles), hypothyroidism (an underactive thyroid gland), insomnia (difficulty falling and staying asleep), dizziness, headache, arthralgia (joint pain), neutropenia (low levels of neutrophils, a type of white blood cell), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), and leucopenia (low white blood cell counts).
Slovenian: pomanjkanje teka, epistaksa (krvavitve iz nosu), izguba teka, hipertenzija (visok krvni tlak), sindrom palmarno-plantarne eritrodisestezije (izpuščaji in odrevenelost na dlaneh in stopalih), hipotiroidizem (nezadostno delovanje ščitnice), nespečnost (težave z uspavanjem in zbujanje), omotica, glavobol, artralgija (bolečine v sklepih), nevtropenija (nizka raven nevtrofilcev, vrste belih krvničk), trombocitopenija (nizka raven trombocitov v krvi), anemija (nizka raven rdečih krvničk) in levkopenija (nizka raven belih krvničk).
English: The most serious side effects reported with Sutent include heart and kidney failure, pulmonary embolism (clot in a blood vessel supplying the lungs), gastrointestinal perforation (holes in the wall of the gut), and internal haemorrhages (bleeding).
Slovenian: Najresnejši neželeni učinki, o katerih so poročali pri zdravilu Sutent, so srčno in ledvično popuščanje, pljučna embolija (strdki v krvnih žilah, ki oskrbujejo pljuča), gastrointestinalne perforacije (luknje v črevesju) in notranje krvavitve.
English: • pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas) that have spread or cannot be removed with surgery.
Slovenian: • nevroendokrinega tumorja trebušne slinavke (tumorja celic trebušne slinavke, ki proizvajajo hormone), ki se je razširil ali pa ga ni mogoče odstraniti s kirurškim posegom.
English: Sutent was more effective than placebo in treating GIST and pancreatic neuroendocrine tumours.
Slovenian: Zdravilo Sutent je bilo pri zdravljenju gastrointestinalnega stromalnega tumorja in nevroendokrinega tumorja trebušne slinavke učinkovitejše od placeba.
English: In metastatic renal cell carcinoma, patients taking Sutent lived for an average of 47.3 weeks without their disease worsening, compared with 22.0 weeks in the patients receiving interferon alfa.
Slovenian: Pri bolnikih z metastatskim karcinomom ledvičnih celic, ki so prejemali zdravilo Sutent, je bilo obdobje brez poslabšanja bolezni v povprečju dolgo 47,3 tedna, pri bolnikih, ki so prejemali interferon alfa, pa 22,0 tedna.
English: Patients with GIST taking Sutent lived for an average of 26.6 weeks without the disease getting worse, compared with 6.4 weeks in the patients taking placebo.
Slovenian: Pri bolnikih z gastrointestinalnim stromalnim tumorjem, ki so prejemali zdravilo Sutent, se bolezen ni poslabšala v povprečju 26,6 tedna, pri bolnikih, ki so prejemali placebo, pa 6,4 tedna.
English: What is Sutent used for?
Slovenian: Za kaj se zdravilo Sutent uporablja?
English: How has Sutent been studied?
Slovenian: Kako je bilo zdravilo Sutent raziskano?
English: For pancreatic neuroendocrine tumours the figures were 11.4 months in the Sutent group and 5.5 months in the placebo group.
Slovenian: Pri bolnikih z nevroendokrinim tumorjem trebušne slinavke, ki so prejemali zdravilo Sutent, je bilo to obdobje dolgo 11,4 meseca, pri tistih, ki so prejemali placebo, pa 5,5 meseca.
English: How is Sutent used?
Slovenian: Kako se zdravilo Sutent uporablja?
English: The dose can be adjusted according to the patient's response to the treatment, but should be kept within the range of 25 to 75 mg. For pancreatic neuroendocrine tumours, Sutent is given at a dose of 37.5 mg once a day without a rest period.
Slovenian: Pri nevroendokrinem tumorju trebušne slinavke se zdravilo Sutent daje v odmerku 37,5 mg enkrat na dan brez obdobja premora.
English: (Invented) name Strength Pharmaceutical Form
Slovenian: Jakost Farmacevtska oblika Pot uporabe
English: 83607 Holzkirchen Germany
Slovenian: 25, 83607 Holzkirchen Nemčija
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SANOHEX AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA SANOHEX IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: The CHMP did not agree that this amount of drug is too small to be relevant and could furthermore not support the Applicant claim that stage 1 is related only to safety.
Slovenian: Odbor CHMP se ni strinjal s tem, da je količina zdravila premajhna, dabi veljala kot pomembna, poleg tega pa ni mogel podpreti trditve predlagatelja, da je 1. stopnja povezana samo z varnostjo.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
Slovenian: DODATEK I ZOZNAM NÁZVOV, FARMACEUTICKÝCH FORIEM, MNOŽSTVÁ ÚČINNÝCH LÁTOK V LIEKOCH, SPÔSOB PODÁVANIA, UCHÁDZAČI, V ČLENSKÝCH ŠTÁTOCH
English: Inhalation use
Slovenian: Za inhaliranje
English: The marketing applications were submitted as hybrid applications under Article 10(3) of Directive 2001/83/EC and the EU reference product is Sultanol Dosier-Aerosol 100 μg/dose, Druckgasinhalation, suspension, (GlaxoSmithKline).
Slovenian: Vloge za dovoljenje za promet z zdravilom so bile predložene v obliki hibridnih vlog v skladu s členom 10(3) Direktive 2001/83/ES, referenčno zdravilo v EU pa je Sultanol Dosier-Aerosol 100 μg/odmerek, inhalacijska raztopina pod tlakom, suspenzija, (GlaxoSmithKline).
English: The Applicant also decided to generate additional spacer data in order to obtain more reliable information on the particle size distribution when the compared inhalers are fitted with their respective spacer devices.
Slovenian: Predlagatelj se je odločil tudi za pridobivanje dodatnih podatkov o podaljšku, da bi pridobil zanesljivejše informacije o porazdelitvi velikosti delcev, kadar so primerjani inhalatorji opremljeni s pripadajočimi podaljševalnimi pripomočki.
English: The CHMP was of the opinion that the bioequivalence study (2207-59-DOS-5) demonstrated equivalency in safety profile when used without a spacer, as well as similar Cmax and Tmax values.
Slovenian: Odbor CHMP je menil, da je študija biološke enakovrednosti (2207-59-DOS-5) dokazala enakovrednost varnostnega profila pri uporabi brez podaljška ter podobne vrednosti Cmax in Tmax.
English: the CHMP has recommended the granting of the Marketing Authorisations for which the valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure are set out in Annex III for Sanohex and associated names (see Annex I).
Slovenian: je CHMP priporočil odobritev dovoljenj za promet z zdravilom, katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so končne različice, oblikovane med postopkom usklajevalne skupine in navedene v Dodatku III za zdravilo Sanohex in z njim povezana imena (glejte Dodatek I).
English: The new formal protocol of the performed retrospective analysis and the new final report on the in vitro data indicated that the 90% CI remained outside the 15% or 20% acceptance range for stage 0, stage 1 and stage 2 and within the 20% CI but outside the 15% CI for stage 3 the 90% CI.
Slovenian: Novi formalni protokol izvedene retrospektivne analize in novo končno poročilo o in vitro podatkih sta pokazala, da je 90-odstotni interval zaupanja ostal zunaj 15- ali 20-odstotnega razpona sprejemljivosti za 0., 1. in 2. stopnjo in znotraj 20odstotnega intervala zaupanja, vendar zunaj 15-odstotnega intervala zaupanja za 3. stopnjo 90
English: Sanohex is a metered dose aerosol inhaler containing a suspension formulation of salbutamol sulphate 100 µg/spray, with HFA 134a as propellant.
Slovenian: Zdravilo Sanohex je aerosolni inhalator z določenim odmerkom, ki vsebuje formulacijo suspenzije salbutamol sulfata 100 µg/pršilo s hidrofluoroalkanom 134a kot pogonskim plinom.
English: - the CHMP considered that Sanohex and the reference product possess the same systemic safety profile, as demonstrated by the bioequivalence in systemic levels (AUC and Cmax),
Slovenian: - CHMP je menil, da imata zdravilo Sanohex in referenčno zdravilo enak profil sistemske varnosti, kot je bilo dokazano z biološko enakovrednostjo na sistemskih ravneh (AUC in Cmax),
English: The pharmacokinetic bioequivalence data also confirmed that Sanohex and the reference product possess the same systemic safety profile since bioequivalence in systemic levels (AUC and Cmax) have been shown, when used with or without a spacer.
Slovenian: Farmakokinetični podatki o biološki enakovrednosti so prav tako potrdili, da imata zdravilo Sanohex in referenčno zdravilo, ob uporabi podaljška ali brez njega, enak profil sistemske varnosti, saj je bila dokazana biološka enakovrednost na sistemskih ravneh (AUC in Cmax).
English: Member State EU/EEA
Slovenian: Država članica
English: Pressurised inhalation, suspension
Slovenian: 100 µg/odmerek Inhalacijska suspenzija pod tlakom
English: County Mayo Ireland
Slovenian: County Mayo Irland
English: 164 94 Kista
Slovenian: 164 94 Kista Sweden
English: Hungary Baxter Hungary Kft. Népfürdő u. 22.
Slovenian: Madžarska Baxter Hungary Kft. Népfürdö u. 22.
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, predlagateljev, imetnikov dovoljenja za promet z zdravilom v državah članicah
English: Sweden Baxter Medical AB Box 63
Slovenian: Baxter Medical AB Box 63
English: Avenue louis Pasteur ZA de Coignières Maurepas 78310 Maurepas France
Slovenian: Avenue louis Pasteur 78310 ZA de Coignieres 78310 Maurepas France
English: Germany Baxter Deutschland GmbH Edisonstr.
Slovenian: Baxter Deutschland GmbH Edisonstr.
English: Romania BAXTER d.o.o.
Slovenian: Romunija BAXTER d.o.o.
English: Kifissias Avenue 368, Halandri, 152 33 Greece
Slovenian: Diophar SA Kifissias 368 Halandri 15233 Greece
English: 11 g/l amino acids and 1,25 mmol/l Ca.
Slovenian: 11 g/l aminokisline and 1,25 mmol/l Ca.
English: Baxter SPA piazzale dell' industria 20 - 00144 Roma, Italy
Slovenian: Piazzale dell'Industria 20 00144 Roma Italy
English: Belgium Baxter SA Boulevard R. Branquart 80 7680 Lessines Belgium
Slovenian: Boulevard R. Branquart 80 7680 Lessines Belgium
English: Denmark Baxter A/S, Gydevang 43, DK-3450 Allerød
Slovenian: Baxter A/S, Gydevang 43, DK-3450 Allerød Denmark
English: Luxembourg Baxter SA, Bd René Branquart 80, B-7860 Lessines Belgium
Slovenian: Luksemburg Baxter S.A. Bd René Branquart 80 B-7860 Lessines Belgium
English: L-Tyrosine Ph.Eur.
Slovenian: L-Tirozin Ph.Eur.
English: Sodium Hydroxide 52.25 g Water for Injections to 100 ml
Slovenian: Laktična kislina 139 g Natrijev hidroksid 52.25 g Voda za injekcije do 100 ml
English: Norfolk IP24 3SE United Kingdom
Slovenian: Thetford IP24 3SE United Kingdom
English: 4.480 g, Sodium chloride Ph. Eur.
Slovenian: 4.480 g, Natrijev klorid Ph. Eur.
English: Baxter MédicoFarmacêutica, Lda.
Slovenian: Portugalska Baxter Médico Farmacêutica Lda
English: Nutrineal PD4 met 11 g/l aminozuren en Ca 1,25 mmol/l, peritoneaaldialysevloeistof
Slovenian: Nutrineal PD4 met 11 g/l aminozuren en Ca 1,25 mmol/l, peritoneaaldialysevloeis tof
English: Baxter AS Gjerdrumsvei 11 0484 Oslo Norway
Slovenian: 0484 Oslo, Norway
English: Zelezna cesta 14, SI-1000 Ljubljana
Slovenian: Zelezna cesta 14, SI-1000 Ljubljana, Slovenia
English: 7,5% (icodextrin)
Slovenian: 7,5% (ikodekstrin)
English: Zona Industrial da Abrunheira - Edifício 10Sintra Business Park, 2710-089 Sintra Portugal
Slovenian: Edificio 10 Sintra Business Park,
English: 0.54 % w/v, Sodium (S)-lactate 0.45 % w/v, Calcium Chloride Ph. Eur.
Slovenian: 0.54 % w/v, Natrijev (S)-laktat 0.45 % w/v, Kalcijev klorid Ph. Eur.
English: 0.714 g L-Arginine Ph.Eur.
Slovenian: 0.714 g L-Arginin Ph.Eur.
English: 0.0257 % w/v, Magnesium Chloride Ph. Eur.
Slovenian: 0.0257 % w/v, Magnezijev klorid Ph. Eur.
English: Natriumklorid Baxter 9 mg/ml solution for infusion intravenous use
Slovenian: Natriumklorid Baxter 9 mg/ml
English: solution for haemodialysis, haemodiafiltration and haemofiltration intraarterial use, intravenous use, hemodialysis
Slovenian: Raztopina za hemodilaizo, hemodiafiltracijo in hemofiltracijo za intraarterijsko uporabo, za intravenozno uporabo, hemodializa
English: 1.071 g, Calcium chloride dihydrate Ph.Eur.
Slovenian: 1.071 g, Kalcijev klorid dihidrat Ph.Eur.
English: Anhydrous Glucose Ph.Eur.
Slovenian: Brezvodna glukoza Ph.Eur.
English: Box 270 Valimotie 15A 00381
Slovenian: Baxter Oy P.O. Box 270 Valimotie 15A 00381 Helsinki Finland
English: Netherlands Baxter B.V., Kobaltweg 49, 3542 CE Utrecht
Slovenian: Nizozemska Baxter B.V Kobaltweg 49
English: 75.00 g/l Icodextrine
Slovenian: 75.00 g/l Ikodekstrin
English: 0.646 g, L-Serine Ph.Eur.
Slovenian: 0.646 g, L-Serin Ph.Eur.
English: 0.184 g, Magnesium chloride hexahydrate Ph.Eur.
Slovenian: 0.184 g, Magnezijev klorid heksahidrat Ph.Eur.
English: Extraneal (Icodextrin 7.5%) Solution for peritoneal dialysis icodextrin 75g/l; sodium chloride 5.4g/l; calcium chloride 0,257g/l; magnesium chloride 0.051g/l; sodium s-lactate 4.5g/l
Slovenian: Extraneal (lcodextrin 7.5%) Solution for peritoneal dialysis ikodekstrin 75g/l; natrijev klorid 5.4g/l; kalcijev klorid 0,257g/l; magnezijev klorid 0.051g/l; natrijev-s-laktat 4.5g/l
English: Thetford,
Slovenian: Abrunheira,
English: 0.951 g, L-Valine Ph.Eur.
Slovenian: 0.951 g, L-Valin Ph.Eur.
English: 7,5 % 75 g / 1000 ml peritoneal use
Slovenian: 7,5 % 75g/1000 ml
English: 75 g/l icodextrine
Slovenian: 75 g/l ikodekstrin
English: 0.850 g, L-Leucine Ph.Eur.
Slovenian: 0.850 g, L-Leucin Ph.Eur.
English: Icodextrin 7.5 % w/v, Sodium Chloride Ph.
Slovenian: Ikodekstrin 7.5 % w/v, Natrijev klorid Ph. Eur.
English: Baxter Healthcare S.A. Moneen Road Castlebar
Slovenian: Baxter Healthcare SA Moneen Road Castlebar
English: 0.955 g, LHistidine Ph.Eur.
Slovenian: 0.955 g, LHistidin Ph.Eur.
English: Slovenia Baxter d.o.o., Zelezna cesta 18 , Ljubljana, SI-1000, Slovenia
Slovenian: Slovenija Baxter d.o.o., Zelezna cesta 18 ,Ljubljana, SI-1000, Slovenia
English: 0.448 % w/v Calcium Chloride Ph.Eur.
Slovenian: 0.448 % w/v Kalcijev klorid Ph.Eur.
English: 0.39 % w/v Calcium Chloride Ph.Eur.
Slovenian: 0.39 % w/v Kalcijev klorid Ph.Eur.
English: 1.020 g, LLysine hydrochloride Ph.Eur.
Slovenian: 1.020 g, L-lizin hidroklorid Ph.Eur.
English: 0.510 g, L-Proline Ph.Eur.
Slovenian: 0.510 g, L-Prolin Ph.Eur.
English: 0.850 g, L-Isoleucine Ph.Eur.
Slovenian: 0.850 g, L-Izoleucin Ph.Eur.
English: Nutrineal PD4 with 1.1% Amino Acids tyrosine 0.03%w/v; tryptophan 0.027%w/v; phenylalanine 0.057%w/v; threonine 0.064%w/v; L-serine 0.051%w/v; L-proline 0.058%w/v; glycine 0.051%w/v; L-alanine 0.095%w/v; valine 0.139%w/v; methionine 0.085%w/v; isoleucine 0.085%w/v; leucine 0.102%w/v; lysine 0.095%w/v; histidine 0/071%w/v; arginine 0.107%w/v; calcium chloride 0.018%w/v; magnesium chloride 0.005%w/v; sodium chloride 0.538%w/v; sodium s-lactate 0.448%w/v
Slovenian: Nutrineal PD4 with 1.1% Amino Acids tyrosin 0.03%w/v; triptofan 0.027%w/v; fenilalanin 0.057%w/v; treonin 0.064%w/v; L-serin 0.051%w/v; L-prolin 0.058%w/v; glicin 0.051%w/v; L-alanin 0.095%w/v; valin 0.139%w/v; metionin 0.085%w/v; izolevcin 0.085%w/v; levcin 0.102%w/v; lizin 0.095%w/v; histidin 0/071%w/v; arginin 0.107%w/v; kalcijev klorid 0.018%w/v; magnezijev klorid 0.005%w/v; natrijev klorid 0.538%w/v; natrijev-s-laktat 0.448%w/v
English: 3.86 % w/v or Glucose Monohydrate Ph.Eur.
Slovenian: 3.86 % w/v ali glukoza monohidrat Ph.Eur.
English: 0.538 % w/v Sodium Lactate Ph.Eur.
Slovenian: 0.538 % w/v Natrijev laktat Ph.Eur.
English: 2.27 % w/v or Glucose Monohydrate Ph.Eur.
Slovenian: 2.27 % w/v ali glukoza monohidrat Ph.Eur.
English: 0.595 g, Glycine Ph.Eur.
Slovenian: 0.595 g, Glicin Ph.Eur.
English: 22,7 g/l glucose anhydrate
Slovenian: 22.7 g/l Brezvodna glukoza
English: 0.270 g, L-Phenylalanine Ph.Eur.
Slovenian: 0.270 g, LFenilalanin Ph.Eur.
English: Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland
Slovenian: Baxter Healthcare S.A. Moneen Road Castlebar, CO. Mayo lreland
English: 1.36 % w/v or Glucose Monohydrate Ph.Eur.
Slovenian: 1.36 % w/v ali glukoza monohidrat Ph.Eur.
English: 0.051 g, Sodium-lactate Ph.Eur.
Slovenian: 0.051 g, Natrijev laktat Ph.Eur.