FrancophonIA/ELRC3.0 huggingface dataset:
English: Very common: Alopecia, rash Common: Nail disorder, pruritus, dry skin, erythema, nail pigmentation/discolouration, skin hyperpigmentation, onycholysis, nail changes
Slovenian: Pogosti: motnje nohtov, srbenje, suha koža, eritem, obarvanje/razbarvanje nohtov, hiperpigmentacija kože, oniholiza, spremembe nohtov
English: Treat with Day 8 dose level and follow with WBC Growth Factors OR Reduce doses 1 dose level from Day 8 doses
Slovenian: Zdravite z ravnijo odmerka 8. dne, nato dajte rastne faktorje belih krvnih celic ALI Zmanjšajte odmerke za eno raven od odmerkov 8. dne
English: Response rate [95% CI] (%) > 1st-line therapy
Slovenian: Stopnja odziva [95-% IZ] (%)
English: Uncommon: Chest discomfort, abnormal gait, swelling, injection site reaction
Slovenian: Občasni: nelagodje v prsnem košu, nenormalna hoja, otekanje, reakcija na mestu vboda
English: • Dry mouth, difficulty in swallowing
Slovenian: • suha usta, oteženo požiranje
English: Non-small cell lung cancer A multicenter, randomized, open-label study was conducted in 1052 chemotherapy-naive patients with Stage IIIb/IV non-small cell lung cancer.
Slovenian: Pri 1.052 bolnikih z nedrobnoceličnim pljučnim rakom stadija IIIb/IV, ki prej še niso prejeli kemoterapije, so opravili multicentrično, randomizirano, odprto študijo.
English: • Decreased blood pressure when standing up, coldness in your hands and feet
Slovenian: • bolečina na mestu tumorja, odmrtje tumorja • znižan krvni tlak v stoječem položaju, mrazenje v dlaneh in stopalih
English: Very common: Nausea, diarrhoea, vomiting, constipation, stomatitis
Slovenian: Zelo pogosti: slabost, driska, bruhanje, zaprtost, stomatitis
English: • Nausea, diarrhoea, constipation, sore mouth, loss of appetite
Slovenian: • slabost, driska, zaprtost, razjede v ustih, izguba teka
English: • Pain in extremities
Slovenian: • bolečine v udih
English: Death or progression, n (%) Median PFS (95% CI) (months) HRA/T (95% CI)
Slovenian: Smrt ali napredovanje bolezni, n (%) Mediana preživetja brez napredovanja bolezni, meseci (95-% IZ)
English: Talk to your doctor or nurse before using Pazenir
Slovenian: Pred začetkom uporabe zdravila Pazenir se posvetujte z zdravnikom ali medicinsko sestro
English: (mg/m2)1
Slovenian: (celice/mm3)
English: Breast cancer
Slovenian: Rak trebušne slinavke
English: Pneumonitis has been reported at a rate of 4% with the use of human serum albumin-paclitaxel nanoparticlesin combination with gemcitabine.
Slovenian: Pnevmonitis se je pojavil pri 4 % bolnikov, kadar so bolniki prejemali paklitaksel, vezan na nanodelce humanega serumskega albumina, skupaj z gemcitabinom.
English: • Pazenir is used together with a medicine called gemcitabine if you have metastatic cancer of the pancreas.
Slovenian: • Če imate metastatskega raka trebušne slinavke (pankreasa), se zdravilo Pazenir uporablja skupaj z zdravilom, ki se imenuje gemcitabin.
English: Uncommon: Dysphagia, flatulence, glossodynia, dry mouth, gingival pain, loose stools, oesophagitis, lower abdominal pain, mouth ulceration, oral pain, rectal haemorrhage
Slovenian: Občasni: disfagija, flatulenca, glosodinija, suha usta, boleče dlesni, mehko blato, ezofagitis, bolečine v spodnjem delu trebuha, ulceracija ust, bolečine v ustih, rektalno krvavenje
English: Confirmed complete or partial overall reponse, n 95% Cl (%)
Slovenian: potrjen popoln ali delen celokupen odziv, n (%) 95-% IZ (%) pA/pT (95,1-% IZ) p-vrednosta
English: Very common: Neutropenia, anaemia, thrombocytopenia Common: Pancytopenia
Slovenian: Zelo pogosti: nevtropenija, anemija, trombocitopenija Pogosti: pancitopenija
English: There was a significant difference in overall response rate in the human serum albumin-paclitaxel nanoparticles/carboplatin arm compared to the control arm in patients with non-small cell lung cancer of squamous histology (N=450, 41% vs. 24%, p<0.001), however this difference did not translate into a difference in PFS or OS.
Slovenian: V skupini s paklitakselom, vezanim na nanodelce humanega serumskega albumina/karboplatinom se je stopnja celokupnega odziva (ORR - Overall Response Rate) značilno razlikovala od kontrolne skupine pri bolnikih z nedrobnoceličnim pljučnim rakom s ploščatocelično histologijo (N = 450, 41 %
English: There were no clinically relevant pharmacokinetic interactions between human serum albumin-paclitaxel nanoparticlesand carboplatin.
Slovenian: Med paklitakselom, vezanim na nanodelce humanega serumskega albumina, in karboplatinom ni bilo klinično pomembnih farmakokinetičnih interakcij.
English: Package leaflet: Information for the user Pazenir 5 mg/ml powder for dispersion for infusion paclitaxel
Slovenian: Navodilo za uporabo Pazenir 5 mg/ml prašek za disperzijo za infundiranje paklitaksel
English: Reduce to next lower dose levela; discontinue treatment if ADR persists
Slovenian: ukinite zdravljenje, če neželeni učinek vztraja
English: • Low levels of potassium in the blood
Slovenian: • znižana koncentracija kalija v krvi
English: Fir st
Slovenian: Ελλάδα
English: Number of deaths (%) Median Overall Survival, months (95% CI) HRA+G/G(95% Cl)a
Slovenian: Celokupno preživetje število smrti, n (%) mediana celokupnega preživetja (95-% IZ) (meseci)
English: • Pain in the breast
Slovenian: • bolečine v trebuhu
English: • Infection in the urinary tract
Slovenian: • okužba sečil
English: Paclitaxel is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Pazenir.
Slovenian: Tako kot pri drugih potencialno toksičnih spojinah je treba tudi z zdravilom Pazenir previdno ravnati.
English: There was a statistically significant improvement in OS for patients treated with human serum albumin-paclitaxel nanoparticles/gemcitabine versus gemcitabine alone, with 1.8 months increase in median OS, 28% overall reduction in risk of death, 59% improvement in 1-year survival, and 125% improvement in 2-year survival rates.
Slovenian: celokupno zmanjšanje tveganja smrti je bilo 28 %, enoletno preživetje se je zvečalo za 59 %, dvoletno preživetje pa za 125 %.
English: Table 3: Dose modifications for other adverse drug reactions in patients with pancreatic adenocarcinoma Adverse Drug Reaction (ADR)
Slovenian: Kratica: ANC = absolutno število nevtrofilcev (ANC=Absolute Neutrophil Count) Preglednica 3: Prilagajanje odmerka pri drugih neželenih učinkih zdravila pri bolnikih z adenokarcinomom trebušne slinavke
English: • Pain in a joint or joints
Slovenian: • bolečine v sklepu ali sklepih
English: In general, the frequency and severity of neurotoxicity was dose-dependent in patients receiving human serum albumin-paclitaxel nanoparticles.
Slovenian: Na splošno je bila pri bolnikih, ki so prejemali paklitaksel, vezan na nanodelce humanega serumskega albumina, pogostnost in resnost nevrotoksičnosti odvisna od odmerka.
English: • Paclitaxel is the part of the medicine that affects the cancer, it works by stopping cancer cells from dividing - this means that they die.
Slovenian: Deluje tako, da prepreči rakavim celicam, da bi se delile - to pomeni, da odmrejo.
English: This multi-centre trial was conducted in patients with metastatic breast cancer, who were treated every 3 weeks with single-agent paclitaxel, either as solvent-based paclitaxel 175 mg/m2 given as a 3-hour infusion with premedication to prevent hypersensitivity (N = 225), or as human serum albuminpaclitaxel nanoparticles 260 mg/m2 given as a 30 minute infusion without premedication (N = 229).
Slovenian: To raziskavo so izvedli v več centrih pri bolnikih z metastatskim rakom dojk, ki so vsake 3 tedne prejemali paklitaksel kot samostojno zdravilo, ali kot paklitaksel na bazi topila v odmerku 175 mg/m2
English: Common: Vertigo Uncommon: Ear pain, tinnitus
Slovenian: Občasni: bolečine v ušesih, tinitus
English: Delay of next cycle due to persistent neutropenia2 (Nadir
Slovenian: ALI odložitev naslednjega cikla zaradi trdovratne nevtropenije2 (najmanjše ANC < 1.500/mm3)
English: However, a subsequent analysis in 981 patients receiving human serum albumin-paclitaxel nanoparticles monotherapy for metastatic breast cancer, of which 15% were ≥ 65 years old and 2% were ≥ 75 years old, showed a higher incidence of epistaxis, diarrhoea, dehydration, fatigue and peripheral oedema in patients ≥ 65 years.
Slovenian: Vendar je poznejša analiza pri 981 bolnikih, ki so prejemali monoterapijo s paklitakselom, vezanim na nanodelce humanega serumskega albumina, za metastatski rak dojk, od katerih je bilo 15 % starih 65 let in več,
English: Patients received a median treatment duration of 3.9 months in the human serum albumin-paclitaxel nanoparticles/gemcitabine arm and 2.8 months in the gemcitabine arm. 32% of patients in the human serum albumin-paclitaxel nanoparticles/gemcitabine arm compared with 15% of patients in the gemcitabine arm received 6 or more months of treatment.
Slovenian: Mediana trajanja zdravljenja v skupini s paklitakselom, vezanim na nanodelce humanega serumskega albumina/gemcitabinom je bila 3,9 meseca, v skupini z gemcitabinom pa 2,8 meseca.
English: There was a statistically significant improvement in PFS for patients treated with human serum albumin-paclitaxel nanoparticles/gemcitabine versus gemcitabine alone, with 1.8 months increase in median PFS.
Slovenian: Pri bolnikih, zdravljenih s paklitakselom, vezanim na nanodelce humanega serumskega albumina/gemcitabinom, v primerjavi s tistimi, ki so se zdravili samo z gemcitabinom, se je preživetje brez napredovanja bolezni statistično značilno izboljšalo, mediano preživetje brez napredovanja bolezni se je podaljšalo za 1,8 meseca.
English: Resume Pazenir at reduced dose when peripheral neuropathy improves to Grade 0 or 1 (see section 4.2).
Slovenian: Ko se periferna nevropatija izboljša na 0. ali 1. stopnjo, nadaljujte zdravljenje z zmanjšanim odmerkom zdravila Pazenir (glejte poglavje 4.2).
English: Teva Nederland B.V. (additional entity) Swensweg 5
Slovenian: (dodatni subjekt) Swensweg 5
English: *Survival [95% CI] (weeks) > 1st-line therapy
Slovenian: *Preživetje [95-% IZ] (tedni)
English: Reduce doses 1 dose level
Slovenian: zmanjšanje odmerkov.
English: Nadir platelets <50,000/mm3
Slovenian: Ukinite zdravljenje najmanjše število trombocitov < 50.000/mm3
English: First
Slovenian: prvo drugo
English: Uncommon: Contusion Rare: Radiation recall phenomenon, radiation pneumonitis
Slovenian: Redki: preobčutljivost predhodno obsevanih predelov, obsevalni pnevmonitis
English: Common: Peripheral oedema, mucosal inflammation, pain, rigors, oedema, weakness, decreased performance status, chest pain, influenzalike illness, malaise, lethargy, hyperpyrexia
Slovenian: Pogosti: periferni edem, vnetje sluznice, bolečine, okorelost, edem, šibkost, manjša zmogljivost, bolečine v prsih, gripi podobna bolezen, slabo počutje,
English: Table 8: Haematologic laboratory-detected abnormalities in pancreatic adenocarcinoma trial Human serum albuminpaclitaxel nanoparticles (125 mg/m2)/ Gemcitabine
Slovenian: Paklitaksel, vezan na nanodelce humanega serumskega albumina (125 mg/m2)/gemcitabin
English: resume at next lower dose levela aSee Table 1 for dose level reductions
Slovenian: nadaljujte z naslednjo nižjo ravnijo odmerkaa a Za zmanjšanja ravni odmerka glejte preglednico 1.
English: Bone marrow suppression (primarily neutropenia) occurs frequently with human serum albuminpaclitaxel nanoparticles.
Slovenian: Hematologija Pri paklitakselu, vezanem na nanodelce humanega serumskega albumina, pogosto pride do zavrtja delovanja kostnega mozga (večinoma nevtropenija).
English: • Coughing with phlegm, shortness of breath when walking or climbing stairs, runny nose, or dry nose, decreased breath sounds, water on the lung, loss of voice, blood clot in the lung, dry throat
Slovenian: plitvejši zvok dihanja, voda v pljučih, izguba glasu, krvni strdek v pljučih, suho žrelo • vetrovi, trebušni krči, bolečine ali razjede na dlesnih, krvavenje iz danke
English: Cranial nerve palsies, vocal cord paresis, and rare reports of severe hypersensitivity reactions have been reported during post-marketing surveillance of human serum albumin-paclitaxel nanoparticles.
Slovenian: V obdobju spremljanja paklitaksela, vezanega na nanodelce humanega serumskega albumina, po začetku trženja so opazili paralizo kranialnih živcev, parezo glasilk in redke primere reakcij hude preobčutljivosti.
English: Common: Infection, urinary tract infection, folliculitis, upper respiratory tract infection, candidiasis, sinusitis
Slovenian: Pogosti: okužbe, okužbe sečil, folikulitis, okužbe zgornjih dihal,
English: Very common: Diarrhoea, vomiting, nausea, constipation Common: Stomatitis, dyspepsia, abdominal pain, dysphagia
Slovenian: Zelo pogosti: navzea, driska, bruhanje, zaprtost, bolečine v trebuhu, bolečina v zgornjem delu trebuha
English: There have been reports of tumour lysis syndrome during treatment with human serum albuminpaclitaxel nanoparticles.
Slovenian: Med zdravljenjem s s paklitakselom, vezanim na nanodelce humanega serumskega albumina,
English: • Rash
Slovenian: • modrice
English: MedDRA = Medical Dictionary for Regulatory Activities: SMQ = Standardized MedDRA Query 1 Based on laboratory assessments: maximal degree of myelosuppression (treated population) 2 Peripheral neuropathy is evaluated using the SMQ neuropathy (broad scope) 3 Pneumonitis is evaluated using the SMQ interstitial lung disease (broad scope)
Slovenian: MedDRA = medicinski slovar za regulativne aktivnosti; SMQ = standardizirana MedDRA poizvedba (Standardized MedDRA
English: Uncommon: Oral candidiasis, nasopharyngitis, cellulitis, herpes simplex, viral infection, pneumonia, catheter-related infection, fungal infection, herpes zoster, injection site infection, sepsis2, neutropenic sepsis2
Slovenian: kandidoza, sinusitis Občasni: oralna kandidoza, nazofaringitis, celulitis, herpes simpleks,
English: Uncommon: Polyneuropathy, areflexia, dyskinesia, hyporeflexia, neuralgia, sensory loss, syncope, postural dizziness, neuropathic pain, tremor
Slovenian: Občasni: polinevropatija, arefleksija, diskinezija, hiporefleksija, nevralgija,
English: The following are the most common and important incidences of adverse reactions related to 421 patients with metastatic adenocarcinoma of the pancreas who were treated with 125 mg/m2 human serum albumin-paclitaxel nanoparticlesin combination with gemcitabine at a dose of 1000 mg/m2
Slovenian: 421 bolnikih z metastatskim adenokarcinomom trebušne slinavke, zdravljenih s 125 mg/m2 paklitaksela, vezanega na nanodelce humanega serumskega albumina, v kombinaciji z gemcitabinom v odmerku 1.000 mg/m2 1., 8. in 15. dan vsakega 28-dnevnega cikla v klinični študiji faze III.
English: If it contacts mucous membranes, the membranes should be flushed thoroughly with water.
Slovenian: Če pride v stik s sluznico, le-to temeljito sperite z vodo.
English: Reconstituted Pazenir dispersion should be administered intravenously using an infusion set incorporating a 15 µm filter.
Slovenian: Da se boste izognili dajanju teh vlaken, dajajte zdravilo Pazenir z infuzijskim sistemom, ki vključuje 15 µm filter.
English: In this phase III randomized, controlled, open-label trial, adverse reactions resulting in death within 30 days of the last dose of study drug were reported for 4% of patients receiving human serum albumin-paclitaxel nanoparticles in combination with gemcitabine and for 4% of patients receiving gemcitabine monotherapy.
Slovenian: ki so se končali s smrtjo v 30 dneh po zadnjem odmerku zdravila v kliničnem preskušanju, pri 4 %
English: Teva Pharmaceuticals Ireland, L-Irlanda Τel: +353 51 321740
Slovenian: Τel: +353 51 321740
English: Common: Pain in extremity, bone pain, back pain, muscle cramps, limb pain
Slovenian: Pogosti: bolečine v udih, bolečine v kosteh, bolečine v hrbtu, mišični krči, bolečine v okončinah
English: The very rare side effects may affect up to 1 in 10,000 people:
Slovenian: • motnja električnega prevodnega sistema srca (atrioventrikularni blok) Zelo redki neželeni učinki se lahko pojavijo pri največ 1 od 10.000 bolnikov:
English: Therefore, in the absence of a PK drug-drug interaction study, caution should be exercised when administering paclitaxel concomitantly with medicinal products known to inhibit either CYP2C8 or CYP3A4 (e.g. ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.
Slovenian: CYP3A4 (npr. ketokonazol in drugi imidazolni antimikotiki, eritromicin, fluoksetin, gemfibrozil,
English: • Bruising
Slovenian: fenitoin)
English: All formulations
Slovenian: Vse formulacije
English: MUPS and capsules
Slovenian: MUPS in kapsule
English: The MAH commits to update the dossier according to the various regulations and the EU Directive 2001/83/EC.
Slovenian: Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo posodobil dokumentacijo v skladu z različnimi uredbami in Direktivo EU 2001/83/ES.
English: CONDITIONS OF THE MARKETING AUTHORISATIONS
Slovenian: DODATEK IV POGOJI DOVOLJENJ ZA PROMET Z ZDRAVILOM
English: The MAH commits to respond to the following unresolved quality issues by discussing and implementing as relevant in the context of an update of the CTD documentation in May 2010.
Slovenian: Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo odgovoril na naslednja nerešena vprašanja glede kakovosti, tako da bo o njih razpravljal in jih upošteval, kakor je treba, v okviru posodobitve dokumentacije CTD maja 2010.
English: The MAH commits to conduct an epidemiological study on the risk of falls and fractures and to provide the results of this study by Q2 of 2011.
Slovenian: Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvedel epidemiološko študijo tveganja padcev in zlomov ter da bo predložil rezultate te študije do drugega četrtletja leta 2011.
English: The MAH commits to update the document 'P3-03 Description of Manufacturing Process and Process Controls for Drug Product'
Slovenian: Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo posodobil dokument „P3-03 Description of Manufacturing Process and Process Controls for Drug Product (P3-03 Opis postopka izdelave in kontrol postopka izdelave zdravila)“.
English: The MAH commits to investigate, justify and introduce the limits for impurities in accordance with the guideline ICH Topic Q3B: Impurities in new Drug Products
Slovenian: Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo proučil, utemeljil in uvedel omejitve nečistoč v skladu s smernico ICH Topic Q3B: Impurities in new Drug Products (ICH tema Q3B: Nečistoče v novih zdravilih).
English: Capsules and solution for injection and solution for infusion
Slovenian: Kapsule in raztopina za injiciranje ter raztopina za infundiranje
English: The MAH commits to investigate, justify and introduce limits for a number of degradation products.
Slovenian: Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo proučil, utemeljil in uvedel omejitve za številne razgradne produkte.
English: The MAH commits to update the specifications with the test uniformity of dosage units.
Slovenian: Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo posodobil specifikacije ob upoštevanju enotnosti preskušanj enot odmerjanja.
English: The MAH commits to clarify the activities of the drug product manufacturer.
Slovenian: Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo pojasnil dejavnosti proizvajalca zdravila.
English: The MAH commits to provide the supporting documents regarding TSE (Transmissible Spongiform Encephalopathies) safety.
Slovenian: Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo predložil dodatno dokumentacijo glede varnosti v zvezi s TSE (transmisivna spongiformna encefalopatija).
English: The MAH commits to amend the product information as relevant based on the outcome of the study.
Slovenian: Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo na podlagi rezultata študije po potrebi spremenil informacije o zdravilu.
English: The MAH commits to provide stability data for the intermediate/bulk product.
Slovenian: Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo predložil podatke o stabilnosti vmesnih/osnovnih izdelkov.
English: Solution for injection and solution for infusion
Slovenian: Raztopina za injiciranje in raztopina za infundiranje
English: The MAH commits to provide the supporting documents and data regarding the stability of the modification of the drug substance omeprazole magnesium and omeprazole.
Slovenian: Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo predložil dodatno dokumentacijo in podatke o stabilnosti modifikacije zdravilnih učinkovin omeprazol magnezij in omeprazol.
English: The MAH commits to provide the supporting documents regarding bioequivalence to the biobatch.
Slovenian: Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo predložil dodatno dokumentacijo o biološki enakovrednosti glede biološke serije.
English: The MAH commits to develop and introduce a second identification method for the drug substance omeprazole.
Slovenian: Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo oblikoval in uvedel drugo metodo identifikacije zdravilne učinkovine omeprazol.
English: The MAH commits to provide the supporting documents regarding the limits of quantifications of the drug product
Slovenian: Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo predložil dodatno dokumentacijo glede omejitev kvantifikacij zdravila.
English: The MAH commits to provide the supporting documents regarding the shelflife specification of the finished product.
Slovenian: Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo predložil dodatno dokumentacijo glede specifikacije roka uporabnosti končnega zdravila.
English: Strength Pharmaceutical Form
Slovenian: Številka EU zaščiteno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
English: More information on Myalepta can be found on the Agency's website: ema.europa.eu/Find medicine.
Slovenian: Več informacij o zdravilu Myalepta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine.
English: This might result in the patient receiving too much or too little of the active substance.
Slovenian: Posledično lahko bolnik prejme preveč ali premalo učinkovine.
English: Information for patients and their parents or carers
Slovenian: Informacije za bolnike in njihove starše ali negovalce
English: It will be adjusted by your doctor according to your response to treatment.
Slovenian: Vaš zdravnik ga bo prilagodil glede na vaš odziv na zdravljenje.
English: For daily doses > 1.5 mg - 5 mg (0.3 - 1.0 mL)
Slovenian: Za dnevne odmerke > 1,5 mg-5 mg (0,3-1,0 ml)
English: Maximum daily dose (injection volume)
Slovenian: Največji dnevni odmerek (volumen za injiciranje)
English: Your pharmacist will give you detailed instructions on how to do this.
Slovenian: Vaš farmacevt vas bo o tem natančno poučil.
English: The size of the syringe depends on the dose prescribed and is determined as follows:
Slovenian: Velikost brizge je odvisna od predpisanega odmerka in se določi, kot sledi:
English: They must however always prepare and give the first dose under supervision of the doctor or nurse.
Slovenian: Vsekakor morajo prvi odmerek vedno pripraviti in dati pod nadzorom zdravnika ali medicinske sestre.
English: The dose should be prescribed in both milligrams and milliliters:
Slovenian: Odmerek je treba predpisati tako v miligramih kot tudi v mililitrih:
English: • The dose depends on your body weight and may be different for men than women.
Slovenian: • Odmerek je odvisen od vaše telesne mase in se lahko razlikuje za moške in ženske.
English: Patients should be reviewed every 6 months to ensure that their injection technique is correct.
Slovenian: Vsakih 6 mesecev je treba preverjati, da je bolnikova tehnika injiciranja pravilna.
English: Females > 40 kg
Slovenian: Ženske > 40 kg
English: 0.3 mL 100 UI insulin
Slovenian: 0,3 ml 100 IE insulina
English: Any remaining solution should be discarded.
Slovenian: Morebitno preostalo raztopino zavrzite.