FrancophonIA/ELRC3.0 huggingface dataset:
English: - Developing chamber for chromatography - Mobile phase: sodium chloride 9 mg/ml (0.9%) solution, bacteriostatic-free - ITLC strips (e.g. ITLC TEC-Control Chromatography Strips, Biodex, Shirley, New York, USA, Art. Nr. 150-772 or equivalent, dimensions: approximately 0.5-1 cm x 6 cm) - Scintillation vials - Liquid scintillation cocktail (e.g. Ultima Gold, catalog No. 6013329, Packard Instruments, USA or equivalent)
Slovenian: - razvijalna komora za kromatografijo; - mobilna faza: raztopina natrijevega klorida 9 mg/ml (0,9 %), brez bakteriostatika; - ploščica za ITLC (npr. ITLC TEC-kontrolne kromatografske ploščice, Biodex, Shirley, New York,
English: These adverse drug reactions are based upon 349 patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma studied in 5 clinical trials.
Slovenian: Ti neželeni učinki temeljijo na podatkih za 349 bolnikov z relapsnim ali neodzivnim nizkostopenjskim, folikularnim neHodgkinovim limfomom ali z NHL s transformacijo celic B, preučevanimi v petih kliničnih preskušanjih.
English: Zevalin is supplied as a kit for the preparation of yttrium-90 radiolabelled ibritumomab tiuxetan.
Slovenian: Zdravilo Zevalin je na voljo v obliki kompleta za pripravo z itrijem-90 označenega ibritumomab tiuksetana.
English: Zevalin is a kit for the preparation of the active substance ibritumomab tiuxetan [
Slovenian: Zdravilo Zevalin je komplet za pripravo zdravilne učinkovine ibritumomab tiuksetana [
English: Thrombocytopenia, Leukocytopenia, Neutropenia, Anaemia*
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija, levkocitopenija, nevtropenija, anemija*
English: Reaction vial: type I glass vial with a rubber stopper (teflon-lined bromobutyl)
Slovenian: Reakcijska viala: viala iz stekla tipa I z gumijastim zamaškom (s teflonom prekrit bromobutil)
English: Y]-radiolabelled Zevalin at activities of 15 MBq/kg and 11 MBq/kg was calculated according to Medical Internal Radiation Dosimetry (MIRD) (Table 3).
Slovenian: In] označenim zdravilom Zevalin so z MIRD (Medical Internal Radiation Dosimetry) izračunali predvideno absorbirano dozo za posamezne organe po aplikaciji z Y] označenega zdravila Zevalin z aktivnostmi 15 MBq/kg in 11 MBq/kg (preglednica 3).
English: Y]-radiolabelled Zevalin is indicated for the treatment of adult patients with rituximab relapsed or refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL).
Slovenian: Y] označeno zdravilo Zevalin je indicirano za zdravljenje odraslih bolnikov z ne-Hodgkinovim limfomom (NHL) folikularnih celic B CD20+, ki je po rituksimabu recidiviral ali je zanj neodziven.
English: One ibritumomab tiuxetan vial contains 3.2 mg ibritumomab tiuxetan* in 2 ml solution (1.6 mg per ml).
Slovenian: Ena viala ibritumomab tiuksetana vsebuje 3,2 mg ibritumomab tiuksetana* v 2 ml raztopine (1,6 mg na ml).
English: Anxiety, Insomnia
Slovenian: Psihiatrične motnje anksioznost, nespečnost
English: During B-cell maturation, CD20 is first expressed in the midstage of B-lymphoblast (pre-B-cell), and is lost during the final stage of B-cell maturation to plasma cells.
Slovenian: Ibritumomab tiuksetan je usmerjen proti antigenu CD20, ki se nahaja na površini malignih in normalnih limfocitov B. Med dozorevanjem B celic se CD20 najprej pojavi pri medstopnji B limfoblastov (predstopnja B celic) in se med končnim stadijem dozorevanja B celic v plazemske celice izgubi.
English: Intracranial haemorrhage while thrombocytopenic*
Slovenian: intrakranialne krvavitve pri trombocitopeniji*
English:  95% of free ionic yttrium-90
Slovenian: Radiokemijska čistota raztopine itrijevega-90 klorida  95 % prostega ioniziranega itrija 90 Bakterijski endotoksini
English: • Hypersensitivity
Slovenian: • Preobčutljivost
English: Spot one strip at a time and run three ITLC strips.
Slovenian: Nanesite na vsako ploščico posebej in postopek izvedite s 3 ploščicami.
English: Ibritumomab tiuxetan vial: type I glass vial with a rubber stopper (teflon-lined bromobutyl) containing 2 ml solution.
Slovenian: Viala ibritumomab tiuksetana: viala iz stekla tipa I z gumijastim zamaškom (s teflonom prekrit bromobutil), ki vsebuje 2 ml raztopine.
English: Each vial contains 3.2 mg ibritumomab tiuxetan in 2 ml solution (1.6 mg per ml).
Slovenian: Ena viala vsebuje 3,2 mg ibritumomab tiuksetana v 2 ml raztopine (1,6 mg na ml).
English: One vial contains 3.2 mg ibritumomab tiuxetan* to be diluted in 2 ml solution (1.6 mg per ml).
Slovenian: Ena viala vsebuje 3,2 mg ibritumomab tiuksetana*, ki se razredči v 2 ml raztopine (1,6 mg na ml).
English: Doses up to 19.2 MBq/kg of Zevalin have been administered in clinical trials.
Slovenian: V kliničnih preskušanjih so dajali odmerke do 19,2 MBq/kg z [
English: Zevalin 1.6 mg/ml kit for radiopharmaceutical preparations for infusion Ibritumomab tiuxetan [
Slovenian: Zevalin 1,6 mg/ml komplet za pripravo radiofarmakov za infundiranje ibritumomab tiuksetan [
English: Time to Disease Progression: interval from the first infusion to disease progression.
Slovenian: IWRC: kriterij IWR (International Workshop Response) ocenjeno z opazovanim razponom trajanje odgovora: interval od nastopa odgovora do progresije bolezni “+” označuje odgovor, ki še traja čas do progresije bolezni: interval med prvo infuzijo in progresijo bolezni
English: Zevalin 1.6 mg/ml kit for radiopharmaceutical preparations Ibritumomab tiuxetan solution Intravenous infusion, after preparation.
Slovenian: Zevalin 1,6 mg/ml komplet za pripravo radiofarmakov za infundiranje raztopina ibritumomab tiuksetana intravenska infuzija, po pripravi
English: Adequate shielding is mandatory.
Slovenian: Obvezna je ustrezna zaščita pred sevanjem.
English: Treatment with [
Slovenian: Način uporabe Z [
English: (lymphocytopenia) - allergic (hypersensitivity) reactions - severe loss of appetite (anorexia) - feeling anxious (anxiety); trouble sleeping (insomnia) - dizziness; headache, - bleeding due to decreased blood platelet counts*, - cough; runny nose - vomiting, stomach (abdominal) pain; diarrhoea; indigestion; throat irritation; constipation - rash; itching (pruritus) - joint pain (arthralgia) aching muscles (myalgia); back pain; neck pain
Slovenian: Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov): - zastrupitev krvi (sepsa)*; okužba pljuč (pljučnica)*; okužba sečnega trakta, glivične okužbe ust kot so izpuščaji v ustih (oralna kandidoza) - druge s krvjo povezane vrste raka (mielodisplastični sindrom (MDS) / akutna mieloidna levkemija (AML))*, **; bolečina zaradi tumorja - zvišana telesna temperatura z zmanjšanim številom določenih belih krvnih celic (febrilna nevtropenija); zmanjšano število vseh krvnih celic (pancitopenija)*; zmanjšano število limfocitov (limfocitopenija) - alergijske (preobčutljivostne) reakcije - resna oblika izgube apetita (anoreksija) - tesnoba (anksioznost) ali težave s spanjem (insomnija) - omotica, glavobol - krvavitev zaradi zmanjšanega števila trombocitov*, - kašelj; izcedek iz nosu - bruhanje, bolečine v trebuhu (abdomnu); driska; prebavne motnje; draženje grla; zaprtost - izpuščaj; srbenje (pruritus) - bolečine v sklepih (artralgija), boleče mišice (mialgija); bolečine v hrbtu; bolečine v vratu - bolečine; gripi podobni simptomi; splošno slabo počutje, znojenje zaradi kopičenja tekočine v rokah in nogah in drugem tkivu (periferni edem); povečano znojenje
English: In addition, the adverse drug reactions marked with ** were observed in the study with 204 patients receiving Zevalin as consolidation therapy after first-line remission induction where indicated.
Slovenian: Poleg tega so bili v študiji z 204 bolniki, ki so prejemali zdravilo Zevalin kot konsolidacijsko zdravljenje po nastopu remisije z zdravljenjem prvega izbora, opaženi neželeni učinki, označeni z **.
English: If you have received more Zevalin than you should Your doctor will treat you, as appropriate, if you have any particular ill effects.
Slovenian: Vaš zdravnik vas bo ustrezno zdravil, če se pojavijo neželeni učinki.
English: Y]radiolabelled Zevalin onto the ITLC strip at its origin.
Slovenian: Y] označeni Zevalin pred nanosom na ploščice za ITLC razredčiti v razmerju 1 : 100.
English: Mucocutaneous reaction (including Stevens Johnson
Slovenian: Bolezni kože in podkožja izpuščaj, pruritus mukokutane reakcije (vključno s Stevens Johnsonovim sindromom) *
English: Contaminated materials must be disposed of as radioactive waste by the authorised route.
Slovenian: Kontaminirane materiale je treba zavreči v skladu z lokalnimi predpisi za radioaktivne odpadke.
English: Marketing Authorisation Holder Spectrum Pharmaceuticals B.V. Prins Bernhardplein 200
Slovenian: Spectrum Pharmaceuticals B.V., Prins Bernhardplein 200, 1097 JB Amsterdam, Nizozemska
English: Consolidation therapy after remission induction in previously untreated patients with follicular lymphoma patients with ≥ 150,000 platelets/mm³: 15 MBq/kg up to a maximum of 1200 MBq for patients with less than 150,000 platelets per mm³ see section ‘4.4' Repeated use: Data on the re-treatment of patients with [90Y]-radiolabelled Zevalin are not available.
Slovenian: - bolniki s 150.000 ali več trombociti/mm3: 15 MBq/kg do največ 1200 MBq - za bolnike z manj kot 150.000 trombociti na mm³ glejte poglavje 4.4
English: If the number of your white blood cells is fewer than 1,500/mm If you have had a bone marrow transplant or have received blood stem cells in the past.
Slovenian: če več kot četrtina vašega kostnega mozga vsebuje nenormalne maligne celice; če ste bili predhodno zdravljeni z obsevanjem, ki je zajelo več kot 25 % vašega kostnega mozga; če dobivate samo zdravilo Zevalin in imate v krvi manj kot 100.000 trombocitov/mm če imate v krvi manj kot 150.000 trombocitov/mm po kemoterapiji; če imate v krvi manj kot 1.500 belih krvnih celic/mm3; če ste v preteklosti imeli presaditev kostnega mozga ali ste prejeli terapijo z matičnimi celicami.
English: Before administration to the patient, the percent radioincorporation of the prepared Y]-radiolabelled Zevalin must be checked according to the procedure outlined below.
Slovenian: Pred aplikacijo radioterapevtika bolniku je treba v skladu s spodaj opisanim postopkom preveriti odstotek vezave radioaktivnosti pripravljenega z [
English: The human radiation dose estimates derived from biodistribution studies in mice with [
Slovenian: Odmerki sevanja za človeka, ocenjeni na podlagi raziskav biološke porazdelitve z [
English: Rituximab is administered in a reduced dose when compared with the approved monotherapy.
Slovenian: V primerjavi z uveljavljeno monoterapijo se rituksimab aplicira v manjšem odmerku.
English: • Intracranial haemorrhage while thrombocytopenic
Slovenian: • intrakranialna krvavitev med trombocitopenijo
English: Formulation buffer vial: type I glass vial with a rubber stopper (teflon-lined bromobutyl) containing 10 ml solution.
Slovenian: Viala s pufrom za pripravo formulacije: viala iz stekla tipa I z gumijastim zamaškom (s teflonom prekrit bromobutil), ki vsebuje 10 ml raztopine
English: Sodium acetate vial: type I glass vial with a rubber stopper (teflon-lined bromobutyl) containing 2 ml solution.
Slovenian: Viala natrijevega acetata: viala iz stekla tipa I z gumijastim zamaškom (s teflonom prekrit bromobutil), ki vsebuje 2 ml raztopine
English: Disodium phosphate dodecahydrate Human albumin solution Hydrochloric acid, diluted (for pH adjustment) Pentetic acid
Slovenian: Viala s pufrom za pripravo formulacije: natrijev hidrogenfosfat dodekahidrat raztopina človeških beljakovin klorovodikova kislina, razredčena (za uravnavo pH) pentetična kislina kalijev klorid kalijev dihidrogen fosfat natrijev klorid natrijev hidroksid voda za injekcije
English: • Severe mucocutaneous reactions
Slovenian: • Hude reakcije kože in sluznic
English: Instructions for determining the percent radioincorporation
Slovenian: NAVODILA ZA PRIPRAVO RADIOFARMAKOV
English: Infections and infestations
Slovenian: Infekcijske in parazitske bolezni infekcija*
English: Disodium phosphate dodecahydrate Sodium hydroxide Potassium dihydrogen phosphate Potassium chloride Pentetic acid
Slovenian: Viala s pufrom za pripravo formulacije: raztopina humanega albumina natrijev klorid dinatrijev fosfat dodekahidrat natrijev hidroksid kalijev dihidrogen fosfat kalijev klorid pentetična kislina klorovodikova kislina, razredčena voda za injekcije
English: Hypersensitivity reaction
Slovenian: Bolezni imunskega sistema preobčutljivostna reakcija
English: What Zevalin looks like and contents of the pack Zevalin is a kit for radiopharmaceutical preparation for infusion, containing: - One ibritumomab tiuxetan glass vial, with 2 ml clear, colourless solution.
Slovenian: Izgled zdravila Zevalin in vsebina pakiranja Zevalin je komplet za pripravo radiofarmaka za infundiranje, ki vsebuje: - eno stekleno vialo z ibritumomab tiuksetanom z 2 ml bistre, brezbarvne raztopine - eno stekleno vialo z natrijevim acetatom z 2 ml bistre, brezbarvne raztopine - eno stekleno vialo s pufrom za pripravo formulacije z 10 ml bistre, rumene do jantarjaste raztopine - eno reakcijsko stekleno vialo (prazno)
English: Patients must not receive growth factor treatment such as G-CSF for 3 weeks prior to Zevalin administration as well as for 2 weeks following completion of the treatment in order to assess the adequate bone marrow reserve correctly and because of the potential sensitivity of rapidly dividing myeloid cells to radiation (see also section 4.5).
Slovenian: Zaradi pravilne ocene rezerve kostnega mozga in možne občutljivosti hitro delečih se mieloičnih celic na sevanje, bolniki ne smejo biti zdravljeni z rastnim faktorjem (npr. G-CSF) 3 tedne pred zdravljenjem z zdravilom Zevalin in še 2 tedna po končanem zdravljenju (glejte tudi poglavje 4.5).
English: A total of 73 patients received the Zevalin therapeutic regimen, and 70 patients received rituximab given as an intravenous infusion at 375 mg/m weekly times 4 doses.
Slovenian: V študijo je bilo vključenih 143 bolnikov, ki pred tem niso prejemali rituksimaba, z recidivnim ali neodzivnim nizkostopenjskim ali folikularnim ne-Hodgkinovim limfomom (NHL) ali z NHL s transformacijo celic B. Skupno 73 bolnikov je dobivalo terapevtsko shemo z zdravilom Zevalin, 70 bolnikov pa je dobilo rituksimab v obliki intravenske infuzije 4 odmerkov po 375 mg/m na teden.
English: Y]-radiolabelled Zevalin is indicated as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma.
Slovenian: Konsolidacijska terapija po nastopu remisije pri predhodno nezdravljenih bolnikih s folikularnim limfomom
English: Before administration to the patient, the percent radioincorporation of the prepared Y]-radiolabelled Zevalin must be checked according to the procedure outlined in section 12.
Slovenian: Pred dajanjem zdravila bolniku je treba preveriti odstotek radiooznačenosti pripravljenega z [
English: Respiratory, thoracic, and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj, rinitis
English: Y]-radiolabelled Zevalin solution.
Slovenian: Y] označenega zdravila Zevalin.
English: After you are given Zevalin
Slovenian: Po prejemu zdravila Zevalin
English: Severe mucocutaneous reactions, including Stevens-Johnson Syndrome, some with fatal outcome, have been reported in association with Zevalin after pretreatment with rituximab.
Slovenian: Redko so poročali, da je bilo zdravljenje z zdravilom Zevalin po predhodnem zdravljenju z rituksimabom povezano s pojavom hudih reakcij kože in sluznic, vključno s Stevens-Johnsonovim sindromom, ki je bil v nekaterih primerih smrten.
English: • NHL with CNS involvement
Slovenian: • NHL s prizadetostjo osrednjega živčevja
English: Animal reproduction studies were not conducted with ibritumomab tiuxetan.
Slovenian: Vpliva ibritumomab tiuksetana na sposobnost razmnoževanja pri živalih niso raziskovali.
English: Extravasation with subsequent infusion site reactions, Damage to lymphomasurrounding tissue and complications due to lymphoma swelling
Slovenian: bolečina, simptomi, podobni gripi, slabotnost, periferni edem, povečano potenje ekstravazacija z naknadno reakcijo na mestu infundiranja, poškodovanje tkiva okoli limfoma in zapleti zaradi oteklega limfoma
English: Y]- or
Slovenian: Y] ali [
English: Zevalin 1.6 mg/ml kit for radiopharmaceutical preparations for infusion
Slovenian: Zevalin 1,6 mg/ml komplet za pripravo radiofarmakov za infundiranje
English: Of these, grade 3 was common, grade 4 uncommon.
Slovenian: Med spremljanjem so se okužbe pojavile pogosto, pri čemer je bila okužba 3. stopnje pogosta in 4. stopnje občasna.
English: - pain; flu-like symptoms; generally feeling unwell (malaise), swelling caused by build-up of fluid in the arms and legs and other tissues (peripheral oedema); increased sweating - high blood pressure (hypertension)** - low blood pressure (hypotension)** - absence of menstruation (amenorrhea)**
Slovenian: - visok krvni pritisk (hipertenzija)** - nizek krvni pritisk (hipotenzija)** - izostanek menstruacije (amenoreja)**
English: Dizziness, Headache
Slovenian: Bolezni živčevja vrtoglavica, glavobol
English: Pack size of 1 kit.
Slovenian: Ovoj vsebuje 1 komplet.
English: • The active substance is ibritumomab tiuxetan.
Slovenian: - Zdravilna učinkovina je ibritumomab tiuksetan.
English: - Pregnancy and lactation (see section 4.6).
Slovenian: - preobčutljivost za rituksimab ali druge iz glodavcev pridobljene beljakovine; - nosečnost in dojenje (glejte poglavje 4.6).
English: Yttrium identification
Slovenian: Identifikacija itrija
English: Y) radiolabelled ibritumomab tiuxetan.
Slovenian: Y) označenega ibritumomab tiuksetana.
English: Estimated Radiation Absorbed Doses From [
Slovenian: Ocenjene absorbirane doze sevanja po aplikaciji z [
English: IBRITUMOMAB TIUXETAN SOLUTION VIAL
Slovenian: VIALA Z RAZTOPINO IBRITUMOMAB TIUKSETANA
English: Organ region of interest Sacrum region of interest Whole body region of interest
Slovenian: timus ščitnica ledvice celo telo
English: Amenorrhea**
Slovenian: Motnje reprodukcije in dojk amenoreja**
English: Asthenia, Pyrexia, Rigors Fatigue**
Slovenian: Splošne težave in spremembe na mestu aplikacije astenija, pireksija, okorelost, utrujenost**
English: Total Alpha impurities
Slovenian: Skupne nečistote alfa pod mejo kvantifikacije*
English: Step 2: Clean your hands
Slovenian: Korak 2: Očistite svoje roke
English: All three injection sites are equally suitable.
Slovenian: Vsa tri mesta vnosa so enako primerna.
English: However, it can be interrupted at any time, if necessary.
Slovenian: Vendar ga lahko prekinemo kadarkoli, če je potrebno.
English: Risk Management plan (RMP)
Slovenian: · Načrt za obvladovanje tveganja (RMP)
English: Therefore, caution should be used in these patients.
Slovenian: Pri teh bolnikih je zato potrebna previdnost.
English: (a) Summary of the safety profile
Slovenian: (a) Povzetek varnostnega profila
English: Your doctor will decide which is best for you.
Slovenian: Vaš zdravnik bo odločil o tem, kaj je najprimernejše za vas.
English: Choose one of the recommended injection sites as shown.
Slovenian: Izberite eno od priporočenih mest injiciranja, kot je prikazano.
English: The frequency of possible side effects listed below:
Slovenian: Pogostnost možnih neželenih učinkov je navedena spodaj:
English: Its use is limited to adult patients (aged 18 years or older).
Slovenian: Uporaba tega zdravila je omejena le na odrasle bolnike (stare 18 let ali več).
English: EU/1/07/400/010 EU/1/07/400/011 EU/1/07/400/012 EU/1/07/400/013 EU/1/07/400/017 EU/1/07/400/018 EU/1/07/400/019 EU/1/07/400/020 EU/1/07/400/021 EU/1/07/400/022 EU/1/07/400/023 EU/1/07/400/024
Slovenian: EU/1/07/400/008 EU/1/07/400/009 EU/1/07/400/010 EU/1/07/400/011 EU/1/07/400/012 EU/1/07/400/013 EU/1/07/400/017 EU/1/07/400/018 EU/1/07/400/019 EU/1/07/400/020 EU/1/07/400/021 EU/1/07/400/022 EU/1/07/400/023 EU/1/07/400/024
English: Not included in the pack:
Slovenian: V pakiranju ni vključeno:
English: · Let the skin dry for approximately 10 seconds.
Slovenian: · Počakajte približno 10 sekund, da se koža posuši.
English: It is important to read and follow these instructions carefully so that you are able to use the pre-filled syringe correctly and safely.
Slovenian: Pomembno je, da pazljivo preberete in sledite tem navodilom, da boste lahko napolnjeno injekcijsko brizgo uporabili pravilno in varno.
English: After preparation of the syringe as described in steps 1 to 5:
Slovenian: Po pripravi injekcijske brizge, kot je opisano v korakih 1 do 5, sledi:
English: · You may see a drop of liquid at the end of the needle.
Slovenian: · Na koncu igle lahko vidite kapljico tekočine.
English: • if you have high blood pressure that cannot be controlled
Slovenian: · če imate visok krvni tlak, ki ni obvladljiv.
English: · The expiration date has passed.
Slovenian: · če je rok uporabe že pretekel.
English: · Any part of the syringe appears to be damaged.
Slovenian: · kateri koli del injekcijske brizge izgleda poškodovan.
English: Your doctor will consider what is the best treatment for you during pregnancy.
Slovenian: Vaš zdravnik bo ocenil, katero zdravljenje je med nosečnostjo za vas najboljše.
English: Adverse reactions observed only during post-marketing are marked (*).
Slovenian: Neželeni učinki, ki so jih opazili le po prihodu zdravila na trg, so označeni (*).
English: This means that you have too few red blood cells and your haemoglobin level is too low (your body's tissues might not receive enough oxygen).
Slovenian: To pomeni, da imate premajhno število rdečih krvnih celic ter premajhno koncentracijo hemoglobina (vaša telesna tkiva lahko zato dobijo premalo kisika).
English: Pinching the skin is important to ensure that you inject under the skin (into fatty tissue) but not any deeper (into muscle).
Slovenian: Kožna guba je pomembna, da zagotovite, da injicirate pod kožo (v maščobno tkivo) in ne globlje (v mišico).
English: This is important to ensure that the syringe and medicine are safe to use.
Slovenian: To je pomembno, da zagotovite, da sta injekcijska brizga in zdravilo varna za uporabo.
English: Date of latest renewal: 15 May 2012
Slovenian: Datum prve odobritve: 20. julij 2007 Datum zadnjega podaljšanja: 15. maj 2012
English: Injection into muscle could result in an uncomfortable injection.
Slovenian: Injekcija v mišico bi lahko povzročila neprijeten občutek.
English: Tell your doctor if you are pregnant, think you are pregnant or intend to become pregnant.
Slovenian: Obvestite zdravnika, če ste noseči, če mislite, da ste noseči ali nameravate zanositi.
English: For instructions on the administration of the medicinal product, see section 6.6.
Slovenian: Za navodila glede uporabe zdravila glejte poglavje 6.6.
English: If clinically indicated, phlebotomy may be performed.
Slovenian: Če je klinično indicirano, lahko opravimo flebotomijo.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Slovenian: Pred uporabo zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: It is recommended that haemoglobin is monitored every two weeks until stabilized and periodically thereafter.
Slovenian: Priporočljivo je kontrolirati koncentracijo hemoglobina vsak drugi teden, dokler ni dosežena koncentracija stabilna, nato pa periodično.
English: · If needed, you may cover the injection site with a small bandage.
Slovenian: · Če je treba, lahko mesto injiciranja pokrijete z majhnim povojem.
English: · Do not inject through clothing.
Slovenian: · Ne injicirajte skozi obleko.
English: The rashes may progress to widespread peeling of the skin and life-threatening complications.
Slovenian: Izpuščaji lahko napredujejo do razširjenega lupljenja kože in življenjsko ogrožajočih zapletov.
English: If you have any of these conditions, your doctor will discuss it with you and must treat you with caution.
Slovenian: Če imate katero koli od navedenih stanj, se bo vaš zdravnik o tem pogovoril z vami in vas skrbno zdravil.
English: Treatment interruption
Slovenian: Prekinitev zdravljenja
English: Your healthcare professional will always record the exact product you are using.
Slovenian: Vaš zdravnik bo vedno zabeležil, točno katero zdravilo uporabljate.