FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious adverse reactions are known to occur with the concomitant use of SSRIs, SNRIs, tricyclic/tetracyclic antidepressants and MAO inhibitors.
Slovenian: Znano je, da se pri sočasni uporabi SSRI, SNRI, tricikličnih in tetracikličnih antidepresivov ter inhibitorjev MAO pojavijo resni neželeni učinki.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Common: skin carcinoma (1.3% vs. 0.7%) Blood and lymphatic system disorders Common: leucopenia (1.3% vs. 0%)
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) Pogosti: rak kože (1,3% proti 0,7%)
English: Blister packs of 7, 10, 28, 30, 100 or 112 tablets PVC/PVDC/Al.
Slovenian: Pretisni omoti iz oPA/aluminij/PVC/aluminija po 7, 10, 28, 30, 100 ali 112 tablet Pretisni omoti iz PVC/PVDC/aluminija po 7, 10, 28, 30, 100 ali 112 tablet Perforirani enoodmerni pretisni omoti iz PVC/PVDC/aluminija po 7 x 1, 10 x 1, 28 x 1, 30 x 1, 100 x 1 ali 112 x 1 tableto
English: Common: decreased weight (4.5% vs. 1.5%) Injury, poisoning and procedural complications Common: fall (4.7% vs. 3.4%)
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih Pogosti: padec (4,7% proti 3,4%)
English: How to take Rasagiline Mylan
Slovenian: Kako jemati zdravilo Razagilin Mylan
English: The recommended dose is 1 tablet of 1 mg taken by mouth once daily.
Slovenian: Običajni odmerek zdravila Razagilin Mylan je 1 tableta po 1 mg peroralno enkrat dnevno.
English: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments.
Slovenian: Pri bolnikih, ki se zdravijo z agonisti dopamina in/ali drugimi dopaminergičnimi zdravljenji, lahko pride do patološkega hazardiranja, povečanega libida, hiperseksualnosti, kompulzivnega zapravljanja ali nakupovanja, prenajedanja in kompulzivnega prenajedanja.
English: Similar reports of ICDs have also been received post-marketing with rasagiline.
Slovenian: Prav tako so bila podobna poročila glede motenj pri obvladovanju impulzov prejeta v obdobju trženja razagilina.
English: Uncommon: myocardial infarction (0.7% vs. 0%) Respiratory, thoracic and mediastinal disorders Common: rhinitis (3.4% vs. 0.7%)
Slovenian: Pogosti: angina pektoris (1,3% proti 0%) Občasni: miokardni infarkt (0,7% proti 0%) Bolezni dihal, prsnega koša in mediastinalnega prostora
English: PC:
Slovenian: C.
English: • Very common (may affect more than 1 in 10 people)
Slovenian: Zelo pogosti (pojavijo se lahko pri najmanj 1 od 10 bolnikov)
English: NN:
Slovenian: A.
English: Common: rash (1.1% vs. 0.3%)
Slovenian: Pogosti: izpuščaj (1,1% proti 0,3%)
English: You must wait at least 14 days after stopping Rasagiline Mylan treatment and starting treatment with MAO inhibitors or pethidine.
Slovenian: Po prenehanju zdravljenja z zdravilom Razagiline Mylan morate počakati vsaj 14 dni, preden začnete z zdravljenjem z zaviralci MAO ali s petidinom.
English: Very common: headache (14.1% vs. 11.9%) Uncommon: cerebrovascular accident (0.7% vs. 0%)
Slovenian: Zelo pogosti: glavobol (14,1% proti 11,9%)
English: • Uncommon (may affect up to 1 in 100 people)
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov)
English: 6.5 Nature and contents of container oPA/Al/PVC/Al.
Slovenian: 6.5 Vrsta ovojnine in vsebina
English: At least five weeks should elapse between discontinuation of fluoxetine and initiation of treatment with rasagiline.
Slovenian: Od prekinitve zdravljenja s fluoksetinom in do začetka zdravljenja z razagilinom mora preteči najmanj pet tednov.
English: • musculoskeletal pain
Slovenian: Bolezni krvi in limfatičnega sistema
English: Common: flatulence (1.3% vs.0%)
Slovenian: Pogosti: levkopenija (1,3% proti 0%)
English: General disorders and administration site conditions Common: fever (2.7% vs. 1.3%), malaise (2% vs. 0%)
Slovenian: Pogosti: siljenje na uriniranje (1,3% proti 0,7%) Splošne težave in spremembe na mestu aplikacije Pogosti: vročica (2,7% proti 1,3%), slabo počutje (2,0% proti 0%)
English: • Common (may affect up to 1 in 10 people)
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov)
English: Tel: + 49-(0) 6172 888 01
Slovenian: Mylan dura GmbH Tel: + 49-(0) 61 72 888 01
English: How to store Rasagiline Mylan
Slovenian: Shranjevanje zdravila Razagilin Mylan
English: Cellulose, microcrystalline Tartaric acid
Slovenian: 6.1 Seznam pomožnih snovi mikrokristalna celuloza vinska kislina koruzni škrob predgelirani koruzni škrob smukec stearinska kislina
English: • prolonged muscle contractions (dystonia)
Slovenian: Zelo pogosti nenavadni gibi (diskinezija) glavobol
English: What Rasagiline Mylan contains - The active substance is rasagiline.
Slovenian: Zdravilna učinkovina je razagilin.
English: Uncommon: vesiculobullous rash (0.7% vs. 0%)
Slovenian: Občasni: možgansko-žilni dogodek (0,7% proti 0%)
English: Uncommon: decreased appetite (0.7% vs. 0%) Psychiatric disorders
Slovenian: Občasni: vezikulobulozni izpuščaj (0,7% proti 0%) Bolezni mišično-skeletnega sistema in vezivnega tkiva
English: After oral administration of
Slovenian: Po peroralni uporabi s
English: SN:
Slovenian: D.
English: Turn over to continue…
Slovenian: Obrnite za nadaljevanje
English: Read other side first
Slovenian: 2. stran Najprej preberite drugo stran
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
English: Date of first authorisation: April 2015
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: April 2015
English: Store in a refrigerator (2C - 8C).
Slovenian: Shranjujte v hladilniku (2 C - 8 C ).
English: The concentration is 10 mg/ml based on protein only**.
Slovenian: Koncentracija je 10 mg/ml na podlagi beljakovine same **.
English: Do not warm Ristempa in any other way (for example, do not warm it in a microwave or in hot water).
Slovenian: Zdravila Ristempa ne smete segrevati na kak drug način (na primer, ne segrevajte v mikrovalovni pečici ali v vroči vodi).
English: See section “Description of selected adverse reactions” below.
Slovenian: Glejte poglavje »Opis izbranih neželenih učinkov« spodaj.
English: Ristempa is for use in adults aged 18 and over.
Slovenian: Zdravilo Ristempa je namenjeno uporabi pri odraslih, starih 18 ali več let.
English: The frequency category was estimated from a statistical calculation based upon 1576 patients receiving Ristempa in nine randomized clinical trials.
Slovenian: Kategorija pogostnosti je ocenjena s statističnim izračunom na podlagi podatkov o 1576 bolnikih, ki so prejemali zdravilo Ristempa v devetih randomiziranih kliničnih preskušanjih.
English: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Slovenian: Zato moramo skrbno spremljati velikost vranice (denimo, s kliničnim pregledom, ultrazvokom).
English: Before you inject Ristempa you must do the following:
Slovenian: Pred injiciranjem zdravila Ristempa, morate narediti naslednje:
English: • if you are allergic to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of this medicine.
Slovenian: • če ste alergični na pegfilgrastim, filgrastim, beljakovine, ki izvirajo iz E. coli, ali katero koli sestavino tega zdravila.
English: RELEASE your thumb.
Slovenian: ODMAKNITE palec.
English: What Ristempa is and what it is used for
Slovenian: Kaj je zdravilo Ristempa in za kaj ga uporabljamo
English: This section contains information on how to give yourself an injection of Ristempa.
Slovenian: To poglavje vsebuje informacije o tem, kako si sami injicirate zdravilo Ristempa.
English: What should I do before I give myself a subcutaneous injection of Ristempa?
Slovenian: Kaj moram narediti, preden si dam subkutano injekcijo zdravila Ristempa?
English: Your doctor may decide that it would be more convenient for you to inject Ristempa yourself.
Slovenian: Mogoče se bo zdravnik odločil, da bi bilo za vas prikladneje, če si zdravilo Ristempa injicirate sami.
English: How do you, or the person injecting you, use Ristempa pre-filled syringe?
Slovenian: Kako naj vi sami ali oseba, ki vam injicira zdravilo, uporabite napolnjeno injekcijsko brizgo zdravila Ristempa?
English: Therefore, physicians should use caution when prescribing Ristempa in patients with sickle cell trait or sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicine with splenic enlargement and vaso-occlusive crisis.
Slovenian: Zato morajo biti zdravniki previdni, kadar predpisujejo zdravilo Ristempa bolnikom s srpastocelično dispozicijo ali s srpastocelično anemijo, spremljati morajo ustrezne klinične parametre in laboratorijski status in biti pozorni na morebitno povezavo tega zdravila z zvečanjem vranice in vazookluzivno krizo.
English: • Ristempa is given as an injection into the tissue just under the skin (subcutaneous injection).
Slovenian: • Zdravilo Ristempa se daje kot injekcija v tkivo tik pod kožo (subkutano injiciranje).
English: Ristempa therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
Slovenian: Zdravljenje z zdravilom Ristempa morajo uvesti in nadzorovati zdravniki, izkušeni v onkologiji in/ali hematologiji.
English: Ristempa has not been tested in pregnant women.
Slovenian: Zdravila Ristempa pri nosečnicah niso preskusili.
English: Ristempa left at room temperature for more than 72 hours should be discarded.
Slovenian: Zdravilo Ristempa, ki je bilo na sobni temperaturi več kot 72 ur, je treba zavreči.
English: Your doctor has given you Ristempa to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.
Slovenian: Vaš zdravnik vam je predpisal zdravilo Ristempa, da bi spodbudilo vaš kostni mozeg (tisti del kosti, ki izdeluje krvničke) k izdelavi več belih krvničk, ki pomagajo vašemu telesu boriti se proti okužbam.
English: This adverse reaction was identified through post-marketing surveillance but not observed in randomised, controlled clinical trials in adults.
Slovenian: Ti neželeni učinki so bili ugotovljeni med spremljanjem v obdobju trženja zdravila, niso pa jih opažali v randomiziranih, kontroliranih kliničnih preskušanjih pri odraslih.
English: Specific interaction or metabolism studies have not been performed, however, clinical trials have not indicated an interaction of Ristempa with any other medicinal products.
Slovenian: Posebnih študij medsebojnega delovanja ali presnove niso izvedli, vendar klinična preskušanja niso pokazala medsebojnega delovanja zdravila Ristempa s kakšnimi drugimi zdravili.
English: However, the long-term effects of Ristempa have not been established in acute myeloid leukaemia; therefore, it should be used with caution in this patient population.
Slovenian: Vendar dolgoročni učinki zdravila Ristempa pri akutni mieloični levkemiji niso ugotovljeni, zato ga je treba pri tej populaciji bolnikov uporabljati previdno.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Ristempa therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Ristempa, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: The safety and efficacy of Ristempa in children has not yet been established.
Slovenian: Varnost in učinkovitost zdravila Ristempa pri otrocih še nista bili dokazani.
English: If you develop or are likely to develop cancers of the blood, you should not use Ristempa, unless instructed by your doctor.
Slovenian: Če se vam bodo pojavili ali je verjetno, da se vam bodo pojavili krvni raki, ne smete uporabljati zdravila Ristempa, razen če vam to naroči zdravnik.
English: Do not touch the needle or push the plunger.
Slovenian: Ne dotaknite se igle in ne pritiskajte na bat
English: Do not shake Ristempa vigorously as this may affect its activity.
Slovenian: Zdravila Ristempa ne smete močno stresati, ker to lahko vpliva na njegovo delovanje.
English: The potency of this product should not be compared to the potency of another pegylated or nonpegylated protein of the same therapeutic class.
Slovenian: Učinkovitosti tega zdravila se ne sme primerjati z učinkovitostjo drugih pegiliranih ali nepegiliranih proteinov iz iste terapevtske skupine.
English: • serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty
Slovenian: • resne alergijske reakcije, vključno z anafilaksijo (slabost, padec krvnega tlaka, težave z
English: The data in the table below describe adverse reactions reported from clinical trials and spontaneous reporting.
Slovenian: Podatki v spodnji tabeli opisujejo neželene učinke, zabeležene v kliničnih preskušanjih in med spontanim poročanjem.
English: In clinical trials, Ristempa has been safely administered 14 days before chemotherapy.
Slovenian: V kliničnih preskušanjih so zdravilo Ristempa varno dajali 14 dni pred kemoterapijo.
English: Before you use a Ristempa pre-filled syringe with automatic needle guard, read this important information:
Slovenian: Pred uporabo zdravila Ristempa v napolnjeni injekcijski brizgi z avtomatskim ščitnikom igle preberite te pomembne informacije:
English: This can be a sign of Acute Respiratory Distress Syndrome (ARDS)
Slovenian: To je lahko znak sindroma akutne dihalne stiske (ARDS).
English: The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and musculoskeletal pain (common).
Slovenian: Neželena učinka, o katerih so najpogosteje poročali, sta bila bolečina v kosteh (zelo pogosto [≥ 1/10]) in mišičnoskeletna bolečina (pogosto).
English: The mechanism of vasculitis in patients receiving Ristempa is unknown.
Slovenian: Mehanizem vaskulitisa pri bolnikih, ki prejemajo zdravilo Ristempa, ni znan.
English: What Ristempa is and what it is used for What you need to know before you use Ristempa
Slovenian: Kaj je zdravilo Ristempa in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Ristempa
English: Ristempa may be used if it is accidentally frozen for a single period of less than 24 hours.
Slovenian: Zdravila Ristempa smete uporabiti, če je bilo pomotoma zamrznjeno eno samo obdobje, krajše od 24 ur.
English: Check the appearance of Ristempa.
Slovenian: Preverite videz zdravila Ristempa.
English: This medicinal product must not be mixed with other medicinal products, particularly with sodium chloride solutions.
Slovenian: Zdravilo se ne sme mešati z drugimi zdravili, predvsem z raztopinami natrijevega klorida.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se z njim posvetujte, preden uporabite to zdravilo.
English: In such circumstances Ristempa should be discontinued at the discretion of the physician and the appropriate treatment given (see section 4.8).
Slovenian: V takih primerih je treba zdravilo Ristempa po presoji zdravnika prenehati dajati in poskrbeti za ustrezno zdravljenje (glejte poglavje 4.8).
English: Ristempa has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Ristempa nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: What you need to know before you use Ristempa
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Ristempa
English: If you forget to inject Ristempa
Slovenian: Če ste si pozabili injicirati zdravilo Ristempa
English: Do not use Ristempa
Slovenian: Ne uporabljajte zdravila Ristempa
English: The safety and efficacy of Ristempa administration in de novo AML patients aged  55 years with cytogenetics t(15;17) have not been established.
Slovenian: Varnost in učinkovitost uporabe zdravila Ristempa pri bolnikih z de novo AML, mlajših od 55 let in s citogenetiko t(15;17), nista ugotovljeni.
English: The safety and efficacy of Ristempa for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
Slovenian: Varnosti in učinkovitosti zdravila Ristempa za mobilizacijo matičnih krvotvornih celic pri bolnikih ali zdravih dajalcih niso primerno ovrednotili.
English: Your doctor will check your blood and urine regularly as Ristempa can harm the tiny filters inside your kidneys (glomerulonephritis).
Slovenian: Zdravnik vam bo redno kontroliral kri in urin, kajti zdravilo Ristempa lahko okvari drobne filtre v ledvicah (povzroči glomerulonefritis).
English: Ristempa may be exposed to room temperature (not above 30C) for a maximum single period of up to 72 hours.
Slovenian: Zdravilo Ristempa sme biti izpostavljeno sobni temperaturi (ne nad 30 C) za enkratno obdobje, ki ne sme preseči 72 ur.
English: In animal models concomitant administration of Ristempa and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Slovenian: Pokazali so, da v živalskih modelih sočasna uporaba zdravila Ristempa in 5-fluorouracila (5-FU) ali drugih antimetabolitov okrepi mielosupresijo.
English: Uncommon side effects (may affect up to 1 in 100 people): • allergic-type reactions, including redness and flushing, skin rash, and raised areas of the skin
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): • reakcije alergijske vrste, vključno s pordelostjo in zardevanjem, izpuščajem na koži in
English: EU/1/15/996/001 1 pack blistered syringe EU/1/15/996/002 1 pack unblistered syringe EU/1/15/996/003 1 pack blistered syringe with needle guard
Slovenian: EU/1/15/996/001 - pakiranje po 1 v pretisnem omotu EU/1/15/996/002 - pakiranje po 1 brez pretisnega omota EU/1/15/996/003 - pakiranje po 1 v pretisnem omotu s ščitnikom igle
English: Your doctor may want to monitor you more closely
Slovenian: Zdravnik vas bo morda moral natančneje kontrolirati.
English: For more information, see section 5.1
Slovenian: Za podrobnosti glejte poglavje 5.1.
English: Other medicines and Ristempa
Slovenian: Druga zdravila in zdravilo Ristempa
English: 9/l after the expected nadir, this medicine should be discontinued immediately.
Slovenian: 9/l, je treba nemudoma prenehati z zdravljenjem s tem zdravilom.
English: Uncommonly, cases have resulted in respiratory failure or Acute Respiratory Distress Syndrome (ARDS), which may be fatal (see section
Slovenian: Občasno so ti primeri povzročili respiratorno insuficienco ali sindrom akutne dihalne stiske (ARDS), ki sta lahko smrtno nevarna (glejte poglavje
English: Elevations in lactate dehydrogenase and alkaline phosphatase Transient elevations in LFT's for ALT or AST1
Slovenian: Preiskave zvišanje laktatdehidrogenaze in alkalne fosfataze1, prehodno zvišanje jetrnih funkcijskih testov za ALT ali AST1
English: If you become pregnant during Ristempa treatment, please inform your doctor.
Slovenian: Če med zdravljenjem z zdravilom Ristempa zanosite, o tem obvestite zdravnika.
English: If you have forgotten a dose of Ristempa, you should contact your doctor to discuss when you should inject the next dose.
Slovenian: Če ste pozabili odmerek zdravila Ristempa, se posvetujte z zdravnikom glede tega, kdaj si boste injicirali naslednji odmerek.
English: The safety and efficacy of Ristempa have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary Acute Myeloid Leukaemia (AML); therefore, it should not be used in such patients.
Slovenian: Varnost in učinkovitost zdravila Ristempa nista raziskani pri bolnikih z mielodisplastičnim sindromom, s kronično mielogeno levkemijo in s sekundarno akutno mieloično levkemijo (AML), zato ga pri takšnih bolnikih ne smete uporabljati.
English: Profile of Median Pegfilgrastim Serum Concentration and Absolute Neutrophil Count (ANC) in Chemotherapy Treated Patients after a Single 6 mg Injection
Slovenian: Profil mediane serumske koncentracije pegfilgrastima in absolutnega števila nevtrofilcev (ANC - 'Absolute Neutrophil Count') pri bolnikih, zdravljenih s kemoterapijo, po eni sami 6 miligramski injekciji
English: Do not administer Ristempa to patients with a history of hypersensitivity to pegfilgrastim or filgrastim.
Slovenian: Zdravila Ristempa ne dajajte bolnikom z anamnezo preobčutljivosti na pegfilgrastim ali filgrastim.
English: You may be encouraged to enrol in Amgen's Pregnancy Surveillance programme.
Slovenian: Lahko vam bo priporočil, da se vključite v program družbe Amgen za spremljanje nosečnosti.
English: Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30C) it must either be used within 3 days or disposed of.
Slovenian: Ko injekcijsko brizgo vzamete iz hladilnika in le-ta doseže sobno temperaturo (pod 30 ºC), jo morate bodisi v 3 dneh porabiti ali pa zavreči.
English: Reference Guide - Read all instructions found in the carton before use
Slovenian: Kratka navodila - Pred uporabo preberite celotna navodila, ki jih najdete v škatli!
English: Treatment with Ristempa alone does not preclude thrombocytopenia and anaemia because full dose myelosuppressive chemotherapy is maintained on the prescribed schedule.
Slovenian: Zdravljenje s samim zdravilom Ristempa ne prepreči trombocitopenije in anemije, ker se hkrati vzdržuje mielosupresivna kemoterapija s polnimi odmerki po predpisani shemi.
English: Nine hundred and twenty eight patients were randomised to receive either a single dose of pegfilgrastim or placebo approximately 24 hours (Day 2) after chemotherapy in each cycle.
Slovenian: Devetstoosemindvajset bolnic so randomizirali na en odmerek pegfilgrastima ali placeba, uporabljen približno 24 ur (2. dan) po kemoterapiji v vsakem ciklusu.
English: The pharmacokinetics of pegfilgrastim were studied in 37 paediatric patients with sarcoma, who received 100 μg/kg pegfilgrastim after the completion of VAdriaC/IE chemotherapy.
Slovenian: Farmakokinetiko pegfilgrastima so raziskali pri 37 pediatričnih bolnikih s sarkomom, ki so po dokončanju kemoterapije z VAdriaC/IE dobili 100 µg/kg pegfilgrastima.
English: Sweet's syndrome (acute febrile dermatosis) Cutaneous vasculitis
Slovenian: Sweetov sindrom (akutna febrilna dermatoza) kožni vaskulitis1,2
English: What Ristempa looks like and contents of the pack Ristempa is a clear, colourless solution for injection in a pre-filled syringe (6 mg/0.6 ml).
Slovenian: Izgled zdravila Ristempa in vsebina pakiranja Zdravilo Ristempa je bistra, brezbarvna raztopina za injiciranje v napolnjeni injekcijski brizgi (6 mg/0,6 ml).
English: Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Ristempa.
Slovenian: Če je zdravilo Ristempa pomotoma izpostavljeno temperaturam pod lediščem za enkratno obdobje, ki ne preseže 24 ur, to ne škoduje njegovi stabilnosti.
English: The safety and efficacy of Ristempa have not been investigated in patients receiving high dose chemotherapy.
Slovenian: Varnosti in učinkovitosti zdravila Ristempa niso raziskovali pri bolnikih, ki prejemajo kemoterapijo v velikih odmerkih.
English: A Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container
Slovenian: A Vzemite podlogo z napolnjeno injekcijsko brizgo iz pakiranja in pripravite opremo, potrebno za injiciranje: alkoholne zložence, kosem vate ali zloženec gaze, obliž in vsebnik za ostre odpadke