FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious haematological adverse reactions such as pancytopenia, agranulocytosis and haemolytic anaemia have been reported following systemic administration of levofloxacin.
Slovenian: Po sistemski uporabi levofloksacina so poročali o resnih hematoloških neželenih učinkih, kot so pancitopenija, agranulocitoza in hemolitična anemija.
English: Once opened, use immediately.
Slovenian: Po odprtju ampule vsebino takoj uporabite.
English: 56 (14 sachets of 4) ampoules This pack also contains one Zirela Nebuliser Handset.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA inhalacijska raztopina za nebulator 56 ampul (14 vrečic s po 4 ampulami) To pakiranje vsebuje tudi en nebulator Zirela.
English: Cycles 1 to 6), the LS Mean change in FEV1 percent predicted ranged between 3.6% to 4.6% except in Cycle 6, where it was close to baseline (-0.15%).
Slovenian: Za podskupino bolnikov, ki so prejemali zdravilo Quinsair ves čas osrednje faze in faze podaljška (tj. 1. do 6. cikel), je bila sprememba povprečne vrednosti LS za napovedani odstotek FEV1 v razponu od 3,6% do 4,6%, razen v 6. ciklu, kjer je bila blizu izhodišča (-0,15%).
English: Reduced susceptibility to levofloxacin can also result from acquisition of plasmids encoding proteins that protect these targets from inhibition.
Slovenian: Odpornost proti levofloksacinu se najpogosteje razvije v stopenjskem procesu in sicer z mutacijami ciljnih mest v DNA girazi in v topoizomerazi IV. Zmanjšana občutljivost za levofloksacin je lahko tudi posledica pridobitve beljakovin, ki kodirajo plazmide, in ščitijo ta ciljna mesta pred zaviranjem.
English: Very rare cases of prolonged (continuing months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple, body systems (musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk factors.
Slovenian: Pri bolnikih, ki so prejemali kinolone in fluorokinolone, so, neodvisno od njihove starosti in obstoječih dejavnikov tveganja, poročali o zelo redkih primerih dolgotrajnih (trajanje več mesecev ali let), onesposabljajočih in potencialno ireverzibilnih neželenih učinkov, ki so vplivali na različne organske sisteme, včasih na več njih (mišično-skeletni sistem, živčevje, duševnost in čutila).
English: 6.6 Special precautions for disposal and other handling For single use only.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
English: • Pregnancy.
Slovenian: • nosečnost
English: Talk to your doctor if you have any concerns or questions about this.
Slovenian: Če imate v tej zvezi kakršne koli pomisleke ali vprašanja, se posvetujte z zdravnikom.
English: The adverse reactions with at least a reasonable possibility of a causal relationship with levofloxacin are presented according to the MedDRA System Organ Classification.
Slovenian: Neželeni učinki z vsaj razumno možnostjo vzročne zveze z levofloksacinom so predstavljeni po razvrstitvi na organske sisteme v skladu z MedDRA. Neželeni učinki zdravila so razvrščeni po pogostnosti, pri čemer so najresnejši neželeni učinki našteti prvi.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Quinsair 240 mg nebuliser solution
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Quinsair 240 mg inhalacijska raztopina za nebulator levofloksacin za inhaliranje
English: How to store Quinsair
Slovenian: Shranjevanje zdravila Quinsair
English: If you are using several different inhaled treatments and other therapies for cystic fibrosis, it is recommended that you use your medicines in the following order: 1st
Slovenian: Če uporabljate več različnih zdravljenj z inhaliranjem in druge terapije za cistično fibrozo, je priporočljivi vrstni red jemanja zdravil naslednji: bronhodilatatorji, dornaza alfa, tehnike čiščenja dihalnih poti, zdravilo Quinsair, inhalirani steroidi.
English: Benign intracranial hypertension
Slovenian: Žilne bolezni hipotenzija
English: Talk to your doctor if you have any questions about this.
Slovenian: Če imate v zvezi s tem kakršna koli vprašanja, se posvetujte z zdravnikom.
English: Ear and labyrinth disorders1
Slovenian: Ušesne bolezni, vključno z motnjami labirinta1
English: Tremor
Slovenian: vrtoglavica
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema anemija*, nevtropenija*
English: Post-marketing serious adverse reactions, including deaths and the requirements for respiratory support, have been associated with fluoroquinolone use in patients with myasthenia gravis.
Slovenian: V obdobju po začetku trženja je bila uporaba fluorokinolonov pri bolnikih z miastenijo gravis povezana z resnimi neželenimi učinki, vključno s smrtjo in potrebo po dihalni podpori.
English: Vomiting, Abdominal pain*, Diarrhoea* Constipation*
Slovenian: Bolezni prebavil navzea, bruhanje, bolečine v trebuhu*, driska*, zaprtje*
English: Quinsair
Slovenian: Zdravilo Quinsair
English: PHARMACEUTICAL FORM AND CONTENTS Nebuliser solution
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA inhalacijska raztopina za nebulator 4 ampule
English: If you experience breathing difficulties when you use Quinsair what additional medicine may your doctor prescribe for you?
Slovenian: Katera dodatna zdravila vam lahko zdravnik predpiše, če se med uporabo zdravila Quinsair pojavijo težave z dihanjem?
English: Immune system disorders
Slovenian: Bolezni imunskega sistema preobčutljivost*
English: Very rare cases of long lasting (up to months or years) or permanent adverse drug reactions, such as tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre-existing risk factors.
Slovenian: Z uporabo kinolonskih in fluorokinolonskih antibiotikov, v nekaterih primerih ne glede na obstoječe dejavnike tveganja, so povezani zelo redki primeri dolgotrajnih (več mesecev ali let trajajočih) ali trajnih neželenih učinkov, kot so vnetja kit, pretrganje kit, bolečine v sklepih, bolečine v okončinah, težave pri hoji, nenormalni občutki, kot so mravljinčenje, ščemenje, žgečkanje, skelenje, odrevenelost ali bolečina (nevropatija), depresija, utrujenost, motnje spanja, motnje spomina, kot tudi okvara sluha, vida, okusa in vonja.
English: Stevens-Johnson syndrome,
Slovenian: Schwartzeve formule pri bolnikih < 18 let).
English: NAME OF THE MEDICINAL PRODUCT Quinsair 240 mg nebuliser solution Levofloxacin
Slovenian: Quinsair 240 mg inhalacijska raztopina za nebulator Levofloksacin
English: - Heart rhythm abnormalities
Slovenian: - Nenormalnosti srčnega ritma
English: Sputum PK exposure in children aged 7 to 16 years old was approximately one-third of adult exposure.
Slovenian: FK izpostavljenosti v serumu so bile podobne pri otrocih, ki so prejemali režim na podlagi telesne mase, kot pri odraslih, ki so prejemali zdravilo Quinsair 240 mg enkrat na dan. FK izpostavljenost v sputumu pri otrocih, starih 7 do 16 let, je znašala približno eno tretjino izpostavljenosti odraslih.
English: Tabulated list of additional adverse reactions reported following systemic administration of levofloxacin
Slovenian: Dodatni neželeni učinki, o katerih so poročali po sistemski uporabi levofloksacina, v obliki preglednice
English: and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics).
Slovenian: • sočasni uporabi učinkovin, za katere je znano, da podaljšujejo interval QT (npr. antiaritmikov iz skupine IA in III, tricikličnih antidepresivov, makrolidov, antipsihotikov),
English: On the front of the ampoule tail Quinsair 240 mg
Slovenian: Na sprednji strani spodnjega dela ampule Quinsair 240 mg inhalacijska raztopina za nebulator levofloksacin za inhaliranje
English: Metabolism and nutrition disorders
Slovenian: Presnovne in prehranske motnje hipoglikemična koma
English: ciprofloxacin or ofloxacin, or to any of the other ingredients of this medicine (listed in section 6) - if you have ever had a problem with your tendons (inflammation of a tendon or a ruptured tendon) during treatment with a quinolone or fluoroquinolone antibiotic - if you suffer from epilepsy - if you are pregnant or breast-feeding
Slovenian: - če ste med zdravljenjem s kakšnim kinolonskim ali fluorokinolonskim antibiotikom kdaj imeli težave s tetivami (vnetje tetive ali raztrganje tetive).
English: Cardiac disorders
Slovenian: Srčne bolezni tahikardija*
English: Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop such as anorexia, jaundice, dark urine, pruritus or tender abdomen.
Slovenian: V primeru, da se pojavijo znaki in simptomi nastanka jetrnega obolenja, kot so anoreksija, zlatenica, temno obarvan urin, srbež ali boleč abdomen, je treba bolniku svetovati, da prekine z zdravljenjem in o tem obvesti zdravnika.
English: Haemoptysis
Slovenian: Ampula
English: Each ampoule contains 240 mg of levofloxacin,
Slovenian: Ena ampula vsebuje količino levofloksacin hemihidrata,
English: What Quinsair looks like and contents of the pack Quinsair is a clear, pale yellow nebuliser solution.
Slovenian: Zdravilo Quinsair je bistra, bledorumena inhalacijska raztopina za nebulator.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LOW DENSITY POLYETHYLENE AMPOULE
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 September 2008.
Slovenian: DATUM PRVE PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja za promet: 15. september 2008.
English: POSSIBLE SIDE EFFECTS”).
Slovenian: MOŽNI NEŽELENI UČINKI«).
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Slovenian: • ko so na voljo nove informacije, ki bi lahko vplivale na trenutna določila o varnosti, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganj
English: Detailed information on this medicinal product is available on the website of the European Medicines
Slovenian: Podrobni podatki o zdravilu so objavljene na spletni strani Evropske agencije za zdravila
English: It is also very important that you call your doctor if you think you may have an infection.
Slovenian: Prav tako je pomembno, da pokličete svojega zdravnika, če sumite, da imate okužbo.
English: Although this interaction has not been formally investigated, there is no evidence that such an
Slovenian: Čeprav te interakcije niso uradno raziskali, ni dokazov, da bi bilo takšno medsebojno delovanje škodljivo.
English: The volume of distribution in blood is approximately 150 ml/kg.
Slovenian: Volumen porazdelitve v krvi znaša približno 150 ml/kg.
English: Name and address of the manufacturer of the biological active substance SICOR Biotech UAB
Slovenian: Ime in naslov izdelovalca biološke zdravilne učinkovine SICOR Biotech UAB
English: Not known:
Slovenian: Nepoznani:
English: It is important to tell your doctor if you are pregnant, think you may be pregnant or plan to get pregnant, as the doctor may decide that you
Slovenian: Pomembno je, da poveste svojemu zdravniku, če ste noseči; mislite, da bi utegnili biti noseči; ali načrtujete zanositev, saj se v tem primeru zdravnik lahko odloči, da ne smete jemati tega zdravila.
English: During clinical studies 541 cancer patients and 188 healthy volunteers were exposed to Filgrastim ratiopharm.
Slovenian: Med kliničnimi študijami je bilo zdravilu Filgrastim ratiopharm izpostavljenih 541 bolnikov z rakom in 188 zdravih prostovoljcev.
English: The recommendation of a minimum yield of 2.0 x 106 CD34+ cells/kg is based on published experience resulting in adequate haematologic reconstitution.
Slovenian: Priporočilo o minimalnem številu 2,0 x 106 CD34+ celic/kg temelji na objavljenih izkušnjah, ki so prispevale k ustrezni hematološki sliki.
English: This medicine is given by injection, either through an intravenous infusion (drip) or into the tissue just under the skin.
Slovenian: To zdravilo se daje z injekcijo, bodisi z intravensko infuzijo (kapalna) ali v tkivo tik pod kožo.
English: The degree of variation between individual patients and between laboratory assays of CD34+ cells mean that direct comparison between different studies is difficult.
Slovenian: Stopnja sprememb med posameznimi bolniki in laboratorijskimi poskusi s celicami CD34+ pomeni, da je neposredna primerjava med različnimi raziskavami težka.
English: You will find detailed information about the ingredient sorbitol (a sugar) in section 2. under the heading “Important information about some of the ingredients of Filgrastim ratiopharm”.
Slovenian: Podrobne podatke o sorbitolu (vrsta sladkorja) boste našli v poglavju 2 pod “ Pomembne informacije o nekaterih sestavinah zdravila ratiogratsim”.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: Thirty-one percent (31%) of patients in studies were documented as having palpable splenomegaly.
Slovenian: Pri enaintridesetih odstotkih (31%) bolnikov, ki so sodelovali v raziskavah, so zabeležili otipljivo splenomegalijo.
English: The most suitable places to inject yourself are: - the abdomen, except for the area around the navel (see picture 3).
Slovenian: Najprimernejši mesti za samoinjiciranje sta: - trebuh, razen predela okrog popka (glejte sliko 3).
English: Pharmacotherapeutic group: Colony stimulating factors, ATC code: L03AA02
Slovenian: Farmakoterapevtska skupina: faktorji, ki spodbujajo rast kolonij, oznaka ATC: L03AA02
English: If you have a fever or any of these symptoms, contact your doctor immediately and go straight to
Slovenian: Če imate zvišano telesno temperaturo ali katerega koli izmed teh simptomov, nemudoma pokličite svojega zdravnika in pojdite naravnost v bolnišnico.
English: Disinfect your skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 5).
Slovenian: Razkužite si kožo z alkoholno krpico in primite kožo s palcem in kazalcem, ne da bi jo stiskali (glejte sliko5).
English: Other special precautions Causes of transient neutropenia such as viral infections should be excluded.
Slovenian: Potrebno je izključiti vzroke prehodne nevtropenije, kot so npr. virusne okužbe.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Slovenian: • v 60-ih dneh od pomembnega (farmakovigilanca ali zmanjšanje tveganja) dogodka • na zahtevo organizacije EMEA
English: Put the needle fully into the skin as shown by your nurse or doctor (see picture 6).
Slovenian: Potisnite iglo do konca v kožo, kot vam je pokazal zdravnik ali medicinska sestra (glejte sliko
English: Regular monitoring of blood counts is recommended (see
Slovenian: Priporoča se redno spremljanje števila krvnih celic (glejte zgoraj).
English: frequency cannot be estimated from the available data.
Slovenian: iz razpoložljivih podatkov pogostosti ni mogoče oceniti.
English: Statistical analysis of the relationship between the number of CD34+ cells re-infused and the rate of platelet recovery after high-dose chemotherapy indicates a complex but continuous relationship.
Slovenian: Statistična analiza odnosa med številom ponovno infundiranih celic CD34+ in hitrostjo obnovitve trombocitov po visoko-odmerni kemoterapiji kaže na zapleteno ampak stalno povezavo.
English: Filgrastim ratiopharm treatment will last for up to 2 weeks and in exceptional cases longer.
Slovenian: Zdravljenje z zdravilom Filgrastim ratiopharm bo trajalo do dveh tednov, le v izjemnih primerih bo trajalo dlje.
English: less than 1 user in 10,000
Slovenian: manj kot 1 bolnik od 10.000 bolnikov
English: If the patient is experiencing fatigue, caution is advised when driving a car or operating machinery.
Slovenian: Če se bolnik počuti utrujenega, mora biti pri vožnji avtomobila ali pri upravljanju s stroji previden.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report
Slovenian: Glede na Smernico CHMP o sistemih za upravljanje s tveganji za zdravila v humani medicini, je potrebno posodobljen Načrt za upravljanje s tveganji oddati istočasno kot periodično poročilo o varnosti zdravila (PSUR).
English: Filgrastim ratiopharm is useful in several different conditions which are:
Slovenian: Zdravilo Filgrastim ratiopharm pomaga pri več različnih stanjih, med katere spadajo:
English: Push the plunger up to the number (ml) on the syringe that matches the dose of Filgrastim ratiopharm that your doctor prescribed.
Slovenian: Bat potisnite navzgor do številke (ml), ki se sklada z odmerkom zdravila Filgrastim ratiopharm, ki vam ga je predpisal vaš zdravnik.
English: aAnalysis includes studies involving bone marrow transplant during this period; some studies used GM-CSF (granulocyte-macrophage-colony stimulating factor) bAnalysis includes patients receiving bone marrow transplant during this period
Slovenian: aAnaliza vključuje študije, ki zajemajo presaditev kostnega mozga v tem obdobju; nekatere študije uporabljajo GM-CSF (faktor, ki spodbuja rast granulocitno-makrofagnih kolonij) bAnaliza vključuje bolnike, ki jim je bil v tem obdobju presajen kostni mozeg
English: The results of flow cytometric analysis of CD34+ cell numbers vary depending on the precise methodology used and therefore, recommendations of numbers based on studies in other laboratories need to be interpreted with caution.
Slovenian: Izidi pretočne citometrične analize števila celic CD34+ se spreminjajo glede na uporabljeno metodologijo, zaradi česar moramo biti pri vrednotenju priporočil o številu, ki temeljijo na različnih raziskavah iz drugih laboratorijev, previdni.
English: Hypersensitivity to the active substance or to any of the excipients.
Slovenian: Preobčutljivost na zdravilno učinkovino ali katerokoli pomožno snov.
English: Do not use it if the date has passed
Slovenian: Ne uporabite ga, če je zadnji dan navedenega meseca že potekel.
English: Cough, sore throat
Slovenian: Pogosti kašelj, vneto grlo
English: Do not warm Filgrastim ratiopharm in any other way (for example, do not warm it in a microwave or in hot
Slovenian: Zdravila Filgrastim ratiopharm ne smete segrevati na kak drug način (na primer v mikrovalovni pečici ali v vroči vodi).
English: This is known as a subcutaneous injection.
Slovenian: Temu se reče subkutano injiciranje.
English: Type I glass pre-filled syringe with a permanently attached stainless steel needle.
Slovenian: Napolnjena injekcijska brizga stekla tipa I s trajno pritrjeno nerjavečo jekleno iglo.
English: Relative risk (95% CI) of GvHD and TRM following treatment with G-CSF after bone marrow
Slovenian: Relativno tveganje (95-% IZ) za GvHD in TRM po zdravljenju z G-CSF po presaditvi kostnega
English: There are many ways an infection may show itself.
Slovenian: Okužbe se kažejo na različne načine.
English: Randomised, single-blind, single dose, crossover studies in 196 healthy volunteers showed that the pharmacokinetic profile of Filgrastim ratiopharm was comparable to that of the reference product after subcutaneous and intravenous administration.
Slovenian: Randomizirane, enojno slepe navzkrižne študije z enkratnim odmerkom pri 196 zdravih prostovoljcih so pokazale, da je farmakokinetičen profil zdravila Filgrastim ratiopharm primerljiv s profilom referenčnega zdravila po subkutanem in intravenskem apliciranju.
English: When diluted in glucose 50 mg/ml (5%) solution for infusion, Filgrastim ratiopharm is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Slovenian: Če je razredčeno v glukozi 50 mg/ml (5%) raztopini za infundiranje, je zdravilo Filgrastim ratiopharm kompatibilno s steklom in vrsto plastičnih snovi, med katerimi so PVC, poliolefin (kopolimer polipropilena in polietilena) in polipropilen.
English: Patients with rare hereditary problems of fructose intolerance should not use this medicinal product.
Slovenian: Bolniki z redkimi dednimi boleznimi in tisti, ki ne prenašajo fruktoze, ne bi smeli jemati tega zdravila.
English: Important information about some of the ingredients of Filgrastim ratiopharm This medicine contains sorbitol (a type of sugar).
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Filgrastim ratiopharm To zdravilo vsebuje sorbitol (vrsta sladkorja).
English: For patients who have not had extensive chemotherapy, one leukapheresis is often sufficient.
Slovenian: Pri bolnikih, ki niso bili izpostavljeni dolgotrajni kemoterapiji, ponavadi zadošča ena levkafereza.
English: However, since a significant percentage of these patients were suffering from leukaemia, a condition known to be associated with Sweet's syndrome, a causal relationship with filgrastim has not been
Slovenian: Ker pa je velik odstotek teh bolnikov obolelih za levkemijo (gre za stanje, za katerega vemo, da je povezano s Sweetovim sindromom), vzročna povezava s filgrastimom ni bila ugotovljena.
English: The efficacy and safety of Filgrastim ratiopharm has been assessed in randomised, controlled phase III studies in breast cancer, lung cancer and Non-Hodgkin-Lymphoma.
Slovenian: Učinkovitost in varnost Filgrastim ratiopharma sta bili ocenjeni v randomiziranih in nadzorovanih študijah faze III pri bolnikih z rakom dojk, rakom na pljučih in Ne-Hodkinovim limfomom.
English: If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Slovenian: Če imate kakršnekoli težave, naj vas ne bo strah poprositi svojega zdravnika ali medicinske sestre za
English: Possible interactions with other haematopoietic growth factors and cytokines have not yet been
Slovenian: Možnih interakcij z drugimi hemotopoetičnimi rastnimi faktorji in citokini v kliničnih študijah niso
English: Before you inject Filgrastim ratiopharm you must do the following: Hold the syringe barrel and gently take the cover from the needle without twisting.
Slovenian: Pred injiciranjem zdravila Filgrastim ratiopharm morate narediti naslednje: Primite telo injekcijske brizge ter nežno in brez sukanja potegnite pokrovček z igle.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with filgrastim should be made taking into account the benefit of breastfeeding to the child and the benefit of filgrastim therapy to the woman.
Slovenian: Odločitev o tem, ali naj mati nadaljuje/prekine z dojenjem ali naj nadaljuje/prekine zdravljenje s filgrastimom, je treba sprejeti glede na to, kakšne koristi ima dojenje za otroka oz. zdravljenje s filgrastimom za mater.
English: Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 106 CD34+ cells/kg recipient bodyweight.
Slovenian: Z levkaferezo je potrebno pričeti 5. dan, če je potrebno, pa z njo nadaljujte tudi 6. dan, da bi zbrali 4 x 106 CD34+ celic/kg telesne mase
English: Your doctor will tell you when to stop using Filgrastim ratiopharm.
Slovenian: Vaš zdravnik vam bo povedal, kdaj morate prenehati jemati zdravilo Filgrastim ratiopharm.
English: The safety profile of Filgrastim ratiopharm observed in these clinical studies was consistent with that reported with the reference product used in these studies.
Slovenian: Varnostni profil zdravila Filgrastim ratiopharm v kliničnih študij se je ujemal z varnostnim profilom referenčnega zdravila, prav tako uporabljenega v teh študijah.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product
Slovenian: Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti