natgillin/translations-raw huggingface dataset:
Not known: cannot be estimated from the available data. 
Neznana pogostnost: ni mogoče oceniti iz razpoložljivih podatkov.
Particular attention should be paid to haematological values and infectious diseases. 
Posebno pozornost je treba nameniti hematološkim vrednostim in infekcijskim obolenjem.
It is important to tell your doctor if you: 
Pomembno je, da svojega zdravnika obvestite, če:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
Your doctor or nurse will give you instructions on how to do this (see information below on instructions for injecting Accofil). 
Zdravnik ali medicinska sestra vam bo dala navodila, kako se to opravi (glej spodnje podatke o navodilih za injiciranje zdravila Accofil).
Your healthcare professional should always record the exact product you are using. 
Zdravstveni delavec mora vedno natančno dokumentirati zdravilo, ki ga uporabljate.
Within each frequency grouping undesirable effects are presented in order of decreasing seriousness. 
Znotraj vsake skupine pogostnosti so neželeni učinki predstavljeni po padajoči resnosti.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. 
Tega zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, navedenimi v poglavju 6.6.
Your treatment with Accofil will usually last for about 14 days. 
Vaše zdravljenje z zdravilom Accofil bo običajno trajalo približno 14 dni.
If there are particles in it, you must not use it. d. 
Če so v njej delci, je ne smete uporabiti.
> 1.0 x 109/L for 3 consecutive days 
> 1,0 x 109/L v obdobju 3 zaporednih dni
• increase of certain enzymes in the blood 
• povečanje nekaterih encimov v krvi
Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present. 
Vezalna protitelesa sicer nastajajo, kot je pričakovano pri vseh bioloških zdravilih, vendar jih do zdaj še niso povezali z nevtralizacijsko aktivnostjo.
If you are a stem cell donor, you must be aged between16 and 60 years. 
Če ste darovalec matičnih celic, morate biti stari od 16 do 60 let.
Accofil is useful in several different conditions which are: 
Zdravilo Accofil se uporablja pri različnih stanjih, kot so:
Do not warm Accofil in any other way (for example, do not warm it in a microwave or in hot water). 
Zdravila Accofil ne smete segrevati na kak drug način (na primer v mikrovalovni pečici ali v vroči vodi).
Therefore, your doctor may decide that you should not use this medicine if you are breast-feeding. 
Zdravnik se lahko zato odloči, da tega zdravila ne smete uporabljati, če dojite.
What should I do before I give myself a subcutaneous injection of Accofil? 
Kaj moram narediti, preden si dam subkutano injekcijo zdravila Accofil?
• think you may be pregnant; or • are planning to have a baby. 
• mislite, da bi lahko bili noseči; ali če • načrtujete zanositev.
If you are receiving this medicine by subcutaneous injection, your doctor may suggest that you learn how to give yourself the injections. 
Če zdravilo prejemate v obliki subkutane injekcije, vam bo zdravnik morda predlagal, da se naučite, kako si injekcijo daste sami.
Clinical trials with filgrastim have included a small number of elderly patients but special studies have not been performed in this group and therefore specific posology recommendations cannot be made. 
V klinična preskušanja s filgrastimom je bilo vključeno majhno število starejših bolnikov, vendar posebne študije v tej skupini niso bile izvedene in zato ni na voljo posebnih priporočil za odmerjanje.
The following information is intended for medical or healthcare professionals only: Accofil does not contain any preservative. 
Naslednje informacije so namenjene samo zdravstvenemu osebju: Zdravilo Accofil ne vsebuje konzervansov.
These changes all reversed after discontinuation of treatment. 
Po prekinitvi zdravljenja so vse spremembe izginile.
What you need to know before you use Accofil Do not use Accofil - If you are allergic (hypersensitive) to filgrastim or any of the other ingredients of this medicine (listed in section 6). 
Kaj morate vedeti, preden boste uporabili zdravilo Accofil Ne uporabljajte zdravila Accofil - če ste alergični (preobčutljivi) na filgrastim ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The degree of variation between individual patients and between laboratory assays of CD34+ cells mean that direct comparison between different studies is difficult. 
Delež odstopanja med posameznimi bolniki in med laboratorijskimi testi za celice CD34+ pomeni, da je neposredna primerjava med različnimi študijami težavna.
The protective sleeve will automatically cover the needle and an audible “click” will be heard to confirm shield activation (see picture 8). 
Zaščitni tulec bo samodejno prekril iglo in zaslišali boste "klik", ki potrjuje namestitev zaščite za iglo (glejte sliko 8).
At the end of this period, the product should not be put back in the refrigerator and should be disposed of. 
Po tem obdobju se zdravila ne sme shraniti nazaj v hladilnik in ga je potrebno zavrči.
Before you inject Accofil you must do the following: 
Pred injiciranjem zdravila Accofil morate narediti naslednje:
Do not use it if the date has passed the last day of the month shown or if it has been kept outside of the refrigerator for more than 15 days or has otherwise expired. 
Ne uporabite ga, če je zadnji dan navedenega meseca že potekel ali če ga več kot 15 dni niste hranili v hladilniku oziroma je zdravilo kako drugače poteklo.
Other medicines and Accofil 
Ostala zdravila in Accofil
It belongs to a group of proteins called cytokines and is very similar to a natural protein (granulocyte-colony stimulating factor [G-CSF]) produced by your own body. 
Sodi v skupino beljakovin, imenovanih citokini, in je zelo podobna naravni beljakovini (granulocitne kolonije spodbujajočemu faktorju [G-CSF]), ki nastaja v vašem telesu.
There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect. 
Iz raziskave o dajanju enkratnega odmerka obstajajo dokazi, da lahko intravenski način dajanja zdravila skrajša trajanje učinka.
This does not affect normal operation of the syringe. 
To ne vpliva na normalno uporabo brizge.
It is recommended that the apheresis centre perform a systematic record and tracking of the stem cell donors for at least 10 years to ensure monitoring of long-term safety. 
Priporoča se, da center za odvzem krvi sistematično beleži in spremlja dajalce matičnih celic vsaj še deset let ter dajalcem tako zagotovi dolgoročno varnost.
If you experience a loss of response or failure to maintain a response with filgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise filgrastim's activity 
Če odziv izgubite ali ga z zdravljenjem s filgrastimom ne morete vzdrževati, bo zdravnik poiskal vzroke, vključno z ugotavljanjem, ali ste razvili protitelesa, ki nevtralizirajo delovanje filgrastima.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP. 
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 vloge dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
Very common: ≥ 1/10 
Zelo pogosti: ≥ 1/10
If you develop or are likely to develop cancers of the blood, you should not use Accofil, unless instructed by your doctor. 
Če se je pri vas razvil ali obstaja verjetnost, da se bo razvil rak krvi, zdravila Accofil ne uporabljajte, razen po navodilu zdravnika.
If you have been told by your doctor that you have an intolerance to some sugars (fructose), contact your doctor before taking this medicine. 
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev (fruktozo), se pred uporabo tega zdravila posvetujte z zdravnikom.
It is unknown whether filgrastim passes over into the breast milk. 
Ni znano, ali filgrastim prehaja v materino mleko.
The needle guard will not activate unless the entire dose has been given. 
Varnostna zaščita se ne bo aktivirala, dokler ne injicirate celotnega odmerka.
The safety and efficacy of filgrastim administration in de novo AML patients aged < 55 years with good cytogenetics [t (8; 21), t (15; 17), and inv (16)] have not been established. 
Varnost in učinkovitost uporabe filgrastima pri bolnikih z na novo nastalo akutno mieloično levkemijo, ki so mlajši od 55 let in imajo dobro citogenetiko [t(8; 21), t(15; 17) in inv (16)], nista bili dokazani.
Your doctor will tell you when to stop using Accofil. 
Zdravnik vam bo povedal, kdaj prenehati z uporabo zdravila Accofil.
A meta-analysis of allogeneic transplant studies, including the results of nine prospective randomized trials, 8 retrospective studies and 1 case-controlled study, did not detect an effect on the risks of acute GvHD, chronic GvHD or early treatment-related mortality. 
Meta-analiza študij alogenskih presaditev, vključno z rezultati devetih prospektivnih randomiziranih preskušanj, 8 retrospektivnih študij in 1 s primeri nadzirane študije ni pokazala vpliva na tveganje akutne GvHD, kronične GvHD ali z zgodnjim zdravljenjem povezane smrtnosti.
Following established chemotherapy for solid tumours, lymphomas, and lymphoid leukaemias, it is expected that the duration of treatment required to fulfil these criteria will be up to 14 days. 
Po uveljavljeni kemoterapiji za trdne tumorje, limfome in pri limfoidini levkemiji se pričakuje, da bo trajanje zdravljenja, če želimo doseči zahtevane kriterije, do 14 dni.
These could be symptoms of a condition called “sepsis” (also called "blood poisoning"), a severe infection with whole-body inflammatory response which can be life threatening and needs urgent medical attention. 
Lahko gre za simptome stanja, ki se imenuje sepsa (ali zastrupitev krvi) in pomeni hudo okužbo z vnetnim odzivom celotnega telesa, ki je lahko življenjsko nevarna in zahteva nujno medicinsko pomoč.
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. 
Statistična analiza odnosa med številom ponovno infundiranih celic CD34+ in hitrostjo obnove trombocitov po kemoterapiji v velikih odmerkih kaže na zapleteno, a stalno medsebojno povezavo.
It is advisable to wait and see how you feel after taking Accofil and before driving or operating machinery. 
Priporočljivo je, da po uporabi zdravila Accofil počakate in ugotovite, kako se počutite, preden upravljate vozila ali stroje.
Other special precautions Causes of transient neutropenia such as viral infections should be excluded. 
Izključiti je treba vzroke prehodne nevtropenije, npr. virusne okužbe.
• The needle safety guard prevents needle stick injuries after use, so no special precautions for disposal are required. 
• Varnostna zaščita za iglo preprečuje poškodbe zaradi vboda z iglo po uporabi, tako da za odstranjevanje niso potrebni nobeni posebni previdnostni ukrepi.
Some cases of splenic rupture were fatal (see section 4.4). 
Nekateri primeri raztrganja vranice so bili smrtni (glejte poglavje 4.4).
The data in the tables below describe adverse reactions reported from clinical trials and spontaneous reporting. 
Podatki v spodnjih preglednicah opisujejo neželene učinke, o katerih so poročali v kliničnih preskušanjih in v spontanem poročanju.
Your doctor has prescribed Accofil for you to help your body make more white blood cells. 
Zdravnik vam je zdravilo Accofil predpisal, da bi telesu pomagalo pri tvorbi več belih krvnih celic.
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. 
Rezultati meritev števila celic CD34+ s pretočno citometrijo se razlikujejo glede na dejansko uporabljeno metodologijo, zato je treba priporočila o številu, ki temeljijo na študijah v drugih laboratorijih, razlagati previdno.
Urinalysis monitoring is recommended. 
Priporočeno je spremljanje z analizo urina.
When peripheral blood progenitor cell transplantation is envisaged it is advisable to plan the stem cell mobilization procedure early in the treatment course of the patient. 
Če je predvidena presaditev krvotvornih matičnih celic iz periferne krvi, je postopek izplavljanja matičnih celic priporočljivo načrtovati v zgodnjem obdobju bolnikovega zdravljenja.
Disinfect the injection site by using an alcohol swab and pinch the skin between your thumb and forefinger, without squeezing it (see picture 5). 
a. Razkužite mesto injiciranja z alkoholno krpico in primite kožo s palcem in kazalcem, ne da bi jo stiskali (glejte sliko 5).
G-CSF can promote growth of myeloid cells in vitro and similar effects may be seen on some nonmyeloid cells in vitro. 
G-CSF lahko in vitro spodbuja rast mieloičnih celic; podobne učinke so in vitro opazili tudi pri nekaterih nemieloičnih celicah.
Then, if ANC remains > 1.0 x 109/L for 3 more consecutive days 
Nato, če ANC ostane > 1,0 x 109/L še v obdobju naslednjih 3 zaporednih dni
Eject unnecessary liquid by pushing the plunger up to the number (mL) on the syringe that matches the prescribed dose. 
Iztisnite odvečno tekočino, tako da pritisnete bat navzgor do številke (ml) na brizgi, ki je enaka predpisanemu odmerku.
Spleen size should be evaluated regularly. 
Velikost vranice je treba redno preverjati.
In clinical studies, 97% of patients who responded had a complete response at doses of ≤ 24 µg/kg/day. 
V kliničnih preskušanjih so pri 97% bolnikov, ki so se odzivali, dosegli popoln odziv z odmerki ≤ 24 µg/kg/dan.
Your doctor will tell you why you are being treated with Accofil. 
Zdravnik vam bo povedal, zakaj se zdravite z zdravilom Accofil.
A very frequent side effect of Accofil use is pain in your muscles or bones (musculoskeletal pain), which can be helped by taking standard pain relief medicines (analgesics). 
Zelo pogost neželeni učinek zdravila Accofil so bolečine v mišicah in kosteh (mišično-skeletne bolečine), ki jih je mogoče olajšati z jemanjem običajnih protibolečinskih zdravil (analgetikov).
For storage conditions of the diluted medicinal product, see section 6.3. 
Za pogoje shranjevanja po redčenju zdravila glejte poglavje 6.3.
For further instructions on dilution prior to infusion see section 6.6. 
Za dodatna navodila glede redčenja pred infundiranjem glejte poglavje 6.6.
• Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2. 
Accofil): • vnetje aorte (velike žile, ki prenaša kri od srca po telesu), glejte poglavje 2.
If required, Accofil may be diluted in 5% glucose. 
Po potrebi lahko zdravilo Accofil razredčite v 5-odstotni glukozi.
Uncommon: ≥ 1/1,000 to < 1/100 Rare: ≥ 1/10,000 to < 1/1,000 Very rare: < 1/10,000 
Občasni: ≥ 1/1.000 do < 1/100 Redki: ≥ 1/10.000 do < 1/1.000 Zelo redki: < 1/10.000
When reversal of neutropenia has been achieved, the minimal effective dose to maintain a normal neutrophil count should be established. 
Ko je napredovanje nevtropenije ustavljeno, je treba določiti najmanjši učinkoviti odmerek za vzdrževanje normalnega števila nevtrofilcev.
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. 
Z levkaferezo je treba začeti 5. dan in jo, če je potrebno, nadaljevati do 6. dne, da se zbere 4 x 106 celic CD34+/kg prejemnikove telesne mase.
What Accofil is and what it is used for 
Kaj je zdravilo Accofil in za kaj ga uporabljamo
Accofil has not been tested in pregnant women. 
Zdravila Accofil pri nosečnicah niso preučevali.
When diluted in 5% glucose, Accofil is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene. 
Če je razredčeno s 5-odstotno raztopino glukoze, je zdravilo Accofil kompatibilno s steklom in različnimi plastičnimi materiali, vključno s PVC, poliolefinom (kopolimerom polipropilena in polietilena) in polipropilenom.
Check the appearance of Accofil. 
c. Preverite videz raztopine Accofil.
Take special care with other products that stimulate white blood cells Accofil is one of a group of products that stimulate the production of white blood cells. 
Posebej pozorni bodite z ostalimi zdravili, ki stimulirajo bele krvničke Zdravilo Accofil spada v skupino zdravil, ki stimulirajo nastajanje belih krvničk.
For patients treated with filgrastim diluted to concentrations below 1.5 MU (15 µg) per ml, human serum albumin (HSA) should be added to a final concentration of 2 mg/ml. 
Pri bolnikih, ki se zdravijo s filgrastimom, razredčenim na koncentracije pod 1,5 M e. (15 mikrogramov) na mililiter, je treba dodati humani serumski albumin (HSA) do končne koncentracije 2 mg/ml.
In randomised clinical trials, a subcutaneous dose of 230 microgram/m2/day (4.0 to 8.4 microgram/kg/day) was used. 
V randomiziranih kliničnih preskušanjih so uporabljali subkutani odmerek 230 mikrogramov/m2/dan (4,0−8,4 mikrogramov/kg/dan).
The effects of Accofil overdose have not been established. 
Učinkov prevelikega odmerjanja zdravila Accofil niso ugotavljali.
Inject only the dose your doctor has told you. 
e. Injicirajte samo odmerek, ki vam ga je predpisal zdravnik.
The timing of leukapheresis: 1 or 2 leukaphereses on days 5 and 6 which is often sufficient. 
Časovni razpored levkafereze: eno do dve levkaferezi 5. in 6. dan, kar pogosto zadošča.
Tell your doctor immediately during treatment: 
Med zdravljenjem takoj povejte zdravniku:
These could be symptoms of an uncommon condition (may affect up to 1 in 100 people) called Capillary Leak Syndrome which causes the blood to leak from the small blood vessels into your body and needs urgent medical attention. 
Lahko gre za simptome občasnega stanja (pojavi se lahko pri največ 1 od 100 bolnikov), ki se imenuje sindrom povečane prepustnosti kapilar in povzroči uhajanje krvi iz drobnih krvnih žil v vaše telo ter zahteva nujno medicinsko pomoč.
For further instructions on dilution with glucose 50 mg/ml (5%) solution prior to infusion see section 6.6. 
Za dodatna navodila glede redčenja z raztopino glukoze 50 mg/ml (5%) pred infundiranjem glejte poglavje 6.6.
For infusions filgrastim should be diluted in 20ml of 5% glucose solution (see section 6.6). 
Za infundiranje je treba filgrastim razredčiti v 20 ml 5-odstotne raztopine glukoze (glejte poglavje 6.6).
Accofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate. 
Zdravilo Accofil je indicirano za zdravljenje trdovratne nevtropenije (ANC manjše ali enako 1,0 x 109/L) pri bolnikih z napredovalo okužbo s HIV z namenom zmanjšanja tveganja bakterijskih okužb, ko druge oblike zdravljenja nevtropenije niso primerne.
Haematuria was common and proteinuria occurred in a small number of patients. 
Pogosto so poročali o hematuriji, pri majhnem številu bolnikov pa se je pojavila proteinurija.
Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk. 
Bolniki, ki so v bližnji preteklosti imeli pljučne infiltrate ali pljučnico, so morda bolj ogroženi.
Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim. 
Dogodki glomerulonefritisa so večinoma izginili po zmanjšanju odmerka ali prenehanju dajanja filgrastima in pegfilgrastima.
Mobilization of PBPC 
Izplavljanje PBPC
• If you have any of the following or a combination of the following side effects: swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. 
• če opazite katerega koli od naslednjih neželenih učinkov ali kombinacijo naslednjih neželenih učinkov: otekanje ali zabuhlost, ki lahko nastopita v povezavi z zmanjšano pogostostjo uriniranja, težave z dihanjem, otekanje trebuha in občutek polnosti ter splošen občutek utrujenosti.
Among these, two cases of platelets < 50 x 109/L were reported and attributed to the leukapheresis procedure. 
Med temi so v dveh primerih poročali o številu trombocitov < 50 x 109/L, kar so pripisovali postopku levkafereze.
Filgrastim is not recommended during pregnancy. 
Uporaba filgrastima med nosečnostjo ni priporočena.
Special care should be taken when administering single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia. 
Posebna previdnost je potrebna, kadar je predpisan en sam kemoterapevtik ali več kemoterapevtikov, za katere se ve, da povzročajo hudo trombocitopenijo.
• high uric acid levels in the blood, which may cause gout (hyperuricaemia) (Blood uric acid increased) 
• visoke ravni sečne kisline v krvi, kar lahko povzroči protin (hiperurikemija) (povišane ravni sečne kisline v krvi)
In randomised, placebo-controlled clinical studies, filgrastim did not increase the incidence of undesirable effects associated with cytotoxic chemotherapy. 
V randomiziranih, s placebom kontroliranih kliničnih študijah filgrastim ni povzročil povečanja števila neželenih učinkov, povezanih s citotoksično kemoterapijo.
Subcutaneous or intravenous use. 
za subkutano ali intravensko uporabo Ne stresajte.
Accofil therapy should only be given in collaboration with an oncology centre which has experience in granulocyte-colony stimulating factor (G-CSF) treatment and haematology and has the necessary diagnostic facilities. 
Zdravljenje z zdravilom Accofil se lahko predpiše samo v sodelovanju z onkološkim centrom, ki ima izkušnje na področju zdravljenja s faktorji, ki spodbujajo rast granulocitnih kolonij (G-CSFgranulocyte-colony stimulating factor) in hematologije, in ki razpolaga z ustreznimi diagnostičnimi pripomočki.
What Accofil is and what it is used for What you need to know before you use Accofil How to use Accofil 
Kaj je zdravilo Accofil in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Accofil Kako uporabljati zdravilo Accofil Možni neželeni učinki
Within its shelf-life and for the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 15 days. 
Znotraj roka uporabnosti lahko pri ambulantni uporabi bolnik vzame zdravilo iz hladilnika in ga hrani pri sobni temperaturi (do 25 °C) enkrat za največ 15 dni.
If more than one leukapheresis is required, particular attention should be paid to donors with platelets < 100 x 109/L prior to leukapheresis; in general apheresis should not be performed if platelets are < 75 x 109/L. 
Če je potrebna več kot ena levkafereza, je treba posebno pozornost nameniti dajalcem, pri katerih število trombocitov pred levkaferezo znaša < 100 x 109/L; običajno se afereze ne sme narediti, če je število trombocitov < 75 x 109/L.
• think you may be pregnant; or 
• ste noseči ali dojite;
The safety and efficacy of filgrastim has not been assessed in normal donors less than 16 years or greater than 60 years of age. 
Varnost in učinkovitost filgrastima pri zdravih dajalcih, mlajših od 16 ali starejših od 60 let, nista bili ocenjeni.
• pain and swelling of the joints, similar to gout (pseudogout) 
• bolečine in oteklost sklepov, podobna protinu (psevdoprotin)
While maintaining pressure on the plunger, remove the syringe from the patient. 
Medtem ko še vedno vzdržujete pritisk na bat, izvlecite iglo iz bolnika.
This medicine also contains sodium less than 1mmol sodium (0.035 mg) per dose, i.e. essentially ‘sodium-free'. 
To zdravilo vsebuje tudi manj kot 1mmol (0,035 mg) natrija na odmerek, kar v bistvu pomeni "brez natrija".