natgillin/translations-raw huggingface dataset:
The needle cover will extend to cover the needle and will lock (see Figure I).
Varovalo igle bo pokrilo iglo in se zaklenilo (glejte sliko I).
Elevations of alanine aminotransferase and aspartate aminotransferase (>5 times ULN), were reported in 1% and <1% of placebo-treated patients and 2% and <1% of patients treated with Plegridy respectively.
Zvišanja alanin-aminotransferaze in aspartat-aminotransferaze (> 5-kratna ULN) so opazili pri 1 % oz. < 1 % bolnikov, zdravljenih s placebom, in 2 % oz. < 1 % bolnikov, zdravljenih z zdravilom Plegridy.
Plegridy has no or negligible influence on the ability to drive and use machines.
Zdravilo Plegridy nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Mean [Median] no. of new or newly enlarging T2 hyperintense lesions (range)
Povprečno [mediano] št. novih ali na novo povečanih hiperintenzivnih lezij T2
Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1, 000 to <1/100) Rare (≥1/10, 000 to <1/1,000)
občasni (≥1/1.000 do <1/100) redki (≥1/10.000 do <1/1.000)
If you do not hear clicking sounds or you do not see green ticks in the injection status window after attempting to inject, the pen may have locked and you may not have received your injection.
Opozorilo: Če po tem, ko ste poskusili injicirati, ne slišite klikanja ali ne vidite zelenih kljukic v okencu za stanje injiciranja, se je injekcijski peresnik morda zaklenil in niste prejeli svojega odmerka.
This should be considered when switching patients between pegylated and non-pegylated interferons (see section 5.1).
To morate upoštevati, ko bolnikom menjujete terapijo s pegiliranim in nepegiliranim interferonom (glejte poglavje 5.1).
If you use more Plegridy than you should
Če ste uporabili večji odmerek zdravila Plegridy, kot bi smeli
• Check that your Plegridy medicine is clear and colourless (See Figure D).
• Prepričajte se, da je vaše zdravilo Plegridy bistro in brezbarvno (glejte sliko D).
The total combined time out of refrigeration at a temperature up to 25°C, should not exceed 30 days.
Skupni čas, ko je zdravilo zunaj hladilnika na temperaturi do 25 °C, ne sme preseči 30 dni.
• Choose an injection site and wipe the skin with an alcohol wipe.
• Izberite mesto injiciranja in očistite kožo z alkoholnim robčkom.
CI: Confidence interval * Sustained disability progression was defined as at least a 1 point increase from baseline EDSS ≥ 1 or 1.5 point increase for patients with baseline EDSS of 0, sustained for 12 / 24 weeks.
* Trajno napredovanje bolezni je bilo opredeljeno kot povečanje vsaj za 1 točko od izhodišča EDSS ≥ 1 ali za 1,5 točke za bolnike z EDSS 0 na izhodišču, ki se je ohranilo 12/24 tednov.
Patients should be advised to discontinue Plegridy and seek immediate medical care if they experience signs and symptoms of anaphylaxis or severe hypersensitivity.
Bolnikom je treba priporočiti, naj se prenehajo zdraviti z zdravilom Plegridy in naj poiščejo nujno medicinsko pomoč, če se pojavijo znaki in simptomi anafilaksije ali hude preobčutljivosti.
It is recommended that a healthcare professional trains patients in the proper technique for self-administering subcutaneous injections using the pre-filled syringe/pre-filled pen.
Priporoča se, da zdravstveni delavec bolnika nauči pravilne tehnike za samoinjiciranje subkutane injekcije z uporabo napolnjene injekcijske brizge/napolnjenega injekcijskega peresnika.
Difficulty breathing
- težave pri dihanju,
Whether to discontinue therapy following a single site of necrosis is dependent on the extent of necrosis (see section 4.8).
Odločitev o prekinitvi zdravljenja po nekrozi na enem mestu injiciranja je odvisna od velikosti mesta nekroze (glejte poglavje 4.8).
Caution should be exercised when Plegridy is administered in combination with medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e.g. some classes of antiepileptics and antidepressants.
Previdno je treba ravnati pri dajanju zdravila Plegridy v kombinaciji z zdravili, ki imajo ozek terapevtski indeks in je njihov očistek v veliki meri odvisen od sistema jetrnega citokroma P450, npr. nekatere vrste antiepileptikov in antidepresivov.
Other things to consider when using Plegridy
Ostale stvari, ki jih morate upoštevati pri uporabi zdravila Plegridy
This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}> <{mesec LLLL}.> Drugi viri informacij
The liquid in the medicinal product window must be clear and colourless.
Tekočina v okencu za zdravilo mora biti bistra in brezbarvna.
• Pull the needle straight out (See Figure K).
• Povlecite iglo naravnost navzven (glejte sliko K).
Talk to your doctor, pharmacist or nurse before injecting Plegridy if you have any of the conditions listed below.
Posvetujte se z zdravnikom, farmacevtom ali medicinsko sestro pred injiciranjem zdravila Plegridy, če imate katero od spodaj navedenih težav.
You should see green stripes.
Morali bi videti zelene kljukice.
Pre-filled syringes/pre-filled pens are for single use only and should be discarded after use.
Vsaka napolnjena injekcijska brizga/napolnjeni injekcijski peresnik je samo za enkratno uporabo in jo/ga je treba po uporabi zavreči.
• If some areas are too difficult for you to reach, ask a carer who has been trained to help you.
• Če katero od teh mest težko dosežete, prosite za pomoč usposobljenega skrbnika.
This is normal and does not need to be expelled before your injection.
To je normalno in mehurčkov pred injiciranjem ni treba odstraniti.
If TMA is diagnosed, prompt treatment is required (considering plasma exchange) and immediate discontinuation of Plegridy is recommended.
Pri diagnozi TMA je potrebno hitro zdravljenje (z upoštevanjem možnosti izmenjave plazme), priporoča pa se takojšnja ukinitev zdravljenja z zdravilom Plegridy.
However, results from a population pharmacokinetic analysis (in patients up to 65 years) suggest that age does not impact peginterferon beta-1a clearance.
Vendar pa rezultati iz populacijske farmakokinetične analize (pri bolnikih, starih do 65 let) kažejo, da starost nima vpliva na očistek peginterferona beta-1a.
Clear and colourless solution with pH 4.5-5.1.
raztopina za injiciranje (injekcija) Bistra in brezbarvna raztopina s pH 4,5 do 5,1.
Interferons are a family of naturally occurring proteins that are induced by cells in response to biological and chemical stimuli, and mediate numerous cellular responses that have been classified as antiviral, antiproliferative, and immunomodulatory in nature.
Interferoni so družina beljakovin, ki se v telesu pojavljajo normalno in jih celice inducirajo v odziv na biološke in kemične dražljaje, in prenašajo številne celične odzive, ki so bili razvrščeni med protivirusne,
You will hear the clicking sounds start.
Zaslišali boste klikanje.
Treatment initiation
Uvedba zdravljenja
(may affect up to 1 in 100 people) - Hives - Changes in your blood which might cause unexplained bruising or bleeding.
(pojavijo se lahko pri največ 1 od 100 bolnikov) - koprivnica, - spremembe v krvi, zaradi katerih se pojavijo nepojasnjene modrice ali krvavitve.
Neopterin concentrations return to baseline after the two week dosing interval.
Koncentracije neopterina so se po dvotedenskem intervalu odmerjanja vrnile na izhodiščne.
- Kidney problems including scarring that may reduce your kidney function
- Težave z ledvicami, vključno z brazgotinjenjem, ki lahko zmanjšajo delovanje ledvic
Elevations of serum hepatic transaminases combined with elevated bilirubin were observed in two patients who had pre-existing liver test abnormalities prior to receiving Plegridy in the clinical trials.
Zvišanja jetrnih transaminaz v serumu v kombinaciji z zvišanjem bilirubina so opazili pri dveh bolnikih, ki sta imela obstoječe nenormalne teste jeter, preden sta v kliničnih preskušanjih začela prejemati zdravilo Plegridy.
Plegridy binds to the type I interferon receptor on the surface of cells and elicits a cascade of intracellular events leading to the regulation of interferon-responsive gene expression.
Zdravilo Plegridy se veže na receptorje interferona tipa I na površini celic in izzove niz dogodkov v celici, ki povzročijo regulacijo izraženosti gena, odzivnega na interferon.
Nephrotic syndrome, glomerulosclerosis
Bolezni sečil nefrotski sindrom, glomeruloskleroza redki
Swelling around the face (lips, tongue or throat) Skin rashes or redness
- oteklost okoli obraza (ustnice, jezik ali grlo),
What Plegridy is and what it is used for 2.
Kaj je zdravilo Plegridy in za kaj ga uporabljamo 2.
An initiation pack is available containing the first 2 doses (63 micrograms and 94 micrograms).
Na voljo je začetno pakiranje, ki vsebuje prva 2 odmerka (63 mikrogramov in
What you need to know before you use Plegridy Do not use Plegridy
Kaj morate vedeti, preden boste uporabili zdravilo Plegridy Ne uporabljajte zdravila Plegridy
Note: • Before you use the Plegridy pre-filled syringe for the first time, your doctor or nurse should show you or your carer how to prepare and inject the Plegridy pre-filled syringe.
Opomba: • Preden prvič uporabite napolnjeno injekcijsko brizgo zdravila Plegridy, morata zdravnik ali medicinska sestra vam ali vašemu skrbniku pokazati, kako se pripravi in injicira napolnjeno injekcijsko brizgo zdravila Plegridy.
Biological effects that may be mediated by Plegridy include up-regulation of anti-inflammatory cytokines (e.g. IL-4, IL-10, IL-27), down-regulation of pro-inflammatory cytokines (e.g. IL-2, IL-12, IFN-γ, TNF-α) and inhibiting the migration of activated T cells across the blood brain barrier; however additional mechanisms may be involved.
Biološki učinki, pri katerih morda posreduje zdravilo Plegridy, vključujejo povišano izražanje protivnetnih citokinov (npr. IL-4, IL-10, IL-27), znižano izražanje provnetnih citokinov (npr. IL-2, IL-12, IFN-γ, TNF-α) in zaviranje migracije aktiviranih celic T skozi krvno možgansko pregrado; vendar morda sodelujejo še dodatni mehanizmi.
If you do miss your usual day, inject as soon as you can and carry on as usual.
Če na običajni dan izpustite odmerek, si zdravilo injicirajte takoj, ko boste lahko, nato pa nadaljujte kot običajno.
Regular thyroid function tests are recommended in patients with a history of thyroid dysfunction or as clinically indicated.
Redni testi delovanja ščitnice se priporočajo pri bolnikih z disfunkcijo ščitnice v anamnezi ali kot je klinično indicirano.
• After 2 hours, check the injection site for redness, swelling, or tenderness.
• Po 2 urah preverite, ali je mesto injiciranja pordelo, oteklo ali občutljivo.
• Slowly push the plunger all the way down until syringe is empty (See Figure I).
• Počasi potisnite bat povsem navzdol, dokler ni injekcijska brizga prazna (glejte sliko I).
This medicinal product contains less than 1 mmol (23 mg) sodium, that is to say it is essentially “sodium-free”.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija, kar v bistvu pomeni »brez natrija«.
Cardiac disease
Bolezen srca
With your other hand, firmly grasp needle cover and pull it straight off the needle (See Figure F).
Z drugo roko trdno primite pokrov igle in ga potegnite naravnost z igle (glejte sliko F).
Patients should be advised to rotate sites for subcutaneous injections.
Bolnikom je treba svetovati, da mesta za subkutano injiciranje menjujejo.
Do not lift your pen off your injection site until the clicking sounds stop and you see green ticks in the injection status window.
Injekcijskega peresnika ne dvignite z mesta za injiciranje, dokler klikanje ne preneha in v okencu stanja injiciranja ne zagledate zelenih kljukic.
However, the development of antibodies against the interferon moiety of peginterferon beta-1a had no discernible impact on safety or clinical efficacy, although the analysis was limited by the low immunogenicity incidence.
Vendar pa ni imel razvoj protiteles proti delu interferona v peginterferonu beta-1a nikakršnega opaznega učinka na varnost ali klinični učinek, čeprav je bila analiza omejena z nizko incidenco imunogenosti.
• If needed, Plegridy may be stored in the closed original carton without refrigeration up to 25°C for up to 30 days.
• Po potrebi je mogoče zdravilo Plegridy shraniti v zaprti originalni škatli na mestu brez hlajenja s temperaturo do 25 °C do največ 30 dni.
Each haemodialysis reduced peginterferon beta-1a concentration by approximately 24%, suggesting that haemodialysis partially removes peginterferon beta-1a from systemic circulation.
Z vsako hemodializo se je koncentracija peginterferona beta-1a zmanjšala za približno 24 %, kar kaže, da hemodializa delno odstrani peginterferon beta-1a iz sistemskega obtoka.
Three percent of patients (18/681) developed persistent antibodies to the PEG moiety of peginterferon beta-1a.
Pri treh odstotkih bolnikov (18/681) so se razvila obstojna protitelesa proti delu PEG v peginterferonu beta-1a.
Table on the inner lid Injection Record Day 0 (63 micrograms) Day 14 (94 micrograms) Date
preglednica na notranjem pokrovu Kartica injiciranja dan 0 (63 mikrogramov) 14. dan (94 mikrogramov) Datum
If you get any of these symptoms: - Any break in the skin together with swelling, inflammation or fluid leaking around the injection site
Če se pojavi kateri od naslednjih simptomov: - vsakršna razpoka na koži skupaj z oteklino, vnetjem ali izcejanjem tekočine iz mesta injiciranja,
The incidence of hepatic transaminase increases was greater in patients receiving Plegridy compared to placebo.
Nenormalnosti jetrnih transaminaz Incidenca zvišanja jetrnih transaminaz je bila večja pri bolnikih, ki so prejemali zdravilo Plegridy, v primerjavi s placebom.
Collect all the supplies you will need to give yourself or to receive an injection.
Nanjo položite vse pripomočke, ki jih boste potrebovali za samoinjiciranje oziroma za injiciranje.
(rare - may affect up to 1 in 1,000 people)
(redki - pojavijo se lahko pri največ 1 od 1.000 bolnikov)
• Using one hand, hold the syringe by the glass barrel.
• Z eno roko držite injekcijsko brizgo za stekleno komoro.
Plegridy every 2 weeks significantly reduced the annualized relapse rate (ARR) by 36% compared to placebo (p=0.0007) at one year (Table 3) with consistent reductions of the ARR noted in subgroups defined by demographic and baseline disease characteristics.
Zdravilo Plegridy vsaka 2 tedna je značilno zmanjšalo letno stopnjo recidiva (ARR) za 36 % v primerjavi s placebom (p = 0,0007) pri enem letu (preglednica 3) z ustreznimi zmanjšanji ARR, ki so jih opazili v podskupini, opredeljeni z demografskimi značilnostmi in značilnostmi bolezni ob izhodišču.
Plegridy is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis (see section 5.1).
Zdravilo Plegridy je indicirano za zdravljenje odraslih bolnikov z recidivno remitentno multiplo sklerozo (glejte poglavje 5.1).
After the injection After Use - Parts of your Plegridy pen (see Figure K):
Po injiciranju Po uporabi - sestavni deli vašega injekcijskega peresnika Plegridy (glejte sliko K):
- Hypersensitivity to natural or recombinant interferon beta or peginterferon or to any of the excipients listed in section 6.1.
4.3 Kontraindikacije - Preobčutljivost na naravni ali rekombinantni interferon beta ali peginterferon ali katero koli pomožno snov, navedeno v poglavju 6.1.
• Each Plegridy pre-filled syringe can be used once only.
• Vsako napolnjeno injekcijsko brizgo zdravila Plegridy smete uporabiti samo enkrat.
Do not use the same injection site for consecutive injections.
Za več zaporednih injiciranj ne uporabite istega mesta injiciranja.
Use the record table printed on the inside of the lid of the Initiation Pack to keep a track of your injection dates.
Uporabite kartico s preglednico na notranji strani pokrova škatle začetnega pakiranja, v katero beležite datume injiciranja.
- If you are unsure of the number of days you have kept a syringe out of the fridge, throw the syringe away.
- Če niste prepričani, koliko dni ste brizgo hranili zunaj hladilnika, brizgo zavrzite.
Remove your Plegridy pack from the fridge and select the appropriate pen (dosage) from the pack.
Vzemite pakiranje zdravila Plegridy iz hladilnika in izberite pravi injekcijski peresnik (odmerek) iz pakiranja.
The pharmacological properties of Plegridy are consistent with those of interferon beta-1a and are believed to be mediated by the protein portion of the molecule.
Farmakološke lastnosti zdravila Plegridy so skladne z lastnostmi interferona beta-1a in predvideva se, da jih povzroča beljakovinski del molekule.
A single-dose study in healthy subjects and subjects with various degrees of renal impairment (mild, moderate, and severe renal impairment as well as subjects with end state renal disease) showed a fractional increase in AUC (13-62%) and Cmax (42-71%) in subjects with mild (estimated glomerular filtration rate 50 to ≤80 mL/min/1.73m2), moderate (estimated glomerular filtration rate 30 to <50 mL/min/1.73m2), and severe (estimated glomerular filtration rate <30 mL/min/1.73m2) renal impairment, compared to subjects with normal renal function (estimated glomerular filtration rate >80 mL/min/1.73m2).
Študija z enim odmerkom pri zdravih osebah in osebah z različnimi stopnjami ledvične okvare (blaga, zmerna in huda ledvična okvara ter pri osebah s končno ledvično odpovedjo) je pokazala frakcijsko povišanje AUC (13-62 %) in Cmax (42-71 %) pri osebah z blago (ocenjena stopnja glomerulne filtracije 50 do ≤ 80 ml/min/1,73 m2), zmerno (ocenjena stopnja glomerulne filtracije 30 do < 50 ml/min/1,73 m2) in hudo (ocenjena stopnja glomerulne filtracije < 30 ml/min/1,73 m2) ledvično okvaro, v primerjavi z osebami z normalnim delovanjem ledvic (ocenjena stopnja glomerulne filtracije > 80 ml/min/1,73 m2).
Therefore if clinical features of TMA are observed, further testing of blood platelet levels, serum LDH, blood films and renal function is recommended.
V primeru opaženih kliničnih značilnosti TMA se zato priporočajo nadaljnji testi ravni trombocitov v krvi, LDH v serumu, krvnih razmazov in delovanja ledvic.
Plegridy can be used during breastfeeding.
Zdravilo Plegridy se lahko uporablja med dojenjem.
The incidence of potentially clinically significant decreases in RBC counts (<3.3 x 1012/L) was similar in Plegridy-treated patients compared to placebo-treated patients.
Incidenca potencialno klinično pomembnih zmanjšanj števila rdečih krvnih celic (< 3,3 x 1012/l) je bila pri bolnikih, zdravljenih z zdravilom Plegridy, podobna kot pri bolnikih, ki so prejemali placebo.
Following subcutaneous administration of peginterferon beta-1a in multiple sclerosis patients, the peak concentration was reached between 1 to 1.5 days post-dose.
Po subkutanem dajanju peginterferona beta-1a bolnikom z multiplo sklerozo je bila najvišja koncentracija dosežena med 1 do 1,5 dneva po odmerku.
Table 1: Titration schedule at initiation Dose
Preglednica 1: Načrt titriranja ob uvedbi zdravljenja
One patient out of 1468 patients who received Plegridy in clinical studies experienced an injection site necrosis which resolved with standard medical treatment.
Eden od 1.468 bolnikov, ki so v kliničnih študijah prejemali zdravilo Plegridy, je imel nekrozo na mestu injiciranja, ki so jo odpravili s standardnim zdravljenjem.
(frequency cannot be estimated from the available data) - Pulmonary arterial hypertension: A disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs.
Neznana pogostnost (neznana pogostnost - pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) - pljučna arterijska hipertenzija: bolezen, ki povzroči hudo zoženje krvnih žil v pljučih, katerega posledica je visok krvni tlak v žilah, po katerih kri teče iz srca v pljuča.
Fertility and developmental studies in rhesus monkeys have been carried out with non-pegylated interferon beta-1a.
Študije plodnosti in razvoja pri opicah Rhesus so opravili z nepegiliranim interferonom beta-1a.
Following repeat dosing of 125 micrograms doses every two weeks by subcutaneous administration, the volume of distribution uncorrected for bioavailability (mean±SE) was 481 ± 105 L.
Po ponavljajočem se odmerjanju 125-mikrogramskih odmerkov vsaka dva tedna po subkutani poti je bil volumen porazdelitve brez korekcije za biološko uporabnost (povprečje ± SN) 481 ± 105 l.
In both patients, cell counts recovered after discontinuation of Plegridy.
Pri obeh bolnikih se je število celic po prekinitvi uporabe zdravila Plegridy popravilo.
See section 6.3 for additional information on storage at room temperature.
Za dodatne informacije o shranjevanju pri sobni temperaturi glejte poglavje 6.3.
- Do not use this medicine if you notice any of the following: - If the syringe is broken.
- Tega zdravila ne uporabljajte, če opazite kaj od naslednjega:
An open-label study in patients switching from interferon beta therapy to Plegridy evaluated the onset and duration of prophylactically treated flu-like symptoms.
V odprti študiji so pri bolnikih, ki so prešli z zdravljenja z interferonom beta na zdravilo Plegridy, ocenjevali začetek in trajanje profilaktično zdravljenih gripi podobnih simptomov.
Patients should be monitored for signs of hepatic injury (see section 4.8).
Bolnike je treba spremljati za pojav znakov poškodb jeter (glejte poglavje 4.8).
Data from patients treated up to 2 years with Plegridy suggests that less than 1% (5/715) developed persistent-neutralising antibodies to the interferon beta-1a portion of peginterferon beta-1a.
Podatki pri bolnikih, ki so se do 2 leti zdravili z zdravilom Plegridy, kažejo, da se pri manj kot 1 % (5/715) razvijejo obstojna nevtralizirajoča protitelesa proti delu interferona beta-1a v peginterferonu beta-1a.
1285 patients received at least 1 year, 1124 patients have received at least 2 years, 947 patients received at least 3 years, and 658 patients received at least 4 years of treatment with Plegridy.
1.285 bolnikov je zdravilo prejemalo vsaj 1 leto, 1.124 bolnikov se je z zdravilom Plegridy zdravilo vsaj 2 leti, 947 bolnikov vsaj 3 leta in 658 bolnikov vsaj 4 leta.
Patients should be monitored for signs of hepatic injury and caution exercised when interferons are used concomitantly with other medicinal products associated with hepatic injury (see sections 4.8 and 5.2).
Bolnike morate spremljati, da ugotovite morebitne znake poškodbe jeter, če se interferoni uporabljajo sočasno z drugimi zdravili, povezanimi s poškodbami jeter (glejte poglavji 4.8 in 5.2).
- Blood clots in the small blood vessels may occur during your treatment.
- Med zdravljenjem se lahko pojavijo krvni strdki v majhnih krvnih žilah.
Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness or light-headedness.
Simptomi lahko vključujejo pogostejše modrice, krvavitve, zvišano telesno temperaturo, izjemno šibkost, glavobol, omotico ali vrtoglavico.
The table summarizes ADRs (incidence above placebo and with a reasonable possibility of causality) from 512 patients treated with Plegridy 125 micrograms subcutaneously every 2 weeks and 500 patients who received placebo for up to 48 weeks and post-marketing data.
V preglednici so povzeti neželeni učinki (incidenca večja kot pri placebu in z razumno možnostjo vzročne povezave) za 512 bolnikov, zdravljenih z zdravilom Plegridy 125 mikrogramov subkutano vsaka 2 tedna, in za 500 bolnikov, ki so placebo prejemali do 48 tednov, in podatki med trženjem zdravila.
Peginterferon beta-1a is a modified long-acting form of interferon.
Peginterferon beta-1a je modificirana dolgodelujoča oblika interferona.
How long to use Plegridy
Kako dolgo uporabljati zdravilo Plegridy
Patients may develop antibodies to Plegridy.
Imunogenost Pri bolnikih se lahko razvijejo protitelesa proti zdravilu Plegridy.
Patients should be monitored for symptoms or signs of decreased peripheral blood counts (see section
Bolnike je treba opazovati za pojav simptomov ali znakov zmanjšanja perifernih krvnih vrednosti (glejte poglavje 4.8).
Do not use your syringe if it has been dropped or is visibly damaged.
Ne uporabite injekcijske brizge, če je padla ali je vidno poškodovana.