natgillin/translations-raw huggingface dataset:
Do not lift your pen off your injection site until the clicking sounds stop and you see green ticks in the injection status window.
Nemojte podići brizgalicu s mjesta injekcije prije nego što prestane zvuk otkucavanja i ugledate zelene kvačice u prozorčiću stanja injekcije.
Patients exhibiting depression should be monitored closely during therapy and treated appropriately.
Bolesnike koji pokazuju simptome depresije treba pomno nadzirati tijekom liječenja i primjereno liječiti.
This should be considered when switching patients between pegylated and non-pegylated interferons (see section 5.1).
To treba uzeti u obzir kod prebacivanja bolesnika između nepegiliranog i pegiliranog interferona (vidjeti dio 5.1).
Efficacy of Plegridy has been demonstrated over placebo.
Djelotvornost Plegridyja dokazana je u usporedbi s placebom.
These will be performed before you start using Plegridy, regularly after treatment with Plegridy has been initiated and then periodically during treatment, even if you have no particular symptoms.
To će se provesti prije početka primjene Plegridyja, redovito nakon početka liječenja Plegridyjem te zatim periodički tijekom liječenja, čak i ako nemate nikakve posebne simptome.
Which pack
Koje pakiranje
In clinical studies, a total of 1468 patients received Plegridy for up to 278 weeks with an overall exposure equivalent of 4217 person-years.
U kliničkim je ispitivanjima ukupno 1468 bolesnika primalo Plegridy do 278 tjedana, pri čemu je ukupna izloženost bila jednaka 4217 bolesnik-godina.
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 pripadaju skupini prirodnih proteina koje stvaraju stanice kao odgovor na biološke i kemijske stimulanse, te posreduju u brojnim staničnim odgovorima koji su klasificirani kao protuvirusni, protuproliferativni i imunomodulacijski odgovori.
The liquid in the syringe must be clear and colourless.
Tekućina u štrcaljki mora biti bistra i bezbojna.
The safety and effectiveness of Plegridy in this age group are not known.
Sigurnost i djelotvornost Plegridyja u ovoj dobnoj skupini nisu poznate.
- If you have used more than one injection of Plegridy in a 7-day period, contact your doctor or nurse straight away.
- Ako ste primijenili više od jedne injekcije Plegridyja u razdoblju od 7 dana odmah se obratite svom liječniku ili medicinskoj sestri za savjet.
You should see a yellow plunger.
Morate vidjeti žuti klip.
(See Figure H).
(pogledajte sliku I).
In patients experiencing flu-like symptoms, the median time to onset was 10 hours (interquartile range, 7 to 16 hours) after injection, and the median duration was 17 hours (interquartile range, 12 to 22 hours).
U bolesnika sa simptomima nalik gripi, medijan vremena od injekcije do nastupa simptoma iznosio je 10 sati (interkvartilni raspon od 7 do 16 sati), a medijan trajanja 17 sati (interkvartilni raspon od 12 do 22 sata).
No serious cardiovascular events were reported in patients who received Plegridy in the ADVANCE study.
Nije bilo prijavljenih ozbiljnih kardiovaskularnih događaja u bolesnika koji su primali Plegridy u ispitivanju ADVANCE.
Do not use the pen if:
Nemojte koristiti brizgalicu:
Use caution when removing the needle cover to avoid getting a needle stick injury.
Budite oprezni dok uklanjate pokrov igle kako se ne biste ozlijedili ubodom na iglu.
They gradually get less as you keep using your injections.
Ti se simptomi postupno smanjuju tijekom primjene Vaših injekcija.
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.
Preporučuje se da zdravstveni radnik poduči bolesnike o ispravnoj tehnici za samostalno davanje supkutane injekcije pomoću napunjene štrcaljke / napunjene brizgalice.
Precautions to be taken before handling or administering the medicinal product Once removed from the refrigerator, Plegridy should be allowed to warm to room temperature (up to 25°C) for about 30 minutes prior to injection.
Mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka Jednom kad se izvadi iz hladnjaka, Plegridy se mora ostaviti da se ugrije na sobnu temperaturu (do 25°C) otprilike 30 minuta prije davanja injekcije.
Speak to your doctor or pharmacist about how much to take and how long to take it.
Posavjetujte se sa svojim liječnikom ili ljekarnikom o tome koliko i kako dugo ćete uzimati jedan od ta dva lijeka.
Less than 1% of patients who received Plegridy during the placebo controlled phase of the ADVANCE study discontinued treatment due to flu-like symptoms.
Manje od 1% bolesnika koji su primali Plegridy tijekom placebom kontrolirane faze ispitivanja ADVANCE, prekinulo je liječenje zbog simptoma nalik gripi.
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.
Nakon ponovljenog doziranja doze od 125 mikrograma svaka dva tjedna supkutanom primjenom, volumen distribucije bez korekcije za bioraspoloživost (srednja vrijednost ± SE) bio je 481 ± 105 l.
• Alcohol wipe
• vata natopljena alkoholom
The incidence of flu-like symptoms (e.g. influenza-like illness, chills, hyperpyrexia, musculoskeletal pain, myalgia, pain, pyrexia) was highest at the initiation of treatment and generally decreased over the first 6 months.
Incidencija simptoma nalik gripi (npr. bolest nalik gripi, zimica, hiperpireksija, mišićno-koštana bol, mialgija, bol, pireksija) bila je najviša na početku liječenja, a općenito se smanjila tijekom prvih 6 mjeseci.
Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.
Bolesnicima s mijelosupresijom može biti potrebno intenzivnije praćenje ukupnog broja krvnih stanica s diferencijalnom krvnom slikom i brojem trombocita.
Make sure you can see the green stripes in the injection status window (see Figure F).
Provjerite vide li se zelene pruge u prozorčiću stanja injekcije (pogledajte sliku F).
Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with Plegridy should be considered.
Potrebno je brzo liječenje nefrotskog sindroma i treba se razmotriti prestanak liječenja Plegridyjem.
Nevertheless, patients with pre-existing significant cardiac disease, such as congestive heart failure, coronary artery disease or arrhythmia should be monitored for worsening of their cardiac condition, particularly during initiation of treatment.
Međutim, kod bolesnika s postojećim značajnim srčanim bolestima, kao što su kongestivno zatajenje srca, koronarna bolest ili aritmija, mora se pratiti znakove pogoršanja srčane funkcije, posebice tijekom početka liječenja.
What you need to know before you use Plegridy 3.
Što morate znati prije nego počnete primjenjivati Plegridy 3.
Patients should be monitored for symptoms or signs of decreased peripheral blood counts (see section
Bolesnike treba pratiti na simptome ili znakove smanjenja broja perifernih krvnih stanica
This may cause the pen to accidently lock.
To može dovesti do slučajnog zaključavanja brizgalice.
- If you are allergic to peginterferon beta-1a, interferon beta-1a or any of the ingredients of this medicine (listed in section 6).
- ako ste alergični na peginterferon beta-1a, interferon beta-1a ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
Plegridy is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis (see section 5.1).
Plegridy je indiciran u odraslih bolesnika za liječenje relapsno remitirajuće multiple skleroze (vidjeti dio 5.1).
Periodic monitoring of early signs or symptoms, e.g. oedema, proteinuria and impaired renal function is recommended, especially in patients at higher risk of renal disease.
Preporučuje se periodičko praćenje ranih znakova ili simptoma, npr. edema, proteinurije i oštećene funkcije bubrega, osobito u bolesnika s većim rizikom od bolesti bubrega.
After the injection After Use - Parts of your Plegridy pen (see Figure K):
Nakon injekcije Nakon primjene - dijelovi brizgalice Plegridy (pogledajte sliku K):
Based on the known pharmacology of interferon beta-1a and clinical experience with interferon beta, the potential for carcinogenicity is expected to be low.
Na temelju poznate farmakologije interferona beta-1a i kliničkog iskustva s interferonom beta, očekuje se da je potencijal za kancerogenost malen.
This is to reduce the risk of injection site reactions.
Kako bi se smanjio rizik od reakcija na mjestu injiciranja,
Dose titration at the initiation of treatment may help to ameliorate flu-like symptoms that can occur at treatment initiation with interferons.
Titriranje doze na početku liječenja može pomoći da se ublaže simptomi nalik gripi koji se mogu pojaviti na početku liječenja interferonima.
The total combined time out of refrigeration at a temperature up to 25°C, should not exceed 30 days.
Ukupno vrijeme izvan hladnjaka na temperaturi do 25°C ne smije biti dulje od 30 dana.
The incidence of hepatic transaminase increases was greater in patients receiving Plegridy compared to placebo.
Incidencija povećanih razina jetrenih transaminaza bila je veća u bolesnika koji su primali Plegridy u usporedbi s placebom.
If TMA is diagnosed, prompt treatment is required (considering plasma exchange) and immediate discontinuation of Plegridy is recommended.
Ako se dijagnosticira TMA, potrebno je hitno započeti liječenje (razmotriti plazmaferezu) i preporučuje se odmah prekinuti liječenje Plegridyjem.
If it is not clear if Plegridy has been stored at room temperature 30 days or more, it should be discarded.
Ako nije poznato je li Plegridy bio čuvan na sobnoj temperaturi 30 dana ili više, mora se baciti.
What Plegridy is and what it is used for 2.
Što je Plegridy i za što se koristi 2.
• You do not see the green stripes in the injection status window.
• ako ne vidite zelene pruge u prozorčiću stanja injekcije
Step 8: Check to make sure you received your full dose of Plegridy (see Figure J)
8. korak: Provjerite kako biste bili sigurni da ste primili cijelu dozu Plegridyja (pogledajte sliku J) a.
You could get a needle injury or the pen may lock.
Mogli biste se ubosti ili bi se brizgalica mogla zaključati.
Remove your Plegridy pack from the fridge and select the appropriate pen (dosage) from the pack.
Izvadite iz hladnjaka pakiranje Plegridyja i odaberite odgovarajuću brizgalicu (veličinu doze)
• Check that your Plegridy medicine is clear and colourless (See Figure D).
• Provjerite da je lijek Plegridy bistar i bezbojan (pogledajte sliku D).
Peginterferon beta-1a was not mutagenic when tested in an in vitro bacterial reverse mutation (Ames) test and was not clastogenic in an in vitro assay in human lymphocytes.
Peginterferon beta-1a nije bio mutagen kada se testirao u in vitro testu bakterijske reverzne mutacije (Ames) i nije bio klastogen u in vitro testu s ljudskim limfocitima.
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.
Povišenja serumskih jetrenih transaminaza u kombinaciji s povišenim bilirubinom zabilježeno je u dva bolesnika koji su imali abnormalnosti jetrenih testova već i prije primanja Plegridyja u kliničkim ispitivanjima.
Re-capping could cause the pen to lock.
Ponovno stavljanje kapice može dovesti do zaključavanja brizgalice.
Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness or light-headedness.
Simptomi mogu uključivati povećano stvaranje modrica, krvarenje, vrućicu, iznimnu slabost, glavobolju, omaglicu ili ošamućenost.
The observed Cmax (mean±SE) was 280 ± 79 pg/mL following repeat dosing of 125 micrograms every two weeks.
(srednja vrijednost ± SE) bila je 280 ± 79 pg/ml nakon ponovljenog doziranja od 125 mikrograma svaka dva tjedna.
*Class label for interferon beta products (see section 4.4).
*Značajka skupine lijekova koji sadrže interferon beta (vidjeti dio 4.4).
a. Check the injection status window.
Provjerite prozorčić stanja injekcije.
Patients should be advised to discontinue Plegridy and seek immediate medical care if they experience signs and symptoms of anaphylaxis or severe hypersensitivity.
Bolesnicima treba savjetovati da prekinu primjenu Plegridyja i odmah zatraže liječničku pomoć ako opaze znakove i simptome anafilaksije ili teške preosjetljivosti.
Whether the mechanism of action of Plegridy in MS is mediated by the same pathway(s) as the biological effects described above is not known because the pathophysiology of MS is only partially understood.
Nije poznato je li mehanizam djelovanja Plegridyja u MS-u isti kao prethodno opisan slijed bioloških učinka, jer patofiziologija MS-a nije u potpunosti razjašnjena.
Of the patients who experienced injection site reactions 95% reported them as mild or moderate in severity.
Od bolesnika koji su prijavili reakcije na mjestu injiciranja 95% ih je prijavilo kao blage ili umjerene težine.
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.
Napomena: • Prije nego što prvi put upotrijebite napunjenu štrcaljku Plegridyja, liječnik ili medicinska sestra moraju Vama ili Vašem njegovatelju pokazati kako pripremiti i ubrizgati Plegridy iz napunjene štrcaljke.
Plegridy should be administered with caution to patients with a history of seizures, to those receiving treatment with anti-epileptics, particularly if their epilepsy is not adequately controlled with anti-epileptics (see section 4.8).
Plegridy treba s osobitom pozornošću davati bolesnicima koji su već imali epileptičke napadaje, bolesnicima koji se liječe antiepilepticima, posebno ako njihova epilepsija nije prikladno kontrolirana antiepilepticima (vidjeti dio 4.8).
Plegridy has no or negligible influence on the ability to drive and use machines.
Upravljanje vozilima i strojevima Plegridy ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
You should see green ticks.
Morate vidjeti zelene kvačice.
• You should hold the pen over your injection site at 90o angle.
• Brizgalicu morate držati iznad mjesta za injekciju pod kutom od 90o.
Nephrotic syndrome (class effects)
Nefrotski sindrom (učinak skupine lijekova)
Proportion with 12 week confirmed disability progression*
Udio s potvrđenom progresijom onesposobljenosti u 12. tjednu*
b. Check the expiry date.
b. Provjerite datum isteka roka valjanosti.
Serious hypersensitivity reactions including cases of anaphylaxis have been reported as a rare complication of treatment with interferon beta, including Plegridy.
Ozbiljne reakcije preosjetljivosti, uključujući slučajeve anafilaksije, prijavljene su kao rijetka komplikacija liječenja interferonom beta, uključujući i Plegridy.
What you need to know before you use Plegridy Do not use Plegridy
Što morate znati prije nego počnete primjenjivati Plegridy Nemojte primjenjivati Plegridy
Step 5: Firmly remove the needle cover
5. korak: Jednim čvrstim potezom skinite pokrov igle
If Plegridy is at room temperature for a total of 30 days, it should be used or discarded.
Ako se Plegridy čuvao na sobnoj temperaturi ukupno 30 dana, mora se upotrijebiti ili baciti.
Peginterferon beta-1a is a modified long-acting form of interferon.
Peginterferon beta-1a je modificirani oblik interferona s dugotrajnim djelovanjem.
In the clinical study conducted, the development of antibodies against the PEG moiety of peginterferon beta-1a had no discernible impact on safety, or clinical efficacy (including annualised relapse rate, MRI lesions, and disability progression).
U provedenom kliničkom ispitivanju razvoj protutijela protiv PEG skupine peginterferona beta-1a nije imao zamjetan utjecaj na sigurnost ili kliničku djelotvornost (uključujući godišnju stopu recidiva, MR lezije i progresiju onesposobljenosti (invalidnosti).
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 učinci koji mogu biti posredovani Plegridyjem, uključuju povećanu ekspresiju protuupalnih citokina (npr. IL-4, IL-10, IL-27), smanjenu ekspresiju proupalnih citokina (npr. IL-2, IL-12, IFNγ, TNFα) i inhibiciju migracije aktiviranih T stanica preko krvno-moždane barijere; no mogu biti uključeni i dodatni mehanizmi.
You should see green stripes.
Trebali biste vidjeti zelene pruge.
Headache, dizziness or light-headedness
- glavobolja, omaglica ili ošamućenost
rash or colour change - Changes in your blood which might cause tiredness or reduced ability to fight infection - Increases in liver enzymes in the blood (will show up in blood tests)
- promjene u krvi koje mogu uzrokovati umor ili smanjenu sposobnost obrane protiv infekcija - povećanje jetrenih enzima u krvi (pokazat će se u krvnim pretragama)
If you remove the cap, do not recap the pen.
Ako skinete kapicu, nemojte je vraćati na brizgalicu.
- Contact a doctor as they may be signs of a possible kidney problem.
Obratite se liječniku jer to mogu biti znakovi mogućih tegoba s bubrezima.
- Hypersensitivity to natural or recombinant interferon beta or peginterferon or to any of the excipients listed in section 6.1.
- Preosjetljivost na prirodni ili rekombinantni interferon beta, peginterferon ili neku od pomoćnih tvari navedenih u dijelu 6.1.
In animals, anovulatory effects were observed at very high doses (see section 5.3).
U vrlo visokim dozama prilikom testiranja na životinjama primijećen je anovulatorni učinak (vidjeti dio 5.3).
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.
* Kontinuirana progresija onesposobljenosti definirana je kao povećanje početnog EDSS ≥1 za najmanje 1 bod ili 1,5 bodova povećanja za bolesnike s početnim EDSS=0, održano kroz 12/24 tjedna.
Worsening of cardiac disease has been reported in patients receiving interferon beta.
Pogoršanja srčanih bolesti zabilježena su u bolesnika koji primaju interferon beta.
This disrupts the messages between the brain and other parts of the body, causing the symptoms of MS.
Kad se mijelin ošteti, prijenos poruka između mozga i ostalih dijelova tijela se poremeti uzrokujući simptome multiple skleroze.
With your other hand, firmly grasp needle cover and pull it straight off the needle (See Figure F).
Drugom rukom čvrsto uhvatite pokrov igle i povucite ga ravno s igle (pogledajte sliku F).
Accordingly, the half-life (t1/2) of peginterferon beta-1a is approximately 2-fold longer than non-pegylated interferon beta-1a in healthy volunteers.
U skladu s tim, poluvijek (t1/2) peginterferona beta-1a je oko 2 puta dulji nego poluvijek nepegiliranog interferona beta-1a u zdravih dobrovoljaca.
The process of covalently conjugating a PEG moiety to a protein can alter the in vivo properties of the unmodified protein, including decreased renal clearance and decreased proteolysis thus extending the circulating half-life.
Postupak kovalentnog vezanja PEG skupine na protein može mijenjati in vivo svojstva nemodificiranog proteina, uključujući smanjenje bubrežnog klirensa i smanjenu proteolizu čime se produljuje njegov poluvijek u cirkulaciji.
However, results from a population pharmacokinetic analysis (in patients up to 65 years) suggest that age does not impact peginterferon beta-1a clearance.
Međutim, rezultati populacijske farmakokinetičke analize (u bolesnika do 65 godina) ukazuju na to da dob ne utječe na klirens peginterferona beta-1a.
Read the instructions for use before you start using Plegridy and each time you get a refill of your prescription.
Pročitajte upute za uporabu prije nego što počnete koristiti Plegridy i svaki put kada ponovno dobijete lijek na recept jer mogu sadržavati nove informacije.
b. Wipe your skin with an alcohol wipe.
Obrišite kožu vatom natopljenom alkoholom.
Plegridy can be used during breastfeeding.
Plegridy se može koristiti tijekom dojenja.
External heat sources such as hot water must not be used to warm Plegridy.
Vanjski izvori topline poput vruće vode ne smiju se koristiti za zagrijavanje Plegridyja.
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.
Farmakološka svojstva Plegridyja u skladu su s onima interferona beta-1a i vjeruje se da su posredovana proteinskim dijelom molekule.
Your doctor may want to check your blood pressure, blood (platelet count) and the function of your kidneys.
Liječnik će Vam možda htjeti provjeriti krvni tlak, provesti krvne pretrage (broj trombocita) i provjeriti funkciju bubrega.
Step 2: Collect your supplies and wash your hands.
2. korak: Prikupite pribor i operite ruke a.
This could lock the pen
To bi moglo zaključati brizgalicu.
Pharmacokinetics observed in multiple sclerosis patients were consistent with those seen in healthy subjects.
Farmakokinetika opažena u bolesnika s multiplom sklerozom bila je dosljedna farmakokinetici opaženoj kod zdravih ispitanika.
Step 11: Check your injection site
11. korak: Pregledajte mjesto injekcije
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.
Od toga je 1285 bolesnika bilo liječeno Plegridyjem najmanje 1 godinu, 1124 bolesnika najmanje 2 godine, 947 bolesnika najmanje 3 godine, a 658 bolesnika najmanje 4 godine.
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.
Podaci bolesnika koji su liječeni do 2 godine Plegridyjem pokazuju da je manje od 1% (5/715) razvilo perzistentna neutralizirajuća protutijela na interferon beta-1a u peginterferonu beta-1a.
Patients should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician.
Bolesnike je potrebno savjetovati da odmah prijave svom liječniku bilo koji simptom depresije i/ili suicidalnih ideacija.
Of the patients who reported flu-like symptoms 90% reported them as mild or moderate in severity.
Od bolesnika koji su prijavili simptome nalik gripi, 90% ih je prijavilo kao simptome blage ili umjerene težine.
• Gently pinch the skin around the cleaned injection site using thumb and forefinger to create a slight bulge (See Figure G).
• Nježno stisnite kožu oko očišćenog mjesta za injekciju koristeći palac i kažiprst tako da se odigne u nabor (pogledajte sliku G).
• After the needle is in, let go of your skin.
• Nakon uvođenja igle u nabor možete otpustiti kožu.
• Plegridy pre-filled syringe should be injected into the abdomen, thigh, or the back of the upper arm. (See Figure E).
• Plegridy u napunjenoj štrcaljki treba ubrizgati u trbuh, natkoljenicu ili stražnju stranu nadlaktice (pogledajte sliku E).
Do not inject into an area of your body where the skin is irritated, red, bruised, tattooed, infected, or scarred.
Nemojte ubrizgati lijek u područje tijela gdje je koža nadražena, osjetljiva, crvena, inficirana ili prekrivena modricama, tetovažama ili ožiljcima.
Plegridy is for subcutaneous use.
Plegridy je namijenjen za supkutanu primjenu.
- For patients with ≥2 relapses in the previous year and at least 1 Gd+ lesion (n=273), the annual relapse rate at 1 year was 0.47 for placebo, 0.35 for Plegridy every 4 weeks, and 0.33 for Plegridy every 2 weeks.
- Za bolesnike s ≥2 relapsa u prethodnoj godini i najmanje 1 Gd+ lezijom (n=273), godišnja je stopa relapsa nakon 1 godine bila 0,47 za placebo, 0,35 za Plegridy svaka 4 tjedna i 0,33 za Plegridy svaka 2 tjedna.