natgillin/translations-raw huggingface dataset:
This regular schedule helps to deliver the treatment as evenly as possible.
Ta redni režim zagotavlja, da zdravilo prejemate kar najbolj enakomerno.
The majority of enzyme elevations were <3 times the upper limit of normal (ULN).
Večina povečanja encimov je bila < 3-kratna zgornja meja normalne vrednosti (ULN, upper limit of normal).
Everyone has their own set of MS symptoms.
Vsak bolnik z MS ima svoj skupek simptomov.
The study design and patient demographics are presented in Table 2.
Zasnova študije in demografski podatki bolnikov so predstavljeni v preglednici 2.
- Contact a doctor for advice.
- se za nasvet obrnite na zdravnika.
Patients who failed previous MS treatment were not included in the study.
Bolniki, pri katerih predhodno zdravljenje MS ni bilo uspešno, niso bili vključeni v študijo.
Results in this subgroup were consistent with those in the overall population.
Rezultati te podskupine so bili skladni z rezultati celotne populacije.
At very high doses, anovulatory and abortifacient effects were observed in animals.
Pri zelo visokih odmerkih so pri živalih opazili anovulacijske in abortivne učinke.
The incidence of the adverse reactions below are expressed according to the following categories:
Incidenca spodnjih neželenih učinkov je izražena po naslednjih kategorijah:
This medicine is used to treat relapsing-remitting multiple sclerosis (MS) in adults aged 18 or over.
To zdravilo se uporablja za zdravljenje recidivne-remitentne multiple skleroze (MS) pri odraslih, starih 18 let ali več.
Interferons are natural substances made in the body to help protect from infections and diseases.
Interferoni so snovi, ki v telesu nastajajo naravno, in pomagajo pri obrambi pred okužbami in boleznimi.
Neutralising antibodies have the potential to reduce clinical efficacy.
Nevtralizirajoča protitelesa potencialno lahko zmanjšajo klinično učinkovitost.
Speak to your doctor or pharmacist about how much to take and how long to take it.
Pogovorite se z zdravnikom ali farmacevtom o tem, koliko tega zdravila lahko vzamete in kako dolgo ga lahko jemljete.
Decreases in white blood cell counts were not associated with an increased risk of infections or serious infections.
Zmanjšanja števila belih krvnih celic niso bila povezana z večjim tveganjem za okužbe ali z resnimi okužbami.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially those used to treat epilepsy or depression.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, zlasti zdravila za zdravljenje epilepsije ali depresije.
The average molecular mass is approximately 44 kDa of which the protein moiety constitutes approximately 23 kDa.
Povprečna molekulska masa je približno 44 kDa, od tega predstavlja beljakovinski del približno 23 kDa.
Results in this subgroup were numerically consistent with those in the overall population but not statistically significant.
Rezultati te podskupine so bili številčno skladni z rezultati celotne populacije, vendar niso bili statistično značilni.
However, do not inject more than once in a 7-day period.
Vendar pa si zdravila ne injicirajte več kot enkrat v 7-dnevnem obdobju.
*Dosed every 2 weeks (14 days)
*odmerjanje vsaka 2 tedna (14 dni)
Depression occurs with increased frequency in the multiple sclerosis population and in association with interferon use.
Depresija se z večjo pogostnostjo pojavlja pri populaciji z multiplo sklerozo in v povezavi z uporabo interferona.
Do not freeze or expose to high temperatures.
Zdravila ne zamrzujte in ne izpostavljajte ga visokim temperaturam.
Therefore, the long-term safety of chronic administration of Plegridy to patients cannot be assessed on the basis of these studies.
Zato dolgotrajne varnosti pri kroničnem dajanju zdravila Plegridy bolnikom ni mogoče oceniti na podlagi teh študij.
Do not use this medicine after the expiry date which is stated on the carton and the label after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki poleg oznake »EXP«.
The primary endpoint was the annualised relapse rate (ARR) over 1 year.
Primarni opazovani dogodek je bila letna stopnja recidivov (ARR, annualised relapse rate) v 1 letu.
In case of over-dose, patients may be hospitalized for observation and appropriate supportive treatment should be given.
V primeru prevelikega odmerjanja se lahko bolnik hospitalizira zaradi opazovanja in je bolniku potrebno dati ustrezno podporno zdravljenje.
The validity of extrapolating these non-clinical data to humans is unknown.
Veljavnost ekstrapolacije teh predkliničnih podatkov na ljudi ni znana.
- Your doctor may still prescribe Plegridy for you, but it's important to let your doctor know if you have had depression or any similar problems affecting your mood in the past.
- Zdravnik vam lahko kljub temu predpiše zdravilo Plegridy, vendar je pomembno, da zdravnika obvestite, da ste v preteklosti imeli depresijo ali drugo težavo, ki vpliva na vaše razpoloženje.
- Blood problems
- Težave s krvjo
• If less than 7 days to the next planned dose: Patients should begin a new 2 week dosing schedule starting from when they administer their missed dose.
• Če je do naslednjega načrtovanega odmerka manj kot 7 dni: Bolnik naj začne nov 2-tedenski režim odmerjanja, ki se začne, ko prejme svoj izpuščeni odmerek.
They may be signs of a possible liver problem.
To so lahko znaki težav z jetri.
If you are new to Plegridy, your doctor may advise you to gradually increase your dose so that you can adjust to the effects of Plegridy before taking the full dose.
Če se z zdravilom Plegridy zdravite na novo, vam bo zdravnik morda svetoval, da svoj odmerek postopoma zvišujete, da se lahko navadite na učinke zdravila Plegridy, preden uporabite polni odmerek.
The safety and effectiveness of Plegridy in this age group are not known.
Varnost in učinkovitost zdravila Plegridy v tej starostni skupini nista znani.
Time*
Odmerek Čas*
The safety and efficacy of Plegridy in children and adolescents aged 0 to 18 years have not been established in multiple sclerosis.
Varnost in učinkovitost zdravila Plegridy pri otrocih in mladostnikih, starih od 0 do 18 let, nista bili dokazani pri multipli sklerozi.
- You will need blood tests to determine your numbers of blood cells, blood chemistry and your levels of liver enzymes.
- Potrebno bo opraviti krvne preiskave za določitev števila vaših krvnih celic, kemijske sestave krvi in ravni vaših jetrnih encimov.
- Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
- Bolniki s hudo depresijo in/ali samomorilnimi mislimi (glejte poglavji 4.4 in 4.8).
You can inject Plegridy yourself without the help of your doctor, if you have been trained how to do this.
Zdravilo Plegridy si lahko injicirate sami, brez zdravnikove pomoči, če ste se tega naučili.
Additional supplies which are not included in the pack (See Figure B):
Dodatni pripomočki, ki niso vključeni v pakiranje (glejte sliko B):
You should see a yellow plunger.
Morali bi videti rumeni bat.
If clinically needed, the use of Plegridy may be considered during pregnancy.
Če je klinično potrebno, se lahko pretehta možnost uporabe zdravila Plegridy med nosečnostjo.
The procedure for the self-administration by the patient should be reviewed periodically especially if injection site reactions have occurred.
Bolnikov postopek samoinjiciranja je treba občasno preverjati, zlasti, če se pojavijo reakcije na mestu injiciranja.
Table 2: Study design
Preglednica 2: Zasnova študije
Patients exhibiting depression should be monitored closely during therapy and treated appropriately.
Bolnike, ki kažejo depresijo, je treba med zdravljenjem skrbno nadzirati in ustrezno zdraviti.
Decreased peripheral blood counts
Zmanjšanje perifernih krvnih vrednosti
Results over 2 years confirmed that efficacy was maintained beyond the placebo controlled first year of the study.
Rezultati za 2 leti so potrdili, da se je učinkovitost ohranila tudi v obdobju po prvem letu s placebom kontrolirane študije.
Data from studies with other interferon beta compounds did not show teratogenic potential.
Podatki iz študij z drugimi sestavinami interferona beta niso pokazale teratogenega potenciala.
Nephrotic syndrome (class effects)
Nefrotski sindrom (učinki skupine)
Your doctor may find changes in your blood and the function of your kidneys.
Zdravnik bo lahko našel spremembe v vaši krvi in delovanju vaših ledvic.
On average, flu-like symptoms begin approximately 10 hours after injection and last between 12 and 24 hours.
Gripi podobni simptomi se začnejo povprečno približno 10 ur po injiciranju in trajajo 12 do 24 ur.
These blood clots could affect your kidneys.
Ti krvni strdki lahko poškodujejo vaše ledvice.
The experience in the randomised, uncontrolled phase (year 2) of the ADVANCE study and in the extension study ATTAIN (treatment received for up to 4 years) was consistent with the experience in the 1 year placebo-controlled phase of the ADVANCE study.
Izkušnje iz randomizirane, nekontrolirane faze (2. leto) študije ADVANCE in iz podaljšane študije ATTAIN (v kateri so se bolniki zdravili do 4 leta) so bile skladne z izkušnjami iz 1-letne, s placebom kontrolirane faze študije ADVANCE.
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.
Kljub temu pa je treba pri bolnikih s pomembno obstoječo boleznijo srca, kot so kongestivno srčno popuščanje, bolezen koronarnih arterij ali aritmija, treba spremljati poslabšanje bolezni srca, zlasti med začetkom zdravljenja.
The potency of this medicinal product should not be compared to the one of another pegylated or non-pegylated protein of the same therapeutic class.
Učinkovitost tega zdravila ni primerljiva z učinkovitostjo drugih pegiliranih ali nepegiliranih beljakovin enakega terapevtskega razreda.
Take paracetamol or ibuprofen half an hour before your Plegridy injection and continue to take paracetamol or ibuprofen for the duration of your flu-like symptoms.
Vzemite paracetamol ali ibuprofen pol ure pred injiciranjem zdravila Plegridy in nadaljujte z jemanjem paracetamola ali ibuprofena, dokler gripi podobni simptomi trajajo.
If it is not clear if Plegridy has been stored at room temperature 30 days or more, it should be discarded.
Če ni jasno, ali je bilo zdravilo Plegridy shranjeno pri sobni temperaturi 30 dni ali več, ga je treba zavreči.
Patients should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician.
Bolnike je treba opozoriti, da morajo takoj poročati o vseh simptomih depresije in/ali samomorilnih misli zdravniku, ki je zdravilo predpisal.
Your pen is now ready to inject.
Vaš injekcijski peresnik je sedaj pripravljen na injiciranje.
Only open the pack when you need a new syringe.
Novo pakiranje odprite le, ko potrebujete novo brizgo.
- If you have used more than one injection of Plegridy in a 7-day period, contact your doctor or nurse straight away.
- Če ste v 7-dnevnem obdobju uporabili več kot eno injekcijo zdravila Plegridy, se takoj posvetujte z zdravnikom ali medicinsko sestro.
Step 2: Collect your supplies and wash your hands.
2. korak: Pripravite pripomočke in si umijte roke.
The safety and efficacy of Plegridy in patients over the age of 65 have not been sufficiently studied due to the limited number of such patients included in clinical trials.
Varnost in učinkovitost zdravila Plegridy pri bolnikih, starih več kot 65 let, nista bili ustrezno preučeni, saj je število takih bolnikov, vključenih v klinična preskušanja, majhno.
MS is a long term illness that affects the central nervous system (CNS), including the brain and spinal cord, in which the body's immune system (its natural defences) damages the protective layer (myelin) that surrounds the nerves in the brain and spinal cord.
MS je dolgotrajna bolezen, ki prizadene osrednji živčni sistem, vključno z možgani in hrbtenjačo, pri kateri telesni imunski sistem (njegova naravna obramba) poškoduje zaščitno plast (mielin), ki obdaja živce v možganih ali hrbtenjači.
See below for simple ways to manage these flu-like symptoms if you get them.
Spodaj so preprosti načini za obvladovanje teh gripi podobnih simptomov, če se pojavijo.
Reversibility of the effects on menstrual cycle length was demonstrated.
Pokazalo se je, da so učinki na dolžino menstrualnega cikla reverzibilni.
Study population
Študijska populacija
b. Wipe your skin with an alcohol wipe.
b. Kožo očistite z alkoholnim robčkom.
c. Check the medicine window and make sure the Plegridy medicine is clear and colourless.
c. Preglejte okence za zdravilo in se prepričajte, da je zdravilo Plegridy bistro in brezbarvno.
If you have a fever, drink plenty of water to keep you hydrated.
Če imate zvišano telesno temperaturo, spijte veliko vode, da ne dehidrirate.
• If 7 days or more to the next planned dose: Patients should administer their missed dose immediately.
• Če je do naslednjega načrtovanega odmerka 7 dni ali več: Bolniku je treba izpuščeni odmerek dati takoj.
Your doctor will tell you how long you need to keep using Plegridy.
Zdravnik vam bo povedal, kako dolgo boste morali uporabljati zdravilo Plegridy.
The Initiation Pack contains your first two injections to gradually adjust your dose.
Začetno pakiranje vsebuje prvi dve injekciji za postopno prilagoditev odmerka.
How Plegridy works Plegridy seems to work by stopping the body's immune system from damaging your brain and spinal cord.
Kaže, da zdravilo Plegridy deluje tako, da imunskemu sistemu telesa prepreči poškodovanje vaših možganov in hrbtenjače.
A patient should not administer two doses of Plegridy within 7 days of each other.
Bolnik ne sme prejeti dveh odmerkov zdravila Plegridy v 7-dnevnem časovnem obdobju.
The European Medicines Agency has deferred the obligation to submit the results of studies with Plegridy in one or more subsets of the paediatric population in treatment of multiple sclerosis (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Plegridy za eno ali več podskupin pediatrične populacije z multiplo sklerozo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
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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.
Postopek kovalentne konjugacije deleža PEG z beljakovino lahko spremeni lastnosti in vivo nemodificirane beljakovine, vključno z zmanjšanim ledvičnim očistkom in zmanjšano proteolizo, zato se podaljša cirkulirajoči razpolovni čas.
If the patient experiences any break in the skin, which may be accompanied by swelling or drainage of fluid from the injection site, the patient should be advised to speak with their doctor.
Če se pri bolniku pojavi poškodba na koži, ki jo lahko spremlja oteklina ali iztekanje tekočine iz mesta injiciranja, je treba bolniku svetovati, da se posvetuje z zdravnikom.
In animals, anovulatory effects were observed at very high doses (see section 5.3).
Pri živalih so pri zelo visokih odmerkih opazili anovulacijske učinke (glejte poglavje 5.3).
This tells you that the injection is happening (see Figure G).
To pomeni, da injiciranje poteka (glejte sliko G).
• If you have a skin reaction and it does not clear up in a few days, contact your doctor or nurse.
• Če imate kožno reakcijo, ki v nekaj dneh ne izgine, se posvetujte z zdravnikom ali medicinsko sestro.
Giving your injection Step 4: Choose and clean your injection site
Dajanje injekcije 4. korak: Izberite in očistite mesto injiciranja.
To minimise the risk of injection site reactions patients should be instructed in the use of an aseptic injection technique.
Za zmanjšanje tveganja reakcij na mestu injiciranja je treba bolnikom dati navodilo, da uporabljajo aseptično tehniko injiciranja.
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).
Pri bolnikih, ki so imeli gripi podobne simptome, je bil mediani čas do njihovega nastopa 10 ur (interkvartilni razpon 7 do 16 ur) po injiciranju, mediano trajanje pa je bilo 17 ur (interkvartilni razpon 12 do 22 ur).
• Find a well-lit, clean, flat surface to work on, like a table.
• Poiščite dobro osvetljeno, čisto in ravno površino, kot je na primer miza.
Day 28
3. odmerek 28. dan
The observed Cmax (mean±SE) was 280 ± 79 pg/mL following repeat dosing of 125 micrograms every two weeks.
Opaženi Cmax (povprečje ± SN) je bil 280 ± 79 pg/ml po ponavljajočem se odmerjanju 125 mikrogramov vsaka dva tedna.
b. Check the medicine window.
b. Preglejte okence za zdravilo.
If you accidentally prick yourself or someone else with the needle in Plegridy, the area affected should be washed immediately with soap and water and a doctor or nurse should be contacted as soon as possible.
Če sebe ali koga drugega po nesreči zbodete z iglo v zdravilu Plegridy, prizadeti predel takoj izperite z milom in vodo in se čim prej posvetujte z zdravnikom ali medicinsko sestro.
b. Check the expiry date.
b. Preverite datum izteka roka uporabnosti.
Prophylactic and concurrent use of anti-inflammatory, analgesic and/or antipyretic treatments may prevent or ameliorate flu-like symptoms sometimes experienced during interferon treatment (see section 4.8).
Profilaktična in sočasna uporaba zdravil proti vnetju, analgetikov in/ali antipiretikov lahko prepreči ali ublaži gripi podobne simptome, ki se včasih pojavijo med zdravljenjem z interferonom (glejte poglavje 4.8).
The usual sites for subcutaneous injections include abdomen, arm, and thigh.
Običajna mesta za subkutano injiciranje vključujejo trebuh, roko in stegno.
The clinical studies indicate that multiple sclerosis patients can receive Plegridy and corticosteroids during relapses.
Klinične študije kažejo, da lahko bolniki z multiplo sklerozo med recidivom prejemajo zdravilo Plegridy in kortikosteroide.
The liquid in the syringe must be clear and colourless.
Tekočina v brizgi mora biti bistra in brezbarvna.
• Keep the needle inserted in for 5 seconds (see Figure J).
• Injekcijsko iglo pustite vstavljeno 5 sekund (glejte sliko J).
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.
Ni znano, ali poteka mehanizem delovanja zdravila Plegridy pri multipli sklerozi po enaki(h) poti(eh), kot zgoraj opisani biološki učinki, saj je patofiziologija multiple skleroze razumljena le delno.
In clinical studies, a total of 1468 patients received Plegridy for up to 278 weeks with an overall exposure equivalent of 4217 person-years.
V kliničnih študijah je vsega skupaj 1.468 bolnikov zdravilo Plegridy prejemalo do 278 tednov z ekvivalentom celokupne izpostavljenosti 4.217 oseb-let).
Note: You might see air bubbles in the medicine window.
Opomba: V okencu za zdravilo boste morda opazili zračne mehurčke.
Find a well-lit, clean, flat surface to work on like a table.
Poiščite dobro osvetljeno, čisto in ravno površino, kot je na primer miza.
Make sure you can see the green stripes in the injection status window (see Figure F).
Prepričajte se, da vidite zelene proge v okencu stanja injiciranja (glejte sliko F).
This might happen several weeks to several years after starting Plegridy.
To se lahko zgodi nekaj tednov do nekaj let po začetku uporabe zdravila Plegridy.
Injection Site open here
Mesto injiciranja odprite tukaj
Pharmacokinetics observed in multiple sclerosis patients were consistent with those seen in healthy subjects.
Farmakokinetika, ki so jo opazili pri bolnikih z multiplo sklerozo, je bila skladna s farmakokinetiko pri zdravih osebah.
a. Check the injection status window.
a. Preglejte okence stanja injiciranja.
• Recommended storage is controlled refrigeration 2°C to 8°C in the closed original carton to protect from light.
• Priporoča se shranjevanje na mestu s kontrolirano temperaturo od 2 °C do 8 °C v zaprti originalni škatli za zagotovitev zaščite pred svetlobo.
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.
Incidenca gripi podobnih simptomov (npr. gripi podobna bolezen, mrzlica, hiperpireksija, mišično-skeletne bolečine, mialgija, bolečina, pireksija) je bila najvišja ob začetku zdravljenja, nato pa se je v prvih 6 mesecih običajno zmanjšala.
Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with Plegridy should be considered.
Potrebno je takojšnje zdravljenje nefrotskega sindroma, razmisliti pa je treba tudi o prekinitvi zdravljenja z zdravilom Plegridy.
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.
Priporoča se občasno spremljanje zgodnjih znakov in simptomov, npr. edema, proteinurije in okvarjenega delovanja ledvic, zlasti pri bolnikih z večjim tveganjem za bolezen ledvic.
Less than 1% of patients who received Plegridy during the placebo controlled phase of the ADVANCE study discontinued treatment due to flu-like symptoms.
Manj kot 1 % bolnikov, ki so dobivali zdravilo Plegridy v s placebom kontrolirani fazi študije ADVANCE, je zdravljenje prekinilo zaradi gripi podobnih simptomov.
Other medicines and Plegridy
Druga zdravila in zdravilo Plegridy
Patients with RRMS, with at least 2 relapses within the prior 3 years, and 1 relapse in the prior year, with an EDSS score of ≤5.0
Bolniki z RRMS, z vsaj 2 recidivoma v predhodnih 3 letih in 1 recidivom v preteklem letu, s seštevkom po EDSS ≤ 5,0
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Dose titration at the initiation of treatment may help to ameliorate flu-like symptoms that can occur at treatment initiation with interferons.
Titriranje odmerka ob uvedbi zdravljenja lahko pomaga ublažiti gripi podobne simptome, ki se lahko pojavijo ob začetku zdravljenja z interferoni.
Only open the pack when you need a new pen.
Novo pakiranje odprite le, ko potrebujete nov peresnik.
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 podlagi znane farmakologije interferona beta-1a in kliničnih izkušenj z interferonom beta se pričakuje, da je kancerogeni potencial nizek.
Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, immunostimulants, interferons, ATC code: L03AB13
Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe in imunomodulatorji, zdravila za spodbujanje imunske odzivnosti, interferoni, oznaka ATC: L03AB13
Table 3: Clinical and MRI results
Preglednica 3: Klinični rezultati in rezultati MRS
Your doctor may want to check your blood pressure, blood (platelet count) and the function of your kidneys.
Zdravnik bo morda preveril krvni tlak, kri (število krvnih ploščic) in delovanje vaših ledvic.
What you need to know before you use Plegridy 3.
Kaj morate vedeti, preden boste uporabili zdravilo Plegridy 3.
Plegridy should be used carefully with medicines that are broken down in the body by a group of proteins called “cytochrome P450” (e.g. some medicines used for epilepsy or depression).
Zdravilo Plegridy je treba z nekaterimi zdravili, ki jih v telesu razgradi skupina beljakovin, imenovanih »citokrom P450«, uporabljati previdno (npr. nekatera zdravila, ki se uporabljajo za epilepsijo ali depresijo).
• Before you use the pen for the first time, your doctor or nurse should show you or your carer how to prepare and inject the pen.
• Preden prvič uporabite napolnjeni injekcijski peresnik, morata zdravnik ali medicinska sestra vam oziroma vašemu skrbniku pokazati, kako se pripravi in uporabi injekcijski peresnik.