natgillin/translations-raw huggingface dataset:
For the full list of side effects reported with Thalidomide Celgene, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Thalidomide Celgene, glejte navodilo za uporabo.
How is Thalidomide Celgene used?
Kako se zdravilo Thalidomide Celgene uporablja?
The active substance in Thalidomide Celgene, thalidomide, is thought to work by blocking the development of cancer cells, and by stimulating some of the specialised cells of the immune system
Učinkovina zdravila Thalidomide Celgene, talidomid, naj bi učinkovala tako, da zavira razvoj rakavih celic ter spodbuja nekatere specifične celice v imunskem sistemu (naravni obrambni mehanizem telesa), da napadejo rakave celice.
The strict conditions put in place to prevent pregnancy and the exposure of unborn children to thalidomide must be met by all men and women taking the medicine.
Vsi moški in ženske, ki jemljejo to zdravilo, morajo izpolnjevati stroge pogoje, določene za preprečevanje nosečnosti in izpostavljanja nerojenih otrok talidomidu.
How does Thalidomide Celgene work?
Kako zdravilo Thalidomide Celgene deluje?
Thalidomide Celgene increased the time patients lived in one main study involving 447 patients with multiple myeloma.
V eni glavni študiji, ki je vključevala 447 bolnikov z multiplim mielomom, je zdravilo Thalidomide Celgene podaljšalo čas preživetja bolnikov.
This summary was last updated in 02-2014.
Povzetek je bil nazadnje posodobljen 2-2014.
Overall, the effect of Eperzan in reducing HbA1c varied between 0.6 and 0.9%.
V celoti je učinek zdravila Eperzan pri zmanjševanju HbA1c znašal med 0,6 % in 0,9 %.
What measures are being taken to ensure the safe and effective use of Eperzan?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Eperzan?
This was considered to be clinically meaningful and there were three-year data showing that this effect was maintained during long-term treatment.
Učinek so zabeležili kot klinično pomemben, triletni podatki pa so pokazali, da se je med dolgotrajnim zdravljenjem ohranil.
The European Commission granted a marketing authorisation valid throughout the European Union for Eperzan on 28 March 2014.
Evropska komisija je dovoljenje za promet z zdravilom Eperzan, veljavno po vsej Evropski uniji, izdala dne 21. marca 2014.
The full EPAR and risk management plan summary for Eperzan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Eperzan sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What is Eperzan and what is it used for?
Kaj je zdravilo Eperzan in za kaj se uporablja?
This is a summary of the European public assessment report (EPAR) for Eperzan.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Eperzan.
A risk management plan has been developed to ensure that Eperzan is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Eperzan je bil pripravljen načrt obvladovanja tveganj.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Eperzan's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Eperzan večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The risks seen with the medicine were similar to those of other medicines in its class and Eperzan has the advantage of being given only once a week.
Tveganja, opažena pri tem zdravilu, so bila podobna tveganjem drugih zdravil v tem razredu, ima pa zdravilo Eperzan to prednost, da se daje samo enkrat na teden.
Patients inject the medicine themselves (after suitable training) under the skin in the abdomen, thigh or the upper arm.
Bolniki si zdravilo injicirajo sami (po ustreznem usposabljanju) pod kožo v trebuh, stegno ali nadlaket.
What benefits of Eperzan have been shown in studies?
Kakšne koristi je zdravilo Eperzan izkazalo v študijah?
What are the risks associated with Eperzan?
Kakšna tveganja so povezana z zdravilom Eperzan?
It works by attaching to receptors for a substance called glucagon-like peptide 1 (GLP-1), which are found on the surface of the cells in the pancreas and stimulate them to release insulin.
Deluje tako, da se veže na receptorje za snov, imenovano glukagonu podoben peptid 1 (GLP-1), ki so na površini celic v trebušni slinavki, in spodbuja njihovo izločanje insulina.
Other information about Eperzan
Druge informacije o zdravilu Eperzan
The main measure of effectiveness was the change in the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached.
Glavno merilo učinkovitosti je bila sprememba vrednosti glikoziliranega hemoglobina (HbA1c), tj. deleža hemoglobina v krvi, vezanega na glukozo.
HbA1c gives an indication of how well the blood glucose is controlled.
HbA1c kaže, kako dobro je glukoza v krvi uravnana
Why is Eperzan approved?
Zakaj je bilo zdravilo Eperzan odobreno?
It is not intended to provide practical advice on how to use Eperzan.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Eperzan, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Eperzan in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Two other medicines, pioglitazone and liraglutide, were found to be more effective as an add-on than Eperzan.
Dve drugi zdravili, tj. pioglitazon in liraglutid, sta bili kot dodatek učinkovitejši kot zdravilo Eperzan.
The most common side effects with Eperzan, affecting more than 1 in 20 people, are diarrhoea, nausea (feeling sick) and reactions at the injection site including rash, redness, or itching.
Najpogostejši neželeni učinki zdravila Eperzan, ki prizadenejo več kot enega bolnika od 20, so driska, slabost (siljenje na bruhanje) in reakcije na mestu injiciranja, vključno z izpuščajem, rdečino ali srbenjem.
Eperzan is available as prefilled pens that contain a powder (30 and 50 mg) and solvent for making a solution to be injected under the skin.
Zdravilo Eperzan je na voljo v napolnjenih peresnikih, ki vsebujejo prašek (30 in 50 mg) in vehikel za pripravo raztopine, ki se injicira pod kožo.
When used in combination with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to avoid hypoglycaemia (low blood sugar levels).
Če bolnik jemlje zdravilo Eperzan s sulfonilsečnino ali insulinom, bo morda treba zmanjšati odmerek sulfonilsečnine ali insulina, da se prepreči hipoglikemija (nizka raven sladkorja v krvi).
For more information about treatment with Eperzan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Eperzan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Eperzan can also be used as an ‘add-on' to other diabetes medicines, including insulin, when these medicines together with exercise and diet are not providing adequate control of blood glucose.
Zdravilo Eperzan se lahko uporablja tudi kot „dodatek“ k drugim zdravilom za zdravljenje sladkorne bolezni, vključno z insulinom, kadar ta zdravila skupaj s telesno dejavnostjo in dieto ne zagotavljajo zadostne urejenosti glukoze v krvi.
For practical information about using Eperzan, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Eperzan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
When Eperzan is injected, albiglutide reaches the receptors in the pancreas and activates them.
Po injiciranju zdravila Eperzan albiglutid doseže receptorje v trebušni slinavki in jih aktivira.
This causes the release of insulin and helps to reduce blood glucose levels and control type 2 diabetes.
To povzroči sprostitev insulina in pomaga zmanjšati ravni glukoze v krvi, s tem pa uravnavati sladkorno bolezen tipa 2.
The CHMP noted that the effects of Eperzan in controlling blood glucose were shown to be clinically meaningful when the medicine was used alone and when compared with other medicines in combination treatments.
Odbor CHMP je zabeležil, da so učinki zdravila Eperzan pri uravnavanju glukoze v krvi klinično pomembni, kadar se zdravilo uporablja samostojno in kadar se primerja z drugimi zdravili v kombiniranih zdravljenjih.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Sladkorna bolezen tipa 2 je bolezen, pri kateri v trebušni slinavki ne nastaja dovolj insulina za uravnavanje ravni glukoze v krvi ali ga telo ne more učinkovito izkoristiti.
Eperzan can be used on its own in patients whose blood glucose levels are not satisfactorily controlled on diet and exercise alone and who cannot take metformin (another diabetes medicine).
Zdravilo Eperzan se lahko uporablja samostojno pri bolnikih, pri katerih ravni glukoze v krvi ni mogoče zadovoljivo uravnavati samo z dieto in telesno dejavnostjo, in pri bolnikih, ki ne morejo jemati metformina (drugega zdravila za zdravljenje sladkorne bolezni).
The active substance in Eperzan, albiglutide, is a ‘GLP-1 receptor agonist'.
Zdravilna učinkovina zdravila Eperzan je albiglutid, ki je „agonist receptorjev GLP-1“.
Eperzan was more effective than placebo at reducing HbA1c levels when used alone, and was more effective than the diabetes medicines sitagliptin and glimepiride and comparable to insulin glargine and insulin lispro when used as add-on to other treatments.
Zdravilo Eperzan je bilo učinkovitejše od placeba pri zmanjševanju ravni HbA1c, kadar se uporablja samostojno, in učinkovitejše od zdravil za zdravljenje sladkorne bolezni sitagliptin in glimepirid ter primerljivo z insulinom glarginom in insulinom lispro, kadar se uporablja kot dodatek k drugim zdravljenjem.
Eperzan is a diabetes medicine that contains the active substance albiglutide.
Eperzan je zdravilo za zdravljenje sladkorne bolezni, ki vsebuje zdravilno učinkovino albiglutid.
The benefits of Eperzan were studied in over 5,000 patients with type 2 diabetes in which Eperzan was compared with placebo (a dummy treatment) or with other diabetes medicines when used as an addon to various combination treatments or when used alone.
Koristi zdravila Eperzan so proučevali pri več kot 5000 bolnikih s sladkorno boleznijo tipa 2, pri katerih so zdravilo Eperzan primerjali s placebom (zdravilom brez zdravilne učinkovine) ali z drugimi zdravili za zdravljenje sladkorne bolezni, kadar se zdravilo Eperzan uporablja kot dodatek k različnim kombiniranim zdravljenjem ali samostojno.
The recommended dose is 30 mg injected once a week, though this may be increased by their doctor to 50 mg depending on the effects on their blood sugar levels.
Zdravnik lahko odmerek zviša na 50 mg, odvisno od vpliva na koncentracijo sladkorja v krvi.
How is Eperzan used?
Kako se zdravilo Eperzan uporablja?
How does Eperzan work?
Kako zdravilo Eperzan deluje?
The final content, format and distribution modalities of both documents should be agreed with the national competent authority in each Member State.
Končno vsebino, obliko in načine distribucije obeh dokumentov je treba določiti v soglasju s pristojnim nacionalnim organom v vsaki državi članici.
The Marketing Authorisation Holder must implement this educational plan nationally, prior to marketing.
Imetnik dovoljenja za promet mora izvesti ta načrt izobraževanja na nacionalni ravni pred začetkom trženja zdravila.
Both documents are to be used as part of an educational plan aiming to minimise risks of medication errors, risk of thromboembolic events due to increased levels of non-proteolytically activated rFXIII in connection with incorrect storage, and risk of off-label use for treatment of breakthrough bleeding.
Oba dokumenta je treba uporabiti v okviru načrta izobraževanja, katerega cilj je zmanjšati tveganja za napake pri uporabi zdravila, tveganje za trombembolične dogodke zaradi zvišane ravni neproteolitično aktiviranega rFXIII v zvezi z nepravilnim shranjevanjem ter tveganje za neodobreno uporabo za zdravljenje vmesnih krvavitev.
• distribution and use of the patient brochure and the need to ensure that the patient has read and understood the brochure
• distribuiranje in uporabo brošure za bolnike ter opozorilo, da je treba poskrbeti, da bolnik brošuro prebere in jo razume
The MAH should ensure harmonisation between terminology used in the brochures and the product information.
Imetnik dovoljenja za promet mora poskrbeti za uskladitev terminologije, uporabljene v brošurah in informacijah o zdravilu.
The physician brochure should contain the following key elements and item:
Brošura za zdravnika mora vsebovati naslednje ključne elemente in postavke:
• embolic and thrombotic events including the increased risk of vessel occlusion in patients at risk of thrombosis
• embolične in trombembolične dogodke, vključno z večjim tveganjem za zaporo žile pri bolnikih, ki imajo tveganje za trombozo
• Summary of Product Characteristics
• povzetek glavnih značilnosti zdravila
• the importance of collecting safety data and how to enrol patients in the PASS and other registries
• pomen zbiranja podatkov o varnosti in navodila, kako vključiti bolnike v študijo o varnosti zdravila (PASS) in druge registre
• appropriate diagnostic procedures to confirm FXIII A-subunit deficiency
• ustrezne diagnostične postopke za potrditev pomanjkanja podenote A FXIII
• how to recognise the potential side effects (thrombosis and embolism)
• navodila, kako prepoznati možne neželene učinke (trombozo in embolijo)
The patient brochure, to be distributed to patients by the prescribers, should contain the following key elements and item:
Brošura za bolnike, ki jo morajo predpisujoči zdravniki izročiti bolnikom, mora vsebovati naslednje ključne elemente in postavke:
• correct handling and the risks associated with mishandling
• pravilno ravnanje in tveganja, povezana z nepravilnim ravnanjem
• the risks associated with incorrect storage and mishandling
• tveganja, povezana z nepravilnim shranjevanjem in ravnanjem
• contraindication of hypersensitivity
• kontraindikacijo zaradi preobčutljivosti
The Marketing Authorisation Holder (MAH) shall ensure that, at launch, a letter is sent to all expected and actual prescribers of NovoThirteen with an Educational Pack containing the following:
Imetnik dovoljenja za promet bo zagotovil, da bo ob začetku trženja zdravila vsem zdravnikom, ki predpisujejo zdravilo NovoThirteen ali za katere se pričakuje, da ga bodo predpisovali, poslano pismo z izobraževalnim kompletom.
• warning and precautions regarding anaphylaxis
• opozorila in previdnostne ukrepe glede anafilakse
The dose volume in millilitres should be calculated based on body weight for each patient using the following formula: Dose volume in ml = 0.042 x subject bw (kg).)
Količino odmerka v mililitrih je treba za vsakega bolnika izračunati glede na telesno maso po naslednji formuli: količina odmerka v ml =
Physician brochure Patient brochure
brošuro za zdravnika in brošuro za bolnika.
• how to safely store, handle, reconstitute and administer the product
• navodila za varno shranjevanje in ravnanje z zdravilom, pripravo in dajanje zdravila
FXIII containing products (The recommended dose of NovoThirteen is 35 IU/kg body weight
• opozorilo o razlikah v odmerjanju in koncentraciji med zdravilom NovoThirteen in drugimi zdravili, ki vsebujejo FXIII (Priporočeni odmerek zdravila NovoThirteen je 35 i.e./kg telesne mase enkrat na mesec v intravenski bolusni injekciji.
• Package Leaflet
• navodilo za uporabo
• you regularly drink alcohol
• redno pijete alkohol.
Date of first authorisation: 28th April 2014 Date of latest renewal:
Datum prve pridobitve: 28. april 2014 Datum zadnjega podaljšanja:
• If you do not feel better, take another inhalation.
• Če se ne počutite bolje, naredite še en vdih.
They may need to change your treatment.
Morda bo treba vaše zdravljenje spremeniti.
The effects include:
Med temi učinki so:
Overview of severe exacerbations in clinical studies
Pregled hudih poslabšanj v kliničnih študijah
• asthma exacerbations in the past requiring medical intervention.
• s poslabšanjem astme v preteklosti, pri katerem je bila potrebna medicinska intervencija.
Reduction in exacerbation rate is statistically significant (P value <0.01) for both comparisons
Zmanjšanje pogostnosti poslabšanj je statistično značilno (vrednost p < 0,01) za obe primerjavi.
Depression, behavioural changes (predominantly in children)
Zelo redki depresija, vedenjske spremembe (pretežno pri otrocih)
• a slowing of the rate of growth of children and adolescents
• upočasnjena rast pri otrocih in mladostnikih,
Vision, blurred (see also section 4.4)
Občasni zamegljen vid (glejte tudi poglavje 4.4)
If you regularly need to use 8 or more inhalations a day, make an appointment to see your doctor.
Če redno potrebujete 8 ali več inhalacij na dan, se dogovorite za pregled pri zdravniku.
Possible systemic effects include
Možni sistemski učinki vključujejo
Some medicines may increase the effects of BiResp Spiromax and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Nekatera zdravila lahko povečajo učinek zdravila BiResp Spiromax in zdravnik vas bo morda želel skrbno spremljati, če jemljeta ta zdravila (vključno z nekaterimi zdravili za HIV: ritonavirjem,
If the wheezing comes on suddenly after using this medicine stop using it and talk to your doctor immediately (see below).
Če se piskajoče dihanje pojavi nenadoma po uporabi tega zdravila, prenehajte uporabljati zdravilo in se takoj posvetujte z zdravnikom (glejte spodaj).
• It is important to use BiResp Spiromax every day, even if you have no asthma or COPD symptoms at the time.
• Pomembno je, da zdravilo BiResp Spiromax uporabite vsak dan, tudi če trenutno nimate simptomov astme ali KOPB.
2 inhalations in the evening.
2 vdiha zvečer.
• Changes in behaviour, especially in children.
• depresija, • spremembe vedenja, posebno pri otrocih,
The use of BiResp Spiromax follows three steps: open, breathe and close which are outlined below.
Uporaba zdravila BiResp Spiromax zajema tri korake: odprite, vdihnite in zaprite, ki so opisani spodaj.
• Do NOT take more than 6 inhalations at a single time.
• NE naredite več kot 6 vdihov naenkrat.
Do NOT use more than 12 inhalations in total in 24 hours.
Skupno v 24 urah ne naredite več kot 12 vdihov.
Treatment groups
Skupine zdravljenja
In 2 other studies with patients seeking medical attention due to acute asthma symptoms, budesonide/formoterol provided rapid and effective relief of bronchoconstriction similar to salbutamol and formoterol.
V dveh drugih študijah z bolniki, ki so poiskali medicinsko pomoč zaradi akutnih simptomov astme, je budezonid/formoterol omogočil hitro in učinkovito olajšanje bronhokonstrikcije podobno kot salbutamol in formoterol.
There was no sign of development of tolerance over time.
V času zdravljenja ni bilo znakov razvoja tolerance.
Also tell your doctor, pharmacist or nurse if you are going to have a general anaesthetic for an operation or for dental work to help lower any risk of interaction with the anesthetic you receive.
Zdravniku, farmacevtu ali medicinski sestri morate tudi povedati, če imate zaradi kirurškega ali zobozdravstvenega posega predvideno splošno anestezijo, da pomagate zmanjšati morebitno tveganje interakcij z anestetikom, ki ga boste prejeli.
You do not need a separate ‘reliever inhaler' for this.
V ta namen ne potrebujete posebnega »inhalatorja z olajševalcem«.
BiResp Spiromax should be used correctly in order to achieve effective treatment.
Zdravilo BiResp Spiromax je treba uporabljati pravilno, da bo doseženo učinkovito zdravljenje.
Median FEV1 at inclusion in the trials was 36% of predicted normal.
Mediana FEV1 ob vključitvi v preskušanja je bila 36 % predvidene normalne FEV 1.
In Study 735, lung function, symptom control, and reliever use were similar in all treatment groups.
V študiji 735 so bili pljučna funkcija, nadzor simptomov in uporaba olajševalca podobni v vseh primerjalnih skupinah.
If symptoms persist after a few minutes, an additional inhalation should be taken.
Če so simptomi po nekaj minutah še vedno prisotni, naj naredijo še 1 vdih.
If patients find the treatment ineffective, or exceed the highest recommended dose of BiResp Spiromax, medical attention must be sought (see section 4.2).
Če bolnik ugotavlja, da je zdravljenje neučinkovito, ali če preseže največji priporočeni odmerek zdravila BiResp Spiromax, mora poiskati zdravniško pomoč (glejte poglavje 4.2).
Budesonide/formoterol maintenance and reliever therapy provided statistically significant and clinically meaningful reductions in severe exacerbations for all comparisons in all 5 studies.
Pri vzdrževalnem in olajševalnem zdravljenju z budezonidom/formoterolom se je pojavilo statistično značilno in klinično pomembno zmanjšanje hudih poslabšanj v vseh primerjavah v vseh petih študijah.
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom.
Paradoxical bronchospasm
Zelo redki paradoksni bronhospazem
Headache, tremor
Pogosti glavobol, tremor
2 inhalations in the morning or
2 vdiha zjutraj ali
• you have severe liver problems.
• če imate hude težave z jetri,
They should be reassessed and their maintenance therapy should be reconsidered.
Zdravnik jih bo ponovno pregledal in ocenil njihovo vzdrževalno zdravljenje.
<1/10), uncommon (≥1/1,000, < 1/100), rare (≥1/10,000, < 1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
(≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
The dosage of BiResp Spiromax is individual and should be adjusted to the severity of the disease.
Odmerjanje zdravila BiResp Spiromax je individualno in ga je treba prilagoditi stopnji resnosti bolezni.
This included a comparison with budesonide/formoterol at a higher maintenance dose with terbutaline as reliever (study 735) and budesonide/formoterol at the same maintenance dose with either formoterol or terbutaline as reliever (study 734) (see table below).
To je vključevalo primerjavo z budezonidom/formoterolom v višjem vzdrževalnem odmerku skupaj s terbutalinom kot olajševalcem (študija 735) in primerjavo z budezonidom/formoterolom v enakem vzdrževalnem odmerku ter s formoterolom ali terbutalinom kot olajševalcem (študija 734) (glejte spodnjo tabelo).
If these effects occur, they are usually mild and usually disappear as you continue to use BiResp Spiromax.
Če se ti učinki pojavijo, so po navadi blagi in po navadi izginejo med nadaljevanjem zdravljenja z zdravilom BiResp Spiromax.
- The other ingredient is lactose monohydrate (see section 2 under ‘BiResp Spiromax contains lactose')
- Pomožna snov je laktoza monohidrat (glejte poglavje 2 pod »Zdravilo BiResp Spiromax vsebuje laktozo«).
• inadequate asthma control and in frequent need of a reliever inhaler.
• z neustrezno nadzorovano astmo, ki pogosto potrebujejo inhalator z olajševalcem.
Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time.
Inhalacijski kortikosteroidi lahko vplivajo na normalno nastajanje steroidnih hormonov v telesu, zlasti če dolgo časa uporabljate velike odmerke.