natgillin/translations-raw huggingface dataset:
The European Medicines Agency decided that Lucentis's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Lucentis večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The interval between two injections of Lucentis into the same eye must be at least four weeks.
Razmak med injiciranji zdravila Lucentis v isto oko mora biti vsaj štiri tedne.
Other information about Lucentis
Druge informacije o zdravilu Lucentis
In both studies, the improvement in vision was maintained over the course of the study.
V obeh študijah se je izboljšanje vida ohranilo skozi celotno študijo.
All of the patients were over 50 years of age and had not been treated for wet AMD before.
Vsi bolniki so bili starejši od 50 let in predhodno še niso bili zdravljeni zaradi te bolezni.
The macula provides the vision needed to see detail for everyday tasks such as driving, reading and recognising faces.
Makula zagotavlja vid, ki je potreben za zaznavanje podrobnosti med vsakdanjimi opravili, na primer pri vožnji avtomobila, branju in prepoznavanju obrazov.
Patients were classified as having experienced no significant worsening of vision if the number of letters that they could see increased, stayed the same, or fell by less than 15.
Bolniki so bili opredeljeni kot bolniki brez znatnega poslabšanja vida, če se je število črk, ki so jih lahko videli, povečalo, ostalo enako oziroma se je zmanjšalo za manj kot 15 črk.
The most common side effects with Lucentis (seen in more than 1 in 10 patients) are increased intraocular pressure (pressure within the eye), headache, vitritis (inflammation in the eye), vitreous detachment (separation of the vitreous from the back of the eye), retinal haemorrhage (bleeding at the back of the eye), visual disturbance, eye pain, vitreous floaters (spots in the vision), conjunctival haemorrhage (bleeding at the front of the eye), eye irritation, sensation of a foreign body in the eye, increased lacrimation (tear production), blepharitis (inflammation of the eyelids), dry eye, ocular hyperaemia (red eye), eye pruritis (itching), arthralgia (joint pain) and nasopharyngitis (inflammation of the nose and throat).
Najpogostejši neželeni učinki zdravila Lucentis (opaženi pri več kot 1 bolniku od 10) so povečan intraokularni tlak (tlak v notranjosti očesa), glavobol, vitritis (vnetje v očesu), odstop steklovine (odluščenje steklovine od zadnjega dela očesa), mrežnična krvavitev (krvavitev v zadnjem delu očesa), motnje vida, bolečine v očeh, delci v steklovini (pikice pred očmi), veznična krvavitev (krvavitev v sprednjem delu očesa), draženje oči, občutek tujka v očesu, povečano solzenje, blefaritis (vnetje vek), suho oko, očesna hiperemija (pordelost oči), očesni pruritus (srbenje), artralgija (bolečine v sklepih) in nazofaringitis (vnetje nosu in grla).
• other sight problems associated with choroidal neovascularisation;
• drugih težav z vidom, ki so povezane s horoidalno neovaskularizacijo;
As for all medicines, data on the use of Lucentis are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Lucentis stalno spremljajo.
What benefits of Lucentis have been shown in studies?
Kakšne koristi zdravila Lucentis so se pokazale v študijah?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lucentis have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Lucentis upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Why is Lucentis authorised in the EU?
Zakaj je bilo zdravilo Lucentis odobreno v EU?
What are the risks associated with Lucentis?
Kakšna tveganja so povezana z zdravilom Lucentis?
Side effects reported with Lucentis are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Lucentis, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
An overview of Lucentis and why it is authorised in the EU
Pregled zdravila Lucentis in zakaj je odobreno v EU
The prefilled syringe contains more than the recommended dose, therefore when preparing the injection, the doctor must expel the excess volume and ensure the injection of the correct dose.
Napolnjena injekcijska brizga vsebuje večji odmerek od priporočenega, zato mora zdravnik pri pripravi injekcije iztisniti odvečno količino in injicirati ustrezni odmerek.
In both studies, the main measure of effectiveness was the change in vision in the affected eye, measured by comparing the number of letters that the patient could see at the end of the treatment period with the number before starting treatment.
V obeh študijah je bilo glavno merilo učinkovitosti sprememba vida prizadetega očesa, kar so merili s primerjanjem števila črk, ki so jih bolniki lahko videli ob koncu zdravljenja, s številom prepoznanih črk pred začetkom zdravljenja.
What is Lucentis and what is it used for?
Kaj je zdravilo Lucentis in za kaj se uporablja?
After one year, between 94 and 96% of the AMD patients receiving Lucentis every month experienced no significant worsening of their vision, compared with 62% of those receiving sham injections and 64% of those treated with verteporfin PDT.
Pri 94 % do 96 % bolnikov s starostno degeneracijo makule, ki so prejemali zdravilo Lucentis vsak mesec, se vid po enem letu ni znatno poslabšal v primerjavi z 62 % tistih, ki so prejemali navidezne injekcije, in 64 % tistih, ki so se zdravili s fotodinamično terapijo z verteporfinom.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific target (called an antigen) that is found in certain cells in the body.
Monoklonsko protitelo je protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna določeno prijemališče (imenovano antigen), ki je prisotno v nekaterih celicah v telesu, in se veže nanj.
For more information about using Lucentis, see the package leaflet or contact your doctor or pharmacist
Za več informacij glede uporabe zdravila Lucentis glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Before each injection, a local anaesthetic is given to reduce or prevent any pain from the injection, and the eye, eyelid and skin around the eye are disinfected.
Pred vsakim injiciranjem je treba bolniku dati lokalni anestetik za zmanjšanje oziroma preprečevanje bolečine ob injiciranju ter razkužiti oko, veko in kožo okoli očesa.
Ranibizumab has been designed to attach to and block a substance called vascular endothelial growth factor A (VEGF-A).
Ranibizumab je bil zasnovan tako, da se veže na snov, imenovano vaskularni endotelijski rastni dejavnik A (VEGF-A), in jo zavira.
• the ‘wet' form of age-related macular degeneration (AMD).
• vlažne oblike starostne degeneracije makule (AMD).
Rarely, endophthalmitis (an infection inside the eye), blindness, serious damage to the retina and cataract (clouding of the lens) can occur.
Redko se lahko pojavijo endoftalmitis (okužba v notranjosti očesa), slepota, huda poškodba mrežnice in katarakta (zameglitev leče).
It is given by intravitreal injection (injection into the vitreous humour, the jelly-like fluid in the eye).
Daje se z intravitrealno injekcijo (injiciranjem v steklovino, tj. želatini podobno tekočino v očesu).
The conditions Lucentis is used to treat are:
Zdravilo Lucentis se uporablja za zdravljenje naslednjih bolezni:
Lucentis was more effective at preventing a worsening of vision than the comparison treatment.
Zdravilo Lucentis je bilo učinkovitejše pri preprečevanju poslabšanja vida kot primerjalno zdravljenje.
The recommended dose for Lucentis is 0.5 mg given as a single intravitreal injection.
Priporočeni odmerek zdravila Lucentis je 0,5 mg v obliki ene injekcije v oko.
The active substance in Lucentis, ranibizumab, is a small piece of a monoclonal antibody.
Učinkovina v zdravilu Lucentis, ranibizumab, je majhen drobec monoklonskega protitelesa.
VEGF-A is a protein that makes blood vessels grow and leak fluid and blood, damaging the macula.
VEGF-A je beljakovina, ki spodbuja rast krvnih žil in iztekanje tekočine in krvi iz njih, kar povzroča poškodbe makule.
The wet form of AMD is caused by choroidal neovascularisation (abnormal growth of blood vessels beneath the retina, which may leak fluid and blood and cause swelling);
Vlažno obliko starostne degeneracije makule povzroča horoidalna neovaskularizacija (nenormalna rast krvnih žil pod mrežnico, iz katerih lahko iztekata tekočina in kri, kar povzroči otekanje);
The main measure of effectiveness was the change in vision in the affected eye after a year of treatment, using a standard eye test with a letter chart.
Glavno merilo učinkovitosti je bila sprememba vida prizadetega očesa leto dni po zdravljenju, kar so merili s standardnim testom vida na črkovni tabeli.
For diabetic macular oedema, Lucentis was studied in two main studies involving a total of 454 patients.
V okviru makularnega edema zaradi sladkorne bolezni so zdravilo Lucentis proučevali v dveh glavnih študijah, ki sta vključevali skupno 454 bolnikov.
Three main studies of Lucentis involved 1,323 patients with the wet form of AMD.
V tri glavne študije zdravila Lucentis je bilo vključenih 1 323 bolnikov z vlažno obliko starostne degeneracije makule.
A second study involved 178 patients with choroidal neovascularisation associated with other conditions, and compared Lucentis with a sham injection.
V drugi študiji je sodelovalo 178 bolnikov s horoidalno neovaskularizacijo, povezano z drugimi bolezenskimi stanji, v njej pa so zdravilo Lucentis primerjali z navideznimi injekcijami.
Two of the studies compared Lucentis with a sham injection ( a procedure similar to a Lucentis injection, in which the syringe is pressed against the surface of the eye but no actual injection is carried out).
V dveh študijah so zdravilo Lucentis primerjali z navideznimi injekcijami (postopkom, podobnim injiciranju zdravila Lucentis, pri katerem se injekcijska brizga prisloni ob površino očesa, do samega injiciranja pa ne pride).
Lucentis is a medicine used to treat adults with certain sight problems caused by damage to the retina (the light-sensing layer at the back of the eye), and more specifically its central region, known as the macula.
Lucentis je zdravilo za zdravljenje odraslih z določenimi težavami z vidom, ki jih povzročajo poškodbe mrežnice (na svetlobo občutljive plasti v zadnjem delu očesa), zlasti pa njenega osrednjega dela, imenovanega makula ali rumena pega.
Lucentis is available as a solution for injection in prefilled syringes or vials, for single use.
Zdravilo Lucentis je na voljo v obliki raztopine za injiciranje v napolnjenih injekcijskih brizgah ali vialah za enkratno uporabo.
The main measure of effectiveness in both was the change in vision using a standard eye test with a letter chart.
Glavno merilo učinkovitosti v obeh študijah je bila sprememba vida, ocenjena na podlagi standardnega testa vida na črkovni tabeli.
The company that makes Lucentis will provide information packs to patients to help them prepare for Lucentis treatment, recognise serious side effects and know when to seek urgent attention from their doctor.
Podjetje, ki izdeluje zdravilo Lucentis, bo bolnikom zagotovilo komplet navodil, ki bodo vsebovala informacije o pripravi na zdravljenje ter nasvete za prepoznavanje hudih neželenih učinkov in stanj, ko morajo poiskati nujno zdravniško pomoč.
How does Lucentis work?
Kako zdravilo Lucentis deluje?
Lucentis was more effective at improving vision than its comparison treatments.
Zdravilo Lucentis je bilo učinkovitejše pri izboljšanju vida kot primerjalna zdravljenja.
• macular oedema (swelling of the macula) caused by diabetes;
• makularnega edema (otekanja makule), ki ga povzroča sladkorna bolezen,
Lucentis was more effective than a sham injection: patients receiving Lucentis at the 0.5 mg dose for six months could see around 11 letters more than patients receiving a sham injection in one study and 14 letters more in the other study.
Zdravilo Lucentis je bilo učinkovitejše od navideznih injekcij: bolniki, ki so šest mesecev prejemali zdravilo Lucentis v odmerku 0,5 mg, so lahko v prvi študiji videli 11 črk več , v drugi študiji pa 14 črk več kot bolniki, ki so prejemali navidezne injekcije.
For macular oedema due to retinal vein occlusion, Lucentis was looked at in two main studies involving a total of 789 patients, where Lucentis was compared with a sham injection.
Pri makularnem edemu zaradi zapore mrežničnih ven so zdravilo Lucentis proučevali v dveh glavnih študijah, ki sta vključevali 789 bolnikov in v katerih so zdravilo Lucentis primerjali z navideznimi injekcijami.
One study compared Lucentis with verteporfin PDT in 277 patients with choroidal neovascularisation associated with pathologic myopia (a severe type of short sightedness).
V prvi študiji so zdravilo Lucentis primerjali s fotodinamično terapijo z verteporfinom pri 277 bolnikih s horoidalno neovaskularizacijo, povezano s patološko kratkovidnostjo (hudo obliko kratkovidnosti).
Choroidal neovascularisation
Horoidalna neovaskularizacija
The first study compared Lucentis with a sham injection.
V prvi študiji so zdravilo Lucentis primerjali z navideznimi injekcijami.
By blocking this factor, ranibizumab reduces the growth of the blood vessels and controls the leakage and swelling.
Ranibizumab z zaviranjem tega dejavnika zmanjšuje rast krvnih žil ter nadzoruje iztekanje tekočine in krvi iz njih in otekanje.
The patients cannot tell whether they received Lucentis or the sham procedure.
Bolniki pri tem ne vedo, ali so prejeli zdravilo Lucentis ali le navidezno injekcijo.
In the second study, patients receiving Lucentis on its own or as an add-on to laser photocoagulation could see after one year an average of 5 letters more than patients receiving laser photocoagulation on its own.
V drugi študiji so bolniki, ki so prejemali zdravilo Lucentis, bodisi kot samostojno zdravilo bodisi kot dodatek k laserski fotokoagulaciji, po enem letu videli povprečno pet črk več kot bolniki, ki so bili zdravljeni le z lasersko fotokoagulacijo.
How is Lucentis used?
Kako se zdravilo Lucentis uporablja?
Treatment with Lucentis is started with one injection every month, with regular checks of the patient's vision and the appearance of the back of the eye, until maximum vision is achieved and/or there are no signs of disease activity; the monitoring and treatment intervals should then be determined by the treating doctor depending on the patient's condition and response.
Zdravljenje z zdravilom Lucentis se začne z eno injekcijo na mesec, čemur sledijo redni pregledi bolnikovega vida in videza zadnjega dela očesa, dokler se ne doseže ustrezno dober vid in/ali odpravijo znaki bolezni.
For choroidal neovascularisation other than that associated with wet AMD, Lucentis has been studied in 2 main studies each lasting a year.
V okviru horoidalne neovaskularizacije, ki ni povezana z vlažno obliko starostne degeneracije makule, so zdravilo Lucentis proučevali v dveh glavnih študijah, od katerih je vsaka trajala leto dni.
In the first study, lasting one year, patients receiving Lucentis could see about 6 letters more than those receiving sham injections.
V prvi študiji, ki je trajala eno leto, so bolniki, ki so prejemali zdravilo Lucentis, videli okoli šest črk več kot tisti, ki so prejemali navidezne injekcije.
Lucentis must not be used in patients who may have an infection of the eye or the area around the eye, or who have severe inflammation within the eye. For the full list of restrictions, see the package leaflet.
Zdravila Lucentis ne smejo uporabljati bolniki, ki utegnejo imeti vneto oko ali področje okoli očesa, ali bolniki s hudim vnetjem znotraj očesa.
The third study compared Lucentis with verteporfin photodynamic therapy (PDT, another treatment for AMD).
V tretji študiji so zdravilo Lucentis primerjali s fotodinamično terapijo z verteporfinom (PDT), tj. drugo vrsto zdravljenja starostne degeneracije makule.
The second study compared Lucentis, given on its own or as an add-on to laser photocoagulation (a treatment for diabetic macular oedema using a laser), with laser photocoagulation on its own.
V drugi študiji so zdravilo Lucentis, injicirano bodisi kot samostojno zdravilo bodisi kot dodatek k laserski fotokoagulaciji (zdravljenju makularnega edema zaradi sladkorne bolezni z uporabo laserja), primerjali z lasersko fotokoagulacijo kot samostojnim zdravljenjem.
It can only be obtained with a prescription and must be given by a qualified eye doctor who is experienced in giving intravitreal injections.
Predpisovanje in izdaja zdravila Lucentis je le na recept, injicirati pa ga mora specialist oftalmolog, ki ima izkušnje z dajanjem intravitrealnih injekcij.
After 2 months of treatment, patients given Lucentis could see around 10 letters more on average than those given sham treatment.
Po dveh mesecih zdravljenja so lahko bolniki, ki so prejemali zdravilo Lucentis, v povprečju videli okoli deset črk več kot tisti, ki so prejemali navidezne injekcije.
Macular oedema due to occlusion of retinal veins
Makularni edem zaradi zapore mrežničnih ven
• macular oedema caused by occlusion (blockage) of the veins behind the retina.
• makularnega edema, ki ga povzroča okluzija (zapora) ven za mrežnico.
On average over the first 3 months of treatment, patients given Lucentis could see around 8 to 9 letters more than those receiving verteporfin PDT.
V povprečju so lahko v prvih treh mesecih bolniki, ki so prejemali zdravilo Lucentis, videli od osem do devet črk več kot tisti, ki so prejemali fotodinamično terapijo z verteporfinom.
For the full list of all side effects of Lucentis, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Lucentis, glejte navodilo za uporabo.
The vision of patients receiving Lucentis also remained better than the vision of those receiving sham injections in a study in which injections were given less frequently, with injections every month for the first three months and then every three months.
Poleg tega je v študiji, v kateri so injekcije dajali manj pogosto, in sicer prve tri mesece vsak mesec, nato pa vsake tri mesece, vid bolnikov, ki so prejemali zdravilo Lucentis, ostal boljši kot vid bolnikov, ki so prejemali navidezne injekcije.
Diabetic macular oedema
Makularni edem zaradi sladkorne bolezni
This summary was last updated in 11-2009.
Povzetek je bil nazadnje posodobljen 11-2009.
Ref.: EMEA/634501/2009 EMEA/H/C/1066
: EMEA/649375/2009 EMEA/H/C/1066
It is available as round tablets (white: 0.5 mg; yellow: 1 mg; pink: 2 mg).
Na voljo je v obliki okroglih tablet (belih: 0,5 mg; rumenih: 1 mg; rožnatih: 2 mg).
Repaglinide Krka is taken before meals, normally up to 15 minutes before each main meal.
Zdravilo Repaglinid Krka se jemlje pred obroki, po navadi največ 15 minut pred vsakim glavnim obrokom.
The European Commission granted a marketing authorisation valid throughout the European Union for Repaglinide Krka to Krka, d.d., Novo mesto on 4 November 2009.
Evropska komisija je dovoljenje za promet z zdravilom Repaglinide Krka, veljavno po vsej Evropski uniji, odobrila družbi Krka, d.d., Novo mesto, dne 4. novembra 2009.
Repaglinide Krka is not recommended for patients below 18 years of age because of a lack of information on safety and effectiveness in this age group.
Uporaba zdravila Repaglinide Krka pri bolnikih, mlajših od 18 let, zaradi pomanjkanja informacij o varnosti in učinkovitosti v tej starostni skupini ni priporočljiva.
This means that Repaglinide Krka is similar to a ‘reference medicine' already authorised in the European Union (EU) called NovoNorm.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu NovoNorm.
What are the benefit and risk of Repaglinide Krka?
Kakšne so koristi in tveganja, povezana z zdravilom Repaglinide Krka?
Repaglinide Krka is a ‘generic medicine'.
Repaglinid Krka je „generično zdravilo“.
Other information about Repaglinide Krka:
Druge informacije o zdravilu Repaglinide Krka:
It is used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) cannot be controlled by diet, weight reduction and exercise.
Uporablja se skupaj z dieto in telesno dejavnostjo za znižanje glukoze (sladkorja) v krvi pri bolnikih, pri katerih hiperglikemije (visoke koncentracije glukoze v krvi) ni mogoče nadzorovati z dieto, zmanjšanjem telesne mase in telesno dejavnostjo.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Repaglinide Krka has been shown to have comparable quality and to be bioequivalent to NovoNorm.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Repaglinide Krka primerljivo raven kakovosti kot zdravilo NovoNorm ter da mu je biološko enakovredno.
The Committee recommended that Repaglinide Krka be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Repaglinide Krka odobri dovoljenje za promet.
Because Repaglinide Krka is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Ker je zdravilo Repaglinide Krka generično zdravilo in je biološko enakovredno referenčnemu zdravilu, velja, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Repaglinide Krka is used in patients who have type 2 diabetes (non-insulin-dependent diabetes).
Zdravilo Repaglinid Krka se uporablja pri bolnikih s sladkorno boleznijo tipa 2 (sladkorno boleznijo, ki ni odvisna od insulina).
Repaglinide Krka can also be used for type 2 diabetes patients whose blood glucose levels are usually controlled well on diet, but are experiencing temporary loss of blood glucose control.
Zdravilo Repaglinide Krka se lahko uporabi tudi pri bolnikih s sladkorno boleznijo tipa 2, pri katerih so ravni glukoze v krvi po navadi dobro nadzorovane z dieto, vendar doživljajo obdobja prehodne izgube nadzora.
Because Repaglinide Krka is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, NovoNorm.
Ker je zdravilo Repaglinide Krka generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu NovoNorm.
Repaglinide Krka is a medicine that contains the active substance repaglinide.
Repaglinid Krka je zdravilo, ki vsebuje zdravilno učinkovino repaglinid.
Repaglinide Krka helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.
Zdravilo Repaglinide Krka spodbuja trebušno slinavko, da med obroki tvori več insulina, zato se uporablja za nadzor sladkorne bolezni tipa 2.
Why has Repaglinide Krka been approved?
Zakaj je bilo zdravilo Repaglinide Krka odobreno?
The full EPAR for Repaglinide Krka can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Repaglinide Krka je na voljo tukaj.
What is Repaglinide Krka?
Kaj je zdravilo Repaglinid Krka?
What is Repaglinide Krka used for?
Za kaj se zdravilo Repaglinid Krka uporablja?
How has Repaglinide Krka been studied?
Kako je bilo zdravilo Repaglinide Krka raziskano?
How is Repaglinide Krka used?
Kako se zdravilo Repaglinide Krka uporablja?
D - 133 42 Berlin, Germany Telephone: +49 30 468-1111
D 13342 Berlin, Nemčija Telefon: +49 30 468-1111
Before you receive Gadograf, tell your doctor if any of these applies to you.
Preden vam dajo zdravilo Gadograf, obvestite zdravnika, če karkoli od naštetega velja za vas.
Tell your doctor if you are pregnant or could be pregnant, since Gadograf should not be used during pregnancy unless it is considered absolutely necessary.
Povejte zdravniku, če ste noseči ali bi lahko bili noseči, ker se zdravilo Gadograf med nosečnostjo ne sme uporabljati, razen če je nujno.
- If you are younger than 18, use of Gadograf is not recommended.
- Če ste mlajši od 18 let, uporaba zdravila Gadograf ni priporočena.