natgillin/translations-raw huggingface dataset:
19 Take special care with Livensa  if you have a history of heart, liver or kidney disease.  if you are diabetic, as testosterone may lower blood glucose levels.  if you have a history of excessive adult acne, body or facial hair, hair loss, enlargement of the clitoris or voice deepening or hoarseness.
19 Bodite posebno pozorni pri uporabi zdravila Livensa  če ste v preteklosti imeli bolezen srca, ledvic ali jeter;  če ste sladkorna bolnica, ker testosteron lahko zniža raven glukoze v krvi;  če ste v preteklosti imeli hude akne v odrasli dobi, poraščenost telesa ali obraza, izpadanje las, povečanje klitorisa, znižanje glasu ali hripavost.
The efficacy of Livensa is reduced if your estrogen therapy is of a certain type (‘ conjugated equine estrogens’).
Učinkovitost zdravila Livensa se zmanjša, če se zdravite z določeno vrsto estrogenov (‘ konjugirani konjski estrogeni ’).
It is not known whether Livensa increases the risk of breast cancer.
Ni znano, ali zdravilo Livensa poveča tveganje za rak dojke.
Children and adolescents Livensa is not for use in children and adolescents.
Otroci in mladostniki Zdravilo Livensa ni namenjeno uporabi pri otrocih in mladostnikih.
Livensa should be replaced twice weekly (each 3 to 4 days).
KAKO UPORABLJATI ZDRAVILO LIVENSA
Where to stick the patch  Stick the patch onto your lower abdomen, below your waist.
Kam nalepiti obliž  Obliž nalepite na spodnji del trebuha, pod pas.
20 Make sure that your skin at the application site is:  clean and dry (free of lotions, moisturisers, and powders)  as smooth as possible (no major creases or skin folds)  not cut or irritated (free of rashes or other skin problems)  unlikely to be rubbed by clothing excessively  preferably free from hair.  When changing your patch, stick the new patch on to a different area of the skin of your abdomen, otherwise you are more likely to cause skin irritation.
20 Prepričajte se, da je koža na mestu namestitve obliža:
Step 4 Fold back the patch and carefully remove the other half of the liner.
21 4. korak Obliž prepognite in previdno odstranite drugo polovico zaščitne plasti.
Use your fingers to
Celoten obliž z dlanjo močno pritisnite ob kožo in držite približno 10 sekund.
21 make sure the edges of the patch stick to the skin.
Potipajte robove in se prepričajte, da so prilepljeni na kožo.
If you use more patches than you should If you have applied more than one patch at a time Remove all the patches sticking on to your skin and consult your doctor or pharmacist for further information on how to continue treatment with Livensa.
Če ste uporabili več obližev, kot bi smeli Če ste nalepili več kot en obliž hkrati Odstranite vse obliže in se posvetujte z zdravnikom ali s farmacevtom o tem, kako nadaljevati zdravljenje z zdravilom Livensa.
22 If you forget to use a patch If you forget to change your patch Change your patch as soon as you remember, and then continue with your regular schedule of patch- change days, even if this means discarding a patch after you have worn it for less than 3-4 days.
22 Če ste pozabili uporabiti obliž Če ste pozabili zamenjati obliž Obliž zamenjajte takoj, ko se spomnite, nato nadaljujte reden razpored menjave obliža, tudi če boste obliž zavrgli potem, ko ste ga imeli manj kot 3– 4 dni.
You should self assess for increased acne, increased hair growth on your face, loss of hair, deepening of your voice or enlargement of your clitoris, which all could be signs of adverse effects of testosterone, which is the active substance in Livensa.
Opazujte te znake povečanja pojava aken, povečane rasti dlak na obrazu, izpadanja las, znižanja glasu ali povečanja klitorisa, ker so lahko znaki neželenih učinkov testosterona, ki je zdravilna učinkovina v zdravilu Livensa.
Do not use Livensa after the expiry date which is stated on the carton and sachet.
Zdravila Livensa ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in zaščitni vrečki.
What Livensa contains The active substance is testosterone.
Kaj vsebuje zdravilo Livensa Zdravilna učinkovina je testosteron.
What Livensa looks like and contents of the pack Livensa is a thin, clear, oval patch with PG T001 stamped on the back.
Izgled zdravila Livensa in vsebina pakiranja Livensa je tanek, prozoren, ovalen obliž z napisom PG T001, natisnjenim na zadnji strani.
Procter & Gamble Pharmaceuticals - Germany GmbH Dr. -Otto-Röhm-Strasse 2-4 D-64331 Weiterstadt Germany
Imetnik dovoljenja za promet z zdravilom in izdelovalec Procter & Gamble Pharmaceuticals - Germany GmbH Dr. - Otto- Röhm- Strasse 2- 4 D- 64331 Weiterstadt Nemčija
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. eu. int/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
Lucentis is a solution for injection into the eye.
Zdravilo Lucentis je raztopina za injiciranje v oko.
It contains the active substance ranibizumab.
Vsebuje zdravilno učinkovino ranibizumab.
Lucentis is used to treat patients with the ‘ wet’ form of age-related macular degeneration (AMD).
Zdravilo Lucentis se uporablja za zdravljenje bolnikov z vlažno obliko starostne degeneracije makule (SDM).
This disease affects the central part of the retina (called the macula) at the back of the eye and causes loss of ‘ straight-ahead’ vision.
Ta bolezen prizadene osrednji del mrežnice (imenovan makula), ki leži na zadnji strani očesa, in povzroči poslabšanje ostrine vida.
The macula provides central vision that is needed to see detail for everyday tasks such as driving, reading and recognising faces.
Makula zagotavlja centralni vid, ki je potreben za izvajanje vsakdanjih opravil, na primer pri vožnji avtomobila, branju in prepoznavanju obrazov.
The wet form of AMD is caused by the formation of abnormal blood vessels under the macula, which may leak fluid and bleed.
Do vlažne oblike bolezni SDM pride zaradi tvorbe nenormalnih krvnih žil pod makulo, ki lahko prepuščajo tekočino in krvavijo.
This causes the loss of vision.
To povzroči okvaro vida.
Lucentis is given as an injection into the affected eye.
Zdravilo Lucentis se daje v obliki injekcije v prizadeto oko.
For the first three months, one injection is given every month.
Prve tri mesece se daje vsak mesec ena injekcija.
After this, the patient’ s vision should be checked every month and another injection given if the vision has become worse.
Nato je treba bolnikov vid preverjati vsak mesec in mu dati novo injekcijo, če se vid poslabša.
The interval between injections must be at least one month.
Interval med injekcijami ne sme biti krajši od enega meseca.
Lucentis must be given by a qualified ophthalmologist (eye specialist) who is experienced at giving this type of injection.
Zdravilo Lucentis sme dajati samo specialist oftalmolog (očesni zdravnik), ki ima izkušnje z dajanjem tovrstnih injekcij.
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 vsako injekcijo je treba bolniku dati lokalni anestetik, ki zmanjša ali prepreči bolečino pri injekciji, ter razkužiti oko, veko in kožo okrog očesa.
Antibiotic eye drops are given for three days before the injection and for three days afterwards to prevent eye infection.
Antibiotične kapljice za oko je treba bolniku dajati tri dni pred injekcijo in tri dni po njej, da se prepreči okužba očesa.
Patients will be taught how to use the eye drops by themselves.
Bolnike je treba poučiti, kako lahko sami uporabljajo kapljice za oči.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in certain cells in the body.
Monoklonsko protitelo je protitelo (vrsta beljakovine), ki je bilo oblikovano tako, da prepozna specifično strukturo (imenovano antigen), ki se nahaja v posameznih celicah v telesu, in se veže nanjo.
Ranibizumab has been designed to block a substance called vascular endothelial growth factor A (VEGF-A).
Ranibizumab blokira učinkovino, imenovano humani rastni dejavnik za žilni endotelij A (VEGF- A).
VEGF-A is found in high levels in the eyes of patients with AMD and makes blood vessels grow and leak fluid.
VEGF- A je v večji količini prisoten v očeh bolnikov z boleznijo SDM ter povzroča rast krvnih žil in prepuščanje tekočine.
These effects worsen the disease.
Ti učinki poslabšajo bolezen.
By blocking this factor, ranibizumab reduces the growth of the blood vessels and leakage.
Ranibizumab blokira ta dejavnik ter tako zmanjša rast krvnih žilic in prepuščanje.
The effects of Lucentis were first tested in experimental models before being studied in humans.
Učinki zdravila Lucentis so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The three main studies of Lucentis involved 1,323 patients with the wet form of AMD.
Tri glavne študije zdravila Lucentis so vključevale 1 323 bolnikov z vlažno obliko bolezni SDM.
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 se pred tem niso zdravili za vlažno obliko SDM.
Two doses of Lucentis were tested:
Testirana sta bila dva odmerka zdravila Lucentis:
0.3 mg and 0.5 mg.
0, 3 mg in 0, 5 mg.
The studies were designed to last up to two years, but only one of the studies had been completed by the time the medicine was assessed.
Študije naj bi trajale do dve leti, vendar je bila do ocene zdravila dokončana samo ena študija.
Two of the studies compared Lucentis to a sham injection.
V dveh študijah so primerjali zdravilo Lucentis s placebo injekcijami.
This is a procedure that is similar to a Lucentis injection, but with no Lucentis and no needle, in which the syringe is pressed against the surface of the eye but no actual injection is carried out.
Gre za postopek, ki je podoben injiciranju zdravila Lucentis, vendar ne vsebujejo zdravila Lucentis in igle, pri njem pa se brizga pritisne ob površino očesa, vendar se dejansko injiciranje ne izvede.
The third study compared Lucentis to verteporfin photodynamic therapy (PDT, another treatment for AMD).
V tretji študiji so primerjali zdravilo Lucentis s fotodinamično terapijo z verteporfinom (PDT, druga oblika zdravljenja bolezni SDM).
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 po enem letu zdravljenja, pri čemer je bil uporabljen standardni očesni test s tabelo s črkovnimi znaki.
Lucentis was more effective at preventing a worsening of vision than its comparators.
Zdravilo Lucentis je bilo pri preprečevanju poslabšanja vida učinkovitejše od primerjalnih zdravil.
Between 94 and 96% of the 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.
Od 94 do 96 bolnikov, ki so vsak mesec prejemali zdravilo Lucentis, ni izkusilo bistvenega poslabšanja vida, medtem ko je bil ta delež pri bolnikih s placebo injekcijami 62%, pri bolnikih, zdravljenih s PDT z verteporfinom, pa 64%.
The 0.5 mg dose appeared to be more effective than the 0.3 mg dose.
Odmerek 0, 5 mg se je izkazal za učinkovitejšega od odmerka 0, 3 mg.
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.
Tudi v študiji, v kateri so bolniki injekcije prejemali manj pogosto, in sicer prve tri mesece vsak mesec, nato pa vsake tri mesece, je vid pri bolnikih, ki so prejemali zdravilo Lucentis, ostal boljši od vida bolnikov, ki so prejemali placebo injekcije.
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 fluid in the eye 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 zvišan intraokularni tlak (tlak v očesu), glavobol, vitritis (vnetje v očesu), odstop steklovine (ločitev tekočine v očesu od zadnjega dela očesa), mrežnična krvavitev (krvavitev v zadnjem delu očesa), motnje vida, bolečine v očesu, delci v steklovini (pikice pri vidu), veznična krvavitev (krvavitev v sprednjem delu očesa), draženje očesa, občutek tujka v očesu, močnejše solzenje, vnetje veke, suho oko, očesna hiperemija (rdeče oko), srbenje v očesu, artralgija (bolečine v sklepih) in nazofaringitis (vnetje nosu in grla).
For the full list of all side effects reported with Lucentis, see the Package Leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Lucentis, glejte navodilo za uporabo.
Rarely, endophthalmitis (an infection inside the eye), serious eye inflammation, damage to the retina and cataract (clouding of the lens) can occur after Lucentis treatment.
Redko se lahko po zdravljenju z zdravilom Lucentis pojavi endoftalmitis (okužba notranjosti očesa), hudo vnetje očesa, poškodba mrežnice in katarakta (zamegljenost leč).
It is important to treat these problems as soon as possible.
Pomembno je, da se te težave zdravijo čimprej.
Their symptoms and instructions about what to do if a patient has them are explained in the Package Leaflet.
Njihovi simptomi in navodila, kako ukrepati pri bolniku s takimi težavami, so razloženi v navodilu za uporabo.
As injections into the eye can cause a temporary increase in the pressure within the eye, the ophthalmologist will check for this after the injection and take corrective measures if needed.
Ker injekcije v oko lahko povzročijo tudi začasno povečanje tlaka v očesu, bo oftalmolog to preveril po injekciji in po potrebi izvedel ustrezne popravne ukrepe.
Lucentis should not be used in patients who may be hypersensitive (allergic) to ranibizumab or any of the other ingredients.
Zdravila Lucentis ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) ranibizumab ali katero koli drugo sestavino.
It 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.
Prav tako ga ne smejo uporabljati bolniki, ki utegnejo imeti okužbo očesa ali območja okrog očesa ali pa hudo vnetje notranjosti očesa.
The Committee for Medicinal Products for Human Use (CHMP) noted that Lucentis is associated with side effects, but that this is balanced by benefits that have been shown convincingly and maintained for up to two years.
Odbor za zdravila za uporabo v humani medicini (CHMP) je ugotovil, da ima zdravilo Lucentis neželene učinke, vendar so ti uravnoteženi z učinkovitostjo, ki je bila prepričljivo prikazana in se je ohranila do dve leti.
The Committee decided that Lucentis’ s benefits are greater than its risks for the treatment of neovascular (wet) AMD.
Odbor je zaključil, da so koristi zdravila Lucentis pri zdravljenju neovaskularne (vlažne) oblike SDM večje od z njim povezanih tveganj.
Since the effectiveness of Lucentis was slightly greater in the patients receiving the 0.5 mg dose and the most common side effects were not serious, the Committee recommended that this dose of Lucentis should be given a marketing authorisation.
Ker je bila učinkovitost zdravila Lucentis nekoliko večja pri bolnikih, ki so prejemali odmerek 0, 5 mg, najpogostejši neželeni stranski učinki pa niso bili resni, je Odbor priporočil, da se dovoljenje za promet odobri za ta odmerek zdravila Lucentis.
Which measures are being taken to ensure the safe use of Lucentis?
Kateri ukrepi se izvajajo za zagotavljanje varne uporabe zdravila Lucentis?
The company that makes Lucentis will provide information packs for doctors (including information on the measures needed to minimise the risk of infection associated with injections into the eye) and for patients (to help them prepare for Lucentis treatment, recognise serious side effects and know
Družba bo tudi podrobneje spremljala neželene učinke in varnost zdravila.
2/ 3 when to seek urgent attention from their doctor).
2/ 3 Druge informacije o zdravilu Lucentis:
The European Commission granted a marketing authorisation valid throughout the European Union for Lucentis to Novartis Europharm Limited on 22 January 2007.
Evropska komisija je dovoljenje za promet z zdravilom Lucentis, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 22. januarja 2007.
The full EPAR for Lucentis can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Lucentis lahko najdete tukaj.
Solution for injection
intravitrealna uporaba
Intravitreal use Vial (glass)
viala (steklena)
Lucentis 10 mg/ ml solution for injection
Lucentis 10 mg/ ml raztopina za injiciranje
One ml contains 10 mg ranibizumab.
En mililiter vsebuje 10 mg ranibizumaba.
Each vial contains 2.3 mg of ranibizumab in 0.23 ml solution.
Vsaka viala vsebuje 2, 3 mg ranibizumaba v 0, 23 ml raztopine.
Ranibizumab is a humanised monoclonal antibody fragment produced in Escherichia coli cells by recombinant DNA technology.
Ranibizumab je fragment humaniziranega monoklonskega protitelesa, pridobljen iz celic bakterije Escherichia coli s tehnologijo rekombinantne DNA.
Sterile, clear, colourless to pale yellow aqueous solution.
Sterilna, bistra, brezbarvna do bledo rumena vodna raztopina.
Lucentis is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD) (see section 5.1).
Zdravilo Lucentis je indicirano za zdravljenje neovaskularne (vlažne) oblike starostne degeneracije makule (SDM) (glejte poglavje 5. 1).
Lucentis must be administered by a qualified ophthalmologist experienced in intravitreal injections.
Lucentis sme aplicirati samo specialist okulist, ki ima izkušnje z intravitrealnimi injekcijami.
The recommended dose for Lucentis is 0.5 mg (0.05 ml).
Priporočeni odmerek zdravila Lucentis je 0, 5 mg (0, 05 ml).
Lucentis treatment is initiated with a loading phase of one injection per month for three consecutive months, followed by a maintenance phase in which patients should be monitored for visual acuity on a monthly basis.
Zdravljenje z zdravilom Lucentis se začne v polnitvenem obdobju z eno injekcijo na mesec in sicer tri zaporedne mesece, sledi pa mu vzdrževalno obdobje, v katerem je treba bolniku enkrat mesečno preverjati ostrino vida.
If the patient experiences a loss of greater than 5 letters in visual acuity (ETDRS or one Snellen line equivalent), Lucentis should be administered.
Če pride do poslabšanja vidne ostrine za več kot 5 črk (ETDRS ali ekvivalent ene Snellenove vrstice), je treba aplicirati Lucentis.
The interval between two doses should not be shorter than 1 month.
Obdobje med zaporednima odmerkoma ne sme biti krajše od enega meseca.
As with all medicinal products for parenteral use, Lucentis should be inspected visually for particulate matter and discoloration prior to administration.
Kot velja za vsa zdravila, ki so namenjena parenteralni uporabi, je treba tudi izgled zdravila Lucentis pred uporabo pregledati glede vsebnosti delcev in spremembe barve.
Before treatment, the patient should be instructed to self-administer antimicrobial drops (four times daily for 3 days before and following each injection).
Bolnike je treba pred zdravljenjem naučiti, da si sami aplicirajo protimikrobne kapljice za oko (štirikrat dnevno 3 dni pred vsako injekcijo in 3 dni po njej).
The patient ’ s medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see section 4.4).
Pred izvedbo intravitrealnega posega je treba pozorno preveriti bolnikovo anamnezo glede preobčutljivostnih reakcij (glejte poglavje 4. 4).
The periocular skin, eyelid and ocular surface should be disinfected and adequate anaesthesia and a broad-spectrum topical microbicide should be administered prior to the injection.
Pred samo injekcijo je treba razkužiti kožo okrog očesa, veko in površino očesa ter bolniku aplicirati ustrezno anestezijo in širokospektralni lokalni antibiotik.
For information on preparation of Lucentis, see section 6.6.
2 Za pripravo zdravila Lucentis glejte poglavje 6. 6.
2 The injection needle should be inserted 3.5-4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe.
Injekcijsko iglo je treba uvesti 3, 5- 4, 0 mm posteriorno od limbusa v steklovinski prostor, usmeriti jo je treba proti središču zrkla, pri tem pa se je treba izogniti horizontalnemu meridianu.
The injection volume of 0.05 ml is then delivered; a different scleral site should be used for subsequent injections.
Pri vsakem naslednjem injiciranju je treba uporabiti drugo mesto vboda na beločnici.
Hepatic impairment Lucentis has not been studied in patients with hepatic impairment.
Okvara jeter Zdravila Lucentis pri bolnikih z okvaro jeter niso proučevali.
Renal impairment Dose adjustment is not needed in patients with renal impairment (see section 5.2).
Okvara ledvic Pri bolnikih z okvaro ledvic prilagajanje odmerkov ni potrebno (glejte poglavje 5. 2).
Children and adolescents Lucentis is not recommended for use in children and adolescents due to a lack of data on safety and efficacy in these sub-populations.
Otroci in mladostniki Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Lucentis pri otrocih in mladostnikih ni priporočljiva.
Elderly No dose adjustment is required in the elderly.
Starejši Pri starejših prilagajanje odmerkov ni potrebno.
Ethnicity Experience with treatment is limited in groups other than Caucasians.
Etnične skupine Pri skupinah, ki ne pripadajo beli rasi, so izkušnje z zdravljenjem omejene.
Treatment with Lucentis is for intravitreal injection only.
Zdravljenje z zdravilom Lucentis je namenjeno samo za intravitrealno injiciranje.
Intravitreous injections, including those with Lucentis, have been associated with endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract (see section 4.8).
Tako kot pri drugih intravitrealnih injekcijah, je tudi injiciranje zdravila Lucentis povezano z endoftalmitisom, intraokularnim vnetjem, regmatogenim odstopom mrežnice, raztrganino mrežnice in iatrogeno travmatsko katarakto (glejte poglavje 4. 8).
Increases in intraocular pressure have been seen within 60 minutes of injection of Lucentis (see section 4.8).
V 60 minutah po injiciranju zdravila Lucentis so opažali zvišan intraokularni tlak (glejte poglavje 4. 8).
Both intraocular pressure and the perfusion of the optic nerve head must therefore be monitored and managed appropriately.
Tako intraokularni tlak kot tudi perfuzijo glave očesnega živca je treba zato spremljati in ustrezno obravnavati.
The safety and efficacy of Lucentis therapy administered to both eyes concurrently have not been studied.
Učinkovitosti in varnosti aplikacije zdravila Lucentis v obe očesi hkrati niso proučevali.
If bilateral treatment is performed at the same time this could lead to an increased systemic exposure, which could increase the risk of systemic adverse events.
Pri hkratnem zdravljenju obeh očes lahko pride do zvišane sistemske izpostavljenosti, kar bi lahko povečalo nevarnost sistemskih neželenih dogodkov.
As with all therapeutic proteins, there is a potential for immunogenicity with Lucentis.
Kot pri vseh terapevtskih proteinih, obstaja tudi pri zdravilu Lucentis možnost imunogenosti.