natgillin/translations-raw huggingface dataset:
The CHMP decided that Javlor's benefits are greater than its risks and recommended that Javlor be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Javlor večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Javlor.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Javlor, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Treatment with Javlor should be started under the supervision of a doctor qualified to use anticancer medicines and is only given in specialised hospital units.
Zdravljenje z zdravilom Javlor je treba začeti pod nadzorom zdravnika, ki je usposobljen za uporabo zdravil proti raku, daje pa se lahko samo v specializiranih bolnišničnih oddelkih.
The most common side effects with Javlor (seen in more than 1 patient in 10) are neutropenia, leucopenia (low white blood cell counts), anaemia (low red blood cell counts), thrombocytopenia (low platelet count), loss of appetite, constipation, abdominal (stomach) pain, vomiting, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth), diarrhoea, alopecia (hair loss), myalgia (muscle pain), asthenia (weakness) or fatigue (tiredness), injection site reaction, fever and weight loss.
Najpogostejši neželeni učinki zdravila Javlor (opaženi pri več kot 1 bolniku od 10) so nevtropenija, levkopenija (nizko število belih krvnih celic), slabokrvnost (nizko število rdečih krvnih celic), trombocitopenija (nizko število trombocitov), izguba teka, zaprtje, bolečine v trebuhu, bruhanje, slabost, stomatitis (vnetje ustne sluznice), driska, alopecija (izpadanje las), mialgija (bolečine v mišicah), astenija (šibkost) ali utrujenost, reakcije na mestu injiciranja, povišana telesna temperatura in izguba telesne mase.
The dose of Javlor to be given is based on the patient's body surface area (calculated using height and weight).
Predpisani odmerek zdravila Javlor je odvisen od telesne površine bolnika (izračunane na podlagi višine in telesne mase).
In this group, those given Javlor lived for 6.9 months compared with 4.3 months for patients who were not given the Javlor.
V tej skupini so bolniki, ki so prejemali zdravilo Javlor, živeli še 6,9 meseca, medtem ko so bolniki, ki zdravila Javlor niso prejemali, živeli še 4,3 meseca.
The doctor may need to adjust the dose by taking into account the patient's age, liver or kidney function and certain side effects that the patient may be experiencing.
Zdravnik bo morda moral prilagoditi odmerek ob upoštevanju bolnikove starosti, delovanja jeter ali ledvic in nekaterih neželenih učinkov, ki bi se lahko pojavili pri bolniku.
In one main study of 370 adults with advanced or metastatic transitional cell carcinoma of the urothelial tract, patients who were given Javlor treatment were compared with patients who were not given any anticancer medicine.
V glavni študiji s 370 odraslimi bolniki z napredovalim ali metastatskim prehodnoceličnim karcinomom urotelija so bolnike, ki so prejemali zdravilo Javlor, primerjali z bolniki, ki niso prejemali nobenega zdravila proti raku.
For more information about treatment with Javlor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Javlor preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The doctor may also delay or stop doses if the patient experiences certain side effects, including low levels of platelets and neutrophils (a type of white blood cell), and certain side effects affecting the heart, liver or lungs.
Zdravnik lahko tudi odloži ali prekine odmerjanje, če se pri bolniku pojavijo nekateri neželeni učinki, vključno z nizkimi ravnmi trombocitov in nevtrofilcev (vrste belih krvničk), in določeni neželeni učinki, ki vplivajo na srce, jetra ali pljuča.
Why has Javlor been approved?
Zakaj je bilo zdravilo Javlor odobreno?
Among all patients in the study, there was no clear evidence of a difference in survival between patients who received Javlor and those who did not.
V študiji ni bilo jasnih dokazov o razliki v preživetju med bolniki, ki so prejemali zdravilo Javlor, in bolniki, ki ga niso prejemali.
Javlor must not be used in people who are hypersensitive (allergic) to vinflunine or other vinca alkaloids.
Zdravila Javlor ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) vinflunin ali druge alkaloide rožnatega zimzelena.
Javlor is used for the treatment of adults with advanced or metastatic ‘transitional cell carcinoma of the urothelial tract' (a cancer that affects the lining of the bladder and the rest of the urinary tract).
Zdravilo Javlor se uporablja za zdravljenje odraslih z napredovalim ali metastatskim „prehodnoceličnim karcinomom urotelija“ (rakom, ki prizadene steno sečnega mehurja in preostali del sečil).
All the patients had previously received treatment with a platinum-containing medicine which failed.
Vsi bolniki so bili predhodno zdravljeni z zdravilom, ki vsebuje platino, vendar zdravljenje ni bilo uspešno.
The recommended dose is 320 mg per m2. Javlor is given as a drip into a vein over a period of
Priporočeni odmerek je 320 mg na m2.
Javlor with best supportive care was more effective than best supportive care alone in prolonging the lives of patients with advanced or metastatic transitional cell carcinoma of the urothelial tract.
Zdravilo Javlor v kombinaciji z najboljšo podporno oskrbo je bilo pri podaljšanju preživetja bolnikov z napredovalim ali metastatskim prehodnoceličnim karcinomom urotelija učinkovitejše od najboljše podporne oskrbe.
The active substance in Javlor, vinflunine, belongs to the group of anticancer medicines known as the vinca alkaloids.
Zdravilna učinkovina v zdravilu Javlor, vinflunin, spada v skupino zdravil proti raku, znanih kot alkaloidi rožnatega zimzelena.
Javlor is used when previous treatment with a platinum-containing anticancer medicine has failed.
Zdravilo Javlor se uporablja, kadar zdravljenje z zdravili proti raku, ki vsebujejo platino, ni bilo uspešno.
For the full list of all side effects reported with Javlor, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Javlor, glejte navodilo za uporabo.
It attaches to a protein in cells called ‘tubulin', which is important in the formation of the internal ‘skeleton' that cells need to assemble when they divide.
Veže se na beljakovino v celicah, imenovano „tubulin“, ki ima pomembno vlogo pri tvorbi notranjega „ogrodja“, ki ga morajo celice zgraditi, ko se delijo Vinflunin ob vezavi na tubulin v rakastih celicah zaustavi tvorbo ogrodja, s čimer prepreči delitev in razmnoževanje rakastih celic.
Measures to prevent constipation, such as laxatives, are recommended after Javlor is given in the first week.
Prvi teden po uporabi zdravila Javlor so priporočljivi tudi ukrepi za preprečevanje zaprtja, kot je npr. jemanje odvajal.
How has Javlor been studied?
Kako je bilo zdravilo Javlor raziskano?
Javlor is a concentrate for solution for infusion (drip into a vein).
Zdravilo Javlor je koncentrat za pripravo raztopine za infundiranje (kapalne infuzije v veno).
20 minutes once every three weeks.
Zdravilo Javlor se dovaja 20 minut kot kapalna infuzija v veno enkrat na tri tedne.
What is Javlor used for?
Za kaj se zdravilo Javlor uporablja?
This is because low levels of haemoglobin (a protein found in red blood cells that carries oxygen around the body) and blood cells (white blood cells and platelets) are frequent side effect of the medicine.
Pred odmerjanjem zdravila Javlor je treba pri bolnikih s krvnimi preiskavami preveriti ravni krvničk in hemoglobina, ker sta nizki ravni hemoglobina (beljakovine v rdečih krvničkah, ki prenaša kisik po telesu) in krvničk (belih krvničk in trombocitov) pogosta neželena učinka zdravila.
How does Javlor work?
Kako zdravilo Javlor deluje?
How is Javlor used?
Kako se zdravilo Javlor uporablja?
Strength Pharmaceutical Form Route of Administration
Farmacevtska oblika Način aplikacije
EU Number
Številka EU Lastniško ime Jakost
The patients were treated for up to 23 months.
Bolnice so zdravili do 23 mesecev.
The European Commission granted a marketing authorisation valid throughout the European Union for Forsteo on 10 June 2003.
Evropska komisija je dovoljenje za promet z zdravilom Forsteo, veljavno po vsej Evropski uniji, izdala 10. junija 2003.
What measures are being taken to ensure the safe and effective use of Forsteo?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Forsteo?
The full EPAR for Forsteo 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) za zdravilo Forsteo je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Forsteo must not be used in children or in young adults whose bones are not yet fully mature, or during pregnancy or breastfeeding.
Ne sme se uporabljati pri otrocih ali mlajših odraslih, katerih kosti še niso popolnoma razvite, oziroma med nosečnostjo ali dojenjem.
It also increases the absorption of calcium from food and prevents too much calcium being lost in the urine.
Poleg tega poveča absorpcijo kalcija iz hrane in preprečuje izgubo velike količine kalcija v urinu.
It also reduced the risk of non-vertebral fractures by 62%, but did not reduce the risk of hip fractures.
Hkrati je za 62 % zmanjšalo tveganje za nevretenčne zlome, vendar ni zmanjšalo tveganja za zlome kolka.
Forsteo has been studied in three main studies.
Zdravilo Forsteo so raziskovali v treh glavnih študijah.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Forsteo have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Forsteo, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The main measure of effectiveness was the number of new vertebral fractures at the end of the study, although the study also looked at non-vertebral fractures.
Glavno merilo učinkovitosti je bilo število novih zlomov vretenc na koncu študije, čeprav so v študiji spremljali tudi nevretenčne zlome.
This is a summary of the European public assessment report (EPAR) for Forsteo.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Forsteo.
A user manual is available for the pen.
Na voljo je priročnik za uporabo peresnika.
For more information about treatment with Forsteo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Forsteo preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
It is available as a solution for injection in prefilled pens (one 2.4 ml prefilled pen contains 600 micrograms of teriparatide).
Na voljo je v obliki raztopine za injiciranje v napolnjenih injekcijskih peresnikih (eden 2,4-mililitrski napolnjeni injekcijski peresnik vsebuje 600 mikrogramov teriparatida).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Forsteo.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Forsteo must not be used in patients who have other bone diseases such as Paget's disease, bone cancer or bone metastases (cancer that has spread to the bone), patients who have had radiation therapy of the skeleton, or patients who have hypercalcaemia (high blood calcium levels), unexplained high levels of alkaline phosphatase (an enzyme) or severe kidney disease.
Zdravilo Forsteo se ne sme uporabljati pri bolnikih, ki imajo druga obolenja kosti, kot so Pagetova bolezen, kostni rak ali metastaze v kosteh (rak, ki se je razširil na kosti), bolnikih, ki so bili na obsevanju okostja, ali bolnikih, ki imajo hiperkalciemijo (visoke ravni kalcija v krvi), tistih z nepojasnjeno visokimi ravnmi alkalne fosfataze (vrste encima) ali hudim obolenjem ledvic.
The study included 429 women and men who had osteoporosis and had been taking glucocorticoids for at least three months.
V študijo je bilo vključenih 429 žensk in moških, ki so imeli osteoporozo in so najmanj tri mesece jemali glukokortikoide.
What benefit has Forsteo shown during the studies?
Kakšne koristi je zdravilo Forsteo izkazalo med študijami?
The most common side effect with Forsteo (seen in more than 1 patient in 10) is pain in the arms or legs.
Najpogostejši neželeni učinek zdravila Forsteo (opažen pri 1 bolniku od 10) so bolečine v rokah ali nogah.
The recommended dose is 20 micrograms of Forsteo given once a day as an injection under the skin of the thigh or abdomen (tummy).
Priporočeni odmerek je 20 mikrogramov zdravila Forsteo, ki se daje enkrat dnevno v obliki injekcije pod kožo stegna ali predela trebuha.
Forsteo is used for the treatment of osteoporosis (a disease that makes bones fragile) in the following groups:
Zdravilo Forsteo se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri naslednjih skupinah:
What is the risk associated with Forsteo?
Kakšna tveganja so povezana z zdravilom Forsteo?
It acts like the hormone to stimulate bone formation by acting on osteoblasts (bone-forming cells).
Deluje enako kot hormon in vzpodbuja tvorbo kosti tako, da deluje na osteoblaste (celice, ki tvorijo kostnino).
The CHMP concluded that Forsteo's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Forsteo večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The studies also showed that the benefits of Forsteo treatment continued to increase for up to two years, with further increases in bone density.
Študije so tudi pokazale, da so bile koristi zdravljenja z zdravilom Forsteo vedno večje v obdobju do največ dveh let, saj se je gostota kosti nadalje povečevala.
Patients should receive calcium and vitamin D supplements if they do not get enough from their diet. Forsteo can be used for up to two years.
Bolniki morajo jemati tudi dodatek kalcija in vitamina D, če ju ne dobivajo dovolj s prehrano.
In these patients, Forsteo has been shown to significantly reduce vertebral (spine) and non-vertebral fractures (broken bones), but not those of the hip;
Pri teh bolnicah je bilo dokazano, da zdravilo Forsteo znatno zmanjšuje pojavnost zlomov vretenc (hrbtenice) in nevretenčnih zlomov, ne pa tudi zlomov kolka;
The active substance in Forsteo, teriparatide, is identical to part of the human parathyroid hormone.
Zdravilna učinkovina v zdravilu Forsteo, teriparatid, je enaka delu človeškega paratiroidnega hormona.
In the study of patients taking glucocorticoids, Forsteo was more effective than alendronate: after 18 months, patients receiving Forsteo had a 7% increase in bone density in the spine, compared with 3% in those receiving alendronate.
V študiji bolnikov, ki so jemali glukokortikoide, je bilo zdravilo Forsteo učinkovitejše od alendronata: po 18 mesecih se je pri bolnikih, ki so prejemali zdravilo Forsteo, gostota kosti v hrbtenici povečala za 7 % v primerjavi s 3 % pri bolnikih, ki so prejemali alendronat.
The first study involved 1,637 women with osteoporosis who had been through the menopause (average age: 69.5 years), in which Forsteo was compared with placebo (a dummy treatment) for an average of 19 months.
V prvo študijo je bilo vključenih 1 637 žensk (povprečna starost: 69,5 leta) s pomenopavzalno osteoporozo, v kateri so zdravilo Forsteo v obdobju povprečno 19 mesecev primerjali s placebom (zdravilom brez zdravilne učinkovine).
The second study looked at the use of Forsteo in 437 men with osteoporosis, comparing its effect on the density of bones in the spine with that of placebo.
V drugi študiji so proučevali uporabo zdravila Forsteo pri 437 moških z osteoporozo in primerjali njegov učinek na gostoto kosti v hrbtenici z učinkom placeba.
Forsteo is a medicine that contains the active substance teriparatide.
Forsteo je zdravilo, ki vsebuje zdravilno učinkovino teriparatid.
An additional study looked at the effects of Forsteo on bone density over two years in 234 women who had been through the menopause.
V dodatni študiji so dve leti proučevali učinke zdravila Forsteo na gostoto kosti pri 234 ženskah po menopavzi.
The third study compared the effects of Forsteo and alendronate (another medicine used to treat osteoporosis) on spine bone density over three years.
V tretji študiji so tri leta primerjali učinke zdravila Forsteo in alendronata (drugega zdravila za zdravljenje osteoporoze) na gostoto kosti v hrbtenici.
Forsteo was more effective than placebo in reducing vertebral fractures: 5% of the women who received Forsteo had a new fracture during the study, compared with 14% in the group who received placebo.
Zdravilo Forsteo je bilo pri zmanjševanju pojavnosti zloma vretenc učinkovitejše od placeba: pri 5 % žensk, ki so prejemale zdravilo Forsteo, je med študijo prišlo do novega zloma vretenc v primerjavi s 14 % bolnic v skupini, ki je prejemala placebo.
Only one two-year course of Forsteo should be given to a patient in their lifetime.
Bolniki lahko v času življenja prejmejo samo en dvoletni cikel zdravljenja z zdravilom Forsteo.
In the study in men, Forsteo increased bone density in the spine by about 6% after an average of almost 12 months.
V študiji, v katero so bili vključeni moški, je zdravilo Forsteo v povprečnem obdobju skoraj 12 mesecevpovečalo gostoto kosti v hrbtenici za okoli 6 %.
Why has Forsteo been approved?
Zakaj je bilo zdravilo Forsteo odobreno?
What is Forsteo used for?
Za kaj se zdravilo Forsteo uporablja?
For the full list of all side effects reported with Forsteo, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Forsteo, glejte navodilo za uporabo.
How has Forsteo been studied?
Kako je bilo zdravilo Forsteo raziskano?
Forsteo reduced the risk of developing a new vertebral fracture over 19 months by 65% compared with placebo.
Zdravilo Forsteo je v primerjavi s placebom za 65 % zmanjšalo tveganje za pojav novega zloma vretenc v 19-mesečnem obdobju študije.
How is Forsteo used?
Kako se zdravilo Forsteo uporablja?
Other information about Forsteo
Druge informacije o zdravilu Forsteo:
You may then hear or feel a click.
Pri tem lahko slišite ali čutite klik.
This is especially important if you take more than one type of insulin.
To je zlasti pomembno, če jemljete več kot eno vrsto insulina.
• how much Tresiba you will need each day
• koliko zdravila Tresiba boste potrebovali vsak dan,
CI: 95% confidence interval.
IZ: 95 % interval zaupanja.
What others need to do if you pass out
Kaj morajo narediti drugi, če se onesvestite
4 Episodes from week 16 in each treatment period
4 Epizode od 16. tedna v vsakem obdobju zdravljenja.
The signs of a serious allergic reaction are:
Znaki resne alergijske reakcije so:
ATC code: A10AE06.
Oznaka ATC: A10AE06.
These reactions are usually mild and transitory and they normally disappear during continued treatment.
Te reakcije so ponavadi blage in prehodne in med nadaljevanjem zdravljenja ponavadi izginejo.
This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
To je lahko nevarno v okoliščinah, v katerih sta ti zmožnosti posebej pomembni (npr. pri vožnji avta ali upravljanju strojev).
Ask your doctor whether you can drive if:
Vprašajte zdravnika, ali lahko vozite, v primeru da:
This medicinal product must not be mixed with any other medicinal products.
Tega zdravila se ne sme mešati s katerim koli drugim zdravilom.
• the local reactions spread to other parts of your body
• razširitev lokalnih reakcij na druge dele telesa,
This is normal, but you must still check the insulin flow.
To je normalno, vendar morate kljub temu preveriti pretok insulina.
If you have poor eyesight, please see section 3.
Če slabo vidite, glejte poglavje 3.
• Do not leave the pen in a car or other place where it can get too hot or too cold.
• Ne puščajte injekcijskega peresnika v avtomobilu ali na drugem mestu, kjer bi lahko postal preveč vroč ali hladen.
For more information, see ‘serious allergic reaction' above.
Za dodatne informacije glejte odstavek »Resna alergijska reakcija« zgoraj.
Your doctor will decide together with you:
Skupaj z zdravnikom se bosta odločila:
Do not stop using your insulin without talking to your doctor.
Ne prenehajte uporabljati vašega insulina, ne da bi se pogovorili z zdravnikom.
6 seconds
6 sekund
Date of latest renewal: 21 September 2017
Datum prve odobritve: 21. januar 2013 Datum zadnjega podaljšanja: 21. september 2017
• Always follow your doctor's recommendation for dose.
• Vedno upoštevajte zdravnikova priporočila glede odmerka.
Before first use
Pred prvo uporabo
Be especially aware of the following:
Še posebej morate biti pozorni na:
Tresiba which has been frozen must not be used.
Zdravila Tresiba, ki je bilo zamrznjeno, se ne sme uporabiti.
Any waste material should be disposed of in accordance with local requirements.
Odpadni material zavrzite v skladu z lokalnimi predpisi.
All cause death
Smrt zaradi katerega koli vzroka
Flexibility in dosing time
Prilagodljivost glede časa odmerjanja
Safety and efficacy have been demonstrated in a long term trial in children aged 1 to less than 18 years.
Varnost in učinkovitost sta bili dokazani v dolgoročnem preskušanju pri otrocih, starih od 1 leta do 18 let.
<1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
< 1/1.000), zelo redki (< 1/10.000) in neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
• turn you on your side
• položiti na bok,
52 weeks of treatment
52 tednov zdravljenja
This is a build-up of acid in the blood because the body is breaking down fat instead of sugar.
To je kopičenje kisline v krvi, ker telo presnavlja maščobo namesto sladkorja.
• If you do not respond to a glucagon injection, you will have to be treated in a hospital.
• Če se ne odzovete na injekcijo z glukagonom, bo potrebno zdravljenje v bolnišnici.
After delivery, insulin requirements usually return rapidly to pre-pregnancy values.
Po porodu se potreba po insulinu običajno hitro vrne na vrednosti pred nosečnostjo.
26 weeks of treatment
26 tednov zdravljenja
When using other medicines, ask your doctor if your treatment needs to be adjusted.
V primeru uporabe drugih zdravil se z zdravnikom posvetujte, ali je treba vaše zdravljenje prilagoditi.
Glucose must be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes.
Glukozo je treba dati intravensko v primeru, da se bolnik v 10 do 15 minutah ne odzove na glukagon.
• when to check your blood sugar level and if you need a higher or lower dose.
• kdaj morate preveriti koncentracijo krvnega sladkorja in ali potrebujete višji ali nižji odmerek.
• you have had too low blood sugar a few times recently.
• ste imeli pred kratkim večkrat prenizek krvni sladkor.
You should therefore monitor your blood sugar level more often than usual.
Koncentracijo krvnega sladkorja morate torej kontrolirati bolj pogosto kot običajno.
This medicinal product is for use by one person only.
To zdravilo je namenjeno uporabi ene same osebe.
Do not inject it into a vein or muscle.
Nikoli ga ne injicirajte v veno ali mišico.
• you suddenly feel unwell with sweating
• nenadno slabo počutje in znojenje,