natgillin/translations-raw huggingface dataset:
Entresto's serious side effects in the main study were similar to those of enalapril, which is already authorised for use in heart failure.
Resni neželeni učinki zdravila Entresto v glavni študiji so bili podobni neželenim učinkom enalaprila, ki je že odobren za uporabo pri srčnem popuščanju.
For the full list of all side effects reported with Entresto, see the package leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Entresto, glejte navodilo za uporabo.
In the main study, Entresto was compared to enalapril, another medicine used for heart failure.
V glavni študiji so zdravilo Entresto primerjali z enalaprilom, drugim zdravilom za zdravljenje srčnega popuščanja.
The study was stopped early because there was compelling evidence that Entresto was more effective than enalapril.
Študijo so zaradi trdnih dokazov, da je zdravilo Entresto učinkovitejše od enalaprila, predčasno prekinili.
A potentially severe side effect, angioedema (rapid swelling of deeper skin tissues as well as the tissues around the throat, causing breathing difficulty), can occur uncommonly (affecting fewer than 1 in 100 people).
Občasno se lahko pojavi potencialno resen neželeni učinek (ki lahko prizadene manj kot 1 osebo od 100), angioedem (hitro otekanje globokih kožnih tkiv in tkiv okrog grla, kar povzroči težave z dihanjem).
How is Entresto used?
Kako se zdravilo Entresto uporablja?
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom zmanjšajo krvni tlak in srce ščitijo pred razvojem fibroze (nastanka brazgotin), ki se pojavi pri srčnem popuščanju.
How does Entresto work?
Kako zdravilo Entresto deluje?
All these reactions disappear within 6 days.
Vse te reakcije izginejo v 6 dneh.
Do not freeze.
Ne zmrzujte.
If such reactions occur, appropriate treatment is recommended.
Če pride do takšnih reakcij, je potrebno ustrezno zdravljenje.
In laboratory studies and field trials:
V laboratorijskih študijah in terenskih preskušanjih:
ATCvet code: QI09AL08.
Oznaka ATC vet: QI09AL08.
Needle length and diameter should be adapted to the age of the animal.
Dolžino in premer igle je treba prilagoditi starosti živali.
Homogenous white to nearly white emulsion after shaking.
Homogena bela do skoraj bela emulzija po stresanju.
This veterinary medicinal product contains mineral oil.
To zdravilo vsebuje mineralno olje.
30938 Burgwedel GERMANY
30938 Burgwedel NEMČIJA
The active substances being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Učinkovina, ki je v osnovi biološkega izvora, namenjene vzbujanju imunosti, ne spada v področje uporabe Uredbe(ES) št. 470/2009.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živalih od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
37008 Carbajosa de la Sagrada, Salamanca
37008 Carbajosa de la Sagrada,
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), (če je potrebno) Podatki niso na voljo.
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
BESEDILO “ZDRAVILO SHRANJUJTE IZVEN POGLEDA IN DOSEGA OTROK”
Cardboard box
Kartonasta škatla
Avoid introduction of contamination.
Pazite, da ne bi prišlo do kontaminacije.
To the user:
Namenjeno uporabniku:
2 ml contains:
2 ml vsebujeta:
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
SPC, so bodisi dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, ne spadajo v področje uporabe Uredbe(ES) št. 470/2009.
Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki.
Milton Keynes Buckinghamshire MK7 7AJ
Milton Keynes Buckinghamshire MK7 7AJ UK
Light mineral oil
lahko mineralno olje
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini razen z zgoraj omenjenim.
When PCV2 and/or M. hyopneumoniae infections occur early the two dose vaccination schedule is recommended.
Kadar se okužbe s PCV2 in/ali M. hyopneumoniae pojavijo zgodaj, se priporoča shema cepljenja z dvema odmerkoma.
In post marketing experience (with single dose vaccination):
V postmarketinških izkušnjah (po shemi cepljenja z enim odmerkom):
Date of first authorisation: 07/11/2014.
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja za promet: 07/11/2014.
These reactions disappear within 12 days after the first vaccination of the two dose vaccination schedule and within 3 days after completion of either the single or the two dose vaccination schedule.
Te reakcije izginejo v 12 dneh po prvem cepljenju pri shemi cepljenja z dvema odmerkoma in v 3 dneh po končanju bodisi sheme z enim odmerkom ali sheme z dvema odmerkoma cepljenja.
Vaccinate pigs by the intramuscular route in the neck.
Prašiče cepite intramuskularno v vrat.
Pharmacotherapeutic group: Immunologicals for Suidae, inactivated viral and inactivated bacterial vaccines for pigs.
Farmakoterapevtska skupina: Imunološka zdravila za prašiče (Suidae), inaktivirana virusna in inaktivirana bakterijska cepiva.
Safety and efficacy data are available which demonstrate that this vaccine can be given with Porcilis PRRS at the same time at separate sites from 3 weeks of age.
Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno dati ob sočasni uporabi cepiva Porcilis PRRS pri različnih mestih dajanja, pri prašičih starejših od 3 tedne.
Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Nenamerno injiciranje/samo-injiciranje lahko povzroči hude bolečine in otekline, zlasti ob injiciranju v sklep ali prst, in lahko v izjemnih primerih, če ni zagotovljena takojšnja zdravniška oskrba, privede do izgube prizadetega prsta.
Cardboard box with 1 or 10 vials of 20, 50, 100, 200 or 500 ml.
Kartonasta škatla z 1 ali 10 vialami po 20, 50, 100, 200 ali 500 ml.
PET (polyethylene terephthalate) vials of 20, 50, 100, 200 or 500 ml, closed with nitrile rubber stoppers and sealed with aluminium caps.
Viale iz PET (polietilen tereftalat) po 20, 50, 100, 200 ali 500 ml, zaprte z zamaški iz nitrilne gume in aluminijasto zaporko.
Accidental injection is dangerous.
Nenamerno injiciranje je nevarno.
Special warnings for each target species: Vaccinate only healthy animals.
Posebna opozorila za vsako živalsko vrsto: Cepite samo zdrave živali.
Pigs for fattening.
Prašiči pitanci.
A transient increase in body temperature very commonly occurs on the day of vaccination (mean ±1 °C, in individual pigs up to 2 °C).
Prehoden dvig telesne temperature se pojavi zelo pogosto na dan cepljenja (povprečno ± 1°C, pri posameznih prašičih do 2°C).
Date of last renewal: dd/mm/yyyyy
Datum zadnjega podaljšanja dovoljenja za promet: dd/mm/yyyy.
Two injections each of 1 ml in pigs starting at 3 days of age with an interval of at least 18 days.
Dve injekciji po 1 ml prašičem pri starosti od 3 dni naprej, v razmiku najmanj 18 dni.
Mild systemic reactions may uncommonly be observed up to one day after vaccination and consist of being less active, a tendency of the animal to lie down and minor signs of discomfort.
Blage sistemske reakcije se lahko občasno pojavijo do en dan po cepljenju in se kažejo v zmanjšani aktivnosti živali s tendenco, da bi se ulegle, in z blažjimi znaki nelagodja.
Special precautions for use in animals: Not applicable.
Posebni previdnostni ukrepi za uporabo pri živalih: Ni smiselno.
To reduce the loss of daily weight gain during the finishing period in face of infections with Mycoplasma hyopneumoniae and/or PCV2 (as observed in field studies).
Za zmanjšanje izgube dnevnega prirasta v končnem razdobju zaradi okužb z mikoplazmo (Mycoplasma hyopneumoniae) in/ali PCV2 (kot so pokazale terenske študije).
Emulsion for injection.
Emulzija za injiciranje.
EXP {month/year} Once broached use within 8 hours.
Načeto zdravilo uporabite v 8 urah.
The temperature returns to normal from 1 to 2 days after the peak temperature is observed.
Temperatura se normalizira v 1 do 2 dneh po opaženi najvišji temperaturi.
Shelf life of the veterinary medical product as packaged for sale: 2 years.
Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti.
Shelf life after first opening the container: 8 hours.
Rok uporabnosti po prvem odpiranju vsebnika: 8 ur.
A hypersensitivity-like reaction may be observed in rare cases after the first vaccination of the two dose vaccination schedule.
V redkih primerih lahko opazimo preobčutljivosti podobne reakcije po prvem cepljenju pri shemi cepljenja z dvema odmerkoma.
A single dose of 2 ml in pigs starting at 3 weeks of age.
En odmerek po 2 ml na prašiča pri starosti od 3 tednov naprej.
Before using the vaccine allow it to reach room temperature (15 °C - 25 °C) and shake well before use.
Preden cepivo uporabite, naj se ogreje na sobno temperaturo (15 °C do 25 °C).
Emulsion for injection
Emulzija za injiciranje
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
NAVEDBA UČINKOVIN(E) IN DRUG(E)IH SESTAVIN
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
PCV2: 18 days after the first vaccination.
PCV2: 18 dni po prvem cepljenju.
Transient local injection site reactions, which are restricted to a slight swelling (maximum 2 cm diameter), may commonly occur directly after vaccination, but reactions may not appear until 12 days after vaccination.
Prehodne lokalne reakcije na mestu injiciranja, ki so omejene na rahlo oteklino (s premerom < 2 cm), se občasno pojavijo takoj po dajanju, vendar se reakcija lahko pojavi do 12 dni po cepljenju.
Transient local injection site reactions, which are restricted to a slight swelling (< 2 cm diameter), may uncommonly occur.
Prehodne lokalne reakcije na mestu injiciranja, ki so omejene na rahlo oteklino (s premerom < 2 cm), se pojavijo občasno.
MSD Animal Health Danube Biotech GmbH Brennaustrasse 1
ŠPANIJA MSD Animal health Danube Biotech GmbH
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER PROIZVAJALEC ZDRAVILA, ODGOVORENE ZA SPROŠČANJE SERIJ, ČE STA RAZLIČNA
For the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues, virus shedding caused by porcine circovirus type 2 (PCV2) infection, and severity of lung lesions caused by Mycoplasma hyopneumoniae infection.
Aktivna imunizacija prašičev za zmanjšanje viremije, virusnega bremena v pljučih in limfnih tkivih, izločanja virusov, ki ga povzroča okužba s cirkovirusom prašičev (PCV2), in resnosti pljučnih poškodb, ki jih povzroča okužba z mikoplazmo (Mycoplasma hyopneumoniae).
Hypersensitivity reactions after vaccination may occur uncommonly.
Občasno se po cepljenju pojavijo preobčutljivostne reakcije.
M. hyopneumoniae inac.
Inaktivirana M. hyopneumoniae
Anaphylactic-type reactions, which may be life-threatening, can occur in very rare cases.
Zelo redko se pojavijo reakcije anafilaktičnega tipa, ki so lahko življenjsko ogrožujoče.
Porcilis PCV M Hyo emulsion for injection for pigs
Porcilis PCV M Hyo emulzija za injiciranje za prašiče
Onset of immunity with single dose vaccination: PCV2: 2 weeks after vaccination.
Nastop imunosti po cepljenju z enim odmerkom: PCV2: 2 tedna po cepljenju.
M. hyopneumoniae: 21 weeks after (the last) vaccination.
M. hyopneumoniae: 21 tednov po (zadnjem) cepljenju.
1 Antigenic units as determined in the in vitro potency test (ELISA).
1Enote antigena, določene z in vitro ELISA testom učinkovitosti 2Relativne enote učinkovitost, določene z referenčnim cepivom
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vials of 100, 200 and 500 ml
PODATKI NA STIČNI OVOJNINI Viale po 100, 200 in 500 ml
Light mineral oil Aluminium hydroxide Sorbitan oleate Polysorbate 80
6.1 Seznam pomožnih snovi lahko mineralno olje aluminijev hidroksid sorbitan oleat polisorbat 80 etilalkohol glicerol natrijev klorid voda za injekcije
Aluminium (as hydroxide)
0,268 ml aluminij (v obliki hidroksida)
The product stimulates the development of active immunity against porcine circovirus type 2 and Mycoplasma hyopneumoniae in pigs.
Cepivo vzbuja razvoj aktivne imunosti proti cirkovirusu prašičev tipa 2 in proti Mycoplasma hyopneumoniae pri prašičih.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
M. hyopneumoniae: 4 weeks after vaccination.
M. hyopneumoniae: 4 tedne po cepljenju.
Per 2 ml: PCV2 ORF2 subunit antigen
PCV2, antigenska podenota ORF2
Name and address of the manufacturers of the biological active substances
Ime in naslov proizvajalcev biološke učinkovine Intervet International BV
Two dose vaccination schedule:
Shema cepljenja z dvema odmerkoma:
Intervet UK Limited Walton Manor Walton,
Intervet UK Limited
Marketing authorisation holder and manufacturer responsible for batch release:
Imetnik dovoljenja za promet z zdravilom in proizvajalec, odgovoren za sproščanje serij:
PACKAGE LEAFLET: Porcilis PCV M Hyo emulsion for injection for pigs
NAVODILO ZA UPORABO: Porcilis PCV M Hyo emulzija za injiciranje za prašiče
Porcine circovirus type 2 (PCV2) ORF2 subunit antigen ≥ 2,828 AU1 Mycoplasma hyopneumoniae J strain inactivated
Učinkovine: cirkovirus prašičev, tip 2 (PCV2), antigenska podenota ORF2 ≥ 2,828 AU1
Onset of immunity with two dose vaccination:
Nastop imunosti po shemi cepljenja z dvema odmerkoma:
M. hyopneumoniae: 3 weeks after the second vaccination.
M. hyopneumoniae: 3 tedne po drugem cepljenju.
The product literature of Porcilis PRRS should be consulted.
Ob sočasni uporabi upoštevajte tudi navodilo za uporabo Porcilis PRRS.
In individual pigs the temperature increase after associated use may commonly exceed 2°C.
Pri posameznih prašičih se lahko telesna temperatura po običajni uporabi poviša za več kot 2 ° C. Temperatura se normalizira v 1 do 2 dneh po opaženi najvišji temperaturi.
4.4 Special warnings for each target species
4.4 Posebna opozorila za vsako ciljno živalsko vrsto Cepite samo zdrave živali.
PCV2 ORF2 subunit antigen ≥ 2,828 AU M. hyopneumoniae inac.
KOLIČINA UČINKOVIN(E) PCV2, antigenska podenota ORF2 ≥ 2828 AU,
Single dose vaccination schedule:
Shema cepljenja z enim odmerkom:
SPAIN
NIZOZEMSKA
Duration of immunity (both vaccination schedules): PCV2: 22 weeks after (the last) vaccination.
PCV2: 22 tednov po (zadnjem) cepljenju.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Further information on Nerlynx can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Nerlynx so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The recommended dose is 6 tablets (240 mg) once a day with food, preferably in the morning.
Priporočeni odmerek je šest tablet (240 mg) enkrat na dan s hrano, najbolje zjutraj.
It is given following treatment with trastuzumab (another medicine used for the same purpose).
Daje se po zdravljenju s trastuzumabom (drugim zdravilom, ki se uporablja za enak namen).
The medicine is available as tablets (40 mg).
Zdravilo je na voljo v obliki tablet (40 mg).
Treatment should be started within a year of finishing treatment with trastuzumab, and is given for 1 year.
Zdravljenje je treba začeti v enem letu po koncu zdravljenja s trastuzumabom in traja eno leto.
What measures are being taken to ensure the safe and effective use of Nerlynx?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Nerlynx?
The Agency therefore decided that Nerlynx's benefits are greater than its risks in this group and it can be authorised for use in the EU.
Agencija je zato zaključila, da so koristi zdravila Nerlynx večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Other information about Nerlynx
Druge informacije o zdravilu Nerlynx
As for all medicines, data on the use of Nerlynx are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Nerlynx stalno spremljajo.
Other common side effects (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting, tiredness, belly pain, rash, decreased appetite, stomatitis (sore, inflamed mouth), and muscle spasms.
Drugi pogosti neželeni učinki (ki se lahko pojavijo pri več kot 1 bolnici od 10) so navzeja (slabost), bruhanje, utrujenost, bolečine v trebuhu, izpuščaj, zmanjšan tek, stomatitis (boleča, vneta usta) in mišični krči.
An overview of Nerlynx and why it is authorised in the EU
Pregled zdravila Nerlynx in zakaj je odobreno v EU
The doctor may also modify the dose if Nerlynx is given with certain other medicines.
Zdravnik lahko odmerek spremeni tudi, če se zdravilo Nerlynx daje skupaj z nekaterimi drugimi zdravili.
What benefits of Nerlynx have been shown in studies?
Kakšne koristi zdravila Nerlynx so se pokazale v študijah?
It is intended for use only in breast cancers that produce high levels of a protein called HER2, which helps cells to divide and grow (HER2-positive breast cancer), and that also have receptors (targets) for the female sex hormones (hormone-receptor positive breast cancer).
Namenjeno je samo za zdravljenje raka dojke, ki tvori visoko raven beljakovine, imenovane HER2, ki pomaga celicam pri delitvi in rasti (HER2-pozitiven rak dojke), in ima tudi receptorje (tarče) za ženske spolne hormone (za hormonske receptorje pozitiven rak dojke).
Because HER2 helps cancer cells to grow and divide, blocking it helps to stop these cells growing and prevents the cancer from coming back.
Ker HER2 rakavim celicam pomaga pri rasti in delitvi, njeno zaviranje ustavi rast teh celic in prepreči ponovitev raka.
Side effects reported with Nerlynx are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Nerlynx, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Why is Nerlynx authorised in the EU?
Zakaj je bilo zdravilo Nerlynx odobreno v EU?
The most common serious side effects are diarrhoea and vomiting.
Najpogostejša resna neželena učinka sta driska in bruhanje.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nerlynx 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 Nerlynx upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Nerlynx has been shown to be more effective than placebo (a dummy treatment) at preventing the cancer from coming back in one main study involving 2,840 women with HER2-positive early breast cancer who had already received trastuzumab.
Zdravilo Nerlynx se je pokazalo kot učinkovitejše od placeba (zdravila brez učinkovine) pri preprečevanju ponovitve raka v eni glavni študiji, v katero je bilo vključenih 2 840 žensk s HER2-pozitivnim zgodnjim rakom dojke, ki so že prejemale trastuzumab.
It attaches to the HER2 protein on the cancer cells, and so blocks its action.
Veže se na beljakovino HER2 na rakavih celicah in tako zavira njeno delovanje.
Although the side effects, particularly diarrhoea, can be severe and lead to treatment being stopped, there would be patients with HER2-positive, hormone-receptor positive early breast cancer for whom treatment with Nerlynx after surgery and trastuzumab would be a reasonable option.
Čeprav so lahko neželeni učinki, zlasti driska, hudi in zahtevajo ustavitev zdravljenja, bi bilo pri nekaterih bolnicah s HER2-pozitivnim, za hormonske receptorje pozitivnim zgodnjim rakom dojke zdravljenje z zdravilom Nerlynx po kirurškem posegu in zdravljenju s trastuzumabom smiselno.
When only women with hormone-receptor positive cancer were considered, about 95% of those given Nerlynx lived another year without the cancer coming back versus 91% of those given placebo.
Če bi upoštevali samo ženske z rakom, pozitivnim za hormonske receptorje, jih je 95 % tistih, ki so prejemale zdravilo Nerlynx, brez ponovitve raka živelo še eno leto, v primerjavi z 91 % tistih, ki so prejemale placebo.
What are the risks associated with Nerlynx?
Kakšna tveganja so povezana z zdravilom Nerlynx?
The European Medicines Agency considered that Nerlynx had been shown to be of benefit in women with HER2-positive early breast cancer, and that this benefit seemed to be mainly in women with hormone-receptor positive disease.
Evropska agencija za zdravila je presodila, da je zdravilo Nerlynx dokazano koristno pri ženskah s HER2-pozitivnim zgodnjim rakom dojke, to korist pa je bilo opaziti predvsem pri ženskah z boleznijo, pozitivno za hormonske receptorje.
For more information about using Nerlynx, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Nerlynx glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What is Nerlynx and what is it used for?
Kaj je zdravilo Nerlynx in za kaj se uporablja?
It must also not be used with certain medicines that affect the way Nerlynx is broken down in the body.
Prav tako se ne sme uporabljati skupaj z nekaterimi drugimi zdravili, ki vplivajo na presnovo zdravila Nerlynx v telesu.
The company that markets Nerlynx will provide a guide for healthcare professionals who prescribe or dispense the medicine, and educational material for patients and carers.
Podjetje, ki trži zdravilo Nerlynx, bo zagotovilo vodnik za zdravstvene delavce, ki predpisujejo ali razdeljujejo to zdravilo, ter izobraževalno gradivo za bolnike in negovalce.
The active substance in Nerlynx, neratinib, is a type of cancer medicine called a tyrosine kinase inhibitor.
Učinkovina zdravila Nerlynx, neratinib, je vrsta zdravila za zdravljenje raka, imenovana zaviralec tirozin-kinaze.
Around 94% of the women given a year's treatment with Nerlynx lived for 1 further year after stopping Nerlynx without their cancer coming back versus 92% of those given placebo.
Približno 94 % žensk, ki so zdravilo Nerlynx prejemale eno leto, je po prenehanju zdravljenja s tem zdravilom brez ponovitve raka živelo še eno leto, v primerjavi z 92 % žensk, ki so prejemale placebo.