natgillin/translations-raw huggingface dataset:
Onbrez Breezhaler is a long-acting beta2-adrenergic agonist, which is only indicated for COPD and should not be used in asthma due to the absence of long-term outcome data in asthma.
Onbrez Breezhaler je dugodjelujući beta2-adrenergički agonist koji je indiciran samo za KOPB i ne treba se koristiti u astmi jer nema podataka o ishodima pri dugotrajnoj primjeni u astmi.
Paediatric population There is no relevant use of Onbrez Breezhaler in the paediatric population (under 18 years).
Nema relevantne primjene Onbrez Breezhaler u pedijatrijskoj populaciji (mlađih od 18 godina).
Clinically relevant effects on prolongation of the QTc-interval have not been observed in clinical studies of Onbrez Breezhaler at recommended therapeutic doses (see section 5.1).
Klinički važni učinci produljenja QTc-intervala nisu bili zapaženi u ispitivanjima Onbrez Breezhalera u preporučenim terapijskim dozama (vidjeti dio 5.1).
Although no clinically relevant effect on the cardiovascular system is usually seen after the administration of Onbrez Breezhaler at the recommended doses, as with other beta2-adrenergic agonists, indacaterol should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2adrenergic agonists.
Iako nije bio zapažen klinički značajan učinak na kardiovaskularni sustav nakon primjene Onbrez Breezhalera u preporučenim dozama, indakaterol treba, kao i druge beta2-adrenergičke agoniste, oprezno primjenjivati u bolesnika s kardiovaskularnim poremećajima (koronarna srčana bolest, akutni infarkt miokarda, srčane aritmije, hipertenzija), u bolesnika s konvulzivnim poremećajima ili tireotoksikozom te u bolesnika koji imaju neuobičajeni odgovor na beta2-adrenergičke agoniste.
Onbrez Breezhaler contains the active substance indacaterol which belongs to a group of medicines called bronchodilators.
Onbrez Breezhaler sadrži djelatnu tvar indakaterol koja pripada skupini lijekova koji se nazivaju bronhodilatatori.
At the recommended doses, the adverse reaction profile of Onbrez Breezhaler in patients with COPD shows clinically insignificant systemic effects of beta2-adrenergic stimulation.
U preporučenim dozama profil nuspojava Onbrez Breezhalera u bolesnika s KOPB-om pokazuje klinički beznačajne sistemske učinke beta2-adrenergičke stimulacije.
If paradoxical bronchospasm occurs Onbrez Breezhaler should be discontinued immediately and alternative therapy substituted.
Ako dođe do pojave paradoksalnog bronhospazma, primjenu Onbrez Breezhalera treba odmah prekinuti i zamijeniti ga drugim lijekom.
The recommended dose is the inhalation of the content of one 150 microgram capsule once a day, using the Onbrez Breezhaler inhaler.
Preporučena doza je udisanje sadržaja jedne kapsule od 150 mikrograma jedanput na dan uz pomoć Onbrez Breezhaler inhalatora.
Onbrez Breezhaler, administered once a day at doses of 150 and 300 microgram consistently provided clinically significant improvements in lung function (as measured by the forced expiratory volume in one second, FEV1) over 24 hours across a number of clinical pharmacodynamic and efficacy studies.
Onbrez Breezhaler primijenjen jedanput na dan u dozi od 150 i 300 mikrograma dosljedno je pružao klinički značajna poboljšanja plućne funkcije (mjereno forsiranim izdisajnim volumenom u jednoj sekundi, FEV1) tijekom 24 sata kroz brojna farmakodinamička ispitivanja i ispitivanja djelotvornosti.
What Onbrez Breezhaler is and what it is used for What you need to know before you use Onbrez Breezhaler How to use Onbrez Breezhaler Possible side effects
Što je Onbrez Breezhaler i za što se koristi Što morate znati prije nego počnete primjenjivati Onbrez Breezhaler Kako primjenjivati Onbrez Breezhaler Moguće nuspojave
Although indacaterol did not affect general reproductive performance in a rat fertility study, a decrease in the number of pregnant F1 offspring was observed in the peri- and post-developmental rat study at an exposure 14-fold higher than in humans treated with Onbrez Breezhaler.
Iako indakaterol nije u pravilu utjecao na reproduktivne parametre u ispitivanju plodnosti u štakora, zapažen je pad broja trudnih F1 potomaka u ispitivanju peri- i post-razvoja u štakora pri izloženosti 14 puta većoj od one u ljudi liječenih Onbrez Breezhalerom.
Immediate hypersensitivity reactions have been reported after administration of Onbrez Breezhaler.
Reakcije preosjetljivosti su odmah bile prijavljene nakon primjene Onbrez Breezhalera.
Onbrez Breezhaler, administered once a day at doses of 150 microgram and 300 microgram, showed clinically meaningful improvements in lung function.
Onbrez Breezhaler primijenjen jedanput na dan u dozama od 150 mikrograma i 300 mikrograma pokazao je klinički značajna poboljšanja plućne funkcije.
How long to continue your treatment with Onbrez Breezhaler Keep using your treatment with Onbrez Breezhaler for as long as your doctor tells you.
Koliko dugo trebate nastaviti svoje liječenje Onbrez Breezhalerom Nastavite svoje liječenje Onbrez Breezhalerom toliko dugo koliko Vam je rekao liječnik.
The inhalation of the content of one 300 microgram capsule once a day, using the Onbrez Breezhaler inhaler has been shown to provide additional clinical benefit with regard to breathlessness, particularly for patients with severe COPD.
Dokazano je da udisanje sadržaja kapsule od 300 mikrograma jedanput na dan uz pomoć Onbrez Breezhaler inhalatora omogućava dodatnu kliničku korist s obzirom na dispneju, osobito u bolesnika s teškim KOPB-om.
Onbrez Breezhaler has not been investigated in patients with not well controlled diabetes mellitus.
Onbrez Breezhaler se nije ispitivao u bolesnika s loše kontroliranom šećernom bolešću.
Onbrez Breezhaler capsules must always be stored in the blister, and only removed immediately before use.
Onbrez Breezhaler kapsule se moraju uvijek čuvati u blisteru te se smiju izvaditi tek neposredno prije primjene.
Your Onbrez Breezhaler pack: Each Onbrez Breezhaler pack contains: one Onbrez Breezhaler inhaler one or more blisters containing Onbrez Breezhaler capsules to be used in the inhaler.
Vaše Onbrez Breezhaler pakiranje: Jedno Onbrez Breezhaler pakiranje sadrži: jedan Onbrez Breezhaler inhalator jedan ili više blistera koji sadrže Onbrez Breezhaler kapsule koje se koriste u inhalatoru.
Onbrez Breezhaler is used to make breathing easier for adult patients who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD).
Onbrez Breezhaler se koristi da bi se olakšalo disanje u odraslih bolesnika koji imaju poteškoće s disanjem zbog plućne bolesti koja se zove kronična opstruktivna plućna bolest (KOPB).
Onbrez Breezhaler is not indicated for the treatment of acute episodes of bronchospasm, i.e. as rescue therapy.
Onbrez Breezhaler nije indiciran za liječenje akutnih epizoda bronhospazma, tj. kao lijek za hitna stanja.
There are no data available for use of Onbrez Breezhaler in patients with severe hepatic impairment.
Nema podataka o primjeni Onbrez Breezhalera u bolesnika s teškim oštećenjem jetre.
If you forget to inhale a dose, inhale just one dose at the usual time the next day.
Ako ste zaboravili primijeniti Onbrez Breezhaler Ako ste zaboravili udahnuti svoju dozu, udahnite samo jednu dozu u uobičajeno vrijeme sljedećeg dana.
Only use the capsules with the inhaler provided in this pack (Onbrez Breezhaler inhaler).
Koristite samo kapsule koje ste dobili uz inhalator u ovom pakiranju (Onbrez Breezhaler inhalator).
Other medicines and Onbrez Breezhaler
Drugi lijekovi i Onbrez Breezhaler
What Onbrez Breezhaler contains - Each Onbrez Breezhaler 150 microgram capsule contains 150 microgram indacaterol as indacaterol maleate.
Što Onbrez Breezhaler sadrži - Svaka Onbrez Breezhaler 150 mikrogramska kapsula sadrži 150 mikrograma indakaterola u obliku indakaterolmaleata.
The Onbrez Breezhaler Phase III clinical development programme involved patients with a clinical diagnosis of moderate to severe COPD.
Program ispitivanja faze III tijekom razvoja Onbrez Breezhalera uključivao je bolesnike s kliničkom dijagnozom umjerenog do teškog KOPB-a.
Breezhaler capsules with any other inhaler, and do not use Onbrez Breezhaler inhaler to take any other capsule medicine.
Onbrez Breezhaler kapsule s nekim drugim inhalatorom i ne koristite Onbrez Breezhaler inhalator za primjenu bilo kojeg drugog lijeka u kapsulama.
What Onbrez Breezhaler is and what it is used for
Što je Onbrez Breezhaler i za što se koristi
Onbrez Breezhaler 150 microgram capsules have a black product code “IDL 150” printed above a black bar and a black company logo ( ) printed below the black bar.
Onbrez Breezhaler 150 mikrograma kapsule imaju crnu oznaku „IDL 150“ otisnutu iznad crne crte i crni logo proizvođača ( ) otisnut ispod crne crte.
In the event of deterioration of COPD during treatment with Onbrez Breezhaler, a reevaluation of the patient and of the COPD treatment regimen should be undertaken.
Ako dođe do pogoršanja KOPB-a tijekom liječenja Onbrez Breezhalerom, bolesnika treba ponovno pregledati i provesti liječenje KOPB-a.
Onbrez Breezhaler 300 microgram capsules have a blue product code “IDL 300” printed above a blue bar and a blue company logo ( ) printed below the blue bar.
Onbrez Breezhaler 300 mikrograma kapsule imaju plavu oznaku „IDL 300“ otisnutu iznad plave crte i plavi logo proizvođača ( ) otisnut ispod plave crte.
The Onbrez Breezhaler inhaler provided with each new prescription should be used.
Potrebno je koristiti Onbrez Breezhaler inhalator koji se dobije sa svakim novim receptom.
What you need to know before you use Onbrez Breezhaler
Što morate znati prije nego počnete primjenjivati Onbrez Breezhaler
Talk to your doctor or pharmacist before using Onbrez Breezhaler if you have asthma (in this case you should not use Onbrez Breezhaler).
Obratite se svom liječniku ili ljekarniku prije nego primijenite Onbrez Breezhaler ako imate astmu (u tom slučaju ne biste trebali koristiti Onbrez Breezhaler). ako imate problema sa srcem. ako imate epilepsiju. ako imate problema sa štitnjačom (tireotoksikoza). ako imate šećernu bolest.
Stop using the medicine and tell your doctor immediately if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine.
Tijekom liječenja Onbrez Breezhalerom, prestanite primjenjivati lijeka i odmah se obratite svom liječniku ako osjetite stezanje grudnog koša, kašljanje, piskanje ili kratkoću daha odmah nakon primjene lijeka.
Upon initiation of treatment with Onbrez Breezhaler plasma glucose should be monitored more closely in diabetic patients.
Nakon početka liječenja Onbrez Breezhalerom, u bolesnika sa šećernom bolešću treba pomno pratiti glukozu u plazmi.
The Onbrez Breezhaler inhaler enables you to inhale the medicine contained in a capsule.
Onbrez Breezhaler inhalator Vam omogućava udisati lijek koji se nalazi u kapsuli.
Show the pack of Onbrez Breezhaler.
Pokažite pakiranje Onbrez Breezhalera.
Always keep the Onbrez Breezhaler inhaler and capsules in a dry place.
Uvijek držite Onbrez Breezhaler inhalator i kapsule na suhom mjestu.
An increase in the daily dose of Onbrez Breezhaler beyond the maximum dose of 300 microgram is not appropriate.
Povećanje dnevne doze iznad doze od 300 mikrograma nije primjereno.
- Each Onbrez Breezhaler 300 microgram capsule contains 300 microgram indacaterol as indacaterol maleate.
- Svaka Onbrez Breezhaler 300 mikrogramska kapsula sadrži 300 mikrograma indakaterola u obliku indakaterolmaleata.
Onbrez Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).
Onbrez Breezhaler je indiciran za terapiju održavanja bronhodilatacije kod opstrukcije dišnih puteva u odraslih bolesnika s kroničnom opstruktivnom plućnom bolesti (KOPB).
INSTRUCTIONS FOR USE OF ONBREZ BREEZHALER INHALER
UPUTE ZA PRIMJENU ONBREZ BREEZHALER INHALATORA
The Onbrez Breezhaler inhaler enables you to inhale the medicine contained in an Onbrez Breezhaler capsule.
Onbrez Breezhaler inhalator Vam omogućuje udisanje lijeka koji se nalazi u Onbrez Breezhaler kapsuli.
When you start a new pack, use the new Onbrez Breezhaler inhaler that is supplied in the pack.
Kada otvorite novo pakiranje, upotrijebite novi Onbrez Breezhaler inhalator koji je priložen u pakiranju.
Onbrez Breezhaler is a single-dose inhalation device.
Onbrez Breezhaler je jednodozni inhalator.
Onbrez Breezhaler capsules must not be swallowed.
Onbrez Breezhaler kapsule se ne smiju progutati.
Carton containing 30 capsules and one Onbrez Breezhaler inhaler.
Kutija sadrži 30 kapsula i jedan Onbrez Breezhaler inhalator.
Driving and using machines It is unlikely that Onbrez Breezhaler will affect your ability to drive and use machines.
Nije vjerojatno da će Onbrez Breezhaler utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
Carton containing 10 capsules and one Onbrez Breezhaler inhaler.
Kutija sadrži 10 kapsula i jedan Onbrez Breezhaler inhalator.
Onbrez Breezhaler contains lactose
Onbrez Breezhaler sadrži laktozu
Onbrez Breezhaler inhaler
Onbrez Breezhaler inhalator
Never place a Onbrez Breezhaler capsule directly into the mouthpiece of the Onbrez Breezhaler inhaler.
Nikada ne stavljajte Onbrez Breezhaler kapsulu direktno u nastavak za usta Onbrez Breezhaler inhalatora.
• When you start a new pack, only use the new Onbrez Breezhaler inhaler that is supplied in the pack.
• Kada otvorite novo pakiranje, koristite samo novi Onbrez Breezhaler inhalator koji se nalazi u ovom pakiranju.
Always use the new Onbrez Breezhaler inhaler that comes with your new pack.
Uvijek koristite Onbrez Breezhaler inhalator koji se nalazi u Vašem novom pakiranju.
Only use the Onbrez Breezhaler inhaler contained in this pack.
Koristite samo Onbrez Breezhaler inhalator koji se nalazi u ovom pakiranju.
• Only use the Onbrez Breezhaler inhaler contained in this pack.
• Koristite samo Onbrez Breezhaler inhalator koji se nalazi u ovom pakiranju.
The magnitude of exposure increases due to interactions does not raise any safety concerns given the safety experience of treatment with Onbrez Breezhaler in clinical studies of up to one year at doses up to twice the maximum recommended therapeutic dose.
Iskustvo iz ispitivanja vezanih uz sigurnost liječenja Onbrez Breezhalerom u trajanju do jedne godine u dozama dvostruko većim od najveće preporučene terapijske doze pokazuje da se s porastom izloženosti zbog interakcija ne smanjuje sigurnost primjene lijeka.
What Onbrez Breezhaler is
Što je Onbrez Breezhaler
Never take the Onbrez Breezhaler inhaler apart.
Nikad nemojte rastavljati Onbrez Breezhaler inhalator.
Common 1 Reports of hypersensitivity have been received from post-approval marketing experience in association with the use of Onbrez Breezhaler.
Prema iskustvima nakon stavljanja gotovog lijeka u promet zabilježeni su slučajevi preosjetljivosti povezani s primjenom Onbrez Breezhalera.
How to store Onbrez Breezhaler Contents of the pack and other information
Kako Onbrez Breezhaler izgleda i sadržaj pakiranja
Do not swallow Onbrez Breezhaler capsules.
Ne gutajte Onbrez Breezhaler kapsule.
Do not store the capsules in the Onbrez Breezhaler inhaler.
Ne čuvajte kapsule u Onbrez Breezhaler inhalatoru.
Onbrez Breezhaler 150 microgram inhalation powder, hard capsules Onbrez Breezhaler 300 microgram inhalation powder, hard capsules indacaterol
Onbrez Breezhaler 150 mikrograma prašak inhalata, tvrde kapsule Onbrez Breezhaler 300 mikrograma prašak inhalata, tvrde kapsule indakaterol
How much Onbrez Breezhaler to use
Koliko Onbrez Breezhalera primijeniti
Never blow into the mouthpiece of the Onbrez Breezhaler inhaler.
Nikad ne pušite u nastavak za usta Onbrez Breezhaler inhalatora.
What Onbrez Breezhaler is used for
Za što se koristi Onbrez Breezhaler
Onbrez Breezhaler 300 microgram inhalation powder, hard capsules
Onbrez Breezhaler 300 mikrograma prašak inhalata, tvrde kapsule
How to use Onbrez Breezhaler
Kako primijeniti Onbrez Breezhaler
Onbrez Breezhaler 150 microgram inhalation powder, hard capsules
Onbrez Breezhaler 150 mikrograma prašak inhalata, tvrde kapsule
Onbrez Breezhaler 300 microgram inhalation powder, hard capsules indacaterol
Onbrez Breezhaler 300 mikrograma prašak inhalata, tvrde kapsule indakaterol
What Onbrez Breezhaler looks like and content of the pack In this pack, you will find an inhaler, together with capsules in blisters.
U ovom pakiranju pronaći ćete jedan inhalator zajedno s kapsulama u blisteru.
How to store Onbrez Breezhaler
Kako čuvati Onbrez Breezhaler
Onbrez Breezhaler 150 microgram inhalation powder, hard capsules indacaterol
Onbrez Breezhaler 150 mikrograma prašak inhalata, tvrde kapsule indakaterol
Never wash the Onbrez Breezhaler inhaler with water.
Nikad nemojte prati Onbrez Breezhaler vodom.
The full EPAR for Ontruzant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Ontruzant nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What is Ontruzant and what is it used for?
Što je Ontruzant i za što se koristi?
This means that Ontruzant is similar to another biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU).
To znači da je lijek Ontruzant sličan drugom biološkom lijeku („referentni lijek”) koji je već odobren u Europskoj uniji (EU).
Ontruzant can cause cardiotoxicity (harm to the heart), including heart failure (when the heart does not work as well as it should).
Ontruzant može uzrokovati kardiotoksičnost (oštećenja srca), uključujući zatajenje srca (kada srce ne radi kako bi trebalo).
Patients who tolerate the first 90-minute infusion can receive subsequent infusions over 30 minutes.
Bolesnici koji su dobro podnijeli prvu infuziju tijekom 90 minuta mogu primati sljedeće infuzije tijekom 30 minuta.
The most common or serious side effects with Ontruzant are heart problems, reactions related to the Ontruzant infusion, reduced levels of blood cells, especially white blood cells, infections and lung problems.
Najčešće ili ozbiljne nuspojave lijeka Ontruzant su problemi sa srcem, reakcije na infuziju lijeka Ontruzant, snižene razine krvnih stanica, posebno bijelih krvnih stanica, infekcije i problemi s plućima.
What measures are being taken to ensure the safe and effective use of Ontruzant?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ontruzant?
In addition, a study involving 875 patients with early or locally advanced breast cancer looked at the effectiveness of Ontruzant and Herceptin.
Osim toga, ispitivanje koje je obuhvatilo 875 bolesnika s ranim ili lokalno uznapredovalim rakom dojke istraživalo je djelotvornost lijekova Ontruzant i Herceptin.
The infusion can be associated with allergic reactions, so the patient should be monitored during and after the infusion.
Moguće su alergijske reakcije povezane s infuzijom, stoga je potreban nadzor bolesnika tijekom i nakon infuzije.
The reference medicine for Ontruzant is Herceptin.
Referentni lijek za Ontruzant jest Herceptin.
Ontruzant is a cancer medicine used to treat the following conditions:
Ontruzant je lijek protiv raka koji se koristi za liječenje sljedećih bolesti:
Ontruzant must not be used in people who are hypersensitive (allergic) to trastuzumab, mouse proteins or to any of the other ingredients.
Ontruzant se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na trastuzumab, mišje proteine ili bilo koji drugi sastojak lijeka.
Absence of invasive cancer cells was noted in the tissue removed at surgery in 52% of women given Ontruzant and 42% of those given Herceptin, but in the light of all the available information from the study this difference was not assessed to be relevant.
Zabilježeno je da nema stanica invazivnog raka u tkivu koje je odstranjeno kirurškim zahvatom u 52 % žena koje su primale lijek Ontruzant i u 42 % žena koje su primale lijek Herceptin, ali je u svjetlu svih dostupnih informacija iz ispitivanja ocijenjeno da ova razlika nije relevantna.
This is a summary of the European public assessment report (EPAR) for Ontruzant.
Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Ontruzant.
What are the risks associated with Ontruzant?
Koji su rizici povezani s lijekom Ontruzant?
Because Ontruzant is a biosimilar medicine, the studies on effectiveness and safety of trastuzumab carried out with Herceptin do not all need to be repeated for Ontruzant.
Budući da je lijek Ontruzant biosličan lijek, ispitivanja učinkovitosti i sigurnosti trastuzumaba provedena za lijek Herceptin nije potrebno ponavljati za lijek Ontruzant.
Ontruzant is a ‘biosimilar medicine'.
Ontruzant je „biosličan lijek”.
It is not intended to provide practical advice on how to use Ontruzant.
Svrha sažetka nije davati praktične savjete o primjeni lijeka Ontruzant.
Ontruzant can only be obtained with a prescription and treatment should be started by a doctor who has experience in the use of cancer medicines.
Ontruzant se izdaje samo na liječnički recept, a liječenje treba započeti liječnik s iskustvom u primjeni lijekova protiv raka.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Ontruzant has been shown to have a comparable quality, safety and effectiveness to Herceptin.
Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Ontruzant dokazao usporedivu kakvoću, sigurnost i učinkovitost kao i Herceptin.
The women received one or the other trastuzumab medicine before and after surgery, with other cancer medicines and radiotherapy according to standard practice.
Žene su dobivale jedan ili drugi lijek koji sadržava trastuzumab prije i nakon kirurškog zahvata, s drugim lijekovima protiv raka i radioterapijom sukladno standardnoj praksi.
The recommended dose depends on the patient's body weight and depends on the condition to be treated and whether Ontruzant is given weekly or three-weekly.
Preporučena doza ovisi o tjelesnoj težini bolesnika i o bolesti koja se liječi te o tome primjenjuje li se Ontruzant jedanput tjedno ili svaka tri tjedna.
Ontruzant can only be used when the cancer has been shown to ‘overexpress HER2': this means that the cancer produces a protein called HER2 in large quantities on the surface of the tumour cells, which makes the tumour cells grow more quickly.
Primjena lijeka Ontruzant moguća je samo ako tumor pokazuje „povećanu ekspresiju HER2”, što znači da rak proizvodi velike količine proteina pod nazivom HER2 na površini tumorskih stanica, zbog čega tumorske stanice brže rastu.
Why is Ontruzant approved?
Zašto je lijek Ontruzant odobren?
By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells.
Vezivanjem na HER2, trastuzumab aktivira djelovanje stanica imunosnog sustava, koje zatim ubijaju tumorske stanice.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ontruzant have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Ontruzant nalaze se u sažetku opisa svojstava i u uputi o lijeku.
On the basis of all the data provided it was concluded that Ontruzant would behave in the same way as Herceptin in its approved indications.
Na temelju svih dostavljenih podataka zaključeno je da će se Ontruzant za odobrene indikacije ponašati na isti način kao Herceptin.
• metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or 5‑fluorouracil (other cancer medicines).
• metastatski rak želuca, u kombinaciji s cisplatinom i kapecitabinom ili 5-fluorouracilom (drugi lijekovi protiv raka).
For more information about treatment with Ontruzant, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o liječenju lijekom Ontruzant pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.