natgillin/translations-raw huggingface dataset:
Any person intending to manufacture, import, possess, sell, supply and/or use of HIPRABOVIS IBR MARKER LIVE must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
prodajati, oskrbovati in/ali uporabljati HIPRABOVIS IBR MARKER LIVE, se mora posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja še pred izdelavo,
Potassium chloride Water for injections
Natrijev klorid Kalijev klorid Voda za injekcije
Pharmacotherapeutic group: Live viral vaccines, bovine rhinotracheitis virus (IBR).
Farmakoterapevtska skupina Živa virusna cepiva za govedo, virus infekcioznega bovinega rinotraheitisa (IBR).
PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD BOX: 5 AND 25 DOSES
PODATKI NA ZUNANJI OVOJNINI ŠKATLA: 5 IN 25 ODMERKOV
Abbreviations: gE-: deleted glycoprotein E; tk-: deleted thymidine kinase; CCID: cell culture infectious dose
Okrajšave: gE-: izbrisan glikoprotein E; tk-: izbrisana timidin kinaza; CCID: odmerek za infekcije celične kulture
Avda la Selva, 135
La Selva, 135
Animals vaccinated with HIPRABOVIS IBR MARKER LIVE will test positive (alongside cattle infected with BoHV-1 field virus or vaccinated with conventional non-marker BoHV-1 vaccines) when samples are analysed in tests based on the identification of antibodies to any other BoHV-1 antigens.
Pri živalih, ki so bile cepljene s cepivom Hiprabovis IBR Marker Live, bo test pozitiven (kot pri govedu, ki je okuženo z divjim virusom BoHV-1 ali je bilo cepljeno s cepivom za BoHV-1 brez markerja), kadar se vzorce analizira s testi, ki temeljijo na identifikaciji protiteles na katerega koli od drugih protiteles za BoHV-1.
Do not store and transport above 25°C).
POSEBNA NAVODILA ZA SHRANJEVANJE Ne shranjujte in prevažajte pri temperaturi nad 25 °C.
Lyophilisate of 5, 25 and 30 doses: Store and transport refrigerated (2 °C - 8 °C).
Liofilizat za 5, 25 in 30 odmerkov: Shranjujte in prevažajte v hladilniku (2 ºC - 8 ºC) Vehikel za 5 in 25 odmerkov:: Shranjujte in prevažajte v hladilniku (2 ºC - 8 ºC)
Solvent for HIPRABOVIS IBR MARKER LIVE
Vehikel za HIPRABOVIS IBR MARKER LIVE
la Selva, 135 17170 Amer (Girona) SPAIN
La Selva, 135 17170 Amer (Girona) ŠPANIJA
Phosphate buffer solution.
Raztopina fosfatnega pufra.
Thereafter a single booster dose of 2 ml should be administered every six months.
Pot zaključenem osnovnem cepljenju je vsakih šest mesecev potreben spodbujevalen odmerek po 2 ml.
Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Sodium chloride
Natrijev hidrogenfosfat dodekahidrat Kalijev dihidrogen fosfat
Vaccinate healthy animals only.
Posebni previdnostni ukrepi za uporabo pri živalih Cepite le zdrave živali.
Vaccinated animals can be differentiated from field virus infected animals due to the marker deletion (gE-) by means of commercial diagnostic kits, unless the animals were previously vaccinated with a conventional vaccine or infected with field virus.
1) za zmanjšanje kliničnih znakov Infekcioznega bovinega rinotraheitisa in izločanje divjega virusa Cepljene živali je mogoče razlikovati od živali, ki so okužene z divjim virusom, na osnovi izbrisa markerja (gE-) s pomočjo komercialnih diagnostičnih kompletov, razen v primeru, ko so živali predhodno cepili z običajnim cepivom ali pa so okužene z divjim virusom.
Live gE- tk- double-gene deleted bovine herpes virus type 1 (BoHV-1), strain CEDDEL: 106.3 - 107.3
Živ gE- tk- Goveji Herpes Virus vrste 1 (BoHV-1) z dvojno delecijo genov, sev CEDDEL: 106.3 - 107.3
Each dose of 2 ml contains: Live gE- tk- double-gene deleted bovine herpes virus type 1 (BoHV-1), strain CEDDEL: 106.3 - 107.3 CCID50.
Vsak odmerek po 2 ml vsebuje: Živ gE- tk- Goveji Herpes Virus vrste 1 (BoHV-1) z dvojno delecijo genov, sev CEDDEL: 106.3 - 107.3 CCID50
PACKAGE LEAFLET: HIPRABOVIS IBR MARKER LIVE
NAVODILO ZA UPORABO HIPRABOVIS IBR MARKER LIVE
The solvent should be allowed to warm to a temperature between 15 and 20 ºC before reconstitution of the lyophilisate.
Preden liofilizat rekonstituirate, je treba vehikel pustiti, da se segreje na 15 ºC in 20 ºC.
lyophilisate and solvent for suspension for injection for cattle.
liofilizat in vehikel za suspenzijo za injiciranje za govedo.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE FOR THE LYOPHILISATE
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Shelf life of the lyophilisate as packaged for sale: 2 years.
Rok uporabnosti liofilizata v pakiranju za prodajo: 2 leti Rok uporabnosti vehikla v pakiranju za prodajo: 5 leti Rok uporabnosti po rekonstituciji v skladu z navodili: 6 ur.
Cardboard box containing 1 bottle with 5 doses of lyophilisate and 1 bottle with 10 ml of solvent.
Kartonska škatla z 1 stekleničko z liofilizatom s 5 odmerki in 1 stekleničko z 10 ml vehikla.
The manufacture, import, possession, sale, supply and/or use of HIPRABOVIS IBR MARKER LIVE may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Izdelava,uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba HIPRABOVIS IBR MARKER LIVE
PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD BOX: 30 DOSES LYOPHILISATE
PODATKI NA ZUNANJI OVOJNINI ŠKATLA: 30 ODMERKOV LIOFILIZATA
Store and transport refrigerated.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte hladilniku.
Solvent: Phosphate buffer solution.
Vehikel: Raztopina fosfatnega pufra
No adverse reactions except those mentioned in section 6 “Adverse reactions” were observed after the administration of a 10-fold vaccine dose.
Po dajanju 10-kratnega odmerka cepiva ni bilo opaziti neželenih učinkov razen tistih, ki so navedeni v točki "Neželeni učinki".
Name and address of the manufacturer of the biological active substances Laboratorios Hipra, S.A.
Ime in naslov izdelovalca(izdelovalcev) biološke zdravilne učinkovine (zdravilnih učinkovin).
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), (če je potrebno) Po dajanju 10-kratnega odmerka cepiva ni bilo opaziti neželenih učinkov razen tistih, ki so navedeni v poglavju 4.6.
Avoid the introduction of contamination during reconstitution and use.
Med rekonstitucijo in uporabo pazite, da ne vnesete kontaminantov.
Cardboard box containing 1 bottle with 25 doses lyophilisate and 1 bottle with 50 ml of solvent.
Kartonska škatla z 1 stekleničko z liofilizatom s 25 odmerki in 1 stekleničko s 50 ml vehikla.. Kartonska škatla z 1 stekleničko z liofilizatom s 30 odmerki Kartonska škatla z 1 stekleničko s 60 ml vehikla.
Each dose of 2 ml: Live gE- tk- double-gene deleted bovine herpes virus type 1 (BoHV-1), strain CEDDEL: 106.3 - 107.3 CCID50.
Goveji Herpes Virus vrste 1 (BoHV-1) z dvojno delecijo genov, sev CEDDEL: 106.3 - 107.3 CCID50 Okrajšave:
HIPRABOVIS IBR MARKER LIVE lyophilisate for suspension for injection.
HIPRABOVIS IBR MARKER LIVE liofilizat za suspenzijo za injiciranje.
HIPRABOVIS IBR MARKER LIVE lyophilisate for suspension for injection for cattle.
HIPRABOVIS IBR MARKER LIVE liofilizat za suspenzijo za injiciranje za govedo.
Monosodium glutamate Sodium chloride
Natrijev glutamat Natrijev klorid Kalijev klorid Saharoza Voda za injekcije
For the active immunisation of cattle from 3 months of age against bovine herpes virus type 1 (BoHV-1) to reduce the clinical signs of Infectious bovine rhinotracheitis (IBR) and field virus excretion.
Za aktivno imunizacijo goveda nad 3 mesece starosti proti Govejemu Herpes Virusu vrste 1 (BoHV
HIPRABOVIS IBR MARKER LIVE lyophilisate and solvent for suspension for injection for cattle.
HIPRABOVIS IBR MARKER LIVE liofilizat in vehikel za suspenzijo za injiciranje za govedo.
Marketing authorisation holder and manufacturer responsible for batch release: LABORATORIOS HIPRA, S.A.
Imetnik dovoljenja za promet z zdravilom in izdelovalec odgovoren za sproščanje serij:
Name and address of the manufacturer responsible for batch release Laboratorios Hipra, S.A.
Ime in naslov izdelovalca(izdelovalcev) zdravila, odgovornega (odgovornih) za sprostitev serije
HIPRABOVIS IBR MARKER LIVE lyophilisate and solvent for suspension for injection.
HIPRABOVIS IBR MARKER LIVE liofilizat in vehikel za suspenzijo za injiciranje.
Lyophilisate: Store and transport refrigerated (2 °C - 8 °C).
Posebna navodila za shranjevanje Liofilizat: Shranjujte in prevažajte v hladilniku (2 ºC - 8 ºC) Vehikel za 5 in 25 odmerkov: Shranjujte in prevažajte v hladilniku (2 ºC - 8 ºC) Vehikel za 30 odmerkov:: Ne shranjujte in prevažajte pri temperaturi nad 25 °C..
For the active immunisation of cattle from 3 months of age against bovine herpes virus type 1 (BoHV1) to reduce the clinical signs of Infectious bovine rhinotracheitis (IBR) and field virus excretion.
za zmanjšanje kliničnih znakov Infekcioznega bovinega rinotraheitisa in izločanje divjega virusa Nastop imunosti: 21 dni po zaključku osnovnega cepljenja.
The patients were followed up for an average of 14.5 months.
V povprečju so bolnike spremljali do 14,5 meseca.
It is available as tablets (5 and 10 mg).
Na voljo je v obliki tablet (5 in 10 mg).
It is recommended that treatment with Efient and aspirin continue for up to a year.
Priporoča se, da se zdravljenje z zdravilom Efient in aspirinom nadaljuje do enega leta.
The European Commission granted a marketing authorisation valid throughout the European Union for Efient on 25 February 2009.
Evropska komisija je dovoljenje za promet z zdravilom Efient, veljavno po vsej Evropski uniji, izdala 25. februarja 2009.
What measures are being taken to ensure the safe and effective use of Efient?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Efient?
The full EPAR for Efient 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 Efient je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Other information about Efient
Druge informacije o zdravilu Efient
The use of Efient is not recommended in patients over 75 years of age, unless the doctor has carefully considered its benefits and risks, and regards treatment with Efient as necessary.
Uporaba zdravila Efient ni priporočena pri bolnikih, starejših od 75 let, razen če je zdravnik skrbno proučil njegove koristi in tveganja in je ocenil, da je zdravljenje z zdravilom Efient potrebno.
In addition, the company that markets Efient will make sure that educational materials are available in all Member States for doctors who will treat patients with the medicine.
Poleg tega bo družba, ki trži zdravilo Efient, poskrbela, da bo v vseh državah članicah zdravnikom, ki bodo bolnike zdravili s tem zdravilom, na voljo izobraževalno gradivo.
A risk management plan has been developed to ensure that Efient is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Efient je bil pripravljen načrt obvladovanja tveganj.
This is a summary of the European public assessment report (EPAR) for Efient.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Efient.
The materials will include information on how to prescribe the medicine safely and to remind doctors that the medicine is not recommended for patients over the age of 75 years.
To bo vključevalo informacije o varnem predpisovanju zdravila in opozorilo zdravnikom, da uporaba zdravila pri bolnikih, starejših od 75 let, ni priporočena.
What benefit has Efient shown during the studies?
Kakšne koristi je zdravilo Efient izkazalo med študijami?
For more information about treatment with Efient, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Efient preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The study involved almost 14,000 adults with acute coronary syndrome who were about to undergo percutaneous coronary intervention.
Študija je vključevala skoraj 14 000 odraslih z akutnim koronarnim sindromom, ki so bili tik pred perkutano koronarno intervencijo.
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 Efient.
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.
At the end of the study, 9% of the patients taking Efient had died from cardiovascular causes or had a heart attack or stroke (643 out of 6,813) compared with 11% of the patients taking clopidogrel (781 out of 6,795).
Ob koncu študije je 9 % (643 od 6 813) bolnikov, ki so jemali zdravilo Efient, umrlo zaradi srčnožilnih vzrokov ali doživelo srčni infarkt ali kap v primerjavi z 11 % (781 od 6 795) bolnikov, ki so jemali klopidogrel.
Efient treatment starts with one 60-mg dose.
Zdravljenje z zdravilom Efient se začne z enim 60-miligramskim odmerkom.
What is the risk associated with Efient?
Kakšna tveganja so povezana z zdravilom Efient?
The Committee recommended that Efient be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Efient izda dovoljenje za promet.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Efient, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Efient is a medicine that contains the active substance prasugrel.
Efient je zdravilo, ki vsebuje zdravilno učinkovino prasugrel.
Why has Efient been approved?
Zakaj je bilo zdravilo Efient odobreno?
The most common side effects with Efient (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), haematoma (a collection of blood under the skin or in a muscle), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), rash, haematuria (blood in the urine), bleeding from needle puncture sites, haematoma at puncture sites and bruising.
Najpogostejši neželeni učinki zdravila Efient (opaženi pri 1 do 10 bolnikih od 100) so anemija (nizko število rdečih krvnih celic), hematom (skupek krvi pod kožo ali v mišici), epistaksa (krvavitev iz nosu), gastrointestinalna krvavitev (krvavitev v želodcu ali črevesju), izpuščaj, hematurija (kri v urinu), krvavitev iz mest vboda igle, hematom na mestih vboda in modrice.
Efient was more effective than clopidogrel at reducing the total number of cardiovascular deaths, heart attacks or strokes.
Zdravilo Efient je bilo učinkovitejše od klopidogrela pri zmanjšanju skupnega števila srčnožilnih smrti, srčnih infarktov in kapi.
The main measure of effectiveness was the reduction in the total number of cardiovascular deaths (deaths due to problems in the heart or blood vessels), heart attacks or strokes.
Glavno merilo učinkovitosti je bilo zmanjšanje skupnega števila srčnožilnih smrti (smrti zaradi težav s srcem ali krvnimi žilami), srčnih infarktov ali kapi.
In one main study Efient, given as a 60-mg starting dose followed by 10-mg ‘maintenance' doses, was compared with clopidogrel (another inhibitor of platelet aggregation), both medicines taken in combination with aspirin.
V eni glavni študiji so zdravilo Efient, ki so ga dajali v začetnem odmerku 60 mg, čemur so mu sledili „vzdrževalni“ odmerki po 10 mg, primerjali s klopidogrelom (drugim zaviralcem agregacije trombocitov), pri čemer so obe zdravili uporabljali v kombinaciji z aspirinom.
In this case, the 5-mg daily dose should be used following a 60-mg starting dose.
V tem primeru se mora po 60-miligramskem začetnem odmerku uporabljati 5-miligramski dnevni odmerek.
Efient must not be used in patients who have a condition that causes excessive bleeding, who have had a stroke or transient ischaemic attack (a temporary reduction in the blood supply to part of the brain), or with severe liver problems.
Zdravila Efient ne smejo uporabljati bolniki z obolenjem, ki povzroča prekomerno krvavitev, bolniki, ki so doživeli kap ali tranzitorno ishemično atako (prehodno zmanjšan dotok krvi v delu možganov) ali imajo hude težave z jetri.
Efient is taken together with aspirin to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) in patients with acute coronary syndrome who are undergoing percutaneous coronary intervention.
Zdravilo Efient se jemlje sočasno z aspirinom za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročijo krvni strdki in zatrditev arterij) pri bolnikih z akutnim koronarnim sindromom, ki so imeli perkutano koronarno intervencijo.
This is then followed by 10 mg taken once a day, except in patients weighing less than 60 kg, who should take 5 mg once a day.
Temu sledi 10-miligramski odmerek enkrat na dan, razen pri bolnikih, ki tehtajo manj kot 60 kg, ki morajo vzeti 5 mg enkrat na dan. Bolniki, ki jemljejo zdravilo Efient, morajo prav tako jemati aspirin, in sicer v odmerku, ki jim ga je predpisal zdravnik.
For the full list of all side effects reported with Efient, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Efient, glejte navodilo za uporabo.
The CHMP decided that Efient's benefits are greater than its risks, when given together with aspirin, for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing primary or delayed percutaneous coronary intervention.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Efient ob sočasni uporabi z aspirinom za preprečevanje aterotrombotičnih dogodkov pri bolnikih z akutnim koronarnim sindromom, ki so imeli primarno ali odloženo perkutano intervencijo, večje od z njim povezanih tveganj.
How has Efient been studied?
Kako je bilo zdravilo Efient raziskano?
The active substance in Efient, prasugrel, is an inhibitor of platelet aggregation.
Zdravilna učinkovina zdravila Efient, prasugrel, je zaviralec agregacije trombocitov.
When the blood clots, this is due to special cells in the blood, the platelets, sticking together (aggregating).
Strjevanje krvi je posledica zlepljanja (agregacije) posebnih celic v krvi, imenovanih trombociti.
What is Efient used for?
Za kaj se zdravilo Efient uporablja?
What is Efient?
Kaj je zdravilo Efient?
How is Efient used?
Kako se zdravilo Efient uporablja?
How does Efient work?
Kako zdravilo Efient deluje?
Prasugrel stops the platelets aggregating by blocking a substance called ADP from binding to a receptor on their surface.
Prasugrel z zaviranjem vezave snovi, imenovane ADP (adenozin difosfat), na receptor na površini trombocitov prepreči njihovo agregacijo.
These changes were reversible.
Te spremembe so bile reverzibilne.
The cycles are repeated.
Cikli se ponavljajo.
Wear loose clothing to protect the skin.
Nosite ohlapna oblačila, da zaščitite kožo.
Even if you do not feel hungry, continue to eat as much as you can to maintain good nutrition.
Čeprav niste lačni, jejte kolikor morete, da ohranite ustrezno hranilno vrednost.
Your doctor will tell you what dose you need to take, when to take it and for how long you need to take it.
Vaš zdravnik vam bo povedal, kakšen odmerek morate vzeti, kdaj ga morate vzeti in koliko časa ga morate jemati.
Calculate BSA to 2 decimal places.
Izračunajte BSA na 2 decimalni mesti.
Rare / Very rare
Redki/zelo redki
Microsatellite instability (MSI)
Mikrosatelitska nestabilnost (MSI)
This treatment cycle is repeated every 4 weeks.
Ta cikel zdravljenja se ponovi vsake 4 tedne.
Brush your teeth and blow your nose gently.
Nežno si umivajte zobe in lahkotno se useknite.
This 28 day period is one treatment cycle.
To 28-dnevno obdobje pomeni en cikel zdravljenja.
All studies were performed in cancer patients.
Vse študije so izvedli z bolniki z rakom.
The dose should be modified as recommended in section 4.2.
Odmerek je treba prilagoditi, kot je priporočeno v poglavju 4.2.
Genetic counseling should be considered.
Priporoča se genetsko svetovanje.
At the time of primary analysis, the median follow-up for overall survival in the full analysis set was 18.3 months.
Ob izvedbi primarne analize je mediana spremljanja glede celokupnega preživetja pri celotni skupini bolnikov znašala 18,3 meseca.
Patient characteristics are provided in Table 8.
Značilnosti bolnikov so navedene v Preglednici 8.
Teysuno must be taken twice daily (morning and evening).
Zdravilo Teysuno morate jemati dvakrat dnevno (zjutraj in zvečer).
No dose advice for this subpopulation can be provided.
Za odmerjanje v tej subpopulaciji ni mogoče dati navodil.
Each dose reduction results in approximately 20-25% reduction of dose.
Pri vsakem zmanjšanem odmerku se odmerek zmanjša za približno 20-25 %.
Black or African American Asian
Črnci ali Afroameričani Azijci
Treatment should not be resumed until dehydration and its underlying causes are corrected or adequately controlled.
Zdravljenje se ne sme ponovno uvesti, dokler dehidracija in njeni izvirni vzroki niso korigirani ali ustrezno nadzorovani.
During a 4-week cycle of treatment
Med 4-tedenskim ciklom zdravljenja
Dose modifications for toxicity should be made according to Tables 1, 3, 4, and 5.
Spremembe odmerkov zaradi toksičnosti morajo potekati skladno s Preglednicami 1, 3, 4 in 5.
Number of capsules for each dose (2 doses/day)
Število kapsul za vsak odmerek (2 odmerka/dan)
• Known dihydropyrimidine dehydrogenase (DPD) deficiency.
• Znano pomanjkanje dihidropirimidin dehidrogenaze (DPD).
Patients with renal impairment (see sections 4.2, 4.3, 4.4, and 5.2)
Bolniki z ledvično okvaro (glejte poglavja 4.2, 4.3, 4.4 in 5.2)
There were no clinically relevant differences in safety between males (N=382) and females (N=139) in the FLAGS study.
V študiji FLAGS ni bilo klinično pomembnih razlik glede varnosti med moškimi (N = 382) in ženskami (N = 139).
In addition, there is post-marketing experience in over 866,000 Asian (mainly Japanese) patients.
Poleg tega se upoštevajo izkušnje z zdravilom po začetku trženja pri več kot 866.000 azijskih (večinoma japonskih) bolnikih.
• At the request of the EMA
• na zahtevo Evropske agencije za zdravila;
126 capsules
126 kapsul
Teysuno capsules are usually taken for 21 days followed by a 7 day rest period (when no capsules are taken).
Teysuno kapsule se običajno jemljejo 21 dni, ki jim sledi 7-dnevni odmor (takrat se kapsule ne jemljejo).
Adjustments during treatment
Prilagoditve med zdravljenjem
Refer to “Dose modifications for special populations / Renal impairment for guidance.”
Za smernice si oglejte “Spremembe odmerkov za posebne populacije/Ledvična okvara”.
American Indian or Alaska Native Other
Ameriški Indijanci ali domorodci Aljaske
CYP2A6 inhibitors
Inhibitorji CYP2A6
Table 8: Demographics and baseline characteristics of patients in the FLAGS study
Preglednica 8: Demografske in izhodiščne značilnosti bolnikov v študiji FLAGS
- Weakness and fatigue, which could be side effects caused by other medicines.
- Oslabelost in utrujenost, ki sta lahko neželena učinka, povzročena z drugimi zdravili.
Millmount Healthcare Limited Block7, City North Business Campus, Stamullen Co. Meath, K32 YD60 Ireland
Millmount Healthcare Limited Block7, City North Business Campus, Stamullen Co. Meath, K32 YD60 Irska
In this study, antitumor activity was measured by best overall tumour response.
V tej študiji se je protitumorska učinkovitost merila z najboljšim skupnim odzivom tumorja.
Elderly (see section 4.2)
Starejši (glejte poglavje 4.2)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 March 2011
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 14. marec 2011 Datum zadnjega podaljšanja: 19. november 2015