natgillin/translations-raw huggingface dataset:
Cartons of 56 x 1 tablets; 7 blister cards of 8 x 1 tablets each in PVC/PVDC/Aluminium perforated unit dose blisters. 
Škatle s 56 x 1 tableto; 7 pretisnih omotov z 8 x 1 tableto, vsaka v perforiranem enoodmernem pretisnem omotu iz PVC/PVDC/aluminija.
MARKETING AUTHORISATION NUMBERS EU/1/06/369/011-016 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/06/369/011-016
Although not specifically studied with the Irbesartan Hydrochlorothiazide BMS, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide. 
Posebnih študij z zdravilom Irbesartan Hydrochlorothiazide BMS ni, kljub temu pa povratnega zvišanja krvnega tlaka pri bolnikih, ki so jemali bodisi irbesartan bodisi hidroklorotiazid, po prenehanju jemanja zdravila niso opazili.
INFORMATION IN BRAILLE Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg 
PODATKI V BRAILLOVI PISAVI Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg
Medicinal product subject to medical prescription 
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
The trough to peak effects measured by cuff during office visits were 68% and 76% for Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg and Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg, respectively. 
Pri merjenju z manšeto v ambulanti je bilo pri bolnikih, ki so jemali zdravilo Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg, to razmerje 68%, pri tistih, ki so dobivali zdravilo Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg, pa 76%.
INFORMATION IN BRAILLE Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg 
PODATKI V BRAILLOVI PISAVI Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg
Each film-coated tablet of Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide. 
Ena Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg filmsko obložena tableta vsebuje 300 mg irbesartana in 25 mg hidroklorotiazida.
Because no information is available regarding the use of Irbesartan Hydrochlorothiazide BMS during breast-feeding, Irbesartan Hydrochlorothiazide BMS is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant. 
Podatkov o uporabi zdravila Irbesartan Hydrochlorothiazide BMS med dojenjem ni na voljo, zato uporaba zdravila Irbesartan Hydrochlorothiazide BMS med dojenjem ni priporočljiva.
Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. 
Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. 
Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
Cartons of 84 film-coated tablets; 6 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters. 
Škatle s 84 filmsko obloženimi tabletami; 6 pretisnih omotov iz PVC/PVDC/aluminija s 14 filmsko obloženimi tabletami.
Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg. 
Zdravilo Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg je namenjeno bolnikom, pri katerih se krvni tlak med zdravljenjem s 300 mg irbesartana ali z zdravilom Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg ni dovolj znižal.
Elderly patients: no dosage adjustment of Irbesartan Hydrochlorothiazide BMS is necessary in elderly patients. 
Starostniki: pri starostnikih odmerka zdravila Irbesartan Hydrochlorothiazide BMS ni treba prilagajati.
Cartons of 98 tablets; 7 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters. 
Škatle z 98 tabletami; 7 pretisnih omotov iz PVC/PVDC/aluminija s 14 tabletami.
Cartons of 56 tablets; 4 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters. 
Škatle s 56 tabletami; 4 pretisni omoti iz PVC/PVDC/aluminija s 14 tabletami.
Cartons of 14 tablets; 1 blister card of 14 tablets in PVC/PVDC/Aluminium blisters. 
Škatle s 14 tabletami; 1 pretisni omot iz PVC/PVDC/aluminija s 14 tabletami.
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg film-coated tablets. 
IME ZDRAVILA Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg filmsko obložene tablete
Cartons of 28 tablets; 2 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters. 
Škatle z 28 tabletami; 2 pretisna omota iz PVC/PVDC/aluminija s 14 tabletami.
Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets. 
Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 56, 84 ali 98 filmsko obloženimi tabletami.
B. 
V
EU/1/06/369/017 - 14 tablets EU/1/06/369/018 - 28 tablets EU/1/06/369/019 - 56 tablets EU/1/06/369/020 - 56 x 1 tablets EU/1/06/369/021 - 84 tablets EU/1/06/369/022 - 98 tablets 
EU/1/06/369/017 - 14 tablet EU/1/06/369/018 - 28 tablet EU/1/06/369/019 - 56 tablet EU/1/06/369/020 - 56 x 1 tableta EU/1/06/369/021 - 84 tablet EU/1/06/369/022 - 98 tablet
Each tablet of Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide. 
Ena Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
Cartons of 28 film-coated tablets; 2 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters. 
Škatle z 28 filmsko obloženimi tabletami; 2 pretisna omota iz PVC/PVDC/aluminija s 14 filmsko obloženimi tabletami.
EU/1/06/369/011 - 14 tablets EU/1/06/369/012 - 28 tablets EU/1/06/369/013 - 56 tablets EU/1/06/369/014 - 56 x 1 tablets EU/1/06/369/015 - 84 tablets EU/1/06/369/016 - 98 tablets 
EU/1/06/369/011 - 14 tablet EU/1/06/369/012 - 28 tablet EU/1/06/369/013 - 56 tablet EU/1/06/369/014 - 56 x 1 tableta EU/1/06/369/015 - 84 tablet EU/1/06/369/016 - 98 tablet
Cartons of 56 film-coated tablets; 4 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters. 
Škatle s 56 filmsko obloženimi tabletami; 4 pretisni omoti iz PVC/PVDC/aluminija s 14 filmsko obloženimi tabletami.
Each tablet of Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide. 
Ena Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
No dosage adjustment of Irbesartan Hydrochlorothiazide BMS is necessary in patients with mild to moderate hepatic impairment (see section 4.3). 
Pri bolnikih z blago do zmerno jetrno okvaro prilagoditev odmerka ni potrebna (glejte poglavje 4.3).
Cartons of 98 film-coated tablets; 7 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters. 
Škatle z 98 filmsko obloženimi tabletami; 7 pretisnih omotov iz PVC/PVDC/aluminija s 14 filmsko obloženimi tabletami.
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in Irbesartan Hydrochlorothiazide BMS, minimal or no effects were reported. 
Pri bolnikih, ki so jemali po 12,5 mg hidroklorotiazida, kolikor ga vsebuje zdravilo Irbesartan Hydrochlorothiazide BMS, je bil ta učinek zelo majhen ali pa ga sploh ni bilo.
EU/1/06/369/023 - 14 tablets EU/1/06/369/024 - 28 tablets EU/1/06/369/025 - 56 tablets EU/1/06/369/026 - 56 x 1 tablets EU/1/06/369/027 - 84 tablets EU/1/06/369/028 - 98 tablets 
EU/1/06/369/023 - 14 tablet EU/1/06/369/024 - 28 tablet EU/1/06/369/025 - 56 tablet EU/1/06/369/026 - 56 x 1 tableta EU/1/06/369/027 - 84 tablet EU/1/06/369/028 - 98 tablet
Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets. 
Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 56, 84 ali 98 filmsko obloženimi tabletami.
Cartons of 14 film-coated tablets; 1 blister card of 14 film-coated tablets in PVC/PVDC/Aluminium blisters. 
Škatle s 14 filmsko obloženimi tabletami; 1 pretisni omot iz PVC/PVDC/aluminija s 14 filmsko obloženimi tabletami.
Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg may be administered in patients insufficiently controlled by Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg. 
Zdravilo Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg je namenjeno bolnikom, pri katerih se krvni tlak med zdravljenjem z zdravilom Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg ni dovolj znižal.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg film-coated tablets. 
IME ZDRAVILA Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg filmsko obložene tablete
Dosage 
aritmija
EU/1/06/369/001 - 14 tablets EU/1/06/369/002 - 28 tablets EU/1/06/369/003 - 56 tablets EU/1/06/369/004 - 56 x 1 tablets EU/1/06/369/005 - 98 tablets 
EU/1/06/369/001 - 14 tablet EU/1/06/369/002 - 28 tablet EU/1/06/369/003 - 56 tablet EU/1/06/369/004 - 56 x 1 tableta EU/1/06/369/005 - 98 tablet
EU/1/06/369/006 - 14 tablets EU/1/06/369/007 - 28 tablets EU/1/06/369/008 - 56 tablets EU/1/06/369/009 - 56 x 1 tablets EU/1/06/369/010 - 98 tablets 
EU/1/06/369/006 - 14 tablet EU/1/06/369/007 - 28 tablet EU/1/06/369/008 - 56 tablet EU/1/06/369/009 - 56 x 1 tableta EU/1/06/369/010 - 98 tablet
Each film-coated tablet of Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide. 
Ena Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg filmsko obložena tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets. 
Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 56, 84 ali 98 filmsko obloženimi tabletami.
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg tablets. 
IME ZDRAVILA Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg tablete
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg tablets irbesartan/hydrochlorothiazide 
Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg tablete irbesartan/hidroklorotiazid
Irbesartan Hydrochlorothiazide BMS is for oral use. 
Zdravilo Irbesartan Hydrochlorothiazide BMS je potrebno zaužiti.
Each film-coated tablet of Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide. 
Ena Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg filmsko obložena tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg film-coated tablets. 
IME ZDRAVILA Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg filmsko obložene tablete
While this is not documented with Irbesartan Hydrochlorothiazide BMS, a similar effect should be anticipated. 
Podoben učinek bi lahko pričakovali pri zdravljenju z zdravilom Irbesartan Hydrochlorothiazide BMS, čeprav to pri zdravljenju z njim ni bilo dokazano.
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide 
Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg filmsko obložene tablete irbesartan/hidroklorotiazid
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg tablets. 
IME ZDRAVILA Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg tablete
Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; 
Kadar je klinično primerno, se lahko razmisli o prehodu iz monoterapije na kombinirano zdravljenje: Zdravilo Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg je namenjeno bolnikom, pri katerih se zvišan krvni tlak med zdravljenjem samo s hidroklorotiazidom ali samo s 150 mg irbesartana ni dovolj znižal.
Film-coating: 
ŠTEVILKA SERIJE Serija:
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide 
Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide 
Irbesartan Hydrochlorothiazide BMS 150 mg/12,5 mg tablete irbesartan/hidroklorotiazid
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide 
Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg tablete irbesartan/hidroklorotiazid
NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide 
Irbesartan Hydrochlorothiazide BMS 300 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
What Irbesartan Hydrochlorothiazide BMS looks like and contents of the pack Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg film-coated tablets are pink, biconvex, ovalshaped, with a heart debossed on one side and the number 2788 engraved on the other side. 
Izgled zdravila Irbesartan Hydrochlorothiazide BMS in vsebina pakiranja Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg filmsko obložene tablete so rožnate barve, bikonveksne in ovalne oblike.
BEFORE YOU TAKE IRBESARTAN HYDROCHLOROTHIAZIDE BMS 
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO IRBESARTAN HYDROCHLOROTHIAZIDE BMS
The European Commission granted a marketing authorisation valid throughout the EU for Biograstim to CT Arzneimittel GmbH on 15 September 2008. 
Evropska komisija je dovoljenje za promet z zdravilom Biograstim, veljavno po vsej Evropski uniji, odobrila družbi CT Arzneimittel GmbH dne 15. septembra 2008.
This means that Biograstim is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine'). 
To pomeni, da je zdravilo Biograstim podobno biološkemu zdravilu, ki je že odobreno v Evropski uniji (EU) in vsebujejo enako zdravilno učinkovino (t.i. „referenčno zdravilo“).
Other information about Biograstim: 
Druge informacije o zdravilu Biograstim:
The most common side effect with Biograstim (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones). 
Najpogostejši neželeni učinek zdravila Biograstim (opažen pri več kot 1 bolniku izmed 10) je mišičnoskeletna bolečina (bolečina v mišicah in kosteh).
During the first 21-day chemotherapy cycle, patients treated with either Biograstim or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo. 
Med prvim 21 dnevnim ciklom kemoterapije so imeli bolniki, zdravljeni bodisi z zdravilom Biograstim ali Neupogen, hudo netropenijo v povprečju 1,1 dan, v primerjavi s 3,8 dnevi pri tistih, ki so prejemali placebo.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) BIOGRASTIM EPAR summary for the public 
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) BIOGRASTIM Povzetek EPAR za javnost
Biograstim is used to stimulate the production of white blood cells in the following situations: 
Zdravilo Biograstim se uporablja za spodbujanje tvorbe belih krvničk v naslednjih primerih:
The active substance in Biograstim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF). 
Učinkovina v zdravilu Biograstim, filgrastim, je zelo podobna človeški beljakovini, imenovani granulocitne kolonije stimulirajoči faktor (granulocyte colony stimulating factor - G-CSF).
To study the safety of Biograstim, two further studies were carried out in patients with lung cancer and with non-Hodgkin's lymphoma. 
Za preučitev varnosti zdravila Biograstim sta bili izvedeni še dve študiji z bolniki s pljučnim rakom in z neHodgkinovim limfomom.
Other side effects may be seen in more than 1 patient in 10, depending on the condition that Biograstim is being used for. 
Pri več kot 1 bolniku izmed 10 se lahko pojavijo tudi drugi neželeni učinki, v odvisnosti od stanja, zaradi katerega se zdravilo Biograstim uporablja.
The Committee recommended that Biograstim be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Biograstim odobri dovoljenje za promet.
What benefit has Biograstim shown during the studies? 
Kakšne koristi je zdravilo Biograstim izkazalo med študijami?
The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Biograstim has been shown to have a comparable quality, safety and efficacy profile to Neupogen. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da je bilo v skladu z zahtevami Evropske unije dokazano, da ima zdravilo Biograstim podoben profil kakovosti, varnosti in učinkovitosti kot zdravilo Neupogen.
Biograstim is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately. 
Zdravilo Biograstim se običajno daje v specializiranem zdravstvenem centru, vendar pa si ga lahko bolniki, ki ga prejemajo s podkožno injekcijo, dajejo tudi sami, pod pogojem, da so bili ustrezno usposobljeni.
Biograstim can also be used in patients who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow. 
Zdravilo Biograstim se lahko uporablja tudi pri bolnikih, ki bi naj darovali matične celice za presaditev, za sproščanje teh celic iz kostnega mozga.
Biograstim should not be used in people who may be hypersensitive (allergic) to filgrastim or any of the other ingredients. 
Zdravila Rebetol se ne sme uporabljati pri ljudeh, ki utegnejo biti preobčutljivi za (alergični na) filgrastim ali katero koli drugo sestavino zdravila.
Treatment with Biograstim and Neupogen brought about similar reductions in duration of severe neutropenia. 
Zdravljenje z zdraviloma Biograstim in Neupogen je privedlo do podobnega skrajšanja trajanja hude nevtropenije.
Biograstim was compared to Neupogen and to placebo (a dummy treatment) in one main study involving 348 patients with breast cancer. 
Zdravilo Biograstim so primerjali z zdravilom Neupogen in placebom v eni glavni študiji, ki je vključevala 348 bolnikov z rakom dojke.
Biograstim is given by injection under the skin or infusion into a vein. 
Zdravilo Cepivo Biograstim se daje z injekcijo pod kožo ali infuzijo v veno.
What is the risk associated with Biograstim? 
Kakšna tveganja so povezana z zdravilom Biograstim?
For the full list of all side effects reported with Biograstim, see the Package Leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Biograstim, glejte navodilo za uporabo.
Biograstim is a solution for injection or for infusion (drip into a vein). 
Zdravilo Biograstim je raztopina za injiciranje ali infundiranje (dajanje v veno).
Why has Biograstim been approved? 
Zakaj je bilo zdravilo Biograstim odobreno?
Biograstim was studied to show that it is comparable to the reference medicine, Neupogen. 
Zdravilo Biograstim so preučevali, da bi dokazali, da je podobno referenčnemu zdravilu Neupogen.
Therefore, the effectiveness of Biograstim was shown to be equivalent to that of Neupogen. 
Tako je bilo dokazano, da je učinkovitost zdravila Biograstim ekvivalentna učinkovitosti zdravila Neupogen.
Therefore, the CHMP's view was that, as for Neupogen, the benefit outweighs the identified risk. 
Zaradi tega je CHMP menil, da so koristi zdravila Biograstim, tako kot pri zdravilu Neupogen, večje od znanih tveganj.
The full EPAR for Biograstim can be found here. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Biograstim je na voljo tukaj.
The reference medicine for Biograstim is Neupogen. 
Referenčno zdravilo za zdravilo Biograstim je zdravilo Neupogen.
What is Biograstim used for? 
Za kaj se zdravilo Biograstim uporablja?
Biograstim is a ‘biosimilar' medicine. 
Zdravilo Biograstim je podobno biološko zdravilo.
How has Biograstim been studied? 
Kako je bilo zdravilo Biograstim raziskano?
What is Biograstim? 
Kaj je zdravilo Biograstim?
How is Biograstim used? 
Kako se zdravilo Biograstim uporablja?
How does Biograstim work? 
Kako zdravilo Biograstim deluje?
It is especially important to tell your doctor if you are taking: 
Še posebej pomembno je, da obvestite svojega zdravnika, če jemljete:
Comparison between formulations 
Primerjava med formulacijama
> 8 × ULN 
> 8 × ZMN
5 years 
5 leta.
EXP {MM/YYYY} Use within 30 days after the first opening 
EXP {MM/LLLL} Uporabite v 30 dneh po prvem odprtju.
Your name: __________________________________________________ Prescribing doctor: ________________________________________ If you have questions about Tracleer ask your doctor. 
Vaše ime: __________________________________________________ Zdravnik, ki je zdravilo predpisal: _______________________________ Če imate kakšna vprašanja o zdravilu Tracleer, se posvetujte z zdravnikom.
Date of first authorisation: 15 May 2002 Date of latest renewal: 20 April 2012 
Datum zadnjega podaljšanja: 20. april 2012
This patient recovered within the 60-day follow-up period. 
Ta bolnik je v 60-dnevnem obdobju spremljanja okreval.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 
Obvestite svojega zdravnika ali farmacevta, če jemljete, ali ste pred kratkim jemali katerokoli zdravilo, vključno z zdravili, ki ste jih dobili brez recepta.
This lowers the blood pressure and relieves the symptoms. 
S tem se zniža krvni tlak in lajšajo simptomi.
Based on these findings and preclinical data, it cannot be excluded that bosentan may have a detrimental effect on spermatogenesis in men. 
Na podlagi teh ugotovitev in predkliničnih podatkov, ni mogoče izključiti možnosti, da ima lahko bosentan škodljiv učinek na spermatogenezo pri moških.
56 dispersible tablets (14 x 4) 
56 disperzibilnih tablet (14 × 4)
If you suspect you may be pregnant, tell your doctor or gynaecologist. 
Če sumite, da ste morda noseči, to povejte svojemu zdravniku ali ginekologu.
Thus its use in adults should be reserved for patients who cannot take the film-coated tablet. 
Zato je uporaba pri odraslih pridržana bolnikom, ki ne morejo zaužiti filmsko obložene tablete.
Important Safety Alerts for Patients taking Tracleer (bosentan) 
Pomembna varnostna opozorila za bolnike, ki jemljejo zdravilo Tracleer (bosentan)
Use enough water to cover the whole tablet. 
Uporabite dovolj vode, da prekrije celo tableto.
No If Yes, write the names of these here: 
Ne Če ste odgovorili z Da, napišite, kaj uporabljate:
However, some patients who show no response after 8 weeks of treatment with Tracleer may respond favourably after an additional 4 to 8 weeks of treatment. 
Nekateri bolniki, ki po 8 tednih zdravljenja z zdravilom Tracleer ne pokažejo nobenega odziva, se lahko ugodno odzovejo po dodatnih 4 ali 8 tednih zdravljenja.
If you notice any of these signs tell your doctor immediately. 
Če opazite katerega od teh znakov, nemudoma obvestite svojega zdravnika.
In the event of late clinical deterioration despite treatment with Tracleer (i.e., after several months of treatment), the treatment should be re-assessed. 
V primeru kasnejšega poslabšanja kliničnega stanja kljub zdravljenju z zdravilom Tracleer (tj. po nekaj mesecih zdravljenja) je treba zdravljenje ponovno oceniti.
We suggest you write the date of your most recent test and also of your next test (ask your doctor for the date) on the Patient Alert Card, to help you remember when your next test is due. 
Predlagamo, da si datum zadnje in naslednje preiskave (svojega zdravnika prosite za datum) zapišete na Opozorilno kartico za bolnika, da si boste lažje zapomnili, kdaj imate naslednjo preiskavo.