natgillin/translations-raw huggingface dataset:
A further study looked at the effect of CellCept oral suspension in 100 children following a kidney transplant.
V drugi študiji so opazovali učinke peroralne suspenzije zdravila CellCept pri 100 otrocih po presaditvi ledvic.
Women able to have children should be tested before starting treatment to ensure that they are not pregnant.
Ženske, ki lahko zanosijo, morajo pred začetkom zdravljenja opraviti test nosečnosti in se prepričati, da je negativen.
Following liver transplant, 38% of the adult patients taking CellCept had rejected their new liver after six months, compared with 48% of those taking azathioprine, but the proportion of patients who had lost their new liver after a year was similar in the two groups, at around 4%.
Po presaditvi jeter je po šestih mesecih pri 38 % odraslih bolnikov, ki so jemali zdravilo CellCept, prišlo do zavrnitve novih jeter, v primerjavi z 48 % tistih, ki so jemali azatioprin, vendar je bil delež bolnikov, pri katerih je prišlo do zavrnitve novih jeter po enem letu, podoben v obeh skupinah, kar je bilo približno 4 %.
In children undergoing kidney transplants, the rejection rates were similar to those seen in adults taking CellCept and lower than those seen in other studies of children who did not receive CellCept.
Pri otrocih, ki so prestali presaditev ledvic, je bil delež zavrnitev podoben deležu pri odraslih, ki so jemali zdravilo CellCept, in nižji od deleža v drugih študijah pri otrocih, ki zdravila niso prejemali.
It has been shown that there is a significant risk of harm to a developing baby and of miscarriage if CellCept is used in pregnancy.
Dokazano je bilo, da obstaja veliko tveganje za poškodbe še nerojenega otroka ali spontani splav, če se zdravilo jemlje med nosečnostjo.
In the body, it is converted into mycophenolic acid, which blocks an enzyme called ‘inosine monophosphate dehydrogenase'.
Zdravilo se v telesu pretvori v mikofenolno kislino, ki zavira encim inozin-monofosfat-dehidrogenaza.
What is the risk associated with CellCept?
Kakšna tveganja so povezana z zdravilom CellCept?
CellCept was as effective as azathioprine and more effective than placebo in preventing the rejection of transplanted kidneys after six months.
Zdravilo CellCept je bilo pri preprečevanju zavrnitve presajenih ledvic po šestih mesecih enako učinkovito kot azatioprin.
For kidney transplants, the recommended dose in adults is 1 g twice a day by mouth (capsules, tablets or oral suspension) starting within 72 hours after the transplant.
Pri presaditvi ledvic je priporočeni odmerek za odrasle 1 g dvakrat na dan peroralno (kapsule, tablete ali peroralna suspenzija), jemanje pa se uvede v 72 urah po presaditvi.
By preventing the production of new DNA, CellCept reduces the rate at which the lymphocytes multiply.
Zdravilo CellCept s preprečevanjem tvorjenja nove DNK zmanjša hitrost razmnoževanja limfocitov.
For heart transplants, the recommended adult dose is 1.5 g twice a day by mouth, starting within five days following the transplant.
Pri presaditvi srca je priporočeni odmerek za odrasle 1,5 g dvakrat na dan peroralno, zdravilo pa se začne jemati v petih dneh po presaditvi.
CellCept mycophenolate mofetil
CellCept mofetilmikofenolat
CellCept is a medicine containing the active substance mycophenolate mofetil.
CellCept je zdravilo, ki vsebuje zdravilno učinkovino mofetilmikofenolat.
Further studies showed that the solution for infusion and the oral suspension produced similar levels of the active substance in the blood as the capsules.
Nadaljnje študije so pokazale, da so bile ravni zdravilne učinkovine v krvi po uporabi raztopine za infundiranje ali peroralne suspenzije približno enake kot pri uporabi kapsul.
For liver transplants in adults, CellCept should be given as a 1-g infusion twice a day for the first four days after the transplant, before the patient is switched to 1.5 g twice a day by mouth as soon as it can be tolerated.
Pri presaditvi jeter pri odraslih je treba zdravilo CellCept prve štiri dni po presaditvi dajati kot 1-gramsko infuzijo dvakrat na dan, takoj ko je bolnik sposoben požirati, pa se preide na peroralno jemanje 1,5 g zdravila dvakrat na dan.
Why has CellCept been approved?
Zakaj je bilo zdravilo CellCept odobreno?
In the heart transplant study, around 38% of adult patients taking CellCept and those taking azathioprine experienced rejection after six months.
V študiji pri presaditvah srca je do zavrnitve organa po šestih mesecih prišlo pri približno 38 % odraslih bolnikov, ki so jemali zdravilo CellCept, in tistih, ki so jemali azatioprin.
For the full list of side effects reported with CellCept, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila CellCept, glejte navodilo za uporabo.
The active substance in CellCept, mycophenolate mofetil, is an immunosuppressive medicine.
Zdravilna učinkovina zdravila CellCept, mofetilmikofenolat, je zdravilo za zmanjšanje imunskega odziva.
For full details of the restrictions with CellCept, see the package leaflet.
Za celoten seznam omejitev pri uporabi zdravila CellCept glejte navodilo za uporabo.
What is CellCept used for?
Za kaj se zdravilo CellCept uporablja?
How has CellCept been studied?
Kako je bilo zdravilo CellCept raziskano?
What is CellCept?
Kaj je zdravilo CellCept?
How does CellCept work?
Kako zdravilo CellCept deluje?
How is CellCept used?
Kako se zdravilo CellCept uporablja?
Pack size
pprašek:
Invented name
Izmišljeno ime Jakost
Strength Pharmaceutical form
Farmacevtska oblika Pot uporabe Stična ovojnina
3.8 micrograms HA**
3,8 mikrogramov**
Suspension and emulsion for emulsion for injection
Suspenzija in emulzija za emulzijo za injiciranje
Split Influenza virus, inactivated, containing antigen* equivalent to: A/California/7/2009 (H1N1)-like strain (NYMC X-179A)
Razgrajen virus gripe*, inaktiviran, vsebuje antigene, ki ustrezajo naslednjim sevom: A/California/7/2009 (H1N1) podoben sevu (NYMC X-179A)
AF03 adjuvant composed of squalene (12.4 milligrams), sorbitan oleate (1.9 milligrams), polyoxyethylene cetostearyl ether (2.4 milligrams) and mannitol (2.3 milligrams)
Adjuvans AF03, ki ga sestavljajo skvalen (12,4 miligramov), sorbitan oleat (1,9 miligramov), polioksietilen cetostearil eter (2,4 miligramov) in manitol (2,3 miligramov).
10 vials (suspension)
10 vial (suspenzije)
After mixing, 1 dose (0.5 ml) contains:
Po premešanju 1 odmerek (0,5 ml) vsebuje:
Intramuscular use
Intramuskular na uporaba
Suspension (H1N1): vial (glass);
Suspenzija (H1N1): viala (steklo);
10 vials (emulsion)
10 vial (emulzije)
Emulsion (adjuvant): vial (glass)
Emulzija (adjuvant): viala (steklo)
* propagated in eggs ** haemagglutinin
razmnožen v jajcih ** izražen v mikrogramih hemaglutinina
Suspension: 1.5 ml Emulsion: 4.5 ml
Suspenzija: 1.5 ml
Content
o ā
Route of Administration
Način uporabe
This summary was last updated in 04-2014.
Povzetek je bil nazadnje posodobljen 04-2014.
It can also be used for the treatment of COPD.
Uporablja se lahko tudi za zdravljenje KOPB.
If patients need to take more than 8 inhalations per day, it is recommended they speak to their doctor to have their asthma therapy reconsidered.
Če bolniki potrebujejo več kot 8 vpihov na dan, je priporočljivo, da se posvetujejo s svojim zdravnikom, ki bo ponovno ocenil njihovo zdravljenje astme.
The full EPAR and risk management plan summary for BiResp Spiromax 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) in povzetek načrta obvladovanja tveganj za zdravilo BiResp Spiromax sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It is used for the treatment of asthma in adults for whom a combination product is considered appropriate.
Uporablja se za zdravljenje astme pri odraslih, za katere je primerna kombinacija zdravil.
Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids.
Budezonid spada v skupino protivnetnih zdravil, ki jih imenujemo kortikosteroidi.
COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing.
KOPB je dolgotrajna bolezen, pri kateri so dihalne poti in zračni mešički v pljučih poškodovani ali blokirani, zaradi česar je dihanje oteženo.
Formoterol is a long-acting beta-2 agonist.
Formoterol je dolgodelujoči agonist adrenergičnih receptorjev beta-2.
This is a summary of the European public assessment report (EPAR) for BiResp Spiromax.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo BiResp Spiromax.
It can be used in patients whose disease is not adequately controlled by treatment with other asthma medicines called corticosteroids and ‘short-acting beta-2 agonists' taken by inhalation, or in patients whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2 agonists' taken by inhalation.
Uporablja se lahko pri bolnikih, pri katerih bolezni ne moremo ustrezno nadzorovati z drugimi zdravili za astmo, imenovanimi inhalacijski kortikosteroidi in kratkodelujoči agonisti adrenergičnih receptorjev beta-2, ali pri katerih je bolezen že ustrezno nadzorovana z inhalacijskimi kortikosteroidi in dolgodelujočimi agonisti adrenergičnih receptorjev beta-2.
The European Commission granted a marketing authorisation valid throughout the European Union for BiResp Spiromax on 28 April 2014.
Evropska komisija je dovoljenje za promet z zdravilom BiResp Spiromax, veljavno po vsej Evropski uniji, odobrila 28. aprila 2014.
BiResp Spiromax is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare-ups) of the disease in the past despite regular treatment.
Zdravilo BiResp Spiromax se uporablja tudi za zdravljenje simptomov hude kronične obstruktivne pljučne bolezni (KOPB) pri odraslih s ponavljajočimi se poslabšanji simptomov bolezni v preteklosti kljub rednemu zdravljenju.
BiResp Spiromax budesonide / formoterol
BiResp Spiromax budezonid/formoterol
This means that it is similar to a ‘reference medicine' containing the same active substances, but BiResp Spiromax is given using a different inhaler.
To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje isti zdravilni učinkovini, vendar se zdravilo BiResp Spiromax uporablja z drugačnim inhalatorjem.
What measures are being taken to ensure the safe and effective use of BiResp Spiromax?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila BiResp Spiromax?
This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.
To povzroči zmanjšano sproščanje snovi, ki sodelujejo v vnetnih procesih, na primer histamina, kar pripomore k ohranjanju prehodnosti dihalnih poti in bolniku olajša dihanje.
Because BiResp Spiromax is a hybrid medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo BiResp Spiromax generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The company initially also applied for a lower strength of BiResp Spiromax, however bioequivalence to the reference product was not demonstrated and the application for this strength was withdrawn.
Prvotno je družba predložila tudi vlogo za manjšo jakost zdravila BiResp Spiromax, vendar biološka enakovrednost z referenčnim zdravilom ni bila dokazana, zato je bila vloga za to jakost umaknjena.
A risk management plan has been developed to ensure that BiResp Spiromax is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila BiResp Spiromax je bil pripravljen načrt obvladovanja tveganj.
It is available as an inhalation powder in a portable inhaler device, and each inhalation provides a fixed dose of the medicine.
Zdravilo je na voljo v obliki praška za inhaliranje v prenosnem pripomočku za inhaliranje, pri čemer se z vsako inhalacijo bolniku dovaja fiksni odmerek zdravila.
It works by attaching to receptors known as beta-2 receptors found in the muscles of the airways.
Deluje tako, da se veže na receptorje, imenovane adrenergični receptorji beta-2, ki jih najdemo v dihalnih mišicah.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for BiResp Spiromax, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila BiResp Spiromax in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell.
Deluje podobno kot kortikosteroidni hormoni, ki naravno nastajajo v telesu, pri čemer se veže na receptorje v različnih vrstah imunskih celic ter tako zmanjša dejavnost imunskega sistema.
The two active substances in BiResp Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Zdravilni učinkovini v zdravilu BiResp Spiromax sta dobro znani in sta prisotni v več zdravilih, ki se samostojno ali v kombinaciji z drugimi zdravili uporabljajo za zdravljenje astme in KOPB.
For more information about treatment with BiResp Spiromax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom BiResp Spiromax preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For the treatment of COPD, the recommended dose is 1 or 2 inhalations twice a day, depending on the strength being used.
Priporočeni odmerek za zdravljenje KOPB je 1 ali 2 vpiha dvakrat na dan, kar je odvisno od uporabljene jakosti.
As asthma reliever therapy, patients can take 1 or 2 additional inhalations of BiResp Spiromax 160/4.5 microgram only to relieve their symptoms.
Pri olajševalnem zdravljenju astme lahko bolniki uporabijo 1 ali 2 dodatna vpiha zdravila BiResp Spiromax 160/4,5 mikrogramov, vendar samo za lajšanje simptomov.
For the regular treatment of asthma, the recommended dose is 1 to 4 inhalations twice a day, depending on the strength being used and the severity of the asthma.
Priporočeni odmerek za redno zdravljenje astme je od 1 do 4 vpihi dvakrat na dan, kar je odvisno od uporabljene jakosti in izraženosti astme.
The higher strength, BiResp Spiromax 320/9 microgram (320 micrograms of budesonide and 9 micrograms of formoterol), can only be used for the regular treatment of asthma and for the treatment of COPD.
Večja jakost zdravila BiResp Spiromax 320/9 mikrogramov (320 mikrogramov budezonida in 9 mikrogramov formoterola) se sme uporabljati samo za redno zdravljenje astme in zdravljenje KOPB.
What are the benefits and risks of BiResp Spiromax?
Kakšne so koristi in tveganja, povezani z zdravilom BiResp Spiromax?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that BiResp Spiromax 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be bioequivalent to the corresponding strengths of Symbicort Turbohaler.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da ima zdravilo BiResp Spiromax v jakostih 160/4,5 mikrogramov in 320/9 mikrogramov primerljivo raven kakovosti kot zdravilo Symbicort Turbohaler ter da mu je biološko enakovredno pri ustrezajočih jakostih.
Other information about BiResp Spiromax
Druge informacije o zdravilu BiResp Spiromax
The reference medicine for BiResp Spiromax is Symbicort Turbohaler.
Referenčno zdravilo za zdravilo BiResp Spiromax je Symbicort Turbohaler.
For practical information about using BiResp Spiromax, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila BiResp Spiromax naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
What is BiResp Spiromax and what is it used for?
Kaj je zdravilo BiResp Spiromax in za kaj se uporablja?
BiResp Spiromax is a medicine that contains the active substances budesonide and formoterol.
BiResp Spiromax je zdravilo, ki vsebuje zdravilni učinkovini budezonid in formoterol.
It is not intended to provide practical advice on how to use BiResp Spiromax.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The Committee recommended that BiResp Spiromax be given marketing authorisation.
Priporočil je, da se za zdravilo BiResp Spiromax izda dovoljenje za promet.
BiResp Spiromax is a ‘hybrid medicine'.
BiResp Spiromax je hibridno zdravilo.
When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Formoterol z vezavo na omenjene receptorje sprošča mišice, kar razširi dihalne poti in bolniku olajša dihanje.
Therefore, the CHMP's view was that, as for Symbicort Turbohaler, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi enako kot pri zdravilu Symbicort Turbohaler odtehtajo znana tveganja.
160/4.5 microgram (160 micrograms of budesonide and 4.5 micrograms of formoterol) can be used for the regular treatment of asthma and when needed as a reliever.
Zdravilo BiResp Spiromax 160/4,5 mikrogramov (160 mikrogramov budezonida in 4,5 mikrograma formoterola) se lahko uporablja za redno zdravljenje astme in po potrebi tudi za olajševalno zdravljenje.
Why is BiResp Spiromax approved?
Zakaj je bilo zdravilo BiResp Spiromax odobreno?
Studies in patients have been limited to tests to determine that BiResp Spiromax is bioequivalent to the reference medicine, Symbicort Turbohaler.
Ker je zdravilo BiResp Spiromax generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Symbicort Turbohaler.
How has BiResp Spiromax been studied?
Kako je bilo zdravilo BiResp Spiromax raziskano?
How does BiResp Spiromax work?
Kako zdravilo BiResp Spiromax deluje?
How is BiResp Spiromax used?
Kako se zdravilo BiResp Spiromax uporablja?
London, 14 December 2006 Doc.
London, 14. december 2006 Sklic dok.
The company presented the results of 2 main studies including 1065 patients.
Podjetje je predložilo rezultate dveh glavnih raziskav, v katere je bilo vključenih 1065 bolnikov.
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Če ste vključeni v klinično preizkušanje in potrebujete več podatkov o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
The tablets contain 80 mg fenofibrate and 500 mg metformin, 80 mg fenofibrate and 850 mg metformin, or 54 mg fenofibrate and 850 mg metformin.
Tablete vsebujejo 80 mg fenofibrata in 500 mg metformina, 80 mg fenofibrata in 850 mg metformina ali 54 mg fenofibrata in 850 mg metformina.
The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Dopis podjetja, s katerim podjetje agencijo EMEA obvešča o umiku vloge, je na voljo tukaj.
This receptor is normally involved in controlling levels of fat in the body.
Ta receptor običajno sodeluje pri uravnavanju ravni maščobe v telesu.
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for SYNORDIA
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo SYNORDIA
Around half of the patients in this study had type 2 diabetes.
Približno polovica bolnikov v tej raziskavi je imela sladkorno bolezen tipa 2.
International non-proprietary name (INN): fenofibrate/metformin hydrochloride
Mednarodno nelastniško ime (INN): fenofibrat/metforminijev klorid
Fenofibrate can help to correct blood fat levels by activating a receptor within cells called ‘peroxisome proliferator activated receptor (PPAR) alpha'.
Fenofibrat lahko pomaga izravnati ravni maščobe v krvi, tako da aktivira receptor v celicah, imenovan »peroksisomski proliferator aktivirajočega receptorja (PPAR) alfa«.
It was hoped that this would make it easier for patients to stick to their treatment.
Cilj tega je bil, da se bolnikom olajša zdravljenje.
Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Ko podjetje pripravi odgovore na vprašanja, jih CHMP pregleda in pred izdajo mnenja lahko zaprosi podjetje še za odgovore na dodatna vprašanja (180. dan).
By activating this receptor, the medicine increases levels of HDL cholesterol and decreases levels of triglycerides and other types of fat.
Z aktiviranjem receptorja zdravilo poveča ravni HDL holesterola ter zmanjša ravni trigliceridov in drugih vrst maščob.
It was intended for use in patients who require both fenofibrate and metformin, and whose condition had already been stabilised by taking these two medicines separately.
Namenjeno naj bi bilo za uporabo pri bolnikih, ki potrebujejo fenofibrat in metformin in katerih stanje se je z ločenim jemanjem teh dveh zdravil že stabiliziralo.
On 7 December 2006, Fournier Laboratories Ireland Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a marketing authorisation for Synordia, for the improvement of glycaemic control and dyslipidaemia in patients with type 2 diabetes.
Podjetje Fournier Laboratories Ireland Ltd je 7. decembra 2006 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da se je odločilo umakniti vlogo za dovoljenje za promet z zdravilom Synordia, namenjenim za izboljšanje glikemičnega nadzora in dislipidemije pri bolnikih s sladkorno boleznijo tipa 2.
The main measure of effectiveness was the change in blood triglyceride levels after 12 weeks.
Glavno merilo učinkovitosti je bila sprememba ravni trigliceridov v krvi po 12 tednih.
What are the consequences of the withdrawal for patients undergoing clinical trials with Synordia?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih zdravila Synordia?
The CHMP was evaluating the initial documentation provided by the company and had not yet made any recommendations.
CHMP je bil v postopku ocenjevanja začetne dokumentacije, ki jo je posredovalo podjetje, in še ni podal nikakršnih priporočil.
Metformin reduces elevated blood glucose levels.
Metformin zniža zvišano raven glukoze v krvi.
It works mainly by inhibiting glucose production and reducing its absorption in the gut.
Učinkuje predvsem tako, da zavira nastajanje glukoze in zmanjšuje njeno absorpcijo v črevesju.
What documentation did the company present to support its application to the CHMP?
Katero dokumentacijo je podjetje predložilo CHMP v podporo svoji vlogi ?
The application was at day 113 when the company withdrew.
Podjetje je umaknilo vlogo na 113. dan.
The active substances in Synordia, fenofibrate and metformin, are both well-known medicines: fenofibrate is a serum lipid reducing agent that has been available in the European Union since 1975, and metformin hydrochloride is an anti-diabetic medicine that has been available since 1959.
Zdravilni učinkovini zdravila Synordia, fenofibrat in metformin, sta dobro znani zdravili: fenofibrat je učinkovina za zmanjšanje lipidov v serumu, ki je na voljo v Evropski uniji od leta 1975, metforminijev klorid pa je zdravilo za zdravljenje sladkorne bolezni, ki je na voljo od leta 1959.
Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Na podlagi pregleda začetne dokumentacije CHMP pripravi seznam vprašanj (120. dan), ki ga pošlje podjetju.
They are combined into one tablet in Synordia in order to reduce the number of tablets the patients need to take every day.
V zdravilu Synordia sta ti dve učinkovini združeni v eni tableti, s čimer se zmanjša število tablet, ki jih morajo vsakodnevno jemati bolniki.