natgillin/translations-raw huggingface dataset:
These enzymes can be found in some receptors on the surface of cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Ti encimi se nahajajo na nekaterih receptorjih na površini rakavih celic, med drugim tudi na receptorjih, ki pospešujejo nenadzorovano deljenje celic.
In the non-comparative studies of CML, Ph+ ALL and GIST, between 26 and 96% of patients showed a response to Glivec.
Pri neprimerjalnih študijah KML, Ph+ ALL in GIST je odziv na zdravljenje izkazalo med 26 in 96 % bolnikov.
In patients with CML, the cancer had got worse in 16% of the patients taking Glivec after five years, compared with 28% of those taking interferon alpha plus cytarabine.
Pri bolnikih s KML se je rak poslabšal pri 16 % bolnikov, ki so jemali zdravilo Glivec pet let, v primerjavi s 28 % tistih, ki so jemali kombinacijo interferona alfa in citarabina.
It is also used alone to treat adults with Ph+ ALL that has returned following previous treatment, or is not responding to other medicines.
Uporablja se tudi samostojno za zdravljenje odraslih s Ph+ ALL, ki se je po predhodnem zdravljenju ponovila, ali če ni odziva na druga zdravila.
Glivec treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood or solid tumours.
Zdravljenje z zdravilom Glivec lahko uvede le zdravnik, ki ima izkušnje z zdravljenjem bolnikov z krvnim rakom ali trdnimi tumorji.
This means that some of their genes have re-arranged themselves to form a special chromosome called the Philadelphia chromosome.
To pomeni, da je pri njih prišlo do prerazporeditve nekaterih genov, s čimer je nastal poseben kromosom, imenovan kromosom Philadelphia.
This study measured how long the patients lived without their cancer getting worse.
V študiji so opazovali, kako dolgo so bolniki živeli, ne da bi se bolezen poslabšala.
Glivec was also better than standard chemotherapy in patients with Ph+ ALL.
Zdravilo Glivec je bilo tudi boljše od standardne kemoterapije pri bolnikih s Ph+ ALL.
The active substance in Glivec, imatinib, is a protein-tyrosine kinase inhibitor.
Zdravilna učinkovina zdravila Glivec, imatinib, je zaviralec protein-tirozin-kinaze.
These included a study involving 1,106 adults that compared Glivec with the combination of interferon alpha plus cytarabine (other anticancer medicines).
Te študije so vključevale študijo s 1 106 odraslimi, v kateri so zdravilo Glivec primerjali s kombinacijo interferona alfa in citarabina (drugih zdravil proti raku).
For Ph+ ALL, Glivec has been examined in three studies involving 456 adults, including one study comparing Glivec with standard chemotherapy (medicines used to kill cancer cells) in 55 newly diagnosed patients.
Pri Ph+ ALL so zdravilo Glivec proučevali v treh študijah, ki so vključevale 456 odraslih, vključno z eno študijo, v kateri so ga primerjali s standardno kemoterapijo (zdravili, ki se uporabljajo za uničevanje rakavih celic) pri 55 bolnikih z na novo ugotovljeno boleznijo.
Glivec is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα;
Zdravilo Glivec se uporablja za zdravljenje odraslih s HES ali KEL, ki imajo specifično preureditev dveh genov, imenovanih FIP1L1 in PDGFRα.
Why has Glivec been approved?
Zakaj je bilo zdravilo Glivec odobreno?
Glivec is used in combination with other anticancer medicines in adults and children who have been newly diagnosed with Ph+ ALL.
Zdravilo Glivec se uporablja v kombinaciji z drugimi zdravili proti raku pri odraslih in otrocih, pri katerih je bila na novo ugotovljena Ph+ ALL.
In the study of patients aged 1 to 22 years who had Ph+ ALL, Glivec was shown to increase how long the patients lived without any major events (such as a relapse).
V študiji bolnikov s Ph+ ALL, starih od 1 so 22 let, se je izkazalo, da je zdravilo Glivec podaljšalo obdobje, v katerem pri bolnikih ni prišlo do večjih dogodkov (kot je recidiv).
For the full list of all side effects reported with Glivec, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Glivec, glejte navodilo za uporabo.
Glivec is used to treat adults with MD/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);
Zdravilo Glivec se uporablja za zdravljenje odraslih z MD/MPD, pri katerih se pojavljajo preureditve gena za receptor za rastni faktor iz trombocitov (PDGFR).
Glivec is a medicine that contains the active substance imatinib.
Glivec je zdravilo, ki vsebuje zdravilno učinkovino imatinib.
This study measured how long the patients lived without their cancer coming back.
V študiji so opazovali, kako dolgo so bolniki živeli, ne da bi se bolezen ponovila.
• myelodysplastic or myeloproliferative diseases (MD/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells.
• mielodisplastične ali mieloproliferativne bolezni (MD/MPD), tj. skupine bolezni, pri katerih telo proizvaja veliko število nenormalnih krvnih celic.
The other study compared Glivec with placebo (a dummy treatment) in 713 patients whose cancer had been removed with surgery.
V drugi študiji so primerjali zdravilo Glivec s placebom (zdravilom brez zdravilne učinkovine) pri 713 bolnikih, pri katerih je bil tumor kirurško odstranjen.
Glivec is used to treat adults with DFSP that cannot be removed with surgery, and in adults who are not eligible for surgery when the cancer has returned after treatment or has spread to other parts of the body.
Zdravilo Glivec se uporablja za zdravljenje odraslih z DFSP, ki ga ni mogoče kirurško odstraniti, in odraslih, ki niso primerni za operacijo, če se je rak po zdravljenju ponovil ali razširil v druge dele telesa.
• dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably.
• protuberantnega dermatofibrosarkoma (DFSP), tj. vrste raka (sarkoma), pri katerem se celice v tkivu pod kožo nenadzorovano delijo.
Glivec is used when the patients are ‘Philadelphia chromosome positive' (Ph+).
Zdravilo Glivec se uporablja pri bolnikih s kromosomom Philadelphia (Ph+).
In patients with GIST that had been removed with surgery, patients taking Glivec lived for longer than those taking placebo without their cancer coming back.
Pri bolnikih z GIST, ki je bil kirurško odstranjen, je pri tistih, ki so jemali zdravilo Glivec, trajalo dlje, da se je bolezen ponovila, kot pri tistih, ki so jemali placebo.
One involved 147 patients whose GIST could not be surgically removed or had spread to other parts of the body, and looked at whether the tumours shrank in size.
Ena je vključevala bolnike, pri katerih gastrointestinalnega stromalnega tumorja ni bilo mogoče kirurško odstraniti ali se je razširil na druge dele telesa, in je proučevala, ali se je tumor zmanjšal.
What is Glivec used for?
Za kaj se zdravilo Glivec uporablja?
• advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), diseases in which eosinophils (another type of white blood cell) start growing out of control.
• napredovalega hipereozinofilnega sindroma (HES) ali kronične eozinofilne levkemije (KEL), tj. bolezni, pri katerih eozinofili (druga vrsta belih krvničk) začnejo nenadzorovano rasti.
How does Glivec work?
Kako zdravilo Glivec deluje?
Glivec is used to treat adults with GIST that cannot be removed with surgery or have spread to other parts of the body, and adults who are at risk of GIST coming back after surgical removal;
Zdravilo Glivec se uporablja za zdravljenje odraslih z GIST, ki ga ni mogoče kirurško odstraniti ali ki se je razširil v druge dele telesa, in odraslih, pri katerih obstaja tveganje za ponovitev GIST po kirurški odstranitvi.
• gastrointestinal stromal tumours (GIST), a type of cancer (sarcoma) of the stomach and bowel, when there is uncontrolled growth of cells in the supporting tissues of these organs.
• gastrointestinalnega stromalnega tumorja (GIST), vrste raka (sarkom) želodca in črevesja, kadar celice v opornem tkivu teh organov nenadzorovano rastejo.
• Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly.
• akutne limfoblastne levkemije (ALL) s prisotnim kromosomom Philadelphia (Ph+), tj. vrste raka, pri kateri se limfociti (druga vrsta belih krvničk) množijo prehitro.
What is Glivec?
Kaj je zdravilo Glivec?
Glivec is used in adults and children who have been newly diagnosed with Ph+ CML and who are not eligible for a bone marrow transplant.
Zdravilo Glivec se uporablja pri odraslih in otrocih z na novo ugotovljeno KML s kromosomom Philadelphia, pri katerih presaditev kostnega mozga ne pride v poštev.
• chronic myeloid leukaemia (CML), a cancer of the white blood cells in which granulocytes (a type of white blood cell) start growing out of control.
• kronične mieloidne levkemije (KML), tj. raka belih krvnih telesc, pri katerem granulociti (vrsta belih krvnih telesc) začnejo nenadzorovano rasti.
How has Glivec been studied?
Kako je bilo zdravilo Glivec raziskano?
How is Glivec used?
Kako se zdravilo Glivec uporablja?
Treatment cycles may be repeated for as long as the patient benefits.
Cikluse zdravljenja je mogoče ponavljati, dokler ima bolnik od njih koristi.
In both studies, the majority of patients were adults.
V obeh študijah so v glavnem sodelovali odrasli bolniki.
Systemic formulations of levofloxacin (such as tablets and solutions for infusion) have been authorised in the EU since the 1990s.
Formulacije levofloksacina za sistemsko uporabo (kot so tablete in raztopine za infundiranje) so v EU odobrene od devetdesetih let prejšnjega stoletja.
It must not be used in pregnant or breastfeeding women.
Zdravila ne smejo uporabljati nosečnice ali ženske, ki dojijo.
The European Commission granted a marketing authorisation valid throughout the European Union for Quinsair on 26 March 2015.
Evropska komisija je dovoljenje za promet z zdravilom Quinsair, veljavno po vsej Evropski uniji, izdala 26. marca 2015.
After 28 days of treatment, the patient stops treatment for 28 days, before starting another 28-day treatment.
Po 28 dneh zdravljenja bolnik to za 28 dni prekine, čemur ponovno sledi 28-dnevno zdravljenje.
This is a summary of the European public assessment report (EPAR) for Quinsair.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Quinsair.
The full EPAR and risk management plan summary for Quinsair 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 Quinsair sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Quinsair?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Quinsair?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Quinsair's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Quinsair večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Other information about Quinsair
Druge informacije o zdravilu Quinsair
In addition, the company that markets Quinsair will carry out a study to investigate the long-term safety of Quinsair when used in clinical practice in the European Union.
Poleg tega bo družba, ki trži zdravilo Quinsair, izvedla študijo, v kateri bodo raziskali njegovo dolgoročno varnost pri uporabi v klinični praksi v Evropski uniji.
Because levofloxacin has a potential risk on cartilage, the use of the product was not considered justified in adolescents.
Ker pri uporabi levofloksacina obstaja tveganje za učinke na hrustanec, je bilo ocenjeno, da njegova uporaba pri mladostnikih ni upravičena.
Levofloxacin is a well-known antibiotic.
Levofloksacin je dobro znan antibiotik.
The most common side effects with Quinsair are cough (seen in 54% of patients), dysgeusia (taste disturbances, 30%) and tiredness/weakness (25%).
Najpogostejši neželeni učinki zdravila Quinsair so kašelj (opažen pri 54 % bolnikov), disgevzija (motnje okušanja, pri 30 %) in utrujenost/šibkost (25 %).
A risk management plan has been developed to ensure that Quinsair is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Quinsair je bil pripravljen načrt obvladovanja tveganj.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Quinsair, 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.
The second study showed that Quinsair was at least as good as tobramycin at improving FEV1 following 1 to 3 treatment cycles.
Druga študija je pokazala, da je bilo zdravilo Quinsair vsaj tako učinkovito kot tobramicin pri izboljšanju FEV1 po enem do treh ciklusih zdravljenja.
The first study, which involved 330 patients, compared Quinsair with placebo (a dummy treatment), while the second, involving 282 patients, compared it with another inhaled antibiotic (tobramycin).
V prvi študiji, v kateri je sodelovalo 330 bolnikov, so zdravilo Quinsair primerjali s placebom (zdravilom brez zdravilne učinkovine), v drugi, v kateri je sodelovalo 282 bolnikov, pa so ga primerjali z drugim antibiotikov za inhaliranje (tobramicinom).
Following 28 days of treatment, the patients taking Quinsair had an improvement in FEV1 of 1.73%, while for patients taking placebo the improvement in FEV1 was of around 0.43%.
Po 28 dneh zdravljenja se je FEV1 pri bolnikih, ki so uporabljali zdravilo Quinsair, izboljšal za 1,73 %, pri bolnikih, ki so uporabljali placebo, pa za približno 0,43 %.
What benefits of Quinsair have been shown in studies?
Kakšne koristi je zdravilo Quinsair izkazalo v študijah?
What are the risks associated with Quinsair?
Kakšna tveganja so povezana z zdravilom Quinsair?
For more information about treatment with Quinsair, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Quinsair preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What is Quinsair and what is it used for?
Kaj je zdravilo Quinsair in za kaj se uporablja?
Why is Quinsair approved?
Zakaj je bilo zdravilo Quinsair odobreno?
Cystic fibrosis is an inherited disease in which there is an accumulation of thick mucus in the lungs that allows bacteria to grow more easily, causing infections.
Cistična fibroza je dedna bolezen, pri kateri se v pljučih kopiči gosta sluz, ki omogoča lažjo rast bakterij, kar povzroča okužbe.
Before using Quinsair, doctors should consider official guidance on the appropriate use of antibiotics.
Preden zdravnik predpiše zdravilo Quinsair, mora pretehtati njegovo uporabo glede na uradne smernice za ustrezno uporabo antibiotikov.
It works by blocking enzymes that P. aeruginosa bacteria use to make copies of their DNA during cell multiplication.
Deluje tako, da zavira encime, s pomočjo katerih bakterije P. aeruginosa med celičnim razmnoževanjem izdelajo kopije DNK.
For the full list of all side effects reported with Quinsair, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Quinsair, glejte navodilo za uporabo.
The active substance in Quinsair, levofloxacin, belongs to the group of antibiotics known as ‘fluoroquinolones'.
Zdravilna učinkovina v zdravilu Quinsair, levofloksacin, spada v skupino antibiotikov, imenovanih „fluorokinoloni“.
The CHMP considered that the modest improvement in FEV1 seen with Quinsair meant that it could help to meet the need for additional inhaled antibiotics to treat long-term P. aeruginosa infections in cystic fibrosis.
Menil je, da majhno izboljšanje FEV1, ki so ga opazili pri uporabi zdravila Quinsair, pomeni, da bi zdravilo lahko pomagalo izpolniti potrebe po dodatnih antibiotikih za inhaliranje za zdravljenje dolgotrajnih okužb z bakterijo P. aeruginosa pri bolnikih s cistično fibrozo.
For practical information about using Quinsair, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Quinsair naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
By doing this, it stops the bacteria that are causing the infection from growing and multiplying.
Tako ustavi rast in razmnoževanje bakterij, ki povzročajo okužbo.
Regarding safety, Quinsair was well tolerated with side effects similar to those of levofloxacin given systemically (throughout the body).
Kar zadeva varnost, so bolniki zdravilo Quinsair dobro prenašali, neželeni učinki pa so bili podobni neželenim učinkom levofloksacina za sistemsko uporabo (ki deluje na celotno telo).
However, the study failed to show that Quinsair is more effective than placebo at increasing the time it took before the patients had an exacerbation (flare-up) of their disease.
Na drugi strani v študiji niso uspeli dokazati, da je zdravilo Quinsair učinkovitejše od placeba pri podaljšanju časa do eksacerbacije (poslabšanja) bolezni pri bolnikih.
It is not intended to provide practical advice on how to use Quinsair.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Quinsair is an antibiotic used for treating long-term lung infection caused by the bacteria Pseudomonas aeruginosa in adults who have cystic fibrosis.
Zdravilo Quinsair je antibiotik, ki se uporablja za zdravljenje dolgotrajne okužbe pljuč z bakterijo Pseudomonas aeruginosa pri odraslih, ki imajo cistično fibrozo.
Quinsair must not be used in patients with epilepsy and those with a history of tendon disorders related to the use of fluoroquinolone antibiotics.
Zdravilo Quinsair se ne sme uporabljati pri bolnikih z epilepsijo in pri tistih, ki so že kdaj imeli težave s kitami, povezane z uporabo fluorokinolonskih antibiotikov.
Quinsair has been investigated in two main studies in patients who had cystic fibrosis with P. aeruginosa lung infection.
Zdravilo Quinsair so raziskali v dveh glavnih študijah, v katerih so sodelovali bolniki s cistično fibrozo in okužbo pljuč z bakterijo P. aeruginosa.
In the first study, Quinsair was shown to be better than placebo at improving the patients' forced expiratory volume in one second (FEV1), adjusted for the patient's age, height and sex. FEV1 is the most air a person can breathe out in one second.
Prva študija je pokazala, da je bilo zdravilo Quinsair boljše od placeba pri izboljšanju forsiranega ekspiracijskega volumna bolnikov v eni sekundi (FEV1), pri čemer so rezultate prilagodili glede na bolnikovo starost, višino in spol.
Quinsair is available as a nebuliser solution in single-dose containers called ‘ampoules'.
Zdravilo Quinsair je na voljo v obliki raztopine za nebulator v enoodmernih vsebnikih, imenovanih „ampule“.
Quinsair is inhaled using a device called Zirela nebuliser system, which converts the solution in the ampoule into a fine mist.
Zdravilo Quinsair se inhalira s pomočjo nebulatorskega sistema Zirela, ki raztopino v ampuli pretvori v fino meglico.
Quinsair contains the active substance levofloxacin.
Zdravilo Quinsair vsebuje zdravilno učinkovino levofloksacin.
How does Quinsair work?
Kako zdravilo Quinsair deluje?
How is Quinsair used?
Kako se zdravilo Quinsair uporablja?
Ref.: EMEA/CHMP/730064/2009
: EMA/730064/2009 EMEA/H/C/997
The main measure of effectiveness was the change in ‘clinical attachment level' (CAL) after 24 weeks.
Glavno merilo učinkovitosti je bila sprememba „klinične ravni pritrjenosti“ (CAL) po 24 tednih.
Questions and answers on the recommendation for the refusal of the marketing authorisation for Gemesis
Vprašanja in odgovori v zvezi s priporočilom za zavrnitev vloge za dovoljenje za promet z zdravilom Gemesis bekaplermin
The CHMP was also concerned about the level of product-related impurities present.
CHMP je bil zaskrbljen tudi zaradi ravni nečistot, prisotnih v izdelku.
The effects of Gemesis were first tested in experimental models before being studied in humans.
Učinki zdravila Gemesis so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
In one main study involving 180 adults with advanced periodontal disease, Gemesis was compared with the matrix alone.
V eni glavni študiji, v kateri je sodelovalo 180 odraslih z napredovalo periodontalno boleznijo so zdravilo Gemesis primerjali z matrico.
On 23 July 2009, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Gemesis, intended for bone and periodontal (around the teeth) regeneration in adults.
Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 23. julija 2009 priporočil zavrnitev vloge za dovoljenje za promet z zdravilom Gemesis, namenjenim kostni in periodontalni (področju okrog zob) regeneraciji pri odraslih.
Becaplermin is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human platelet-derived growth factor.
Bekaplermin se izdeluje z metodo, znano kot „tehnologija rekombinantne DNK“: izdela ga celica, ki je prejela gen (DNK), s katerim lahko tvori človeški rastni faktor iz trombocitov.
The company that applied for authorisation is BioMimetic Therapeutics Ltd.
Vlogo za dovoljenje je predložila družba BioMimetic Therapeutics Ltd.
What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Gemesis?
Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Gemesis?
Therefore, at that point in time, the CHMP was of the opinion that the benefits of Gemesis did not outweigh its risks.
Zato je bil CHMP v tem času mnenja, da koristi zdravila Gemesis ne presegajo z njim povezanih tveganj.
Growth factors are proteins that stimulate cells to multiply.
Rastni faktorji so beljakovine, ki spodbujajo razmnoževanje celic.
The CHMP was of the opinion that the main study failed to show that Gemesis was effective in treating periodontal defects.
CHMP je menil, da glavna študija ni dokazala učinkovitosti zdravila Gemesis pri zdravljenju periodontalnih težav.
The active substance in Gemesis, becaplermin, is a recombinant human platelet-derived growth factor (PDGF).
Zdravilna učinkovina v zdravilu Gemesis, bekaplermin, je rekombinantni človeški rastni faktor iz trombocitov (PDGH).
The CHMP refusal was confirmed after re-examination.
Zavrnitev je bila po ponovni presoji mnenja potrjena.
The kit consists of a prefilled syringe containing the active substance becaplermin and a cup containing granules of β-tricalcium phosphate to be used as a matrix.
Sestavljen je iz prednapolnjene brizge, ki vsebuje zdravilno učinkovino bekaplermin, in skodelico z zrnci β-trikalcijevega fosfata, ki se uporablja kot matrica.
What was Gemesis expected to be used for?
Za kaj naj bi se zdravilo Gemesis uporabljalo?
What is Gemesis?
Kaj je zdravilo Gemesis?
CAL is a measure of the loss of support to the teeth from surrounding tissue.
CAL je merilo za izgubo opore, ki jo zobu ponuja tkivo, s katerim je obdan.
Becaplermin was expected to work in the same way as human platelet-derived growth factor, stimulating cell growth in the bone and gums around the teeth and helping tissue to heal.
Bekaplermin naj bi deloval enako kot človeški rastni faktor iz trombocitov, torej naj bi spodbujal rast celic v kosteh in dlesnih okoli zob in pospešil celjenje tkiva.
Hence, the CHMP recommended that Gemesis be refused marketing authorisation.
CHMP je zato priporočil zavrnitev dovoljenja za promet z zdravilom Gemesis.