natgillin/translations-raw huggingface dataset:
The follitropin alfa in Bemfola, as well as in the reference product GONAL-f, is produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced, which makes them able to produce human FSH.
Folitropin alfa v zdravilu Bemfola in referenčnem zdravilu GONAL-f pa proizvajajo z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri so v celice vstavili gen (DNK), s katerim lahko te tvorijo humani FSH.
Bemfola is given to stimulate the ovaries to produce more than one egg at a time;
Zdravilo Bemfola se daje za spodbujanje jajčnikov k proizvodnji več kot enega jajčeca naenkrat;
Bemfola has been shown to be comparable to the reference medicine, GONAL-f.
Zdravilo Bemfola se je izkazalo za primerljivo z referenčnim zdravilom GONAL-f.
The active substance in Bemfola, follitropin alfa, is a copy of the natural hormone FSH.
Zdravilna učinkovina v zdravilu Bemfola, folitropin alfa, je kopija naravnega hormona FSH.
Bemfola must not be used in people who are hypersensitive (allergic) to follitropin alfa, FSH, or any of the other ingredients.
Zdravila Bemfola ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) folitropin alfa, FSH ali katero koli drugo sestavino zdravila.
For practical information about using Bemfola, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Bemfola naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
In the body, FSH controls reproductive function: in women, it stimulates the production of eggs in the ovaries; in men, it stimulates the production of sperm in the testicles.
Hormon FSH v telesu nadzoruje funkcijo reprodukcije: pri ženskah spodbuja nastajanje jajčec v jajčnikih, pri moških pa nastajanje semenčic v modih.
It must not be used in patients with tumours of the pituitary gland or hypothalamus, or cancer of the breast, womb or ovary.
Prav tako se ne sme uporabljati pri bolnikih s tumorji hipofize ali hipotalamusa ali z rakom na dojkah, maternici ali jajčnikih.
Bemfola is a medicine that contains the active substance follitropin alfa.
Bemfola je zdravilo, ki vsebuje zdravilno učinkovino folitropin alfa.
In women, Bemfola must not be used when there is enlargement of an ovary or a cyst that is caused by something other than polycystic ovarian disease, or when there is unexplained bleeding from the vagina.
Pri ženskah se zdravilo Bemfola ne sme uporabljati ob povečanih jajčnikih ali prisotnosti cist, ki niso posledica sindroma policističnih jajčnikov, ali pri nepojasnjenem krvavenju iz nožnice.
Bemfola is used together with human chorionic gonadotrophin (hCG) therapy to stimulate sperm production.
Zdravilo Bemfola se uporablja skupaj z zdravljenjem s humanim horionskim gonadotropinom (hCG) za spodbujanje nastanka sperme.
Bemfola is available as a solution for injection in a prefilled pen.
Zdravilo Bemfola je na voljo v obliki raztopine za injiciranje v napolnjenem injekcijskem peresniku.
Therefore, the CHMP's view was that, as for GONAL-f, the benefits of Bemfola outweigh the identified risks.
Zato je menil, da njegove koristi enako kot pri zdravilu GONAL-f odtehtajo znana tveganja.
For the full list of all side effects reported with Bemfola, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Bemfola, glejte navodilo za uporabo.
Bemfola is given together with a medicine containing LH to stimulate the eggs to mature in the ovaries;
Zdravilo Bemfola se daje skupaj z zdravili, ki vsebujejo LH, kar spodbudi jajčeca, da dozorijo v jajčnikih;
In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also seen in more than 1 patient in 10.
Pri več kot 1 ženski od 10 so opazili tudi nastanek ovarijskih cist (vrečic s tekočino v jajčnikih) in glavobol.
Bemfola is a ‘biosimilar medicine'.
Zdravilo Bemfola je „podobno biološko zdravilo“.
How is Bemfola used?
Kako se zdravilo Bemfola uporablja?
The dose of Bemfola and how often it is given depend on why it is being used and on the patient's response to treatment.
Zdravilo Bemfola se daje z injekcijo pod kožo enkrat na dan. Odmerek zdravila Bemfola in pogostost odmerjanja sta odvisna od razloga za uporabo in od bolnikovega odziva na zdravljenje.
For more information, please see the package leaflet.
Za več informacij glejte navodilo za uporabo.
How does Bemfola work?
Kako zdravilo Bemfola deluje?
It is available as ‘orodispersible' tablets (5, 10, 15 and 20 mg).
Na voljo je v obliki orodisperzibilnih tablet (5, 10, 15 in 20 mg).
Patients over 65 years of age and patients who have reduced liver or kidney function may need a lower starting dose of 5 mg per day.
Bolniki, starejši od 65 let, in bolniki z zmanjšanim delovanjem jeter ali ledvic bodo morda potrebovali nižji začetni odmerek, in sicer 5 mg na dan.
Three studies were also carried to show that, when taken by mouth, the two medicines produce equivalent levels of olanzapine in the blood.
Opravljene so bile tudi tri študije, ki so pokazale, da obe zdravili pri peroralnem jemanju dosegata enake ravni olanzapina v krvi.
The full EPAR for Zyprexa Velotab 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 Zyprexa Velotab je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Zyprexa Velotab is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Zdravilo Zyprexa Velotab je prav tako učinkovito pri vzdrževanju izboljšanja stanja pri bolnikih, ki so se odzvali na začetno zdravljenje.
For more information about treatment with Zyprexa Velotab, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Zyprexa Velotab preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The European Commission granted a marketing authorisation valid throughout the European Union for Zyprexa Velotab on 3 February 2000.
Evropska komisija je dovoljenje za promet z zdravilom Zyprexa Velotab, veljavno po vsej Evropski uniji, odobrila dne 3. februarja 2000.
This is a summary of the European public assessment report (EPAR) for Zyprexa Velotab.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zyprexa Velotab.
Zyprexa Velotab contains the same active substance as another medicine called Zyprexa that has been authorised in the European Union (EU) since 1996.
Zdravilo Zyprexa Velotab vsebuje enako zdravilno učinkovino kot zdravilo Zyprexa, ki je v Evropski uniji (EU) odobreno že od leta 1996.
Zyprexa Velotab must not be used in people who are hypersensitive (allergic) to olanzapine or any of the other ingredients.
Zdravila Zyprexa Velotab ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) olanzapin ali katero koli drugo sestavino zdravila.
The most common side effects with Zyprexa Velotab (seen in more than 1 patient in 10) are somnolence (sleepiness), weight gain, orthostatic hypotension (sudden drop in blood pressure on standing up) and raised levels of prolactin (a hormone).
Najpogostejši neželeni učinki zdravila Zyprexa Velotab (opaženi pri več kot 1 od 10 bolnikov) so somnolenca (zaspanost), povečanje telesne mase, ortostatska hipotenzija (nenaden padec krvnega tlaka v stoječem položaju) in zvišane koncentracije prolaktina (hormona).
Because of this, the studies done with Zyprexa were used to support the use of Zyprexa Velotab.
Zato tega so bile študije, opravljene v zvezi z zdravilom Zyprexa, uporabljene tudi v podporo uporabi zdravila Zyprexa Velotab.
The recommended starting dose of Zyprexa Velotab depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Priporočeni začetni odmerek zdravila Zyprexa Velotab je odvisen od bolezni, ki jo zdravimo: pri shizofreniji in za preprečevanje maničnih epizod se uporablja 10-miligramski odmerek na dan, pri zdravljenju maničnih epizod pa se uporablja 15-miligramski odmerek na dan, razen ob souporabi drugih zdravil, ko lahko začetni odmerek znaša 10 mg na dan. Odmerek se prilagodi glede na to, kako se bolnik odziva na zdravljenje in kako ga prenaša.
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 Zyprexa Velotab.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Zyprexa Velotab, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The CHMP decided that Zyprexa Velotab's benefits are greater than its risks and recommended that Zyprexa Velotab be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Zyprexa Velotab večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Like Zyprexa, Zyprexa Velotab was more effective at improving symptoms than placebo (a dummy treatment).
Tako kot zdravilo Zyprexa se je tudi zdravilo Zyprexa Velotab pri izboljšanju simptomov izkazalo za učinkovitejšega kot placebo (zdravilo brez zdravilne učinkovine).
Zyprexa Velotab is used to treat adults with schizophrenia.
Zdravilo Zyprexa Velotab se uporablja za zdravljenje odraslih s shizofrenijo.
The active substance in Zyprexa Velotab, olanzapine, is an antipsychotic medicine.
Zdravilna učinkovina zdravila Zyprexa Velotab, olanzapin, je antipsihotično zdravilo.
Other information about Zyprexa Velotab
Druge informacije o zdravilu Zyprexa Velotab
Zyprexa Velotab was as effective as the medicines that it was compared with for the treatment of adults with schizophrenia, the treatment of moderate to severe manic episodes in adults, and the prevention of recurrence in adults with bipolar disorder.
Zdravilo Zyprexa Velotab je bilo pri zdravljenju shizofrenije, zdravljenju zmernih do težkih maničnih epizod pri odraslih in pri preprečevanju ponovitev epizod pri odraslih z bipolarno motnjo enako učinkovito kot zdravila, s katerimi so ga primerjali.
For the full list of all side effects reported with Zyprexa Velotab, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Zyprexa Velotab, glejte navodilo za uporabo.
What benefit has Zyprexa Velotab shown during the studies?
Kakšne koristi je zdravilo Zyprexa Velotab izkazalo med študijami?
Zyprexa Velotab is a medicine that contains the active substance olanzapine.
Zdravilo Zyprexa Velotab je zdravilo, ki vsebuje zdravilno učinkovino olanzapin.
The orodispersible tablets are taken by being placed on the tongue, where they disintegrate quickly in the saliva, or by mixing them in water before swallowing.
Običajni razpon odmerkov je od 5 do 20 mg na dan. Orodisperzibilne tablete se zaužije tako, da se jih položi na jezik, kjer jih slina hitro raztopi, ali tako, da se pred zaužitjem zmešajo z vodo.
What is the risk associated with Zyprexa Velotab?
Kakšna tveganja so povezana z zdravilom Zyprexa Velotab?
Zyprexa Velotab is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Zdravilo se uporablja tudi za zdravljenje zmernih do težkih maničnih epizod (izjemno privzdignjenega razpoloženja) pri odraslih.
Why has Zyprexa Velotab been approved?
Zakaj je bilo zdravilo Zyprexa Velotab odobreno?
How has Zyprexa Velotab been studied?
Kako je bilo zdravilo Zyprexa Velotab raziskano?
What is Zyprexa Velotab used for?
Za kaj je zdravilo Zyprexa Velotab uporablja?
What is Zyprexa Velotab?
Kaj je zdravilo Zyprexa Velotab?
How is Zyprexa Velotab used?
Kako se zdravilo Zyprexa Velotab uporablja?
How does Zyprexa Velotab work?
Kako zdravilo Zyprexa Velotab deluje?
However, all other concerns remain.
Vendar pa vsi ostali zadržki ostajajo.
The applicant requested a re-examination of the opinion.
Predlagatelj je zahteval ponovni pregled podanega mnenja.
There was also insufficient evidence of maintenance of the medicine's effects.
Poleg tega ni bilo dovolj dokazov o ohranjanju učinka zdravila.
International non-proprietary name (INN): natalizumab
Mednarodno nelastniško ime (INN): natalizumab
The balance of benefits and risks for TYSABRI remains unchanged.
Razmerje med koristmi in tveganji za zdravilo TYSABRI ostaja nespremenjeno.
The main measure of effectiveness was the proportion of patients whose symptoms improved after 10 weeks.
Glavno merilo učinkovitosti je bil delež bolnikov, pri katerih so se simptomi po 10 tednih izboljšali.
What is happening for TYSABRI for the treatment of multiple sclerosis?
Kaj se dogaja v zvezi z zdravilom TYSABRI za zdravljenje multiple skleroze?
The main measure of effectiveness was the proportion of patients maintaining a response over an additional nine months of treatment.
Glavno merilo učinkovitosti je bil delež bolnikov, ki so ohranili odziv v nadaljnjih devetih mesecih zdravljenja.
In November 2007, following the re-examination, the CHMP removed their concern regarding the effectiveness of the medicine in patients starting treatment.
Novembra 2007, po ponovnem pregledu, je CHMP umaknil svoje zadržke glede učinkovitosti zdravila pri bolnikih, ki so z zdravljenjem začeli.
It was to be used alone, or in combination with other medicines for Crohn's disease.
Zdravilo naj bi se uporabljalo samostojno ali v kombinaciji z drugimi zdravili za Crohnovo bolezen.
The company that applied for authorisation is Elan Pharma International Ltd.
Družba, ki je predložila vlogo za dovoljenje, je Elan Pharma International Ltd.
There are no consequences of this opinion on the use of TYSABRI, which also contains natalizumab, in its authorised indication.
To mnenje nima posledic za uporabo zdravila TYSABRI, ki prav tako vsebuje natalizumab, pri odobrenih indikacijah.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Monoklonsko protitelo je protitelo (vrsta beljakovine), ki je zasnovano za prepoznavanje in vezanje na določeno strukturo (imenovano antigen), ki jo najdemo na določenih celicah telesa.
It was to be used in patients who had an inadequate response to or could not take conventional treatments for the disease, and who have evidence of active inflammation.
Zdravilo naj bi se uporabljalo pri bolnikih, ki so imeli nezadosten odziv na običajna zdravila za to bolezen ali pa teh niso mogli jemati in ki so kazali znake aktivnega vnetja.
This was expected to prevent them from moving from the bloodstream into the gut wall, reducing the inflammation in the gut and improving the symptoms of Crohn's disease.
S tem naj bi se preprečilo premikanje teh celic iz krvi v steno črevesja, kar bi zmanjšalo vnetje črevesja in izboljšanje simptomov Crohnove bolezni.
Natalizumab has been designed to bind to specific types of integrin (α4β1 and α4β7 integrins), proteins found on the surface of most leucocytes (the white cells in the blood that are involved in the inflammation process).
Natalizumab je oblikovan za vezanje na točno določene vrste integrina (integrina α4β1 in α4β7), beljakovini, ki se nahajata na površini večine levkocitov (belih krvničk v krvi, ki sodelujejo v procesih vnetja).
QUESTIONS AND ANSWERS ON RECOMMENDATION FOR THE REFUSAL OF THE MARKETING AUTHORISATION for NATALIZUMAB ELAN PHARMA
VPRAŠANJA IN ODGOVORI GLEDE PRIPOROČILA ZA ZAVRNITEV VLOGE ZA DOVOLJENJE ZA PROMET z zdravilom NATALIZUMAB ELAN PHARMA
After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed their recommendation for the refusal of the marketing authorisation on 15 November 2007.
CHMP je pretehtal razloge za to zahtevo, nato je ponovno pregledal prvotno mnenje in dne 15. novembra 2007 potrdil priporočilo za zavrnitev vloge za dovoljenje za promet z zdravilom.
The active substance in Natalizumab Elan Pharma, natalizumab, has been available in the European Union for the treatment of multiple sclerosis since 2006 as TYSABRI.
Zdravilna učinkovina v zdravilu Natalizumab Elan Pharma, natalizumab, je v Evropski uniji za zdravljenje multiple skleroze na voljo od leta 2006 pod imenom TYSABRI.
The CHMP also had concerns over the safety of Natalizumab Elan Pharma in patients with Crohn's disease, because of a risk of serious infections, including the brain infection progressive multifocal leucoencephalopathy (PML).
CHMP je prav tako izrazil skrb glede varnosti zdravila Natalizumab Elan Pharma pri bolnikih s Crohnovo boleznijo zaradi tveganja hudih okužb, ki vključujejo možgansko okužbo, imenovano progresivna multifokalna levkoencefalopatija (PML).
In July 2007, the CHMP was concerned that there was insufficient evidence to show the effectiveness of Natalizumab Elan Pharma.
Julija 2007 je CHMP izrazil zaskrbljenost, da ni zadostnih dokazov, ki bi kazali na učinkovitost zdravila Natalizumab Elan Pharma.
The effects of Natalizumab Elan Pharma were first tested in experimental models before being studied in humans.
Učinki zdravila Natalizumab Elan Pharma so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The effects of Natalizumab Elan Pharma were tested in two main studies involving a total of 905 patients with moderate to severe Crohn's disease.
Učinke zdravila Natalizumab Elan Pharma so preučevali v dveh glavnih študijah, ki sta vključevali skupaj 905 bolnikov z zmerno do hudo Crohnovo boleznijo.
On 19 July 2007, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Natalizumab Elan Pharma concentrate for solution for infusion, intended for the treatment of Crohn's disease.
Dne 19 julija 2007 je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel negativno mnenje in priporočil zavrnitev dovoljenja za promet z zdravilom Natalizumab Elan Pharma, koncentratom za raztopino za infundiranje, ki je namenjen za zdravljenje Crohnove bolezni.
In the study of patients starting treatment with Natalizumab Elan Pharma, the effects of the medicine were modest.
V študiji pri bolnikih, ki so začeli svoje zdravljenje z zdravilom Natalizumab Elan Pharma, so bili učinki zdravila skromni.
By blocking the α4β7 integrin, natalizumab was expected to prevent the leucocytes from attaching to the surface of cells within the gut.
Natalizumab naj bi z zaviranjem integrina α4β7 preprečil vezanje levkocitov na površino celic v črevesju.
Natalizumab Elan Pharma is a concentrated solution that is diluted to make a solution for infusion (drip into a vein).
Zdravilo Natalizumab Elan Pharma je koncentrirana raztopina, ki se razredči za pripravo raztopine za infundiranje (vnašanje v veno po kapljicah).
What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Natalizumab Elan Pharma?
Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preizkušanjih zdravila/ programih sočutne uporabe z zdravilom Natalizumab Elan Pharma?
Therefore, at that point in time, the CHMP was of the opinion that the benefits of Natalizumab Elan Pharma in the treatment of Crohn's disease did not outweigh its risks.
CHMP je bil takrat mnenja, da koristi zdravila Natalizumab Elan Pharma pri zdravljenju Crohnove bolezni niso odtehtali z njim povezanih tveganj.
Natalizumab Elan Pharma was expected to be used to treat moderate to severe, active Crohn's disease, a disease causing inflammation of the gut.
Zdravilo Natalizumab Elan Pharma naj bi se uporabljalo za zdravljenje zmerne do hude, aktivne Crohnove bolezni, ki povzroča vnetje črevesja.
The active substance in Natalizumab Elan Pharma, natalizumab, is a monoclonal antibody.
Zdravilna učinkovina v zdravilu Natalizumab Elan Pharma, natalizumab, je monoklonsko protitelo.
The company informed the CHMP that there are no clinical trials or compassionate use programmes using Natalizumab Elan Pharma ongoing in the European Union for the treatment of Crohn's disease.
Podjetje je CHMP obvestilo, da trenutno ne poteka nobeno klinično preizkušanje ali program sočutne uporabe, v katerih bi se za zdravljenje Crohnove bolezni uporabljalo zdravilo Natalizumab Elan Pharma.
The 354 patients who responded to treatment with Natalizumab Elan Pharma then went on to enter the second study, in which the effects of Natalizumab Elan Pharma in maintaining the response to treatment were compared with those of placebo.
354 bolnikov, ki so se odzvali na zdravljenje z zdravilom Natalizumab Elan Pharma, je nato vstopilo v drugo študijo, v kateri so učinke zdravila Natalizumab Elan Pharma pri ohranjanju odziva na
The first study compared the effects of starting treatment with Natalizumab Elan Pharma with that of placebo (a dummy treatment) in all 905 patients.
V prvi študiji so učinke začetka zdravljenja z zdravilom Natalizumab Elan Pharma primerjali z učinki placeba (zdravila brez zdravilne učinkovine) pri vseh 905 bolnikih.
What is Natalizumab Elan Pharma?
Kaj je zdravilo Natalizumab Elan Pharma?
Hence, the CHMP recommended that Natalizumab Elan Pharma be refused marketing authorisation.
Zato je CHMP priporočil zavrnitev dovoljenja za promet z zdravilom Natalizumab Elan Pharma.
What was Natalizumab Elan Pharma expected to be used for?
Za kaj naj bi se zdravilo Natalizumab Elan Pharma uporabljalo?
How is Natalizumab Elan Pharma expected to work?
Kako naj bi zdravilo Natalizumab Elan Pharma delovalo?
It contains the active substance natalizumab.
Zdravilo vsebuje zdravilno učinkovino natalizumab.
The safety and efficacy of Velmetia in children and adolescents from birth to < 18 years of age have not been established.
Varnost in učinkovitost zdravila Velmetia pri otrocih in mladostnikih, od rojstva do starosti < 18 let, nista bili dokazani.
See section 2, Do not take Velmetia.
Glejte poglavje 2, Ne jemljite zdravila Velmetia.
If you stop taking Velmetia, your blood sugar may rise again.
Če prenehate jemati zdravilo Velmetia, se vam krvni sladkor lahko ponovno poviša.
Velmetia is contraindicated in patients with:
Zdravilo Velmetia je kontraindicirano pri:
If no adequate strength of Velmetia is available, individual monocomponents should be used instead of the fixed-dose combination.
Če ni na voljo ustrezne jakosti zdravila Velmetia, je treba namesto fiksne kombinacije uporabiti posamične monokomponente.
Do not take Velmetia: - if you are allergic to sitagliptin or metformin or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Velmetia: - če ste alergični na sitagliptin ali metformin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
What Velmetia is and what it is used for
Kaj je zdravilo Velmetia in za kaj ga uporabljamo
Velmetia must be discontinued at the time of surgery under general, spinal or epidural anaesthesia.
Uporabo zdravila Velmetia je treba v času kirurškega posega pod splošno, spinalno ali epiduralno anestezijo prekiniti.
The European Medicines Agency has waived the obligation to submit the results of studies with Velmetia in all subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Velmetia za vse podskupine pediatrične populacije za sladkorno bolezen tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
During treatment with Velmetia, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Med zdravljenjem z zdravilom Velmetia bo zdravnik vsaj enkrat letno preveril delovanje ledvic, če pa ste starejša oseba in/ali se vam delovanje ledvic slabša, pa še pogosteje.
Your doctor may ask you to stop Velmetia.
Zdravnik vam bo morda naročil, da prenehate z jemanjem zdravila Velmetia.