natgillin/translations-raw huggingface dataset:
Excipient with known effect Each pre-filled syringe contains 0.45 mg phenylalanine.
Pomožne snovi z znanim učinkom Ena napolnjena injekcijska brizga vsebuje 0,45 mg fenilalanina.
Silapo 3 000 IU/0.9 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.9 ml solution for injection contains 3 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 3 000 i.e./0,9 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 0,9 ml raztopine za injiciranje vsebuje 3 000 mednarodnih enot (i.e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
Silapo 6 000 IU/0.6 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 6 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 6 000 i.e./0,6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 0,6 ml raztopine za injiciranje vsebuje 6 000 mednarodnih enot (i.e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
1 pre-filled syringe contains 1 000 IU Epoetin zeta
1 napolnjena ijekcijska brizga vsebuje 1 000 i.e. epoetin zeta
You may be given iron supplements before and during Silapo treatment to make it more effective.
Za učinkovitejše zdravljenje boste morda pred zdravljenjem z zdravilom Silapo in med njim prejemalo dodatek z železom.
Silapo 40 000 IU/1 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1 ml solution for injection contains 40 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 40 000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 1 ml raztopine za injiciranje vsebuje 40 000 mednarodnih enot (i.e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
Silapo 10 000 IU/1 ml solution for injection in pre-filled syringe 1 ml solution for injection in pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating.
Silapo 10 000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 ml raztopine za injiciranje v napolnjeni brizga iz stekla tipa I s fiksno jekleno iglo in zamaškom s teflonsko prevleko.
Epoetin alfa
Navodilo shranite.
Respiratory, thoracic and mediastinal disorders
Presnovne in prehranske motnje hiperkaliemija občasni
Excipient with known effect Each pre-filled syringe contains 0.40 mg phenylalanine.
Pomožne snovi z znanim učinkom Ena napolnjena injekcijska brizga vsebuje 0,40 mg fenilalanina.
Silapo 2 000 IU/0.6 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 2 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 2 000 i.e./0,6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 0,6 ml raztopine za injiciranje vsebuje 2 000 mednarodnih enot (i.e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
Excipient with known effect Each pre-filled syringe contains 0.15 mg phenylalanine.
Pomožne snovi z znanim učinkom Ena napolnjena injekcijska brizga vsebuje 0,15 mg fenilalanina.
Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe EU/1/07/432/001
Silapo 1 000 i.e./0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/07/432/001
Excipient with known effect Each pre-filled syringe contains 0.30 mg phenylalanine.
Pomožne snovi z znanim učinkom Ena napolnjena injekcijska brizga vsebuje 0,30 mg fenilalanina.
Silapo 2 000 IU/0.6 ml solution for injection in pre-filled syringe 0.6 ml solution for injection in pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating.
Silapo 2 000 i.e./0,6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 0,6 ml raztopine za injiciranje v napolnjeni brizga iz stekla tipa I s fiksno jekleno iglo in zamaškom s teflonsko prevleko.
Silapo 6 000 IU/0.6 ml solution for injection in pre-filled syringe 0.6 ml solution for injection in pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating.
Silapo 6 000 i.e./0,6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 0,6 ml raztopine za injiciranje v napolnjeni brizga iz stekla tipa I s fiksno jekleno iglo in zamaškom s teflonsko prevleko.
Silapo 6 000 IU Injection Epoetin zeta iv/sc use
Silapo injekcija 6 000 i.e. epoetin zeta i.v.
Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe 0.3 ml solution for injection in pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating.
Silapo 1 000 i.e./0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 0,3 ml raztopine za injiciranje v napolnjeni brizga iz stekla tipa I s fiksno jekleno iglo in zamaškom s teflonsko prevleko.
Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.3 ml solution for injection contains 1 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 1 000 i.e./0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 0,3 ml raztopine za injiciranje vsebuje 1 000 mednarodnih enot (i.e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
Silapo 40 000 IU Injection Epoetin zeta iv/sc use
Silapo injekcija 40 000 i.e. epoetin zeta i.v.
1 pre-filled syringe of 0.4 ml solution for injection 6 pre-filled syringes of 0.4 ml solution for injection
1 napolnjena injekcijska brizga z 0,4 ml raztopine za injiciranje 6 napolnjenih injekcijskih brizg z 0,4 ml raztopine za injiciranje
1 pre-filled syringe of 0.3 ml solution for injection 6 pre-filled syringes of 0.3 ml solution for injection
1 napolnjena injekcijska brizga z 0,3 ml raztopine za injiciranje 6 napolnjenih injekcijskih brizg z 0,3 ml raztopine za injiciranje
Investigations
Splošni podatki
Excipient with known effect Each pre-filled syringe contains 0.50 mg phenylalanine.
Pomožne snovi z znanim učinkom Ena napolnjena injekcijska brizga vsebuje 0,50 mg fenilalanina.
Silapo 4 000 IU Injection Epoetin zeta iv/sc use
Silapo injekcija 4 000 i.e. epoetin zeta i.v.
Adverse reactions during treatment with erythropoietin are observed predominantly in patients with chronic renal failure or underlying malignancies.
V glavnem se neželeni učinki med zdravljenjem z eritropoetinom pojavijo pri bolnikih s kronično ledvično okvaro ali malignimi obolenji, izrazijo pa se najpogosteje kot z odmerkom povezano z glavobol in zvišanjem krvnega tlaka Nastopi lahko hipertenzivna kriza s simptomi, ki so podobni encefalopatiji.
Silapo 30 000 IU Injection Epoetin zeta iv/sc use
Silapo injekcija 30 000 i.e. epoetin zeta i.v.
If the haemoglobin level reaches 15 g/dl, or higher, during the preoperative period, administration of Silapo should be stopped and further dosages should not be administered.
Če je pri preiskavah krvi pred kirurškim posegom ugotovljeno povečanje koncentracije hemoglobina na 15 g/dl ali več, je treba prenehati z dajanjem zdravila Silapo.
Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe Epoetin zeta
Silapo 1 000 i.e./0,3 ml raztopine za injiciranje v napolnjeni injekcijski brizgi epoetin zeta
Silapo 3 000 IU Injection Epoetin zeta iv/sc use
Silapo injekcija 3 000 i.e. epoetin zeta i.v.
Silapo 10 000 IU Injection Epoetin zeta iv/sc use
Silapo injekcija 10 000 i.e. epoetin zeta i.v.
Silapo 10 000 IU/1 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1 ml solution for injection contains 10 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 10 000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 1 ml raztopine za injiciranje vsebuje 10 000 mednarodnih enot (i.e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
1 pre-filled syringe of 0.6 ml solution for injection 6 pre-filled syringes of 0.6 ml solution for injection
1 napolnjena injekcijska brizga z 0,6 ml raztopine za injiciranje 6 napolnjenih injekcijskih brizg z 0,6 ml raztopine za injiciranje
Silapo 1 000 IU Injection Epoetin zeta iv/sc use
Silapo injekcija 1 000 i.e. epoetin zeta i.v.
Silapo 2 000 IU Injection Epoetin zeta iv/sc use
Silapo injekcija 2 000 i.e. epoetin zeta i.v.
Decreasing the dose by one dosing step should be considered if there is a rapid increase in haemoglobin (>2g/dlover 4weeks).
Če pride do hitrega zvišanja ravni hemoglobina (> 2 g/dl v 4 tednih), je treba razmisliti o zmanjšanju odmerka za en odmerni korak.
Anaemia symptoms and sequelae may vary with age, gender and overall burden of disease; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
Simptomi anemije in posledična bolezenska stanja se lahko spreminjajo glede na starost, spol in skupno bolezensko breme.
Silapo may be given during the dialysis session or after you have received a dialysis session.
Zdravilo Silapo se lahko daje med dializo ali pa po njej.
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
Simptomi anemije in posledična bolezenska stanja se lahko spreminjajo glede na starost, spol in skupno breme bolezni.
Silapo should be withheld when the haemoglobin concentration exceeds 12 g/dl (7.5 mmol/l).
Začasna prekinitev odmerjanja in zmanjšanje odmerka Zdravljenje z Silapo je treba prekiniti, kadar koncentracija hemoglobina preseže 12 g/dl (7,5 mmol/).
Changing from injecting into a vein to injecting under the skin (from intravenous into subcutaneous injection)
Menjava med injiciranjem v žilo in pod kožo (med intravenskim in subkutanim injiciranjem) Ko bo Vaše stanje pod nadzorom, boste začeli dobivati običajne odmerke zdravila Silapo.
This summary was last updated in 05-2015.
Povzetek je bil nazadnje posodobljen 05-2015.
Because the disease is rare, many of the children were included in more than one of the studies.
Ker je bolezen redka, je bilo več otrok vključenih v več kot eno študijo.
The studies lasted between 15 months and eight years, and the main measure of effectiveness was the speed of growth.
Študije so trajale od 15 mesecev do osem let, glavno merilo učinkovitosti pa je bila hitrost rasti.
The European Commission granted a marketing authorisation valid throughout the European Union for Increlex on 3 August 2007.
Evropska komisija je dovoljenje za promet z zdravilom Increlex, veljavno po vsej Evropski uniji, izdala 3. avgusta 2007.
Increlex has been authorised under ‘Exceptional Circumstances'.
Zdravilo Increlex je bilo odobreno „v izjemnih okoliščinah“.
The injection should be carried out shortly before or after a meal or snack.
Injekcijo je treba dati neposredno pred obrokom oziroma prigrizkom ali po njem.
It should never be injected into a vein.
Zdravilo se ne sme nikoli injicirati v žilo.
European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
Evropska agencija za zdravila bo vsako leto pregledala vse razpoložljive nove informacije in posodobila ta povzetek, če bo to potrebno.
For more information, see the summary of product characteristics.
Za več informacij glejte povzetek glavnih značilnosti zdravila.
IGF-1 is important in determining how tall a child grows.
IGF-1 ima zelo pomemben vpliv na to, do kakšne višine bo otrok zrasel.
What measures are being taken to ensure the safe and effective use of Increlex?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Increlex?
It does this by stimulating cells to divide and grow and to absorb nutrients, supporting the growth of body tissues.
Ta hormon spodbuja celice, da se delijo in rastejo ter vsrkavajo hranilne snovi, kar pospešuje rast telesnih tkiv.
The maximum dose is 0.12 mg per kilogram twice a day.
Največji dovoljeni odmerek je 0,12 mg na kilogram dvakrat dnevno.
When the results of the studies were looked at together, the average growth rate was 2.8 cm per year before treatment.
Ob upoštevanju skupnih rezultatov študij je bila povprečna stopnja rasti pred zdravljenjem 2,8 cm na leto.
This means that because the disease is rare, it has not been possible to obtain complete information about Increlex.
To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh podatkov o zdravilu.
This is a summary of the European public assessment report (EPAR) for Increlex.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Increlex.
Treatment should be interrupted if the patient cannot eat for any reason.
Če bolnik iz kakršnega koli razloga ne more jesti, je treba zdravljenje prekiniti.
Some of the studies also included children who had defects in the gene for growth hormone (GH) and who had developed antibodies against GH.
Nekatere študije so vključevale tudi otroke s poškodovanim genom za rastni hormon (GH), ki so proti njemu razvili protitelesa.
Increlex has been studied in five studies involving a total of 76 children aged between one and 15 years with severe primary IGF-1 deficiency, nine of whom had received another type of recombinant IGF-1 before joining these studies.
Zdravilo Increlex so proučevali v petih študijah, v katerih je sodelovalo skupno 76 otrok, starih od enega do 15 let, s hudim primarnim pomanjkanjem IGF-1, pri čemer jih je devet pred vključitvijo v te študije prejemalo drugo vrsto rekombinantnega IGF-1.
The company that makes Increlex will carry out a long-term study looking at the safety of the medicine, when treatment is started in young children and continued into adulthood.
Družba, ki proizvaja zdravilo Increlex, bo izvedla dolgoročno raziskavo o varnosti zdravila v primeru, ko se zdravljenje začne pri majhnih otrocih in nadaljuje v obdobju odraslosti.
The company applied for an authorisation to use Increlex in these children, but withdrew its application after the end of the medicine's assessment, as this disease is not listed in the medicine's ‘orphan' designation.
Družba je zaprosila za dovoljenje za uporabo zdravila Increlex pri teh otrocih, vendar je ob zaključku ocenjevanja zdravila umaknila vlogo, saj ta bolezen ni navedena v določitvi zdravila kot zdravila sirote.
The dose should be tailored for each patient according to the speed of growth and side effects.
Odmerek je treba prilagoditi vsakemu posameznemu bolniku glede na hitrost rasti in neželene učinke.
The company will also supply dose calculators to help doctors and patients (or their carers) to work out the appropriate dose.
Priskrbela bo tudi računala za izračun odmerkov, ki bodo v pomoč zdravnikom in bolnikom (ali njihovim skrbnikom) pri določanju ustreznega odmerka.
Patients with this condition have low levels of the hormone insulin-like growth factor-1 or IGF-1, which is required for normal growth.
Takšni bolniki imajo zelo nizke ravni hormona, imenovanega insulinu podoben rastni faktor-1 ali IGF-1, ki je potreben za normalno rast.
The recommended starting dose is 0.04 mg per kilogram body weight twice a day.
Priporočeni začetni odmerek znaša 0,04 mg na kilogram telesne mase dvakrat dnevno.
For more information about treatment with Increlex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Increlex preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The CHMP decided that Increlex's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Increlex večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Increlex works in the same way as natural IGF-1, replacing the missing hormone and helping the child to grow taller.
Zdravilo Increlex deluje enako kot naravni IGF-1 ter tako nadomešča manjkajoči hormon in pomaga otrokom pri rasti.
The most common side effects with Increlex (seen in more than 1 patient in 10) are headache, hypoglycaemia (low blood sugar levels), vomiting (being sick), injection site hypertrophy (lumps at the site of injection) and otitis media (infection of the middle ear).
Najpogostejši neželeni učinki zdravila Increlex (opaženi pri več kot 1 od 10 bolnikov) so glavobol, hipoglikemija (nizka raven sladkorja v krvi), bruhanje, hipertrofija na mestu injiciranja (zatrdline na mestu injiciranja) in otitis media (vnetje srednjega ušesa).
Other information about Increlex
Druge informacije o zdravilu Increlex
The summary of the opinion of the Committee for Orphan Medicinal Products for Increlex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Increlex je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Increlex must not be used in premature babies or newborns.
Zdravilo se ne sme uporabljati pri nedonošenčkih ali novorojenčkih.
Treatment with Increlex should be supervised by doctors who have experience in the diagnosis and treatment of patients with growth disorders.
Zdravljenje z zdravilom Increlex mora nadzorovati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolnikov z motnjami rasti.
A risk management plan has been developed to ensure that Increlex is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Increlex je bil pripravljen načrt obvladovanja tveganj.
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 Increlex.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Increlex must not be used in patients who have, or are thought to have active neoplasia (abnormal cell growth).
Zdravila Increlex ne smejo uporabljati bolniki, ki imajo ali utegnejo imeti aktivno neoplazijo (nenormalno rast celic).
The active substance in Increlex, mecasermin, is a copy of the hormone IGF-1.
Zdravilna učinkovina zdravila Increlex, mekasermin, je kopija hormona IGF-1.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Increlex, 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.
Because the number of patients with primary IGF-1 deficiency is low, the disease is considered ‘rare', and Increlex was designated an ‘orphan medicine' (a medicine used in rare diseases) on 22 May 2006.
Ker je bolnikov s primarnim pomanjkanjem IGF-1 malo, velja ta bolezen za redko, zato je bilo zdravilo Increlex 22. maja 2006 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
The full EPAR for Increlex 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 Increlex je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What benefit has Increlex shown during the studies?
Kakšne koristi je zdravilo Increlex izkazalo med študijami?
One study compared Increlex with placebo (a dummy treatment) in eight patients, but the others did not compare Increlex with any other treatments.
V eni študiji so primerjali zdravilo Increlex s placebom (zdravilom brez zdravilne učinkovine) pri osmih bolnikih, v drugih študijah pa zdravila Increlex niso primerjali z nobenim drugim zdravilom.
What is the risk associated with Increlex?
Kakšna tveganja so povezana z zdravilom Increlex?
Increlex caused the speed of growth to increase.
Zdravilo Increlex je pospešilo hitrost rasti.
Increlex is used for the long-term treatment of patients aged two to 18 years who are short for their age due to a condition known as ‘severe primary insulin-like growth factor-1 deficiency'.
Zdravilo Increlex se uporablja za dolgotrajno zdravljenje bolnikov, starih od dve do 18 let, ki so za svojo starost premajhni zaradi „hudega primarnega pomanjkanja insulinu podobnega rastnega faktorja-1“.
For the full list of all side effects and restrictions with Increlex, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Increlex glejte navodilo za uporabo.
This increased to 8.0 cm in the first year of treatment and 5.8 cm in the second.
Ta se je v prvem letu zdravljenja povečala na 8,0 cm, v drugem letu pa na 5,8 cm. Od četrtega leta zdravljenja dalje se je stopnja rasti ustalila pri približno 4,7 cm na leto.
Increlex is a solution for injection that contains the active substance mecasermin.
Zdravilo Increlex je raztopina za injiciranje, ki vsebuje zdravilno učinkovino mekasermin.
Additionally, the company that markets Increlex will supply information packs to doctors and patients explaining how the medicine is used and its side effects.
Poleg tega bo družba, ki izdeluje zdravilo Increlex, za zdravnike in bolnike pripravila informativne brošure z razlago uporabe zdravila in njegovih neželenih učinkov.
What information is still awaited for Increlex?
Katere informacije o zdravilu Increlex še pričakujemo?
Why has Increlex been approved?
Zakaj je bilo zdravilo Increlex odobreno?
Increlex is given by injection under the skin, and the injection site should be changed with each injection.
Zdravilo Increlex se daje z injekcijo v podkožje, pri čemer je treba za vsako naslednjo injekcijo izbrati drugo mesto injiciranja.
Treatment with Increlex should be stopped if neoplasia develops.
Če se pojavi neoplazija, je treba zdravljenje z zdravilom Increlex ustaviti.
How has Increlex been studied?
Kako je bilo zdravilo Increlex raziskano?
How is Increlex used?
Kako se zdravilo Increlex uporablja?
What is Increlex used for?
Za kaj se zdravilo Increlex uporablja?
How does Increlex work?
Kako zdravilo Increlex deluje?
This overview was last updated in 08-2019.
Povzetek je bil nazadnje posodobljen 08-2019.
Further information on Forxiga can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Forxiga.
Nadaljnje informacije o zdravilu Forxiga so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Forxiga.
What measures are being taken to ensure the safe and effective use of Forxiga?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Forxiga?
Forxiga received a marketing authorisation valid throughout the EU on 11 November 2012.
Za zdravilo Forxiga je bilo 11. novembra 2012 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
An overview of Forxiga and why it is authorised in the EU
Pregled zdravila Forxiga in zakaj je odobreno v EU
As for all medicines, data on the use of Forxiga are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Forxiga stalno spremljajo.
Other information about Forxiga
Druge informacije o zdravilu Forxiga
It can also be used as ‘add-on' treatment to other diabetes medicines.
Prav tako se lahko uporablja kot dodatek drugim zdravilom za zdravljenje sladkorne bolezni.
What benefits of Forxiga have been shown in studies?
Kakšne koristi zdravila Forxiga so se pokazale v študijah?
The Agency concluded that the benefits of Forxiga outweigh its risks and recommended that it be granted marketing authorisation.
Agencija je zaključila, da so koristi zdravila Forxiga večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
Why is Forxiga authorised in the EU?
Zakaj je zdravilo Forxiga odobreno v EU?
Side effects reported with Forxiga are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Forxiga, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.