natgillin/translations-raw huggingface dataset:
The final opinion was converted into a Decision by the European Commission on 1 October 2007.
Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 1. oktobra 2007.
* Note: The information given in this document and Annexes reflects the CHMP Opinion dated 19 July 2007.
*Opomba: Informacije, podane v tem dokumentu in v Dodatkih odražajo mnenje CHMP z dne 19. julija 2007.
The list of product names concerned is given in Annex I.
Seznam zadevnih imen izdelkov je podan v Dodatku I.
The referral procedure started on 21 September 2006.
Napotitveni postopek se je začel 21. septembra 2006.
Written explanations were provided by the Marketing Authorisation Holder on 4 January 2007.
Pisna pojasnila je imetnik dovoljenja za promet z zdravilom predložil dne 4. januarja 2007.
Oral explanations were given on 20 June
Ustna pojasnila so bila podana dne 20. junija 2007.
On 19 July 2007, based on evaluation of the currently available data and the Rapporteurs' assessment reports, the CHMP considered that the benefit/risk profile of veralipride-containing medicinal products is negative and therefore adopted an opinion recommending the withdrawal of the Marketing Authorisation for all medicinal products containing veralipride.
Dne 19. julija 2007 je CHMP na podlagi trenutno razpoložljivih podatkov in poročevalčevih poročil o oceni menil, da je razmerje med koristmi in tveganji zdravil, ki vsebujejo veralipride negativno, in je zato izdal mnenje, s katerim priporoča umik dovoljenja za promet z vsemi zdravili, ki vsebujejo veralipride.
COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31 REFERRAL FOR Agreal and associated names (see annex I) International Non-Proprietary Name (INN): Veralipride
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 31 ZA Agreal in z njim povezana imena (glejte Dodatek I) Mednarodno nelastniško ime (INN): Veralipride
On 7 September 2006, following the withdrawal of veralipride from the Spanish market due to reports of serious side effects affecting the nervous system, the European Commission referred the matter to the EMEA under Article 31 of Directive 2001/83/EC.
Po umiku zdravila veralipride s španskega trga zaradi poročil o resnih neželenih stranskih učinkih, ki vplivajo na živčni sistem, je Evropska komisija dne 7. septembra 2006 napotila zadevo na agencijo EMEA v skladu s členom 31 Direktive 2001/83/ES.
Veralipride was approved since 1979 for the indication of treatment of vasomotor symptoms (hot flushes) associated with the menopause.
Veralipride je od leta 1979 odobren za zdravljenje vazomotornih simptomov (navali vročine), povezanih z menopavzo.
Until June 2005, veralipride was also marketed in Spain.
Do junija 2005 je bil na tržišču tudi v Španiji.
An extra drop should be given 30 to 120 minutes before the operation begins.
Dodatno kapljico je treba nanesti 30 do 120 minut pred začetkom operativnega posega.
If other eye medicines are also being used, there should be a gap of at least five minutes between using each medicine.
Če se uporabljajo tudi druga zdravila za oči, mora med uporabo posameznega zdravila preteči vsaj pet minut.
Treatment should begin one day before the cataract operation.
Z zdravljenjem je treba začeti en dan pred operacijo katarakte.
The European Commission granted a marketing authorisation valid throughout the European Union for Nevanac on 11 December 2007.
Evropska komisija je dovoljenje za promet z zdravilom Nevanac, veljavno po vsej Evropski uniji, izdala 11. decembra 2007.
What measures are being taken to ensure the safe and effective use of Nevanac?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Nevanac?
The full EPAR for Nevanac 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 Nevanac je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The main measure of effectiveness was either the proportion of patients in whom treatment had been successful (with no or few signs of inflammation in the eye), or the proportion of patients whose treatment had failed (with signs of moderate or severe inflammation in the eye).
Glavno merilo učinkovitosti je bil bodisi delež bolnikov, pri katerih je bilo zdravljenje uspešno (ki niso imeli več ali so imeli le malo znakov vnetja očesa), ali delež bolnikov, pri katerih zdravljenje ni bilo uspešno (ki so imeli znake zmernega ali hudega vnetja očesa).
What benefit has Nevanac shown during the studies?
Kakšne koristi je zdravilo Nevanac izkazalo med študijami?
These were measured two weeks after surgery.
Znake so merili dva tedna po operativnem posegu.
For more information about treatment with Nevanac, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Nevanac preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This is a summary of the European public assessment report (EPAR) for Nevanac.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Nevanac.
Additionally, contact lens wear is not recommended during the postoperative period following cataract surgery.
Poleg tega nošnja kontaktnih leč ni priporočljiva v obdobju po operaciji katarakte.
Treatment is continued after the operation for 2 to 3 weeks when used to prevent pain and inflammation, or up to 60 days when used to reduce the risk of macular oedema.
Zdravljenje se po operativnem posegu nadaljuje dva do tri tedne, če se zdravilo uporablja za preprečevanje bolečine in vnetja, ali do 60 dni, če se uporablja za zmanjšanje tveganja makularnega edema.
The main measure of effectiveness was the number of patients who developed macular oedema within 90 days of surgery.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se je v 90 dneh po operativnem posegu razvil makularni edem.
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 Nevanac.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Nevanac, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The CHMP decided that Nevanac's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Nevanac večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Other information about Nevanac
Druge informacije o zdravilu Nevanac
What is the risk associated with Nevanac?
Kakšna tveganja so povezana z zdravilom Nevanac?
The company also carried out studies to show that Nevanac 3 mg/ml given once a day was more effective than placebo and had the same effect in preventing and treating pain and inflammation as Nevanac 1 mg/ml given three times a day.
Družba je izvedla tudi študije, da bi pokazala, da je bilo zdravilo Nevanac 3 mg/ml dano enkrat na dan učinkovitejše od placeba in da je imelo enak učinek pri preprečevanju in zdravljenju bolečine in vnetja kot zdravilo Nevanac 1 mg/ml, dano trikrat na dan.
By reducing the production of prostaglandins in the eye, Nevanac can reduce complications caused by eye surgery, such as inflammation, pain and swelling.
Z zmanjšanjem tvorjenja prostaglandinov v očesu lahko zdravilo Nevanac zmanjša zaplete, ki jih povzroči operativni poseg na očeh, kot so vnetje, bolečina in otekanje.
When Nevanac was compared with placebo, around 70% of the patients using Nevanac had no signs of inflammation after two weeks, compared with 17% to 59% of those using placebo.
Ko so zdravilo Nevanac primerjali s placebom, okoli 70 % bolnikov, ki so uporabljali zdravilo Nevanac, po dveh tednih ni imelo znakov vnetja, v primerjavi s 17 % do 59 % tistih, ki so uporabljali placebo.
Why has Nevanac been approved?
Zakaj je bilo zdravilo Nevanac odobreno?
The first main study used Nevanac 1 mg/ml whereas the other 2 main studies used Nevanac 3 mg/ml.
V prvi glavni študiji so uporabili zdravilo Nevanac 1 mg/ml, v drugih dveh glavnih študijah pa zdravilo Nevanac 3 mg/ml.
Therefore, patients should be advised not to wear contact lenses during treatment with Nevanac.
Zato je treba bolnikom med prejemanjem zdravila Nevanac odsvetovati nošnjo kontaktnih leč.
Nevanac is an eye drop suspension that contains the active substance nepafenac (1 and 3 mg/ml).
Nevanac je suspenzija v obliki kapljic za oko, ki vsebuje zdravilno učinkovino nepafenak (1 in 3 mg/ml).
Nevanac must not be used in people who are hypersensitive (allergic) to nepafenac, to any of the other ingredients or to other NSAIDs.
Zdravila Nevanac ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) nepafenak ali katero koli drugo sestavino zdravila ali na druga nesteroidna protivnetna zdravila.
Like other NSAIDs, Nevanac must not be used in patients who have previously had an attack of asthma, hives or inflammation of the nasal passages when they take aspirin or other NSAIDs.
Podobno kot drugih nesteroidnih protivnetnih zdravil tudi zdravila Nevanac ne smejo uporabljati bolniki, ki so ob zaužitju aspirina ali drugih nesteroidnih protivnetnih zdravil že doživeli napad astme, dobili izpuščaje ali imeli vnetje nosne votline.
Nevanac is used in adults to prevent and treat the pain and inflammation that can occur after an operation to remove a cataract from the eye.
Zdravilo Nevanac se uporablja pri odraslih za preprečevanje in zdravljenje bolečin ter vnetij, ki se lahko pojavijo po operativni odstranitvi katarakte iz očesa.
Nevanac is also used to reduce the risk of macular oedema (swelling in the macula, the central part of the retina at the back of the eye) that can occur after cataract surgery in adult diabetes patients.
Zdravilo Nevanac se uporablja tudi za zmanjšanje tveganja makularnega edema (otekanja v rumeni pegi, osrednjem delu mrežnice v zadnjem delu očesa), ki se lahko pojavi po operaciji katarakte pri odraslih sladkornih bolnikih.
The most common side effects with Nevanac (seen in up to 1 in 100 patients) are inflammation of the surface of the eye, defects in the cornea, the sensation of a foreign body in the eye, and crust forming at edge on the eyelids.
Najpogostejši neželeni učinki zdravila Nevanac (opaženi pri več kot 1 bolniku od 10) so vnetje površine oči, okvare v roženici, občutek tujka v očesu in kraste, ki se naredijo na robovih vek.
Another three studies, in a total of 981 patients, compared Nevanac used three times a day, either with placebo, with ketorolac eye drops (another NSAID) or with both placebo and ketorolac.
V drugih treh študijah, ki so vključevale skupaj 981 bolnikov, so zdravilo Nevanac, uporabljeno trikrat na dan, primerjali s placebom, s kapljicami za oko, ki vsebujejo ketorolak (drugo nesteroidno protivnetno zdravilo), ali s placebom in ketorolakom.
In the study comparing Nevanac with ketorolac, around 65% of both groups of patients showed no or few signs of inflammation.
V študiji, v kateri so zdravilo Nevanac primerjali s ketorolakom, približno 65 % bolnikov iz obeh skupin ni imelo nobenih znakov vnetja ali pa je bilo teh znakov malo.
For reducing the risk of macular oedema, Nevanac has been compared with placebo in three main studies involving 1483 diabetes patients with retinopathy (damage to the retina) undergoing cataract surgery.
Pri zmanjšanju tveganja makularnega edema so zdravilo Nevanac primerjali s placebom v eni glavni študiji, v kateri je sodelovalo 1483 sladkornih bolnikov z retinopatijo (poškodbo mrežnice), ki so prestali operacijo katarakte.
For the prevention and treatment of pain and inflammation, Nevanac 1 mg/ml has been studied in four main studies involving a total of 1,201 patients undergoing cataract surgery.
Učinkovitost zdravila Nevanac v odmerku 1 mg/ml pri preprečevanju in zdravljenju bolečine in vnetja je bila raziskana v štirih glavnih študijah, ki so vključevale skupaj 1 201 bolnika, pri katerem je bila opravljena operacija katarakte.
Nevanac contains benzalkonium chloride, which is known to discolour soft contact lenses.
Zdravilo Nevanac vsebuje benzalkonijev klorid, ki dokazano obarva mehke kontaktne leče.
The active substance in Nevanac, nepafenac, is a ‘prodrug' of amfenac.
Zdravilna učinkovina v zdravilu Nevanac, nepafenak, je „predzdravilo“ amfenaka.
For the full list of all side effects reported with Nevanac, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Nevanac, glejte navodilo za uporabo.
In the second and third study, 2.3% and 5.9% of patients taking Nevanac 3 mg/ml developed macular oedema, respectively, compared with between 17.3% and 14.3% of patients taking placebo.
V drugi in tretji študiji se je makularni edem razvil pri 2,3 % oziroma 5,9 % bolnikih, ki so jemali zdravilo Nevanac, v primerjavi s 17,3 % oziroma 14,3 % bolnikov, ki so jemali placebo.
In the study comparing different numbers of drops daily, the patients using Nevanac 1 mg/ml three times a day had the lowest failure rate.
V študiji, v kateri so primerjali različno število kapljic na dan, je bilo zdravljenje bolnikov, ki so uporabljali zdravilo Nevanac 1 mg/ml trikrat dnevno, najuspešnejše.
In the first study, 3.2% of patients taking Nevanac 1 mg/ml developed macular oedema (4 out of 125), compared with 16.7% of patients taking placebo (21 out of 126).
V prvi študiji se je makularni edem razvil pri 3,2 % (4 od 125) bolnikov, ki so jemali zdravilo Nevanac, v primerjavi s 16,7 % (21 od 126) bolnikov, ki so jemali placebo.
How has Nevanac been studied?
Kako je bilo zdravilo Nevanac raziskano?
In diabetes patients, Nevanac was more effective than placebo in reducing the risk of macular oedema.
Pri sladkornih bolnikih je bilo zdravilo Nevanac pri zmanjševanju tveganja makularnega edema učinkovitejše od placeba.
Nevanac was more effective than placebo and as effective as ketorolac in reducing signs of inflammation.
Zdravilo Nevanac je bilo pri zmanjševanju znakov vnetja učinkovitejše od placeba in enako učinkovito kot ketorolak.
This means that it is converted into amfenac in the eye. Amfenac is a non-steroidal anti-inflammatory drug (NSAID).
Amfenak je nesteroidno protivnetno zdravilo (NSAID).
One drop of Nevanac is given into the affected eye(s), either three times a day with the 1 mg/ml strength, or once a day if using the 3 mg/ml strength.
V prizadeto oko (obe očesi) se daje ena kapljica zdravila Nevanac trikrat na dan v odmerku 1 mg/ml ali enkrat na dan v odmerku 3 mg/ml.
One study compared Nevanac 1 mg/ml used once, twice or three times a day with placebo (dummy eye drops) in 220 patients.
V eni študiji so pri 220 bolnikih zdravilo Nevanac 1 mg/ml, uporabljeno enkrat, dvakrat ali trikrat na dan, primerjali s placebom (kapljicami za oko brez zdravilne učinkovine).
What is Nevanac used for?
Za kaj se zdravilo Nevanac uporablja?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nevanac have also been included in the summary of product characteristics and the package leaflet.
V povzetek glavnih značilnosti zdravila in navodilo za uporabo so bili vključeni priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo tega zdravila upoštevati zdravstveni delavci in bolniki.
How does Nevanac work?
Kako zdravilo Nevanac deluje?
How is Nevanac used?
Kako se zdravilo Nevanac uporablja?
What is Nevanac?
Kaj je zdravilo Nevanac?
The usual dose is one tablet taken once a day with food.
Običajni odmerek je ena tableta, ki se jemlje enkrat na dan sočasno s hrano.
This means that it is similar to a ‘reference medicine' already authorised in the European Union (EU)
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Viread.
The full EPAR for Tenofovir disoproxil Mylan 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 Dizoproksiltenofovirat Mylan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It is used in patients with liver damage but whose liver is still working properly (compensated liver disease).
Uporablja se pri bolnikih z okvaro jeter, ki sicer še vedno ustrezno delujejo (kompenzirana jetrna bolezen).
The company that makes Tenofovir disoproxil Mylan will also ensure that all doctors who are expected to prescribe or use the medicine are provided with educational materials containing important safety information, particularly on the risks and precautions relating to kidney function and the bones.
Družba, ki izdeluje zdravilo Dizoproksiltenofovirat Mylan, bo zagotovila tudi, da bodo vsi zdravniki, ki naj bi predpisovali ali uporabljali to zdravilo, prejeli izobraževalno gradivo, ki bo vsebovalo pomembne varnostne informacije, zlasti o tveganjih in previdnostnih ukrepih, ki se nanašajo na delovanje ledvic in kosti.
This is a summary of the European public assessment report (EPAR) for Tenofovir disoproxil Mylan.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Dizoproksiltenofovirat Mylan.
In adults, it can also be used for those patients with liver damage whose liver is not working properly (decompensated liver disease) and those patients who do not respond to treatment with lamivudine (another medicine for hepatitis B).
Pri odraslih se lahko uporablja tudi pri tistih bolnikih z okvaro jeter, pri katerih ta ne delujejo ustrezno (dekompenzirana jetrna bolezen), in tistih, ki se ne odzivajo na zdravljenje z lamivudinom (drugim zdravilom za zdravljenje okužbe z virusom hepatitisa B).
Tenofovir disoproxil Mylan, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Zdravilo Dizoproksiltenofovirat Mylan v kombinaciji z drugimi protivirusnimi zdravili zniža količino virusa HIV v krvi in jo vzdržuje na nizki ravni.
The Committee recommended that Tenofovir disoproxil Mylan be approved for use in the EU.
Priporočil je, da se zdravilo Dizoproksiltenofovirat Mylan odobri za uporabo v EU.
Tenofovir is a nucleotide reverse-transcriptase inhibitor (NRTI).
Tenofovir je zaviralec nukleotidne reverzne transkriptaze (NRTI).
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Tenofovir disoproxil Mylan has been shown to have comparable quality and to be bioequivalent to Viread.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Dizoproksiltenofovirat Mylan primerljivo raven kakovosti kot zdravilo Viread ter da mu je biološko enakovredno.
What measures are being taken to ensure the safe and effective use of Tenofovir disoproxil Mylan?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Dizoproksiltenofovirat Mylan?
Tenofovir disoproxil Mylan is used to treat adults and adolescents from 12 years of age infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Zdravilo Dizoproksiltenofovirat Mylan se uporablja za zdravljenje odraslih in mladostnikov, starejših od 12 let, ki so okuženi z virusom človeške imunske pomanjkljivosti tipa 1 (HIV 1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
Because Tenofovir disoproxil Mylan is a generic 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 Dizoproksiltenofovirat Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Tenofovir disoproxil Mylan does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo Dizoproksiltenofovirat Mylan ne ozdravi okužbe z virusom HIV ali aidsa, vendar pa lahko upočasni slabšanje imunskega sistema ter prepreči razvoj okužb in bolezni, povezanih z aidsom.
Tenofovir disoproxil Mylan is also used to treat chronic (long-term) hepatitis B virus infection in adults and adolescents from 12 years of age.
Dizoproksiltenofovirat Mylan se uporablja tudi za zdravljenje kronične (dolgotrajne) okužbe z virusom hepatitisa B pri odraslih in mladostnikih, starejših od 12 let.
For patients who have taken medicines to treat HIV infection before, doctors should only prescribe Tenofovir disoproxil Mylan once they have looked at the antiviral medicines the patient has taken before or the likelihood of the virus's response to antiviral medicines.
Bolnikom, ki so predhodno že jemali zdravila za zdravljenje okužbe z virusom HIV, smejo zdravniki predpisati zdravilo Dizoproksiltenofovirat Mylan šele potem, ko se seznanijo s protivirusnimi zdravili, ki jih je bolnik jemal pred tem, oziroma ko ocenijo, kakšna je verjetnost, da se bo virus odzval na protivirusna zdravila.
Tenofovir also interferes with the action of an enzyme produced by the hepatitis-B virus called ‘DNA polymerase', which is involved in the formation of viral DNA.
Tenofovir prav tako ovira delovanje encima, ki ga proizvaja virus hepatitisa B, imenovan „DNK-polimeraza“, ki je vključen v proces nastajanja virusne DNK.
In HIV infection, it blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself in the cells it has infected.
Pri okužbi z virusom HIV zavira dejavnost reverzne transkriptaze, tj. encima, ki ga tvori virus HIV in ki mu omogoča razmnoževanje v okuženih celicah.
Tenofovir disoproxil Mylan can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection or chronic hepatitis B. Tenofovir disoproxil Mylan is available as tablets (245 mg) to be taken by mouth.
Predpisovanje in izdaja zdravila Dizoproksiltenofovirat Mylan je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV ali kroničnega hepatitisa B. Zdravilo Dizoproksiltenofovirat Mylan je na voljo v obliki tablet (245 mg), ki se jemljejo peroralno.
Tenofovir disoproxil Mylan stops the virus making DNA and prevents it from multiplying and spreading.
Zdravilo Dizoproksiltenofovirat Mylan ustavi tvorbo DNK v virusu in tako prepreči njegovo razmnoževanje in širjenje.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tenofovir disoproxil Mylan have also been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Dizoproksiltenofovirat Mylan upoštevati zdravstveni delavci in bolniki, so prav tako vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For more information about treatment with Tenofovir disoproxil Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Dizoproksiltenofovirat Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What are the benefits and risks of Tenofovir disoproxil Mylan?
Kakšne so koristi in tveganja, povezani z zdravilom Dizoproksiltenofovirat Mylan?
Because Tenofovir disoproxil Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Viread.
Ker je zdravilo Dizoproksiltenofovirat Mylan generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Viread.