natgillin/translations-raw huggingface dataset:
16 Beneficial effects of Enviage on mortality and cardiovascular morbidity and target organ damage are currently unknown.
Ugodni vplivi zdravila Enviage na umrljivost, kardiovaskularno obolevnost in prizadetost tarčnih organov trenutno niso znani.
17 5.3 Preclinical safety data
17 insuficience.
6.3 Shelf life
18 6. 3 Rok uporabnosti
18 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
Via Provinciale Schito 131 I-80058 Torre Annunziata/ NA Italy
Via Provinciale Schito 131 I- 80058 Torre Annunziata/ NA Italija
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2 (dated 5 July 2006) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 2 (z dne 5. junija 2006), predstavljen v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 30 May 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt za obvladovanje tveganja Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, ki je bil sprejet v različici načrta za obvladovanje tveganja (RMP) z dne 30. maja 2007, predstavljenem v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities. • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached. • At the request of the EMEA.
Poleg tega je treba posodobljen načrt za obvladovanje tveganja predložiti: • kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja • v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja) • na zahtevo Evropske agencije za zdravila (EMEA).
25 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
25 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
26 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
26 PODATKI NA ZUNANJI OVOJNINI
INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)
VMESNA ŠKATLA V SKUPNEM PAKIRANJU (BREZ PODATKOV ZA “ BLUE BOX ”)
28 film-coated tablets Component of a multipack comprising 3 packs, each containing 28 tablets.
14 filmsko obloženih tablet del skupnega pakiranja z 20 škatlami po 14 tablet 28 filmsko obloženih tablet del skupnega pakiranja s 3 škatlami po 28 tablet.
49 film-coated tablets Component of a multipack comprising 2 packs, each containing 49 tablets.
49 filmsko obloženih tablet del skupnega pakiranja z 2 škatlama po 49 tablet
84 film-coated tablets (3x28) 98 film-coated tablets (2x49) 280 film-coated tablets (20x14)
84 filmsko obloženih tablet (3x28) 98 filmsko obloženih tablet (2x49) 280 filmsko obloženih tablet (20x14)
28 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
28 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX)
ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA (VKLJUČENI PODATKI ZA “ BLUE BOX ”)
84 film-coated tablets Multipack comprising 3 packs, each containing 28 tablets.
84 filmsko obloženih tablet skupno pakiranje s 3 škatlami, vsaka škatla vsebuje 28 tablet.
98 film-coated tablets Multipack comprising 2 packs, each containing 49 tablets.
98 filmsko obloženih tablet skupno pakiranje z 2 škatlama, vsaka škatla vsebuje 49 tablet.
280 film-coated tablets Multipack comprising 20 packs, each containing 14 tablets.
280 filmsko obloženih tablet skupno pakiranje z 20 škatlami, vsaka škatla vsebuje 14 tablet.
49 film-coated tablets Component of a multipack comprising 2 packs, each containing 49 tablets.
30 filmsko obloženih tablet del skupnega pakiranja s 3 škatlami po 30 tablet 49 filmsko obloženih tablet del skupnega pakiranja z 2 škatlama po 49 tablet
84 film-coated tablets (3x28) 90 film-coated tablets (3x30) 98 film-coated tablets (2x49) 280 film-coated tablets (20x14)
84 filmsko obloženih tablet (3x28) 90 filmsko obloženih tablet (3x30) 98 filmsko obloženih tablet (2x49) 280 filmsko obloženih tablet (20x14)
90 film-coated tablets Multipack comprising 3 packs, each containing 30 tablets.
90 filmsko obloženih tablet skupno pakiranje s 3 škatlami, vsaka škatla vsebuje 30 tablet.
What Enviage is and what it is used for 2.
Kaj je zdravilo Enviage in za kaj ga uporabljamo 2.
Before you take Enviage 3.
Kaj morate vedeti, preden boste vzeli zdravilo Enviage 3.
How to take Enviage 4.
Kako jemati zdravilo Enviage 4.
How to store Enviage 6.
Shranjevanje zdravila Enviage 6.
WHAT ENVIAGE IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ENVIAGE IN ZA KAJ GA UPORABLJAMO
BEFORE YOU TAKE ENVIAGE
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO ENVIAGE
Do not take Enviage
Ne jemljite zdravila Enviage
If you
- če ste alergični (preobčutljivi) na aliskiren ali katerokoli sestavino zdravila Enviage; če mislite,
think you may be allergic, ask your doctor for advice.
da bi lahko bili alergični, se posvetujte z zdravnikom;
- during the last 6 months of pregnancy or if you are breast-feeding, see section Pregnancy and
- v zadnjih 6 mesecih nosečnosti ali če dojite, glejte poglavje Nosečnost in dojenje;
- if you are taking ciclosporin (a medicine used in transplantation to prevent organ rejection or for
če jemljete ciklosporin (zdravilo, ki se ga uporablja pri presaditvah za preprečevanje zavrnitve
other conditions, e. g. rheumathoid arthritis or atopic dermatitis) or verapamil (a medicine used to lower blood pressure, to correct hearth rhythm or to treat angina pectoris) or quinidine (a medicine used to correct heart rhythm).
organa ali pri drugih boleznih, na primer pri revmatoidnem artritisu ali atopijskem dermatitisu), če jemljete verapamil (zdravilo za zniževanje krvnega tlaka, uravnavanje srčnega ritma ali za zdravljenje angine pektoris) ali če jemljete kinidin (zdravilo za uravnavanje srčnega ritma).
- if you are taking a diuretic (a type of medicine also known as “ water ” tablets which increases
- kadar jemljete diuretike (vrsta zdravil za odvajanje vode, ki povečuje količino urina, ki nastaja v
the amount of urine you produce).
telesu);
- if you have impaired kidney function.
- če imate moteno delovanje ledvic.
39 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
39 Uporaba drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Your doctor may need to change your dose and/ or to take other precautions if you are taking one of the following medicines:
Morda vam bo moral zdravnik spremeniti odmerke ali svetovati druge previdnostne ukrepe ali pa oboje, če jemljete katero od naslednjih zdravil:
These include potassium-
- zdravila, ki vam povečajo količino kalija v krvi, med njimi so diuretiki, ki varčujejo s kalijem,
sparing diuretics, potassium supplements.
in nadomestki kalija;
- furosemide, a medicine belonging to the type known as diuretics, or “ water” tablets, which is
- furosemid, to je zdravilo, ki sodi v skupino zdravil imenovano diuretiki ali tablete za odvajanje
used to increase the amount of urine you produce.
vode, zaradi katerih se poveča količina urina, ki nastaja v telesu; ketokonazol, to je zdravilo za zdravljenje glivičnih okužb.
Taking Enviage with food and drink You should take Enviage with a light meal once a day, preferably at the same time each day.
Jemanje zdravila Enviage skupaj s hrano in pijačo Zdravilo Enviage je treba jemati z lahkim obrokom enkrat na dan, najbolje vsak dan ob istem času.
Pregnancy and breast-feeding Do not take Enviage if you are pregnant.
Nosečnost in dojenje Če ste noseči, ne jemljite zdravila Enviage.
Driving and using machines You may feel dizzy and this can affect your ability to concentrate.
Vpliv na sposobnost upravljanja vozil in strojev Morda boste nekoliko omotični in se zato ne boste mogli zbrati.
HOW TO TAKE ENVIAGE
KAKO JEMATI ZDRAVILO ENVIAGE
The usual starting dose is one 150 mg tablet once daily.
Običajni začetni odmerek je ena 150- miligramska tableta enkrat na dan.
Depending on how you respond to the treatment your doctor may prescribe a higher dose of one 300 mg tablet once daily.
Odvisno od vašega odziva na zdravljenje vam bo zdravnik morda predpisal višji odmerek, to je eno 300- miligramsko tableto na dan.
Method of administration It is recommended that you take the tablets with some water.
Način uporabe Tablete je priporočljivo zaužiti z malo vode.
If you take more Enviage than you should If you have accidentally taken too many Enviage tablets, consult a doctor immediately.
Če ste vzeli večji odmerek zdravila Enviage, kot bi smeli Če ste pomotoma vzeli več tablet zdravila Enviage, kot bi smeli, se takoj posvetujte z zdravnikom.
40 If you forget to take Enviage If you forget to take a dose of Enviage, take it as soon as you remember and then take the next dose at its usual time.
40 prejšnji odmerek.
Common (affecting less than 1 in 10 patients):
Pogosti (pojavijo se pri manj kot 1 od 10 bolnikov): driska.
Skin rash.
Občasni (pojavijo se pri manj kot 1 od 100 bolnikov): kožni izpuščaj.
HOW TO STORE ENVIAGE
SHRANJEVANJE ZDRAVILA ENVIAGE
The expiry date refers to the last day of that month.
Shranjujte pri temperaturi do 30 °C.
What Enviage contains
Kaj vsebuje zdravilo Enviage
- The active substance is aliskiren (as hemifumarate) 150 mg.
- Zdravilna učinkovina je aliskiren (v obliki hemifumarata) 150 mg.
- The other ingredients are crospovidone, hypromellose, magnesium stearate, macrogol,
- Pomožne snovi so: krospovidon, hipromeloza, magnezijev stearat, makrogol, mikrokristalna
microcrystalline cellulose, povidone, colloidal anhydrous silica, talc, titanium dioxide (E 171), black iron oxide (E 172), red iron oxide (E 172).
celuloza, povidon, brezvodni koloidni silicijev dioksid, smukec, titanov dioksid (E 171), črni železov oksid (E 172), rdeči železov oksid (E 172).
What Enviage looks like and contents of the pack Enviage 150 mg film coated tablets are light-pink, biconvex round tablets, imprinted “ IL ” on one side and “ NVR” on the other side.
Izgled zdravila Enviage in vsebina pakiranja Enviage 150 mg filmsko obložene tablete so bikonveksne okrogle tablete svetlo roza barve, z oznako ‘ IL ’ na eni strani in ‘ NVR ’ na drugi.
Manufacturer Novartis Farma S. p. A.
Izdelovalec Novartis Farma S. p. A.
- if you are taking a diuretic (a type of medicine also known as “ water” tablets which increases
- kadar jemljete diuretike (vrsta zdravil za odvajanje vode, ki povečuje količino urina, ki nastaja v
44 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
44 Uporaba drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
used to increase the amount of urine you produce.
vode, zaradi katerih se poveča količina urina, ki nastaja v telesu;
- ketoconazole, a medicine used to treat fungal infections.
- ketokonazol, to je zdravilo za zdravljenje glivičnih okužb.
45 If you forget to take Enviage If you forget to take a dose of Enviage, take it as soon as you remember and then take the next dose at its usual time.
Če pa je že skoraj čas za naslednji odmerek, preprosto vzemite 45 samo naslednji odmerek ob običajnem času.
However, if it is almost time for your next dose you should simply take the next tablet at the usual time.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
- The active substance is aliskiren (as hemifumarate) 300 mg.
- Zdravilna učinkovina je aliskiren (v obliki hemifumarata) 300 mg.
What Enviage looks like and contents of the pack Enviage 300 mg film coated tablets are light-red, biconvex, ovaloid tablets, imprinted “ IU” on one side and “ NVR” on the other side.
Izgled zdravila Enviage in vsebina pakiranja Enviage 300 mg filmsko obložene tablete so bikonveksne ovalne tablete svetlo rdeče barve, z oznako ‘ IU ’ na eni strani in ‘ NVR ’ na drugi.
46 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Invented name
Ime zdravila
Route of administration Packaging
Pot uporabe
Film-coated tablet
filmsko obložena tableta peroralna uporaba
Oral use Bottle (HDPE)
plastenka (HDPE)
Oral solution
peroralna raztopina peroralna uporaba
1 bottle, (240 ml)+ 10 ml oral dosing syringe and adapter
1 plastenka, (240 ml) + 10 ml peroralna odmerna brizga in nastavek
It is available as diamond-shaped tablets (white:
Na voljo je v tabletah v obliki diamanta (bele tablete:
150 mg; grey:
150 mg; sive tablete:
300 mg) and as an oral solution (10 mg/ ml).
300 mg) ter v obliki peroralne raztopine (10 mg/ ml).
Epivir is an antiviral medicine.
Zdravilo Epivir je protivirusno zdravilo.
It is used in combination with other antiviral medicines to treat adults and children infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Uporablja se v kombinaciji z drugimi protivirusnimi zdravili pri zdravljenju odraslih in otrok, okuženih z virusom humane imunske pomanjkljivosti (HIV), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (AIDS).
Treatment with Epivir should be initiated by a doctor who has experience in the management of HIV infection.
Zdravljenje z zdravilom Epivir mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužb z virusom HIV.
The recommended dose of Epivir for patients over 12 years of age is 300 mg daily.
Priporočeni odmerek zdravila Epivir pri bolnikih, starejših od 12 let, je 300 mg dnevno.
This can be given either once a day (two 150 mg tablets or one 300 mg tablet) or as one 150 mg tablet twice a day.
Ta odmerek se lahko daje enkrat dnevno (dve tableti po 150 mg ali ena tableta po 300 mg) ali kot ena tableta po 150 mg dvakrat dnevno.
In children weighing more than 30 kg, the adult dose of 150 mg twice a day should be used.
Pri otrocih, ki tehtajo več kot 30 kg, je treba uporabiti 150- miligramski odmerek za odrasle dvakrat dnevno.
In children weighing between 14 and 30 kg, the dose depends on body weight.
Pri otrocih, ki tehtajo od 14 do 30 kg, je odmerek odvisen od telesne mase.
Children aged over three months who weigh less than 14 kg should be given the oral solution at a dose of 4 mg per kilogram body weight twice a day, up to a maximum of 300 mg per day.
Otrokom, starim več kot tri mesece, ki tehtajo manj kot 14 kg, je treba dajati peroralno raztopino v odmerku 4 mg na kilogram telesne mase dvakrat dnevno, vendar največ 300 mg na dan.
Epivir tablets should ideally be swallowed without crushing.
Najbolje je, da tableto zdravila Epivir pogoltnete celo, ne da bi jo poprej zdrobili.
Patients who cannot swallow tablets should use the oral solution, or they may crush and add the tablets to a small amount of food or drink, before taking the dose immediately.
Bolniki, ki ne morejo pogoltniti cele tablete, naj uporabijo peroralno raztopino ali pa tableto zdrobijo in jo pred zaužitjem pomešajo z majhno količino hrane ali pijače.
The dose of Epivir needs to be adjusted in patients who have severe problems with their kidneys.
Pri bolnikih, ki imajo resne težave z ledvicami, je treba odmerek zdravila Epivir prilagoditi.
Epivir can be taken with or without food.
Zdravilo Epivir se lahko jemlje s hrano ali brez nje.
The active substance in Epivir, lamivudine, is a nucleoside reverse transcriptase inhibitor (NRTI).
Zdravilna učinkovina zdravila Epivir, lamivudin, je nukleozidni zaviralec reverzne transkriptaze (NRTI).
It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Ta preprečuje delovanje reverzne transkriptaze, encima, ki ga proizvaja virus HIV in ki omogoča okužbo celic in tvorbo novih virusov.
Epivir does not cure HIV infection or AIDS,
Zdravilo
Reproduction is authorised provided the source is acknowledged. but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Epivir ne ozdravi okužbe s HIV ali AIDS- a, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z AIDS- om.
Epivir has been studied in five main studies involving almost 3,000 adults.
Zdravilo Epivir so preučevali v petih glavnih študijah, v katere je bilo vključenih skoraj 3000 odraslih.
The studies examined the effects of Epivir on the levels of HIV in the blood (viral load) and the number of CD4 T-cells in the blood (CD4 cell count).
V študijah so preučevali učinke zdravila Epivir na ravni virusa HIV v krvi (virusno breme) in število CD4 T- celic v krvi (število celic CD4).
The fifth study compared the effects of adding Epivir or placebo (a dummy treatment) to existing treatment for HIV infection in 1,895 adults who had been taking antiviral medicines for at least four weeks.
V peti študiji so primerjali učinke dodajanja zdravila Epivir ali placeba (zdravila brez zdravilne učinkovine) obstoječemu zdravljenju okužbe s HIV pri 1895 odraslih, ki so vsaj štiri tedne jemali protivirusna zdravila.
This study looked at how many patients developed an illness associated with AIDS or died after a year’ s treatment.
V tej študiji so preučevali, pri koliko bolnikih se je razvila bolezen, povezana z AIDS- om, ali koliko bolnikov je umrlo po enoletnem zdravljenju.
Epivir was also studied in 615 children.
Zdravilo Epivir so preučevali tudi pri 615 otrocih.
The study compared the effects of Epivir taken with zidovudine to didanosine (another antiviral medicine) taken alone.
V študiji so učinke zdravila Epivir, uporabljenega v kombinaciji z zidovudinom, primerjali z didanozinom (drugim protivirusnim zdravilom), dajanim samostojno.
The study measured how long it took the children to develop an AIDS-related illness.
V študiji so merili, koliko časa je preteklo, preden se je pri otrocih pojavila bolezen, povezana z AIDS- om.
In the first four studies in adults, Epivir, taken in combination with zidovudine, increased CD4 cell counts more than the comparator medicines after 24 weeks of treatment.
V prvih štirih študijah z odraslimi je po 24 tednih zdravljenja zdravilo Epivir, dajano v kombinaciji z zidovudinom, povečalo število celic CD4 bolj kot primerjalna zdravila.
The combination also reduced viral loads in all studies after two to four weeks of treatment, but this effect was temporary.
Kombinacija je v vseh študijah po dveh do štirih tednih zdravljenja zmanjšala tudi virusno breme, vendar pa je bil ta učinek le začasen.
128 (9%) of the 1,369 patients taking Epivir developed an AIDS-related illness or died, compared with 95 (20%) of the 471 patients taking placebo.
V peti študiji, izvedeni pri odraslih, je dodajanje zdravila Epivir obstoječemu zdravljenju zmanjšalo tveganje za napredovanje bolezni ali nastop smrti: bolezen, povezana z AIDS- om, ali smrt je nastopila pri 128 (9%) od 1369 bolnikov, ki so jemali zdravilo Epivir, v primerjavi z enakim izidom pri 95 (20%) od 471 bolnikov, ki so jemali placebo.
Similar results were seen in HIV- infected children.
Podobni rezultati so bili opaženi pri otrocih, okuženih s HIV.
The most common side effects with Epivir (seen in between 1 and 10 patients in 100) are diarrhoea, nausea (feeling sick), vomiting, headache, insomnia (difficulty sleeping), cough, nasal symptoms, rash, muscle disorders, arthralgia (joint pain), alopecia (hair loss), fever, abdominal (tummy) pain or cramps, malaise (feeling unwell) and fatigue (tiredness).
Najpogostejši neželeni učinki zdravila Epivir (opaženi pri 1 do 10 bolnikih izmed 100) so driska, slabost, bruhanje, glavobol, nespečnost (težave s spanjem), kašelj, nazalni simptomi, izpuščaji, mišična obolenja, artralgija (bolečine v sklepih), alopecija (izpadanje las), povišana telesna temperatura, bolečine ali krči v trebuhu, neugodje (slabo počutje) in utrujenost.
For the full list of all side effects reported with Epivir, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Epivir, glejte navodilo za uporabo.
Epivir should not be used in patients with severe liver disease or who may be hypersensitive (allergic) to lamivudine or any of the other ingredients.
Zdravila Epivir ne smejo uporabljati osebe s hudimi obolenji jeter oziroma ljude, ki utegnejo biti preobčutljivi za (alergični na) lamivudin ali katero koli drugo sestavino zdravila.
As with other anti-HIV medicines, patients taking Epivir may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Kot pri drugih zdravilih proti okužbi z virusom HIV lahko pride tudi pri bolnikih, ki jemljejo zdravilo Epivir, do lipodistrofije (spremembe v porazdelitvi telesne maščobe), osteonekroze (odmiranja kostnega tkiva) ali sindroma imunske reaktivacije (simptomov okužbe, ki jih povzroči izboljšanje stanja imunskega sistema).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Epivir.
Bolniki, ki imajo težave z jetri (vključno z okužbo s hepatitisom B ali C) so z jemanjem zdravila Epivir izpostavljeni večjemu tveganju, da pride do poškodb jeter.
As with all other NRTIs, Epivir may also cause lactic acidosis (a build-up of lactic acid in the body) and, in the babies of mothers taking Epivir during pregnancy, mitochondrial dysfunction (damage to the energy-producing components within cells that can cause problems in the blood).
Tako kot drugi zaviralci nukleozidne reverzne transkriptaze lahko tudi zdravilo Epivir povzroči laktacidozo (kopičenje mlečne kisline v telesu), pri dojenčkih mater, ki so med nosečnostjo jemale zdravilo Epivir, pa mitohondrijsko disfunkcijo (poškodbo komponent za proizvajanje energije v celicah, kar se lahko odraža v težavah s krvjo).
The Committee for Medicinal Products for Human Use (CHMP) decided that Epivir’ s benefits are greater than its risks in combination with other antiretroviral medicinal products for the treatment of HIV infected adults and children.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Epivir v kombinaciji z drugimi protiretrovirusnimi zdravili pri zdravljenju odraslih in otrok, okuženih s HIV, večje od z njim povezanih tveganj.
The Committee recommended that Epivir be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Epivir odobri dovoljenje za promet.
Epivir was originally authorised under ‘ Exceptional Circumstances’, because, for scientific reasons, limited information was available at the time of approval.
Zdravilo Epivir je bilo prvotno odobreno v „ izjemnih okoliščinah “, saj so bile zaradi znanstvenih razlogov ob odobritvi na voljo le omejene informacije.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 7 January 1998.
Ker je družba posredovala zahtevane dodatne informacije, so „ izjemne okoliščine “ prenehale veljati 7. januarja 1998.
Other information about Epivir:
2/ 3 Druge informacije o zdravilu Epivir: