natgillin/translations-raw huggingface dataset:
(functionally anephric, requiring intermittent haemodialysis)* Recommended dose of Emtriva 10 mg/ ml oral solution every 24 hours
odmerek Emtriva 10 mg/ ml peroralne raztopine vsakih 24 ur
If Emtriva is discontinued in patients co-infected with HIV and HBV, these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
15 Če se jemanje zdravila Emtriva prekine pri bolnikih s hkratno HIV in HBV okužbo, je treba pri teh bolnikih skrbno nadzorovati znake poslabšanja hepatitisa (glejte poglavje 4. 4).
14 4.3 Contraindications
4. 3 Kontraindikacije
The safety and efficacy of the reduced doses provided in section 4.2 are based on single dose pharmacokinetic data and modelling and have not been clinically evaluated.
Varnost in učinkovitost zmanjšanega odmerka, kot je prikazano v poglavju 4. 2, temeljita na farmakokinetičnih podatkih pri enkratnem odmerku in modeliranju ter še nista bili klinično ovrednoteni.
Therefore, clinical response to treatment and renal function should be closely monitored in patients treated with a reduced dose of emtricitabine (see sections 4.2 and 5.2).
Zato je potrebno pozorno nadzorovati klinični odziv na zdravljenje in ledvično funkcijo pri bolnikih, ki se zdravijo z zmanjšanim odmerkom emtricitabina (glejte poglavji 4. 2 in 5. 2).
Caution should be exercised when administering nucleoside analogues to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol).
16 Previdnostni ukrepi so potrebni pri uporabi analogov nukleozidov pri vsakemu bolniku (posebno pri debelih ženskah) s hepatomegalijo, hepatitisom ali drugim znanim rizičnim faktorjem obolenja jeter in hepatične steatoze (vključujoč določena zdravila in alkohol).
15 Patients at increased risk should be followed closely.
Bolniki s povečanim tveganjem morajo biti pod skrbnim nadzorom.
Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
Kombinacija antiretrovirusnega zdravljenja je pri bolnikih, okuženih z virusom HIV, povezana s prerazporeditvijo telesne maščobe (lipodistrofijo).
The long-term consequences of these events are currently unknown.
Dolgoročne posledice lipodistrofije trenutno niso poznane.
Any child exposed in utero to nucleoside and nucleotide analogues, even HIV negative children, should have clinical and laboratory follow-up and should be fully investigated for possible mitochondrial dysfunction in case of relevant signs or symptoms.
Vse otroke, tudi HIV- negativn, ki so bili in utero izpostavljeni nukleozidnim in nukleotidnim analogom, je treb klinično in laboratorijsko spremljati ter jih v primeru relevantnih znakov ali simptomov glede možne
In HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART, combination antiretroviral therapy) nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične patogene in povzroči resna klinična stanja ali poslabšanje simptomov.
Any inflammatory symptoms
Ustrezni primeri so citomegalovirusni retinitis, generalizirane in/ ali žariščne okužbe z mikobakterijami in s Pneumocystis carinii povzročena pljučnica.
16 should be evaluated and treatment instituted when necessary.
Kakršnekoli vnetne simptome je treba obravnavati in uvesti zdravljenje, kadar je potrebno.
Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/ or long-term exposure to combination antiretroviral therapy (CART).
Čeprav je vzrokov verjetno več (vključno z uporabo kortikosteroidov, uživanjem alkohola, hudo imunosupresijo, višjim indeksom telesne mase), so o primerih osteonekroze poročali zlasti pri bolnikih z napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART, combination antiretroviral therapy) ali obojim.
This medicinal product contains 254 mg of sodium per dose which should be taken into consideration by patients on a controlled sodium diet.
To zdravilo vsebuje 254 mg natrija na odmerek, kar morajo upoštevati bolniki, ki so na dieti z nadzorovanim vnosom natrija.
Given that the potential risks to developing human foetuses are unknown, the use of emtricitabine in women of childbearing potential must be accompanied by the use of effective contraception.
18 Glede na to, da potencialni vpliv na razvoj humanega zarodka ni znan, morajo ženske v rodni dobi uporabljati emtricitabin skupaj z učinkovitim kontracepcijskim sredstvom.
However,
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
17 patients should be informed that dizziness has been reported during treatment with emtricitabine.
Vendar je bolnike potrebno opozoriti, da se lahko v času zdravljenja z emtricitabinom pojavi omotica.
The adverse reactions with suspected (at least possible) relationship to treatment in adults are listed below by body system organ class and absolute frequency.
Neželene reakcije z domnevno (vsaj možno) zvezo z zdravljenjem pri odraslih bolnikih so navedene spodaj glede na organske sisteme in absolutno frekvenco.
Skin and subcutaneous tissue disorders:
19 Bolezni kože in podkožja:
The adverse reaction profile in patients co-infected with HBV is similar to that observed in patients
Neželene reakcije pri bolnikih, ki so hkrati okuženi še s HBV, so podobne tistim, ki jih imajo bolniki, okuženi z virusom HIV brez hkratne okužbe s HBV.
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump) (see section 4.4).
Kombinirano antiretrovirusno zdravljenje lahko spremlja pri bolnikih z okužbo z virusom HIV prerazporeditev telesne maščobe (lipodistrofija), vključno z zmanjšanjem periferne in obrazne podkožne maščobe, povečanjem notranje trebušne in visceralne maščobe, hipertrofijo dojk in kopičenjem maščevja na zadnji strani vratu (buffalo hump) (glejte poglavje 4. 4).
Emtricitabine is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate, which competitively inhibits HIV-1 reverse transcriptase, resulting in DNA chain termination.
20 Celični encimi fosforilirajo emtricitabin v emtricitabin 5 '- trifosfat, ki kompetitivno inhibira HIV- 1 reverzno transkriptazo, kar rezultira v prekinitvi verige DNA.
In combination studies of emtricitabine with protease inhibitors, nucleoside, nucleotide and non-nucleoside analogue inhibitors of HIV reverse transcriptase, additive to synergistic effects were observed.
V študijah kombinacije emtricitabina z zaviralci proteaz, z nukleozidnimi, nukleotidnimi in ne - nukleozidnimi analogi zaviralcev HIV reverzne transkriptaze so opazili aditivne ali celo sinergistične učinke.
19 When tested for activity against laboratory strains of HBV, the 50% inhibitory concentration (IC50) value for emtricitabine was in the range of 0.01 to 0.04 µmol/ l.
Pri testih aktivnosti proti laboratorijskim sevom HBV je bila 50% inhibitorna koncentracija (IC50) za emtricitabin v razponu od 0, 01 do 0, 04 µmol/ l.
Emtricitabine-resistant viruses were cross-resistant to lamivudine, but retained sensitivity to other nucleoside reverse transcriptase inhibitors (NRTIs) (zidovudine, stavudine, tenofovir, abacavir, didanosine and zalcitabine), all non-nucleoside reverse transcriptase inhibitors (NNRTIs) and all protease inhibitors (PIs).
Virusi odporni na emtricitabin, so bili navzkrižno odporni na lamivudin, a so ohranili občutljivost za druge nukleozidne zaviralce reverzne transkriptaze (NRTI, nucleoside reverse transcriptase inhibitors) (zidovudin, stavudin, tenofovir, abacavir, didanozin in zalcitabin), na vse ne- nukleozidne zaviralce reverzne transkriptaze (NNRTI, non- nucleoside reverse transcriptase inhibitors) in vse zaviralce proteaz (PI, protease inhibitors).
5.2 Pharmacokinetic properties
Po peroralni uporabi emtricitabina se le- ta hitro in znatno absorbira in doseže najvišjo koncentracijo v plazmi v 1- 2 urah.
The absolute bioavailability of emtricitabine from Emtriva 200 mg hard capsules was estimated to be 93% and the absolute bioavailability from Emtriva 10 mg/ ml oral solution was estimated to be 75%.
Ocenjena absolutna biološka uporabnost emtricitabina, uporabljenega v obliki Emtriva 200 mg trde kapsule, je 93% in ocenjena absolutna vrednost biološke uporabnosti emtricitabina, uporabljenega v obliki Emtriva 10 mg/ ml peroralne raztopine, je 75%.
In a pilot study in children and a definitive bioequivalence study in adults, the Emtriva 10 mg/ ml oral solution was shown to have approximately 80% of the bioavailability of the Emtriva 200 mg hard
V pilotski študiji pri otrocih in bioekvivalentni študiji pri odraslih je biološka uporabnost Emtriva 10 mg/ ml peroralne raztopine predstavljala približno 80% biološke uporabnosti Emtriva 200 mg trdih kapsul.
Intracellular pharmacokinetics:
22 Znotrajcelične farmakokinetične lastnosti:
The systemic emtricitabine exposure (mean ± standard deviation) increased from 11.8±2.9 µg·h/ ml in subjects with normal renal function to 19.9±1.1, 25.0±5.7 and 34.0±2.1 µg·h/ ml, in patients with mild, moderate and severe renal impairment, respectively.
Pri osebah z normalno ledvično funkcijo znaša sistemska izpostavljenost emtricitabinu 11, 8 ± 2, 9 µg· h/ ml (povprečje ± standardni odklon) in naraste do 19, 9 ± 1, 1, 25, 0 ± 5, 7 ter do 34, 0 ± 2, 1 µg· h/ ml pri bolnikih z blago, zmerno in resno oslabelostjo.
In patients with ESRD on haemodialysis, approximately 30% of the emtricitabine dose was recovered in dialysate over a 3 hour dialysis period which had been started within 1.5 hours of emtricitabine
Pri bolnikih z ledvičnim obolenjem v zadnji fazi (ESRD, end- stage renal disease) na hemodializi je bilo približno 30% odmerka emtricitabina pridobljenega v dializatu po 3 urah dialize, s katero je bolnik začel v roku 1, 5 ure po uporabi emtricitabina (pretok krvi je 400 ml/ min in pretok dializata je približno 600 ml/ min).
The mean AUC in 77 infants, children and adolescents receiving 6 mg/ kg emtricitabine once daily as oral solution or 200 mg emtricitabine as hard capsules once daily was similar to the mean AUC of 10.0 µg·h/ ml in 20 adults receiving 200 mg hard capsules once daily.
Povprečna vrednost AUC pri 77 dojenčkih, otrocih in mladostnikih, ki so dobivali 6 mg/ kg emtricitabina v obliki peroralne raztopine enkrat dnevno ali 200 mg emtricitabina v obliki trdih kapsul enkrat dnevno je bila podobna povprečni vrednosti AUC 10, 0 µg· h/ ml pri 20 odraslih, ki so dobivali 200 mg trde kapsule enkrat dnevno.
Cotton candy flavouring Disodium edetate Hydrochloric acid Methyl parahydroxybenzoate (E218) Propylene glycol Propyl parahydroxybenzoate (E216) Sodium hydroxide Sodium phosphate monobasic hydrate Sunset yellow (E110) Purified water Xylitol (E967)
aroma sladkorne pene (Cotton candy flavouring) dinatrijev edetat klorovodikova kislina metilparahidroksibenzoat (E218) propilenglikol propilparahidroksibenzoat (E216) natrijev hidroksid natrijev dihidrogenfosfat hidrat oranžno FCF (E110) prečiščena voda ksilitol (E967)
22 6.3 Shelf life
6. 3 Rok uporabnosti
45 days.
45 dni od prvega odprtja.
Do not store above 25°C.
Po odprtju: shranjujte pri temperaturi do 25 °C.
The pack also contains a 30 ml polypropylene measuring cup with 1.0 ml graduations.
Pakiranje vsebuje še 30 ml polipropilensko merico z 1, 0 ml skalo.
Patients should be instructed that any solution left in the bottle 45 days after opening should be discarded according to local requirements or returned to the pharmacy.
Bolniki morajo biti opozorjeni, da se raztopina zdravila, ki ostane v plastenki po preteku 45 dni od odprtja plastenke, ne sme več uporabljati in jo je potrebno ali uničiti v skladu z lokalnimi predpisi ali vrniti nazaj v lekarno.
23 ANNEX II
25 DODATEK II
Gilead Science Limited Unit 13 Stillorgan Industrial Park Blackrock County Dublin Ireland
Gilead Science Limited Unit 13 Stillorgan Industrial Park Blackrock County Dublin Irska
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s smernicami Odbora za zdravila za uporabo v humani medicini (CHMP) za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen načrt za obvladovanje tveganja predložen hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR, Periodic Safety Update Report).
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 mora biti posodobljen načrt za obvladovanje tveganja predan: • Ko prispe nova informacija, ki lahko vpliva na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja. • V 60- ih dneh od pomembnega mejnika (farmakovigilančnega ali povezanega z zmanjševanjem tveganja). • Na zahtevo Evropske agencije za zdravila (EMEA).
PSURs:
PSURi
The Marketing Authorisation Holder will submit PSUR’ s on an annual basis.
Imetnik dovoljenja za promet bo vsako leto predložil redno posodobljeno poročilo o varnosti zdravila.
25 ANNEX III
27 DODATEK III
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
29 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Gilead Sciences Intl Ltd Cambridge CB21 6GT United Kingdom
Gilead Sciences Intl Ltd Cambridge CB21 6GT Velika Britanija
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
31 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
34 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Emtriva 10 mg/ ml oral solution Emtricitabine
Emtriva 10 mg/ ml peroralna raztopina emtricitabin
Each ml contains 10 mg emtricitabine.
1 ml vsebuje 10 mg emtricitabina.
Contains E110, E216, E218, and sodium.
Vsebuje E110, E216, E218 in natrij.
INFORMATION FOR THE USER
37 NAVODILO ZA UPORABO
What Emtriva is and what it is used for 2.
Kaj je zdravilo Emtriva in za kaj ga uporabljamo 2.
Before you take Emtriva 3.
Kaj morate vedeti, preden boste vzeli zdravilo Emtriva 3.
How to take Emtriva 4.
Kako jemati zdravilo Emtriva 4.
How to store Emtriva 6.
Shranjevanje zdravila Emtriva 6.
WHAT EMTRIVA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO EMTRIVA IN ZA KAJ GA UPORABLJAMO
Emtriva is a treatment for Human Immunodeficiency Virus (HIV) infection in adults, children and infants above 4 months of age.
Zdravilo Emtriva se uporablja za zdravljenje okužbe z virusom HIV pri odraslih, otrocih in dojenčkih, starih več kot 4 mesece.
You can still pass on HIV to others while you’ re taking this drug, so it is important to take precautions to avoid infecting other people.
Virus HIV lahko še vedno prenesete tudi na druge kljub jemanju tega zdravila, zato je pomembno, da uporabljate zaščitne ukrepe, ki preprečujejo okužbo drugih oseb.
BEFORE YOU TAKE EMTRIVA
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO EMTRIVA
Do not take Emtriva
Ne jemljite zdravila Emtriva
• If you are allergic (hypersensitive) to emtricitabine or any of the other ingredients of Emtriva 200 mg hard capsules listed at the end of this leaflet.
• Če ste alergični (preobčutljivi) na emtricitabin ali katerokoli sestavino trdih kapsul Emtriva 200 mg, ki so navedene na koncu tega navodila.
Take special care with Emtriva
38 Bodite posebno pozorni pri uporabi zdravila Emtriva
• Tell your doctor if you have had kidney disease, or if tests have shown problems with your kidneys.
• Obvestite svojega zdravnika, če ste kdaj prej imeli bolezni ledvic ali če so preiskave kazale na težave z ledvicami.
Before starting treatment, your doctor may order blood tests to assess kidney function 36 and may advise you to take the capsules less often or prescribe Emtriva oral solution.
Pred začetkom zdravljenja bo zdravnik morda naredil krvne preiskave, da bo ocenil delovanje ledvic in vam morda svetoval, da jemljete kapsule manj pogosto ali vam bo predpisal peroralno raztopino Emtriva.
• Do not give Emtriva to infants under 4 months of age.
• Zdravila Emtriva ne dajajte dojenčkom, starim manj kot 4 mesece.
• If you are diabetic, overweight or have high cholesterol, talk to your doctor.
• Če ste sladkorni bolnik, imate prekomerno telesno maso ali visok holesterol, se posvetujte z zdravnikom.
Combination antiretroviral therapies may raise blood sugar, increase blood fats (hyperlipaemia), cause changes to body fat, and resistance to insulin (see section 4, Possible side effects).
Kombinirano protiretrovirusno zdravljenje lahko poviša nivo sladkorja in količino maščob v krvi (hiperlipidemija) ter povzroči spremembe v telesnih maščobah in odpornost na insulin (glejte poglavje 4, Možni neželeni učinki).
• Once you start taking Emtriva, look out for possible signs of lactic acidosis.
• Ko začnete jemati zdravilo Emtriva, bodite pozorni na možne simptome laktične acidoze.
Medicines containing nucleoside analogues, including Emtriva, can cause lactic acidosis (excess of lactic acid in your blood), together with an enlarged liver.
Zdravila, ki vsebujejo analoge nukleozidov, vključno z zdravilom Emtriva, lahko povzročijo laktično acidozo (preveliko količino mlečne kisline v krvi) skupaj s povečanimi jetri.
This is a rare but serious side effect; it has occasionally been fatal.
To je redek, vendar resen neželeni učinek, ki je lahko včasih usoden.
Lactic acidosis occurs more often in women, particularly if they are very overweight.
Laktična acidoza se pogosteje pojavlja pri ženskah, še posebej, če imajo občutno preveliko telesno maso.
If you have liver disease you may also be more at risk of getting this condition.
Če imate jetrno bolezen, je verjetnost večja, da bi se enaki simptomi pojavili tudi pri vas.
While you are being treated with Emtriva, your doctor will monitor you closely for any signs that you may be developing lactic acidosis.
V času zdravljenja z zdravilom Emtriva bo vaš zdravnik pozorno nadzoroval znake, ki bi pri vas lahko nakazovali razvoj laktacidoze.
Deep, rapid breathing Drowsiness Nausea (feeling sick), vomiting and stomach pain notice any of these symptoms, tell your doctor immediately.
Če opazite katerega od teh simptomov, o tem nemudoma obvestite zdravnika.
These may be signs that your body’ s improved immune system is fighting infection.
Ti simptomi so lahko znak, da se izboljšani imunski sistem vašega telesa bojuje proti okužbi.
Taking other medicines
39 Jemanje drugih zdravil
You should not take Emtriva if you are already taking other medicines that contain emtricitabine, lamivudine or zalcitabine, which are also used to treat HIV infection, unless otherwise directed by your doctor.
Zdravila Emtriva ne smete jemati, če že jemljete druga zdravila, ki vsebujejo emtricitabin, lamivudin ali zalcitabin, ki se prav tako uporabljajo za zdravljenje okužbe z virusom HIV, razen če vaš zdravnik ne odredi drugače.
They will advise if Emtriva can be taken with your other medicines.
Svetovala vam bosta, ali smete zdravilo Emtriva uporabljati hkrati z vašimi drugimi zdravili.
37 Do not stop your treatment without contacting your doctor.
Ne prekinite zdravljenja brez posvetovanja z zdravnikom.
There are no clinical data on the use of Emtriva in pregnant women and it is not usually used unless absolutely necessary.
Klinični podatki o uporabi zdravila Emtriva pri nosečnicah niso na voljo in zdravila Emtriva se običajno ne uporablja, razen če to ni nujno potrebno.
In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Pri otrocih, katerih matere so med nosečnostjo jemale nukleozidne zaviralce reverzne transkriptaze (NRTI, nucleoside reverse transcriptase inhibitors), je korist zaradi zaščite proti virusu HIV odtehtala tveganje zaradi neželenih učinkov.
It is not yet known whether the active substance in this medicine passes into human breast milk.
Ni še znano, ali zdravilna učinkovina tega zdravila prehaja v materino mleko.
HOW TO TAKE EMTRIVA
KAKO JEMATI ZDRAVILO EMTRIVA
• Always take Emtriva exactly as your doctor has told you.
• Pri jemanju zdravila Emtriva natančno upoštevajte zdravnikova navodila.
• Adults: one 200 mg hard capsule each day with or without food.
• Odrasli: ena 200 mg trda kapsula dnevno z ali brez hrane.
Swallow the hard capsule with a glass of water. • Children and adolescents up to 18 years of age who weigh at least 33 kg and who are able to swallow hard capsules: one 200 mg hard capsule, each day with or without food.
Trdo kapsulo pogoltnite s kozarcem vode. • Za otroke in mladino do 18. leta starosti, ki tehtajo najmanj 33 kg, in ki lahko pogoltnejo trdo kapsulo: ena 200 mg trda kapsula dnevno z ali brez hrane.
For infants from 4 months, children, and patients who are unable to swallow hard capsules and patients with kidney problems, Emtriva is available as a liquid (an oral solution).
40 Za dojenčke, stare najmanj 4 mesece, otroke in bolnike, ki ne morejo pogoltniti trde kapsule, in za bolnike z ledvičnimi težavami je zdravilo Emtriva na voljo tudi kot tekočina (peroralna raztopina).
38 • Your doctor will prescribe Emtriva with other antiretroviral medicines.
• Zdravnik vam bo predpisal zdravilo Emtriva skupaj z drugimi protiretrovirusnimi zdravili.
If you do miss a dose of Emtriva, take it as soon as you can, and then take your next dose at its regular time.
Če ste pozabili vzeti odmerek zdravila Emtriva, ga vzemite čim prej in nato vzemite naslednji odmerek ob običajnem času.
If it is almost time for your next dose anyway, forget about the missed dose.
Če je že skoraj čas za vaš naslednji odmerek, pozabljenega odmerka ne vzemite.
If you are sick (vomit) If it’ s less than an hour since you took Emtriva, take another capsule.
Če vam je slabo (če bruhate) Če je manj kot ena ura odkar ste vzeli zdravilo Emtriva, vzemite še eno kapsulo.
• Don’ t stop taking Emtriva without talking to your doctor.
• Ne prenehajte jemati zdravila Emtriva, ne da bi se prej posvetovali s svojim zdravnikom.
• If you have both HIV infection and hepatitis B, it is especially important not to stop your Emtriva treatment without talking to your doctor first.
• Če ste okuženi hkrati z virusom HIV in hepatitisom B, je še zlasti pomembno, da ne prenehate z zdravljenjem z zdravilom Emtriva, ne da bi se prej posvetovali s svojim zdravnikom.
Like all medicines, Emtriva can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Emtriva neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Tell your doctor about any of the following side effects:
Obvestite zdravnika, če imate kateregakoli od naslednjih neželenih učinkov:
Very common side effects (These can affect more than 1 user in 10)
Zelo pogosti neželeni učinki (Prizadenejo lahko več kot 1 od 10 uporabnikov)
• headache, diarrhoea, feeling sick (nausea)
• glavobol, driska, slabost (navzea)
• muscle pain and weakness (if creatine kinase levels in the blood are increased)
• bolečine v mišicah in mišična oslabelost (če so nivoji kreatinske kinaze v krvi povišani)
39 Common side effects (These can affect 1 to 10 users in 100)
Pogosti neželeni učinki (Prizadenejo lahko 1 do 10 od 100 uporabnikov)