natgillin/translations-raw huggingface dataset:
Emtriva oral solution is a clear, orange to dark orange solution that comes in bottles containing 170 mL with a measuring cup.
Peroralna raztopina Emtriva je prozorna tekočina, oranžne do temno oranžne barve, na voljo v 170 ml plastenki skupaj z merico.
This indication is based on studies in treatment-naïve patients and treatment-experienced patients with stable virological control.
Indikacija temelji na študijah bolnikov, ki se zdravijo prvič in bolnikov, ki se zdravijo že dalj časa ter imajo stabilno stanje virusa v telesu.
Non-clinical data on emtricitabine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
5.3 Predklinični podatki o varnosti Predklinični podatki o emtricitabinu na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
Emtriva 200 mg hard capsules may be taken with or without food.
Emtriva 200 mg trde kapsule se lahko uporablja s hrano ali brez.
Discontinuation of Emtriva therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis (see section 4.4).
Prekinitev zdravljenja z zdravilom Emtriva pri bolnikih s hkratno HIV in HBV okužbo je lahko povezana s hudimi akutnimi poslabšanji hepatitisa (glejte poglavje 4.4).
Caution should be exercised when emtricitabine is co-administered with medicinal products that are eliminated by active tubular secretion as such co-administration may lead to an increase in serum concentrations of either emtricitabine or a co-administered medicinal product, due to competition for this elimination pathway (see section 4.5).
Posebno pozornost zahteva sočasna uporaba emtricitabina in zdravil, ki se izločajo iz telesa z aktivno tubularno sekrecijo, ker lahko takšna sočasna uporaba, zaradi kompeticije za to pot izločanja, vodi k povišanju serumskih koncentracij bodisi emtricitabina bodisi sočasno uporabljenega zdravila (glejte poglavje 4.5).
Nervous system disorders: Very common:
Bolezni živčevja: Zelo pogosti:
In infants and children older than 4 months, the majority of patients achieved or maintained complete suppression of plasma HIV-1 RNA through 48 weeks (89% achieved ≤ 400 copies/mL and 77% achieved ≤ 50 copies/mL).
Pri dojenčkih in otrocih starejših od 4 mesecev je večina v 48. tednih dosegla ali ohranila popolno supresijo plazemske HIV-1 RNA (89 % je doseglo ≤ 400 virionov/ml in 77 % je doseglo
Use the measuring cup provided in the carton to measure the correct dose.
Pri odmeri pravilnega odmerka si pomagajte z merico, ki je priložena v škatli.
Please refer to the Summary of Product Characteristics for Emtriva 200 mg hard capsules.
Prosimo, upoštevajte povzetek glavnih značilnosti Emtriva 200 mg trdih kapsul.
Table 1: Dose interval guidelines for 200 mg hard capsules adjusted according to creatinine clearance
Preglednica 1: Smernice intervala odmerjanja 200 mg trdih kapsul, prilagojene očistku kreatinina
Patients with chronic hepatitis B or C infection treated with CART are at increased risk of experiencing severe, and potentially fatal, hepatic adverse events.
Pri bolnikih s kronično okužbo s hepatitisom B ali C, ki se zdravijo s CART, je povečana možnost resnega in potencialno usodnega neželenega delovanja jeter.
If the patient vomits within 1 hour of taking Emtriva, another dose should be taken.
Če bolnik v roku 1 ure od jemanja zdravila Emtriva bruha, naj vzame drugi odmerek.
Emtriva oral solution contains sunset yellow (E110) which may cause allergic reactions, methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Emtriva peroralna raztopina vsebuje oranžno FCF (E110), ki lahko povzroči alergijske reakcije, metilparahidroksibenzoat (E218) in propilparahidroksibenzoat (E216), ki tudi lahko povzročita alergijske rekacije (lahko zapoznele).
elevated amylase including elevated pancreatic amylase, elevated serum lipase, vomiting, abdominal pain, dyspepsia Hepatobiliary disorders: Common:
zvišana amilaza vključno z zvišano pankreasno amilazo, povišanje serumske lipaze, bruhanje, bolečine v trebuhu, dispepsija Bolezni jeter, žolčnika in žolčevodov: Pogosti:
Each hard capsule contains 200 mg of emtricitabine.
Vsaka trda kapsula vsebuje 200 mg emtricitabina.
• If you have both HIV infection and hepatitis B, it is especially important not to stop your
• 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.
The following side effects are uncommon (these can affect up to 1 in every 100 patients):
Naslednji neželeni učinki so občasni (pojavijo se lahko pri največ 1 od 100 bolnikov):
If Emtriva is discontinued in patients co-infected with HIV and hepatitis B virus (HBV), these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Če se jemanje zdravila Emtriva prekine pri bolnikih s hkratno okužbo s HIV in z virusom hepatitisa B (HBV), je treba pri teh bolnikih skrbno nadzorovati znake poslabšanja hepatitisa (glejte poglavje 4.4).
Pack size: 30 hard capsules.
Velikost pakiranja: 30 trdih kapsul.
Emtricitabine is not recommended as monotherapy for the treatment of HIV infection.
Emtricitabin se ne priporoča za samostojno terapijo pri zdravljenju okužbe z virusom HIV.
Emtriva oral solution can be taken with or without food.
Peroralno raztopino Emtriva lahko jemljete z ali brez hrane.
Emtriva contains the active substance emtricitabine.
Zdravilo Emtriva vsebuje zdravilno učinkovino emtricitabin.
Emtricitabine did not inhibit the enzyme responsible for glucuronidation.
Emtricitabin ni inhibiral delovanja encima za glukuronidacijo.
Exacerbations of hepatitis after discontinuation of treatment: In HIV infected patients co-infected with HBV, exacerbations of hepatitis may occur after discontinuation of treatment (see section 4.4).
Eksacerbacije hepatitisa po prekinitvi zdravljenja: Pri bolnikih, okuženih s HIV, ki so hkrati okuženi s HBV, se lahko po prekinitvi zdravljenja pokažejo znaki eksacerbacije hepatitisa (glejte poglavje 4.4).
elevated serum aspartate aminotransferase (AST) and/or elevated serum ALT, hyperbilirubinaemia Skin and subcutaneous tissue disorders: Common:
povišanje serumske aspartat-aminotransferaze (AST) in/ali povišanje serumske ALT, hiperbilirubinemija Bolezni kože in podkožja: Pogosti:
Recommended dose interval for 200 mg hard capsules
Pripročen interval odmerjanja za 200 mg trde kapsule
Table 1: Daily doses of Emtriva 10 mg/mL oral solution adjusted according to creatinine clearance
Preglednica 1: Dnevni odmerki Emtriva 10 mg/ml peroralne raztopine prilagojeni očistku kreatinina
If overdose occurs, the patient should be monitored for signs of toxicity and standard supportive treatment applied as necessary.
Pri bolniku, ki je prejel prevelik odmerek zdravila, je potrebno biti pozoren na znake zastrupitve in če je potrebno, pričeti z osnovnim podpornim zdravljenjem zastrupitve.
There is insufficient information on the effects of emtricitabine in newborns/infants.
Dojenje Pokazalo se je, da se emtricitabin izloča v materino mleko Podatki o učinku emtricitabina na dojene novorojence/otroke so nezadostni.
Consequently, either a dose interval adjustment (using Emtriva 200 mg hard capsules) or a reduction in the daily dose of emtricitabine (using Emtriva 10 mg/mL oral solution) is required in all patients with creatinine clearance < 30 mL/min.
Posledično je pri vseh bolnikih z očistkom kreatinina < 30 ml/min potrebna ali prilagoditev intervala odmerjanja (pri uporabi Emtriva 200 mg trdih kapsul) ali znižanje dnevnega odmerka emtricitabina (pri uporabi Emtriva 10 mg/ml peroralne raztopine).
Table 1 below provides daily doses of Emtriva 10 mg/mL oral solution according to the degree of renal insufficiency.
Spodnja preglednica 1 prikazuje dnevne odmerke Emtriva 10 mg/ml peroralne raztopine glede na stopnjo ledvične insuficience.
Please refer to the Summary of Product Characteristics for Emtriva 10 mg/mL oral solution.
Prosimo, upoštevajte povzetek glavnih značilnosti Emtriva 10 mg/ml peroralne raztopine.
The content of the bottle should be used up within 45 days of opening.
Po odprtju plastenke morate raztopino uporabiti v roku 45 dni.
Amber-coloured polyethylene terephthalate (PET) bottle with a child-resistant closure.
Rumeno rjava polietilenska tereftalatska (PET) plastenka z za otroke varno zaporko.
You do not need to take another dose if you were sick more than an hour after taking Emtriva.
Še enega odmerka vam ni treba vzeti, če je bruhanje nastopilo več kot eno uro po zaužitju zdravila Emtriva.
Emtriva is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infected adults and children aged 4 months and over.
Zdravilo Emtriva v kombinaciji z drugimi protiretrovirusnimi zdravili je indicirano za zdravljenje odraslih in otrok, starih 4 mesece in več, okuženih z virusom humane imunske pomanjkljivosti-1
Elderly: Emtriva has not been studied in patients over the age of 65.
Starejši: Zdravila Emtriva niso proučevali pri bolnikih, starejših od 65 let.
The following side effects are common (these can affect up to 10 in every 100 patients):
Naslednji neželeni učinki so pogosti (pojavijo se lahko pri največ 10 od 100 bolnikov):
Dose or dose interval adjustment is required in all patients with creatinine clearance < 30 mL/min (see sections 4.2, 4.4 and
Pri vseh bolnikih z očistkom kreatinina < 30 ml/min je potrebno prilagoditi odmerek ali interval odmerjanja (glejte poglavji 4.2, 4.4 in 5.2).
One 200 mg hard capsule every 72 hours
Ena 200 mg trda kapsula vsakih 72 ur
General disorders and administration site conditions: Common:
Splošne težave in spremembe na mestu aplikacije: Pogosti:
Hepatic insufficiency
Jetrna insuficienca
Elderly patients are more likely to have decreased renal function; therefore caution should be exercised when treating elderly patients with Emtriva.
Verjetnost, da je ledvična funkcija pri starejših bolnikih zmanjšana, je večja, zato je pri zdravljenju starejših bolnikov z zdravilom
Each mL contains 10 mg of emtricitabine.
1 ml vsebuje 10 mg emtricitabina.
Method of administration Emtriva 200 mg hard capsules should be taken once daily, orally with or without food.
Način uporabe Zdravilo Emtriva 200 mg trde kapsule se jemljejo enkrat dnevno, peroralno, s hrano ali brez.
One 200 mg hard capsule every 24 hours
Ena 200 mg trda kapsula vsakih 24 ur
Administration of Emtriva 200 mg hard capsules with a high-fat meal or administration of Emtriva 10 mg/mL oral solution with a low-fat or high-fat meal did not affect systemic exposure (AUC0-∞) of emtricitabine; therefore Emtriva 200 mg hard capsules and Emtriva 10 mg/mL oral solution may be administered with or without food.
Uporaba Emtriva 200 mg trdih kapsul hkrati z zelo mastnim obrokom ali uporaba Emtriva 10 mg/ml peroralne raztopine z malo mastnim ali zelo mastnim obrokom ni imela učinka na sistemsko izpostavljenost (AUC0-∞) emtricitabinu.
In addition to the adverse reactions experienced by adults, anaemia and skin discolouration occurred more frequently in clinical trials involving HIV infected paediatric patients (see section 4.8).
Poleg neželenih reakcij, ki so jih doživeli odrasli, sta se v kliničnih študijah s pediatričnimi bolniki, okuženimi z virusom HIV, pogosteje pojavili anemija in sprememba obarvanosti kože (glejte poglavje 4.8).
After opening the bottle, do not store above 25°C.
Po odprtju shranjujte plastenko pri temperaturi do 25 °C.
Dose or dose interval adjustment is required in all patients with creatinine clearance < 30 mL/min (see section 4.4).
Pri vseh bolnikih z očistkom kreatinina < 30 ml/min je potrebno prilagoditi odmerek ali interval odmerjanja (glejte poglavje 4.4).
Resistance: HIV-1 resistance to emtricitabine develops as the result of changes at codon 184 causing the methionine to be changed to a valine (an isoleucine intermediate has also been observed) of the HIV reverse transcriptase.
Rezistenca: Rezistenca virusa HIV-1 na emtricitabin se razvije kot posledica sprememb v kodonu 184
Magnesium stearate (E572) Microcrystalline cellulose (E460) Povidone (E1201)
Vsebina kapsule krospovidon magnezijev stearat (E572) mikrokristalna celuloza (E460)
Emtriva 10 mg/mL oral solution may be taken with or without food.
Emtriva 10 mg/ml peroralna raztopina se lahko jemlje s hrano ali brez.
Emtriva hard capsules have a white opaque body with a light blue opaque cap. Each capsule is printed with “200 mg” on the cap and “GILEAD” and [Gilead logo] on the body in black ink.
Na vsaki kapsuli je s črnim črnilom na pokrovčku odtisnjeno “200 mg” ter na telesu “GILEAD” in [Gilead logo].
If you are sick (vomit) If it's less than an hour since you took Emtriva, take another capsule.
Če je manj kot ena ura odkar ste vzeli zdravilo Emtriva, vzemite še eno kapsulo.
Each Emtriva hard capsule contains 200 mg of emtricitabine.
Vsaka trda kapsula zdravila Emtriva vsebuje 200 mg emtricitabina.
Printing ink containing Black iron oxide (E172) Shellac (E904)
Vsebina črnila: črn železov oksid (E172), šelak (E904)
Patients receiving emtricitabine or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Pri bolnikih, ki se zdravijo z emtricitabinom ali s katerokoli drugo obliko protiretrovirusne terapije, se lahko še naprej razvijajo oportunistične okužbe in drugi zapleti okužbe z virusom HIV.
Due to this difference in bioavailability, 240 mg emtricitabine administered as the oral solution should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule.
Zaradi te razlike v biološki uporabnosti, naj bi 240 mg emtricitabina, uporabljenega v obliki peroralne raztopine, zagotavljalo podoben plazemski nivo kot je opazen po uporabi emtricitabina v obliki 200 mg trde kapsule.
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Poročajo o avtoimunskih boleznih (kot sta Gravesova bolezen in avtoimunski hepatitis); čas do njihovega nastanka je spremenljiv, zato se lahko pojavijo tudi več mesecev po začetku zdravljenja
Mechanism of action and pharmacodynamic effects Emtricitabine is a synthetic nucleoside analogue of cytidine with activity that is specific to HIV-1, HIV-2and HBV.
Emtricitabin je sintetični nukleozidni analog citidina z učinkovanjem, ki je specifično HIV-1, HIV-2
Due to a difference in the bioavailability of emtricitabine between the hard capsule and oral solution presentations, 240 mg emtricitabine administered as the oral solution (24 mL) should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule (see section 5.2).
Zaradi razlike v biološki uporabnosti emtricitabina, uporabljenega v obliki trde kapsule ali v obliki peroralne raztopine, naj bi 240 mg emtricitabina, uporabljenega v obliki peroralne raztopine (24 ml), zagotavljalo podoben plazemski nivo, kot je opazen po uporabi emtricitabina v obliki ene 200 mg trde kapsule (glejte poglavje 5.2).
Emtriva has not been studied in patients over 65 years of age.
Zdravila Emtriva niso proučevali pri bolnikih starejših od 65 let.
Emtriva has not been studied in patients over the age of 65.
Zdravila Emtriva niso proučevali pri bolnikih, starejših od 65 let.
If you stop taking Emtriva • Don't stop taking Emtriva without talking to your doctor.
• Ne prenehajte jemati zdravila Emtriva, ne da bi se prej posvetovali s svojim zdravnikom.
Emtriva 200 mg hard capsules
Emtriva 200 mg trde kapsule
Emtriva 10 mg/mL oral solution should be taken once daily, orally with or without food.
Zdravilo Emtriva 10 mg/ml perorala raztopina se jemlje enkrat dnevno, peroralno, s hrano ali brez.
In addition to the adverse reactions reported in adults, anaemia (9.5%) and skin discolouration (31.8%) occurred more frequently in clinical trials involving HIV infected paediatric patients.
Poleg neželenih reakcij, o katerih so poročali pri odraslih, so se v kliničnih študijah s pediatričnimi bolniki, okuženimi z virusom HIV, pogosteje pojavili anemija (9,5 %) in sprememba obarvanosti kože (31,8 %).
Due to a difference in the bioavailability of emtricitabine between the hard capsule and oral solution presentations, 240 mg emtricitabine administered as the oral solution should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule (see section 5.2).
Zaradi razlike v biološki uporabnosti emtricitabina, uporabljenega v obliki trde kapsule ali v obliki peroralne raztopine, naj bi 240 mg emtricitabina, uporabljenega v obliki peroralne raztopine, zagotavljalo podoben plazemski nivo kot je opazen po uporabi emtricitabina v obliki ene 200 mg trde kapsule (glejte poglavje 5.2).
Indigotine (E132) Titanium dioxide (E171)
Ovojnica kapsule: želatina, indigotin (E132), titanov dioksid (E171)
Capsule contents: microcrystalline cellulose (E460), crospovidone, magnesium stearate (E572), povidone (E1201)
• Druge sestavine zdravila so: Vsebina kapsule: mikrokristalna celuloza (E460), krospovidon, magnezijev stearat (E572),
Emtriva 200 mg hard capsules Emtricitabine
Emtriva 200 mg trde kapsule emtricitabin
Emtriva 10 mg/mL oral solution Emtricitabine
Emtriva 10 mg/ml peroralna raztopina emtricitabin
The cup has lines to indicate each mL of solution.
Merica ima črtice, ki označujejo mililitre raztopine.
Xylitol (E967)
povidon (E1201)
Emtriva is also available as a 10 mg/mL oral solution for use in infants aged 4 months and over, children and patients who are unable to swallow hard capsules and patients with renal insufficiency.
Zdravilo Emtriva je pri dojenčkih, starih 4 mesece ali več, otrocih in bolnikih, ki ne morejo pogoltniti trdih kapsul ter bolnikih z ledvično insuficienco na voljo tudi v obliki 10 mg/ml peroralne raztopine.
Therefore, children who weigh at least 33 kg may take either one 200 mg hard capsule daily or the oral solution up to a maximum dose of 240 mg (24 mL), once daily.
enkrat dnevno vzamejo ali eno 200 mg trdo kapsulo ali maksimalno dozo 240 mg (24 ml) peroralne raztopine.
Viruses resistant to zidovudine, didanosine and NNRTIs retained their sensitivity to emtricitabine (IC50 = 0.002 µmol/l to 0.08 µmol/l).
(zidovudin, stavudin, tenofovir, abacavir in didanozin), na vse ne-nukleozidne zaviralce reverzne transkriptaze (NNRTI, non-nucleoside reverse transcriptase inhibitors) in vse PI. Virusi, odporni na zidovudin, didanozin in NNRTI-je so obdržali svojo občutljivost za emtricitabin (IC50 = od 0,002 µmol/l do 0,08 µmol/l).
The blood levels obtained after taking one Emtriva 200 mg hard capsule are similar to those obtained after taking 24 mL of the oral solution.
Emtriva 200 mg je podoben nivoju po uporabi 24 ml peroralne raztopine.
Immune system disorders: Common:
Bolezni imunskega sistema:
Emtriva 10 mg/mL oral solution
Emtriva 10 mg/ml peroralna raztopina
Capsule contents Crospovidone
Peroralna raztopina.
Sodium phosphate monobasic hydrate Sunset yellow (E110) Purified water
propilenglikol propilparahidroksibenzoat (E216) natrijev hidroksid natrijev dihidrogenfosfat hidrat oranžno FCF (E110) prečiščena voda ksilitol (E967)
Therapy should be initiated by a physician experienced in the management of HIV infection.
4.2 Odmerjanje in način uporabe Terapijo mora izvajati zdravnik, ki že ima izkušnje z zdravljenjem okužbe z virusom HIV.
Emtricitabine-resistant viruses were cross-resistant to lamivudine, but retained sensitivity to other nucleoside reverse transcriptase inhibitors (NRTIs) (zidovudine, stavudine, tenofovir, abacavir and didanosine), all non-nucleoside reverse transcriptase inhibitors (NNRTIs) and all 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)
In an open-label, non-comparative study, pharmacokinetic data were obtained from 20 neonates of HIV infected mothers who received two 4-day courses of emtricitabine oral solution between the first week of life and 3 months of age at a dose level of 3 mg/kg once daily.
okuženih z virusom HIV, ki so prejemali dva 4-dnevna cikla emtricitabina v obliki peroralne raztopine, od prvega tedna do 3 mesecev starosti z odmerkom 3 mg/kg enkrat dnevno.
This medicine contains 36 mg of sodium (main component of cooking/table salt) per 24 mL dose.This is equivalent to 1.8% of the recommended maximum daily dietary intake of sodium for an adult.
To zdravilo vsebuje 36 mg natrija (glavna sestavina kuhinjske/namizne soli) na odmerek 24 ml.
Therefore, clinical response to treatment and renal function should be closely monitored in patients treated with emtricitabine at prolonged dosing intervals (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 emtricitabinom s podaljšanimi intervali odmerjanja
Tabulated summary of adverse reactions
Povzetek neželenih reakcij, prikazan v preglednici
Please refer to the package leaflets of the other antiretrovirals for guidance on how to take those medicines.
Prosimo, preberite si navodila za uporabo tudi drugih protiretrovirusnih zdravil.
Metabolism and nutrition disorders: Common:
alergijska reakcija Presnovne in prehranske motnje:
• Do not breast-feed if you are taking Emtriva.
• Če jemljete zdravilo Emtriva, ne dojite.
Contact your doctor again before you restart taking Emtriva capsules.
Preden začnete ponovno jemati kapsule Emtriva, se posvetujte z zdravnikom.
allergic reaction
Opozorila in previdnostni ukrepi
Each mL of Emtriva oral solution contains 10 mg of emtricitabine.
1 ml Emtriva peroralne raztopine vsebuje 10 mg emtricitabina.
ANNEX III LABELLING AND PACKAGE LEAFLET
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI OZNAČEVANJE NA NALEPKI PLASTENKE IN ŠKATLI
How much 10 mg/mL solution to take (mL)
Dnevno Telesna masa (kg) Odmerek emtricitabina (mg) Koliko 10 mg/ml peroralne raztopine je treba vzeti (ml)
Contact your doctor again before you restart taking Emtriva oral solution.
Preden začnete ponovno jemati peroralno raztopino Emtriva, se posvetujte z zdravnikom.
170 mL oral solution.
FARMACEVTSKA OBLIKA IN VSEBINA 170 ml, peroralna raztopina.
There is a separate Package Leaflet for Emtriva 10 mg/mL oral solution.
Za uporabo peroralne raztopine Emtriva 10 mg/ml je na voljo posebno navodilo za uporabo.
insomnia, abnormal dreams Nervous system disorders: Very common:
anemija2 Bolezni imunskega sistema:
Emtriva may cause dizziness.
Emtriva potrebna previdnost
If you have difficulty in swallowing the capsules, tell your doctor.
Obvestite zdravnika, če imate težave s požiranjem kapsul.
Package leaflet: Information for the user Emtriva 200 mg hard capsules
Navodilo za uporabo Emtriva 200 mg trde kapsule emtricitabin
Gilead Sciences Ireland UC
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Gilead Sciences Ireland UC
London, 24 April 2008 Doc.
London, 24. april 2008 Sklic na dok.
International non-proprietary name (INN): clofarabine
Mednarodno nelastniško ime (INN): klofarabin
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF A CHANGE TO THE MARKETING AUTHORISATION for EVOLTRA
VPRAŠANJA IN ODGOVORI V ZVEZI S UMIKOM SPREMEMBE DOVOLJENJA ZA PROMET z zdravilom EVOLTRA
After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Potem, ko je CHMP ocenil odgovore družbe na seznam vprašanj, je še vedno ostalo nerešenih nekaj pomembnih vprašanj.
Evoltra was designated as an orphan medicine for this condition on 8 May 2003.
Zdravilo Evoltra je bilo dne 8. maja 2003 določeno kot zdravilo sirota za to bolezen.