natgillin/translations-raw huggingface dataset:
Protocol 011 named Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) was a Phase 2/3 randomized open-label trial which evaluated safety and immunogenicity of Ervebo in adults ≥18 years of age working in healthcare facilities or on frontline activities related to the Ebola response in Sierra Leone.
faze, ki je ovrednotilo varnost in imunogenost cepiva Ervebo pri odraslih, starih ≥ 18 let, ki so delali v zdravstvenih ustanovah ali so sodelovali v frontnih dejavnostih, povezanih z odzivom na ebolo v Sierri Leone.
Anaphylactic reaction
anafilaktična reakcija zelo redki
Any unused vaccine or waste material should be disposed in compliance with the institutional guidelines for genetically modified organisms or biohazardous waste, as appropriate.
Neuporabljeno cepivo ali odpadni material zavrzite v skladu s smernicami, ki v ustanovi veljajo za odpadke z genetsko spremenjenimi organizmi ali za biološko nevarne odpadke, kot je ustrezno.
Transient decrease in white blood cells
Prehodno zmanjšanje števila levkocitov
Have a bleeding disorder or bruise easily
Če imate kakšno motnjo strjevanja krvi ali ste nagnjeni k podplutbam
• Ervebo is a colourless to slightly brownish-yellow liquid.
• Cepivo Ervebo je brezbarvna do rahlo rjavorumena tekočina.
Pharmacotherapeutic group: Vaccines, Viral Vaccine, ATC code: J07BX02
Oznaka ATC: J07BX02
Do not receive Ervebo if you:
Cepiva Ervebo ne smete prejeti:
clusters) vaccinated in the immediate arm and 1,429 subjects (46 clusters) eligible and consented on Day 0 in the delayed arm.
Končna primarna analiza je zajela 2.108 oseb (51 gruč) iz skupine s takojšnjim cepljenjem in 1.429 oseb (46 gruč), ki so bile na dan 0 primerne in so dale soglasje za vključitev v študijo, iz skupine z odloženim cepljenjem.
Ervebo should be administered by the intramuscular (IM) route.
Cepivo Ervebo mora biti injicirano intramuskularno (i.m.)
What Ervebo contains
Kaj vsebuje cepivo Ervebo
After thawing, the vaccine should be used immediately; however, in-use stability data have demonstrated that once thawed, the vaccine can be stored for up to 14 days at 2°C to 8°C prior to use.
Vendar pa so podatki o stabilnosti med uporabo pokazali, da je mogoče po odtajanju cepivo pred uporabo shranjevati do 14 dni pri temperaturi od 2 do 8 °C.
• Ervebo should be administered intramuscularly.
• Cepivo Ervebo injicirajte intramuskularno.
Ervebo solution for injection rVSVΔG-ZEBOV-GP, live IM
Ervebo raztopina za injiciranje rVSVΔG-ZEBOV-GP, z živimi virusi i.m.
• If you get a rash where the skin is broken after receiving Ervebo, cover it until it heals.
• Če se vam po prejetju cepiva Ervebo na poškodovani koži pojavi izpuščaj, ga pokrijte, dokler se ne pozdravi.
Immunocompromised individuals
Imunsko oslabeli bolniki
Thrombocytopenia and coagulation disorders
Trombocitopenija in motnje strjevanja krvi
If you get any side effects, talk to your healthcare worker.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravstvenim delavcem.
If you get a rash where the skin is broken after receiving Ervebo, cover it until it heals.
Če se vam po prejetju cepiva Ervebo na poškodovani koži pojavi izpuščaj, ga pokrijte, dokler se ne pozdravi.
Ervebo solution for injection Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP, live)
Ervebo raztopina za injiciranje cepivo proti virusu Ebola Zaire (rVSVΔG-ZEBOV-GP, z živimi virusi)
This is because you could pass the vaccine to them through your body fluids.
Viruse iz cepiva bi namreč na takšno osebo lahko prenesli s svojimi telesnimi tekočinami.
• If you might be in close contact with, or in the same household as someone who may be pregnant or breast-feeding during the 6 weeks after you receive Ervebo, tell your healthcare worker.
• Zdravstvenemu delavcu morate povedati, če boste v 6 tednih po cepljenju s cepivom Ervebo morda v tesnem stiku ali v istem gospodinjstvu z osebo, ki je morda noseča ali doji.
The MAH should provide additional data to confirm that the active substance (AS) process is properly validated.
Imetnik dovoljenja za promet s cepivom mora predložiti dodatne podatke, ki potrjujejo, da je postopek izdelave učinkovine ustrezno validiran.
• Withdraw the entire content of the vaccine from the vial using a sterile needle and syringe.
• S sterilno iglo in injekcijsko brizgo iz viale izvlecite celotno vsebino cepiva.
• Contact with bats, apes and monkeys or with blood, fluids and raw meat prepared from these animals (bushmeat) or meat from an unknown source.
tekočinami in surovim mesom teh živali in z mesom neznanega izvora.
• Fever,
• mrzlica
• Withdraw the entire content of Ervebo from the vial using a sterile needle and syringe.
• S sterilno iglo in injekcijsko brizgo iz viale izvlecite celotno vsebino cepiva Ervebo.
Month 12* GMT (n) [95% CI]
12. mesec* GMT (n) [95 % IZ]
• Respiratory hygiene
• zvišana telesna temperatura
LIST OF EXCIPIENTS
• oteklost sklepov
Month 24 GMT (n) [95% CI]
24. mesec GMT (n) [95 % IZ]
Month 1 GMT (n) [95% CI]
1. mesec GMT (n) [95 % IZ]
• Tell your healthcare worker if you have a problem with bleeding or you bruise easily.
• Če imate kakšno težavo s strjevanjem krvi ali če se vam zlahka pojavijo podplutbe, morate o tem obvestiti zdravstvenega delavca.
You should not receive Ervebo if any of the above apply to you.
Če kaj od navedenega velja za vas, ne smete dobiti cepiva Ervebo.
Month 6 GMT (n) [95% CI]
6. mesec GMT (n) [95 % IZ]
Injection site pain Injection site erythema Injection site swelling
zvišana telesna temperatura utrujenost bolečina na mestu injiciranja eritem na mestu injiciranja oteklost na mestu injiciranja zelo pogosti mrzlica hiperhidroza (znojenje)
GMT (n) [95% CI]
Izhodišče GMT (n) [95 % IZ]
Frequencies are reported as:
Bolezni prebavil:
The reason for this difference is unknown.
Razlog za to razliko ni znan.
Date of first authorisation: 24 October 2003 Date of latest renewal: 22 September 2008
Datum prve odobritve: 24. oktober 2003 Datum zadnjega podaljšanja: 22. september 2008
The mechanism is unknown.
Mehanizem ni znan.
It may also help to increase the number of T cells called CD4 cells.
Prav tako lahko tudi pomaga povečati število celic T, imenovanih celice CD4.
Swallow the hard capsule with a glass of water.
Trdo kapsulo pogoltnite s kozarcem vode.
1 See section 4.8, Description of selected adverse reactions for more details.
1 Glejte poglavje 4.8, Opis izbranih neželenih reakcij za več podrobnosti.
< 15 (functionally anephric, requiring intermittent haemodialysis)*
< 15 (funkcionalno anefričen, zahteva intermitentno hemodializo)*
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.
Most of these combinations have not been studied in humans.
Večina od teh študij ni bila opravljena na ljudeh.
• If you are allergic to emtricitabine or any of the other ingredients of this medicine (listed in section 6).
• Če ste alergični na emtricitabin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
 If this applies to you, tell your doctor immediately.
 Če to velja za vas, o tem nemudoma obvestite zdravnika.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10) or uncommon (≥ 1/1,000 to < 1/100).
Frekvence so definirane kot zelo pogoste (≥ 1/10), pogoste (≥ 1/100 do < 1/10) ali občasne (≥ 1/1.000
• muscle pain and weakness (if creatine kinase levels in the blood are increased)
• bolečine v mišicah in mišična oslabelost (če so ravni kreatin-kinaze v krvi povišane)
If you are sick (vomit)
Če vam je slabo (če bruhate)
Store in a refrigerator (2°C - 8°C) until opened.
Shranjujte v hladilniku (2 °C - 8 °C), dokler ne odprete.
Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
Nemudoma obvestite zdravnika o vsakem novem ali nenavadnem simptomu potem, ko ste prenehali z zdravljenjem, še posebej o simptomih, ki jih povezujete z okužbo s hepatitisom B.
The safety and efficacy of these doses have not been clinically evaluated.
Varnost in učinkovitost teh odmerkov še nista bili klinično ovrednoteni.
It is known that the virus can be passed to the baby in breast milk.
Znano je, da se virus lahko prenese na otroka z materinim mlekom.
Phenotypic analysis showed no significant changes in emtricitabine susceptibility unless the M184V/I mutation had developed.
Fenotipska analiza ni pokazala bistvenih sprememb v občutljivosti za emtricitabin, razen če se je razvila mutacija M184V/I.
If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you.
Če ste okuženi s hepatitisom B, bo vaš zdravnik skrbno razmislil o najboljšem režimu zdravljenja za vas.
Keep the carton with you so that you can easily describe what you have taken.
S seboj imejte škatlo, da boste lahko opisali, kaj ste zaužili.
Adults with renal insufficiency
Odrasli z ledvično insuficienco
Although the mean Cmax and Cmin were approximately 20% higher and mean AUC was 16% higher in females compared to males, this difference was not considered clinically significant.
Čeprav je bila povprečna vrednost Cmax in Cmin pri ženskah višja za približno 20 % in povprečna vrednost AUC višja za 16 % kot pri moških, ta razlika ni klinično pomembna.
* Assumes a 3-hour haemodialysis session three times a week commencing at least 12 h after administration of the last dose of emtricitabine.
* Predpostavlja 3-urno hemodializo trikrat tedensko, z začetkom vsaj 12 ur po uporabi zadnjega odmerka emtricitabina.
The frequency category of uncommon was estimated from a statistical calculation based on the total number of patients exposed to emtricitabine in these clinical studies (n = 1,563).
Kategorija pogostnosti občasna je bila ocenjena s statističnim izračunom na podlagi skupnega števila bolnikov, izpostavljenih emtricitabinu v teh kliničnih študijah (n = 1.563).
In general, the pharmacokinetics of emtricitabine in infants, children and adolescents (aged 4 months up to 18 years) are similar to those seen in adults.
Na splošno so farmakokinetične lastnosti emtricitabina pri dojenčkih, otrocih in mladostnikih (v starosti od 4 mesecev do 18 let) podobne tistim, ki so bile opažene pri odraslih.
Ethnicity No clinically important pharmacokinetic difference due to ethnicity has been identified.
Etnična pripadnost Ni bilo identificirane klinično pomembne farmakokinetične razlike glede na etnično pripadnost.
Emtriva [outer packaging only]
Emtriva [samo na zunanji ovojnini]
This is because the active substance in this medicine passes into human breast milk.
To je zato, ker zdravilna učinkovina tega zdravila prehaja v materino mleko.
After opening: The solution should be used within 45 days.
Po odprtju: Raztopina mora biti uporabljena v roku 45 dni.
Up to 30% of the emtricitabine dose can be removed by haemodialysis.
Do 30 % odmerka emtricitabina se lahko odstrani s hemodializo.
If you experience dizziness while taking Emtriva, do not drive and do not use any tools or machines.
Če ste v času zdravljenja z uporabo zdravila Emtriva omotični, ne vozite avtomobila in ne upravljajte z orodji ali stroji.
Blisters made of polychlorotrifluorethylene (PCTFE) / polyethylene (PE) / polyvinylchloride (PVC) / aluminium.
Pretisni omot je narejen iz poliklorotrifluoretilena (PCTFE)/polietilena (PE)/polivinilklorida (PVC)/ aluminija.
It must be used in combination with other antiretrovirals.
Uporabljati se mora v kombinaciji z drugimi protiretrovirusnimi zdravili.
• If you could get pregnant during treatment with Emtriva, you must use an effective method of contraception to stop you getting pregnant.
• Če bi lahko med zdravljenjem z zdravilom Emtriva zanosili, morate uporabljati učinkovito kontracepcijsko metodo, ki preprečuje zanositev.
A moderate amount of data on pregnant women (between 300 and1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with emtricitabine.
Manjše število podatkov pri nosečnicah (med 300 in 1.000 izpostavljenih nosečnosti) ne kaže na malformacije ali feto/neonatalno toksičnost, povezane z emtricitabinom.
• You must not take Emtriva during pregnancy unless specifically directed by your doctor.
• Zdravila Emtriva ne smete jemati med nosečnostjo, razen če je to posebej odredil vaš zdravnik.
Therefore Emtriva is not recommended for use in those aged less than 4 months (for pharmacokinetic data in this age group, see section 5.2).
Zato se uporaba zdravila Emtriva pri bolnikih, mlajših od 4 mesecev ne priporoča (za farmakokinetične podatke v tej starostni skupini glejte poglavje 5.2).
The safety and efficacy of the dose interval adjustments to every 72 or 96 hours in patients with creatinine clearance < 30 mL/min have not been clinically evaluated.
Varnost in učinkovitost teh prilagoditev intervala odmerjanja na vsakih 72 ali 96 ur pri bolnikih z očistkom kreatinina < 30 ml/min še nista bili klinično ovrednoteni.
It is not known whether emtricitabine can be removed by peritoneal dialysis.
Ni znano, ali se lahko emtricitabin odstrani s peritonealno dializo.
If the production of red blood cells is reduced, a child may have symptoms of tiredness or breathlessness.
Če je tvorba rdečih krvnih telesc zmanjšana, se pri otroku lahko pojavijo znaki utrujenosti ali zadihanosti.
Although there are limited clinical data on the use of Emtriva in pregnant women, it is not usually used unless absolutely necessary.
Čeprav so na voljo nezadostni klinični podatki o uporabi zdravila Emtriva pri nosečnicah, se zdravila Emtriva ponavadi ne uporablja, razen če je nujno potrebno.
Other medicines and Emtriva
Druga zdravila in zdravilo Emtriva
There is insufficient evidence to determine whether re-initiation of emtricitabine alters the course of post-treatment exacerbations of hepatitis.
Ni dovolj dokazov, s katerimi bi določili, ali je ponoven začetek zdravljenja z emtricitabinom spremenil potek poslabšanja hepatitisa po zdravljenju.
The systemic clearance of emtricitabine averaged 307 mL/min (4.03 mL/min/kg).
Sistemski očistek emtricitabina je v povprečju 307 ml/min (4,03 ml/min/kg).
If it is almost time (less than 12 hours) for your next dose anyway, forget about the missed dose.
Če je že skoraj čas za vaš naslednji odmerek (manj kot 12 ur), pozabljenega odmerka ne vzemite.
• dizziness, weakness, difficulty sleeping, abnormal dreams
• omotica, oslabelost, težave s spanjem, nenavadne sanje
The YMDD mutation confers resistance to both emtricitabine and lamivudine.
Mutacija YMDD povzroča odpornost tako na emtricitabin kot na lamivudin.
The use of emtricitabine may be considered during pregnancy, if necessary.
Če je potrebno, se lahko pretehta možnost uporabe emtricitabina med nosečnostjo.
If there is evidence of exacerbations of liver disease in such patients, interruption or discontinuation of treatment must be considered.
Če se opazi poslabšanje obolenja jeter pri teh bolnikih, je potrebno razmisliti o prekinitvi ali prenehanju tovrstnega zdravljenja.
• Your doctor will prescribe Emtriva with other antiretroviral medicines.
• Zdravnik vam bo predpisal zdravilo Emtriva skupaj z drugimi protiretrovirusnimi zdravili.
If you have taken Emtriva during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Če ste zdravilo Emtriva jemali med nosečnostjo, vas lahko zdravnik naroči na redne preiskave krvi in druge diagnostične preiskave, da bo nadzoroval razvoj vašega otroka.
Animal studies do not indicate harmful effects of emtricitabine on fertility.
Študije na živalih ne kažejo škodljivih učinkov emtricitabina na plodnost.
Emtriva may lower the amount of HIV in the blood (viral load).
Zdravilo Emtriva lahko zniža prisotnost virusa HIV v krvi (viral load).
After first opening: 45 days.
45 dni od prvega odprtja.
As a general rule, it is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV to the infant.
Splošno priporočljivo je, naj s HIV okužene ženske v nobenem primeru ne dojijo, da se prepreči prenos HIV na dojenčka.
The adverse reactions with suspected (at least possible) relationship to treatment in adults from clinical trial and post-marketing experience are listed in Table 2 below by body system organ class and frequency.
Neželene reakcije z domnevno (vsaj možno) zvezo z zdravljenjem pri odraslih bolnikih iz klinične študije in izkušenj v obdobju trženja zdravila so navedene spodaj v preglednici 2 glede na organske sisteme in frekvenco.
• headache, diarrhoea, feeling sick (nausea)
• glavobol, driska, občutek siljenja na bruhanje (navzea)
You should not take Emtriva if you are already taking other medicines that contain emtricitabine or lamivudine, 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 ali lamivudin, ki se prav tako uporabljajo za zdravljenje okužbe z virusom HIV, razen če vaš zdravnik ne odredi drugače.
Where available, resistance testing may be appropriate.
Kadar je le mogoče, je predhodno priporočljivo opraviti test rezistence.
However, limited data are available on the efficacy and safety of emtricitabine (as a 200 mg hard capsule once daily) in patients who are co-infected with HIV and HBV.
Vendar pa so na voljo omejeni podatki o učinkovitosti in varnosti uporabe emtricitabina (v obliki 200 mg trde kapsule enkrat dnevno) pri bolnikih s hkratno okužbo s HIV in HBV.
Intracellular pharmacokinetics: In a clinical study, the intracellular half-life of emtricitabine-triphosphate in PBMCs was 39 hours.
Znotrajcelične farmakokinetične lastnosti: V kliničnih študijah je bila znotrajcelična razpolovna doba emtricitabin-trifosfata v PBMC 39 ur.
Stopping treatment with Emtriva may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.
Prenehanje zdravljenja z zdravilom Emtriva lahko zmanjša učinkovitost zdravljenja okužbe s HIV, ki vam ga je predpisal zdravnik.
It is advised to write the date of removal from the refrigerator on the package.
Priporočljivo je, da na ovojnino zapišete datum, ko ste zdravilo vzeli iz hladilnika.
Administration of up to 1,200 mg emtricitabine has been associated with the adverse reactions listed above (see section 4.8).
Uporabo do maksimalno 1.200 mg emtricitabina spremljajo neželeni učinki, navedeni zgoraj (glejte poglavje 4.8).
Table 2: Tabulated summary of adverse reactions associated with emtricitabine based on clinical study and post-marketing experience
Preglednica 2: Povzetek neželenih reakcij, povezanih z emtricitabinom na podlagi izkušenj iz kliničnih študij in izkušenj v obdobju trženja zdravila
Tell your doctor about any of the following side effects: Most frequent side effects
Obvestite zdravnika, če imate kateregakoli od naslednjih neželenih učinkov: Najpogostejši neželeni učinki
Pharmacotherapeutic group: Nucleoside and nucleotide reverse transcriptase inhibitors, ATC code: J05AF09
Farmakoterapevtska skupina: Nukleozidni in nukleotidni zaviralci reverzne transkriptaze, oznaka ATC: J05AF09
This dose is half of that approved for infants aged 4 months and over (6 mg/kg).
To je polovica odmerka, odobrenega za dojenčke, stare 4 mesece ali več (6 mg/kg).
This HIV-1 mutation was observed in vitro and in HIV-1 infected patients.
Ta mutacija virusa HIV-1 je bila opažena in vitro in pri bolnikih, okuženih z virusom
Emtricitabine is active in vitro against HBV.
Emtricitabin je aktiven in vitro proti virusu HBV.
Make sure that you understand how to measure and give the right amount of oral solution according to the weight of the person being treated.
Prepričajte se, da znate pravilno odmeriti in uporabiti ustrezno količino peroralne raztopine ob upoštevanju telesne mase zdravljenega bolnika.
It is important not to miss a dose of Emtriva.
Pomembno je, da ne pozabite vzeti nobenega odmerka zdravila Emtriva.
Do not take a double dose to make up for a forgotten hard capsule.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjo trdo kapsulo.
Elderly: There are no safety and efficacy data available in patients over the age of 65 years.
Starostniki: Ni razpoložljivih podatkov o varnosti in učinkovitosti uporabe pri bolnikih, starejših od 65 let.
A measuring cup is provided (see section 6.5).
Merica je priložena (glejte poglavje 6.5).
Patients co-infected with HBV
Bolniki, ki so okuženi hkrati še s HBV
However, no adjustment in the recommended daily dose for adults should be required unless there is evidence of renal insufficiency.
Vendar za odrasle ni potrebno prilagajanje priporočenega dnevnega odmerka razen v primeru ledvične insuficience.
Based on the results of these in vitro experiments and the known elimination pathways of emtricitabine, the potential for CYP450 mediated interactions involving emtricitabine with other medicinal products is low.
Ob upoštevanju rezultatov tovrstnih in vitro poskusov in znanih poti izločanja emtricitabina je možnost CYP450 posredovanih interakcij, ki vključujejo emtricitabin skupaj z drugimi zdravili, majhna.
In some of these patients, HBV reactivation was associated with more severe liver disease, including decompensation and liver failure.
Pri nekaterih od teh bolnikov je bila reaktivacija virusa HBV povezana s hujšo boleznijo jeter, vključno z dekompenzacijo in odpovedjo delovanja jeter.
If you have a history of liver disease or chronic hepatitis B infection your doctor may conduct blood tests in order to carefully monitor liver function.
Če ste imeli jetrne bolezni ali okužbo s kroničnim hepatitisom B, bo vaš zdravnik morda opravil krvne preiskave za skrbno nadzorovanje jetrne funkcije.
Assessment of adverse reactions from clinical study data is based on experience in three studies in adults (n = 1,479) and three paediatric studies (n = 169).
Ugotavljanje neželenih reakcij iz podatkov kliničnih študij temelji na izkušnjah treh študij z odraslimi bolniki (n = 1.479) in treh pediatričnih študij (n = 169).
When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient.
Pri določanju novega režima zdravljenja pri bolnikih z neuspešnim predhodnim protiretrovirusnim režimom je potrebno posebno pozornost nameniti vzorcem mutacij kot posledic uporabe različnih zdravil in poteku zdravljenj pri posameznem bolniku.
However, 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.
In case of concomitant antiviral therapy for hepatitis B or C, please also refer to the relevant Summary of Product Characteristics for these medicinal products.
V primeru spremljajočega antivirusnega zdravljenja okužbe s hepatitisom B ali C, upoštevajte prosimo ustrezen povzetek glavnih značilnosti za ta zdravila.
Contents of the pack and other information What Emtriva contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Emtriva
Relevant examples include cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Ustrezni primeri vključujejo citomegalovirusni retinitis, generalizirane in/ali žariščne mikobakterijske okužbe in s Pneumocystis jirovecii povzročena pljučnica.
If you are older than this and are prescribed Emtriva, your doctor will monitor you carefully.
Če ste starejši od 65 let in so vam predpisali zdravilo Emtriva, vas bo zdravnik skrbno nadzoroval.
Therefore Emtriva should not be used during breastfeeding.
Zato se zdravilo Emtriva med dojenjem ne sme uporabljati.
The clear solution is orange to dark orange in colour.
Prozorna raztopina je oranžne do temno oranžne barve.
There is no clinical experience of the use of emtricitabine in infants less than 4 months of age.
Ni kliničnih izkušenj z uporabo emtricitabina pri dojenčkih, mlajših od 4 mesecev.
Emtriva should always be combined with other medicines to treat HIV infection.
Zdravilo Emtriva je treba vedno kombinirati z drugimi zdravili za zdravljenje okužbe z virusom HIV.