natgillin/translations-raw huggingface dataset:
Experience in patients with HBeAg positive CHB and compensated liver disease: in controlled studies, 1 year of lamivudine therapy significantly suppressed HBV DNA replication (34-57% of patients were below the assay detection limits (Abbott Genostics solution hybridization assay, LLOD < 1.6pg/ ml)], normalised ALT level (40-72% of patients), induced HBeAg seroconversion (HBeAg loss and HBeAb detection with HBV DNA loss [by conventional assay], 16-18% of patients), improved histology (38-52% of patients had a ≥ 2 point decrease in the Knodell Histologic Activity Index [HAI]) and reduced progression of fibrosis (in 3-17% of patients) and progression to cirrhosis.
Izkušnje pri HBeAg pozitivnih bolnikih s CHB in kompenzirano jetrno boleznijo: v nadzorovanih študijah je enoletno zdravljenje z lamivudinom znatno zavrlo replikacijo HBV DNA [pri 34 do 57% bolnikov je bila pod mejo dokazljivosti s testom (Abbott Genostics hibridizacijski test v raztopini, LLOD < 1, 6 pg/ ml)], normaliziralo aktivnost ALT (pri 40 do 72% bolnikov), sprožilo serokonverzijo HBeAg (izginotje HBeAg ter pojav protiteles HBeAb z izginotjem HBV DNA [z običajnimi testi] pri 16 do 18% bolnikov), izboljšalo histološko sliko (pri 38 do 52% bolnikov se je Knodell- ov histološki indeks aktivnosti [HAI] znižal za ≥ 2 točki) in zmanjšalo progresijo fibroze (pri 3 do 17% bolnikov) in progresijo v cirozo.
Table 2:
18 Tabela 2:
19 Subjects,% (no.)
Osebe,% (št.)
All patients Baseline ALT ≤ 1 x ULN2 Baseline ALT > 2 x ULN
- Vsi bolniki - Bolniki z izhodiščno vrednostjo ALT ≤ 1 x ZMN2
(15/ 40) (1/ 11) (9/ 15)
72 (13/ 18) 33 (2/ 6)
72 33 100
60 (9/ 15)
(13/ 18) (2/ 6) (11/ 11)
100 (11/ 11)
67
67 (12/ 18)
- Week 260
260. teden normalna vrednost
1 Patients designated as YMDD variant were those with ≥ 5% YMDD variant HBV at any annual time-point during the 5-year period.
1 Bolniki z YMDD varianto so bolniki, ki so v obdobju 5- ih let imeli v katerem koli časovnem obdobju ≥ 5% YMDD variante HBV.
Patients categorised as non-YMDD variant were those with > 95% wild-type HBV at all annual time-points during the 5-year study period
Bolniki brez YMDD variante so bolniki, ki so med 5 letnim trajanjem študije v vseh časovnih obdobjih
In a long-term follow-up study of patients who had previously seroconverted and discontinued lamivudine, late virological relapse occurred in 39% of the subjects.
V študiji dolgotrajnega spremljanja bolnikov, ki so se po serokonverziji prenehali zdraviti z lamivudinom, je pri 39% oseb prišlo do poznega relapsa.
A comparison of post-treatment ALT elevations between weeks 52 and 68 in patients who discontinued lamivudine at week 52 and patients in the same studies who received placebo throughout the treatment course is shown in Table 3.
V tabeli 3 je prikazano zvišanje ALT po zdravljenju med 52. in 68. tednom pri bolnikih, katerim so v 52. tednu ukinili lamivudin, v primerjavi z bolniki v isti študiji, ki so celo
20 Table 3:
Tabela 3:
Addition of 10 mg adefovir dipivoxil once daily to ongoing lamivudine 100mg for 52 weeks resulted in a median decrease in HBV DNA of 4.6 log10 copies/ ml.
52- tedensko zdravljenje z lamivudinom v odmerku 100 mg in dodatkom 10 mg
Improvement in liver function was also seen after one year of therapy.
20 adefovirjevega dipivoksila enkrat dnevno je vrednosti HBV DNA v povprečju zmanjšalo za 4, 6 log10 kopij/ ml.
Experience in patients with decompensated liver disease: placebo controlled studies have been regarded as inappropriate in patients with decompensated liver disease, and have not been undertaken.
Izkušnje pri bolnikih z dekompenzirano jetrno boleznijo: s placebom nadzorovane študije pri bolnikih z dekompenzirano jetrno boleznijo se smatrajo kot neprimerne, zato niso bile izvedene.
21 In non-controlled studies, where lamivudine was administered prior to and during transplantation, effective HBV DNA suppression and ALT normalisation was demonstrated.
V nenadzorovanih študijah, kjer so lamivudin dajali pred ali med transplantacijo, je bila dokazana učinkovita supresija HBV DNA in normalizacija ALT.
The difference in the HBeAg seroconversion rates (HBeAg and HBV DNA loss with HBeAb detection) between placebo and lamivudine was not statistically significant in this population (rates after one year were 13% (12/ 95) for placebo versus 22% (42/ 191) for lamivudine; p=0.057).
Pri tej populaciji razlika v odstotkih serokonverzije HBeAg (izginotje HBeAg in HBV DNA ter pojav protiteles HBeAb) med placebom in lamivudinom ni bila statistično signifikantna (po enem letu je bila 13% (12/ 95) za placebo v primerjavi z 22% (42/ 191) za lamivudin; p = 0, 0057).
The incidence of YMDD variant HBV was similar to that observed in adults, ranging from 19% at week 52 up to 45% in patients treated continuously for 24 months.
Pojavnost YMDD variante HBV je bila podobna tisti, ki so jo opazili pri odraslih, v obsegu od 19% v 52. tednu do 45% pri bolnikih, ki so se kontinuirano zdravili 24 mesecev.
Limited data shows lamivudine penetrates the central nervous system and reaches the cerebro-spinal fluid (CSF).
21 Omejeni podatki kažejo, da lamivudin prodira v centralni živčni sistem in doseže cerebrospinalno tekočino (CSF - "cerebro- spinal fluid").
22 Elimination:
Izločanje:
Sucrose (20% w/ v) Methyl Parahydroxybenzoate (E218) Propyl Parahydroxybenzoate (E216) Citric Acid (anhydrous) Propylene Glycol Sodium Citrate Artificial strawberry flavour Artificial banana flavour Purified water
Saharoza (20% w/ v) Metilparahidroksibenzoat (E218) Propilparahidroksibenzoat (E216)
Cartons containing 240 ml lamivudine oral solution 5 mg/ ml in an opaque, white, high-density polyethylene (HDPE) Bottle with a polypropylene child resistant closure.
Škatlice, ki vsebujejo 240 ml peroralne raztopine lamivudina (5 mg/ ml) v neprosojnih, belih plastenkah iz polietilena visoke gostote (HDPE), z za otroke varno zaporko iz polipropilena.
The pack includes a clear polypropylene oral dosing syringe and a polyethylene syringe-adapter.
Škatlici je priložena tudi prozorna peroralna odmerna brizga iz polipropilena in polietilenski nastavek za brizgo.
The oral dosing syringe is provided for accurate measurement of the prescribed dose of oral solution.
Za natančno odmerjanje predpisanega odmerka peroralne raztopine je priložena peroralna odmerna brizga.
Instructions for use are included in the pack.
Navodilo za uporabo je priloženo v škatlici.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION 24 Date of first authorisation:
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
Glaxo Wellcome Operations Priory Street, Ware Hertfordshire SG12 0DJ United Kingdom.
Glaxo Wellcome Operations Priory Street, Ware Hertfordshire SG12 0DJ Velika Britanija
Not applicable.
26 DODATEK III
OUTER CARTON FOR TABLETS:
ZUNANJA OVOJNINA ZA TABLETE:
28 tablet box
ŠKATLICA Z 28 TABLETAMI
Each film-coated tablet contains lamivudine 100 mg
Ena filmsko obložena tableta vsebuje 100 mg lamivudina.
31 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS:
30 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
28 tablet box
ŠKATLA Z 28 TABLETAMI
NAME OF THE MARKETING AUTHORISATION HOLDER
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM/ PROIZVAJALCA
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
31 PODATKI NA ZUNANJI OVOJNINI
84 tablet box
ŠKATLA S 84 TABLETAMI
34 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS:
33 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU:
35 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
34 PODATKI NA ZUNANJI OVOJNINI
Zeffix 5 mg/ ml oral solution Lamivudine
Zeffix 5 mg/ ml peroralna raztopina lamivudin
240 ml oral solution containing 5 mg/ ml lamivudine
240 ml peroralne raztopine vsebuje 5 mg/ ml lamivudina.
37 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL FOR ORAL SOLUTION
NALEPKA ZA PLASTENKO PERORALNE RAZTOPINE
Contents 240 ml oral solution containing 5 mg/ ml lamivudine
240 ml peroralne raztopine vsebuje 5 mg/ ml lamivudina.
PACKAGE LEAFLET
39 NAVODILO ZA UPORABO
Zeffix 100 mg film-coated tablets Lamivudine
Zeffix 100 mg filmsko obložene tablete Lamivudin
- Keep this leaflet.
– Navodilo shranite.
- If you have further questions, ask your doctor or pharmacist.
Morda ga boste želeli ponovno prebrati. – Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom. – Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim. – Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Before you take Zeffix 3.
Preden vzamete zdravilo Zeffix 3.
How to take Zeffix 4.
Kako jemati zdravilo Zeffix 4.
How to store Zeffix 6.
Shranjevanje zdravila Zeffix 6.
WHAT ZEFFIX IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ZEFFIX IN ZA KAJ GA UPORABLJAMO
Zeffix belongs to a group of medicines called antivirals.
Zeffix spada v skupino protivirusnih zdravil.
It is used for the treatment of hepatitis B virus infection.
Uporablja se za zdravljenje okužbe z virusom hepatitisa B.
Zeffix is used to treat patients 18 years of age or over with long term (chronic) hepatitis B.
Zeffix se uporablja za zdravljenje bolnikov, starih 18 let ali več, z dolgotrajnim (kroničnim) hepatitisom B.
Hepatitis B is a virus which infects the liver, and leads to liver damage.
Hepatitis B je virus, ki okuži jetra in povzroči njihovo okvaro.
Treatment with Zeffix can reduce the amount of hepatitis B virus in your body.
Zdravljenje z Zeffixom lahko zmanjša količino virusa hepatitisa B v vašem telesu.
BEFORE YOU TAKE ZEFFIX
PREDEN VZAMETE ZDRAVILO ZEFFIX
Do not take Zeffix:
Ne jemljite zdravila Zeffix
• if you are allergic (hypersensitive) to lamivudine or to any of the other ingredients of Zeffix.
• če ste alergični na (preobčutljvi za) lamivudin ali katero koli drugo sestavino zdravila Zeffix.
If you are not sure please consult your doctor.
Če niste prepričani, se posvetujte s svojim zdravnikom.
Take special care with Zeffix
Bodite posebno pozorni pri jemanju zdravila Zeffix
Zeffix reduces the amount of hepatitis B virus in your body, and keeps the liver disease under control, therefore reducing health problems relating to your liver in the future.
Zeffix zmanjšuje količino virusa hepatitisa B v vašem telesu in tako obvladuje jetrno bolezen, torej zmanjšuje vaše kasnejše zdravstvene težave z jetri.
For effective treatment you will need to take Zeffix every day.
Za učinkovito zdravljenje boste morali Zeffix jemati vsak dan.
Patients respond to the treatment differently, therefore it is not known for how long you will have to take this medicine.
Bolniki odgovorijo na zdravljenje različno, zato ni znano, kako dolgo boste morali jemati to zdravilo.
Your doctor will be checking your response to treatment by taking regular blood samples.
Zdravnik vam bo redno jemal vzorce krvi in tako preverjal odgovor na zdravljenje.
The results of these tests will help your doctor to decide when your treatment with Zeffix can be stopped.
Rezultati teh testov bodo zdravniku pomagali pri odločitvi, kdaj naj prekine vaše zdravljenje z Zeffixom.
Before treatment with Zeffix you should have discussed any additional medical problems that you have with your doctor.
Pred zdravljenjem z Zeffixom se morate o vseh svojih dodatnih zdravstvenih težavah pogovoriti z zdravnikom.
If you have kidney disease the dose of this medicine may have to be reduced, as it is your kidneys that are mainly responsible for getting rid of the medicine from your body.
Če imate bolezen ledvic, bo morda treba zmanjšati odmerek tega zdravila, saj so zlasti
Zeffix is available as an oral solution.
Zeffix je na voljo tudi v obliki peroralne raztopine.
This means that your doctor can prescribe a lower dose for you if necessary.
To pomeni, da vam lahko vaš zdravnik po potrebi predpiše manjši odmerek.
41 Do not stop taking Zeffix without instruction from your doctor, as there is a small risk of your hepatitis getting worse.
Ne prenehajte z jemanjem zdravila Zeffix, ne da vam bi tako naročil vaš zdravnik, obstaja namreč manjše tveganje za poslabšanje hepatitisa.
When you stop taking Zeffix your doctor will monitor you for at least the following four months to check for any problems.
Ko boste prenehali jemati Zeffix, vas bo vaš zdravnik še vsaj naslednje štiri mesece nadziral zaradi kakršnih koli težav.
This will mean taking blood samples to check for any abnormal liver enzymes, indicating liver damage.
Jemal vam bo vzorce krvi in preverjal morebitne nepravilnosti jetrnih encimov, ki bi kazale na okvaro jeter.
The active substance in Zeffix is lamivudine.
V zdravilu Zeffix je zdravilna učinkovina lamivudin.
If you are already taking this medicinal product for HIV infection, your doctor will continue to treat you with the higher dose, usually 150 mg twice a day, as the lower dose of 100 mg lamivudine is insufficient to treat HIV infection.
Če to zdravilo že jemljete zaradi okužbe z virusom HIV, vas bo vaš zdravnik še naprej zdravil z večjim, običajno 150 mg, odmerkom dvakrat dnevno, saj manjši 100 mg odmerek lamivudina ne zadostuje za zdravljenje okužbe z virusom HIV.
Because your medicine helps to control your hepatitis B and it is not yet known whether it will cure it, you are still at risk of transmitting this virus to others through sexual contact or by blood transfer, and you should use appropriate precautions to prevent this.
Ker vam vaše zdravilo pomaga obvladati hepatitis B, ni pa še znano, če ga bo tudi pozdravil, še vedno obstaja tveganje za prenos virusa na druge s spolnim stikom ali s krvjo, zato morate za preprečitev tega uporabiti ustrezne varnostne ukrepe.
There is an effective vaccine available to protect those at risk from becoming infected with hepatitis B virus.
Za zaščito oseb, pri katerih obstaja tveganje za okužbo z virusom hepatitisa B, je na voljo učinkovito cepivo.
Taking other medicines Some medicines may affect the action of Zeffix.
Jemanje drugih zdravil Nekatera zdravila lahko vplivajo na delovanje zdravila Zeffix.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pomembno je, da svojega zdravnika obvestite o vseh zdravilih, ki jih jemljete ali ste jih pred kratkim jemali, tudi o tistih, ki ste jih dobili brez recepta.
Zeffix should not be taken with zalcitabine.
Zdravila Zeffix ne smete vzeti, če jemljete zdravilo, ki vsebuje zalcitabin.
Taking Zeffix with food and drink Zeffix can be taken with food or on an empty stomach.
Jemanje zdravila Zeffix skupaj s hrano in pijačo Zeffix se lahko jemlje s hrano ali na prazen želodec.
Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Nosečnost in dojenje Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katero koli zdravilo.
Tell your doctor if you are pregnant, or are planning to become pregnant, or if you are breast-feeding.
Če ste noseči, načrtujete nosečnost ali dojite, to povejte svojemu zdravniku.
Your doctor will advise whether you should continue to take Zeffix while you are pregnant.
Zdravnik vam bo povedal, če morate med nosečnostjo še naprej jemati Zeffix.
Do not stop treatment with Zeffix without your doctor’ s advice.
Ne prekinjajte zdravljenja z Zeffixom, ne da bi se prej posvetovali z zdravnikom.
Since lamivudine and the virus pass into breast milk it is recommended that mothers taking Zeffix do not breast-feed their infants.
Ker lamivudin in virus prehajata v materino mleko je priporočljivo, da matere, ki jemljejo zdravilo Zeffix, svojih otrok ne dojijo.
Driving and using machines No studies on the effect of Zeffix on the ability to drive and use machines have been performed.
Vpliv na sposobnost upravljanja vozil in strojev Študije, ki bi preučevale vpliv zdravila Zeffix na sposobnost upravljanja vozil in strojev, niso bile izvedene.
HOW TO TAKE ZEFFIX
KAKO JEMATI ZDRAVILO ZEFFIX
Always takeZeffix exactly as your doctor has told you.
Pri jemanju zdravila Zeffix natančno upoštevajte zdravnikova navodila.
The recommended dose of Zeffix is one tablet (100 mg lamivudine) once a day.
Priporočeni odmerek zdravila Zeffix je ena tableta (100 mg lamivudina) enkrat dnevno.
The tablet should be swallowed whole with water.
Tableto morate pogoltniti celo skupaj z vodo.
It can be taken with food or on an empty stomach.
Lahko jo vzamete s hrano ali na prazen želodec.
Your doctor will advise you on how long you will need to take the medicine for.
Vaš zdravnik vam bo povedal, kako dolgo boste morali jemati zdravilo.
Your doctor may need to reduce your dose of Zeffix if you have kidney problems.
Če imate težave z ledvicami, vam bo morda zdravnik moral odmerek Zeffixa zmanjšati.
It may be necessary for you to take an oral solution instead of tablets so that the dose of your medicine can be accurately reduced.
Da bi se odmerek vašega zdravila lahko natančno zmanjšal, boste morda morali namesto tablet jemati peroralno raztopino.
42 If you take more Zeffix than you should Accidentally taking too much of your medicine is unlikely to cause any serious problems.
41 Če ste vzeli večji odmerek zdravila Zeffix, kot bi smeli Če po nesreči vzamete prevelik odmerek zdravila, je malo verjetno, da bi prišlo do kakršnih koli resnih težav.
However, you should tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
Kljub temu pa se morate za dodatni nasvet obrniti na svojega zdravnika ali farmacevta ali pa na urgentni oddelek najbližje bolnišnice.
If you forget to take Zeffix If you forget to take your medicine, take it as soon as you remember and then continue to take it as instructed.
Če ste pozabili vzeti zdravilo Zeffix Če ste svoje zdravilo pozabili vzeti, ga vzemite takoj, ko se spomnite, in nato nadaljujte tako, kot vam je bilo naročeno.
If you stop taking Zeffix You must not stop taking Zeffix without consulting your doctor.
Če ste prenehali jemati zdravilo Zeffix Ne prenehajte z jemanjem zdravila Zeffix, če se o tem predhodno niste posvetovali z vašim zdravnikom.
If you have any further questions on the use of this product, ask you doctor or pharmacist.
Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom ali farmacevtom.
Like all medicines, Zeffix can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Zeffix neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
In clinical trials, the number and type of side effects reported in patients taking Zeffix were generally similar to those reported in patients taking an inactive substance (placebo).
V kliničnih študijah so število in vrsta neželenih učinkov pri bolnikih, ki so jemali Zeffix, večinoma podobni kot pri bolnikih, ki so jemali navidezno zdravilo (placebo).
The most commonly reported were tiredness, respiratory tract infections, throat discomfort, headache, stomach discomfort and pain, nausea, vomiting and diarrhoea.
Najpogosteje so poročali o utrujenosti, okužbah dihal, težavah z grlom, glavobolu, težavah in bolečini v želodcu, siljenju na bruhanje, bruhanju in driski.
However, increases in liver enzymes and enzymes produced in the muscles were sometimes more commonly reported in patients taking Zeffix (see below).
Ne glede na to, so pri bolnikih, ki so jemali zdravilo Zeffix, pogosteje poročali o zvišanih vrednostih jetrnih encimov in encimov, ki so nastali v mišicah (glejte spodaj).
Side effects thought to be caused by Zeffix are listed below:
Neželeni učinki, ki bi lahko bili povezani z jemanjem zdravila Zeffix so:
Very common side effects (in more than 10 in 100 patients)
Zelo pogosti neželeni učinki (pri več kot 10 od 100 bolnikov)
Increases in enzymes produced by the liver called transaminases
Povišanja vrednosti jetrnih encimov, tako imenovanih transaminaz
Common side effects (in more than 1 in 100 patients)
Pogosti neželeni učinki (pri več kot 1 od 100 bolnikov)
Increases in an enzyme called creatine phosphokinase produced in the muscles
Povišanja vrednosti encima kreatin- fosfokinaze, ki nastane v mišicah
side effects (in less than 1 in 10,000 patients)
Zelo redki neželeni učinki (pri manj kot 1 od 10. 000 bolnikov)
Reductions in platelets, blood cells important for blood clotting.
Zmanjšanje števila trombocitov, krvnih celic ki so pomembne za strjevanje krvi.
If you have a low platelet count you may notice you bruise more easily
Če so vam izmerili nizko število trombocitov boste mogoče večkrat opazili podkožne krvavitve.
Cramps, muscle pains and breakdown of muscle Marked worsening of liver disease after Zeffix is stopped or during treatment if resistance develops.
Značilno poslabšanje jetrnih bolezni v primeru prekinitve jemanja zdravila Zeffix ali med zdravljenjem, če se razvije rezistenca.
This can be fatal in some patients.
Pri nekaterih bolnikih je to lahko smrtno.
Some people may be allergic to medicines.
Nekateri ljudje so lahko na zdravila alergični.
If you have any of the following symptoms soon after taking Zeffix STOP taking the medicine and tell your doctor immediately:
Če ste vzeli Zeffix in nato v kratkem doživeli katerega izmed naslednjih znakov, takoj PRENEHAJTE jemati zdravilo in nemudoma obvestite svojega zdravnika:
* Sudden wheeziness and chest pain or tightening. * Swelling of eyelids, face or lips. * Skin rash or ‘hives’ anywhere on the body.
* Nenadno sopenje in bolečina v prsih ali tiščanje. * Oteklina očesnih vek, obraza ali ustnic. * Kožni izpuščaji ali ‘ koprivnica ’ kjer koli po telesu.
43 5.
42 5.
HOW TO STORE ZEFFIX
SHRANJEVANJE ZDRAVILA ZEFFIX
Do not store above 30 °C.
Shranjujte pri temperaturi do 30 ºC.
Do not use Zeffix after the expiry date which is stated on the tablet carton and blister pack..
Zdravila Zeffix ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu.
What Zeffix contains
Kaj vsebuje zdravilo Zeffix
The other ingredients are: microcrystalline cellulose, sodium starch glycollate, magnesium stearate, hypromellose, titanium dioxide, macrogol 400, polysorbate 80, synthetic yellow and red iron oxide.
Pomožne snovi so: mikrokristalna celuloza, natrijev karboksimetilškrob, magnezijev stearat, hipromeloza, titanov dioksid, makrogol 400, polisorbat 80, sintetični rumeni in rdeči železov oksid.
Zeffix film-coated tablets are supplied in tamper evident foil blister packs containing 28 or 84 tablets.
Zeffix filmsko obložene tablete so na voljo v škatlicah, ki vsebujejo 28 ali 84 tablet v pretisnih omotih z zaščito, ki dokazuje, da še niso bile odprte.
The tablets are butterscotch coloured, capsule shaped, biconvex and engraved “GX CG5” on one face.
Tablete so karamelne barve, v obliki kapsule, bikonveksne in imajo na eni strani vtisnjeno oznako “ GX CG5 ”.
Glaxo Wellcome Operations Priory Street Ware Herts SG12 0DJ United Kingdom
Glaxo Wellcome Operations Priory Street Ware Herts SG12 0DJ Velika Britanija
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
43 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Italia GlaxoSmithKline S.p.A.
44 Italia GlaxoSmithKline S. p. A.
This leaflet was approved on
Navodilo je bilo odobreno
Zeffix 5 mg/ml oral solution Lamivudine
Zeffix 5 mg/ ml peroralna raztopina Lamivudin
It may harm them even if
Morda ga boste želeli ponovno prebrati. – Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom. – Zdravilo je bilo predpisano vam osebno in ga ne smete ga dajati drugim.
Do not take Zeffix: • if you are allergic (hypersensitive) to lamivudine or to any of the other ingredients of Zeffix.
• če ste alergični na (preobčutljivi za) lamivudin ali katero koli drugo sestavino zdravila Zeffix.
If you are not sure please consult your doctor
Če niste prepričani, se posvetujte s svojim zdravnikom.
Your doctor will advise you on the correct dose of Zeffix to take if required.
Če bo treba, vam bo natančen odmerek določil vaš zdravnik.