natgillin/translations-raw huggingface dataset:
Adopted at the 30 November - 3 December 2015 PRAC
Sprejeto na zasedanju odbora PRAC, ki je potekalo od 30. novembra do 3. decembra 2015
BEFORE YOU TAKE X
PREDEN BOSTE VZELI ZDRAVILO X
Talk to your doctor if you have any concerns.
Če imate kakršne koli skrbi, se posvetujte s svojim zdravnikom.
BEFORE YOU TAKE DUVAVIVE
PREDEN BOSTE VZELI ZDRAVILO DUVAVIVE
For tibolone containing products
Za zdravila, ki vsebujejo tibolon
TACHOSIL (Human fibrinogen, human thrombin)Intestinal obstruction (EPITT no 18373)
TACHOSIL (humani fibrinogen, humani trombin)obstrukcija črevesja (EPITT št. 18373)
What you need to know before TachoSil is used Warnings and precautions
Kaj morate vedeti, preden boste uporabili zdravilo TachoSil Opozorila in previdnostni ukrepi
Hormone replacement therapy (HRT) medicinal products, which are not pharmaceutical forms for vaginal use, containing oestrogens or combined oestrogens-progestagens (tibolone containing products also concerned); DUAVIVE (bazedoxifene, oestrogens conjugated) - Increased risk of ovarian cancer (EPITT no 18258)
Zdravila za hormonsko nadomestno zdravljenje (HNZ), ki niso v farmacevtski obliki za vaginalno uporabo, ki vsebujejo estrogene ali kombinacijo estrogenov in progestagenov (prav tako zdravila, ki vsebujejo tibolon); zdravilo DUAVIVE (bazedoksifen, konjugirani estrogeni) - povečano tveganje za raka jajčnikov (EPITT št. 18258)
Ovarian cancer is rare - much rarer than breast cancer.
Rak jajčnikov je redek - bistveno redkejši od raka dojke.
Pressure is applied with moistened gloves or a moist pad.
Pritisk vršite z navlaženimi rokavicami ali vlažno blazinico.
A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women currently using HRT compared to women who have never used HRT (RR 1.43, 95% CI 1.31-1.56).
Pri metaanalizi 52 epidemioloških študij so poročali o povečanem tveganju za raka jajčnikov pri ženskah, ki trenutno uporabljajo HNZ, v primerjavi z ženskami, ki niso nikoli uporabljale HNZ (RR 1,43, 95 % CI 1,31-1,56).
To prevent the development of tissue adhesions at undesired sites, ensure tissue areas outside the desired application area are adequately cleansed before administration of TachoSil (see section 6.6).
Za preprečevanje lepljenja tkiv na neželenih mestih se prepričajte, da so predeli tkiv zunaj želenega območja nanosa pred nanosom zdravila TachoSil primerno očiščeni (glejte poglavje 6.6).
Summary of product characteristics (SmPC) section 4.4: Special warnings and precautions for use
Povzetek glavnih značilnosti zdravila, poglavje 4.4: Posebna opozorila in previdnostni ukrepi
After pressing TachoSil to the wound, the glove or the pad must be removed carefully.
Po končanem pritiskanju zdravila TachoSil na rano morate rokavico ali blazinico pazljivo odstraniti.
Frequency ‘unknown': Intestinal obstruction (in abdominal surgeries) General disorders and administration site conditions: Frequency ‘unknown': Adhesions
Neznana pogostnost: obstrukcija črevesja (pri abdominalnih operacijah) Splošne težave in spremembe na mestu aplikacije:
For DUAVIVE product
Za zdravilo DUAVIVE
Due to the strong affinity of collagen to blood, TachoSil may also stick to surgical instruments, or gloves or adjacent tissues covered with blood.
Zaradi močne afinitete kolagena do krvi, se lahko zdravilo TachoSil prime tudi na kirurške instrumente, ali rokavice ali sosednja tkiva, na katerih je kri.
After abdominal surgery and if TachoSil sticks to nearby tissues, it is possible that scar tissues can develop in the operated area.
Če se po operaciji trebušne votline zdravilo TachoSil prilepi na bližnja tkiva, lahko na operiranem območju nastane zabrazgotinjeno tkivo.
To avoid TachoSil from being pulled loose it may be held in place at one end, e.g. with a pair of forceps.
Da zdravila TachoSil ne potegnete z rane, ga lahko na enem koncu pritrdite na mestu, npr. s pinceto.
Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only or combined oestrogen-progestagen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.
Epidemiološki podatki iz obširne metaanalize kažejo rahlo zvečano tveganje pri ženskah, ki uporabljajo samo estrogensko ali kombinacijo estrogenskega in progestagenskega HNZ, kar postane očitno po petih letih uporabe in se po prenehanju sčasoma počasi zmanjšuje.
Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.
Epidemiološki podatki iz obširne metaanalize kažejo rahlo zvečano tveganje pri ženskah, ki uporabljajo samo estrogensko HNZ, kar postane očitno po petih letih uporabe in se po prenehanju sčasoma počasi zmanjšuje.
In the Million Women Study, taking 5 years of HRT tibolone resulted in 1 extra case per 2500 users (see Section 4.4).
V študiji Million Women Study je 5-letna uporaba HRT tibolona povzročila en dodaten primer na 2 500 uporabnic (glej poglavje 4.4).
Events of adhesions to gastrointestinal tissues leading to gastrointestinal obstruction have been reported with use in abdominal surgery carried out in proximity to the bowel.
Pri uporabi zdravila v abdominalni kirurgiji v bližini črevesa so poročali o primerih lepljenja na gastrointestinalna tkiva, kar je povzročilo gastrointestinalno obstrukcijo.
Your surgeon will make sure to clean the operating area when applying TachoSil to reduce this risk.
Vaš kirurg bo za zmanjšanje tveganja pred nanosom zdravila TachoSil očistil območje, ki ga bo operiral.
Scar tissues can cause surfaces in your bowel to stick together, which can lead to blockage of the bowel.
To lahko povzroči, da se površine v črevesu zlepijo skupaj, kar lahko privede do zapore črevesa.
In the Million Women Study, it was shown that the relative risk for ovarian cancer with use of tibolone was similar to the risk associated with use of other types of HRT.
Študija Million Women Study je pokazala, da je relativno tveganje za raka jajčnikov pri uporabi tibolona podobno tveganju, povezanemu z uporabo drugih vrst HNZ.
This study showed that the relative risk for ovarian cancer with tibolone was similar to the risk with other types of HRT.
Ta študija je pokazala, da je relativno tveganje za raka jajčnikov pri uporabi tibolona podobno tveganju, povezanemu z uporabo drugih vrst HNZ.
Scar tissues may develop in some patients after surgery and use of TachoSil.
Pri nekaterih bolnikih lahko po operaciji in uporabi zdravila TachoSil nastane zabrazgotinjeno tkivo.
For oestrogen only and combined oestrogen-progestagen HRT products
Za zdravila za HNZ s samo estrogenskim ali kombinacijo estrogenskega in progestagenskega zdravljenja
TachoSil may stick to surgical instruments, or gloves or adjacent tissues covered with blood.
Zdravilo TachoSil se lahko prime na kirurške instrumente in, rokavice ali sosednja tkiva, na katerih je kri.
It is important to note that failure to adequately clean adjacent tissues may cause adhesions (see section 4.4).
Upoštevajte, da lahko do lepljenja pride, če nezadostno očistite sosednja tkiva (glejte poglavje 4.4).
This can be avoided by cleansing surgical instruments, and gloves and adjacent tissues before application.
Temu se lahko izognete tako, da očistite kirurške instrumente, rokavice in sosednja tkiva pred nanosom.
Long-term (at least 5-10 years) use of oestrogen-only HRT products has been associated with a slightly increased risk of ovarian cancer (see section 4.8).
Dolgotrajna uporaba (vsaj 5-10 let) samo estrogenskega zdravljenja je povezana z rahlo zvečanim tveganjem za raka jajčnikov (glejte poglavje 4.8).
With use of X, the increased risk of ovarian cancer is similar to other types of HRT.
Pri uporabi zdravila X je zvečano tveganje za raka jajčnikov podobno tveganju, povezanemu z uporabo drugih vrst HNZ.
The use of oestrogen-only HRT has been associated with a slightly increased risk of ovarian cancer.
Uporaba samo estrogenskega HNZ zdravljenjem je bila povezana z rahlo zvečanim tveganjem za raka jajčnikov.
In the Million Women Study For women aged 50 to 54 years taking 5 years of HRT, this resultsed in about 1 extra case per 2,5000 users.
V študiji Million Women Study Pri ženskah, starih od 50 do 54 let, ki uporabljajo HNZ pet let, to povzroča je to povzročilo približno en dodaten primer na 2 5000 uporabnic.
For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users.
Pri ženskah, starih od 50 do 54 let, je 5-letna uporaba HNZ povzročila približno en dodaten primer na 2 000 uporabnic.
Cleanse surgical instruments, or gloves and adjacent tissues, if necessary.
Po potrebi očistite kirurške instrumente, ali rokavice in sosednja tkiva.
Some other studies, including the Women's Health Initiative (WHI) trial, suggest that the longterm use of combined HRTs may confer be associated with a similar, or slightly smaller risk (see Section 4.8).
Nekatere druge študije, vključno s preskušanjem Women's Health Initiative (WHI), kažejo, da je dolgotrajna uporaba kombiniranih HNZ lahko pomeni povezana s podobnim ali rahlo manjšim tveganjem (glejte poglavje 4.8).
In the Million Women Study 5 years of HRT resulted in 1 extra case per 2500 users.
V študiji Million Women Study je 5-letna uporaba HNZ povzročila en dodatni primer na 2 500 uporabnic.
The use of oestrogen-only or combined oestrogen-progestagen HRT has been associated with a slightly increased risk of ovarian cancer.
Uporaba HNZ, ki vsebuje samo estrogen ali kombinacijo estrogena in progestagena, je bila povezana z rahlo zvečanim tveganjem za raka jajčnikov.
Some other studies, including the WHI trial, suggest that use of combined HRTs may be associated with a similar or slightly smaller risk (see Section 4.8).
Nekatere druge študije, vključno s preskušanjem WHI, kažejo, da je uporaba kombiniranih HNZ lahko povezana s podobnim ali rahlo manjšim tveganjem (glejte poglavje 4.8).
In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.
Pri ženskah, starih od 50 do 54 let, ki ne uporabljajo HNZ, bodo v 5-letnem obdobju diagnosticirali raka jajčnikov pri približno dveh ženskah od 2 000.
Bowel obstruction and pain following abdominal surgeries can also occur.
Prav tako lahko pride do zapore črevesa in bolečin v trebuhu.
Some other studies, including the WHI trial, suggest that the long-term use of combined HRTs may confer be associated with a similar, or slightly smaller risk (see Section 4.8).
Nekatere druge študije, vključno s preskušanjem WHI, kažejo, da je dolgotrajna uporaba kombiniranih HNZ lahko pomeni povezana s podobnim ali rahlo manjšim tveganjem (glejte poglavje 4.8).
A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years.
Pri ženskah, ki uporabljajo HNZ vsaj 5 do 10 let, so poročali o rahlo zvečanem tveganju za raka jajčnikov.
For women who have been taking HRT for 5 years, there will be between 2 and about 3 cases per 21000 users (i.e. up to about 1 extra case).
Pri ženskah, ki uporabljajo HNZ pet let, bodo raka jajčnikov odkrili pri približno med 2 in treh izmed 2 1000 uporabnic (tj. do približno en primer več).
For women who have been taking HRT for 5 years, there will be between 2 and about 3 cases per 21,000 users (i.e. about up to 1 extra case).
Pri ženskah, ki uporabljajo HNZ pet let, bodo raka jajčnikov odkrili pri približno med 2 in treh zmed 2 1000 uporabnic (tj. do približno en primer več).
Gastrointestinal disorders:
Bolezni prebavil:
Long term uUse of estrogen-only and or combined estrogen-progestogen HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed (see Section 4.4).
Dolgotrajna uUporaba samo estrogenskega in ali kombinacije estrogenskega in progestagenskega HNZ je povezana z rahlo zvečanim tveganjem za diagnosticiranje raka jajčnikov (glejte poglavje 4.4).
Long-term uUse of oestrogen-only and or combined oestrogen-progestagen HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed (see Section 4.4).
Dolgotrajna uUporaba samo estrogenskega zdravljenjem in ali kombinacije estrogenskega in progestogenskega HNZ je povezana z rahlo zvečanim tveganjem za diagnosticiranje raka jajčnikov (glejte poglavje 4.4).
SmPC section 4.4: Special warnings and precautions for use Ovarian cancer
Povzetek glavnih značilnosti zdravila, poglavje 4.8: Neželeni učinki Rak jajčnikov
For example, in women aged 50 to 5469 who are not taking HRT, on average about 2 women in 21,000 will be diagnosed with ovarian cancer over a 5year period.
Na primer pri ženskah, starih od 50 do 5469 let, ki ne uporabljajo HNZ, bodo v obdobju petih let v povprečju pri približno dveh ženskah izmed 21 000 odkrili raka jajčnikov.
For example, in Wwomen aged 50 to 5469 who are not taking HRT, on average about 2 women in 21000 will be diagnosed with ovarian cancer over a 5year period.
Na primer pri Žženskah, starih od 50 do 5469 let, ki ne uporabljajo HNZ, bodo v obdobju 5 let v povprečju pri približno dveh ženskah izmed 2 1000 odkrili raka jajčnikov.
Other adverse reactions have been reported in association with oestrogen and oestrogenprogestogen treatment:
Povzetek glavnih značilnosti zdravila, poglavje 4.8: Neželeni učinki V zvezi z zdravljenjem z estrogenom in kombinacijo estrogena in progestogena so poročali tudi o drugih neželenih učinkih:
Long-term uUse of oestrogen-only HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed (see Section 4.4).
Dolgotrajna uUporaba HNZ s samo estrogenskim zdravljenjem estrogenskega HNZ je povezana z zvečanim tveganjem za diagnosticiranje raka jajčnikov (glejte poglavje 4.4).
It is important to note that failure to adequately clean adjacent tissues may cause adhesions.
Upoštevajte, da lahko do lepljenja pride, če nezadostno očistite sosednja tkiva.
Inactivated Rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037: ≥70% cELISA40* (*) ≥=70% of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40.
--1 Inaktivirani virus hemoragične bolezni kuncev tipa 2 (RHDV2), sev V-1037 ≥70 % cELISA40* (*) ≥ 70 % cepljenih kuncev bo imelo titer protiteles cELISA 40 ali več.
Vial (glass) 0.5 ml (1 dose)
0,5 ml
EU (MA) Number
EU (MA) številka Izmišljeno ime Jakost
10 vials Zero days
(1 odmerek vialami
Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Po navadi so takšne reakcije opažali v prvih nekaj tednih ali mesecih po začetku CART.
50 to <200 200 to <350
od 50 do < 200 od 200 do < 350
Date of latest renewal: 21 September 2018
Datum zadnjega podaljšanja: 21. september 2018
Keep the bottle tightly closed.
Vsebnik shranjujte tesno zaprt.
→ Read the information in Section 4 of this leaflet.
→ Preberite informacije v poglavju 4 tega navodila.
CD4 cells are a type of white blood cells that are important in helping your body to fight infection.
Celice CD4 so vrsta belih krvnih celic, ki so pomembna pomoč telesu v boju proti okužbi.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 January 2014
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 20. januar 2014
To control your HIV infection, and to stop your illness from getting worse, you must keep taking all your medicines, unless your doctor tells you to stop taking any.
Za obvladovanje okužbe s HIV in preprečevanje poslabšanja bolezni morate nadaljevati z jemanjem vseh vaših zdravil, razen če vam zdravnik ne naroči, da katerega prenehate jemati.
Extremadura 3, 09400 Aranda De Duero, Burgos, Spain OR
Extremadura 3, 09400 Aranda De Duero, Burgos, Španija ALI
40 or greater
40 ali več
The mechanism for the decrease is unknown.
Mehanizem tega zmanjšanja ni pojasnjen.
Please refer to section 4.5.
Prosimo glejte poglavje 4.5.
After the functional monotherapy phase, subjects had the opportunity to re-optimize their background regimen when possible.
Po fazi funkcionalne monoterapije so imele osebe možnost ponovne optimizacije njihove osnovne sheme, kadar je bilo to mogoče.
†Other clades included: Complex (43), F1 (32), A1 (18), BF (14), all others <10.
†Drugi podtipi so vključevali: kompleks (43), F1 (32), A1 (18), BF (14), vse druge < 10.
Children 6 to less than 12 years of age
Otroci v starosti od 6 do manj kot 12 let
• suicide attempt*
• poskus samomora*
As a result of that, it also increases the CD4 cell count in your blood.
Posledica tega je, da se poveča tudi število celic CD4 v krvi.
* particularly in patients who have had depression or mental health problems before
*zlasti pri bolnikih, ki so že imeli probleme z depresijo ali duševnim zdravjem
It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Priporočljivo je, da ženske, okužene z virusom HIV, pod nobenim pogojem ne dojijo svojih otrok, da bi se izognile prenosu virusa HIV.
Not everyone responds to treatment with Tivicay in the same way.
Na zdravljenje z zdravilom Tivicay se vsi ne odzivajo enako.
When Tivicay is taken twice a day, your doctor may advise you to take with food.
Kadar pa se zdravilo Tivicay jemlje dvakrat na dan, vam bo zdravnik morda svetoval, da ga vzemite med jedjo.
The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection.
Simptomi avtoimunih bolezni se lahko pojavijo mnogo mesecev po tem, ko ste začeli jemati zdravila za zdravljenje okužbe z virusom HIV.
Food increased the extent and slowed the rate of absorption of dolutegravir.
Hrana poveča obseg in upočasni hitrost absorpcije dolutegravirja.
‡ Adjusted mean treatment difference was statistically significant (p<0.001)
‡ Prilagojena srednja razlika v zdravljenju je bila statistično značilna (p < 0,001)
• if you are allergic to dolutegravir or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na dolutegravir ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
• swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
• oteklino, včasih obraza ali ust (angioedem), ki povzroča oteženo dihanje
These changes are not considered to be clinically relevant since they do not reflect a change in glomerular filtration rate.
Te spremembe niso klinično pomembne, saj ne odražajo spremembe v hitrosti glomerulne filtracije.
→ If you think any of these apply to you, tell your doctor.
→ Če menite, da kar koli od navedenega velja za vas, povejte svojemu zdravniku.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Nadaljnja obravnava mora biti v skladu s kliničnimi indikacijami oziroma priporočili nacionalnega centra za zastrupitve, če so na voljo.
OSS: combined genotypic and phenotypic resistance (Monogram Biosciences Net Assessment)
OSS: skupaj genotipska in fenotipska odpornost (ocena po Monogram Biosciences Net)
• suicidal thoughts*
• samomorilne misli*
Approximately one third of the patients were infected with an HIV non-B subtype; these characteristics were similar between treatment groups.
Približno ena tretjina bolnikov je bila okužena z ne-B podtipom HIV; te značilnosti so bile primerljive med zdravljenimi skupinami.
• rifampicin, to treat tuberculosis (TB) and other bacterial infections
• rifampicin, za zdravljenje tuberkuloze (TBC) in drugih bakterijskih okužb
Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Pogostnosti so opredeljene kot: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000).
Gender Male Female Race White African-America/African Heritage/Other Age (years)
Spol moški ženske Rasa belci afroameričani/afriški staroselci/ostali Starost (leta)
Established and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in Table 2.
Ugotovljene in hipotetične interakcije z izbranimi protiretrovirusnimi in ne-protiretrovirusnimi zdravili so navedene v Preglednici 2.
Tivicay does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level.
Zdravilo Tivicay ne ozdravi okužbe z virusom HIV, ampak zmanjša količino virusa v telesu in jo vzdržuje na nizki ravni.
Tivicay can be taken with or without food.
Zdravilo Tivicay se lahko vzame s hrano ali brez nje.
*particularly in patients with a pre-existing history of depression or psychiatric illness.
*zlasti pri bolnikih z že obstoječo anamnezo depresije ali psihiatrične bolezni
Total blood and plasma drug-related radioactivity concentration ratios averaged between 0.441 to 0.535, indicating minimal association of radioactivity with blood cellular components.
Celotno razmerje koncentracije z zdravilom povezane radioaktivnosti v krvi in plazmi je povprečno med 0,441 in 0,535; to kaže na minimalno povezanost radioaktivnosti s celičnimi elementi krvi.
HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles).
Okužba s HIV se prenaša s spolnim stikom z nekom, ki ima okužbo, ali z okuženo krvjo (na primer s souporabo injekcijskih igel).
Tivicay can also affect how some other medicines work.
Zdravilo Tivicay lahko vpliva tudi na delovanje drugih zdravil.
Raltegravir/elvitegravir was part of the current failing regimen in 98/183 patients (part of prior failing therapies in the others).
Raltegravir/elvitegravir je bil del trenutno neuspešne sheme pri 98/183 bolnikih (del predhodnih neuspešnih terapij pri ostalih).
Adolescents aged 12 and above
Mladostniki, stari 12 let in več
The R263K mutation was also selected in vitro (see above).
Mutacija R263K je bila izbrana tudi in vitro (glejte zgoraj).
If you are pregnant, if you become pregnant, or if you are planning to have a baby:
Nosečnost Če ste noseči, če zanosite ali načrtujete zanositev:
Week 24 (N=161)
24. teden (N=161)
• difficulty breathing In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders).
• oteženo dihanje V redkih primerih, ko se imunski sistem okrepi, lahko ta napade tudi zdrava telesna tkiva (avtoimune bolezni).
Tivicay is always used in combination with other anti-retroviral medicines (combination therapy).
Zdravilo Tivicay se vedno uporablja v kombinaciji z drugimi protiretrovirusnimi zdravili (kombinirano zdravljenje).
Based on data from other CYP3A4 inhibitors, a marked increase is not expected.
Na podlagi podatkov o drugih zaviralcih CYP3A4 ni pričakovati opaznega povišanja.
Dolutegravir ↔ (Not studied)
nelfinavir dolutegravir ↔ (ni raziskano)
(cps/mL)
(kopij/ml)
• increase in the level of enzymes produced in the muscles (creatine phosphokinase).
• zvišane vrednosti encimov, ki nastajajo v mišicah (kreatin fosfokinaza)
Limited experience of single higher doses (up to 250 mg in healthy subjects) revealed no specific symptoms or signs, apart from those listed as adverse reactions.
Omejene izkušnje z enkratnim višjim odmerkom (do 250 mg pri zdravih osebah) niso razkrile nobenih specifičnih simptomov ali znakov, razen tistih, naštetih med neželenimi učinki.
Using strain NL432, mutations E92Q (FC 3) and G193E (also FC 3) were selected.
NL432 so bile izbrane mutacije E92Q (tudi FC 3) in G193E (FC 3).
Co-treatment with atazanavir increases the exposure of dolutegravir markedly, and should not be used in combination with this high dose, since safety with the resulting dolutegravir exposure has not been established.
Sočasno zdravljenje z atazanavirjem izrazito poveča izpostavljenost dolutegravirju in se ga v kombinaciji s tem visokim odmerkom ne sme uporabljati, ker varnost posledične izpostavljenosti dolutegravirju ni ugotovljena.
Do not use this medicine after the expiry date which is stated after EXP on the carton and bottle.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in vsebniku poleg oznake »EXP«.
Week 48 (N=160)
48. teden (N=160)