natgillin/translations-raw huggingface dataset:
bN is based on subjects with moderate or greater scalp psoriasis at baseline who were re-randomised to APR 30 twice daily at week 32.
bN temelji na preskušancih z zmerno ali hudo psoriazo lasišča v izhodišču, ki so jih po 32 tednih ponovno randomizirali na APR 30 dvakrat na dan. Preskušance z manjkajočimi podatki so upoštevali, kot da se niso odzvali na zdravljenje.
The 20 mg tablets also contain iron oxide yellow (E172).
20-miligramske tablete vsebujejo tudi rumeni železov oksid (E172).
Bronchitis
ZDRAVILOM
Each film-coated tablet contains 30 mg of apremilast.
Ena filmsko obložena tableta vsebuje 30 mg apremilasta.
*p ≤ 0.01 for apremilast vs. placebo **p ≤ 0.001 for apremilast vs. placebo a N is the number of patients as randomised and treated
**p ≤ 0,001 za apremilast proti placebu.
In studies PALACE 1, PALACE 2 and PALACE 3, significant improvements were demonstrated in healthrelated quality of life, as measured by the changes from baseline in the physical functioning (PF) domain of the Short Form Health Survey version 2 (SF-36v2), and in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-fatigue) scores in patients treated with apremilast compared to placebo at weeks 16 and 24.
Merili so spremembe v telesnem delovanju (PF - Physical Functioning) s pomočjo kratkega vprašalnika o zdravstvenem stanju, verzija 2 (SF-36v2), in funkcijsko oceno zdravljenja kronične bolezni - utrujenost (FACIT - utrujenost; Functional Assessment of Chronic Illness Therapy - Fatigue) pri bolnikih, zdravljenih z apremilastom v primerjavi s placebom, od izhodišča do 16. in 24. tedna.
Each film-coated tablet contains 10 mg of apremilast.
Ena filmsko obložena tableta vsebuje 10 mg apremilasta.
NAME OF THE MEDICINAL PRODUCT Otezla 30 mg tablets apremilast
IME ZDRAVILA Otezla 30 mg tablete apremilast
No dose adjustment is necessary for patients with hepatic impairment.
Pri bolnikih z okvaro jeter prilagajanje odmerka ni potrebno.
• frequent bowel movements
• pogosto iztrebljanje blata,
Nervous system disorders
Načrt titriranja odmerka
Otezla 10 mg film-coated tablets
Otezla 10 mg filmsko obložene tablete
The proportion of patients with ACR 20/50/70 (responses in studies PALACE 1, PALACE 2 and PALACE 3, and the pooled data for studies PALACE 1, PALACE 2 and PALACE 3) for apremilast 30 mg twice daily at week 16 are shown in Table 3.
Delež bolnikov, pri katerih je prišlo v 16. tednu zdravljenja z apremilastom 30 mg dvakrat dnevno do odzivov ACR 20/50/70 (odzivi v študijah PALACE 1, PALACE 2 in PALACE 3 ločeno ter združeni podatki za študije PALACE 1, PALACE 2 in PALACE 3), je prikazan v preglednici 3.
DMARDs N=162
N=162
Among patients who were initially randomised to apremilast 30 mg twice daily treatment, the change from baseline in the HAQ-DI score at week 52 was -0.333 in the apremilast 30 mg twice daily group in a pooled analysis of the open label phase of studies PALACE 1, PALACE 2 and PALACE 3.
Pri bolnikih, ki so bili v začetku randomizirani na zdravljenje z apremilastom 30 mg dvakrat dnevno, je bila v 52. tednu v združeni analizi odprte faze študij PALACE 1, PALACE 2 in PALACE 3 v tej skupini sprememba rezultata HAQ-DI od izhodišča -0,333.
DMARDs N=168
N=168
DMARDs N=169
N=169
Otezla 20 mg film-coated tablets
Otezla 20 mg filmsko obložene tablete
Reductions in maternal body weight and weight gain, and one death associated with difficulty in delivering pups were observed at 300 mg/kg/day.
Pri odmerku 300 mg/kg/dan so opazili zmanjšanje in zvečanje materine telesne mase in en primer smrti, povezan z oteženo skotitvijo mladičev.
croscarmellose sodium and magnesium stearate.
Jedro tablete mikrokristalna celuloza laktoza monohidrat premreženi natrijev karmelozat magnezijev stearat
What plaque psoriasis is
Kaj je psoriaza v plakih
DMARDs N=167
N=167
Otezla 30 mg film-coated tablets
Otezla 30 mg filmsko obložene tablete
Otezla 30 mg tablets apremilast
Otezla 30 mg filmsko obložene tablete apremilast
Change in Pruritus VASf (mm), mean± SD Change in DLQIg, mean± SD
PASI 90, n (%) odstotna sprememba BSAe povprečje± SD sprememba pruritusa VASf (mm), povprečje ±
No dose adjustment is needed in patients with mild and moderate renal impairment.
Pri bolnikih z blago in zmerno okvaro ledvic prilagajanje odmerka ni potrebno.
• hives (urticaria)
• koprivnica (urtikarija),
The Otezla 20 mg film-coated tablet is a brown, diamond shaped film-coated tablet with “APR” engraved on one side and “20” on the opposite side.
Otezla 20 mg filmsko obložena tableta je rjava filmsko obložena tableta v obliki romba z vtisnjenim napisom “APR” na eni strani in “20” na drugi strani.
Pink, diamond shaped 10 mg film-coated tablet of 8 mm length with “APR” engraved on one side and “10” on the opposite side.
Rožnata 10 mg filmsko obložena tableta v obliki romba, dolžine 8 mm, z vtisnjenim napisom “APR” na eni strani in “10” na drugi strani.
The Otezla 10 mg film-coated tablet is a pink, diamond shaped film-coated tablet with “APR” engraved on one side and “10” on the opposite side.
Otezla 10 mg filmsko obložena tableta je rožnata filmsko obložena tableta v obliki romba z vtisnjenim napisom “APR” na eni strani in “10” na drugi strani.
• stomach pain
• bolečina v želodcu,
Decreased appetite*
Presnovne in prehranske motnje pogosti zmanjšan apetit*
Brown, diamond shaped 20 mg film-coated tablet of 10 mm length with “APR” engraved on one side and “20” on the opposite side.
Rjava 20 mg filmsko obložena tableta v obliki romba, dolžine 10 mm, z vtisnjenim napisom “APR” na eni strani in “20” na drugi strani.
PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet
FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložena tableta 56 filmsko obloženih tablet 168 filmsko obloženih tablet
The Otezla 30 mg film-coated tablet is a beige, diamond shaped film-coated tablet with “APR” engraved on one side and “30” on the opposite side.
Otezla 30 mg filmsko obložena tableta je bež filmsko obložena tableta v obliki romba z vtisnjenim napisom “APR” na eni strani in “30” na drugi strani.
Cyclic AMP also modulates levels of anti-inflammatory cytokines such as IL-10.These pro- and anti-inflammatory mediators have been implicated in psoriatic arthritis and psoriasis.
Ciklični AMP tudi modulira koncentracije protivnetnih citokinov, npr. IL-10.
Titanium dioxide (E171)
Filmska obloga polivinilalkohol titanov dioksid (E171) makrogol (3350) smukec rdeči železov oksid (E172)
Placebo
placebo DMARDs
Beige, diamond shaped 30 mg film-coated tablet of 12 mm length with “APR” engraved on one side and “30” on the opposite side.
Bež 30 mg filmsko obložena tableta v obliki romba, dolžine 12 mm, z vtisnjenim napisom “APR” na eni strani in “30” na drugi strani.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg of apremilast.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 30 mg apremilasta.
Musculoskeletal and connective tissue disorders
Bolezni mišičnoskeletnega sistema in vezivnega tkiva pogosti bolečina v hrbtu*
How to store Otezla
Kako jemati zdravilo Otezla
• weight loss
• izguba telesne mase,
Underweight patients
Bolniki s premajhno telesno maso
PASIc 75, n (%) sPGAd of Clear or Almost Clear, n (%) PASI 50, n (%) PASI 90, n (%) Percent Change BSAe (%) mean± SD
N PASIc 75, n (%)
Infections and infestations
Razvoj zarodka in plodu
In Studies ESTEEM 1 and ESTEEM 2, significant improvements (reductions) in nail psoriasis, as measured by the mean percent change in Nail Psoriasis Severity Index (NAPSI) from baseline, were observed in patients receiving apremilast compared to placebo-treated patients at week 16 (p< 0.0001 and p=0.0052, respectively).
izmerjene s povprečno odstotno spremembo indeksa izraženosti psoriaze nohtov (Nail Psoriasis Severity Index (NAPSI)) od izhodišča (p< 0,0001 oziroma p=0,0052).
• nausea
• bruhanje,
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja občasni izpuščaj urtikarija neznana angioedem
Otezla contains lactose
Zdravilo Otezla vsebuje laktozo
Diarrhoea* Nausea*
Bolezni prebavil zelo pogosti driska*
• diarrhoea
• driska,
Dyspepsia
Odmerjanje
General disorders and administration site conditions
Splošne težave in spremembe na mestu aplikacije pogosti utrujenost
These reactions have often been transitory.
Ti učinki so bili pogosto prehodni.
• if they drink alcohol
• ki pijejo alkohol,
Then continue your treatment as before.
Nadaljujte z zdravljenjem tako, kot prej.
Assessed using a non-inferiority margin of 10%.
Ocenjeno z uporabo meje neinferiornosti 10 %.
This helps maintain the number of CD4 cells in your blood.
To pomaga ohranjati število celic CD4 v vaši krvi.
→ Tell your doctor immediately.
→ Takoj obvestite svojega zdravnika.
Individual components have been investigated in adolescents (12 to 17 years).
Posamezne komponente so raziskovali pri mladostnikih (starih od 12 do 17 let).
→ If you think this applies to you, tell your doctor.
→ Če menite, da to velja za vas, povejte svojemu zdravniku.
The clinical relevance of these findings is unknown.
Klinična pomembnost teh ugotovitev ni znana.
Use in adolescents
Uporaba pri mladostnikih
This medicine is not for use in children under 12 years of age, because it has not been studied in these patients.
Otroci To zdravilo ni namenjeno otrokom, mlajšim od 12 let, ker njegova uporaba pri teh bolnikih ni bila raziskana.
Your doctor will monitor the effectiveness of your treatment.
Zdravnik bo spremljal učinkovitost vašega zdravljenja.
• weakness beginning in the hands and feet and moving up towards the trunk of the body.
• oslabelost, ki se začne v rokah in stopalih in se širi navzgor proti trupu
If you miss a dose, take it as soon as you remember.
Če ste pozabili na odmerek, ga vzemite, kakor hitro se spomnite.
Symptoms may include:
Simptomi lahko vključujejo:
You need to be aware of the extra risks:
Zavedati se morate, da je tveganje večje:
• if you have moderate or severe liver disease
• če imate zmerno ali hudo bolezen jeter
Tell your doctor if you are taking any of the medicines in the following list:
Povejte svojemu zdravniku, če jemljete katero od zdravil z naslednjega seznama:
A similar effect was not seen in rats even at very high systemic exposure.
Pri podganah podobnega učinka niso opazili, tudi pri zelo visoki sistemski izpostavljenosti ne.
Effect of human serum
Vpliv humanega seruma
Gender Male Female Race White African-American/African Heritage/Other Age (years)
Spol moški ženske Rasa belci afroameričani/afriško poreklo/drugo Starost (leta)
N = Number of subjects in each treatment group
N = število preiskovancev v vsaki terapevtski skupini.
• The recommended dose of Dovato is one tablet once a day.
• Priporočeni odmerek zdravila Dovato je ena tableta enkrat na dan.
Do not take Dovato:
Ne jemljite zdravila Dovato:
If you are pregnant, think you may be pregnant, or if you are planning to have a baby:
Če ste noseči, mislite, da bi lahko bili noseči ali načrtujete zanositev:
Such infections may have been “silent” and not detected by the weak immune system before treatment was started.
Takšne okužbe lahko potekajo »tiho« in jih oslabljeni imunski sistem pred začetkom zdravljenja ne zazna.
The absolute bioavailability of oral lamivudine in adults is approximately 80-85%.
Absolutna biološka razpoložljivost lamivudina po peroralnem dajanju pri odraslih znaša približno 80 - 85 %.
Like all medicines, this medicine can cause side effects, although not everybody gets them, so it is very important to talk to your doctor about any changes in your health.
Kot vsa zdravila, ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih, zato je zelo pomembno, da se z zdravnikom pogovorite o vseh spremembah, ki jih opazite glede vašega zdravja.
Component of a multipack, can't be sold separately.
Sestavni del pakiranja po več enot, ki se ne prodaja ločeno.
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 v telesu pomembne za boj proti okužbi.
Reference should be made to treatment guidelines.
Upoštevati je treba smernice za zdravljenje.
Pooled analysis also stratified by study.
Združena analiza je bila stratificirana tudi glede na študijo.
Pharmacokinetic parameters are comparable to those reported in adults.
Farmakokinetični parametri so primerljivi s tistimi pri odraslih.
If possible, show them the Dovato pack.
Po možnosti jima pokažite ovojnino zdravila Dovato.
Do not stop taking Dovato without consulting your doctor, as this may harm you and your unborn child.
Brez posvetovanja z zdravnikom ne prenehajte jemati zdravila Dovato, ker to lahko škoduje vam in vašemu nerojenemu otroku.
• abnormal dreams
• nenormalne sanje
The table should not be considered exhaustive but is representative of the classes studied.
Preglednice ne gre jemati, kot da je dokončna, je pa reprezentativna za preučevane skupine.
Dovato should be used during pregnancy only if the expected benefit justifies the potential risk to the foetus.
Zdravilo Dovato se lahko uporablja v nosečnosti samo, če pričakovana korist upravičuje morebitno tveganje za plod.
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), not known (cannot be estimated from the available data).
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), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Not everyone responds to treatment with Dovato in the same way.
Na zdravljenje z zdravilom Dovato se vsi ne odzivajo enako.
Transmission of HIV
Prenašanje virusa HIV
Interaction geometric mean change (%)
Geometrijsko povprečje spremembe (%)
Double blind therapy will continue up to week 96, followed by open label therapy up to week 148.
Dvojno slepo zdravljenje se bo nadaljevalo do 96. tedna, sledilo bo odprto zdravljenje do 148. tedna.
→ Don't drive or operate machinery unless you are sure you're not affected.
→ Ne vozite ali upravljajte strojev, če niste prepričani, da zdravilo na vas tako ne vpliva.
Swallow the tablet with some liquid.
Tableto pogoltnite z nekaj tekočine.
If you get any symptoms of infection or if you notice any of the symptoms above:
Če se pri vas pojavijo simptomi okužbe in vnetja ali če opazite katerega od zgoraj naštetih simptomov:
Your doctor may decide to adjust your dose or that you need extra check ups.
Zdravnik se lahko odloči, da vam prilagodi odmerek ali da potrebujete dodatne kontrolne preglede.
What you need to know before you take Dovato 3.
Kaj morate vedeti, preden boste vzeli zdravilo Dovato 3.
• if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, don't stop Dovato without your doctor's advice, as your hepatitis may come back)
• če ste kdaj imeli bolezen jeter, vključno s hepatitisom B ali C (če imate okužbo s hepatitisom B, ne prenehajte jemati zdravila Dovato brez posveta z vašim zdravnikom, saj se lahko hepatitis ponovi)
Dovato does not cure HIV infection; it keeps the amount of virus in your body at a low level.
Zdravilo Dovato ne ozdravi okužbe z virusom HIV, ampak vzdržuje količino virusa v telesu na nizki ravni.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila
→ Read the information ‘Allergic reactions' in section 4 of this leaflet.
→ Preberite odstavek »Alergijske reakcije« v poglavju 4 tega navodila.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Kakršnekoli vnetne simptome je treba oceniti in uvesti zdravljenje, kadar je potrebno.
• depression (feelings of deep sadness and unworthiness)
• depresija (občutki globoke žalosti in nevrednosti)
• rifampicin, to treat tuberculosis (TB) and other bacterial infections
• rifampicin, za zdravljenje tuberkuloze (TB) in drugih bakterijskih okužb
• swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
• oteklina, včasih obraza ali ust (angioedem), ki povzroča oteženo dihanje
• This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
• To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni “brez natrija”.
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 več mesecev po tem, ko ste začeli jemati zdravila za zdravljenje okužbe z virusom HIV.
The observed lamivudine half-life of elimination is 18 to 19 hours.
Opazovani eliminacijski razpolovni čas lamivudina znaša od 18 do 19 ur.
If you have taken Dovato during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Če ste zdravilo Dovato jemali med nosečnostjo, vas lahko zdravnik naroči na redne preiskave krvi in druge diagnostične preiskave, da bo spremljal razvoj vašega otroka.
What Dovato is and what it is used for 2.
Kaj je zdravilo Dovato in za kaj ga uporabljamo 2.
If you get any of the following symptoms:
Če se vam pojavi kateri od naslednjih simptomov:
Clinically significant interaction unlikely.
Klinično pomembna interakcija ni verjetna.
• if they have been taking combination therapy for a long time
• ki jemljejo kombinirano terapijo dalj časa,
The European Medicines Agency has deferred the obligation to submit the results of studies with Dovato in one or more subsets of the paediatric population in the treatment of HIV infection.
Evropska agencija za zdravila (EMA) je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Dovato za eno ali več podskupin pediatrične populacije za zdravljenje okužbe s HIV.
Women who are HIV-positive must not breast feed because HIV infection can be passed on to the baby in breast milk.
Ženske, ki so HIV-pozitivne, ne smejo dojiti, saj se okužba z virusom HIV lahko z materinim mlekom prenese na otroka.
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, v nobenem primeru ne dojijo svojih otrok, da bi se izognile prenosu virusa HIV.
Effects on electrocardiogram
Vpliv na elektrokardiogram
• if you are allergic (hypersensitive) to dolutegravir or lamivudine or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični (preobčutljivi) na dolutegravir ali lamivudin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The most frequently reported adverse reactions are headache (3%), diarrhoea (2%), nausea (2%) and insomnia (2%).
Najpogosteje poročani neželeni učinki so bili glavobol (3 %), diareja (2 %), navzea (2 %) in nespečnost (2
Signs of osteonecrosis include:
Znaki osteonekroze so:
These changes are not clinically significant.
Te spremembe niso klinično pomembne.
The safety and efficacy of Dovato in children aged less than 12 years or weighing less than 40 kg have not been established.
Varnost in učinkovitost zdravila Dovato pri otrocih, mlajših od 12 let ali ki tehtajo manj kot 40 kg, nista bili dokazani.
Stopping Dovato can affect your health and how future treatment works.
Prenehanje jemanja zdravila Dovato lahko vpliva na vaše zdravje in na to, kako bodo delovala prihodnja zdravljenja.
There are limited data available on the use of Dovato in patients aged 65 years and over.
Na voljo so omejeni podatki o uporabi zdravila Dovato pri bolnikih, starih 65 let ali več.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
V primeru sočasnega protiretrovirusnega zdravljenja hepatitisa B ali C upoštevajte tudi relevantne informacije o zdravilu za ta zdravila.
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).
Dovato has no or negligible influence on the ability to drive and use machines.
Zdravilo Dovato nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
The frequency category of rare was estimated based on post-marketing reports.
Kategorija pogostnosti "redki" je ocenjena na podlagi poročil po prihodu zdravila na trg.
A similar study was not conducted with lamivudine.
Podobnih študij z lamivudinom niso izvajali.
• difficulty sleeping (insomnia)
• težave s spanjem (nespečnost)
Established and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in Table 1.
Ugotovljene in hipotetične interakcije z izbranimi protiretrovirusnimi in ne-protiretrovirusnimi zdravili so navedene v Preglednici 1.
• if they are also taking anti-inflammatory medicines called corticosteroids
• ki obenem jemljejo protivnetna zdravila, imenovana kortikosteroidi,
• palpitations (rapid or irregular heartbeat) or tremor
• palpitacije (hiter ali nepravilen srčni utrip) ali tremor
• liver failure (signs may include yellowing of the skin and the whites of the eyes or unusually dark urine)
• odpoved jeter (znaki lahko vključujejo porumenelost kože in beločnic ali nenavadno temen urin)
If you forget to take Dovato
Če ste pozabili vzeti zdravilo Dovato
This is an uncommon reaction (may affect up to 1 in 100 people) in people taking dolutegravir.
To je občasna reakcija (pojavi se lahko pri največ 1 od 100 bolnikov) pri bolnikih, ki jemljejo dolutegravir.
For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
Pri lipidih v nekaterih primerih obstajajo dokazi, da gre za učinek zdravljenja, medtem ko za povečanje telesne mase ni trdnih dokazov, ki bi ga povezovali s katerim koli določenim zdravljenjem.
• emtricitabine, etravirine, efavirenz, nevirapine or tipranavir/ritonavir, to treat HIV infection
• emtricitabin, etravirin, efavirenz, nevirapin ali tipranavir/ritonavir, za zdravljenje okužb z virusom HIV
The changes are not considered to be clinically relevant and do not reflect a change in glomerular filtration rate.
Te spremembe niso klinično pomembne in ne odražajo spremembe v hitrosti glomerulne filtracije.
Dovato can also affect how some other medicines work.
Zdravilo Dovato lahko vpliva tudi na delovanje drugih zdravil.
A large amount of data on the use of lamivudine in pregnant women (more than 3000 outcomes from first trimester) indicates no malformative toxicity.
Velika količina podatkov o uporabi lamivudina pri nosečnicah (več kot 3000 primerov izpostavljenosti v prvem trimesečju) ne nakazuje malformacijske toksičnosti.
arthralgia, muscle disorders (including myalgia)
artralgija, mišične okvare (vključno z mialgijo)
These changes are linked to the inhibiting effect of dolutegravir on renal tubular transporters of creatinine.
Te spremembe so povezane z zaviralnim učinkom dolutegravirja na ledvične tubularne kreatininske prenašalce.
Antihistamines (histamine H2 receptor antagonists) Ranitidine
Antihistaminiki ( antagonisti histaminskega receptorja H2) ranitidin
Dovato can be taken with or without food (see section 5.2).
Zdravilo Dovato se lahko jemlje s hrano ali brez nje (glejte poglavje 5.2).
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Opisani so bili primeri osteonekroze, zlasti pri bolnikih s splošno znanimi dejavniki tveganja, napredovano boleznijo HIV ali dolgotrajno izpostavljenostjo CART.
Sorbitol solution (3.2 g, 10.2 g, 13.4 g)/Lamivudine
Sorbitol raztopina sorbitola (3,2 g, 10,2 g, 13,4 g)/lamivudin
Symptoms usually include fever, plus some of the following:
Simptomi običajno vključujejo povišano telesno temperaturo in še katerega od naslednjih: