natgillin/translations-raw huggingface dataset:
The European Medicines Agency has deferred the obligation to submit the results of studies with Xelevia in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Xelevia za vse skupine pediatrične populacije za sladkorno bolezen tipa 2 (za podatek o uporabi pri pediatrični populaciji glejte poglavje 4.2).
What Xelevia looks like and contents of the pack
Izgled zdravila Xelevia in vsebina pakiranja
If you forget to take Xelevia
Če ste pozabili vzeti zdravilo Xelevia
Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Xelevia and periodically thereafter.
Ker prilagoditev odmerka temelji na ledvični funkciji, pred začetkom zdravljenja z zdravilom Xelevia in periodično tekom zdravljenja priporočamo oceno ledvične funkcije.
Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal products In clinical trials of Xelevia as monotherapy and as part of combination therapy with medicinal products not known to cause hypoglycaemia (i.e. metformin and/or a PPAR agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Hipoglikemija pri zdravljenju v kombinaciji z ostalimi antihiperglikemiki V kliničnih preskušanjih zdravila Xelevia kot samostojnega zdravila in v kombinaciji z drugimi zdravili za katere ni znano, da povzročijo hipoglikemijo (tj. metforminom in/ali agonistom PPAR), so pri bolnikih, ki so jemali sitagliptin, poročali o podobnih deležih hipoglikemije kot pri bolnikih, ki so jemali placebo.
If you stop taking Xelevia
Če ste prenehali jemati zdravilo Xelevia
Since co-administration of a high-fat meal with sitagliptin had no effect on the pharmacokinetics, Xelevia may be administered with or without food.
Sočasno zaužitje sitagliptina ter obroka z veliko maščobami ni vplivalo na farmakokinetiko, zato se zdravilo Xelevia lahko jemlje s hrano ali brez nje.
Xelevia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Zdravilo Xelevia je indicirano tudi kot dodatno zdravljenje k insulinu (z metforminom ali brez), če z dieto in s telesno aktivnostjo ter stabilnim odmerkom insulina urejenost glikemije ni zadostna.
For patients with severe renal impairment (GFR ≥ 15 to <30 mL/min) or with end-stage renal disease (ESRD) (GFR < 15 mL/min), including those requiring haemodialysis or peritoneal dialysis, the dose of Xelevia is 25 mg once daily.
Pri bolnikih s hudo ledvično okvaro (GFR ≥ 15 do < 30 ml/min) ali bolnikih s končno ledvično odpovedjo (ESRD - end-stage renal disease) (GFR < 15 ml/min), vključno s tistimi, ki potrebujejo hemodializo ali peritonealno dializo, je odmerek zdravila Xelevia 25 mg enkrat na dan.
Xelevia has not been studied in patients with severe hepatic impairment and care should be exercised (see section 5.2).
Pri bolnikih s hudo jetrno okvaro uporaba zdravila Xelevia ni raziskana, zato je potrebna previdnost (glejte poglavje 5.2).
If a dose of Xelevia is missed, it should be taken as soon as the patient remembers.
Če bolnik izpusti odmerek zdravila Xelevia, ga mora vzeti takoj, ko se spomni.
Method of administration Xelevia can be taken with or without food.
Način uporabe Zdravilo Xelevia lahko bolnik jemlje skupaj s hrano ali brez nje.
When Xelevia is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see section 4.4).
Pri uporabi zdravila Xelevia v kombinaciji s sulfonilsečnino ali z insulinom lahko po potrebi zmanjšate odmerek sulfonilsečnine ali insulina, da se tako zmanjša tveganje za pojav hipoglikemije (glejte poglavje 4.4).
Xelevia has no or negligible influence on the ability to drive and use machines.
Zdravilo Xelevia nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
How to take Xelevia
Kako jemati zdravilo Xelevia
Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Xelevia (see section 4).
Pri bolnikih, ki so prejemali zdravilo Xelevia, so poročali o primerih vnetja trebušne slinavke (pankreatitisa) (glejte poglavje 4).
For patients with moderate renal impairment (GFR  30 to < 45 mL/min), the dose of Xelevia is 50 mg once daily.
Pri bolnikih z zmerno ledvično okvaro (GFR ≥ 30 do < 45 ml/min) je odmerek zdravila Xelevia 50 mg enkrat na dan.
It is important to stay on the diet and exercise recommended by your doctor while taking Xelevia.
Med jemanjem zdravila Xelevia je pomembno, da se držite diete in telesne aktivnosti, ki vam ju je priporočil zdravnik.
What Xelevia contains
Kaj vsebuje zdravilo Xelevia
Xelevia is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
Zdravilo Xelevia spada v skupino peroralnih antidiabetikov, imenovanih zaviralci dipeptidil peptidaze 4 (DPP-4).
Compared to normal healthy control subjects, plasma AUC of sitagliptin was increased by approximately 1.2-fold and 1.6-fold in patients with mild renal impairment (GFR ≥ 60 to
V primerjavi z zdravimi kontrolnimi preiskovanci je bila plazemska AUC sitagliptina pri bolnikih z blago ledvično okvaro (GFR ≥ 60 do < 90 ml/min) približno 1,2-krat večja, pri bolnikih z zmerno ledvično okvaro (GFR ≥ 45 do < 60 ml/min) pa približno 1,6-krat večja.
If a hypersensitivity reaction is suspected, Xelevia should be discontinued.
Če obstaja sum na preobčutljivostno reakcijo, morate prenehati zdravljenje z zdravilom Xelevia.
Xelevia should not be used during breast-feeding.
Med dojenjem se zdravila Xelevia ne sme jemati.
The level of digoxin in your blood may need to be checked if taking with Xelevia.
Med sočasnim jemanjem z zdravilom Xelevia vam bodo morda morali preveriti vrednosti digoksina v krvi.
Xelevia contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.
Zdravilo Xelevia vsebuje učinkovino sitagliptin, ki spada v skupino zdravil, imenovano zaviralci DPP-4 (zaviralci dipeptidil peptidaze 4).
If pancreatitis is suspected, Xelevia and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Xelevia should not be restarted.
Ob sumu na pankreatitis je treba prenehati z jemanjem zdravila Xelevia in drugih zdravil, ki bi lahko povzročila pankreatitis.
- type 1 diabetes - diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss,
- sladkorno bolezen tipa 1 - diabetično ketoacidozo (zaplet sladkorne bolezni z visokim krvnim sladkorjem, hitrim hujšanjem, siljenjem na bruhanje ali bruhanjem) - kakršne koli težave z ledvicami v sedanjosti ali v preteklosti - alergijsko reakcijo na zdravilo Xelevia (glejte poglavje 4)
No dose adjustment for Xelevia is necessary for patients with mild or moderate hepatic impairment (Child-Pugh score  9).
Pri bolnikih z blago ali zmerno jetrno okvaro (ocena po Child-Pugh-u  9) odmerka ni treba prilagoditi.
In addition, patients should be alerted to the risk of hypoglycaemia when Xelevia is used in combination with a sulphonylurea or with insulin.
Poleg tega je treba bolnike, ki jemljejo zdravilo Xelevia skupaj s sulfonilsečnino ali z insulinom, opozoriti na tveganje za pojav hipoglikemije.
Marketing Authorisation Holder Merck Sharp & Dohme B.V. Waarderweg 39
Imetnik dovoljenja za promet z zdravilom: Merck Sharp & Dohme B.V.
Skin and subcutaneous tissue disorders pruritus
Bolezni kože in podkožja pruritus občasni angioedem neznana pogostnost
EU/1/07/382/013 14 film-coated tablets EU/1/07/382/014 28 film-coated tablets EU/1/07/382/023 30 film-coated tablets EU/1/07/382/015 56 film-coated tablets EU/1/07/382/016 84 film-coated tablets EU/1/07/382/024 90 film-coated tablets EU/1/07/382/017 98 film-coated tablets EU/1/07/382/018 50 x 1 film-coated tablets
EU/1/07/382/013 14 filmsko obloženih tablet EU/1/07/382/014 28 filmsko obloženih tablet EU/1/07/382/023 30 filmsko obloženih tablet EU/1/07/382/015 56 filmsko obloženih tablet EU/1/07/382/016 84 filmsko obloženih tablet EU/1/07/382/024 90 filmsko obloženih tablet EU/1/07/382/017 98 filmsko obloženih tablet EU/1/07/382/018 50 x 1 filmsko obložena tableta
EU/1/07/382/007 14 film-coated tablets EU/1/07/382/008 28 film-coated tablets EU/1/07/382/021 30 film-coated tablets EU/1/07/382/009 56 film-coated tablets EU/1/07/382/010 84 film-coated tablets EU/1/07/382/022 90 film-coated tablets EU/1/07/382/011 98 film-coated tablets EU/1/07/382/012 50 x 1 film-coated tablets
EU/1/07/382/007 14 filmsko obloženih tablet EU/1/07/382/008 28 filmsko obloženih tablet EU/1/07/382/021 30 filmsko obloženih tablet EU/1/07/382/009 56 filmsko obloženih tablet EU/1/07/382/010 84 filmsko obloženih tablet EU/1/07/382/022 90 filmsko obloženih tablet EU/1/07/382/011 98 filmsko obloženih tablet EU/1/07/382/012 50 x 1 filmsko obložena tableta
How to store Xelevia
Shranjevanje zdravila Xelevia
Xelevia 25 mg film-coated tablets Sitagliptin
Xelevia 25 mg filmsko obložene tablete sitagliptin
EU/1/07/382/001 14 film-coated tablets EU/1/07/382/002 28 film-coated tablets EU/1/07/382/019 30 film-coated tablets EU/1/07/382/003 56 film-coated tablets EU/1/07/382/004 84 film-coated tablets EU/1/07/382/020 90 film-coated tablets EU/1/07/382/005 98 film-coated tablets EU/1/07/382/006 50 x 1 film-coated tablets
EU/1/07/382/001 14 filmsko obloženih tablet EU/1/07/382/002 28 filmsko obloženih tablet EU/1/07/382/019 30 filmsko obloženih tablet EU/1/07/382/003 56 filmsko obloženih tablet EU/1/07/382/004 84 filmsko obloženih tablet EU/1/07/382/020 90 filmsko obloženih tablet EU/1/07/382/005 98 filmsko obloženih tablet EU/1/07/382/006 50 x 1 filmsko obložena tableta
Xelevia 100 mg film-coated tablets
Xelevia 100 mg filmsko obložene tablete
Xelevia 100 mg film-coated tablets Sitagliptin
Xelevia 100 mg filmsko obložene tablete sitagliptin
Xelevia 25 mg film-coated tablets
Xelevia 25 mg filmsko obložene tablete
Xelevia 50 mg film-coated tablets Sitagliptin
Xelevia 50 mg filmsko obložene tablete sitagliptin
Xelevia 50 mg film-coated tablets
Xelevia 50 mg filmsko obložene tablete
If bullous pemphigoid is suspected, Xelevia should be discontinued.
Ob sumu na bulozni pemfigoid je treba zdravljenje z zdravilom Xelevia prekiniti.
Paediatric No studies with Xelevia have been performed in paediatric patients.
Otroci Pri otrocih študij z zdravilom Xelevia niso izvedli.
Chimeric yellow fever dengue virus serotype 1* (live, attenuated).............................................4.5 - 6.0 log10 CCID50/dose** Chimeric yellow fever dengue virus serotype 2* (live, attenuated).............................................4.5 - 6.0 log10 CCID50/dose** Chimeric yellow fever dengue virus serotype 3* (live, attenuated).............................................4.5 - 6.0 log10 CCID50/dose** Chimeric yellow fever dengue virus serotype 4* (live, attenuated).............................................4.5 - 6.0 log10 CCID50/dose** * Produced in Vero cells by recombinant DNA technology.
Himerni virus rumene mrzlice denga - serotip 1 (živ, oslabljen)*..................................................................... 4.5 - 6.0 log10 CCID50/odmerek** Himerni virus rumene mrzlice denga - serotip 2 (živ, oslabljen)*..................................................................... 4.5 - 6.0 log10 CCID50/odmerek** Himerni virus rumene mrzlice denga - serotip 3 (živ, oslabljen)*..................................................................... 4.5 - 6.0 log10 CCID50/odmerek** Himerni virus rumene mrzlice denga - serotip 4 (živ, oslabljen)*..................................................................... 4.5 - 6.0 log10 CCID50/odmerek**
This product contains genetically modified organisms (GMOs).
To cepivo vsebuje genetsko spremenjene organizme.
** CCID50: 50% Cell Culture Infectious Dose.
**CCID50: 50 % infekcijski odmerek v celični kulturi (CCID - Cell Culture Infectious Dose).
--¹ After reconstitution, one dose (0.5 mL) contains:
Po rekonstituciji en odmerek (0,5 ml) vsebuje:
Powder: 5 doses; solvent: 2.5 ml
Prašek: 5 odmerkov; vehikel: 2,5 ml
5 sets of 2 vials (1 with powder + 1 with solvent, 5 doses each)
5 kompletov z 2 vialama (1 s praškom + 1 z vehiklom, 5 odmerkov vsakega)
1 vial + 1 pre-filled syringe
1 viala + 1 napolnjena injekcijska brizga
10 vials + 10 pre-filled syringes
10 vial + 10 napolnjenih injekcijskih brizg
1 vial + 1 pre-filled syringe + 2 needles
1 viala + 1 napolnjena injekcijska brizga + 2 igli
Some patients have actually committed suicide.
Nekaj bolnikov je dejansko naredilo samomor.
This is to be expected and is not a cause for concern.
To je pričakovano in ni razlog za skrb.
• Look in the window.
• Poglejte v okence.
- thoughts about threatening the life of others.
- misli, kako ogroziti življenja drugih.
Some bubbles may be present, but this is normal.
Prisotnih je lahko nekaj mehurčkov, vendar je to normalno.
Date of first authorisation: 29 May 2000 Date of latest renewal: 29 May 2010
Datum prve odobritve: 29. maj 2000 Datum zadnjega podaljšanja: 29. maj 2010
The frequency of such re-activation appears to be low.
Pogostnost takšne reaktivacije se zdi majhna.
- The contents should now be completely dissolved.
Vsebina naj bi bila zdaj popolnoma raztopljena.
Before reconstitution 3 years.
Pred rekonstitucijo 3 leta
If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards.
Če pride do te reakcije, jim je treba svetovati, naj si potem temeljito sperejo usta.
From a microbiological point of view, the product is to be used immediately.
Z mikrobiološkega stališča je treba zdravilo uporabiti takoj.
You will need the following supplies that are included in the package:
Potrebovali boste naslednji pribor, ki je priložen v pakiranju:
- have heart disease that has not been well controlled during the past 6 months.
- imate srčno bolezen, ki v zadnjih 6 mesecih ni bila dobro nadzorovana.
• Wash your hands well with soap and warm water.
• Dobro si umijte roke z milom in toplo vodo.
In those patients the SVR was 12 %.
Pri teh bolnikih je bil SVR 12 %.
The study results are summarized in Table 15.
Rezultati študije so povzeti v preglednici 15.
Please read the instructions carefully and follow them step by step.
Prosimo, natančno preberite navodila in sledite vsakemu koraku posebej.
Elderly ( 65 years of age)
Starostniki (starost  65 let)
% (number) of patients
% (število) bolnikov
Therefore, your blood will be checked regularly to be sure that the HIV infection is not getting worse.
Zato boste redno napoteni na krvne preiskave, da se zdravnik prepriča, da se okužba z virusom HIV ne slabša.
- have had any serious illness affecting breathing or blood.
- ste imeli kakršno koli resno bolezen, ki je vplivala na dihanje ali kri.
Number of capsules (200 mg)
Število kapsul (200 mg)
Take/administer the dose of this medicine as soon as you remember, but only if within 1-2 days after the forgotten dose.
Uporabite odmerek tega zdravila takoj, ko se spomnite, vendar le v času 1-2 dni po pozabljenem odmerku.
Some children did not reach their projected height within 1-5.5 years after completing treatment.
Nekateri otroci tudi niso dosegli pričakovane telesne višine v obdobju 1 do 5,5 let po zaključku zdravljenja.
A patient may be missing or have had a different result for week 4 or week 12.
Možno je, da manjka en bolnik oziroma da je imel v 4. tednu ali v 12. tednu različna rezultata.
Use this solution immediately.
To raztopino uporabite takoj.
Of these, sixty-three were sustained responders.
Triinšestdeset od teh je imelo trajen odziv.
It is considered that graft rejection reactions may be induced.
Smatra se, da lahko pride do reakcij zavrnitve presadka.
• Find a well-lit, clean flat work surface such as a table.
• Izberite dobro osvetljeno, čisto in ravno delovno površino, na primer mizo.
If necessary, the dose may be changed during treatment.
Če bo potrebno, bo morda odmerek spremenil med zdravljenjem.
You may hear a "click" sound.
Morda boste zaslišali "klik".
Bilirubin - direct
Bilirubin - direktni
Your doctor will monitor you for signs and symptoms of these conditions.
Zdravnik vas bo spremljal glede znakov in simptomov teh bolezni.
Response at end of treatment 49 % 41 % 33 % 24 % 65 % 56 % 54 % Sustained response
Odziv na koncu zdravljenja 49 % 41 % 33 % 24 % 65 % 56 % 54 % Trajni odziv
Let the skin air dry.
Pustite, da se koža na zraku posuši.
Pull the needle straight out of the skin.
Izvlecite iglo naravnost ven iz kože.
Bilirubin - indirect
Bilirubin - indirektni
Ask a family member or close friend to help you stay alert to signs of depression or changes in your behaviour.
Prosite družinskega člana ali dobrega prijatelja, naj vam pomaga biti pozoren na znake depresije ali spremembe vedenja.
Any or all of these activities may contribute to interferon's therapeutic effects.
Kateri koli od teh učinkov ali vsi skupaj lahko prispevajo k terapevtskemu delovanju interferona.
- are taking telbivudine.
- jemljete telbivudin.
Children and adolescents This medicine is not recommended for use in patients under the age of 3 years.
Otroci in mladostniki To zdravilo ni priporočljivo za uporabo pri bolnikih, mlajših od 3 let.
Your doctor will determine the correct dose for you.
Zdravnik bo določil pravi odmerek za vas.
Be sure the solution is at room temperature up to 25°C.
Prepričajte se, da je raztopina pri sobni temperaturi do 25 °C.
- are allergic to any interferon.
- ste alergični na kateri koli interferon.
Standard methods to increase elimination of the medicinal product, e.g., dialysis, have not been shown to be useful.
Običajne metode za povečanje izločanja zdravila, na primer dializa, se niso izkazale za koristne.
In terms of activity, about one-third of sustained responders showed improvement and none showed worsening.
Kar zadeva učinkovitost, se je pri približno eni tretjini bolnikov s trajnim odzivom pokazalo izboljšanje bolezni, pri nobenem od bolnikov pa ni prišlo do poslabšanja.
This medicine is intended for subcutaneous use.
To zdravilo je namenjeno subkutani uporabi.
If it is very close to your next injection, do not double the dose to make up for the forgotten dose, but continue your treatment as usual.
Če je čas za vašo naslednjo injekcijo zelo blizu, ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek, ampak zdravljenje nadaljujte kot ponavadi.
Other side effects that have been reported in adults include:
Ostali neželeni učinki, o katerih so poročali pri odraslih, so:
Fluid replacement may be necessary.
Lahko je potrebno tudi nadomeščati tekočino.
When this medicine is used alone, some of these effects are less likely to occur, and some have not occurred at all.
Ko se to zdravilo uporablja samostojno, je manj verjetno, da se pojavijo nekateri od teh učinkov, nekateri učinki pa se sploh ne pojavijo.
In all three treatment groups, sustained virologic response rates were similar.
V vseh treh terapevtskih skupinah so bili deleži trajnega virološkega odziva podobni.
The mechanisms involved in clearance of interferons in man have not yet been fully elucidated.
Mehanizmi, ki sodelujejo pri očistku interferonov pri človeku, še niso popolnoma pojasnjeni.
Ask your healthcare provider or pharmacist for an appropriate container.
Zdravstvenega delavca ali farmacevta prosite za ustrezen vsebnik.
During treatment, some patients may experience eye problems, or loss of vision in rare instances.
Med zdravljenjem imajo lahko nekateri bolniki težave z očmi ali v redkih primerih izgubijo vid.
The effect of this medicine on human pregnancy is not known.
Učinek tega zdravila na nosečnost pri človeku ni znan.
The decision to extend therapy to one year of treatment should be based on prognostic factors (e.g., genotype, age > 40 years, male gender, bridging fibrosis).
Odločitev za podaljšanje terapije na eno leto mora temeljiti na prognostičnih dejavnikih (npr. genotip, starost > 40 let, moški spol, premostitvena fibroza).
Unknown frequency side effects (frequency cannot be estimated from the available data): - Wanting to harm others.
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): želja škodovati drugim.
Another approximately 2 % had a transient decrease below the lower limit of normal.
Pri drugih približno 2 % bolnikov je prišlo do prehodnega zmanjšanja vrednosti pod spodnjo mejo normale.
< 12 g/dl after four weeks of dose reduction
< 12 g/dl po štirih tednih zmanjševanja odmerka
Additional 5 seconds ensures complete dose delivery.
Dodatnih 5 sekund zagotavlja, da je injiciran celotni odmerek.
Children and adolescents are particularly prone to develop depression when being treated with this medicine and ribavirin.
Otroci in mladostniki so še posebej nagnjeni k depresiji, kadar so zdravljeni s tem zdravilom in ribavirinom.
Dose reduction of boceprevir is not recommended.
Zmanjšanja odmerka boceprevirja ne priporočamo.
These events included suicidal ideation and attempted suicide (see section 4.4).
Med temi pojavi so bile samomorilne misli in poskusi samomora (glejte poglavje 4.4).
Your doctor should carry out an eye examination before starting your treatment.
Zdravnik naj vam pred začetkom zdravljenja opravi pregled oči.
These studies were limited to four weeks due to the appearance of anti-interferon antibodies in most monkeys.
Trajanje teh študij je bilo omejeno na štiri tedne zaradi pojava protiteles proti interferonu pri večini opic.
You are now ready to inject the dose.
Zdaj ste pripravljeni na injiciranje odmerka.
If it gets worse, your doctor will decide whether or not your ribavirin treatment needs to be changed.
Če se poslabša, se bo zdravnik odločil, ali je pri vas potrebna sprememba zdravljenja z ribavirinom ali ne.
Transient rashes do not necessitate interruption of treatment.
Prehodni izpuščaji pa ne zahtevajo prekinitve zdravljenja.
Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8ºC.
Kemično in fizikalno stabilnost med uporabo so dokazali za čas 24 ur pri temperaturi med 2 °C in 8 ºC.
With your other hand, hold the syringe as you would a pencil.
Z drugo roko primite brizgo tako, kot bi držali svinčnik.
In case of any changes in vision, you must tell your doctor and have a prompt and complete eye examination.
V primeru kakršne koli spremembe vida, morate to povedati zdravniku in imeti takoj natančen pregled oči.
Detailed information on this medicinal product is available on the web-site of the European Medicines Agency http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
(%)) in previously untreated children and adolescents by genotype and treatment duration - All subjects n = 107 24 weeks
(%)) pri predhodno nezdravljenih otrocih in mladostnikih glede na genotip in trajanje zdravljenja - vsi preiskovanci n = 107 24 tednov
- have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely.
- imate ali ste imeli okužbo z virusom hepatitisa B, ker vas bo zdravnik morda želel bolj skrbno spremljati.
Positive predictive value
Pozitivna napovedna vrednost
Anorexia, decreased appetite
anoreksija, zmanjšan apetit
Pen (CLEARCLICK)
peresnik (CLEARCLICK)
If the solution is cold, warm the syringe between your palms.
Če je raztopina hladna, brizgo ogrejte med dlanmi.
Effects on fertility have not been determined.
Učinka na plodnost niso določali.
Keep your work area, your hands, and the injection site clean to decrease the risk of infection.
Pazite, da bodo delovna površina, vaše roke in mesto injiciranja ostali čisti, da boste zmanjšali tveganje za okužbo.
It is not known whether the components of this medicinal product are excreted into experimental animal or human milk (see section 4.6 for relevant human data on pregnancy and lactation).
Ni znano, ali se sestavine tega zdravila izločajo v materino mleko pri preskušanih živalih in pri človeku (glejte poglavje 4.6 za ustrezne podatke o nosečnosti in dojenju pri človeku).