natgillin/translations-raw huggingface dataset:
MARKETING AUTHORISATION NUMBER(S) EU/1/14/956/001 2 pre-filled pens
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/956/001 2 napolnjena peresnika EU/1/14/956/002 4 napolnjeni peresniki
Treatment with Trulicity 1.5 mg resulted in similar lowering of HbA1c and patients achieving HbA1c targets of < 7.0 % and ≤ 6.5 % compared to liraglutide.
Zdravljenje z zdravilom Trulicity 1,5 mg in 0, 75 mg je povzročilo podobno zmanjšanje vrednosti HbA1c kot pri liraglutidu, bolniki pa so dosegli ciljne vrednosti HbA1c < 7,0 % in ≤ 6,5 %.
The rates of documented symptomatic hypoglycaemia with Trulicity 0.75 mg, Trulicity 1.5 mg, and placebo were 0.15, 0.16 and 0.12 episodes/patient/year, respectively.
Stopnje dokumentirane simptomatske hipoglikemije za zdravilo Trulicity 0,75 mg, zdravilo Trulicity 1,5 mg in placebo so bile 0,15, 0,16 oziroma 0,12 epizode/bolnika/leto.
It is not known if dulaglutide could harm your unborn child. Women who could become pregnant should use contraception during treatment with dulagutide.
Ni znano, ali lahko dulaglutid škoduje vašemu nerojenemu otroku.
With both Trulicity 0.75 mg and 1.5 mg, a significantly higher percentage of patients reached a target HbA1c of < 7.0% and ≤ 6.5% at 24 weeks compared to placebo.
Pri zdravljenju z zdravilom Trulicity 0,75 mg ali 1,5 mg je v 24. tednu bistveno višji odstotek bolnikov dosegel ciljno vrednost HbA1c < 7,0 % in ≤ 6,5 %, v primerjavi s placebom.
Name and address of the manufacturer(s) responsible for batch release Eli Lilly Italia S.p.A.
Ime in naslov proizvajalca (proizvajalcev), odgovornega (odgovornih) za sproščanje serij
Pack sizes of 4 or multipacks of 12 (3 packs of 4) pre-filled syringes.
Pakiranja po 4 ali večja pakiranja po 12 (3 pakiranja po 4) napolnjenih injekcijskih brizg.
The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and 0.75 mg, and exenatide twice daily were 0.19, 0.14, and 0.75 episodes/patient/year, respectively.
Stopnja dokumentirane simptomatske hipoglikemije za zdravilo Trulicity 1,5 mg in 0,75 mg ter eksenatid dvakrat na dan je bila 0,19, 0,14, in 0,75 epizod/bolnika/leto.
Dulaglutide 1.5 mg once weekly (n=192)
Dulaglutid 1,5 mg enkrat na teden (n=192)
Dulaglutide 1.5 mg once weekly (n=142)
Dulaglutid 1,5 mg enkrat na teden (n=142)
the syringe.
injekcijsko brizgo.
The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and 0.75 mg, and sitagliptin were 0.19, 0.18, and 0.17 episodes/patient/year, respectively.
Stopnja dokumentirane simptomatske hipoglikemije za zdravilo Trulicity 1,5 mg in 0,75 mg in sitagliptin je bila 0,19, 0,18, in 0,17 epizod/bolnika/leto.
Each pre-filled syringe contains 0.5 ml of solution.
Vsaka napolnjena injekcijska brizga vsebuje 0,5 ml raztopine.
SC
V
Each pen contains one weekly dose of Trulicity (0.75 mg).
En peresnik vsebuje en tedenski odmerek zdravila Trulicity (0,75 mg).
Dulaglutide 1.5 mg once weekly (n=269)
Dulaglutid 1,5 mg enkrat na teden (n=269)
Instructions for use Trulicity 1.5 mg solution for injection in pre-filled syringe dulaglutide
Navodila za uporabo Trulicity 1,5 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku dulaglutid
Dulaglutide 0.75 mg once weekly (n=190)
Dulaglutid 0,75 mg enkrat na teden (n=190)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (without Blue Box) component of a multipack - PRE-FILLED SYRINGE
ZUNANJA ŠKATLA (brez modrega okenca), sestavni del pakiranja - VEČJE PAKIRANJENAPOLNJEN INJEKCIJSKI PERESNIK
DISPOSAL OF SYRINGE
ODLAGANJE INJEKCIJSKE BRIZGE
- Trulicity 0.75 mg: Each pre-filled syringe contains 0.75 mg of dulaglutide in 0.5 ml solution.
- Trulicity 0,75 mg: Ena napolnjena injekcijska brizga vsebuje 0,75 mg dulaglutida v 0,5 ml raztopine.
Trulicity 1.5 mg solution for injection Each pre-filled syringe contains 1.5 mg of dulaglutide* in 0.5 ml solution.
Trulicity 1,5 mg raztopina za injiciranje Ena napolnjena injekcijska brizga vsebuje 1,5 mg dulaglutida* v 0,5 ml raztopine.
Instructions for use Trulicity 0.75 mg solution for injection in pre-filled syringe dulaglutide
Navodila za uporabo Trulicity 0,75 mg raztopina za injiciranje v napolnjeni injekcijski brizgi dulaglutid
Dulaglutide 0.75 mg once weekly (n=293)
Dulaglutid 0,75 mg enkrat na teden (n=293)
No dose adjustment for metformin IR is recommended when given with dulaglutide.
Ob sočasnem dajanju metformina IR z dulaglutidom prilagajanje odmerka metformina IR ni priporočeno.
Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800
Tel.: + 31-(0) 30 60 25 800
Dulaglutide 0.75 mg once weekly (n=141)
24 tednov Dulaglutid 0,75 mg enkrat na teden (n=141)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trulicity 0.75 mg solution for injection in pre-filled pen dulaglutide
IME ZDRAVILA IN POT(I) UPORABE Trulicity 0,75 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku dulaglutid subkutana uporaba
MARKETING AUTHORISATION NUMBER(S) EU/1/14/956/010
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/956/010 13.
Dulaglutide 0.75 mg once weekly (n=302)
Dulaglutid 0,75 mg enkrat na teden (n=302)
Pack sizes of 2, 4 or multipacks of 12 (3 packs of 4) pre-filled pens.
Pakiranja po 2, 4 ali večja pakiranja po 12 (3 pakiranja po 4) napolnjenih injekcijskih peresnikov.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/956/003
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/956/003
The incidence of documented symptomatic hypoglycaemia when dulaglutide 1.5 mg was used with sulphonylurea alone was 11.3% and the rate was 0.90 events/patient/year, and there were no episodes of severe hypoglycaemia.
Pogostnost dokumentirane simptomatske hipoglikemije ob uporabi dulaglutida 1,5 mg s samo sulfonilsečnino je bila 11,3 %, stopnja pa 0,90
1 UNCAP
1 ODPRITE
QUALITATIVE AND QUANTITATIVE COMPOSITION Trulicity 0.75 mg solution for injection Each pre-filled syringe contains 0.75 mg of dulaglutide* in 0.5 ml solution.
Trulicity 0,75 mg raztopina za injiciranje Ena napolnjena injekcijska brizga vsebuje 0,75 mg dulaglutida* v 0,5 ml raztopine.
Dulaglutide 0.75 mg once weekly (n=272)
Dulaglutid 0.75 mg enkrat na teden (n=272)
No dose adjustment for oral contraceptives is required when given together with dulaglutide.
Pri aplikaciji skupaj z dulaglutidom prilagoditev odmerka peroralnih kontraceptivov ni potrebna.
Trulicity 1.5 mg and 0.75 mg were superior to metformin (1500-2000 mg/day) in the reduction in HbA1c and a significantly greater proportion of patients reached an HbA1c target of < 7.0 % and ≤ 6.5 % with Trulicity 1.5 mg and Trulicity 0.75 mg compared to metformin at 26 weeks.
Odmerka zdravila Trulicity 1,5 mg in 0,75 mg sta bila superiorna od metformina (1500-2000 mg/dan) pri zmanjševanju vrednosti HbA1c in bistveno večji delež bolnikov je dosegel ciljno vrednost HbA1c < 7,0 %
- Trulicity 1.5 mg: Each pre-filled syringe contains 1.5 mg of dulaglutide in 0.5 ml solution.
Trulicity 1,5 mg: Ena napolnjena injekcijska brizga vsebuje 1,5 mg dulaglutida v 0,5 ml raztopine.
Cumulative reporting of gastrointestinal events up to 104 weeks with dulaglutide 0.75mg and 1.5 mg, respectively, included nausea (12.9% and 21.2 %), diarrhoea (10.7% and 13.7 %) and vomiting (6.9% and 11.5 %).
0,75 mg in 1,5 mg je vključevalo slabost (12,9 % oziroma 21,2 %), drisko (10,7 % oziroma 13,7 %) in bruhanje (6,9% oziroma 11,5 %).Ti učinki so bili po jakosti običajno blagi ali zmerni, vrh pa so dosegli v prvih 2 tednih zdravljenja in postopoma upadali v naslednjih 4 tednih, nato pa ostali relativno stalni.
Store in the original package in order to protect from light.
Shranjujte v originalni ovojnini, da zagotovite zaščito pred svetlobo.
Dulaglutide 0.75 mg once weekly (n=280)
Dulaglutid 0,75 mg enkrat na teden (n=280)
Dulaglutide 0.75 mg once weekly (n=270)
Dulaglutid 0,75 mg enkrat na teden (n=270)
Each syringe delivers one dose only.
Vsaka injekcijska brizga je namenjena le za enkratno uporabo.
ABOUT TRULICITY PRE-FILLED PEN
O NAPOLNJENEM INJEKCIJSKEM PERESNIKU TRULICITY
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trulicity 1.5 mg solution for injection in pre-filled pen dulaglutide
IME ZDRAVILA IN POT(I) UPORABE Trulicity 1,5 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku dulaglutid subkutana uporaba
Remove the pen from your skin.
• Umaknite peresnik s kože.
At 52 weeks, Trulicity 1.5 mg demonstrated superior lowering in HbA1c to insulin glargine which was maintained at 78 weeks; whereas lowering in HbA1c with Trulicity 0.75 mg was non-inferior to insulin glargine.
Po 52 tednih je zdravilo Trulicity 1,5 mg dokazalo superiorno znižanje HbA1c kot insulin glargin; ta učinek se je ohranil tudi po 78 tednih.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (with Blue Box) multipack - PRE-FILLED SYRINGE
ZUNANJA ŠKATLA (z modrim okencem) VEČJE PAKIRANJE - NAPOLNJENA INJEKCIJSKA BRIZGA
Instructions for use Trulicity 0.75 mg solution for injection in pre-filled pen dulaglutide
Navodila za uporabo Trulicity 0,75 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku dulaglutid
assessed for HbA1c only ** p < 0.001 dulaglutide treatment group compared to placebo ## p < 0.001 dulaglutide treatment group compared to sitagliptin
* p < 0.05, ** p < 0,001 skupina, zdravljena z dulaglutidom v primerjavi s placebom.
Dulaglutide 1.5 mg once weekly (n=295)
Dulaglutid 1,5 mg enkrat na teden (n=299)
Warnings and precautions Talk to your doctor, pharmacist or nurse before using Trulicity if: - you are on dialysis as this medicine is not recommended.
Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Trulicity se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro,
Trulicity 0.75 mg solution for injection in pre-filled syringe Trulicity 1.5 mg solution for injection in pre-filled syringe dulaglutide
Trulicity 0,75 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Trulicity 1,5 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
Sitagliptin exposure was unaffected when coadministered with a single dose of dulaglutide.
Po sočasnem dajanju sitagliptina in enkratnega odmerka dulaglutida je ostala izpostavljenost sitagliptinu nespremenjena.
BACK
spredaj zadaj
You may want to mark your calendar to remind you when to inject your next dose.
Da se boste spomnili, kdaj morate vzeti naslednji odmerek, si dan označite na koledarju.
Tabulated list of adverse reactions
V preglednici predstavljeni neželeni učinki
Dulaglutide 1.5 mg once weekly (n=273)
52 tednov Dulaglutid 1,5 mg enkrat na teden (n=273)
What Trulicity contains The active substance is dulaglutide.
Zdravilna učinkovina je dulaglutid.
INSERT 3.
2 VSTAVITE
Dulaglutide 1.5 mg once weekly (n=239)
24 tednov Dulaglutid 1,5 mg enkrat na teden (n=239)
Dulaglutide 1.5 mg once weekly (n=279)
26 tednov Dulaglutid 1,5 mg enkrat na teden (n=279)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (with Blue Box) - multipack - PRE-FILLED PEN
ZUNANJA ŠKATLA (z modrim okencem) - VEČJE PAKIRANJE - NAPOLNJENA INJEKCIJSKA BRIZGA
Children and adolescents
POGLEDA OTROK
Other things you should know
Druge stvari, ki jih morate vedeti
• Take 1 hour before or 2 hours after a meal.
• Vzemite 1 uro pred ali 2 uri po obroku.
The basis for their contributions to resistance, however, is complex.
Vendar pa je osnova za njihov prispevek k rezistenci kompleksna.
Date of first authorisation: 04 October 1996 Date of latest renewal: 18 July 2011
Datum prve odobritve: 04. oktober 1996 Datum zadnjega podaljšanja: 18. julij 2011
It is not known how often this may happen (cannot be estimated from the available data), but the reaction can sometimes be severe and include shock
Ni znano, kako pogosto se to lahko zgodi (ni mogoče oceniti iz razpoložljivih podatkov), vendar je reakcija včasih lahko huda in vključuje tudi šok.
It is however especially important that you:
Še posebej je pomembno, da:
Other substitutions were observed less frequently.
Ostale substitucije so opazili redkeje.
In some patients additional factor VIII was given.
Nekateri bolniki so dodatno dobivali faktor VIII.
This may be because the body is able to start fighting infections again.
To je lahko posledica tega, da se telo lahko spet začne boriti proti okužbam.
CD4 cells are an important part of your immune system.
CD4 celice so pomemben del vašega imunskega sistema.
If this happens, do not drive or operate machines.
Če se to zgodi, ne vozite in ne upravljajte s stroji.
Medicinal products listed above are not repeated in Table 1 and 2 unless specific interaction data is available.
Zgornja zdravila niso ponovno navedena v tabelah 1 in 2, razen če so na razpolago posebni podatki o medsebojnem delovanju.
• if you are taking any of the following medicines:
• če jemljete katero od zdravil:
Please see ‘Warnings and precautions' in Section 2 above.
Prosimo, glejte 'Opozorila in previdnostni ukrepi' v poglavju 2.
Interaction via effects on transport proteins cannot be excluded.
Interakcije preko učinkov na transportne beljakovine ne moremo izključiti.
Refer also to sections 4.2 and 4.3.
Prosimo preberite tudi poglavji 4.2 ter 4.3.
The main role of the immune system is to protect you from infections.
Glavna vloga vašega imunskega sistema je, da vas zaščiti pred okužbo.
The pharmacokinetic parameters in the second study were comparable.
Parametri farmakokinetike v drugi študiji so bili primerljivi.
In more than a half of the reported cases, treatment with PIs was continued or re-introduced if treatment had been discontinued.
V več kot polovici poročanih primerov so zdravljenje s PI nadaljevali ali ponovno uvedli, če je bilo zdravljenje prekinjeno.
You may still get infections or other illnesses related to HIV.
Še vedno lahko dobite okužbe ali druge bolezni, povezane z virusom HIV.
When to take
Kdaj vzeti
A causal relationship has been evoked, although the mechanism of action has not been elucidated.
Verjetno obstaja vzročna povezava, čeprav mehanizem delovanja ni pojasnjen.
How often they happen is not known:
Kako pogosto se pojavljajo, ni znano.
The appropriate doses for this combination, with respect to efficacy and safety, have not been established.
Ustreznih odmerkov za to kombinacijo glede na učinkovitost in varnost niso ugotovili.
You may need to have blood tests to check how your liver is working.
Mogoče boste morali narediti krvne teste, da bodo preverili delovanje vaših jeter.
Your doctor will monitor how this medicine works for you.
Zdravnik bo spremljal, kako zdravilo deluje na vas.
None of these substitutions was either necessary or sufficient for resistance.
Nobena od teh substitucij ni bila ne nujna ne zadostna za pojav rezistence.
The clinical significance of this finding is unknown.
Klinični pomen teh ugotovitev ni znan.
Acute haemolytic anaemia has been reported which in some cases was severe and progressed rapidly.
Poročali so o akutni hemolitični anemiji, ki je bila v nekaterih primerih huda in je hitro napredovala.
Within studies, this effect is sustained also after prolonged periods of follow-up.
Znotraj raziskav se ta učinek ohrani tudi po daljšem obdobju spremljanja.
This medicine contains lactose (type of sugar).
To zdravilo vsebuje laktozo (vrsta sladkorja).
• if you are allergic to indinavir or any of the other ingredients of this medicine (listed in Section 6).
• če ste alergični na indinavir ali katero koli sestavino tega zdravila (navedeno v poglavju 6)
• pain and difficulty moving shoulder.
• bolečina in težave pri premikanju rame
• difficulty getting to sleep
• težave s spanjem
• lower the amount of HIV in your body (your ‘viral load')
• zmanjšati količino virusa HIV v telesu ('virusno obremenitev')
On rare occasions the muscle problems can be serious (rhabdomyolysis).
V redkih primerih so težave z mišicami lahko resne (rabdomioliza).
Mothers should be instructed to discontinue breast feeding during treatment.
Materam je treba naročiti, naj v času zdravljenja prekinejo z dojenjem.
For optimal absorption, CRIXIVAN should be administered without food but with water 1 hour before or 2 hours after a meal.
Za optimalno absorpcijo se zdravila CRIXIVAN ne sme jemati s hrano, ampak z vodo eno uro pred obrokom ali dve uri po njem.
In general, however, higher levels of resistance resulted from the co-expression of greater numbers of substitutions at the eleven identified positions.
Na splošno je višjo stopnjo rezistence sprožila koekspresija večjega števila substitucij na enajstih ugotovljenih mestih.
Midazolam (parenteral)
Midazolam (parenteralni)
Currently available data in children above the age of 4 years are described in sections 4.8, 5.1, and 5.2.
Podatki, ki so trenutno na voljo za otroke, starejše od 4 let, so podani v poglavjih 4.8, 5.1 in 5.2.
Use the lowest possible dose of atorvastatin with careful monitoring.
Uporabite najmanjši mogoči odmerek atorvastatina in skrbno spremljajte.
During pregnancy, it has been demonstrated that the systemic exposure of indinavir is relevantly decreased (PACTG 358.
Dokazano je, da je med nosečnostjo sistemska izpostavljenost indinavirja ustrezno znižana (PACTG 358.
HIV is spread by blood or sexual contact with a person with HIV.
Virus HIV se prenaša s krvjo ali s spolnim stikom z osebo, okuženo z virusom HIV.
• If you are pregnant, think you may be pregnant or are planning to have a baby, only take CRIXIVAN if your doctor decides it is clearly necessary.
• Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, lahko zdravilo CRIXIVAN jemljete le, če zdravnik odloči, da je to nujno potrebno.
• lower the risk that you get illnesses related to HIV
• zmanjšati tveganje za pojav bolezni, povezanih z virusom HIV,
Some of these events were associated with mild elevation of serum creatinine.
Nekaj teh dogodkov je bilo povezanih z rahlim zvišanjem serumskega kreatinina.
This happens in some people with advanced HIV infection (AIDS) and who have had HIV related infections before.
To se zgodi pri nekaterih bolnikih z napredovano okužbo s HIV (AIDS), ki so že imeli okužbe, povezane s HIV.
This is called combination antiretroviral therapy.
To se imenuje kombinirano antiretrovirusno zdravljenje.
• low red blood cell count
• nizko število rdečih krvnih celic
No specific dose recommendation can be given.
Ni posebnih priporočil za odmerjanje.
• feeling numb or unusual feeling of the skin.
• občutek odrevenelosti ali nenavaden občutek na koži
The mean half-life of indinavir increased to approximately 2.8 hours.
Povprečen razpolovni čas indinavirja je narasel na približno 2,8 ur.
• Do not stop taking CRIXIVAN without talking to your doctor.
• Ne prenehajte z jemanjem zdravila CRIXIVAN, ne da bi se o tem posvetovali z zdravnikom.
Eighteen patients completed the study to week 48.
18 bolnikov je študijo končalo do 48. tedna.
• raise your CD4 (T) cell count.
• povečati število CD4 (T) celic.
• allergies
• alergija
The recommended doses are:
Priporočeni odmerki so:
Indinavir and didanosine formulations containing buffer should be administered at least one hour apart on an empty stomach.
Formulacije indinavirja in didanozina, ki vsebujejo pufer, je treba dajati v razmiku vsaj ene ure, na prazen želodec.
• altered taste sensations
• spremenjen okus
Indinavir was rapidly eliminated with a half-life of 1.8 hours.
Indinavir se je izločal hitro z razpolovnim časom 1,8 ure.
• blood in your urine.
• kri v urinu
If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Če opazite kakršne koli simptome okužbe ali druge simptome, kot so oslabelost mišic, šibkost, ki se začne v dlaneh in stopalih in se širi navzgor proti trupu telesa, palpitacije, tremor ali hiperaktivnost, prosimo takoj obvestite zdravnika, ki bo poskrbel za primerno zdravljenje.
The pharmacokinetics of indinavir in these 11 patients at 6 weeks postpartum were generally similar to those observed in non-pregnant patients in another study (see section 4.6).
Farmakokinetika indinavirja pri teh 11 bolnicah je bila 6 tednov po porodu na splošno podobna kot pri ne nosečih bolnicah v drugi raziskavi (glejte poglavje 4.6 ).
Interaction unknown.
Interakcija ni znana.
There are no data to suggest that indinavir affects the ability to drive and use machines.
Nimamo podatkov, ki bi nakazovali, da indinavir vpliva na sposobnost vožnje in upravljanja s stroji.
• severe pain, tenderness or weakness in your muscles - this is more likely to happen if you are taking cholesterol-lowering medicines called ‘statins' (such as simvastatin).
• huda bolečina, občutljivost ali šibkost v mišicah - to je bolj verjetno, če jemljete zdravila za zniževanje holesterola, imenovana 'statini' (kot je simvastatin).
Many of these adverse reactions were also identified as common pre-existing or frequently occurring medical conditions in this population.
Za veliko teh neželenih učinkov so ugotovili, da so ali pogosta že obstoječa stanja ali pogosta obolenja te populacije.
There are no data available regarding potential effects of CRIXIVAN treatment on male or female fertility.
Ni podatkov o potencialnih učinkih zdravljenja z zdravilom CRIXIVAN na plodnost pri moških ali ženskah.
So you still need to keep seeing your doctor while you are taking CRIXIVAN.
Zato je še vedno potrebno, da obiskujete zdravnika, medtem ko jemljete zdravilo CRIXIVAN.
Distribution Indinavir was not highly bound to human plasma proteins (39 % unbound).
Porazdelitev Indinavir se ni močno vezal na plazemske beljakovine (39 % nevezanega).
Children and adolescents CRIXIVAN is not recommended in children under the age of 18 years.
Otroci in mladostniki Uporaba zdravila CRIXIVAN pri otrocih in mladostnikih do 18. leta starosti ni priporočljiva.
On the basis of current pharmacodynamic data, indinavir must be used in combination with other antiretroviral agents.
Na podlagi trenutnih farmakodinamskih podatkov moramo indinavir uporabljati v kombinaciji z drugimi protiretrovirusnimi zdravili.
This will help lower the risk of you getting kidney stones.
S tem se zmanjša možnost nastanka ledvičnih kamnov.
Please see ‘Do not take CRIXIVAN' and ‘Do not take either CRIXIVAN or ritonavir' above under Section 2 for an important list of medicines that you must not combine with CRIXIVAN.
Prosimo, glejte podpoglavji 'Ne jemljite zdravila CRIXIVAN' in 'Ne jemljite niti zdravila CRIXIVAN niti ritonavirja' v poglavju 2 za pomemben seznam zdravil, ki jih ne smete kombinirati z zdravilom CRIXIVAN.
• signs of infection - this may be a previous infection which comes back soon after anti-HIV treatment is started.
• simptomi okužbe - to je lahko predhodna okužba, ki se ponovi, ko se začne zdravljenje proti HIV.
isolated asymptomatic hyperbilirubinaemia, increased ALT and AST
izolirana asimptomatična hiperbilirubinemija, povečani ALT in AST
• It is recommended that women with HIV do not breast-feed.
• Priporočeno je, naj ženske, okužene z virusom HIV, ne dojijo.
This is to stop HIV being passed on to their baby.
S tem se prepreči prenos virusa HIV na otroka.
Ritonavir is used for increasing the blood levels of CRIXIVAN or, less frequently and then at higher doses, for HIV treatment.
Ritonavir se uporablja za zvišanje zdravila CRIXIVAN v krvi, ali manj pogosto in pri višjih odmerkih, za zdravljenje okužb s HIV.
Less than 20 % of indinavir is excreted renally.
Manj kot 20 % indinavirja se izloča preko ledvic.
CRIXIVAN is used at the same time as other HIV treatments (antiretroviral medicines).
Zdravilo CRIXIVAN se uporablja istočasno z drugimi HIV zdravili (protiretrovirusnimi zdravili).
There are also other side effects that you may get while taking this medicine such as increased bleeding in haemophiliacs, muscle problems, signs of infection, and bone problems.
Obstajajo tudi drugi neželeni učinki, ki jih lahko dobite v času jemanja zdravila, kot so povečano krvavljenje pri hemofilikih, težave z mišicami, znaki okužbe in težave s kostmi.
It is not known whether indinavir is excreted in human milk.
Ni znano, ali se indinavir izloča v materino mleko.
Since CRIXIVAN must be taken at intervals of 8 hours, a schedule convenient for the patient should be developed.
Ker je treba CRIXIVAN jemati v 8-urnih intervalih, je treba narediti načrt jemanja, ki je primeren za bolnika.