natgillin/translations-raw huggingface dataset:
Diovan 80 mg capsules, hard can be used for three different conditions:
Diovan 80 mg trde kapsule je mogoče uporabljati pri zdravljenju treh bolezni:
Diovan can be given together with other treatment for heart attack, and your doctor will decide which treatment is suitable for you.
O tem, katero zdravljenje je primerno za vas, se bo odločil vaš zdravnik.
Diovan and associated names (see Annex I) 160 mg film-coated tablets Valsartan
Diovan in sorodna imena (glejte Dodatek I) 160 mg filmsko obložene tablete Valsartan
The therapeutic indication for heart failure is supported primarily by a large long-term morbidity trial Valsartan Heart Failure Trial (Val-HeFT) Valsartan reduced the risk related to first morbid event, mortality, the total number of Heart Failure (HF) hospitalizations.
Terapevtska indikacija za srčno popuščanje je v glavnem podprta z obsežnim dolgoročnim preskušanjem obolevnosti, kjer so raziskovali vpliv valsartana pri srčnem popuščanju (Val-HeFT).
Evaluation of post-myocardial infarction patients should always include assessment of renal function.
Pregled bolnikov po miokardnem infarktu mora vedno vključevati oceno ledvične funkcije.
Diovan is used when a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors (a medication to treat heart failure) cannot be used or it may be used in addition to ACE inhibitors when beta blockers (another medication to treat heart failure) cannot be used.
Zdravilo Diovan uporabimo takrat, kadar ne moremo uporabiti zdravila iz skupine, ki se imenuje zaviralci angiotenzinske konvertaze (ACE) (zdravila pri zdravljenju srčnega popuščanja), lahko pa ga uporabimo poleg zaviralca ACE, kadar ne moremo uporabiti antagoniste adrenergičnih receptorjev beta (druga vrsta zdravil pri zdravljenju srčnega popuščanja).
Diovan and associated names (see Annex I) 40 mg film-coated tablets Valsartan
Diovan in sorodna imena (glejte Dodatek I) 40 mg filmsko obložene tablete Valsartan
Evaluation of post-myocardial infarction patients should always include assessment of renal function (see section
Pregled bolnikov po miokardnem infarktu mora vedno vključevati oceno ledvične funkcije (glejte poglavje 4.2).
Diovan and associated names (see Annex I) 160 mg capsules, hard Valsartan
Diovan in sorodna imena (glejte Dodatek I) 160 mg trde kapsule Valsartan
Diovan and associated names (see Annex I) 80 mg film-coated tablets Valsartan
Diovan in sorodna imena (glejte Dodatek I) 80 mg filmsko obložene tablete Valsartan
There was no difference in all-cause mortality, cardiovascular mortality or morbidity when beta blockers were administered together with the combination of valsartan + captopril, valsartan alone, or captopril alone.
Pri uporabi antagonistov adrenergičnih receptorjev beta skupaj s kombinacijo valsartana in kaptoprila, skupaj samo z valsartanom ali skupaj samo s kaptoprilom ni bilo razlik v umrljivosti iz vseh vzrokov ter v kardiovaskularni umrljivosti in obolevnosti.
Diovan and associated names (see Annex I) 80 mg capsules, hard Valsartan
Diovan in sorodna imena (glejte Dodatek I) 80 mg trde kapsule Valsartan
Diovan and associated names (see Annex I) 40 mg capsules, hard Valsartan
Diovan in sorodna imena (glejte Dodatek I) 40 mg trde kapsule Valsartan
The main discussion for this section concerned the presentation of ADRs in the SPC.
Glavna razprava v zvezi s tem poglavjem se je nanašala na prikaz neželenih učinkov v povzetku glavnih značilnosti zdravila.
• if you are being treated for heart failure, a triple combination with ACE inhibitors and beta blockers (medications to treat heart failure) is not recommended.
• Če se zdravite zaradi srčnega popuščanja, ni priporočena uporaba trojne kombinacija z zaviralci
Heart Failure
Jetrna okvara
DATE OF REVISION OF THE TEXT [To be completed nationally]
6.3 Rok uporabnosti [Izpolni država članica]
Whereas
e
Diovan 320 mg film-coated tablets can be used
Diovan 320 mg filmsko obložene tablete je mogoče uporabljati:
The antihypertensive effect is substantially present within 2 weeks, and maximal effects are attained within 4 weeks.
Priporočen začetni odmerek zdravila Diovan je 80 mg enkrat na dan. Do znatnega antihipertenzivnega učinka pride v 2 tednih, do največjega učinka pa v 4 tednih.
Myalgia
Jakost
Dizziness, Postural dizziness
PRETISNI OMOTI
--1 Per 1 ml dose: live feline calicivirus (strain F9) 104.6-106.1 CCID50; live feline viral rhinotracheitis virus (strain F2) 105.0-106.6 CCID50 ; live feline panleucopenia virus (strain LR 72) 103.7-104.5 CCID50; and purified p45 FeLV-envelope antigen, minimum quantity 102 μg
--1 Na odmerek 1 ml: Živ virus mačje kalicivirus (sev F9) 104.6 -106.1 CCID50; Živ virus mačjega virusnega rinotraheitisa (sev F2) 105.0 -106.6 CCID50; Živ virus mačje panlevkopenije (sev LR 72) 103.7 -104.5 CCID50; in minimalna količina prečiščenega antigena ovojnice p 45FeLV 102 µg
150 (3x50) capsules
150 (3x50) kapsul
150 mg Film-coated tablet Oral use
150 mg filmsko obložena tableta
The main measure of effectiveness was based on changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after 12 weeks.
Glavno merilo učinkovitosti je bila sprememba forsiranega ekspiracijskega volumna (FEV1 - največja količina zraka, ki jo oseba lahko izdihne v eni sekundi) pri bolnikih po 12 tednih.
The full EPAR for Hirobriz Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Hirobriz Breezhaler je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It works by attaching to beta-2 receptors that are found in the muscle cells of many organs and that cause the muscles to relax.
Deluje tako, da se veže na receptorje beta 2, ki se nahajajo v mišičnih celicah številnih organov in povzročajo sprostitev mišic.
European Commission granted a marketing authorisation valid throughout the European Union for Hirobriz Breezhaler on 30 November 2009.
Evropska komisija je dovoljenje za promet z zdravilom Hirobriz Breezhaler, veljavno po vsej Evropski uniji, izdala 30. novembra 2009.
This is a summary of the European public assessment report (EPAR) for Hirobriz Breezhaler.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Hirobriz Breezhaler.
Therefore, the Agency decided that Hirobriz Breezhaler's benefits are greater that its risks and recommended that it be given marketing authorisation.
Zato je zaključila, da so koristi zdravila Hirobriz Breezhaler večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
Overall, the effects of the 150 and 300 microgram doses of Hirobriz Breezhaler were similar, but the results showed that the 300 microgram dose may provide better relief in patients with more severe disease.
V celoti so bili učinki 150- in 300-mikrogramskih odmerkov zdravila Hirobriz Breezhaler podobni, vendar pa rezultati kažejo, da je 300-mikrogramski odmerek pri bolnikih s hujšimi oblikami bolezni zagotovil večje olajšanje.
COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing.
Kronična obstruktivna pljučna bolezen je dolgotrajna bolezen, pri kateri so dihalne poti in zračni mešički v pljučih poškodovani ali blokirani, kar povzroča težko vdihavanje in izdihavanje zraka.
On average, the increase in FEV1 in patients who received Hirobriz Breezhaler was between 150 to 190 ml, while for patients who received placebo the change in FEV1 ranged from a decrease of 10 ml to an increase of 20 ml.
Pri bolnikih, ki so prejeli zdravilo Hirobriz Breezhaler, je izboljšanje FEV1 v povprečju znašalo med 150 in 190 ml, medtem ko je pri bolnikih, ki so prejeli placebo, sprememba FEV1 segala od poslabšanja za 10 ml do izboljšanja za 20 ml.
The most common side effects with Hirobriz Breezhaler (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat) and upper respiratory tract infection (infection of the nose and throat).
Najpogostejša neželena učinka zdravila Hirobriz Breezhaler (ki lahko prizadeneta več kot 1 bolnika od 10) sta nazofaringitis (vnetje nosu in žrela) in okužba zgornjih dihal (okužba nosu in grla).
Hirobriz Breezhaler capsules, which contain a powder for inhalation, are only used with a Hirobriz Breezhaler inhaler and must not be swallowed.
Kapsule zdravila Hirobriz Breezhaler, ki vsebujejo prašek za inhaliranje, se uporabljajo samo z inhalatorjem Hirobriz Breezhaler in se jih ne sme pogoltniti.
In three main studies involving over 4,000 patients with COPD, Hirobriz Breezhaler was compared with placebo (a dummy treatment), tiotropium or formoterol (other inhaled medicines used to treat COPD).
V treh glavnih študijah, ki so vključevale več kot 4 000 bolnikov s KOPB, so zdravilo Hirobriz Breezhaler primerjali s placebom (zdravilom brez zdravilne učinkovine), tiotropijem ali formoterolom (drugima inhalacijskima zdraviloma, ki se uporabljata za zdravljenje KOPB).
Hirobriz Breezhaler is used for maintenance (regular) treatment.
Zdravilo Hirobriz Breezhaler se uporablja za vzdrževalno (redno) zdravljenje.
What measures are being taken to ensure the safe and effective use of Hirobriz Breezhaler?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Hirobriz Breezhaler?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hirobriz Breezhaler have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Hirobriz Breezhaler upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For more information about treatment with Hirobriz Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Hirobriz Breezhaler preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Hirobriz Breezhaler is a medicine that is used to keep the airways open in adults with chronic obstructive pulmonary disease (COPD).
Zdravilo Hirobriz Breezhaler se uporablja za vzdrževanje odprtih dihalnih poti pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB).
The Agency also noted that there were no major safety concerns with Hirobriz Breezhaler, with side effects being manageable and similar to other beta-2 adrenergic receptor agonist medicines.
Ugotovila je tudi, da ni večjih pomislekov glede njegove varnosti, saj so njegovi neželeni učinki obvladljivi in podobni kot pri drugih agonistih adrenergičnih receptorjev beta 2.
The active substance in Hirobriz Breezhaler, indacaterol, is a beta-2 adrenergic receptor agonist.
Zdravilna učinkovina v zdravilu Hirobriz Breezhaler, indakaterol, je agonist adrenergičnih receptorjev beta 2.
The European Medicines Agency concluded that Hirobriz Breezhaler was shown to be effective at improving lung function in COPD.
Evropska agencija za zdravila je zaključila, da je zdravilo Hirobriz Breezhaler dokazano učinkovito pri izboljševanju delovanja pljuč pri KOPB.
For practical information about using Hirobriz Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Hirobriz Breezhaler naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
When Hirobriz Breezhaler is inhaled, indacaterol reaches the receptors in the airways and activates them.
Ko bolnik vdihne zdravilo Hirobriz Breezhaler, indakaterol doseže receptorje v dihalnih poteh in jih aktivira.
Other information about Hirobriz Breezhaler
Druge informacije o zdravilu Hirobriz Breezhaler
For the full list of all side effects and restrictions with Hirobriz Breezhaler, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Hirobriz Breezhaler glejte navodilo za uporabo.
What is Hirobriz Breezhaler and what is it used for?
Kaj je zdravilo Hirobriz Breezhaler in za kaj se uporablja?
Hirobriz Breezhaler was more effective than placebo at improving how well the lungs work in patients with COPD.
Zdravilo Hirobriz Breezhaler je bilo pri izboljšanju delovanja pljuč bolnikov s KOPB učinkovitejše od placeba.
What benefits of Hirobriz Breezhaler have been shown in studies?
Kakšne koristi je zdravilo Hirobriz Breezhaler izkazalo v študijah?
What are the risks associated with Hirobriz Breezhaler?
Kakšna tveganja so povezana z zdravilom Hirobriz Breezhaler?
Why is Hirobriz Breezhaler approved?
Zakaj je bilo zdravilo Hirobriz Breezhaler odobreno?
Hirobriz Breezhaler can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Hirobriz Breezhaler je le na recept.
How does Hirobriz Breezhaler work?
Kako zdravilo Hirobriz Breezhaler deluje?
How is Hirobriz Breezhaler used?
Kako se zdravilo Hirobriz Breezhaler uporablja?
It is not intended to provide practical advice on how to use Hirobriz Breezhaler.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 May 2014
Datum prve odobritve: 14. maj 2014
Elderly (over 65 years of age)
Starejši (stari več kot 65 let)
Laboratory parameter
Laboratorijski parameter
2 Alone or in combination with other substitutions (includes mixtures).
2 Samostojno ali v kombinaciji z drugimi substitucijami (vključuje mešanice).
Propulsive Cisapride
Propulzivi cisaprid
If you do, your medicine may not work properly.
zdravilo morda ne bo ustrezno delovalo.
Clinical study examining QT interval
Klinične študije, v katerih so preučevali interval QT
4 Patients with these combinations are also included in other rows describing the individual substitutions.
4 Bolniki z navedenimi kombinacijami so šteti tudi v drugih vrsticah, v katerih so navedene samostojne substitucije.
Phase 3 study in Asian patients
Študija faze 3 pri bolnikih azijskega porekla
122, 155 and/or 168.
122, 155 in/ali 168.
3 Substitutions only observed in combinations with other emerging substitutions at one or more of the NS3 positions 80,
3 Substitucije, ki so jih opažali samo v kombinacijah z drugimi novimi substitucijami na enem ali več položajih NS3: 80,
In particular tell your doctor or pharmacist if you take any of the following medicines:
Zdravnika ali farmacevta obvestite zlasti v primeru, da jemljete katero od naslednjih zdravil:
C212 (Phase 3)
C212 (faza 3)
No serious adverse reactions were reported.
O resnih neželenih učinkih niso poročali.
Pack sizes of 7 or 28 capsules.
Velikost pakiranja: 7 ali 28 kapsul.
30-150 mg once daily, individualised dose
30-150 mg enkrat na dan, individualno odmerjanje
HCV genotype 4a - 4d
HCV genotipa 4a - 4d
Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for 48 hours in an appropriate clinical setting.
Bolnike, z velikom tveganjem za pojav bradikardije je treba 48 ur neprekinjeno spremljati v ustreznem kliničnem okolju.
Sensitivity to sunlight
Občutljivost na svetlobo
BMI ≥ 30 kg/m2
ITM ≥ 30 kg/m2
Excipient with known effect: each capsule contains 78.4 mg of lactose (as monohydrate).
Pomožne snovi z znanim učinkom: ena kapsula vsebuje 78,4 mg laktoze (v obliki laktoze monohidrata).
The type of food does not affect exposure to simeprevir.
Vrsta hrane ne vpliva na izpostavljenost simeprevirju.
Carcinogenicity studies with simeprevir have not been conducted.
Študij karcinogenosti simeprevirja niso izvedli.
5 Two patients had emerging single substitution I170T.
5 Pri dveh bolnikih je prišlo do enojne substitucije I170T.
In addition, tell your doctor if you take any medicines used to treat irregular heart beat or high blood pressure.
Zdravniku povejte tudi, če jemljete katero koli zdravilo za zdravljenje motenj srčnega ritma ali visokega krvnega tlaka.
If you are pregnant, think you might be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
ULN = Upper Limit of Normal.
ZMN = zgornja meja normalnih vrednosti.
Simeprevir is extensively bound to plasma proteins (> 99.9%), primarily to albumin and, to a lesser extent, alfa-1-acid glycoprotein.
Simeprevir se močno veže na beljakovine v plazmi (> 99,9%), največ na albumin in manj na alfa-1-kisli glikoprotein.
3 Recommended duration of treatment provided that patient does not meet a stopping rule (see table 3).
3 Priporočeno trajanje zdravljenja, pod pogojem, da bolnik ne doseže smernic za ukinitev zdravljenja (glejte preglednico 3).
EU/1/14/924/002 (28 capsules)
EU/1/14/924/002 (28 kapsul)
What OLYSIO is and what it is used for What you need to know before you take OLYSIO How to take OLYSIO
Kaj je zdravilo OLYSIO in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo OLYSIO Kako jemati zdravilo OLYSIO
In Europe, the prevalence was lower, 19% (73/377) in patients with HCV genotype 1a and 0.3% (3/877) in genotype 1b.
V Evropi je bila prevalenca manjša, 19% (73/377) pri bolnikih s HCV genotipa 1a in 0,3% (3/877) pri bolnikih s HCV genotipa 1b.
Amylase and lipase elevations were not associated with pancreatitis.
Zvečanje koncentracij amilaze in lipaze ni bilo povezano s pankreatitisom.
1 WHO worst toxicity grades 1 to 4.
1 največja stopnja toksičnosti po SZO 1 do 4
Hyperbilirubinemia Grade 1
Hiperbilirubinemija stopnja 1
Study HPC3007
Študija HPC3007
The long-term clinical impact of the emergence or persistence of simeprevir-resistance-associated substitutions is unknown.
Dolgoročni klinični pomen pojavljanja oziroma vztrajanja substitucij, ki povzročajo odpornost na simeprevir, ni znan.
OLYSIO is available in packs containing 7 capsules (1 blister) or 28 capsules (4 blisters).
Zdravilo OLYSIO je na voljo v pakiranjih po 7 kapsul (1 pretisni trak) ali po 28 kapsul (4 pretisni trakovi).
5 Comparison based on historic controls.
5 Primerjava s podatki zgodovinskih kontrol.
C206 (ASPIRE; Phase 2)
C206 (ASPIRE; faza 2)
The adverse reactions are listed by system organ class (SOC) and frequency: 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).
(≥ 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).
ANTIHISTAMINES Astemizole Terfenadine
ANTIHISTAMINIKI astemizol terfenadin
Lipase Grade 1
Lipaza stopnja 1
C208 - C216 (QUEST-1 and QUEST-2;
C208 - C216 (QUEST-1 in QUEST-2; faza 3)
Table 4: Interactions and dose recommendation with other medicinal products Medicinal products by therapeutic areas
Preglednica 4: Interakcije in priporočila za odmerjanje z drugimi zdravili
Genotype 1 (N = 9) Genotype 2 (N = 6) Genotype 3 (N = 8) Genotype 4 (N = 8) Genotype 5 (N = 7) Genotype 6 (N = 8)
genotip 1 (N = 9) genotip 2 (N = 6) genotip 3 (N = 8) genotip 4 (N = 8) genotip 5 (N = 7) genotip 6 (N = 8)
4 Patient individualised dose at the discretion of the physician, according to local clinical practice.
4 Odmerek, prilagojen posameznemu bolniku po presoji zdravnika glede na lokalne klinične smernice.
- If you are a woman, you must not become pregnant during treatment and for several months afterwards.
- Če ste ženska, ne smete zanositi med zdravljenjem in še nekaj mesecev po zaključku zdravljenja.
Mean (SE) change in HCV RNA at day 7/8 (log10 IU/mL)
Srednja (SE) sprememba v HCV RNA na dan 7/8 (log10 i.e./ml)
* darunavir/ritonavir + 50 mg simeprevir compared to 150 mg simeprevir alone.
* darunavir/ritonavir + 50 mg simeprevirja v primerjavi s 150 mg simeprevirja samostojno
Any substitution at NS3 position 43, 80, 122, 155, 156, or 1682
katera koli substitucija na položaju NS3 43, 80, 122, 155, 156 ali 1682
How to remove capsule Press either edge of the pocket to push the capsule through the foil, as shown.
Kako iztisniti kapsulo iz žepka Kot je prikazano na sliki, pritisnite na rob žepka in potisnite kapsulo skozi folijo.
4.6 Fertility, pregnancy and lactation
4.6 Plodnost nosečnost in dojenje
12 weeks N = 286
12 tednov n = 286
Patients with cirrhosis1
Bolniki s cirozo1
NARCOTIC ANALGESICS Methadone7
OPIOIDNI ANALGETIKI metadon7
Tell your doctor immediately if you are taking OLYSIO with sofosbuvir and any medicines for heart problems, and during treatment you experience: - shortness of breath - light-headedness - palpitations - fainting.
Takoj obvestite zdravnika če jemljete zdravilo OLYSIO, sofosbuvir in katerokoli zdravilo za zdravljenje težav s srcem in se med zdravljenjem pojavijo: - zasoplost - omotica - palpitacije - omedlevica.
The capsule should be swallowed as a whole.
Kapsule je treba pogoltniti cele.
None of the patients discontinued treatment due to ‘blood bilirubin increased'.
Noben bolnik pa ni prekinil zdravljenja zaradi 'zvečanja koncentracije bilirubina v krvi'.
White gelatin capsule of approximately 22 mm in length, marked with “TMC435 150” in black ink.
Bela želatinska kapsula dolžine približno 22 mm z oznako "TMC435 150", natisnjeno s črnim barvilom.
HMG CO-A REDUCTASE INHIBITORS Rosuvastatin
ZAVIRALCI REDUKTAZE HMG-CoA rosuvastatin
Oral: 0.075 mg/kg Intravenous:
0,075 mg/kg intravenski:
If you forget to take OLYSIO - If it is more than 12 hours until your next dose, take the missed dose as soon as possible with food.
Če ste pozabili vzeti zdravil OLYSIO - Če je do naslednjega odmerka več kot 12 ur, vzemite pozabljeni odmerek čimprej skupaj s hrano.
If the capsule shell is indented or bent - without being broken or opened - the capsule can still be used.
Če pa je kapsula vdrta ali zmečkana, ni pa zlomljena ali odprta, kapsulo lahko uporabite.
Dexlansoprazole Esomeprazole Lansoprazole Pantoprazole Rabeprazole
dekslansoprazol esomeprazol lansoprazol pantoprazol rabeprazol
Environmental Risk Assessment (ERA) Simeprevir is classified as a PBT (persistent, bioaccumulative and toxic) substance (see section 6.6).
Simeprevir je opredeljen kot snov, ki izpolnjuje kriterije PBT (je obstojen, bioakumulativen in strupen) (glejte poglavje 6.6).
The clinical relevance of this difference in viral breakthrough rates is unknown.
Klinični pomen razlik v stopnjah virusnega preboja med različnimi podskupinami ni znan.
2 Out of the 3 patients with on-treatment failure, 2 patients experienced viral breakthrough and one patient discontinued treatment early due to an adverse event.
2 Med 3 bolniki z neuspehom v času zdravljenja sta imela 2 bolnika virusni preboj, en bolnik pa je zdravljenje kmalu zaključil zaradi neželenega učinka.
Co-administration is not recommended.
Sočasna uporaba ni priporočena.
INFORMATION IN BRAILLE olysio 150 mg
PODATKI V BRAILLOVI PISAVI olysio 150 mg
Hepatitis B virus (HBV) co-infection
Sočasna okužba z virusom hepatitisa B (HBV)
Study1
Študija1
ANTITUSSIVE Dextromethorphan (DXM)
ANTITUSIKI dekstrometorfan (DXM)
Age (years) median (range) % above 65 yrs Male gender Race White Black/African American Hispanic
Starost (leta) mediana (razpon) % nad 65 let Moški Rasa belci črna rasa/afroameričani
Female patients of childbearing potential and male patients with female partners of childbearing potential must use an effective form of contraception during treatment with ribavirin and after completion of ribavirin treatment for a duration as specified in the Summary of Product Characteristics for ribavirin.
Bolnice, ki so v rodni dobi, in bolniki s partnerkami v rodni dobi morajo uporabljati učinkovito metodo kontracepcije v času zdravljenja in po zaključku zdravljenja z ribavirinom še tako dolgo, kot je opredeljeno v Povzetku glavnih značilnosti zdravila za ribavirin.
Dosage adjustment or interruption of medicinal products used in combination with OLYSIO for the treatment of CHC
Prilagajanje odmerkov ali začasna prekinitev zdravljenja z zdravili, ki se uporabljajo v kombinaciji z zdravilom OLYSIO za zdravljenje CHC
HIV PRODUCTS Antiretroviral - CCR5 antagonist Maraviroc
ZDRAVILA ZA ZDRAVLJENJE OKUŽBE S HIV Protiretrovirusna zdravila - antagonist CCR5 maravirok