natgillin/translations-raw huggingface dataset:
No dose adjustment of oral contraceptives is necessary when co-administered with Triumeq.
Pri sočasni uporabi z zdravilom Triumeq prilagajanje odmerka peroralnih kontraceptivov ni potrebno.
Separate preparations of dolutegravir, abacavir or lamivudine are available in cases where discontinuation or dose adjustment of one of the active substances is indicated.
V primeru indikacije za ukinitev ali prilagoditev odmerka ene izmed zdravilnih učinkovin so na voljo ločena zdravila z dolutegravirjem, abakavirjem ali lamivudinom.
No relevant effects were seen on the QTc interval, with doses of dolutegravir exceeding the clinical dose by approximately 3-fold.
Pri odmerkih, ki presegajo klinični odmerek dolutegravirja za približno 3-krat, ni bilo opaziti pomembnih vplivov na interval QTc.
PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets.
30 filmsko obloženih tablet.
Table 6: Demographics and Week 48 virologic outcomes of randomized treatment of ARIA (snapshot algorithm)
Preglednica 6: Demografski podatki in virološki izidi randomiziranega zdravljenja v študiji ARIA po 48 tednih (»snapshot« algoritem)
There are no data available on the effects of the combination of dolutegravir, abacavir and lamivudine in animals, except a negative in vivo rat micronucleus test which tested the effects of the combination of abacavir and lamivudine.
Z izjemo negativnega mikronukleus testa, izvedenega in vivo na podganah, s katerim so testirali učinke kombinacije abakavir in lamivudin, drugi podatki o učinkih kombinacije dolutegravir, abakavir in lamivudin na živalih niso na voljo.
Drug interactions
Interakcije
Lymphopenia
lopinavir 
Treatment with Triumeq must be stopped without delay if HSR cannot be ruled out on clinical grounds, and therapy with Triumeq or other abacavir or dolutegravir containing products must never be re-initiated.
Če se na podlagi kliničnih podatkov preobčutljivostne reakcije ne da izključiti, je treba terapijo z zdravilom Triumeq takoj ukiniti, zdravljenja s tem ali katerim koli drugim zdravilom, ki vsebujejo abakavir ali dolutegravir pa se ne sme nikoli ponovno uvesti.
A single dose of 50 mg of dolutegravir was administered to 8 subjects with moderate hepatic impairment (Child-Pugh class B) and to 8 matched healthy adult controls.
Osem preiskovancev z zmerno okvaro jeter (Child-Pugh B) in 8 usklajenih zdravih odraslih primerjalnih oseb, je prejelo enkratni odmerek 50 mg dolutegravirja.
Since the dose of dolutegravir is 50 mg twice daily when coadministered with nevirapine, the coadministration of nevirapine with Triumeq is not recommended.
Ker je pri sočasnem dajanju z nevirapinom odmerek dolutegravirja 50 mg dvakrat dnevno, se sočasna uporaba nevirapina z zdravilom Triumeq ne priporoča.
Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with tipranavir/ritonavir, the coadministration of tipranavir/ritonavir with Triumeq is not recommended.
Ker je pri sočasnem dajanju s tipranavirjem/ritonavirjem odmerek dolutegravirja 50 mg dvakrat dnevno, se sočasna uporaba tipranavirja/ritonavirja z zdravilom Triumeq ne priporoča.
Since the dose of dolutegravir is 50 mg twice daily when co-administered with rifampicin, the co-administration of rifampicin with Triumeq is not recommended.
Ker je pri sočasnem dajanju z rifampicinom odmerek dolutegravirja 50 mg dvakrat dnevno, se sočasna uporaba rifampicina z zdravilom Triumeq ne priporoča.
Interaction not studied (Inhibition of alcohol dehydrogenase)
(Zavrtje alkoholne dehidrogenaze)
Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir, 600 mg abacavir (as sulfate) and 300 mg lamivudine.
Ena tableta vsebuje 50 mg dolutegravirja (v obliki natrijeve soli), 600 mg abakavirja (v obliki sulfata) in 300 mg lamivudina.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 50 mg dolutegravir (as sodium), 600 mg abacavir (as sulfate), 300 mg lamivudine.
Ena filmsko obložena tableta vsebuje 50 mg dolutegravirja (v obliki natrijeve soli), 600 mg abakavirja (v obliki sulfata), 300 mg lamivudina.
Dolutegravir ↓ AUC ↓ 57% Cmax ↓ 39% Cτ ↓ 75%
efavirenz/dolutegravir dolutegravir AUC  57% Cmax  39% C  75%
Fever, lethargy, malaise, oedema, lymphadenopathy, hypotension, conjunctivitis, anaphylaxis
Ostalo povišana telesna temperatura, letargija, splošno slabo počutje, edem, limfadenopatija, padec krvnega tlaka, konjunktivitis, anafilaktični šok
In HIV-1-infected adult subjects following dolutegravir 50 mg once daily, the steady-state pharmacokinetic parameters (geometric mean [%CV]) based on population pharmacokinetic analyses were AUC(0-24) = 53.6 (27) µg.h/mL, Cmax = 3.67 (20) µg/mL, and Cmin = 1.11 (46) µg/mL.
AUC(0-24) = 53,6 (27) g.h/ml, Cmax = 3,67 (20) g/ml, in Cmin = 1,11 (46) g/ml.
Early Switch ABC/DTG/3TC FDC N=275 n (%)
Zgodnji prehod ABC/DTG/3TC FDC N = 275 n (%)
• medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly
• redna uporaba zdravil (večinoma raztopine), ki vsebujejo sorbitol ali druge sladkorne alkohole
Tablet coating
NALEPKA NA PLASTENKI
Resistance in vitro and in vivo: (abacavir and lamivudine) Abacavir-resistant isolates of HIV-1 have been selected in vitro and in vivo and are associated with specific genotypic changes in the RT codon region (codons M184V, K65R, L74V and Y115F).
Povezani so bili s specifičnimi genotipskimi spremembami kodonskega področja RT (kodoni M184V, K65R, L74V in Y115F).
Lopinavir+ritonavir/ Dolutegravir
lopinavir+ritonavir/dolutegravir dolutegravir AUC  4%
In vitro, lamivudine did not inhibit or induce CYP enzymes (such as CYP3A4, CYP2C9 or CYP2D6) and demonstrated no or weak inhibition of OATP1B1, OAT1B3, OCT3, BCRP, P-gp, MATE1 or MATE2-K. Lamivudine is therefore not expected to affect the plasma concentrations of drugs that are substrates of these enzymes or transporters.
In vitro lamivudin ni ne zaviral ne induciral encimov CYP (npr. CYP3A4, CYP2C9 ali CYP2D6) in ni zaviral ali je le šibko zaviral OATP1B1, OAT1B3, OCT3, BCRP, P-gp, MATE1 ali MATE2-K.
Elevated liver function tests, hepatitis, hepatic failure
Jetra/trebušna slinavka povišane vrednosti testov delovanja jeter, odpoved jeter
AUC ↔ Cmax ↓35% Methadone: CL/F ↑22%
metadon: CL/F 22%
Immune reactivation syndrome
Virusni neodziv†
pancreatitis1
1, parestezija
Dolutegravir ↔ AUC ↑ 1% Cmax ↓ 3% Cτ ↓ 8% Tenofovir ↔
Nukleozidni zaviralci reverzne transkriptaze (NRTIs) tenofovir dolutegravir AUC  1% Cmax  3% Cτ  8% tenofovir 
Lopinavir+ritonavir/ Abacavir
lopinavir + ritonavir/ abakavir ritonavir  abakavir AUC ↓ 32 %
Antacids and supplements Magnesium/ aluminium-containing antacids/Dolutegravir
Antacidi in dodatki magnezij antacidi, ki vsebujejo aluminij/dolutegravir dolutegravir AUC  74% Cmax  72%
In vivo, dolutegravir did not have an effect on midazolam, a CYP3A4 probe.
Učinki dolutegravirja, abakavirja in lamivudina na farmakokinetiko drugih zdravil Dolutegravir in vivo ne vpliva na midazolam, testni substrat za CYP3A4.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg dolutegravir (as sodium), 600 mg of abacavir (as sulfate) and 300 mg of lamivudine.
Ena filmsko obložena tableta vsebuje 50 mg dolutegravirja (v obliki natrijeve soli), 600 mg abakavirja (v obliki sulfata) in 300 mg lamivudina.
Nausea, vomiting, diarrhoea, abdominal pain, mouth ulceration
Prebavila navzea, bruhanje, driska, bolečine v trebuhu, razjede v ustih
Do not take an antacid during the 6 hours before you take Triumeq, or for at least 2 hours after you take it. (See also Section 3).
V 6 urah pred jemanjem zdravila Triumeq ali vsaj 2 uri po tem, ko ste ga vzeli, ne jemljite antacida.
Psychiatric disorders:
Psihiatrične motnje: Zelo pogosti:
INFORMATION IN BRAILLE triumeq
Druga zdravila in zdravilo Triumeq
Dolutegravir ↑ AUC ↑ 62% Cmax ↑ 34% Cτ ↑ 121%
atazanavir + ritonavir /dolutegravir dolutegravir AUC  62% Cmax  34% C  121%
Dolutegravir ↔ AUC ↑ 11% Cmax ↑ 7% Cτ ↑ 28%
lopinavir+ritonavir+etravirin/ dolutegravir dolutegravir  AUC  11 % Cmax  7 % C  28 %
Do not take an antacid during the 6 hours before you take Triumeq, or for at least 2 hours after you take it. Other acid-lowering medicines like ranitidine and omeprazole can be taken at the same time as Triumeq.
V 6 urah pred jemanjem zdravila Triumeq ali vsaj 2 uri po tem, ko ste ga vzeli, ne jemljite dodatkov ali multivitaminskih pripravkov, ki vsebujejo kalcij, železo ali magnezij.
Each bottle contains 30 film-coated tablets and a desiccant.
Vsaka plastenka vsebuje 30 ali 90 filmsko obloženih tablet.
Dolutegravir hypersensitivity
Preobčutljivost na dolutegravir
Dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (Complex binding to polyvalent ions)
C24  39% (Tvori kompleks s polivalentnimi ioni)
Herbal products
PODATKI NA ZUNANJI OVOJNINI
Miscellaneous
laktacidoza
Darunavir ↔ Ritonavir ↔ (induction of UGT1A1 and CYP3A enzymes)
darunavir  ritonavir  (indukcija encimov UGT1A1 in CYP3A)
Hepatic impairment
Virološki neuspeh
Antiretroviral medicinal products Non-nucleoside reverse transcriptase inhibitors Etravirine without boosted protease inhibitors /
Protiretrovirusna zdravila Nenukleozidni zaviralci reverzne transkriptaze etravirin brez okrepljenih zaviralcev proteaz /dolutegravir dolutegravir AUC  71% Cmax  52% C  88%
Fosamprenavir↔ Ritonavir ↔ (induction of UGT1A1 and CYP3A enzymes)
fosamprenavir ritonavir (indukcija encimov UGT1A1 in CYP3A)
Dolutegravir ↔ AUC ↑ 7%
Druga protivirusna zdravila boceprevir dolutegravir  AUC  7%
Neurological/Psychiatry
periferna nevropatija
Rifabutin
rabdomioliza
AUC ↓ 32%
C24  6%
Musculoskeletal
, mišične motnje
The metabolites and unchanged abacavir account for about 83% of the administered abacavir dose in the urine.
Približno 83% prejetega odmerka abakavirja se izloči v obliki presnovkov ali v nespremenjeni obliki z urinom, ostanek se izloči z blatom.
Dolutegravir↓ AUC ↓ 35% Cmax ↓ 24% Cτ ↓ 49%
fosamprenavir+ritonavir/ dolutegravir dolutegravir AUC  35% Cmax  24% C  49%
controls) (inhibition of UGT1A1 and CYP3A enzymes)
(indukcija encimov UGT1A1 in CYP3A)
Headache, paraesthesia
navzea, driska
AUC ↑ 145 %
AUC  Cmax  35%
The risk for abacavir HSR to occur is high for patients who test positive for the HLA-B*5701 allele.
Pri bolnikih s pozitivnim testom za prisotnost alela HLA-B*5701 je tveganje za pojav preobčutljivostne reakcije na abakavir visoko.
Dolutegravir ↓ AUC ↓ 71% Cmax ↓ 52% Cτ ↓ 88%
rifabutin dolutegravir  AUC  5% Cmax  16% Cτ  30%
Management of ABC HSR reaction
Preobčutljivostne reakcije na abakavir
Respiratory tract
• oteženo dihanje
• being sick (vomiting)
• siljenje na bruhanje (navzea)
Iron supplements/Dolutegravir Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (Complex binding to polyvalent ions)
darunavir+ritonavir+etravirin/ dolutegravir dolutegravir  AUC  25 % Cmax  12 % C  36 %
peripheral neuropathy1, paraesthesia1 Respiratory, thoracic and mediastinal disorders: Common:
Bolezni dihal, prsnega koša in mediastinalnega prostora: Pogosti:
No recommendation on dose reduction is possible in patients with mild hepatic impairment due to substantial variability of abacavir exposure.
Ker je pri bolnikih z blago jetrno okvaro izpostavljenost abakavirju precej variabilna, pri tej populaciji bolnikov ne moremo podati priporočil glede zmanjšanja odmerka.
• hair loss
• pomanjkanje teka
Day 1 to W 24 Day 1 to W 24 Day 1 to W48 W24 to W48
Od 1. dne do 48. tedna
Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with etravirine (without boosted protease inhibitors), efavirenz, nevirapine, rifampicin, tipranavir/ritonavir, carbamazepine, phenytoin, phenobarbital and St. John's wort, the use of Triumeq is not recommended for patients taking these medicines (see section 4.5).
Ker je priporočeni odmerek dolutegravirja med sočasno uporabo z etravirinom (brez okrepljenih zaviralcev proteaz), efavirenzom, nevirapinom, rifampicinom tipranavirjem/ritonavirjem,
Clinical description of HSRs
Klinični opis preobčutljivostnih reakcij
Spain
Španija ali
None.
Nobene.
This summary was last updated in October 2013.
Povzetek je bil nazadnje posodobljen oktobra 2013.
These clinical signs normally resolve without treatment.
Ti klinični znaki običajno izzvenijo brez zdravljenja.
The safety of the vaccine has been addressed in both laboratory and field conditions: a temporary increase in body temperature (up to 1.7°C) is very common during the first 24 hours after vaccination.
Varnost cepiva je bila preizkušena v laboratorijskih in terenskih pogojih: prehodno povišanje telesne temperature (za največ 1,7 °C) je zelo pogosto v prvih 24 urah po cepljenju.
Severe anaphylactic (allergic) reactions are uncommon but may be lethal.
Hude anafilaktične (alergijske) reakcije so redke, vendar utegnejo biti smrtne.
The European Commission granted a marketing authorisation valid throughout the European Union, for Suvaxyn PCV on 24 July 2009.
Evropska komisija je dovoljenje za promet z zdravilom Suvaxyn PCV, veljavno po vsej Evropski uniji, odobrila dne 24. julija 2009.
The area of local tissue reactions is in general below 5 cm in diameter, but in some cases a larger swelling may occur.
Površina lokalne reakcije tkiva običajno meri 5 cm v premeru, v nekaterih primerih pa se lahko pojavi tudi večja oteklina.
The effectiveness of Suvaxyn PCV has been studied in laboratory and field studies in a large number of pigs.
Učinkovitost zdravila Suvaxyn PCV so proučevali z laboratorijskimi in terenskimi študijami, v katere je bilo vključeno veliko število prašičev.
Local tissue reactions in the form of swelling at the injection site are very common and may last for up to 26 days.
Zelo pogoste so lokalne reakcije tkiva v obliki otekline na mestu injiciranja in lahko trajajo do 26 dni.
Exceptionally, in some herds a large proportion of animals may react after vaccination.
Izjemoma se lahko v nekaterih čredah reakcije na cepljenje pojavijo pri večjem deležu živali.
Porcine circovirus recombinant virus (cpcv) 1-2, inactivated
inaktivirani rekombinantni prašičji cirkovirus (cpcv) 1-2
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Suvaxyn PCV exceed the risks for the approved indications and recommended that Suvaxyn PCV be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Suvaxyn PCV večje od z njim povezanih tveganj, kadar se zdravilo uporablja za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
In the future, the immune system will be able to recognise the protein from the disease-causing virus and produce antibodies more quickly when it is exposed to such viruses.
Imunski sistem bo tako v prihodnosti sposoben prepoznati beljakovino iz virusa, ki povzroča bolezen, in zaradi tega hitreje tvoriti protitelesa ob ponovni izpostavitvi tovrstnim virusom.
Suvaxyn PCV is a vaccine that contains a recombinant (modified) porcine circovirus which has been inactivated (killed).
Suvaxyn PCV je cepivo, ki vsebuje rekombinirani (spremenjeni) prašičji cirkovirus, ki je bil inaktiviran (uničen).
Other information about Suvaxyn PCV:
Druge informacije o zdravilu Suvaxyn PCV:
When a pig is given the vaccine, the immune system recognises the killed viruses as ‘foreign' and makes antibodies against them.
Ko prašiča cepimo, imunski sistem prepozna inaktivirane viruse kot tujke in proti njim razvije protitelesa.
Suvaxyn PCV is a suspension for injection.
Zdravilo Suvaxyn PCV je suspenzija za injiciranje.
Immediate mild hypersensitivity-like reactions may occur commonly after vaccination (affecting up to 1 in 10 animals) resulting in short-lived clinical signs such as vomiting.
Pogosto (pri največ 1 od 10 živali) se lahko po cepljenju pojavijo takojšnje blažje preobčutljivostne reakcije, ki se kažejo v obliki kratkotrajnih kliničnih znakov, kot je denimo bruhanje.
It has been demonstrated that the vaccine, when administered as recommended to piglets from 3 weeks of age induces active immunisation against Porcine Circovirus Type 2 (PCV2) and is able to reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues caused by porcine circovirus infection, as well as to reduce clinical signs -including loss of daily weight gain- and death associated with Post-Weaning Multisystemic Wasting Syndrome (PMWS).
Ugotovljeno je bilo, da cepivo, ki se v skladu s priporočili injicira pujskom, starejšim od 3 tednov, vzpostavi aktivno imunizacijo proti prašičjemu cirkovirusu tipa 2 (PCV2), zmanjša virusno breme v krvi in limfoidnem tkivu, deluje proti lezijam v limfoidnem tkivu, ki jih povzroča okužba s prašičjim cirkovirusom, in ublaži klinične znake, vključno s pomanjkanjem dnevnega pridobivanja telesne mase, ter preprečuje pogin, povezan z multisistemskim sindromom hiranja po odstavitvi (PMWS).
What benefit has Suvaxyn PCV shown during the studies?
Kakšne koristi je zdravilo Suvaxyn PCV izkazalo med študijami?
Suvaxyn PCV is used to vaccinate pigs over the age of 3 weeks to reduce viral load in blood and lymphoid tissues and protect the pigs against the lesions in lymphoid tissues caused by Porcine Circovirus Type 2 as well as the reduced weight gain and potentially even death that is associated with Post-Weaning Multisystemic Wasting Syndrome (PMWS).
Zdravilo Suvaxyn PCV se uporablja za cepljenje prašičev, starejših od 3 tednov, za zmanjšanje virusnega bremena v krvi in limfoidnem tkivu ter za zaščito prašičev pred lezijami limfoidnega tkiva, ki jih povzroča prašičji cirkovirus tipa 2, in za preprečevanje prepočasnega pridobivanja telesne mase in morebiti celo pogina, povezanega z multisistemskim sindromom hiranja po odstavitvi (PMWS).
Suvaxyn PCV is a vaccine.
Zdravilo Suvaxyn PCV je cepivo.
What is the risk associated with Suvaxyn PCV?
Kakšna tveganja so povezana z zdravilom Suvaxyn PCV?
These studies were well-designed to demonstrate the efficacy of the vaccine in the face of PMWS outbreaks: farms that were selected had a history of PMWS and the disease was confirmed to occur before starting of the respective studies, using internationally accepted standards.
Na kmetijah, izbranih za študije, je bil v preteklosti prisoten multisistemski sindrom hiranja po odstavitvi, v skladu z mednarodno sprejetimi standardi pa je bilo potrjeno, da se je bolezen pojavila pred začetkom zadevnih študij.
Suvaxyn PCV contains small amounts of a form of the pig virus that has been modified to produce a protein from the form of the virus that causes disease, but killed so that it does not cause the disease and cannot spread.
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“, kako naj se brani pred boleznijo.Cepivo Suvaxyn PCV vsebuje majhne količine ene od oblik prašičjega virusa, ki je bil spremenjen tako, da lahko tvori beljakovino iz oblike virusa, ki povzroča bolezen, in hkrati uničen, zato posledično nima več sposobnosti povzročanja bolezni in širjenja.
Why has Suvaxyn PCV been approved?
Zakaj je bilo zdravilo Suvaxyn PCV odobreno?
How has Suvaxyn PCV been studied?
Kako je bilo zdravilo Suvaxyn PCV raziskano?
What is Suvaxyn PCV used for?
Za kaj se zdravilo Suvaxyn PCV uporablja?
The withdrawal period for Suvaxyn PCV is zero days.
Karenca za cepivo Suvaxyn PCV je nič dni.
What is Suvaxyn PCV?
Kaj je zdravilo Suvaxyn PCV?
How does Suvaxyn PCV work?
Kako zdravilo Suvaxyn PCV deluje?
‘Essential' means that the hypertension has no obvious cause
Izraz „esencialna“ pomeni, da za hipertenzijo ni očitnega vzroka.
MicardisPlus must not be used in women who are more than three months pregnant.
Zdravila MicardisPlus ne smejo uporabljati ženske, ki so noseče več kot tri mesece.
The full EPAR for MicardisPlus 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 MicardisPlus je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The European Commission granted a marketing authorisation valid throughout the European Union for MicardisPlus on 19 April 2002
Evropska komisija je dovoljenje za promet z zdravilom MicardisPlus, veljavno po vsej Evropski uniji, izdala 19. aprila 2002.
What measures are being taken to ensure the safe and effective use of MicardisPlus?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila MicardisPlus?
This is a summary of the European public assessment report (EPAR) for MicardisPlus.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo MicardisPlus.
The most common side effect with MicardisPlus (seen in between 1 and 10 patients in 100) is dizziness.
Najpogostejši neželeni učinek zdravila MicardisPlus (opažen pri 1 do 10 bolnikih od 100) je omotica.
MicardisPlus has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension.
Zdravilo MicardisPlus so proučevali v petih glavnih študijah, v katerih je sodelovalo skupno 2 985 bolnikov z blago do zmerno hipertenzijo.
Other information about MicardisPlus
Druge informacije o zdravilu MicardisPlus
For more information about treatment with MicardisPlus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom MicardisPlus preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
A risk management plan has been developed to ensure that MicardisPlus is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila MicardisPlus je bil pripravljen načrt obvladovanja tveganj.
MicardisPlus is taken by mouth once a day with liquid.
Zdravilo MicardisPlus se jemlje peroralno enkrat na dan s tekočino.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for MicardisPlus.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
It is available as oval tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide).
Na voljo je v obliki ovalnih tablet (40 mg ali 80 mg telmisartana in 12,5 mg hidroklorotiazida; 80 mg telmisartana in 25 mg hidroklorotiazida).
In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, MicardisPlus must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension).
Pri bolnikih s sladkorno boleznijo tipa 2 ali bolnikih z zmerno ali hudo okvaro ledvic se zdravilo MicardisPlus ne sme uporabljati v kombinaciji z zdravili, ki vsebujejo aliskiren (zdravilo za zdravljenje esencialne hipertenzije).
It works by increasing urine output, reducing the amount of fluid in the blood and reducing the blood pressure.
Ta povzroča povečano izločanje seča ter s tem zmanjšanje količine tekočine v krvi in znižanje krvnega tlaka.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for MicardisPlus including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What benefit has MicardisPlus shown during the studies?
Kakšne koristi je zdravilo MicardisPlus izkazalo med študijami?
What is the risk associated with MicardisPlus?
Kakšna tveganja so povezana z zdravilom MicardisPlus?
Care must be taken when using MicardisPlus with other medicines that have an effect on blood potassium levels.
Posebna pozornost je potrebna, kadar se zdravilo MicardisPlus jemlje sočasno z drugimi zdravili, ki vplivajo na ravni kalija v krvi.