natgillin/translations-raw huggingface dataset:
Monitoring of liver chemistries is recommended in patients with hepatitis B and/or C co-infection.
U bolesnika s istodobnom infekcijom hepatitisom B i/ili C preporučuje se praćenje biokemijskih pokazatelja jetrene funkcije. (Vidjeti dio 'Bolesnici s kroničnim hepatitisom B ili C'
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 nije inhibirao ni inducirao CYP enzime (kao što su CYP3A4, CYP2C9 ili CYP2D6) te nije inhibirao ili je slabo inhibirao OATP1B1, OAT1B3, OCT3, BCRP, P-gp, MATE1 ili MATE2-K.
Dolutegravir ↔ AUC ↑ 11% Cmax ↑ 6%
Kortikosteroidi prednizon dolutegravir ↔ AUC ↑ 11% Cmax ↑ 6% Cτ ↑ 17%
Discontinued study/study drug for other reasons§ Missing data during window but on study
Prekid sudjelovanja u ispitivanju/primjene ispitivanog lijeka zbog nuspojave ili smrti‡ Prekid sudjelovanja u ispitivanju/primjene ispitivanog lijeka zbog drugih razloga§ Nema podataka za promatrano razdoblje, ali bolesnik sudjeluje u ispitivanju
In vivo, dolutegravir did not have an effect on midazolam, a CYP3A4 probe.
Učinak dolutegravira, abakavira i lamivudina na farmakokinetiku drugih lijekova In vivo dolutegravir nije utjecao na midazolam, probni supstrat za CYP3A4.
Table 5: Demographics and Week 48 virologic outcomes of randomized treatment of FLAMINGO (snapshot algorithm)
Tablica 5: Demografske značajke i virološki ishodi u 48. tjednu randomiziranog liječenja u ispitivanju
Dolutegravir ↔ AUC ↑ 1% Cmax ↓ 3% Cτ ↓ 8% Tenofovir ↔
Nukleozidni inhibitori reverzne transkriptaze (NRTI) tenofovir emtricitabin, didanozin, stavudin, zidovudin dolutegravir ↔ AUC ↑ 1% Cmax ↓ 3% Cτ ↓ 8% tenofovir ↔
The adjusted difference in proportion and 95% CI [ABC/DTG/3TC vs current ART] were 3.4%; 95% CI: [-9.1, 2.4].
naspram dotadašnje antiretrovirusne terapije) iznosili su 3,4% odnosno 95% CI: (-9,1; 2,4).
asthenia, fever1, malaise1
astenija, vrućica1, malaksalost1
Dolutegravir hypersensitivity
Preosjetljivost na dolutegravir
Dolutegravir ↓ AUC ↓ 59% Cmax ↓ 47% Cτ ↓ 76%
tipranavir+ritonavir/ dolutegravir dolutegravir ↓ AUC ↓ 59% Cmax ↓ 47% Cτ ↓ 76%
Investigations: Common:
umor često:
NAME OF THE MEDICINAL PRODUCT Triumeq 50 mg/600 mg/300 mg film-coated tablets dolutegravir/abacavir/lamivudine
Triumeq 50 mg/600 mg/300 mg filmom obložene tablete dolutegravir/abakavir/lamivudin
Psychiatric disorders:
Psihijatrijski poremećaji: vrlo često:
Dolutegravir ↓ AUC ↓ 49% Cmax ↓ 33% Cτ ↓ 73%
Antikonvulzivi karbamazepin/dolutegravir dolutegravir ↓ AUC ↓ 49% Cmax ↓ 33% Cτ ↓ 73%
Missing data during window but on study
Nema podataka za promatrano razdoblje, ali bolesnik sudjeluje u ispitivanju
Darunavir ↔ Ritonavir ↔ (induction of UGT1A1 and CYP3A enzymes)
darunavir ↔ ritonavir ↔ (indukcija enzima UGT1A1 i CYP3A)
Vistor hf.
Probir na HLA
Management of ABC HSR reaction
Zbrinjavanje reakcije preosjetljivosti na abakavir
In the primary 48 weeks analysis, the proportion of patients with virologic suppression in the dolutegravir + ABC/3TC arm, was superior to the EFV/TDF/FTC arm, p=0.003, the same treatment difference was observed in subjects defined by baseline HIV RNA level (< or > 100,000 copies/mL).
U primarnoj analizi 48 tjedana liječenja, udio bolesnika s virološkom supresijom u skupini liječenoj kombinacijom dolutegravir + ABC/3TC bio je superioran u odnosu na skupinu koja je primala
Discontinued study/study drug due to adverse event or death‡
Prekid sudjelovanja u ispitivanju/primjene ispitivanog lijeka zbog nuspojave ili smrti‡ Prekid sudjelovanja u ispitivanju/primjene ispitivanog lijeka zbog drugih razloga§
What Triumeq looks like and contents of the pack Triumeq film-coated tablets are purple, biconvex, oval tablets, debossed with “572 Trı” on one side.
Triumeq filmom obložene tablete su ljubičaste, bikonveksne, ovalne tablete s utisnutom oznakom
Very rare side effects that may show up in blood tests are: • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
• nemogućnost koštane srži da proizvede nove crvene krvne stanice (izolirana aplazija crvenih krvnih stanica) Ako primijetite bilo koju nuspojavu
What Triumeq contains - The active substances are dolutegravir, abacavir and lamivudine.
- Djelatne tvari su dolutegravir, abakavir i lamivudin.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 50 mg dolutegravir (as sodium), 600 mg abacavir (as sulfate), 300 mg lamivudine.
Jedna filmom obložena tableta sadrži 50 mg dolutegravira (u obliku dolutegravirnatrija), 600 mg abakavira (u obliku abakavirsulfata) i 300 mg lamivudina.
Virologic Success Virologic Failure Reasons Data in window not below threshold No Virologic Data Discontinued due to AE or death Discontinued for other reasons Missing data during window but on study ABC/DTG/3TC FDC = abacavir/dolutegravir/lamivudine fixed-dose combination; AE = adverse event; ART = antiretroviral therapy; HIV-1 = human immunodeficiency virus type 1; ITT-E = intent-to-treat exposed; W = week.
ABC/DTG/3TC = abakavir/dolutegravir/lamivudin; HIV-1 = virus humane imunodeficijencije tipa 1; ITT-E (intent-to-treat exposed) = populacija predviđena za liječenje izložena lijeku.
Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with St. John's wort, DTG/ABC/3TC FDC is not recommended.
S obzirom da je preporučena doza dolutegravira 50 mg dvaput na dan kad se primjenjuje istodobno s gospinom travom, fiksna kombinacija dolutegravir/abakavir/lamivudin se ne preporučuje.
Hepatic impairment
• otežanim disanjem
Hypersensitivity reactions
Klinički opis reakcija preosjetljivosti
Dolutegravir↓ (Not studied, decrease expected due to induction of UGT1A1 and CYP3A enzymes, a similar reduction in exposure as observed with carbamazepine is
Biljni lijekovi gospina trava/dolutegravir dolutegravir↓ (nije ispitivano, očekuje se smanjenje koncentracije zbog indukcije enzima UGT1A1 i CYP3A,
De novo resistance in patients failing therapy in SINGLE, SPRING-2 and FLAMINGO
De novo rezistencija u bolesnika s neuspješnim odgovorom na liječenje u ispitivanjima SINGLE,
Virologic Outcomes of Randomized Treatment of SINGLE at 48 Weeks (Snapshot algorithm)
Tablica 3: Virološki ishodi randomiziranog liječenja u ispitivanju SINGLE nakon 48 tjedana
Abacavir
triumeq
Antidiabetics Metformin/Dolutegravir
Hematološki simptomi limfopenija
Effect of dolutegravir: NGMN ↔ AUC ↓ 2% Cmax ↓ 11%
NGMN ↔ AUC ↓ 2% Cmax ↓ 11%
• muscle pain and discomfort
• bol i nelagoda u mišićima
Dolutegravir
Učinci dolutegravira:
Metformin ↑ Dolutegravir ↔ When co-administered with dolutegravir 50mg QD:
Antidijabetici metformin/dolutegravir metformin ↑ dolutegravir ↔ Kad se istodobno primjenjuje s dolutegravirom 50 mg jedanput na dan: metformin
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.
Ne smijete uzeti antacid unutar 6 sati prije primjene lijeka Triumeq niti još najmanje 2 sata nakon njegove primjene.
If you have stopped taking Triumeq because of a hypersensitivity reaction, you must NEVER AGAIN take Triumeq, or any other medicine containing abacavir.
Ako ste prestali uzimati Triumeq zbog reakcije preosjetljivosti, NIKADA VIŠE ne smijete uzeti
Dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32%
multivitaminski pripravci (koji sadrže kalcij, željezo i magnezij)/dolutegravir dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32%
Virologic Failure Reasons Data in window not below 50 c/mL threshold Discontinued for lack of efficacy Discontinued for other reason while not below threshold No Virologic Data
Prekid liječenja zbog drugih razloga dok razina nije bila ispod granične vrijednosti
Contact your doctor immediately: 1 if you get a skin rash, OR 2 if you get symptoms from at least 2 of the following groups: fever shortness of breath, sore throat or cough nausea or vomiting, diarrhoea or abdominal pain severe tiredness or aches and pains, or generally feeling ill.
vrućica nedostatak zraka, grlobolja ili kašalj mučnina ili povraćanje ili proljev ili bol u trbuhu izrazit umor ili tupi bolovi i probadanje ili opće loše osjećanje Liječnik će Vam možda savjetovati da prestanete uzimati Triumeq.
AUC ↓ 25% Cmax ↓ 12% Cτ ↓ 36%
darunavir+ritonavir+etravirin/ dolutegravir dolutegravir ↓ AUC ↓ 25% Cmax ↓ 12% Cτ ↓ 36%
Female
OBLIK
• stomach ache
• glavobolja • proljev
• headache
• glavoboljom
Dolutegravir ↔ AUC ↓ 4% Cmax ↔ 0% C24 ↓ 6%
lopinavir+ritonavir/ dolutegravir lopinavir+ritonavir/ abakavir dolutegravir ↔ AUC ↓ 4% Cmax ↔ 0% C24↔↓ 6%
No recommendation on dose reduction is possible in patients with mild hepatic impairment due to substantial variability of abacavir exposure.
Zbog znatne varijabilnosti u izloženosti abakaviru, ne može se dati preporuka za smanjenje doze u bolesnika s blagim oštećenjem jetrene funkcije.
Asymptomatic creatine phosphokinase (CPK) elevations mainly in association with exercise have also been reported with dolutegravir therapy.
Tijekom terapije dolutegravirom prijavljena su i asimptomatska povećanja razine kreatin fosfokinaze,
fatigue
Dojenje
This summary was last updated in October 2013.
Sažetak je posljednji put ažuriran u listopadu 2013.
These clinical signs normally resolve without treatment.
Ovi klinički znakovi normalno nestaju bez liječenja.
The vaccine also contains ‘adjuvants' to stimulate a better response.
Cjepivo sadrži i „adjuvans” za stimulaciju boljeg odgovora.
This protects the pigs against the disease.
Na taj se način svinje štite od bolesti.
Exceptionally, in some herds a large proportion of animals may react after vaccination.
Iznimno, u pojedinim stadima veliki dio životinja može reagirati nakon cjepljenja.
Severe anaphylactic (allergic) reactions are uncommon but may be lethal.
Ozbiljne anafilaktičje (alergijske) reakcije nisu uobičajene, no smrtonosne su.
The area of local tissue reactions is in general below 5 cm in diameter, but in some cases a larger swelling may occur.
Područje lokalnih reakcija tkiva uglavnom je manje od 5 cm u promjeru, no u određenim slučajevima mogu nastupiti veća oticanja.
The European Commission granted a marketing authorisation valid throughout the European Union, for Suvaxyn PCV on 24 July 2009.
Europska komisija izdala je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji za proizvod Suvaxyn PCV dana 24. srpnja 2009.
Local tissue reactions in the form of swelling at the injection site are very common and may last for up to 26 days.
Lokalne reakcije tkiva u obliku oticanja u mjestu injekcije vrlo su uobičajene te mogu trajati i do 26 dana.
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.
Sigurnost cjepiva ispitana je u laboratorijskim i terenskim uvjetima: privremeno povećanje tjelesne temperature (do 1,7°C) uobičajeno je tijekom prva 24 sata nakon cjepljenja.
The effectiveness of Suvaxyn PCV has been studied in laboratory and field studies in a large number of pigs.
Djelotvornost VMP-a Suvaxyn PCV ispitana je u laboratorijskim i terenskim ispitivanjima na velikom broju svinja.
Porcine circovirus recombinant virus (cpcv) 1-2, inactivated
Rekombinirani cirkovirus svinja (cpcv) 1-2, inaktivirani
When a pig is given the vaccine, the immune system recognises the killed viruses as ‘foreign' and makes antibodies against them.
Nakon što svinja primi cjepivo, imunosni sustav prepoznaje ubijene viruse kao „strano” tijelo i proizvodi protutijela protiv njih.
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.
Neposredne blage reakcije slične preosjetljivosti uobičajene su nakon cjepljenja (zahvaćaju do 1 u 10 životinja) i rezultiraju kratkoročnim kliničkim znakovima poput povraćanja.
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.
Ubuduće imunosni sustav može prepoznati protein iz virusa koji uzrokuje bolest te brže proizvesti protutijela nakon što je izložen takvim virusima.
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.
Suvaxyn PCV sadrži male količine oblika virusa svinja koji je modificiran za stvaranje proteina iz oblika virusa koji uzrokuje bolest, no ubijen je tako da ne uzrokuje bolest i ne može se širiti.
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 veterinarsko-medicinske proizvode (CVMP) zaključio je da koristi od VMP-a Suvaxyn PCV nadmašuju rizike za odobrene indikacije i preporučio je da se za VMP Suvaxyn PCV izda odobrenje za stavljanje VMP-a u promet.
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.
Ova su ispitivanja bila dobro osmišljena za demonstraiju djelotvornosti cjepiva u trenutku izbijanja SKOP-a: odabrane su farme kod kojih je prethodno izbijao SKOP te je bolest potvrđena prije započinjanja dotičnog ispitivanja primjenom međunarodno prihvaćenih standarda.
Suvaxyn PCV is a vaccine that contains a recombinant (modified) porcine circovirus which has been inactivated (killed).
Suvaxyn PCV je cjepivo koje sadrži rekombinirani (modificirani) cirkovirus svinja koji je inaktiviran (ubijen).
Suvaxyn PCV is a suspension for injection.
Suvaxyn PCV je suspenzija za injekciju.
This document is a summary of the European Public Assessment Report.
Ovo je sažetak Europskoga javnog izvješća o procjeni veterinarsko-medicinskog proizvoda.
The withdrawal period for Suvaxyn PCV is zero days.
Razdoblje karencije za Suvaxyn PCV je nula dana.
The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Omjer koristi i rizika dostupan je u modulu znanstvene odluke ovog EPAR-a.
Other information about Suvaxyn PCV:
Druge informacije o VMP-u Suvaxyn PCV:
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).
Dokazano je da cjepivo, ako se primjenjuje sukladno preporukama u prašćića starijih od 3 tjedana života, inducira imunizaciju protiv cirkovirusa svinja tip 2 (PCV2) i može smanjiti virusno opterećenje u krvi i limfnim tkivima, te lezije u limfnim tkivima povezane s infestacijom cirkovirusom u svinja te suzbiti kliničke znakove - uključujući gubitak dnevnog prirasta - i smrtnost uzrokovane sindromom kržljavosti odbijene prasadi (SKOP).
The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption.
Razdoblje karencije je vrijeme treba proći nakon primjene veterinarsko-medicinskog proizvoda i klanja životinje te korištenja mesa za prehranu ljudi.
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).
Suvaxyn PCV koristi se za cijepljenje svinja starijih od 3 tjedna kako bi se smanjilo virusno opterećenje u krvi i limfnim tkivima, te lezije u limfnim tkivima povezane cirkovirusom svinja tip 2, kao i povećanje tjelesne težine, a potencijalno čak i smrtnost povezana sa sindromom kržljavosti odbijene prasadi (SKOP).
Suvaxyn PCV is a vaccine.
Suvaxyn PCV je cjepivo.
What is the risk associated with Suvaxyn PCV?
Koji su rizici povezani s VMP-om Suvaxyn PCV?
Why has Suvaxyn PCV been approved?
Zašto je Suvaxyn PCV odobren?
What is Suvaxyn PCV?
Što je Suvaxyn PCV?
What benefit has Suvaxyn PCV shown during the studies?
Koje su koristi VMP-a Suvaxyn PCV utvrđene tijekom ispitivanja?
What is Suvaxyn PCV used for?
Za što se Suvaxyn PCV koristi?
How does Suvaxyn PCV work?
Kako djeluje Suvaxyn PCV?
How has Suvaxyn PCV been studied?
Kako se Suvaxyn PCV ispitivao?
The full EPAR for MicardisPlus can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek MicardisPlus nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Its use during the first three months of pregnancy is not recommended.
Ne preporuča se primjena u žena tijekom prva tri mjeseca trudnoće.
MicardisPlus must not be used in women who are more than three months pregnant.
MicardisPlus ne smiju uzimati žene koje su trudne dulje od tri mjeseca.
In all studies, the main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
U svim ispitivanjima glavna mjera djelotvornosti bilo je smanjenje dijastoličkog krvnog tlaka (krvni tlak izmjeren između dva otkucaja srca).
MicardisPlus has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension.
MicardisPlus je ispitivan u pet glavnih ispitivanja kojima je obuhvaćeno ukupno 2985 bolesnika s umjerenom hipertenzijom.
MicardisPlus telmisartan / hydrochlorothiazide
MicardisPlus telmisartan/hidroklorotiazid
In four of these studies, MicardisPlus was compared with placebo (a dummy treatment) and with telmisartan taken alone in a total of 2,272 patients.
U četiri od tih ispitivanja MicardisPlus je uspoređen s placebom (prividnim liječenjem) i s telmisartanom koji je samostalno uzimalo ukupno 2272 bolesnika.
It works by increasing urine output, reducing the amount of fluid in the blood and reducing the blood pressure.
Djeluje povećavajući količinu izbačenog urina, smanjujući količinu tekućine u krvi i snižavajući krvni tlak.
MicardisPlus is taken by mouth once a day with liquid.
MicardisPlus se uzima kroz usta jednom na dan s tekućinom, uz ili bez obroka.
The most common side effect with MicardisPlus (seen in between 1 and 10 patients in 100) is dizziness.
Najčešća nuspojava lijeka MicardisPlus (uočena kod više od 10 na 100 bolesnika) je vrtoglavica.
This is a summary of the European public assessment report (EPAR) for MicardisPlus.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku MicardisPlus.
For more information about treatment with MicardisPlus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom MicardisPlus pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
What measures are being taken to ensure the safe and effective use of MicardisPlus?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka MicardisPlus?
The European Commission granted a marketing authorisation valid throughout the European Union for MicardisPlus on 19 April 2002
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek MicardisPlus na snazi u Europskoj uniji od 19. travnja 2002.
Other information about MicardisPlus
Ostale informacije o lijeku MicardisPlus
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.
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka MicardisPlus.
Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension.
Hidroklorotiazid je diuretik, te predstavlja drugu vrstu liječenja hipertenzije.
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).
U bolesnika s tipom 2 dijabetesa ili u bolesnika s umjerenim ili ozbiljnim oštećenjem funkcije bubrega, MicardisPlus se ne smije koristiti u kombinaciji s lijekovima koji sadrže aliskiren (koji se također koristi za liječenje esencijalne hipertenzije).
By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Blokiranjem receptora na koja se angiotenzin II inače veže, telmisartan sprječava djelovanje hormona i omogućuje širenje krvnih žila.
A risk management plan has been developed to ensure that MicardisPlus is used as safely as possible.
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka MicardisPlus.
Care must be taken when using MicardisPlus with other medicines that have an effect on blood potassium levels.
Potreban je oprez prilikom uzimanja lijeka MicardisPlus zajedno s drugim lijekovima koji utječu na razinu kalija u krvi.
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.
Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek MicardisPlus nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
The dose of MicardisPlus to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets.
Doza lijeka MicardisPlus koja se primjenjuje ovisi o dozi telmisartana koju je bolesnik prethodno uzimao: bolesnici koji su primali 40 mg telmisartana trebaju uzimati tablete od 40/12,5 mg, a bolesnici koji su primali 80 mg telmisartana trebaju uzimati tablete od 80/12,5 mg.
The Committee recommended that MicardisPlus be given marketing authorisation.
Odbor je preporučio izdavanje odobrenja za stavljanje lijeka MicardisPlus u promet.
MicardisPlus was more effective at reducing diastolic blood pressure than telmisartan taken alone and than placebo.
MicardisPlus je bio djelotvorniji u snižavanju dijastoličkog krvnog tlaka u odnosu na monoterapiju telmisartanom i placebo.
The Committee for Medicinal Products for Human Use (CHMP) decided that MicardisPlus's benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone.
Odbor za lijekove za humanu uporabu (CHMP) odlučio je da koristi od lijeka MicardisPlus nadmašuju s njim povezane rizike za liječenje esencijalne hipertenzije u bolesnika čiji se krvni tlak ne kontrolira primjereno monoterapijom telmisartana.
Why has MicardisPlus been approved?
Zašto je MicardisPlus odobren?
The fifth study compared the effects of remaining on the 80/12.5 mg tablet with switching to the 80/25 mg tablet in 713 patients who had not responded to the 80/12.5 mg tablet.
Peto je ispitivanje usporedilo djelovanje preostalih na tabletama jačine 80/12,5 mg s tabletom jačine 80/25 mg u 713 bolesnika koji nisu odgovorili na tablete jačine 80/12,5 mg.