Examples of using Fixed-dose combination in English and their translations into Hungarian
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Test: single fixed-dose combination tablet taken under fasted conditions.
It is recommended toestablish the appropriate dosage of inhaled corticosteroid before any fixed-dose combination can be used in patients with severe asthma.
DuoPlavin is a fixed-dose combination medicinal product for continuation of therapy in.
The Triumeq tablet has been shown to be bioequivalent to dolutegravir single entity tablet andabacavir/lamivudine fixed-dose combination tablet(ABC/3TC FDC) administered separately.
Kivexa is a fixed-dose combination of two nucleoside analogues(abacavir and lamivudine).
Pharmacokinetic parameters for the respective substances were comparable after the administration of budesonide andformoterol as monoproducts or as the fixed-dose combination.
Since Atripla is a fixed-dose combination product, the dose of efavirenz cannot be altered(see section 4.5).
Descovy 200/10 mg in combination with darunavir 800 mg and cobicistat 150 mg,administered as a fixed-dose combination tablet, was studied in treatment- naive subjects, see section 5.1.
BYVALSON is the first and only fixed-dose combination(FDC) of a beta blocker(BB) and angiotensin II receptor blocker(ARB) available in the U.S.
Clinical efficacy of Descovy was established from studies conductedwith emtricitabine and tenofovir alafenamide when given with elvitegravir and cobicistat as the fixed-dose combination tablet E/C/F/TAF.
The fixed-dose combination tablet of abacavir/ lamivudine(FDC) has been shown to be bioequivalent to lamivudine and abacavir administered separately.
Aerivio Spiromax isnot intended as the treatment of asthma when a fixed-dose combination of salmeterol and fluticasone propionate is required for the first time.
Since Atripla is a fixed-dose combination product, the dose of efavirenz cannot be altered; therefore, voriconazole and Atripla must not be co-administered(see section 4.5).
This adverse reaction was identified through post-marketing surveillance for Eviplera(fixed-dose combination) but not observed in randomised controlled clinical studies for Eviplera.
Since Atripla is a fixed-dose combination product, the dose of efavirenz cannot be altered; therefore, voriconazole and Atripla must not be co-administered(see section 4.3 and Table 1).
The studies described below(GOAL, TORCH and SMART)were carried out with this same fixed-dose combination, salmeterol xinafoate and fluticasone propionate, but studied a previously authorised product;
A fixed-dose combination therapy of budesonide and formoterol fumarate dihydrate should therefore not be given together with β adrenergic blockers(including eye drops) unless there are compelling reasons.
The safety profile of naltrexone/ bupropion(NB)presented below is based on clinical studies performed with the fixed-dose combination(adverse reactions at an incidence of at least 0.1% and twice that of placebo).
The fixed-dose combination of budesonide and formoterol, and the corresponding monoproducts have been shown to be bioequivalent with regard to systemic exposure of budesonide and formoterol, respectively.
There have been seven retrospective reports of findings consistent with neural tube defects, including meningomyelocele, all in mothers exposed to efavirenz-containing regimens(excluding any efavirenz-containing fixed-dose combination tablets) in the first trimester.
Ledipasvir+Sofosbuvir is a two-drug fixed-dose combination product that contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet.
In study GS-US-292-0112, the efficacy and safety of emtricitabine and tenofovir alafenamide were evaluated in an open-label clinical study in which 242 HIV-1 infected patients with mild to moderate renal impairment(eGFRCG: 30-69 mL/min) were switched to emtricitabine and tenofovir alafenamide(10 mg)given with elvitegravir and cobicistat as a fixed-dose combination tablet.
There are no data available for use of a fixed-dose combination of budesonide and formoterol fumarate dihydrate in patients with hepatic or renal impairment.
Administration of a fixed-dose combination therapy of budesonide and formoterol fumarate dihydrate to women who are breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
In pharmacokinetic studies with and without a charcoal blockage,BiResp Spiromax was evaluated by comparing it with an alternative authorised fixed-dose combination inhaled product containing the same active substances, budesonide and formoterol and has been shown to be equivalent in both systemic exposure(safety) and pulmonary deposition(efficacy).
The safety andefficacy of the 5 mg saxagliptin/10 mg dapagliflozin fixed-dose combination was evaluated in three phase 3, randomised, double-blind, active/placebo-controlled clinical trials in 1169 adult subjects with type 2 diabetes mellitus.
The comparative bioavailability ofDUTREBIS(150 mg lamivudine/300 mg raltegravir) fixed-dose combination tablet was assessed relative to individual components administered concomitantly(150 mg of lamivudine and 400 mg of raltegravir) in 108 healthy subjects.
Relative to fasting conditions, the administration of boosted elvitegravir as the fixed-dose combination 150 mg elvitegravir/150 mg cobicistat/200 mg emtricitabine/245 mg tenofovir disoproxil with a light meal(approximately 373 kcal, 20% fat) or high-fat meal(approximately 800 kcal, 50% fat) resulted in increased exposures of elvitegravir.
In clinical studies of 866 treatment-naïve adult patients receiving emtricitabine and tenofovir alafenamide with elvitegravir andcobicistat as the fixed-dose combination tablet elvitegravir 150 mg/ cobicistat 150 mg/ emtricitabine 200 mg/ tenofovir alafenamide( as fumarate) 10 mg( E/ C/ F/ TAF) through 96 weeks, the most frequently reported adverse reactions were diarrhoea( 7%), nausea( 10%), and headache( 6%).