Examples of using Multi-dose formulation in English and their translations into Hungarian
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In clinical studies, over 1800 patients havebeen treated with LUMIGAN 0.3 mg/mL(multi-dose formulation).
After 12 months of treatment with GANFORT(multi-dose formulation), the incidence of iris pigmentation was 0.2%.
Increased brown iris pigmentation hasalso been observed during treatment with GANFORT(multi-dose formulation).
Additional side effects havebeen seen in patients using GANFORT(multi-dose formulation) and so may possibly be seen with GANFORT single-dose.
No enhancement of the systemic absorption of the individual activesubstances has been observed with GANFORT(multi-dose formulation).
In two 12-month studies of GANFORT(multi-dose formulation) in which systemic absorption was measured, no accumulation was observed of either of the individual components.
In addition to the adverse reactions seen with LUMIGAN 0.3 mg/mL single-dose, Table 3 lists additional adverse reactions thatwere seen with LUMIGAN 0.3 mg/mL(multi-dose formulation).
Repeated dose ocular toxicity studies of GANFORT(multi-dose formulation) showed no special hazard for humans.
There have been rare spontaneous reports of reactivation of previouscorneal infiltrates or ocular infections with bimatoprost 0.3 mg/mL eye drops, solution(multi-dose formulation).
Existing literature data for GANFORT(multi-dose formulation) suggest that evening dosing may be more effective in IOP lowering than morning dosing.
A 12 week(double-masked, randomized, parallel group) clinical study compared the efficacy and safety of LUMIGAN 0.3mg/mL single-dose with LUMIGAN 0.3 mg/mL(multi-dose formulation).
Table 2 listsadditional adverse reactions reported with GANFORT(multi-dose formulation) that may potentially occur with GANFORT single-dose.
Based on studies of GANFORT(multi-dose formulation), the IOP-lowering effect of GANFORT is non-inferior to that achieved by adjunctive therapy of bimatoprost(once daily) and timolol(twice daily).
Plasma bimatoprost and timolol concentrations were determined in a crossoverstudy comparing the monotherapy treatments to GANFORT(multi-dose formulation) treatment in healthy subjects.
In clinical studies, LUMIGAN 0.3 mg/mL(multi-dose formulation) was used concomitantly with a number of different ophthalmic beta-blocking agents without evidence of interactions.
LUMIGAN 0.3 mg/mL single-dose also achieved equivalent IOPlowering efficacy with LUMIGAN 0.3 mg/mL(multi-dose formulation) in average eye IOP at each follow-up timepoint at weeks 2, 6 and 12.
No interactions are anticipated in humans, since systemic concentrations of bimatoprost areextremely low(less than 0.2 ng/mL) following ocular dosing with bimatoprost 0.3 mg/mL eye drops, solution(multi-dose formulation).
At 12 months,the incidence of iris pigmentation with bimatoprost 0.3 mg/mL(multi-dose formulation) was 1.5%(see section 4.8) and did not increase following 3 years treatment.
A 12-week(double-masked, randomized, parallel group)clinical study compared the efficacy and safety of GANFORT single-dose with GANFORT(multi-dose formulation) in patients with glaucoma or ocular hypertension.
GANFORT single-dose also achieved equivalent IOP-lowering efficacy to GANFORT(multi-dose formulation) in average eye and worse eye IOP at each follow-up timepoint at weeks 2, 6 and 12.
Mean changes from baseline worse eye IOP ranged from -9.16 to -7.98 mm Hg for GANFORT(single-dose) group,and from -9.03 to -7.72 mm Hg for the GANFORT(multi-dose formulation) group across the 12-week study.
Table 2 lists adverse reactions that were seenin a 12 month clinical study with LUMIGAN 0.3 mg/mL(multi-dose formulation), but were reported at a higher frequency than with LUMIGAN 0.3 mg/mL(single-dose).
Compared to treatment with beta-blocker alone,adjunctive therapy with beta-blocker and LUMIGAN 0.3 mg/mL(multi-dose formulation) lowered mean morning(08:00) intraocular pressure by -6.5 to -8.1 mmHg.
LUMIGAN 0.3 mg/mL single-dose achieved non-inferiorIOP-lowering efficacy to LUMIGAN 0.3 mg/mL(multi-dose formulation) for worse eye IOP change from baseline in patients with glaucoma or ocular hypertension.
Table 1 presents the adverse reactions that were reported during clinical studies of both GANFORT single-dose and Ganfort multi-dose formulations(within each frequency grouping, adverse reactions are presented in order of decreasing seriousness) or in the post-marketing period.
Table 1 presents the adverse reactions that havebeen reported during clinical studies with all GANFORT formulations(multi-dose and single-dose)(within each frequency grouping, adverse reactions are presented in order of decreasing seriousness) or in the post-marketing period.