Jardiance Европейски съюз - словашки - EMA (European Medicines Agency)

jardiance

boehringer ingelheim international gmbh - empagliflozin - diabetes mellitus, type 2; heart failure; renal insufficiency, chronic - lieky používané pri cukrovke - type 2 diabetes mellitusjardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesfor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 a 5. of the annex. heart failurejardiance is indicated in adults for the treatment of symptomatic chronic heart failure.  chronic kidney diseasejardiance is indicated in adults for the treatment of chronic kidney disease.

Trimbow Европейски съюз - словашки - EMA (European Medicines Agency)

trimbow

chiesi farmaceutici s.p.a. - beclometasone dipropionate, formoterol fumarate disodný, glycopyrronium bromid - pľúcna choroba, chronická obštrukcia - drogy obštrukčnej choroby dýchacích ciest, - maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. copdmaintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5. asthmamaintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.

PLEUMOLYSIN Словакия - словашки - ŠÚKL (Štátny ústav pre kontrolu liečiv)

pleumolysin

teva czech industries s.r.o., Česká republika - Ópiové deriváty a mukolytiká - 52 - expectorantia, mucolytica

Tulissin Европейски съюз - словашки - EMA (European Medicines Agency)

tulissin

virbac s.a. - tulatromycín - antibakteriálne látky na systémové použitie - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. prítomnosť ochorenia v stáde by sa mala stanoviť pred metafylaktickou liečbou. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. prítomnosť ochorenia v stáde by sa mala stanoviť pred metafylaktickou liečbou. the product should only be used if pigs are expected to develop the disease within 2–3 days. ovce: liečba skorých štádií infekčnej podkožne (zápal pažeráka) spojená s virulentným dichelobacter nodosus, ktorý si vyžaduje systémovú liečbu.

Tulaven Европейски съюз - словашки - EMA (European Medicines Agency)

tulaven

ceva santé animale - tulatromycín - antibakteriálne látky na systémové použitie - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. prítomnosť ochorenia v stáde by sa mala stanoviť pred metafylaktickou liečbou. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. prítomnosť ochorenia v stáde by sa mala stanoviť pred metafylaktickou liečbou. the product should only be used if pigs are expected to develop the disease within 2–3 days. ovce: liečba skorých štádií infekčnej podkožne (zápal pažeráka) spojená s virulentným dichelobacter nodosus, ktorý si vyžaduje systémovú liečbu.

Lydaxx Европейски съюз - словашки - EMA (European Medicines Agency)

lydaxx

vetoquinol - tulatromycín - antibakteriálne látky na systémové použitie - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. prítomnosť ochorenia v stáde by sa mala stanoviť pred metafylaktickou liečbou. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. prítomnosť ochorenia v stáde by sa mala stanoviť pred metafylaktickou liečbou. the product should only be used if pigs are expected to develop the disease within 2–3 days. ovce: liečba skorých štádií infekčnej podkožne (zápal pažeráka) spojená s virulentným dichelobacter nodosus, ktorý si vyžaduje systémovú liečbu.

Increxxa Европейски съюз - словашки - EMA (European Medicines Agency)

increxxa

elanco gmbh - tulatromycín - antibakteriálne látky na systémové použitie - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. prítomnosť ochorenia v stáde by sa mala stanoviť pred metafylaktickou liečbou. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. prítomnosť ochorenia v stáde by sa mala stanoviť pred metafylaktickou liečbou. the product should only be used if pigs are expected to develop the disease within 2–3 days. ovce: liečba skorých štádií infekčnej podkožne (zápal pažeráka) spojená s virulentným dichelobacter nodosus, ktorý si vyžaduje systémovú liečbu.

Tulinovet Европейски съюз - словашки - EMA (European Medicines Agency)

tulinovet

vmd n.v. - tulatromycín - antibacterials for systemic use, macrolides - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. prítomnosť ochorenia v stáde by sa mala stanoviť pred metafylaktickou liečbou. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. prítomnosť ochorenia v stáde by sa mala stanoviť pred metafylaktickou liečbou. the product should only be used if pigs are expected to develop the disease within 2–3 days. ovce: liečba skorých štádií infekčnej podkožne (zápal pažeráka) spojená s virulentným dichelobacter nodosus, ktorý si vyžaduje systémovú liečbu.

Rexxolide Европейски съюз - словашки - EMA (European Medicines Agency)

rexxolide

dechra regulatory b.v. - tulatromycín - antibakteriálne látky na systémové použitie - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. prítomnosť ochorenia v stáde by sa mala stanoviť pred metafylaktickou liečbou. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. prítomnosť ochorenia v stáde by sa mala stanoviť pred metafylaktickou liečbou. the product should only be used if pigs are expected to develop the disease within 2–3 days. ovce: liečba skorých štádií infekčnej podkožne (zápal pažeráka) spojená s virulentným dichelobacter nodosus, ktorý si vyžaduje systémovú liečbu.

Heplisav B Европейски съюз - словашки - EMA (European Medicines Agency)

heplisav b

dynavax gmbh - povrchový antigén hepatitídy b - Žltačka typu b - vakcíny - heplisav b is indicated for the active immunisation against hepatitis b virus infection (hbv) caused by all known subtypes of hepatitis b virus in adults 18 years of age and older. the use of heplisav b should be in accordance with official recommendations. it can be expected that hepatitis d will also be prevented by immunisation with heplisav b as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection.