natgillin/translations-raw huggingface dataset:
The largest mean (90% upper confidence bound) differences from placebo in baseline- and individually corrected QT was 3.1 (4.7) ms for Bevespi Aerosphere (14.4 /10 micrograms) and 7.6 (9.2) ms for glycopyrronium/formoterol with eight times the recommended dose of glycopyrronium and four times the recommended dose of formoterol.
Rezultati s placebom in učinkovino (moksifloksacinom) kontrolirane temeljite študije QT ("thorough QT study") pri 69 zdravih preiskovancih niso dokazali klinično pomembnega vpliva na interval QT ob upoštevanju mejne vrednosti 10 ms. Največja povprečna (90 % zgornja meja zaupanja) razlika v intervalu QT glede na izhodiščno vrednost in korigirano za posameznika, je bila v primerjavi s placebom 3,1 (4,7) ms za zdravilo Bevespi Aerosphere (14,4/10 mikrogramov) in 7,6 (9,2) ms pri odmerjanju glikopironija/formoterola z osemkratno vrednostjo priporočenega odmerka glikopironija in štirikratno vrednostjo priporočenega odmerka formoterola.
This means that there are 110 puffs of medicine left in the pressurised container (See Figure 2b).
To pomeni, da je v tlačnem vsebniku preostalo še 110 vpihov (glejte sliko 2b).
• Remove the cap from the mouthpiece (See Figure 3).
• Odstranite pokrovček z ustnika (glejte sliko 3).
Read this instructions for use and the package leaflet before you start using Bevespi Aerosphere and each time you get a new inhaler.
Ta navodila za uporabo zdravila in celotno Navodilo za uporabo preberite, preden začnete uporabljati zdravilo Bevespi Aerosphere.
• Bevespi Aerosphere comes as a pressurised container with a dose indicator that fits into an actuator.
• Zdravilo Bevespi Aerosphere je na voljo v tlačnem vsebniku, ki ima kazalnik odmerka in je vložen v sprožilnik.
Bevespi Aerosphere contains two active substances called glycopyrronium and formoterol fumarate dihydrate.
Zdravilo Bevespi Aerosphere vsebuje dve učinkovini imenovani glikopironij in formoterolijev fumarat dihidrat.
If you forget to use Bevespi Aerosphere
Če ste pozabili uporabiti zdravilo Bevespi Aerosphere
Based on available data, no adjustment of the dosage of Bevespi Aerosphere in geriatric patients is necessary.
Glede na podatke, ki so na voljo, starejšim bolnikom odmerka zdravila Bevespi Aerosphere ni treba prilagoditi.
The parts of your Bevespi Aerosphere inhaler (See Figure 1):
Deli inhalatorja Bevespi Aerosphere (glejte sliko 1):
Improvements compared to formoterol were observed in PINNACLE 2 (see Table 2).
V študiji PINNACLE 2 so opažali izboljšanje v primerjavi z uporabo formoterola (glejte preglednico 2).
Pharmacotherapeutic group: Drugs for obstructive airway diseases: adrenergics in combination with anticholinergics, ATC code: R03AL07.
Farmakoterapevtska skupina: Zdravila za obstruktivne pljučne bolezni, adrenergiki v kombinaciji z antiholinergiki.
o Do not use the Bevespi Aerosphere pressurised container with an actuator from any other inhaler.
o Tlačnega vsebnika z zdravilom Bevespi Aerosphere ne uporabljajte z nobenim drugim sprožilnikom iz katerega od drugih inhalatorjev.
Animal reproduction studies with glycopyrronium have shown reduced rat and rabbit fetal weights, and low body weight gain of rat offspring before weaning was observed at considerably higher systemic exposures than those reached during clinical use.
Študije vpliva na sposobnost razmnoževanja na živalih z glikopironijem so pokazale manjšo maso plodov pri podganah in kuncih ter slabo pridobivanje telesne mase podganjih mladičev pred odstavitvijo pri precej večji sistemski izpostavljenosti od dosežene pri klinični uporabi.
Do not use Bevespi Aerosphere if you are breast-feeding unless your doctor tells you that you can.
Če dojite, ne uporabljajte zdravila Bevespi Aerosphere, razen če vam zdravnik svetuje, da ga lahko.
Bevespi Aerosphere 7.2 micrograms/5 micrograms pressurised inhalation, suspension
Bevespi Aerosphere 7,2 mikrograma/5 mikrogramov inhalacijska suspenzija pod tlakom
• The pointer points between 100 and 120 after you use 10 more puffs.
• Po uporabi dodatnih 10 vpihov kazalec kaže med oznaki 100 in 120.
If you find it difficult breathing in and pressing the inhaler at the same time talk to your doctor or pharmacist.
Uporaba zdravila Bevespi Aerosphere z ustnikom Če težko hkrati vdihnete in pritisnete inhalator, se posvetujte z zdravnikom ali farmacevtom.
o Throw away the pouch and the drying packet.
o Vrečko in zavojček s sušilnim sredstvom zavrzite.
Glycopyrronium (N=451)
z glikopironijem (N = 451)
This means that there are 120 puffs of medicine left in the pressurised container (See Figure 2a).
To pomeni, da je v tlačnem vsebniku preostalo še 120 vpihov (glejte sliko 2a).
No pharmacokinetic studies have been performed with Bevespi Aerosphere in patients with hepatic impairment.
Z zdravilom Bevespi Aerosphere niso izvedli farmakokinetičnih študij pri bolnikih z okvaro jeter.
This means that there are 100 puffs of medicine left in the pressurised container (See Figure 2c).
To pomeni, da je v tlačnem vsebniku preostalo še 100 vpihov (glejte sliko 2c).
Glycopyrronium (N=439)
z glikopironijem (N = 439)
• feeling sick (nausea)
• občutek slabosti s siljenjem na bruhanje (navzea)
The other ingredients are norflurane, 1,2- distearoyl-sn-glycero-3-phosphocholine and calcium chloride.
Druge sestavine zdravila so norfluran, 1,2-distearoil-sn-glicero-3-fosfoholin in kalcijev klorid.
This corresponds to a metered dose of glycopyrronium bromide 10.4 micrograms equivalent to 8.3 micrograms of glycopyrronium, and formoterol fumarate dihydrate 5.8 micrograms.
To ustreza odmerjenemu odmerku 8,3 mikrograma glikopironija v obliki 10,4 mikrograma glikopironijevega bromida in 5,8 mikrograma formoterolijevega fumarata dihidrata.
If you stop using Bevespi Aerosphere
Če ste prenehali uporabljati zdravilo Bevespi Aerosphere
The terminal elimination half-life of formoterol following oral inhalation derived via population pharmacokinetics analysis was 13 hours.
S populacijsko farmakokinetično analizo ocenjeni končni razpolovni čas izločanja formoterola po peroralni inhalaciji je bil 13 ur.
Bevespi Aerosphere also showed improvements in peak FEV1 within 2 hours post-dose over 24 weeks relative to placebo, glycopyrronium and formoterol (p<0.0001) [see Table 2].
Zdravilo Bevespi Aerosphere je v 24 tednih izboljšalo tudi najvišji FEV1 v 2 urah po odmerku v primerjavi s placebom, glikopironijem in formoterolom (p < 0,0001) [glejte preglednico 2].
What Bevespi Aerosphere looks like and contents of the pack
Izgled zdravila Bevespi Aerosphere in vsebina pakiranja
• Your Bevespi Aerosphere inhaler comes in a foil pouch that contains a drying packet (desiccant).
• Zdravilo Bevespi Aerosphere je na voljo v vrečki iz folije, ki vsebuje zavojček s sušilnim sredstvom (sušilom).
number in Intent to Treat population primary endpoint in all studies PINNACLE 1 and PINNACLE 2 used SAC-TDI.
V študijah PINNACLE 1 in PINNACLE 2 so uporabili SAC-TDI.
Repeat steps 2 to 7 to take your second puff of Bevespi Aerosphere.
Za drugi vpih zdravila Bevespi Aerosphere ponovite postopek od 2. do 7. koraka.
Linear pharmacokinetics were observed for glycopyrronium (dose range: 14.4 to 115.2 mcg) and formoterol (dose range: 2.4 to 19.2 mcg) after oral inhalation.
14,4 do 115,2 mikrogramov) in pri formoterolu (razpon odmerkov: od 2,4 do 19,2 mikrogramov).
However, these animal experimental results have little relevance to man. A slight increase in the incidence of uterine leiomyomas has been observed in rats and mice treated with formoterol; an effect which is considered to be a class-effect in rodents after long-term exposure to high doses of β2-adrenoreceptor agonists.
Pri podganah in miših, ki so prejemale formoterol, so opažali rahlo povečanje pojavnosti materničnih leiomiomov; ta učinek je domnevno učinek skupine pri glodalcih po dolgotrajni izpostavljenosti velikim odmerkom agonistov adrenergičnih receptorjev β2.
Table 1Adverse reactions by frequency and system organ class (SOC)
Neželeni učinki po pogostnosti in organskih sistemih Organski sistem
In studies PINNACLE 1, PINNACLE 2 and PINNACLE 4, Bevespi Aerosphere showed improvements in trough FEV1 over 24 weeks relative to placebo, glycopyrronium and formoterol (p<0.0001) [see Table 2].
V študijah PINNACLE 1, PINNACLE 2 in PINNACLE 4 je zdravilo Bevespi Aerosphere v 24 tednih izboljšalo najnižji FEV1 v primerjavi s placebom, glikopironijem in formoterolom (p < 0,0001) [glejte preglednico 2].
Your inhaler may not feel empty and it may seem as though it still works.
Morda se vam bo zdelo, da inhalator še ni povsem prazen in da še deluje, vendar v primeru nadaljnje uporabe ne bi več prejeli pravilne količine zdravila pri vpihu.
Preparing your Bevespi Aerosphere inhaler for use:
Priprava inhalatorja Bevespi Aerosphere za uporabo:
Evidence of transfer of glycopyrronium and formoterol into maternal milk in rats has been reported.
Pri podganah so poročali o dokazih prehajanja glikopironija in formoterola v mleko.
The terminal elimination half-life of glycopyrronium following oral inhalation derived via population pharmacokinetics analysis was 15 hours.
S populacijsko farmakokinetično analizo ocenjeni končni razpolovni čas izločanja glikopironija po peroralni inhalaciji je bil 15 ur.
The pharmacokinetics of formoterol was best described by a two compartment disposition model with a first-order rate constant of absorption and linear elimination.The typical clearance (CL/F) of formoterol was 99 L/h.
Farmakokinetiko formoterola je najbolje opisal dvoprostorni model odstranjevanja s konstanto absorpcije prvega reda in linearnim izločanjem.
Shake the inhaler well before each priming puff.
Pred vsakim sproščanjem vpiha osnovne priprave inhalator dobro pretresite.
Bevespi Aerosphere is for inhalation use.
Zdravilo Bevespi Aerosphere je namenjeno za inhaliranje.
TOP VIEW
POGLED OD ZGORAJ
Immediate breathing difficulties If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using Bevespi Aerosphere: Stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.
Prenehajte uporabljati to zdravilo in takoj poiščite zdravniško pomoč, saj gre lahko za resno stanje, ki ga imenujemo paradoksni bronhospazem.
Do not press down too hard on the pressurised container.
Na tlačni vsebnik ne pritiskajte premočno, da ne bi sprožili sprostitve vpiha zdravila.
Norflurane 1,2-distearoyl-sn-glycero-3-phosphocholine and calcium chloride.
norfluran, 1,2-distearoil-sn-glicero-3-fosfoholin in kalcijev klorid
There were improvements compared to formoterol in PINNACLE 1 and PINNACLE 2.
V študijah PINNACLE 1 in PINNACLE 2 je prišlo do izboljšanja v primerjavi s formoterolom.
How to use Bevespi Aerosphere
Kako uporabljati zdravilo Bevespi Aerosphere
Agitation Restlessness Insomnia
Psihiatrične motnje anksioznost pogosti agitiranost nemir nespečnost občasni
In PINNACLE 1, PINNACLE 2 and PINNACLE 4, Bevespi Aerosphere provided an improvement in disease-specific health-related quality of life, as indicated by a reduction in the St George's Respiratory Questionnaire (SGRQ) total score over 24 weeks compared to placebo and glycopyrronium [see Table 2].
V študijah PINNACLE 1, PINNACLE 2 in PINNACLE 4 je zdravilo Bevespi Aerosphere izboljšalo za bolezen specifično zdravstveno kakovost življenja, ugotovljeno z zmanjšanjem celotne ocene SGQR (St. George's Respiratory Questionnaire), v 24 tednih v primerjavi s placebom in glikopironijem [glejte preglednico 2].
It is unlikely that this medicine will affect your ability to drive and use machines.
Ni verjetno, da bi to zdravilo vplivalo na vašo sposobnost upravljanja vozil in strojev, vendar lahko pride do omotice in slabosti s siljenjem na bruhanje, ki sta pogosta neželena učinka zdravila.
The estimated glycopyrronium Vc/F (volume of the central compartment), and Vp1/F (volume of the peripheral compartment) are 741 L, and 2990 L, respectively, via population pharmacokinetic analysis.
S populacijsko farmakokinetično analizo ocenjeni Vc/F (volumen centralnega prostora) glikopironija je 741 l in njegov Vp1/F (volumen perifernega prostora) je 2990 l. V razponu koncentracij od 2 do 500 nmol/l je segala vezava glikopironija na beljakovine v plazmi od 43 do 54 %.
In three Phase III, 24-week studies (PINNACLE 1, PINNACLE 2 and PINNACLE 4) Bevespi Aerosphere provided improvements over placebo in lung function (as measured by morning pre-dose trough forced expiratory volume in 1 second [FEV1]), with a demonstrated onset of action at 5 minutes following administration of the first dose on Day 1 (improvement over placebo by 187 mL, 186 mL and 179 mL in PINNACLE 1, PINNACLE 2 and PINNACLE 4, respectively [p <0.001]).
Dokazan je bil začetek delovanja v 5 minutah po uporabi prvega odmerka 1. dan (izboljšanje v primerjavi s placebom za 187 ml v PINNACLE 1, za 186 ml v PINNACLE 2 in za 179 ml v PINNACLE 4 [p < 0,001]).
The mouthpiece is covered with an orange protective cap. Bevespi Aerosphere is supplied in a foil pouch that contains a drying packet (desiccant) and packed into a carton.
Zdravilo Bevespi Aerosphere je na voljo v vrečki iz folije, ki vsebuje zavojček s sušilnim sredstvom (sušilom) in je pakirana v škatli.
France or
Francija ali
Dose adjustments are not necessary based on the effect of age, sex and weight on the pharmacokinetic parameters of glycopyrronium and formoterol.
Glede na farmakokinetične parametre glikopironija in formoterola prilagajanje odmerka na osnovi starosti, spola in telesne mase ni potrebno.
The estimated formoterol Vc/F (volume of the central compartment), and Vp1/F (volume of the peripheral compartment) are 1030 L, and 647 L, respectively, via population pharmacokinetic analysis.
S populacijsko farmakokinetično analizo ocenjeni Vc/F (volumen centralnega prostora) formoterola je 1030 l in njegov Vp1/F (volumen perifernega razdelka) je 647 l. V razponu koncentracij od 10 do 500 nmol/l je segala vezava formoterola na beljakovine v plazmi od 46 do 58 %.
In PINNACLE 1 and PINNACLE 2, Bevespi Aerosphere provided improvements in breathlessness as demonstrated by Self-administered Computerised Transitional Dyspnoea Index (SAC TDI) focal score over 24 weeks compared to placebo and glycopyrronium (see Table 2).
V študiji PINNACLE 1 in PINNACLE 2 je zdravilo Bevespi Aerosphere izboljšalo težko dihanje, kot je bilo dokazano s fokalno oceno računalniško podprte ocene indeksa spreminjanja dispneje v času po navedbi bolnika (SAC TDI-Self-administered Computerised Transitional Dyspnoea Index), v 24 tednih v primerjavi s placebom in glikopironijem (glejte preglednico 2).
INHALER LABEL (ACTUATOR)
NALEPKA INHALATORJA (SPROŽILNIK)
• For inhalation use only.
Samo za inhaliranje.
NAMES OF THE MARKETING AUTHORISATION HOLDER
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Aerosphere (N=510) vs placebo (N=223)
s placebom (N = 223)
In PINNACLE 4, Bevespi Aerosphere provided improvements in breathlessness as demonstrated by TDI focal score over 24 weeks compared to placebo and glycopyrronium (see Table 2).
V študiji PINNACLE 4 je zdravilo Bevespi Aerosphere izboljšalo težko dihanje, kot je bilo dokazano s fokalno oceno TDI v 24 tednih v primerjavi s placebom in glikopironijem (glejte preglednico 2).
120 actuations (1 inhaler)
inhalacijska suspenzija pod tlakom 120 sprožitev (1 inhalator)
Bevespi Aerosphere 7.2 micrograms / 5 micrograms pressurised inhalation, suspension glycopyrronium / formoterol fumarate dihydrate
Bevespi Aerosphere 7,2 mikrograma/5 mikrogramov inhalacijska suspenzija pod tlakom glikopironij/formoterolijev fumarat dihidrat
• Use Bevespi Aerosphere exactly as your doctor tells you to.
Pri uporabi zdravila Bevespi Aerosphere natančno upoštevajte navodila zdravnika.
6.1 List of excipients
6.1 Seznam pomožnih snovi norfluran
Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including glycopyrronium or formoterol.
Po uporabi antagonistov muskarinskih receptorjev in simpatikomimetikov, tudi glikopironija in formoterola, se lahko pojavijo učinki na srce in ožilje, npr. motnje srčnega ritma, kakršni sta atrijska fibrilacija in tahikardija.
Bevespi Aerosphere 7.2 mcg/5 mcg pressurised inhalation glycopyrronium/formoterol fumarate dihydrate Inhalation use
Bevespi Aerosphere 7,2 μg/5 μg inhalacijska tekočina pod tlakom glycopyrronium/formoterol fumarate dihydrate za inhaliranje
Aerosphere (N=551) vs placebo (N=235)
s placebom (N = 235)
Each single actuation (delivered dose, ex-actuator) contains glycopyrronium bromide 9 micrograms equivalent to 7.2 micrograms of glycopyrronium, and 5 micrograms of formoterol fumarate dihydrate.
Ena sprožitev (oddani odmerek iz sprožilnika) vsebuje 7,2 mikrograma glikopironija v obliki 9 mikrogramov glikopironijevega bromida in 5 mikrogramov formoterolijevega fumarata dihidrata.
Priming your Bevespi Aerosphere inhaler:
Osnovna priprava inhalatorja Bevespi Aerosphere:
Each single actuation contains glycopyrronium bromide equivalent to 7.2 micrograms of glycopyrronium, and 5 micrograms of formoterol fumarate dihydrate.
Ena sprožitev vsebuje 7,2 mikrograma glikopironija v obliki glikopironijevega bromida in 5 mikrogramov formoterolijevega fumarata dihidrata.
• The pointer points to 100 after you take 10 more puffs.
• Po uporabi dodatnih 10 vpihov kazalec kaže proti oznaki 100.
Aerosphere (N=526) vs placebo (N=219)
s placebom (N = 219)
Bevespi Aerosphere (N=551) vs formoterol fumarate (N=480)
s formoterolijevim fumaratom (N = 480)
How to clean your Bevespi Aerosphere inhaler:
Čiščenje inhalatorja Bevespi Aerosphere:
120 actuations (1 inhaler).
inhalacijska suspenzija pod tlakom 120 sprožitev (1 inhalator).
• you have an eye problem called narrow-angle glaucoma (also called angle-closure glaucoma)
• če imate očesno bolezen, imenovano "glavkom ozkega zakotja" (ki jo imenujemo tudi "glavkom zaprtega zakotja").
oC.
vpihov.
Bevespi Aerosphere (N=510) vs formoterol fumarate (N=437)
s formoterolijevim fumaratom (N = 437)
Each single puff delivers a dose of 9 micrograms glycopyrronium bromide (equivalent to 7.2 micrograms of glycopyrronium), and 5 micrograms of formoterol fumarate dihydrate.
Z enim vpihom bolnik prejme odmerek 7,2 mikrograma glikopironija v obliki 9 mikrogramov glikopironijevega bromida in 5 mikrogramov formoterolijevega fumarata dihidrata.
• Prime the inhaler by shaking it and actuating into the air four times before first use or two times when the inhaler has not been used for more than seven days, has been exposed to low temperatures, or has been dropped.
Če inhalator ni bil uporabljen več kot sedem dni, je bil izpostavljen nizki temperaturi ali je kam padel, za osnovno pripravo zadošča dvakratna sprožitev.
The active substances are glycopyrronium and formoterol fumarate dihydrate.
Kaj vsebuje zdravilo Bevespi Aerosphere Učinkovini sta glikopironij in formoterolijev fumarat dihidrat.
Pointer
Kazalec
Bevespi Aerosphere (N=526) vs formoterol fumarate (N=449)
s formoterolijevim fumaratom (N = 449)
OTHER
DAN
Talk to your doctor or pharmacist before using Bevespi Aerosphere if:
Pred uporabo zdravila Bevespi Aerosphere se posvetujte z zdravnikom ali farmacevtom:
Aerosphere (N=510) vs
Zdravilo Bevespi Aerosphere (N = 510) v prim.
Nervous system disorders
β-adrenergični blokatorji
Bevespi Aerosphere (N=551) vs glycopyrronium (N=474)
Zdravilo Bevespi Aerosphere (N = 551) v prim.
Cardiovascular effects
• mišični krči
LIST OF EXCIPIENTS
Okence kazalnika odmerkov
Metabolism and nutrition disorders
Presnovne in prehranske motnje hiperglikemija občasni
Aerosphere (N=526) vs
Zdravilo Bevespi Aerosphere (N = 526) v prim.
• dry mouth
Bolezni prebavil suhost ust
Palpitations
Hipokaliemija
The terminal half-life is approximately 10 hours.
Končna razpolovna doba je približno 10 ur.
The following indications were agreed upon:
Dogovorjene so bile naslednje indikacije:
About two third of the dose are excreted unchanged in urine.
Približno dve tretjini odmerka se izloči nespremenjenega z urinom.
A list of Questions was adopted by the CHMP, highlighting the main areas of divergences.
CHMP je sprejel seznam vprašanj, v katerih je izpostavil glavna področja odstopanja.
(Slovenia) Brnciceva 1
(Slovenija) Brnciceva 1
The CHMP agreed with the harmonised text but maintained its lower age limit of 2 years.
CHMP se je strinjal z usklajenim besedilom, vendar ohranil svojo nižjo starostno omejitev 2 let.
Post-marketing experience
Postmarketinške izkušnje
The apparent volume of distribution is 0.50 l/kg.
Navidezni volumen porazdelitve je 0,50 l/kg.
The diluted solution should be taken immediately.
Razredčeno raztopino je treba zaužiti takoj.
Please follow these instructions, otherwise Zyrtec may not be fully effective.
Prosimo upoštevajte navodila, drugače zdravilo Zyrtec ne bo popolnoma učinkovito.
McNeil Denmark Aps Bregnerødvej 133
McNeil Danska Aps Bregnerødvej 133
Your doctor will then decide what measures, if any, should be taken.
Vaš zdravnik bo nato določil katere ukrepe sprejeti, če je to potrebno.
Your doctor will then assess the severity and decide on any further measures that may be necessary.
Zdravnik bo ocenil resnost in se odločil za morebitne dodatne ukrepe.
20068 Peschiera Borromeo (MI) Italy
20068 Peschiera Borromeo (MI) Italija
The new dose will be determined by your Doctor.
Nov odmerek bo določil vaš zdravnik.
B - 2600 Berchem Belgium
B - 2600 Berchem Belgija
SLO - 1001 Ljubljiana Slovenia
SLO - 1001 Ljubljiana Slovenija
Should overdose occur, symptomatic or supportive treatment is recommended.
Če pride do prevelikega odmerjanja, priporočamo simptomatsko ali podporno zdravljenje.
Kruczkowskiego, 8 00 - 380 Warszawa Poland
Kruczkowskiego, 8 00 - 380 Warszawa Poljska
Adverse event (WHO-ART)
Neželeni dogodek (WHO-ART)
Read all of this leaflet carefully because it contains important information for you.
Pred uporabo natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
NL-4822 NK Breda Nederland
NL-4822 NK Breda Nizozemska
For cetirizine very rare clinical data on exposed pregnancies are available.
Za cetirizin je na voljo zelo malo kliničnih podatkov nosečnic, ki so bile izpostavljene zdravilu.
After an overdose, the side effects described below may occur with increased intensity.
Po zaužitju prevelikega odmerka se lahko spodaj opisani neželeni učinki pojavijo s povečano intenzivnostjo.
The experimental effects observed in animals or at higher than recommended doses and not in line with the indication should be deleted.
Izkustvene učinke, ki so bili opaženi pri živalih ali višjih odmerkih od priporočenih in ki niso v skladu z indikacijo, je treba izbrisati.
04010 Borgo San Michele (LT) Italy
04010 Borgo San Michele (LT) Italija
Sardenya 346 - 350 E - 08025 Barcelona Spain
Sardenya 346 - 350 E - 08025 Barcelona Španija
Cetirizine 10 mg (n= 3260)
cetirizin 10 mg (n = 3260)
UCB Magyarország Kft Árpád fejedelem útja 26-28 1023 Budapest Hungary
UCB Magyarország Kft Árpád fejedelem útja 26-28 1023 Budapest Madžarska
[To be completed nationally] {Name and address} {tel} {fax} {e-mail}
[Dopolniti lokalno] {Ime in naslov} {tel.} {fax} {e-mail}
How and when should you take Zyrtec?
Kako in kdaj jemati zdravilo Zyrtec?
D-76139 Karlsruhe GERMANY
D-76139 Karlsruhe NEMČIJA
In particular, frequencies were added to the listing of events, as observed from pharmacovigilance surveys.
Zlasti so bile na seznam dodane pogostnosti pojavov, kot so bile zaznane s farmakovigilančnimi študijami.
Regarding section 5.1 Pharmacodynamic properties, the MAH was asked to reword section 5.1 and retain only the properties that are relevant with regards to the therapeutic effects.
V zvezi z razdelkom 5.1 Farmakodinamične lastnosti je bil imetnik dovoljenja za promet z zdravilom zaprošen, da preoblikuje razdelek 5.1 in obdrži le lastnosti, ki so pomembne v zvezi s terapevtskimi učinki.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ZYRTEC AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA ZYRTEC IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
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There is no known specific antidote to cetirizine.
Znanega specifičnega antidota za cetirizin ni.