natgillin/translations-raw huggingface dataset:
In 152 subjects aged > 60 years the anti-HA antibody seroprotection and seroconversion rates against A/Indonesia/5/2005 at day 42 after two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were 23% and the seroconversion factor was 2.7.
Pri 152 preiskovancih, starejših od 60 let je bil delež serološke zaščite protiteles anti-HA in delež serokonverzije proti A/Indonesia/5/2005 po dveh odmerkih cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Vietnam/1194/2004 (H5N1) na 42 dan 23°%.
GlaxoSmithKline Biologicals Branch of SmithKline Beecham Pharma GmbH & Co. KG Zirkustraße 40, D-01069 Dresden Germany
KG Zirkustraße 40, D-01069 Dresden Nemčija
In another clinical study, 39 subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 fourteen months after they had received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 administered on day 0 and day 21.
V drugi klinični študiji je 39 preiskovancev, starih od 18 do 60 let, dobilo cepivo z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Indonesia/05/2005 štirinajst mesecev potem, ko so dobili dva odmerka cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Vietnam/1194/2004 na dan 0 in 21.
“Possible side effects” may affect the ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Nekateri učinki, navedeni v poglavju 4, "Možni neželeni učinki", lahko vplivajo na sposobnost vožnje in upravljanja s stroji.
Tell the doctor requesting these tests that you have recently received Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals
Zdravnika, ki želi opraviti takšne preiskave opozorite, da ste bili pred kratkim cepljeni s cepivom Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg.
Do not have Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg if any of the above apply to you.
Ne cepite se s cepivom Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg, če karkoli od naštetega velja za vas.
You will receive two doses of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Prejeli boste dva odmerka cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg.
A minor infection such as a cold should not be a problem, but your doctor will advise whether you can still be vaccinated with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Blažja okužba, npr. prehlad, ne bi smela biti težava, vendar se pred cepljenjem s cepivom Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg o tem vseeno posvetujte s svojim zdravnikom.
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should under no circumstances be administered intravascularly or intradermally.
Cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg se v nobenem primeru ne sme injicirati v žilo ali v kožo.
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg suspenzija in emulzija za emulzijo za injiciranje prepandemično cepivo proti gripi (H5N1) z delci virionov, inaktivirano (z adjuvansom)
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is a vaccine for use in adults from 18 years old.
Cepivo Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg uporabljamo pri odraslih, starejših od 18 let.
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension for emulsion for injection Prepandemic influenza vaccine (H5N1)
Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg suspenzija za emulzijo za injiciranje prepandemično cepivo proti gripi (H5N1)
These side effects may occur with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Ti neželeni učinki se lahko pojavijo tudi pri cepivu Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg.
Like all medicines, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg can cause side effects, although not everybody gets them.
Kot vsa cepiva ima lahko tudi cepivo Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg neželene učinke, ki pa se ne pojavijo pri vseh cepljenih osebah.
• Swollen glands in the neck, armpit or groin
• oteklina vratnih, podpazdušnih ali dimeljskih bezgavk.
The volume of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg (5 ml) after mixing corresponds to 10 doses of vaccine.
Količina cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg po mešanju (5 ml) ustreza 10 odmerkom
After mixing, 1 dose (0.5 ml) contains:
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Po premešanju 1 odmerek (0,5 ml) vsebuje:
A 4-fold increase in serum neutralising antibody against A/Indonesia/5/2005 was achieved in >90% of subjects after two doses regardless of the schedule.
Ne glede na shemo, je > 90°% preiskovancev pod dveh odmerkih imelo 4-kraten porast titra nevtralizacijskih protiteles proti A/Indonesia/5/2005.
Take special care with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg:
Bodite posebno pozorni pri cepljenju s cepivom Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg:
Booster factor3
Faktor serokonverzije3
What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is and what it is used for Before you receive Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Kaj je cepivo Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg in za kaj ga uporabljamo Kaj morate vedeti, preden boste cepljeni s cepivom Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg Kako uporabljati cepivo Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg
One pack of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg consists of:
Eno pakiranje cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg vsebuje:
What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is and what it is used for
Kaj je cepivo Prepandemično cepivo proti gripi H5N1 (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg in za kaj ga uporabljamo
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should not be given:
S cepivom Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg ne smete biti cepljeni:
Emulsion for emulsion for injection for Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg
Emulzija za emulzijo za injiciranje za Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg
No data have been generated in pregnant women with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg or with any other vaccine that contains the AS03 adjuvant.
O uporabi cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg ali kateregakoli drugega cepiva z adjuvansom AS03 pri nosečnicah ni podatkov.
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension for emulsion for injection IM
Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg suspenzija za emulzijo za injiciranje i.m.
Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB02
FARMAKOLOŠKE LASTNOSTI 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: Cepiva proti gripi, oznaka ATC: J07BB02 Imunski odziv proti A/Vietnam/1194/2004:
There is no information on the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg in pregnant or breast-feeding women.
O uporabi cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg med nosečnostjo in dojenjem ni podatkov.
The side effects listed below have occurred with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg in clinical studies:
Neželeni učinki, ki so navedeni spodaj, so se pojavili v kliničnih raziskavah s cepivom Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg:
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg consists of two containers:
Cepivo Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg je na voljo v dveh vsebnikih:
The doctor or nurse will give Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg as an injection into your upper arm muscle.
Cepivo Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg vam bo zdravnik ali medicinska sestra dal/dala v obliki injekcije v mišico nadlakti.
What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg looks like and contents of the pack
Izgled cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg in vsebina pakiranja
Anti-HA responses against A/Indonesia/5/2005 following administration of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were as follows:
Po uporabi cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Vietnam/1194/2994 je bil odziv anti-HA proti A/Indonesia/5/2005 naslednji:
How to store Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg
Kako uporabljati cepivo Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg
There are no data regarding the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg during lactation.
O uporabi cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg med dojenjem ni podatkov.
PSUR submission when Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is used during the influenza pandemic:
Predložitev periodičnega poročila o varnosti zdravila pri uporabi cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg med pandemijo gripe:
What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg contains
Kaj vsebuje cepivo Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg
Therefore, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is not intended to be given at the same time as other vaccines.
O sočasnem cepljenju s cepivom Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg in drugimi cepivi ni podatkov, zato cepivo Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg ni namenjeno za uporabo skupaj z drugimi cepivi.
Before you receive Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg
Shranjevanje cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg
There are no data on the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg given at the same time as other vaccines.
Podatki o spremljanju cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg po pridobitvi dovoljenja za promet niso na voljo.
Only do this once.
To napravite enkrat.
Date of first authorisation: 13 April 2012 Date of latest renewal: 11 January 2017
Datum prve odobritve: 13 April 2012 Datum zadnjega podaljšanja: 11 Januar 2017
Absolute mL
Absolutni ml
(See Table 1).
(glejte preglednico 1).
- Worsening of symptoms.
- Poslabšanje simptomov.
Your doctor will tell you how long to use this medicine for.
Zdravnik vam bo povedal, kako dolgo jemati to zdravilo.
- Breathe out, and then breathe normally again.
- Izdihnite in spet normalno dihajte.
Adults 18 years of age and over
Odrasli, stari 18 let in več
The applicant is requested to submit periodic analysis of the CF study every 6 months for 3 years and annually for 2 years.
Predlagatelj mora predložiti redne analize študije CF vsakih 6 mesecev v obdobju 3 let in letno v obdobju 2 let.
Note: There were some differences in analysis methods across the 3 studies.
Opomba: metode analiziranja v teh treh študijah so se med seboj nekoliko razlikovale.
There are no data available for children under 12 years of age.
Za otroke, mlajše od 12 let, ni razpoložljivih podatkov.
Patients should be advised to carefully read them.
Bolnikom je treba naročiti, naj navodilo temeljito preberejo.
The first dose is taken in 4 steps:
Prvi odmerek se vzame v 4 fazah:
No formal interaction studies have been conducted.
Formalnih študij medsebojnega delovanja niso izvedli.
Initiation dose (6 to 17 years of age)
Začetni odmerek (starost od 6 do 17 let)
If the capsule has not emptied you may need to repeat steps 6 to 8.
Če se kapsula ni izpraznila, morate ponoviti postopek od 6. do 8. točke.
It is not known if this medicine passes into the breast milk.
Ni znano, ali to zdravilo prehaja v materino mleko.
This happens commonly, which may affect up to 1 in 10 people.
To je pogosto in se lahko pojavi pri do 1 bolniku od 10.
• acute bleeding ≥240 ml in a 24-hour period
• akutna krvavitev ≥240 ml v obdobju 24 ur,
Leave it to dry in the air - lay it on its side with the mouth-piece open.
Posušite ga na zraku - položite ga na bok z odprtim ustnikom.
Inhaled antibiotics (if applicable)
5. inhalirani antibiotiki (če je potrebno).
Absolute % predicted Relative % predicted
Absolutna sprememba napovedane % ravni Relativna sprememba napovedane % ravni
For patients receiving several respiratory therapies, the recommended order is:
Pri bolnikih, ki prejemajo več terapij za dihala, je priporočeni vrstni red:
However, if it is nearly time for the next dose, skip the missed dose.
Če pa je skoraj čas za naslednji odmerek, pozabljeni odmerek preskočite.
Dornase alfa (if applicable) 5.
4. dornaza alfa (če je potrebno);
Put in the capsule - First make sure your hands are dry.
Vstavite kapsulo - Najprej se prepričajte, da imate suhe roke.
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (≥1/100,000 to <1/10,000); not known (cannot be estimated from the available data).
Opredelitev pogostnosti: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (≥1/100.000 do <1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
The safety profile of Bronchitol has been evaluated in clinical studies involving more than 1200 patients.
Varnostni profil zdravila Bronchitol je bil ovrednoten v kliničnih študijah, ki so vključevale več kot 1200 bolnikov.
The Tmax after inhaled administration was 1.5 ± 0.5 hours.
Vrednost Tmax po inhaliranju je bila 1,5 ± 0,5 ure.
The inhaler device is to be replaced after one week of use.
Inhalator je treba zamenjati po enem tednu uporabe.
Productive cough can contribute to sputum clearance.
Produktivni kašelj lahko prispeva k očistku sputuma.
o The need for monitoring and when to withhold treatment.
o potreba po spremljanju in primeri, ko je treba zdravljenje prekiniti.
Cleaning the inhaler - Usually your inhaler will give you the correct dose of medicine for 7 days without needing cleaning.
Čiščenje inhalatorja - Običajno bo inhalator zagotovil pravilni odmerek zdravila 7 dni brez potrebe po čiščenju.
Repeat steps 3 to 10 for each capsule - Perform these steps for each of the ten capsules.
Ponovite postopek od 3. do 10. točke za vsako kapsulo - Postopek ponovite za vsako kapsulo od desetih.
All FEV1 measurements and SpO2 monitoring should be performed 60 seconds after dose inhalation.
Vse meritve FEV1 in spremljanje SpO2 je treba začeti 60 sekund po inhalaciji odmerka.
The recommended dose of Bronchitol is 400 mg twice a day.
Priporočeni odmerek zdravila Bronchitol je 400 mg dvakrat na dan.
You must let it fully dry, this can take up to 24 hours.
Inhalator morate popolnoma posušiti, kar lahko traja 24 ur.
This happens commonly.
To je pogosto.
As well as using Bronchitol you will normally keep using the other medicines you take for cystic fibrosis.
Poleg zdravila Bronchitol boste še naprej kot običajno uporabljali druga zdravila, ki jih jemljete za cistično fibrozo.
- Have the evening dose at least 2 to 3 hours before you go to bed.
- Večerni odmerek vzemite vsake 2 do 3 ure pred spanjem.
It also helps improve the condition of your lungs and your breathing.
Ravno tako izboljša stanje pljuč in dihanje.
As a result you may get a ‘productive cough', which also helps to remove mucus from your lungs.
Posledično boste lahko imeli „produktivni kašelj,“ ki pripomore k odstranjevanju sluzi iz pljuč.
- Coughing up blood or blood in your sputum.
- Če izkašljate kri ali opazite kri v sputumu.
The mean terminal half-life in adults was approximately 4 to 5 hours from serum and approximately 3.66 hours from urine.
Pri odraslih je bila povprečna končna razpolovna doba iz seruma približno 4 do 5 ur, iz urina pa 3,66 ure.
Available data from studies DPM-CF-301 and 302 suggest that no dose adjustments are required for these patient populations.
Razpoložljivi podatki iz študij DPM-CF-301 in 302 kažejo, da prilagoditev odmerka za ti populaciji bolnikov ni potrebna.
The 2-week treatment pack is for treatment use.
Pakiranje za dvotedensko zdravljenje je namenjeno zdravljenju.
- Take a steady deep breath in, to fill your lungs - then hold your breath for 5 seconds.
- Z enakomernim globokim vdihom napolnite pljuča, nato pa držite dih 5 sekund.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Pogoji in zahteve za predložitev z zadnjimi podatki dopolnjenih rednih poročil o varnosti zdravila so določeni na seznamu referenčnih datumov Unije (seznam EURD), člen 107c(7) Direktive 2001/83/ES in spremembah, objavljenih na evropskem spletnem portalu za zdravila.
Do not try to loosen the capsule by pressing the piercing buttons again.
Ne poskušajte sprostiti kapsule s ponovnim pritiskanjem gumbov za prediranje.
At the end of the initiation dose you will have taken 10 capsules (400 mg) which is the same as the usual dose.
Na koncu začetnega odmerka boste prejeli 10 kapsul (400 mg), kolikor znaša običajni odmerek.
Overall, the comparison of AUCs between Day 1 and Day 7 showed a time independence of pharmacokinetics, indicating linearity at the dose level administered in this study.
Primerjava vrednosti AUC med 1. in 7. dnem je v splošnem kazala časovno neodvisnost farmakokinetike, kar kaže na linearnost pri odmerkih, uporabljenih v tej študiji.
When administered intravenously, mannitol is eliminated largely unchanged by glomerular filtration and 87% of the dose is excreted in the urine within 24 hours.
Intravensko uporabljeni manitol se izloči večinoma nespremenjen z glomerulno filtracijo in 87 % odmerka se izloči v urin v 24 urah.
The doctor may give you oxygen and medicines to help you breathe.
Zdravnik vam bo morda za lažje dihanje dal kisik in zdravila.
The safety profile of Bronchitol is based on the safety data from Phase III clinical studies (including data from the initiation dose assessment).
Varnostni profil zdravila Bronchitol temelji na varnostnih podatkih kliničnih študij III. faze (vključno s podatki ocene začetnega odmerka).
- If your inhaler breaks, use your second inhaler and talk to your doctor.
- Če se inhalator pokvari, uporabite drugi inhalator in se posvetujte s svojim zdravnikom.
Lung deposition studies have demonstrated a 24.7% deposition of inhaled mannitol confirming its distribution to the target organ.
V študijah nalaganja v pljučih so dokazali 24,7-odstotno nalaganje inhaliranega manitola, kar potrjuje njegovo porazdelitev v ciljnem organu.
The limited data available in adolescents aged 12 to 17 years indicate the pharmacokinetic parameters of inhaled mannitol are similar to the adult population.
Omejena količina podatkov v populaciji mladostnikov, starih od 12 do 17 let, nakazuje na to, da so farmakokinetični parametri inhaliranega manitola podobni kot v odrasli populaciji.
p value
Vrednost p
In a study of 18 healthy male adult volunteers, the absolute bioavailability of mannitol powder for inhalation by comparison to mannitol administered intravenously was 0.59% ± 0.15.
V študiji pri 18 zdravih moških odraslih prostovoljcih je bila absolutna biološka uporabnost manitola v obliki praška za inhalacijo v primerjavi z intravensko uporabljenim manitolom 0,59 % ± 0,15.
o How to interpret the results of the Bronchitol initiation dose assessment as Pass, Fail or Incomplete.
o kako interpretirati izide ocene začetnega odmerka zdravila Bronchitol kot pozitivne, negativne ali nepopolne.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
This requires the inhalation of the contents of ten capsules via the inhaler device twice a day.
To zahteva inhalacijo vsebine desetih kapsul prek inhalatorja dvakrat na dan.
This is because piercing the capsule more than once may make it split or break-up.
Če kapsulo predrete večkrat, se lahko prepolovi ali razpade.