natgillin/translations-raw huggingface dataset:
Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
40 Imetnik dovoljenja za promet z zdravilom Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Velika Britanija
40 Manufacturer Novartis Pharmaceuticals UK, Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Novartis Pharmaceuticals UK, Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Velika Britanija
42 Annex:
42 Dodatek:
The following instructions are intended to explain how to prepare Extavia for administration and how to inject Extavia yourself.
Naslednja navodila pojasnjujejo, kako zdravilo Extavia pripravite za uporabo in kako si ga sami injicirate.
Your doctor or his/her assistant will help you to learn the process of self-administration.
Zdravnik ali njegovo osebje vas bodo naučili postopka samoinjiciranja.
P ART I:
DEL I:
A) General advice B) Getting ready to inject C) Reconstituting the solution, step by step D) Drawing up the injection E) Making the injection manually (to make an injection with an auto-injector, refer to the instructions for use provided with the auto-injector) F) Quick review of the process
A) Splošni nasveti B) Priprava na injiciranje C) Rekonstitucija raztopine po korakih D) Izvlek količine za injiciranje E) Priprava klasične injekcije z brizgo (za injiciranje z avtoinjektorjem glejte navodila za uporabo, ki so priložena avtoinjektorju) F) Kratek pregled postopka
- Set up a permanent storage area in a convenient location out of the reach of children so that
- Izberite trajno, primerno, otrokom nedostopno mesto, kjer boste imeli zdravilo Extavia in druge
your Extavia and other supplies are always easy to find.
pripomočke vedno pri roki.
For details on storage conditions see section 5 of the leaflet, “How to store Extavia”.
Shranjevanje zdravila Extavia v Navodilu za uporabo.
This makes it easier to remember
Tako si lažje zapomnite in načrtujete
and easier to plan a block of time when you will not be interrupted.
čas, ko ne želite, da vas med injiciranjem kdo prekine.
After mixing Extavia, you should
Ko zmešate zdravilo Extavia, ga
administer the injection immediately (if Extavia is not used immediately, see section 5 of the leaflet, “How to store Extavia”).
Shranjevanje zdravila Extavia v Navodilu za uporabo).
- Be consistent - use Extavia as described in section 3 of the leaflet, “How to use Extavia”.
Kako uporabljati
Always double -check your dosage.
Vedno dvakrat preverite svoj odmerek.
- Keep your syringes and syringe disposal unit out of the reach of children; lock the supplies if
- Brizge in posode za odstranjevanje brizg hranite zunaj dosega otrok; če je mogoče, hranite
possible.
potrebščine zaklenjene.
43 B) Getting ready to inject
B) Priprava na injiciranje
You should inject Extavia into the fatty layer between the skin and muscle (that is, subcutaneously, about 8 to 12 mm under the skin).
Zdravilo Extavia injicirajte v maščobno plast med kožo in mišico (to je subkutano, približno 8 do 12 mm pod kožo).
The best places for injections are where the skin is loose and soft, and away from joints, nerves, bones, for example the abdomen, arm, thigh or buttocks.
Najboljše mesto za injiciranje je predel, kjer je koža mlahava in mehka, proč od sklepov, živcev in kosti, na primer trebuh, roka, stegno ali zadnjica.
Important:
43 Pomembno:
Follow the sequence described in the schedule at the end of the Annex (see II) Rotating injection sites) and you will come back to your first injection site area after 8 injections (16 days).
Na prvo mesto injiciranja se boste vrnili po 8 injekcijah (16 dni).
An example of a medication record is also included.
Priložen je primer zapisovanja dajanja zdravila.
1 Extavia vial (with powder for solution for injection) 1 pre-filled syringe of solvent for Extavia (sodium chloride solution (0.54% (w/v))
Potrebujete zdravilo: • 1 vialo zdravila Extavia (s praškom za raztopino za injiciranje) • 1 napolnjeno injekcijsko brizgo z vehiklom za zdravilo Extavia (0, 54- odstotna raztopina natrijevega klorida (m/ v))
a needle suitable for reconstitution 30-gauge needle (for manual injection) OR a 27-gauge needle (for use with an auto- injector)
Za rekonstitucijo in injiciranje zdravila potrebujete naslednje pripomočke: • iglo, ki je primerna za rekonstitucijo zdravila • iglo velikosti 30 (za klasično injiciranje z brizgo) ALI iglo velikosti 27 (za uporabo z avtoinjektorjem) • alkoholne blazinice Potrebovali boste tudi posodo za odstranjevanje uporabljenih brizg in igel.
Alternatively, you can use an Extavia Application Kit (supplied separately from your medicine), which contains a vial adapter for reconstituting your medicine, needles for injecting your medicine, alcohol wipes and a disposal unit for used needles, as well as instructions on how to use these components.
Namesto navedenega lahko uporabite tudi komplet za pripravo in uporabo zdravila Extavia (ni priložen zdravilu, lahko ga dobite ločeno), ki vsebuje adapter z iglo za vialo za rekonstitucijo zdravila, igle za injiciranje zdravila, alkoholne blazinice, posodo za odstranjevanje uporabljenih igel in navodila za uporabo teh pripomočkov.
2 - Open the Extavia vial and put it on the table.
2 - Odprite vialo z zdravilom Extavia in jo položite na mizo.
3 - Clean the top of the vial with an alcohol wipe, moving the wipe in one direction only.
Vialo brišite samo v eni smeri.
4 – Take out the pre-filled solvent syringe from its package.
4 - Brizgo, napolnjeno z vehiklom, vzemite iz ovojnine.
44 5 - Take the needle suitable for reconstitution out of its wrapping and place it firmly onto the tip (nozzle) of the syringe.
5 - Odstranite ovojnino z igle, ki je primerna za rekonstitucijo in jo čvrsto pritrdite na konico (nastavek) brizge.
6 - Holding the Extavia vial on a stable surface, slowly insert the needle of the syringe (containing 1.2 ml of liquid) all the way through the stopper of the vial.
6 - V vialo z zdravilom Extavia na čvrsti podlagi počasi vstavite iglo brizge (ki vsebuje 1, 2 ml tekočine) skozi zamašek viale.
Injecting solvent directly onto the powder will cause excess foaming.
44 Injiciranje vehikla neposredno na prašek bo povzročilo čezmerno penjenje.
Transfer all the solvent to the vial.
Ves vehikel prenesite v vialo.
8 - After the solvent in the syringe has been completely injected into the Extavia vial, hold the vial between your thumb, forefinger and middle finger with the needle and syringe resting against your hand and swirl the vial gently to completely dissolve the powder of Extavia.
8 - Ko je v viali z zdravilom Extavia ves vehikel iz brizge, vialo primite s palcem, kazalcem in sredincem tako, da sta igla in brizga naslonjeni na vašo roko, in nežno obračajte vialo, da se prašek zdravila Extavia povsem raztopi.
If foam is present –- which can happen if the vial is shaken or swirled too vigorously – let the vial sit undisturbed until the foam settles.
Če je v viali pena, kar se lahko zgodi, če jo premočno pretresete ali zavrtite, pustite vialo mirovati, da se pena usede.
D) Drawing up the solution for injection
D) Izvlek raztopine za injiciranje
10 - In order to redraw the solution back into the syringe, turn the syringe-vial-assembly, needle pointing upwards.
10 - Raztopino povlecite nazaj v brizgo tako, da obrnete sestavo brizge in viale z iglo usmerjeno navzgor.
11 - Any excessive air rises to the top of the solution.
11 - Ves odvečni zrak se povzpne na površje raztopine.
Remove the air bubbles by gently tapping the syringe and pushing the plunger to the 1 ml mark, or to the volume prescribed by your doctor.
Zračne mehurčke odstranite tako, da nežno potrkate po brizgi bat pa potisnete do oznake za 1 ml, oziroma do prostornine, ki vam jo je predpisal zdravnik.
OR
13 - Odstranite ovojnino z igle velikosti 30 (če injicirate z brizgo brez uporabe avtoinjektorja) in jo čvrsto pritrdite na konico (nastavek) brizge ALI
- Take the 27-gauge needle (if you are injecting using an auto-injector), take it out of its wrapping
- odstranite ovojnino z igle velikosti 27 (če injicirate z avtoinjektorjem) in jo čvrsto pritrdite na
and place it firmly onto the tip (nozzle) of the syringe.
konico (nastavek) brizge.
45 15 - You are now ready to inject.
15 - Sedaj ste pripravljeni na injiciranje.
If, for some reason, you are not able to inject Extavia immediately, you can keep the reconstituted solution in the syringe in a refrigerator for up to 3 hours before using.
Če si zaradi kakršnegakoli razloga zdravila Extavia ne morete vbrizgati takoj, lahko rekonstituirano raztopino v brizgi do 3 ure hranite v hladilniku.
E) Making the injection manually (to make an injection with an auto-injector, refer to the instructions for use provided with the auto-injector)
45 E) Klasično injiciranje z brizgo (za injiciranje z avtoinjektorjem glejte navodila za uporabo, ki so priložena avtoinjektorju)
1 - Choose an area for the injection (see advice at the start and the diagrams at the end of this Annex), and make a note of it in your medication record.
1 - Izberite mesto injiciranja (glejte nasvet na začetku in v diagramih ob koncu tega Dodatka) in dogodek zabeležite v kartici uporabe zdravila.
3 - Remove the cap from the needle by pulling and not twisting it.
Pokrov povlecite in ga ne upogibajte.
6 - Inject the medicine using a slow, steady push on the plunger.
6 - S počasnim, enakomernim potiskom na bat injicirajte zdravilo.
7 - Discard the syringe in the disposal unit.
7 - Brizgo zavrzite v posodo za odstranjevanje.
46 F) Quick review of the process
F) Kratek pregled postopka
Take out the contents needed (1 vial, 1 pre-filled syringe, 2 alcohol wipes, needle suitable for reconstitution, 30-gauge needle (for use for manual injection) OR 27-gauge needle (for use with an auto-injector)).
Pripravite potrebne pripomočke (1 vialo, 1 napolnjeno brizgo, 2 alkoholna robčka, iglo, ki je primerna za rekonstitucijo, iglo velikosti 30 (za klasično injekcijo z brizgo) ALI iglo velikosti 27 (za uporabo z avtoinjektorjem)).
Take off the cap from the vial and clean the rubber stopper with an alcohol wipe.
Z viale odstranite pokrov in očistite gumijasti zamašek z alkoholnim robčkom.
Unwrap the needle suitable for reconstitution and fix it to the syringe from which you removed the tip cap before.
Odvijte iglo, ki je primerna za rekonstitucijo, in jo pritrdite na brizgo, s konice katere ste pred tem sneli pokrov.
Transfer the solvent from the syringe to the vial by pushing the plunger in all the way.
Vehikel iz brizge prenesite v vialo tako, da pritisnete bat do konca.
Turn the syringe-vial-assembly over, then withdraw plunger to redraw the solution.
Sestavo brizge in viale obrnite navzgor, in izvlecite bat, da izvlečete raztopino.
Unwrap the 30-gauge needle (for use for manual injection) OR 27-gauge needle (for use with an auto-injector) and connect it to the syringe.
Odvijte iglo velikosti 30 (za klasično injekcijo z brizgo) ALI iglo velikosti 27 (za uporabo z avtoinjektorjem) in jo nataknite na brizgo.
47 PART II:
46 DEL II:
On our example schedule each area is split again into 6 injection sites (which adds up to 48 injection sites altogether), left, right, upper, middle and lower part of each area.
V našem primeru je vsak predel razdeljen na 6 mest injiciranja (kar skupno tvori 48 mest injiciranja): na zgornji, srednji in spodnji del na levi in desni strani.
Rotation Schedule To help you rotate the injection sites appropriately we recommend that you keep a record of the date and location of your injection.
Načrt izmeničnega injiciranja Da bi ustrezno rotirali mesta injiciranja, priporočamo, da si datum in mesto zapišete.
Rotation Cycle 4 Rotation Cycle 5:
Rotacijski cikel 5:
Upper left section of each area Lower right section of each area Middle left section of each area Upper right section of each area Lower left section of each area Middle right section of each area
Zgornji levi del vsakega predela Spodnji desni del vsakega predela Srednji levi del vsakega predela Zgornji desni del vsakega predela Spodnji levi del vsakega predela Srednji desni del vsakega predela
48 PART III:
47 DEL III:
EXTAVIA Medication record
Kartica o uporabi zdravila EXTAVIA
− Start with your first injection (or your last injection if you are not a new Extavia user).
- Začnite s prvo injekcijo (ali zadnjo injekcijo, če niste novi uporabnik zdravila Extavia).
− Select an injection site.
- Izberite mesta injiciranja.
If you have already been using Extavia start with the area that has not been used during the last rotation cycle, i.e. the past 16 days).
zadnjem rotacijskem ciklusu, tj. zadnjih 16 dni, niste uporabili.
− After your injection, fill in the used injection site and date in the table in your injection record (See the example:
- Po injekciji v tabelo v kartici vpišite datum in mesto injiciranja, ki ste ga uporabili (glejte
Keeping track of your injection sites and dates).
Zapisovanje mest injiciranja in datumov).
49 ROTATION SCHEDULE:
10– 15 cm od rame
AREA 1
PREDEL 1.
AREA 2
komolca
10 – 15 cm from groin
PREDEL
AREA 7
Leva roka
ed EPAR summary for the public
et Povzetek EPAR za javnost
ris This document is a summary of the European Public Assessment Report (EPAR).
om Ta dokument je povzetek Evropskega javnega poročila o oceni zdravila (EPAR).
It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to
Pojasnjuje, kako
ho reach their recommendations on how to use the medicine.
pr je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene raziskave, na podlagi česar je oblikoval priporočila glede uporabe zdravila.
If you need more information about your medical condition or your treatment, read the Package
Če potrebujete več informacij o vašem zdravstvenem stanju ali zdravljenju, preberite Navodila za
ut Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
za uporabo (ki so prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
Če želite več informacij o podlagi za priporočila CHMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
ra of the EPAR).
Kaj je zdravilo Exubera?
What is Exubera? ge Exubera is a fast-acting insulin powder for inhalation (breathing in).
Exubera je hitrodelujoči insulin v obliki praška za inhaliranje (vdihovanje).
Exubera contains 1 mg or 3 mg of the active substance human insulin. n lo What is Exubera used for?
Exubera vsebuje 1 mg ali 3 mg zdravilne učinkovine humanega insulina. vo Za kaj se zdravilo Exubera uporablja?
Exubera is an insulin used for the treatment of adults with type 2 diabetes, when it is not properly o
Exubera je insulin, ki ga uporabljamo za zdravljenje odraslih bolnikov s sladkorno boleznijo tipa 2, do
controlled with anti-diabetes tablets.
kadar ta ni ustrezno nadzorovana z uporabo antidiabetičnih tablet.
Exubera can also be used for certain adults with type 1 diabetes, tn
Zdravilo Exubera lahko uporabljamo tudi za določene odrasle bolnike s sladkorno boleznijo tipa 1, za katere je lahko ob upoštevanju možnih tveganj, koristna zamenjava hitrodelujočega insulina, ki se injicira pod kožo, s ā
who can benefit from replacing fast-acting subcutaneous insulin by this inhaled insulin, taking into account the potential risks.
tem insulinom, ki se vdihava.
The medicine can only be obtained with a prescription. uc
Zdravilo se dobi samo na recept. ve
How is Exubera used? od
Kako se zdravilo Exubera uporablja?
Exubera is used only with its insulin inhaler.
praška in je pakiran v pretisnem omotu.
The insulin is contained as a powder in a blister.
prek ust vdihne v pljuča.
To take a dose, the patient places the blister in the inhaler, and inhales it through the mouth into the lungs. pr
Pred začetkom uporabe zdravila Exubera mora bolniku zdravnik ali medicinska sestra razložiti, kako pravilno uporabljati inhalator, da se zmanjša tveganje in zagotovi, da ni
Before starting Exubera, a doctor or a nurse must explain to the patient how to use the inhaler properly to minimise risk and ensure that the patient gets the best benefit from their treatment.
Zdravnik za vsakega bolnika določi začetni odmerek, časovni razpored odmerkov ter načrt prilagajanja le- teh.
This al
Ta je odvisen od bolnikovega odziva in potreb (kot so prehrana, lo
depends on the patient’ s response and requirements (e. g. diet, physical activity and life-style).
telesna dejavnost in življenjski stil).
A 1 mg unit dose blister gives about the same in
Pretisni omot z odmerkom 1 mg zagotovi enak odmerek kot podkožno injiciranje 3 ME hitrodelujočega vi
dose as an injection of 3 IU of fast-acting subcutaneous insulin and a 3 mg unit dose blister about the same as 8 IU of fast-acting subcutaneous insulin.
insulina, pretisni omot z odmerkom 3 mg zagotovi približno tak odmerek kot podkožno injiciranje 8 ME hitrodelujočega insulina.
So Exubera is not suitable when small (less than 3 ic
Zato zdravilo Exubera ni primerno, kadar so potrebna majhna (manj kot ra
IU) adjustments of insulin are necessary (for example in patient with low body weight). ed
Zd
Diabetes is a disease in which the body does not produce enough insulin to control the level of blood M
Sladkorna bolezen je bolezen, pri kateri telo ne izdeluje dovolj insulina, da bi obvladovalo raven krvnega sladkorja.
The insulin in Exubera is produced by a method known as ‘ recombinant DNA technology ’ which means that the insulin is made by a bacterium which has received a gene (DNA) that makes it able to produce the insulin.
Insulin v zdravilu Exubera je izdelan z metodo, imenovano ‘ tehnologija rekombinantne DNA ’, kar pomeni, da insulin izdeluje bakterija, ki je prejela gen (DNA), ki ji omogoča izdelovanje insulina.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Exubera deluje 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 85 45 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Exubera been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 85 45 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged pri sladkorni bolezni tipa 1, ko trebušna slinavka ne more izdelati dovolj insulina, in pri sladkorni bolezni tipa 2, ko telo ni zmožno učinkovito uporabljati insulina.
What benefit has Exubera shown during the studies?
et Kakšne koristi je zdravilo Exubera izkazalo med raziskavami?
Overall, in studies in type 1 and type 2 diabetes, Exubera gave similar blood glucose control to that
om V splošnem je v raziskavah sladkorne bolezni tipa 1 in 2 zdravilo Exubera omogočalo podoben nadzor ravni krvnega sladkorja, kot ga daje hitrodelujoči podkožni humani insulin.
ris The most common side effects of Exubera are hypoglycaemia (low blood glucose) and cough.
pr Najpogostejša neželena učinka zdravila Exubera sta hipoglikemija (nizka raven glukoze v krvi) in kašelj.
If a patient smokes, the amount of insulin that is absorbed from the lungs greatly increases and this may
Če bolnik kadi, se količina insulina, ki se absorbira iz pljuč, močno poveča, kar lahko poveča
ho increase the risk of hypoglycaemia.
za nevarnost za hipoglikemijo.
Three
Namesto enega 3 mg odmerka ne smemo uporabiti treh
ut 1 mg doses should not be used instead of one 3 mg dose because this gives a higher insulin dose and may increase the risk of hypoglycaemia.
a odmerkov po 1 mg, ker to pomeni višji odmerek insulina in lahko poveča nevarnost za hipoglikemijo.
For the full description of the side effects reported with
nj Celovit opis možnih neželenih učinkov, o katerih so poročali pri uporabi zdravila Exubera, najdete v Navodilih za uporabo.
ra Exubera, please see the package leaflet.
V raziskavah je Exubera pokazala majhen negativni učinek na pljučno funkcijo, ki lahko po prenehanju uporabe zdravila Exubera izzveni.
During the studies, Exubera showed a small negative effect on lung function that may disappear when
Če bolnik že ima pljučno obolenje, ni jasno, kako vo uporaba zdravila Exubera vpliva na pljuča ali kako pljučna bolezen vpliva na vnos insulina iz pljuč.
If a patient already has lung disease, it is not clear how the use of Exubera affects their lungs or how the lung disease affects the intake of insulin from the lungs.
Bolniki s slabo ali nestabilno pljučno funkcijo, denimo, z astmo, emfizemom ali kroničnim bronhitisom, zdravila Exubera ne smejo uporabljati. do
Patients with poor or unstable lung function, such as asthma, emphysema or chronic bronchitis, should not use Exubera. n Exubera should not be used in people who may be hypersensitive (allergic) to human insulin or any of lo the other ingredients. o
Zdravila Exubera ne smejo uporabljati ljudje, ki utegnejo biti preobčutljivi za (alergični na) humani insulin ali na katero od drugih sestavin. ā
Why has Exubera been approved?
Zakaj je bilo zdravilo Exubera odobreno? ve
greater than its risks in certain adult patients with diabetes when used as described in the Product information, and recommended that Exubera be given marketing authorisation. uc
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da koristi zdravila Exubera presegajo njena tveganja pri določenih odraslih bolnikih s sladkorno boleznijo ob uporabi, kot je opisano v Navodilu za uporabo, zato priporoča odobritev dovoljenja za promet z zdravilom Exubera. a
What are the measures to minimise the risk associated with Exubera? od
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Exubera? m
The company that makes Exubera will carry out studies to further test its safety, particularly in patients who might have an increased risk of side effects, such as patients with asthma or chronic obstructive pulmonary disease.
Podjetje, ki izdeluje zdravilo Exubera, bo opravilo raziskave za nadaljnje preskušanje njene varnosti, zlasti pri bolnikih, ki bi lahko imeli povečano tveganje za neželene učinke, kot so bolniki z astmo ali ni
that are produced in response to treatment with Exubera).
kronično obstruktivno pljučno boleznijo.
The company will also monitor side effects, provide educational material, and improve the design of the blister packs so that it is easier to tell the difference between the 1 mg and 3 mg doses. al in
neželene učinke, priskrbelo izobraževalno gradivo in izboljšalo zasnovo pretisnih omotov, da bo lažje razlikovati med odmerki po 1 mg in 3 mg. vi
Other information about Exubera:
Druge informacije o zdravilu Exubera: ra
for Exubera on 24 January 2006.
Evropska komisija je dovoljenje za promet z zdravilom Exubera, veljavno po vsej Evropski uniji, odobrila dne 24. januarja 2006.
The marketing authorisation holder is Pfizer Limited. ed
Zd
M
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Exubera je na voljo tukaj.
This summary was last updated in 08-2006
Ta povzetek je bil nazadnje posodobljen 08- 2006.
EU Number EU/ 1/ 05/ 327/ 001
om EU/ 1/ 05/ 327/ 001
Pharmaceutical Form Inhalation powder, pre-
Prašek za inhaliranje, odmerjen
Route of Administration Inhalation use
Za inhaliranje
Package size 30 x 1 blisters (1 pouch)
Enoodmerni pretisni omot za predrtje (PVC/ Alu)
blister (PVC/ Alu)
30 x 1 pretisni omot (vrečka)
Inhalation powder, pre- dispensed
Prašek za inhaliranje,
perforated unit dose blister (PVC/ Alu)
(PVC/ Alu)
60 x 1 blisters (2 pouches)
(2 vrečki)
90 x 1 blisters (3 pouches)
(3 vrečke)
ho EU/ 1/ 05/ 327/ 004
EU/ 1/ 05/ 327/ 004
Inhalation powder, pre- dispensed
Prašek za inhaliranje, odmerjen
perforated unit dose blister (PVC/ Alu)
Enoodmerni pretisni omot za predrtje (PVC/ Alu)
180 x 1 blisters (6 pouches)
180 x 1 pretisni omot (6 vrečk)
EU/ 1/ 05/ 327/ 005
a EU/ 1/ 05/ 327/ 005
Inhalation powder, pre-
Prašek za inhaliranje, odmerjen
270 x 1 blisters (9 pouches)
Enoodmerni pretisni omot za predrtje (PVC/ Alu)
blister (PVC/ Alu)
270 x 1 pretisni omot (9 vrečk)
EU/ 1/ 05/ 327/ 006
nj EU/ 1/ 05/ 327/ 006
ra
lje
blister (PVC/ Alu)
(PVC/ Alu)
2 IRUs
(4 vrečke) + 2 IRUs
270 x 1 blisters (9 pouches) + 6 IRUs
(9 vrečk) + 6 IRUs
ge EU/ 1/ 05/ 327/ 008
do EU/ 1/ 05/ 327/ 008