natgillin/translations-raw huggingface dataset:
Saturated sodium chloride solution (SSCS)1 (1 See section 1.) below) 4.
Dva generatorja za razvijanje s pokrovi Nasičena raztopina natrijevega klorida (SSCS) 1 (1 Glejte točko 1.) spodaj) 3.
One 1 ml syringe and 21-gauge needle 6.
Eno 1 ml injekcijsko brizgo in 21 gauge iglo 6.
8 1) Saturated sodium chloride solution (SSCS) May be prepared by adding about five grams of sodium chloride to the bottom of one chromatography chamber; add approximately 10 millilitres of distilled water to the solid sodium chloride and shake periodically during 10 to 15 minutes.
1) Nasičena raztopina natrijevega klorida (SSCS) Pripravi se jo lahko z dodajanjem 5 gramov natrijevega klorida na dno ene od kromatografskih komor; trdnemu natrijevemu kloridu dodajte približno 10 mililitrov destilirane vode in periodično stresajte 10 do 15 minut.
2) 1:1 Methanol / 1M Ammonium Acetate (MAM) 1M Ammonium Acetate - Add 3.9 ± 0.1 grams of solid ammonium acetate to a 50 ml volumetric flask.
2.) 1: 1 metanol/ 1M amonijev acetat (MAM) 1M amonijev acetat – dodajte 3, 9 ± 0, 1 grama trdnega amonijevega acetate v 50 ml graduirano bučko.
1:1 Methanol / 1M Ammonium Acetate (MAM) - Carefully mix one part methanol with one part 1M Ammonium Acetate.
1: 1 metanol/ 1M amonijev acetate (MAM) – Previdno pomešajte en del metanola z enim delom 1M amonijevega acetate.
Pour the MAM and SSCS into separate developing tanks to a depth of approximately 0.5 cm.
Natočite MAM in SSCD v dva ločena generatorja za razvijanje do globine približno 0, 5 cm.
Mark two Gelman ITLC-SG strips with a light pencil at 1 cm from the bottoms of each.
Dva Gelman ITLC- SG trakova označite s svetlim svinčnikom 1 cm od kraja.
Spot one drop (approximately 5-10 microlitres) of 99mTc-depreotide at the origin of each strip using the hypodermic needle.
Kanite kapljico (približno 5- 10 mikrolitrov) 99mTc- depreotida na začetek vsakega traku z 3. uporabo hipodermične igle.
CAUTION:
Pazite, da se nanešene kapljice ne posušijo.
Do not allow the needle to touch the strip.
OPOZORILO: z iglo se ne smete dotakniti traku.
Place one ITLC-SG strip in the MAM developing solvent.
Postavite eden ITLC- SG trak v MAM topilo, ki se razvija.
Place the second ITLC-SG strip in the SSCS developing solvent.
Postavite drugi ITLC- SG trak v SSCS topilo, ki se razvija.
Do not allow the sides of the strip to contact the side of the tank.
Pazite, da se robovi traku ne dotaknejo stranic generatorja.
Percent technetium-99m non-mobile material = A
Odstotni delež tehnecija- 99m nemobilna faza = A
Radioactivity in bottom piece of ITLC-SG MAM strip (Rf 0-0.40) A = 100 x ---------------------------------------------------------------------------------- Total radioactivity in both pieces of ITLC-SG MAM strip
radioaktivnost spodnjega kosa ITLC- SG MAM traku (Rf 0- 0, 40) A = 100 x ------------------------------------------------------------------------------- Celotna radioaktivnost obeh kosov ITLC- SG MAM traku
Percent technetium (99mTc) pertechnetate, technetium-99m labelled glucoheptonate and technetium-99m labelled edetate = B
Odstotni delež tehnecijevega (99mTc) pertehnetata, s tehnecijem- 99m označenega glukoheptonata in s tehnecijem- 99m označenega edetata = B
Radioactivity in top piece of ITLC-SG SSCS strip (Rf 0.75-1.0) B = 100 x ------------------------------------------------------------------------------ Total radioactivity in both pieces of ITLC-SG SSCS Strip
9 radioaktivnost zgornjega kosa ITLC- SG SSCS traku (Rf 0, 75 – 1, 0) A = 100 x ------------------------------------------------------------------------------------ Celotna radioaktivnost obeh kosov ITLC- SG SSCS traku
Percent 99mTc-depreotide:
Odstotni delež 99mTc- depreotida:
100 - (A + B).
100 – (A+B).
9 Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
CONDITIONS OF THE MARKETING AUTHORISATION
POGOJI ZA DOVOLJENJE ZA PROMET Z ZDRAVILOM
NeoSpect 47 micrograms, kit for radiopharmaceutical preparation
NeoSpect 47 mikrogramov, komplet za pripravo radiofarmaka
47 micrograms depreotide as depreotide trifluoroacetate
47 mikrogramov depreotida v obliki depreotidnega trifluoroacetata
Sodium α -D-glucoheptonate dihydrate, stannous chloride dihydrate, disodium edetate, hydrochloric acid and/ or sodium hydroxide q. s.
Natrijev α- D- glukoheptonat dihidrat, kositrov (II) klorid dihidrat, dinatrijev edetat, klorovodikova kislina in/ ali natrijev hidroksid q. s.
1 vial 5 vials
5 vial.
EXPIRY DATE
DATUMJ IZTEKA ROKA UPORABNOSTI ZDRAVILA
Store in a freezer at or below – 10 °C.
Shranjujte v zmrzovalniku pri ali pod - 10˚C.
After reconstitution, store at 15 °C – 25 °C and use within 5 hours.
Po rekonstituciji, shranjujte pri temperaturi med 15˚C – in 25˚C in uporabite v manj kot 5 urah.
NeoSpect 47 micrograms, kit for radiopharmaceutical preparation Depreotide Intravenous use
NeoSpect 47 mikrogramov, komplet za pripravo radiofarmaka Depreotid Za intravensko uporabo.
You may need to read it again.
Natančno preberite to navodilo za uporabo.
- If you have any further questions, ask your doctor.
Vsebuje podatke o vašem zdravilu. • Navodilo shranite.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Morda ga boste želeli ponovno prebrati. • Če imate dodatna vprašanja, se posvetujte z zdravnikom. • Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
2.
Kaj je zdravilo NeoSpect in za kaj ga uporabljamo 2.
3.
Kaj morate vedeti, preden boste uporabili zdravilo NeoSpect 3.
4.
Kako uporabljati zdravilo Neospect 4.
6.
Shranjevanje zdravila NeoSpect 6.
WHAT NeoSpect IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO NeoSpect IN ZA KAJ GA UPORABLJAMO
Product type NeoSpect is a radiopharmaceutical product used for diagnostic purposes.
Vrsta zdravila NeoSpect je radiofarmacevtski izdelek, ki se uporablja za diagnostične namene.
A diagnostic radiopharmaceutical is a product which, when injected, temporarily collects in a particular part of the body (for example a tumour).
Diagnostični radiofarmacevtski izdelek je izdelek, ki se po injiciranju začasno nakopiči v določenem delu telesa (n. pr. v tumorju).
What NeoSpect is used for NeoSpect is for diagnostic use only.
Za kaj uporabljamo NeoSpect NeoSpect je samo za diagnostične namene.
BEFORE YOU USE NeoSpect
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO NeoSpect
Do not use NeoSpect
Ne uporabljajte zdravila NeoSpect 1.
- if you are allergic (hypersensitive) to depreotide or any of the other ingredients of NeoSpect or
2.
- if there is any possibility that you are pregnant.
3.
- if you are breast-feeding.
Če dojite.
Take special care with NeoSpect
Bodite posebno pozorni pri uporabi zdravila NeoSpect 1.
- if you are suffering from diabetes or other related conditions
Če imate sladkorno bolezen ali druga z njo povezana stanja 2.
- if you have a renal disease
Če imate ledvično bolezen 3.
- if you have a liver disease
Če imate jetrno bolezen
NeoSpect is not recommended for use in children under 18 years of age, as data are not available for this age group.
NeoSpect se ne priporoča za uporabo pri otrocih mlajših od 18 let, ker za to starostno skupino ni
19 The use of NeoSpect does involve exposure to small amounts of radioactivity, however your doctor will always consider the possible risks and benefits when considering the use of this product.
19 podatkov.
Taking other medicines There is only limited data available regarding interactions with other products.
O medsebojnem delovanju z drugimi zdravili so na voljo le omejeni podatki.
Pregnancy and breast-feeding You should tell your doctor if there is any possibility that you are pregnant, or if you are breast- feeding.
Nosečnost in dojenje Zdravnika morate obvestiti, če obstaja kakršnakoli možnost, da ste noseči ali če dojite.
Driving and using machines No studies on the effects on the ability to drive and use machines have been performed.
Vpliv na sposobnost upravljanja vozil in uporabo strojev Študije o vplivu na sposobnost za vožnjo in upravljanje strojev niso bile opravljene.
HOW TO USE NeoSpect
KAKO UPORABLJATI ZDRAVILO Neospect 3.
Dosage and administration
Odmerjanje in način uporabe
The recommended dosage is one vial (approximately 47 micrograms of depreotide) labelled with 555-740 MBq of technetium-99m.
Priporočeno odmerjanje je ena viala (približno 47 mikrogramov depreotida) označena s 555– 740 MBq tehnecija- 99m.
The scanning may take place 2-4 hours after injection of NeoSpect.
Slikanje (skeniranje) je lahko 2- 4 ure po injekciji NeoSpecta.
Any 99mTc-depreotide which remains in your body, will naturally lose its radioactivity within 2-3 days.
Ves v telesu preostali 99mTc - depreotid, bo izgubil svojo radioaktivnost po naravni poti v 2- 3 dneh.
Overdose If overdose is suspected, symptomatic treatment will be administered.
Preveliko odmerjanje Kadar se sumi na prevelik odmerek, se uvede simptomatsko zdravljenje.
20 Most of the side effects reported were transient and of mild intensity.
20 Najpogosteje so poročali o:
*
* *
headache *
glavobolu bruhanju
* headache *
* *
nausea
slabosti driski
vomiting * dia
trebušni bolečini
* vomiting *
*
diarrhoea
omotici
dizziness
rdečici
* flushing *
utrujenosti
What NeoSpect contains
Kaj vsebuje zdravilo NeoSpect
- The other ingredients are sodium glucoheptonate dihydrate, stannous chloride dihydrate,
- Druge sestavine so natrijev α- D- glukoheptonat dihidrat, kositrov (II) klorid dihidrat, dinatrijev
disodium edetate and hydrochloric acid and/ or sodium hydroxide to adjust pH.
edetat, klorovodikova kislina in/ ali natrijev hidroksid za uravnavanje pH.
When a solution of the radioactive substance sodium pertechnetate (99mTc) is added to the vial, 99mTc-depreotide is formed.
Ko v vialo dodamo raztopino radioaktivne spojine natrijevega pertehnetata (99mTc), nastane 99mTc- depreotid.
21 Manufacturer responsible for batch release:
Izdelovalec odgovoren za sproščanje serij:
is the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
o je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene študije, na podlagi
er What is Nespo?
Kaj je zdravilo Nespo?
It contains the active ng substance darbepoetin alfa.
Vsebuje zdravilno učinkovino darbepoetin alfa.
See the Package Leaflet for full details. lo
Za več informacij glejte Navodilo za vo
What is Nespo used for? no
uporabo. do
Nespo is used to treat anaemia (fewer red blood cells in the blood than normal) in two groups of patients: • adults and children over one year of age with anaemia caused by long-term kidney failure, when ct
Zdravilo Nespo se uporablja za zdravljenje anemije (v krvi je manj eritrocitov kot normalno) pri dveh skupinah bolnikov: ā
the body does not produce enough of the natural hormone erythropoietin, du
• odraslih in otrocih, starih več kot eno leto, z anemijo, ki je nastala zaradi dolgotrajne ledvične ve
• adult patients with certain types of cancer who are receiving chemotherapy (the medicines used to treat cancer), when the chemotherapy stops the bone marrow producing enough blood cells.
odpovedi, kadar telo ne tvori dovolj naravnega hormona eritropoetina. • odraslih z določeno vrsto raka, ki prejemajo kemoterapijo (zdravila za zdravljenje raka), ko kemoterapija prepreči zadostno proizvodnjo krvnih celic v kostnem mozgu.
The ro
Zdravilo Nespo se a
types of cancer where Nespo can be used are ‘ non-myeloid’ (do not affect the bone marrow).
lahko uporablja za „ nemieloidne “ vrste rake (tiste, ki ne prizadenejo kostnega mozga).
The medicine can only be obtained with a prescription. lp
Zdravilo se dobi samo na recept. m ni
How is Nespo used? a
Kako se zdravilo Nespo uporablja?
Nespo treatment should be initiated by a doctor who has experience in treating either of the two types in
Zdravljenje z zdravilom Nespo mora uvesti zdravnik, ki ima izkušnje z zdravljenjem katere koli izmed zgoraj navedenih anemij.
Nespo is injected intravenously (into a vein) or subcutaneously (under the skin).
Zdravilo Nespo se vbrizga intravensko (v žilo) ali subkutano (pod kožo). ilo
every week (or 0.75 micrograms/ kg every other week) in adults and children with kidney failure aged ed
Uporabljeni odmerek je odvisen od namena uporabe zdravila Nespo in znaša od 0, 45 mikrogramov na kilogram vsak teden (ali 0, 75 mikrogramov/ kg vsak drugi teden) pri ledvični odpovedi pri odraslih in v
11 years or older, to 6.75 micrograms/ kg every three weeks in cancer patients.
Pri otrocih ra
Lower doses may be necessary for children with kidney failure aged 10 years or below.
z ledvično odpovedjo, starih 10 let ali manj, bo morda potrebno uporabiti nižje odmerke.
Haemoglobin is the protein in M
V vseh primerih so odmerki prilagojeni tako, da vzdržujejo koncentracijo hemoglobina v priporočljivih Zd
red blood cells that carries oxygen around the body.
Hemoglobin je beljakovina v rdečih krvnih celicah, ki prenaša kisik po telesu.
Darbepoetin alfa is 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Darbepoetin alfa, zdravilna učinkovina zdravila Nespo, deluje natanko tako kot naravni eritropoetin, ki ga proizvaja telo, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged produced by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes the cell able to produce darbepoetin alfa.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged vendar pa majhna razlika v njegovi strukturi pomeni, da darbepoetin alfa učinkuje dlje in se tako lahko daje manj pogosto kot naravni eritropoetin.
The effectiveness of Nespo has been studied in patients with long-term kidney disease, where it was compared with recombinant human erythropoietin in four studies involving over 1,200 patients, and in patients receiving chemotherapy for cancer such as lung cancer, myeloma or lymphoma, where it was compared with placebo (a dummy treatment) in two studies involving 669 patients.
Glavno merilo učinkovitosti pri bolnikih
The main measure of effectiveness in patients with kidney disease was the increase in haemoglobin.
o z ledvičnim obolenjem je bil porast koncentracije hemoglobina.
In patients receiving
Pri bolnikih, ki so prejemali
ed chemotherapy, the main measure of effectiveness was the reduction in number of patients who needed a blood transfusion.
pr kemoterapijo, je bilo glavno merilo učinkovitosti zmanjšanje števila bolnikov, ki so potrebovali transfuzijo krvi.
Nespo has also been studied in 124 children with long-term kidney disease to check that it is absorbed
Zdravilo Nespo so preučevali tudi pri 124 otrocih z dolgotrajnim ledvičnim obolenjem, kjer so
is in the same way as in adults.
za ugotavljali, ali se absorbira na enak način kot pri odraslih.
or What benefit has Nespo shown during the studies?
Kakšne koristi je zdravilo Nespo izkazalo med raziskavami?
th Nespo was as effective as human recombinant erythropoietin at increasing the haemoglobin levels in
a Tako pri intravenskem kot pri subkutanem dajanju je bilo zdravilo Nespo pri zviševanju koncentracije
au patients with kidney disease, and at keeping these levels maintained after they had been improved, whether given as an intravenous or subcutaneous injection.
nj hemoglobina pri bolnikih z obolenjem ledvic in pri ohranjanju dosežene koncentracije tako učinkovito kot humani rekombinantni eritropoetin.
In cancer patients receiving chemotherapy, fewer patients treated with Nespo needed a blood transfusion compared with those given placebo.
Pri bolnikih z rakom, ki so prejemali kemoterapijo, je lje transfuzijo krvi potrebovalo manj bolnikov, zdravljenih z zdravilom Nespo, v primerjavi s tistimi bolniki, ki so prejemali placebo. vo
What is the risk associated with Nespo? er ng The most common side effects with Nespo (seen in between 1 and 10 patients in 100) are headache, hypertension (high blood pressure), thrombosis (blood clots), injection site pain, arthralgia (joint pain) lo and peripheral oedema (fluid retention).
Najpogostejši neželeni učinki zdravila Nespo (opaženi pri 1 do 10 bolnikih izmed 100) so glavobol, do
For the full list of all side effects reported with Nespo, see the Package Leaflet. no
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Nespo, glejte Navodilo za uporabo. ā
Nespo should not be used in people who may be hypersensitive (allergic) to darbepoetin alfa or any of the other ingredients, or in patients who have poorly controlled high blood pressure. ct
Zdravila Nespo se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) ve
Why has Nespo been approved?
Zakaj je bilo zdravilo Nespo odobreno? m
greater than its risks for the treatment of anaemia associated with chronic renal failure in adults and paediatric patients, and of symptomatic anaemia in adult cancer patients with non-myeloid ro
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Nespo pri zdravljenju anemije, povezane s kronično odpovedjo ledvic pri odraslih in pediatričnih bolnikih, in ni
malignancies receiving chemotherapy.
simptomatske anemije pri odraslih onkoloških bolnikih z nemieloidnimi malignomi, ki prejemajo kemoterapijo, večje od z njim povezanih tveganj.
The Committee recommended that Nespo be given marketing authorisation. lp
Odbor je zato je priporočil, da se za zdravilo Nespo odobri dovoljenje za promet. ilo
Other information about Nespo: a
Druge informacije o zdravilu Nespo: v
The European Commission granted a marketing authorisation valid throughout the European Union in
Evropska komisija je dovoljenje za promet z zdravilom Nespo, veljavno po vsej Evropski uniji, ra
for Nespo to Dompé Biotec S. p. A. on 8 June 2001.
odobrila družbi Dompé Biotec S. p. A. dne 8. junija 2001.
The marketing authorisation was renewed on 8 June 2006. ic ed
Zd
M
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Nespo je na voljo tukaj.
d EU Number
et Številka EU
Packaging
Pot uporabe zdravila
Package size
Vsebnost
Administration
Velikost pakiranja
ris EU/ 1/ 01/ 184/ 001
m EU/ 1/ 01/ 184/ 001
Subcutaneous or intravenous use
Za subkutano ali
pre-filled syringe (glass)
za
0.4 ml (25 µg/ ml)
injiciranje
4 pre-filled syringes
intravensko uporabo
th EU/ 1/ 01/ 184/ 003
a EU/ 1/ 01/ 184/ 003
u
nj
syringe (glass)
injiciranje
syringe
intravensko uporabo
a EU/ 1/ 01/ 184/ 004
je ol EU/ 1/ 01/ 184/ 004
Subcutaneous or intravenous use
Za subkutano ali intravensko
r EU/ 1/ 01/ 184/ 005
do EU/ 1/ 01/ 184/ 005
Subcutaneous or
Za subkutano ali intravensko uporabo
EU/ 1/ 01/ 184/ 006
ā EU/ 1/ 01/ 184/ 006
n
ve
syringes
1 napolnjena brizga
pre-filled syringe (glass)
im
0.3 ml (100 µg/ ml)
injiciranje
1 pre-filled syringe
intravensko uporabo
EU/ 1/ 01/ 184/ 008
n EU/ 1/ 01/ 184/ 008
o
ilo
pre-filled syringe (glass)
injiciranje
0.4 ml (100 µg/ ml)
intravensko
1 pre-filled syringe
d uporabo
c EU/ 1/ 01/ 184/ 010
Z EU/ 1/ 01/ 184/ 010
du
Jakost
injection
Farmacevtska
intravenous use
Pot uporabe
syringe (glass)
Velikost pakiranja
syringes
zdravila
intravenous use
intravensko
syringe (glass)
(steklena) napolnjena brizga
syringe
0, 5 ml (100 µg/ ml)
lp
p
syringes
intravensko
EU/ 1/ 01/ 184/ 013
za uporabo EU/ 1/ 01/ 184/ 013
Nespo
ja
60 µg
injiciranje
Solution for
intravensko uporabo
Subcutaneous or
n
in
60 µg
injection
Raztopina za
intravenous use
Za subkutano ali
syringe
o uporabo
c EU/ 1/ 01/ 184/ 015
ov EU/ 1/ 01/ 184/ 015
Subcutaneous or
Za subkutano ali intravensko
injection
d uporabo
intravenous use
(steklena) napolnjena brizga
syringe
4 napolnjene brizge
ed EU/ 1/ 01/ 184/ 016
EU/ 1/ 01/ 184/ 016
pre-filled syringe (glass)
eā
0.4 ml (200 µg/ ml)
injiciranje
4 pre-filled syringes
intravensko
EU/ 1/ 01/ 184/ 017
v uporabo EU/ 1/ 01/ 184/ 017
syringe
intravensko
EU/ 1/ 01/ 184/ 018
im uporabo EU/ 1/ 01/ 184/ 018
4 pre-filled syringes d
4 napolnjene brizge
EU Number
n
Pharmaceutical
intravensko
Route of
ilo uporabo
Packaging
(steklena) napolnjena brizga
Package size
0, 3 ml (500 µg/ ml)
Administration
1 napolnjena brizga
0.3 ml (500 µg/ ml)
intravensko
1 pre-filled syringe
ra uporabo
o EU/ 1/ 01/ 184/ 020
d EU/ 1/ 01/ 184/ 020
pre-filled
Zaščiteno
0.6 ml (500 µg/ ml)
Farmacevtska
1 pre-filled
Pot uporabe
u
Ovojnina
injection
Vsebnost
intravenous use
Velikost pakiranja
syringe (glass)
oblika
syringe
zdravila
r EU/ 1/ 01/ 184/ 023
EU/ 1/ 01/ 184/ 023
vial (glass)
p
1 ml (15 µg/ ml)
injiciranje
injection
intravensko
EU/ 1/ 01/ 184/ 024
za uporabo EU/ 1/ 01/ 184/ 024
injection
(steklena) viala
intravenous use
1 ml (25 µg/ ml)
lo EU/ 1/ 01/ 184/ 025
EU/ 1/ 01/ 184/ 025
vial (glass)
injiciranje
1 ml (25 µg/ ml)
intravensko
1 vial
o uporabo
EU/ 1/ 01/ 184/ 026
ov EU/ 1/ 01/ 184/ 026
o
d uporabo
intravenous use
1 ml (40 µg/ ml)
tn EU/ 1/ 01/ 184/ 027
EU/ 1/ 01/ 184/ 027
vial (glass)
eā
1 ml (40 µg/ ml)
injiciranje
1 vial
intravensko
c EU/ 1/ 01/ 184/ 028
v uporabo EU/ 1/ 01/ 184/ 028
du
a
EU/ 1/ 01/ 184/ 029
im uporabo EU/ 1/ 01/ 184/ 029
ro
n
injection
ilo uporabo
intravenous use
(steklena) viala
vial (glass)
v
1 ml (60 µg/ ml)
injiciranje
intravenous use
ra uporabo
EU/ 1/ 01/ 184/ 031
d EU/ 1/ 01/ 184/ 031
1 ml (500 µg/ ml)
1 napolnjena brizga
1 pre-filled syringe
1 ml (500 µg/ ml)
1 ml (500 µg/ ml)
Farmacevtska
4 pre-filled
Pot uporabe
in
Ovojnina
intravenous use
(v nepretisni
syringe (non-
0, 375 ml (40 µg/ ml)
0.375 ml (40 µg/ ml)
p (v nepretisni
M blister) d EU Number
injiciranje
Package size
intravensko
ris EU/ 1/ 01/ 184/ 035
za ovojnini) uporabo EU/ 1/ 01/ 184/ 035
1 pre-filled syringe (non-
1 napolnjena brizga
o blister) EU/ 1/ 01/ 184/ 036
injiciranje
Nespo
intravensko
30 µg
nj
Solution for
uporabo
Subcutaneous or
ovojnini)
th
30 µg
syringe (glass)
lje (v nepretisni
syringe (non-
injiciranje
u blister)
o ovojnini) uporabo
a EU/ 1/ 01/ 184/ 037
ov EU/ 1/ 01/ 184/ 037
1 pre-filled syringe (non-
1 napolnjena brizga (v nepretisni
r blister)
ovojnini)
0.5 ml (100 µg/ ml)
eā (v nepretisni
1 pre-filled syringe (non-
injiciranje
n blister)
intravensko
lo EU/ 1/ 01/ 184/ 039
v ovojnini) uporabo EU/ 1/ 01/ 184/ 039
1 pre-filled syringe (non- blister)
1 napolnjena brizga
syringe (non- blister)
intravensko
c EU/ 1/ 01/ 184/ 041
(v nepretisni
Nespo
ilo
100 µg
uporabo
Solution for
ovojnini)
du
Nespo
syringe (non- blister)
ra ovojnini) uporabo
ro EU/ 1/ 01/ 184/ 042
d EU/ 1/ 01/ 184/ 042
pre-filled syringe (glass)
1 napolnjena brizga
0.3 ml (500 µg/ ml)
injiciranje
1 pre-filled syringe (non-
Velikost pakiranja
a blister)
zdravila
c
m
syringe (glass)
(v nepretisni
syringe (non-
0, 4 ml (25 µg/ ml)
i blister)
ovojnini) 1 napolnjeni
Subcutaneous use
Za subkutano
pre-filled pen (glass) (SureClick)
p injekcijski peresnik
M EU/ 1/ 01/ 184/ 046
za (SureClick) EU/ 1/ 01/ 184/ 046
pre-filled pen (glass) (SureClick)
(stekleni) napolnjeni
1 pre-filled pen d
1 napolnjeni
EU Number
ja
Invented
injiciranje
Strength
uporabo
Pharmaceutical
injekcijski peresnik (SureClick)
Package size
injekcijski peresnik
Administration
1 napolnjeni
pre-filled pen (glass)
injiciranje
0.5 ml (40 µg/ ml)
injekcijski peresnik
1 pre-filled pen
o (SureClick)
o (SureClick) EU/ 1/ 01/ 184/ 048
ov EU/ 1/ 01/ 184/ 048
pre-filled pen
(stekleni) napolnjeni injekcijski peresnik
injection
d (SureClick)
u (SureClick)
1 napolnjeni
pre-filled pen (glass)
(stekleni) napolnjeni
0.4 ml (100 µg/ ml)
eā injekcijski peresnik
1 pre-filled pen
injiciranje
r (SureClick)
injekcijski peresnik
ge EU/ 1/ 01/ 184/ 050
v (SureClick) EU/ 1/ 01/ 184/ 050
n (SureClick)
injiciranje
lo EU/ 1/ 01/ 184/ 051
im (SureClick) EU/ 1/ 01/ 184/ 051
0.4 ml (200 µg/ ml)
v injekcijski peresnik
tn
uporabo