natgillin/translations-raw huggingface dataset:
When administering using the manual pre-filled syringe, allow the pre-filled syringe to reach room temperature before injecting.
V primeru uporabe napolnjene injekcijske brizge za ročno injiciranje pustite napolnjeno injekcijsko brizgo, da pred injiciranjem doseže sobno temperaturo.
Pinch (without squeezing) the skin using your thumb and forefinger.
Kožo primite (ne da bi jo stiskali) med palec in kazalec.
The needle cap of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
Pokrovček igle pri napolnjeni injekcijski brizgi vsebuje suho naravno gumo (derivat lateksa), ki lahko povzroča alergične reakcije.
Serious allergic reactions, including anaphylaxis can occur in patients receiving pegfilgrastim (uncommon) (see section 4.4).
Bolnikom, ki prejemajo pegfilgrastim, se lahko pojavijo resne alergijske reakcije, vključno z anafilaksijo (občasno) (glejte poglavje 4.4).
The pre-filled syringe for use with the on-body injector may be exposed at room temperature for no longer than 36 hours prior to filling the on-body injector.
Napolnjena injekcijska brizga, namenjena za uporabo z injektorjem, sme biti na sobni temperaturi največ 36 ur pred polnjenjem injektorja.
There is insufficient information on the excretion of pegfilgrastim/metabolites in human milk, a risk to the newborns/infants cannot be excluded.
Ni dovolj podatkov o izločanju pegfilgrastima/presnovkov v materino mleko.
• are planning to have a baby.
• načrtujete zanositev.
Aortitis has been reported after G-CSF administration in healthy subjects and in cancer patients.
Po dajanju G-CSF zdravim osebam in bolnikom z rakom so poročali o aortitisu.
Do not try to inject yourself if you have not been trained.
Če vas samoinjiciranja še niso naučili, si ne poskušajte sami dajati injekcij.
If it is flashing red, contact your healthcare provider immediately.
Če utripa rdeče, se nemudoma posvetujte z zdravnikom.
Pack size of one pre-filled syringe in blistered packaging co-packed with an on-body injector.
Velikost pakiranja z eno napolnjeno injekcijsko brizgo v pretisnem pakiranju, pakirano skupaj z injektorjem.
Neulasta contains the active substance pegfilgrastim.
Zdravilo Neulasta vsebuje učinkovino pegfilgrastim.
No dose change is recommended in patients with renal impairment, including those with end-stage renal disease.
Pri bolnikih z okvaro ledvic odmerka ni treba spreminjati; to velja tudi za bolnike s končno odpovedjo ledvic.
Fill indicator
Kazalnik polnosti
Pre-filled syringe (Type I glass), with a rubber stopper, stainless steel needle and needle cap with or without an automatic needle guard.
Napolnjena injekcijska brizga (iz stekla tipa I) z gumijastim zamaškom, nerjavečo jekleno iglo in pokrovčkom igle z avtomatskim ščitnikom igle ali brez njega.
Do not attempt to remove the clear pre-filled syringe safety guard from the pre-filled syringe.
Ne poskušajte odstraniti prozornega varnostnega ščitnika z napolnjene injekcijske brizge.
Pegfilgrastim Conc.
pegfilgrastima ANC
Do not remove the grey needle cap from the pre-filled syringe until you are ready to inject.
Ne odstranite sivega pokrovčka igle z napolnjene injekcijske brizge, dokler niste pripravljeni za injiciranje.
If the on-body injector was placed on the back of your arm, a caregiver must be available to monitor its status.
Če je bil telesni injektor nameščen na zadnjo stran nadlakta, morate imeti na voljo skrbnika, ki nadzoruje stanje injektorja.
• coughing up blood (haemoptysis).
• izkašljevanje krvi (hemoptiza).
In two randomised, double-blind, pivotal studies in patients with high-risk stage II-IV breast cancer undergoing myelosuppressive chemotherapy consisting of doxorubicin and docetaxel, use of pegfilgrastim, as a single once per cycle dose, reduced the duration of neutropenia and the incidence of febrile neutropenia similarly to that observed with daily administrations of filgrastim (a median of 11 daily administrations).
do IV. stadiju na mielosupresivni kemoterapiji z doksorubicinom in docetakselom je uporaba pegfilgrastima v obliki enega samega odmerka na cikel skrajšala trajanje nevtropenije in incidenco febrilne nevtropenije, podobno kot so opazili pri vsakodnevni uporabi filgrastima (mediana števila dnevnih aplikacij je bila 11).
Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for pegfilgrastim to filgrastim in patients with de novo acute myeloid leukaemia (AML) (see section 5.1).
Pri bolnikih z de novo akutno mieloično levkemijo (AML) omejeni klinični podatki kažejo primerljiv učinek pegfilgrastima in filgrastima na čas do okrevanja po hudi nevtropeniji (glejte poglavje 5.1).
BLISTER PACK FOR SYRINGE WITH AUTOMATIC NEEDLE GUARD
PRETISNI OMOT ZA BRIZGO Z AVTOMATIČNIM ŠČITNIKOM IGLE
Contact your healthcare provider immediately.
Nemudoma se posvetujte z zdravnikom.
Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have been reported in patients treated with pegfilgrastim.
Pri bolnikih, ki se zdravijo s pegfilgrastimom, so poročali o preobčutljivosti, vključno z anafilaktičnimi reakcijami, ki se pojavijo med začetnim ali nadaljnjim zdravljenjem.
The on-body injector delivers your Neulasta dose with an under-the-skin (subcutaneous) injection.
Injektor injicira odmerek zdravila Neulasta s podkožno (subkutano) injekcijo.
Generally asymptomatic cases of splenomegaly and cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim (see section 4.8).
Po uporabi pegfilgrastima so poročali o splošno asimptomatskih primerih splenomegalije, in o primerih rupture vranice, vključno z nekaterimi smrtnimi primeri (glejte poglavje 4.8).
If the on-body injector is not empty, contact your healthcare provider immediately as you may need a replacement dose.
Če injektor ni prazen, se nemudoma posvetujte z zdravnikom, kajti morda boste potrebovali nadomestni odmerek.
Each pre-filled syringe contains 0.64 mL of solution that delivers 6 mg of pegfilgrastim (10 mg/mL) to be used with the on-body injector.
Vsaka napolnjena injekcijska brizga vsebuje 0,64 ml raztopine, ki injicira 6 mg pegfilgrastima (10 mg/ml) in se mora uporabljati z injektorjem, ki se pritrdi na telo.
Instructions for injecting with the Neulasta pre-filled syringe
Navodila za injiciranje zdravila Neulasta z uporabo napolnjene injekcijske brizge
• Upper part of your thigh.
• zgornji del stegna.
• Inflammation of aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely in cancer patients and healthy donors.
• pri bolnikih z rakom in zdravih darovalcih so redko poročali o vnetju aorte (velike žile, ki prenaša kri od srca po telesu).
The on-body injector must be filled using the co-packed pre-filled syringe.
Injektor je treba napolniti s priloženo napolnjeno injekcijsko brizgo.
SYRINGE LABEL
OZNAKA BRIZGE
One 6 mg dose (a single pre-filled syringe) of Neulasta is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.
Za vsak cikel kemoterapije priporočajo en 6 miligramski odmerek (eno napolnjeno injekcijsko brizgo) zdravila Neulasta, ki je dana vsaj 24 ur po citotoksični kemoterapiji.
• Contact your healthcare provider immediately if the on-body injector comes away from your skin at any time before your full dose has been delivered, do not reapply it.
• Nemudoma se posvetujte z zdravnikom, če se vam injektor odlepi od kože kadar koli prej, preden dobite celoten odmerek; injektorja ne nameščajte nazaj.
The on-body injector must only be used with the Neulasta pre-filled syringe co-packed in the carton.
Injektor je dovoljeno uporabiti le z napolnjeno injekcijski brizgo zdravila Neulasta, priloženo v škatli.
For use with the on-body injector only.
Samo za uporabo z injektorjem, ki se pritrdi na telo.
The back of the arm may only be used if there is a caregiver available to monitor the status of the on-body injector.
Zadnjo stran nadlakta je dovoljeno uporabiti le, če lahko stanje injektorja nadzoruje skrbnik.
If the on-body injector has been knocked or pulled, the cannula may become dislodged.
Če z injektorjem kam zadenete ali ga potegnete, se kanila lahko premakne.
• Mark the box of the description that represents your on-body injector after it has been used.
• Označite okvirček pri opisu, ki ustreza stanju uporabljenega injektorja.
Call your healthcare provider immediately as you may need a replacement dose.
Nemudoma se posvetujte z zdravnikom, kajti morda boste potrebovali nadomestni odmerek.
Do not put the grey needle cap back on used pre-filled syringes.
Sivega pokrovčka igle ne nameščajte nazaj na uporabljeno injekcijsko brizgo.
Each pre-filled syringe for use with the on-body injector contains 0.64 mL of solution for injection.
Ena napolnjena injekcijska brizga za uporabo z injektorjem vsebuje 0,64 ml raztopine za injiciranje.
Common cases of thrombocytopenia have been reported.
Pogosto so poročali o primerih trombocitopenije.
- The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections.
- Pomožne snovi so natrijev acetat, sorbitol (E420), polisorbat 20 in voda za injekcije.
Pack size of one pre-filled syringe, in either blistered or non-blistered packaging.
Pakiranje z 1 napolnjeno injekcijsko brizgo v pretisnem omotu ali v pakiranju brez pretisnega omota.
For a more comfortable injection, leave the pre-filled syringe at room temperature for about 30 minutes before injecting.
Da injiciranje ne bo neprijetno, pustite napolnjeno injekcijsko brizgo približno 30 minut pred injiciranjem na sobni temperaturi.
Keep the syringe and sharps disposal container out of sight and reach of children.
Brizgo in vsebnik za ostre odpadke shranjujte nedosegljivo otrokom!
One pre-filled syringe with blister wrapping and with an on-body injector.
Ena napolnjena injekcijska brizga v pretisnem omotu in z injektorjem, ki se pritrdi na telo.
• Do not use baths, hot tubs, whirlpool baths, or saunas while wearing the on-body injector.
• Medtem ko imate nameščen injektor, ne uporabljajte bazenov, vročih kopeli, vrtinčastih kopeli ali savn.
Do not remove the on-body injector before the dose delivery is complete.
Ne odstranite injektorja, dokler injiciranje odmerka ni dokončano.
Elevations in lactate dehydrogenase and alkaline phosphatase1;
Preiskave zvišanje laktat-dehidrogenaze in alkalne fosfataze1, prehodno zvišanje jetrnih funkcijskih testov za ALT ali AST1
There is a risk of medication error, particularly a partial or missed dose of pegfilgrastim, in the event of a device failure or malfunction with the on-body injector.
V primeru odpovedi ali nepravilnega delovanja injektorja obstaja tveganje za napako pri uporabi zdravila, zlasti za injiciranje le delnega odmerka ali za izpuščen odmerek pegfilgrastima.
Unless your doctor directs you otherwise, you must stop breast-feeding if you use Neulasta.
Če uporabljate zdravilo Neulasta, morate prenehati dojiti, razen če vam zdravnik ne naroči drugače.
• Do not remove the on-body injector before the dose delivery is complete.
• Ne odstranite injektorja, dokler injiciranje odmerka ni dokončano.
Pulmonary haemorrhage
Srpastocelična anemija
The on-body injector uses acrylic adhesive and may result in an allergic reaction.
Za namestitev injektorja je uporabljeno akrilno lepilo, ki lahko povzroči alergijsko reakcijo.
SYRINGE LABEL FOR USE WITH ON-BODY INJECTOR
OZNAKA BRIZGE ZA UPORABO Z INJEKTORJEM, KI SE PRITRDI NA TELO
Solution for injection (injection) with on-body injector (Onpro kit).
raztopina za injiciranje (injekcija) raztopina za injiciranje (injekcija) z injektorjem, ki se pritrdi na telo (komplet Onpro)
Do not remove the cap from the syringe until you are ready to inject.
Ne snemite pokrovčka z injekcijske brizge, dokler niste pripravljeni na injiciranje.
• not to remove the on-body injector until after dose delivery is complete
• da se injektorja ne odstrani, dokler injiciranje odmerka ni dokončano
Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL (10 mg/mL) solution for injection.
Vsaka napolnjena injekcijska brizga vsebuje 6 mg pegfilgrastima v 0,6 ml (10 mg/ml) raztopine za injiciranje.
If the on-body injector has been knocked or moved, this may become dislodged.
Če z injektorjem kam zadenete ali se premakne, se kanila lahko premakne.
For further instructions on how to inject yourself with Neulasta, please read the section at the end of this leaflet.
Nadaljnja navodila za samoinjiciranje zdravila Neulasta si preberite v poglavju na koncu tega Navodila za uporabo.
On a clean, well-lit work surface, place the new pre-filled syringe and the other supplies.
Novo napolnjeno injekcijsko brizgo in ostalo opremo položite na čisto, dobro osvetljeno delovno površino.
B Grab the edge of the adhesive pad.
B Primite rob lepljive blazinice.
• if you have an allergy to acrylic adhesives.
• če ste alergični na akrilna lepila.
 Status light is red, contact your healthcare provider immediately as you may need a replacement dose.
 Lučka stanja je rdeča, nemudoma se posvetujte z zdravnikom, kajti morda boste potrebovali nadomestni odmerek.
Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with pegfilgrastim treatment.
V povezavi z zdravljenjem s pegfilgrastimom so redko poročali o Stevens-Johnsonovem sindromu (SJS), ki je lahko smrtno nevaren ali smrten.
Very common side effects (may affect more than 1 in 10 people):
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):
If it was placed on the back of your arm, a caregiver must be available to monitor your on-body injector.
Če je bil injektor nameščen na zadnjo stran nadlakta, morate imeti na voljo skrbnika, ki injektor nadzoruje.
Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration.
Po uporabi G-CSF so poročali o neželenih reakcijah na pljučih, zlasti intersticijski pljučnici.
Dripping fluid from your on-body injector
Kapljanje tekočine od injektorja
Splenic rupture including some fatal cases is uncommonly reported following administration of pegfilgrastim (see section 4.4).
Občasno je bila po uporabi pegfilgrastima opisana ruptura vranice, vključno z nekaj smrtnimi primeri (glejte poglavje 4.4).
Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis) Haemoptysis
Bolezni dihal, prsnega koša in mediastinalnega prostora sindrom akutne dihalne stiske pljučne neželene reakcije (intersticijska pljučnica, pljučni edem, pljučni infiltrati in pljučna fibroza) hemoptiza pljučna hemoragija
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema trombocitopenija levkocitoza1
• a pre-filled syringe for manual administration; or
• napolnjeno injekcijsko brizgo za ročno injiciranje, ali
A small (n = 83), Phase II, randomised, double-blind study in patients receiving chemotherapy for de novo acute myeloid leukaemia compared pegfilgrastim (single dose of 6 mg) with filgrastim, administered during induction chemotherapy.
faze pri bolnikih, ki so dobivali kemoterapijo zaradi de novo akutne mieloične levkemije, je primerjala pegfilgrastim (enkraten odmerek 6 mg) s filgrastimom ob aplikaciji med indukcijsko kemoterapijo.
Do not attempt to remove the peelable label on the pre-filled syringe barrel before administering your injection.
Ne poskušajte odstraniti nalepke z valja napolnjene injekcijske brizge pred dajanjem injekcije.
Each pre-filled syringe for manual administration contains 0.6 mL of solution for injection.
Vsaka napolnjena injekcijska brizga za ročno injiciranje vsebuje 0,6 ml raztopine za injiciranje.
If you use more Neulasta than you should contact your doctor, pharmacist or nurse.
Če ste uporabili večji odmerek zdravila Neulasta, kot bi smeli Če uporabite več zdravila Neulasta, kot bi smeli, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Neulasta 6 mg solution for injection in pre-filled syringe with on-body injector
Neulasta 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi z injektorjem, ki se pritrdi na telo (injektor)
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja kontaktni dermatitis1
Anaphylaxis
Odmerjanje
If the needle is exposed, contact your healthcare provider immediately.
Če je vidna gola igla, se nemudoma posvetujte z zdravnikom.
Rare side effects (may affect up to 1 in 1000 people):
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
• swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
• oteklost ali zabuhlost, ki jo lahko spremlja manj pogostejše odvajanje urina, težko dihanje,
Uncommon events of cutaneous vasculitis have been reported in patients treated with pegfilgrastim.
Občasno so pri bolnikih, zdravljenih s pegfilgrastimom, poročali o dogodkih kožnega vaskulitisa.
If you have questions about how to inject, please ask your doctor, nurse, pharmacist for assistance.
Če imate kakšna vprašanja o injiciranju zdravila, se za pomoč obrnite na svojega zdravnika, medicinsko sestro ali farmacevta.
Slowly peel off the on-body injector.
Počasi odlepite injektor.
Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL of solution.
Ena napolnjena injekcijska brizga vsebuje 6 mg pegfilgrastima v 0,6 ml raztopine.
Only a solution that is clear and colourless should be injected.
Injicirati smete samo raztopino, ki je bistra in brezbarvna.
A pre-filled syringe is used to fill the on-body injector.
Za polnitev injektorja se uporablja napolnjena injekcijska brizga.
If it is flashing red, contact your healthcare provider immediately as you may need a replacement dose.
Če utripa rdeče, se nemudoma posvetujte z zdravnikom, saj boste morda potrebovali nadomestni odmerek.
Uncommon elevations in liver function tests (LFTs) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), have been observed in patients after receiving pegfilgrastim following cytotoxic chemotherapy.
Občasno so se bolnikom, ki so po citotoksični kemoterapiji dobili pegfilgrastim, pojavila zvišanja jetrnih funkcijskih testov za alanin-aminotransferaze (ALT) ali aspartat-aminotransferaze (AST).
• Keep children away from the used on-body injector.
• Uporabljene injekcijske brizge shranjujte nedosegljive otrokom.
Uncommon side effects (may affect up to 1 in 100 people):
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov):
Neulasta 6 mg solution for injection
Neulasta 6 mg raztopina za injiciranje
Solution for injection in a single use pre-filled syringe with automatic needle guard (0.6 mL).
Raztopina za injiciranje v napolnjeni injekcijski brizgi z avtomatskim ščitnikom igle (0,6 ml) za enkratno uporabo.
 The on-body injector leaked, contact your healthcare provider immediately as you may need a replacement dose.
 Injektor je puščal, nemudoma se obrnite na zdravnika, kajti morda boste potrebovali nadomestni odmerek.
• Avoid knocking or pulling the on-body injector.
• Izogibajte se temu, da bi z injektorjem kam zadeli ali bi ga potegnili.
Injection site reactions, including injection site erythaema (uncommon) as well as injection site pain (common) have occurred on initial or subsequent treatment with pegfilgrastim.
Med začetnim ali nadaljnjim zdravljenjem s pegfilgrastimom so se pojavile reakcije na mestu injiciranja, vključno z eritemom na mestu injiciranja (občasno) kot tudi bolečino na mestu injiciranja (pogosto).
Talk to your doctor, pharmacist or nurse before using Neulasta:
Pred začetkom uporabe zdravila Neulasta se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim.
Pri bolnikih, ki so dobivali filgrastim ali pegfilgrastim, so poročali o glomerulonefritisu.
With the exception of the youngest age group (0-5 years), the mean AUC in paediatric subjects appeared similar to that for adult patients with high-risk stage II-IV breast cancer and receiving 100 mcg/kg pegfilgrastim after the completion of doxorubicin/docetaxel (see sections 4.8 and 5.1).
do IV. stadiju, ki so dobile 100 µg/kg pegfilgrastima po dokončanju doksorubicina/docetaksela (glejte poglavji 4.8 in 5.1).
Neulasta 6 mg solution for injection in pre-filled syringe
Neulasta 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Metabolism and nutrition disorders
Trombocitopenija in anemija
Solution for injection in a single use pre-filled syringe (0.6 mL).
Raztopina za injiciranje v napolnjeni injekcijski brizgi (0,6 ml) za enkratno uporabo.
Using Neulasta with the on-body injector
Uporaba zdravila Neulasta z injektorjem, ki se pritrdi na telo (injektor)
The safety and efficacy of Neulasta have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g. nitrosoureas.
Pri bolnikih, ki dobivajo kemoterapijo, povezano z odloženo mielosupresijo, na primer nitrozouree, varnosti in učinkovitosti zdravila Neulasta niso ovrednotili.
OUTER CARTON FOR UNBLISTERED SYRINGE
OZNAKA BRIZGE V OVOJNINI BREZ PRETISNEGA OMOTA
Neulasta 6 mg solution for injection with on-body injector pegfilgrastim
Neulasta 6 mg raztopina za injiciranje z injektorjem, ki se pritrdi na telo (injektor) pegfilgrastim
Stop using Neulasta and seek medical attention immediately if you notice any of the symptoms described in section 4.
Če opazite katerega od simptomov, opisanih v poglavju 4, prenehajte uporabljati zdravilo Neulasta in nemudoma poiščite zdravniško pomoč.
Syringe label Used syringe barrel
Nalepka brizge Uporabljeni valj brizge
BLISTER PACK FOR SYRINGE TO BE USED WITH ON-BODY INJECTOR
PRETISNI OMOT ZA BRIZGO, KI SE MORA UPORABITI Z INJEKTORJEM, KI SE PRITRDI NA TELO
The on-body injector must only be used with the co-packed pre-filled syringe.
Injektor je dovoljeno uporabiti le z napolnjeno injekcijski brizgo, priloženo v pakiranju.
Neulasta 6 mg solution for injection pegfilgrastim
Neulasta 6 mg raztopina za injiciranje pegfilgrastim
Acute Respiratory Distress
Neželene reakcije na pljučih
Sodium acetate* Sorbitol (E420) Polysorbate 20
6.1 Seznam pomožnih snovi natrijev acetat* sorbitol (E420) polisorbat 20 voda za injekcije
Cannula window
Okence kanile
• application site reactions which may include redness, bleeding, bruising, pain and discomfort have been seen with the on-body injector.
Med uporabo injektorja so poročali o reakcijah na mestu namestitve (vključno s krvavitvijo, bolečino, nelagodjem, podplutbo in eritemom).
Back of upper arm
nadlaket trebuh zgornji del stegna
CLINICAL PARTICULARS
Sestavni deli
Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 6 mg pegfilgrastima* v 0,6 ml raztopine za injiciranje.
• If there is blood, press a clean cotton ball or gauze pad on the application site.
• Če opazite kri, na mesto dajanja zdravila pritisnite s kosmom vate ali zložencem iz gaze.
Grab the pre-filled syringe safety guard to remove the pre-filled syringe from the tray.
Napolnjeno injekcijsko brizgo vzemite iz podloge tako, da jo primete za njen varnostni ščitnik.
OUTER CARTON FOR BLISTERED SYRINGE
ŠKATLA ZA BRIZGO V PRETISNEM OMOTU
UNBLISTERED SYRINGE LABEL
Samoinjiciranje zdravila Neulasta
Belly
Bat
Common side effects (may affect up to 1 in 10 people):
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):
You should check with your doctor or pharmacist if you are unsure.
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
London, 20 August 2009 Doc.
London, 20. avgust 2009 Sklic dok.
Ref. EMEA/505188/2009 EMEA/H/C/1069
: EMEA/702709/2009 EMEA/H/C/1069
The summary of opinion of the Committee for Orphan Medicinal Products for Bosatria is available here.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Bosatria je na voljo tukaj.
The main measure of effectiveness was the number of patients who could have their daily prednisone dose reduced to 10 mg or lower for a period of eight weeks.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih so lahko dnevni odmerek prednizona za 8 tednov zmanjšali na 10 mg ali manj.