natgillin/translations-raw huggingface dataset:
Dispose of the used syringe in a sharps container (closable, puncture resistant container).
Uporabljeno iglo odvrzite v vsebnik za ostre predmete (vsebnik s pokrovom, odporen proti prebodu).
The carton contains the pre-filled syringe individually sealed in a plastic blister.
Škatla vsebuje napolnjeno injekcijsko brizgo, posamezno pakirano v plastičnem pretisnem omotu.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
B. POGOJI ALI OMEJITVE GLEDE OSKRBE ALI UPORABE
This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 6 mg, kar v bistvu pomeni 'brez natrija'.
After the medicine has been injected, the needle guard will be activated to cover the needle.
Po injiciranju zdravila je treba iglo pokriti tako, da aktivirate ščitnik igle.
Your doctor will check your blood and urine regularly as pegfilgrastim can harm the tiny filters inside your kidneys (glomerulonephritis).
Zdravnik vam bo redno kontroliral kri in urin, kajti pegfilgrastim lahko okvari drobne filtre v ledvicah
Holding the pre-filled syringe as shown, slowly depress the plunger as far as it will go so that the plunger head is completely between the needle guard wings.
Počasi potisnite bat kolikor je mogoče daleč, tako da je glava bata v celoti med krilci ščitnika igle.
Important: Read the package leaflet before handling the pre-filled syringe.
Pomembno: Pred rokovanjem z napolnjeno injekcijsko brizgo preberite priloženo navodilo.
A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain.
Na diagnozo rupture vranice moramo pomisliti pri bolnikih, ki poročajo o bolečini v zgornjem levem delu trebuha ali v predelu lopatice.
Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Ziextenzo.
Če je zdravilo Ziextenzo pomotoma izpostavljeno temperaturam pod lediščem za enkratno obdobje, ki ne preseže 24 ur, to ne škoduje njegovi stabilnosti.
Gently pinch the skin at the injection site and insert the needle as shown.
Kožo nežno primite na mestu injiciranja in zabodite iglo, kot je prikazano.
Ziextenzo is a clear, colourless to slightly yellowish solution for injection in a pre-filled syringe (6 mg/0.6 mL).
Zdravilo Ziextenzo je bistra, brezbarvna do rahlo rumenkasta raztopina za injiciranje v napolnjeni injekcijski brizgi (6 mg/0,6 ml).
Inspect the pre-filled syringe.
Preglejte napolnjeno brizgo.
Take the carton containing the blistered pre-filled syringe out of the refrigerator and leave it unopened for approximately 15-30 minutes so that it reaches room temperature.
Škatlo, v kateri je napolnjena injekcijska brizga v pretisnem omotu, vzemite iz hladilnika in jo za približno 15-30 minut pustite neodprto, da se segreje na sobno temperaturo.
Ziextenzo is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells).
Zdravilo Ziextenzo se uporablja za skrajšanje trajanja nevtropenije (zmanjšano število belih krvničk) in zmanjševanje pojavljanja febrilne nevtropenije (zmanjšano število belih krvničk z zvišano telesno temperaturo), ki ju lahko povzroča uporaba citotoksične kemoterapije (zdravila, ki uničujejo hitro rastoče celice).
Store in the refrigerator between 2 °C and 8 °C.
Shranite jo v hladilniku pri temperaturi od 2 °C do 8 °C.
The figure below shows a ready to use syringe.
Spodnja slika prikazuje brizgo za uporabo.
Important safety information Caution: Keep the pre-filled syringe out of the sight and reach of children.
Pomembne varnostne informacije Pozor: Napolnjeno injekcijsko brizgo shranjujte nedosegljivo otrokom.
Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Ziextenzo.
Ob uporabi zdravila Ziextenzo so poročali o hudih kožnih reakcijah (Stevens-Johnsonov sindrom).
What Ziextenzo looks like and contents of the pack
Izgled zdravila Ziextenzo in vsebina pakiranja
Ziextenzo has no or negligible effect on the ability to drive or use machines.
Zdravilo Ziextenzo nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
The usual dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled syringe and it should be given at least 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.
Običajni odmerek je ena 6-miligramska subkutana injekcija (podkožna injekcija) z napolnjeno injekcijsko brizgo, ki jo morate prejeti vsaj 24 ur po zadnjem odmerku kemoterapije na koncu vsakega cikla kemoterapije.
In a placebo-controlled, double blind study in patients with breast cancer the effect of pegfilgrastim on the incidence of febrile neutropenia was evaluated following administration of a chemotherapy regimen associated with a febrile neutropenia rate of 10-20% (docetaxel 100 mg/m2 every 3 weeks for 4 cycles).
V dvojno slepi, s placebom kontrolirani študiji pri bolnicah z rakom na dojki so ocenili učinek pegfilgrastima na incidenco febrilne nevtropenije po uporabi takšne sheme kemoterapije, ki je povezana z 10-20-% deležem febrilne nevtropenije (docetaksel 100 mg/m2 vsake 3 tedne za 4 cikluse).
Stop using Ziextenzo if you develop these symptoms and contact your doctor or seek medical attention immediately.
Če se vam pojavijo ti simptomi, prenehajte uporabljati zdravilo Ziextenzo in se nemudoma posvetujte z zdravnikom ali poiščite zdravniško pomoč.
Keep the plunger fully depressed while you carefully pull the needle straight out from the injection site and let it go off your skin.
Bat držite do konca potisnjen, iglo pa nežno izvlecite iz mesta injiciranja ter jo odstranite s kože.
Check to ensure the plastic transparent needle guard is situated over the barrel of the glass syringe.
Prepričajte se, da je prozorni plastični ščitnik igle nad telesom steklene injekcijske brizge.
Once a syringe has been removed from the refrigerator and has reached room temperature (not above 35 °C) it must either be used within 120 hours or disposed of.
Ko injekcijsko brizgo vzamete iz hladilnika in le-ta doseže sobno temperaturo (do 35 °C), jo morate bodisi v 120 urah porabiti ali pa zavreči.
Cases of capillary leak syndrome have been reported in the post-marketing setting with granulocyte colony-stimulating factor use.
V obdobju trženja zdravila so poročali o primerih sindroma kapilarne prepustnosti med uporabo granulocitne kolonije spodbujajočega faktorja.
• Sharps disposal container.
• Vsebnik za odstranjevanje ostrih predmetov.
Do not rub the injection site.
Injiciranega mesta ne drgnite.
The syringes are provided with an automatic needle guard.
Injekcijske brizge so na voljo z avtomatskim ščitnikom igle.
Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli.
biotehnološko pridobljena iz bakterij E. coli.
Store the blistered pre-filled syringe in its carton to protect it from light.
Napolnjeno injekcijsko iglo v pretisnem omotu shranite v škatli, da jo zaščitite pred svetlobo.
Do not use the pre-filled syringe after the expiry date which is stated on the carton or syringe label.
Napolnjene injekcijske brizge ne uporabljajte po datumu izteka roka uporabnosti, ki je naveden na škatli ali nalepki injekcijske brizge.
See section 2 “Ziextenzo contains sorbitol (E420) and sodium”.
Glejte poglavje 2 "Zdravilo Ziextenzo vsebuje sorbitol (E 420) in natrij".
This medicine contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg / mL.
To zdravilo vsebuje 30 mg sorbitola v napolnjeni injekcijski brizgi, kar je enako 50 mg/ml.
Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon [≥ 1/1,000 to < 1/100]).
Med začetnim ali nadaljnjim zdravljenjem s pegfilgrastimom so se pojavile preobčutljivostne reakcije, vključno z izpuščajem na koži, urtikarijo, angioedemom, dispnejo, eritemom, zardevanjem in hipotenzijo (občasno [≥ 1/1.000 do < 1/100]).
Ziextenzo may be exposed to room temperature (not above 35 °C) for a maximum single period of up to 120 hours.
Zdravilo Ziextenzo sme biti izpostavljeno sobni temperaturi (do 35 °C) za enkratno obdobje, ki ne sme preseči 120 ur.
Do not remove the needle cap until just before you give the injection.
Pokrovček igle odstranite tik pred injiciranjem.
If you become pregnant during Ziextenzo treatment, please inform your doctor.
Če med zdravljenjem z zdravilom Ziextenzo zanosite, o tem obvestite zdravnika.
(acute febrile dermatosis)1,2;
Sweetov sindrom (akutna febrilna dermatoza)1,2; kožni vaskulitis1,2
Ziextenzo is for subcutaneous use.
Zdravilo Ziextenzo se uporablja subkutano.
General warnings and precautions
Splošna opozorila in previdnostni ukrepi
Capillary Leak Syndrome, which can be life-threatening if treatment is delayed, has been reported as uncommon (≥ 1/1,000 to < 1/100) in cancer patients undergoing chemotherapy following administration of granulocyte colony-stimulating factors; see section 4.4 and section “Description of selected adverse reactions” below.
Občasno (≥ 1/1.000 do < 1/100) so pri bolnikih z rakom, ki so prejemali kemoterapijo po uporabi granulocitne kolonije spodbujajočega faktorja, poročali o sindromu kapilarne prepustnosti, ki je lahko smrtno nevaren, če ni zdravljen takoj; glejte poglavje 4.4 in poglavje »Opis izbranih neželenih učinkov«
Dispose of the used pre-filled syringe immediately after use in a sharps container.
Uporabljene igle takoj po uporabi zavrzite v vsebnik za ostre predmete.
Contents of the pack and other information
Shranjevanje zdravila Ziextenzo Vsebina pakiranja in dodatne informacije
Ziextenzo may be used if it is accidentally frozen for a single period of less than 24 hours.
Zdravilo Ziextenzo smete uporabiti, če je bilo pomotoma zamrznjeno eno samo obdobje,
- The other ingredients are glacial acetic acid, sorbitol (E420), polysorbate 20, sodium hydroxide and water for injections.
- Druge sestavine so ledocetna kislina, sorbitol (E 420), polisorbat 20, natrijev hidroksid in voda za injekcije.
Pre-filled syringe (Type I glass), with a rubber plunger stopper, a plunger rod, a stainless steel needle and a rubber needle cap with an automatic needle guard.
Napolnjena injekcijska brizga (iz stekla tipa I) z gumijastim batnim zamaškom, batom, nerjavečo jekleno iglo in pokrovčkom igle z avtomatskim ščitnikom igle.
Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain)
Bolezni mišično skeletnega sistema in vezivnega tkiva bolečina v kosteh mišično-skeletna bolečina (mialgija, artralgija, bolečina v okončini, bolečina v hrbtu,
What you additionally need for your injection:
Oprema, ki jo boste potrebovali:
Before use, Ziextenzo solution should be inspected visually for particulate matter.
Pred uporabo morate raztopino zdravila Ziextenzo pregledati glede vidnih delcev.
• Cotton ball or gauze.
• Vatirani tampon ali gaza.
Excipients: glacial acetic acid, sorbitol (E420), polysorbate 20, sodium hydroxide, water for injections.
Pomožne snovi: ledocetna kislina, sorbitol (E 420), polisorbat 20, natrijev hidroksid, voda za injekcije.
Instructions for use of Ziextenzo pre-filled syringe
Navodila za uporabo napolnjene injekcijske brizge Ziextenzo
Excipients with known effect Each pre-filled syringe contains 30 mg sorbitol (E420).
Vsaka napolnjena injekcijska brizga vsebuje 30 mg sorbitola (E 420).
For further instructions on how to inject yourself with Ziextenzo, please read the section at the end of this leaflet.
Nadaljnja navodila za samoinjiciranje zdravila Ziextenzo si preberite v poglavju na koncu tega Navodila za uporabo.
How to use Ziextenzo
Kako uporabljati zdravilo Ziextenzo
In a second study (n = 310), which used a weight-adjusted dose (100 µg/kg), the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.7 days, compared with 1.8 days in the filgrastim group (difference 0.03 days, 95% CI-0.36, 0.30).
V drugi študiji (n = 310), v kateri so uporabljali za telesno maso popravljen odmerek (100 μg/kg), je bilo srednje trajanje nevtropenije 4. stopnje v skupini s pegfilgrastimom 1,7 dni, v skupini s filgrastimom pa 1,8 dni (razlika 0,03 dneva, 95 % IZ je -0,36, 0,30).
Ziextenzo contains the active substance pegfilgrastim.
Zdravilo Ziextenzo vsebuje učinkovino pegfilgrastim.
Pack size of one pre-filled syringe in a blistered packaging.
Velikost pakiranja z eno napolnjeno injekcijsko brizgo v pretisnem omotu.
Carefully pull the needle cap straight off. You may see a drop of liquid at the end of the needle.
Na koncu igle boste mogoče videli kapljico tekočine.
Prior to use‚ remove the pre-filled syringe from the refrigerator and allow Ziextenzo to reach room temperature (up to a maximum of 35 °C) for approximately 15-30 minutes.
Pred uporabo odstranite napolnjeno iglo iz hladilnika in jo za približno 15-30 minut pustite, da se zdravilo Ziextenzo segreje na sobno temperaturo (do največ 35 °C).
Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobne informacije so objavljene na spletni strani Evropske agencije za zdravila - http://www.ema.europa.eu.
Do not use this medicine if you notice it is cloudy or there are particles in it. Do not throw away any medicines via wastewater or household waste.
Ne uporabite tega zdravila, če opazite, da je zdravilo motno ali da v njem plavajo delci.
Never leave the pre-filled syringe unattended where others might tamper with it. Do not shake the pre-filled syringe.
Napolnjene brizge nikoli ne pustite brez nadzora na kraju, kjer bi lahko prišla v roke drugih.
Pulmonary haemorrhage
hemoptiza pljučna hemoragija
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).
Ziextenzo contains sorbitol (E420) and sodium
Zdravilo Ziextenzo vsebuje sorbitol (E 420) in natrij
The injections should be given into the thigh, abdomen or upper arm. For instructions on handling of the medicinal product before administration, see section 6.6.
Za navodila glede ravnanja z zdravilom pred dajanjem injekcije glejte poglavje 6.6.
If the transparent needle guard is covering the needle cap (as shown below) the syringe has been activated, DO NOT use this syringe and take a new syringe.
Če pokrovček igle pokriva prozoren ščitnik igle (kot je prikazano spodaj), je bila brizga aktivirana.
The injection site
Raztopina za injiciranje
In a phase II (n = 37) multicentre, randomised, open-label study of paediatric sarcoma patients receiving 100 mcg/kg pegfilgrastim following cycle 1 of vincristine, doxorubicin and cyclophosphamide (VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils < 0.5 x 109) was observed in younger children aged 0-5 years (8.9 days) compared to older children aged 6-11 years and 12-21 years (6 days and 3.7 days, respectively) and adults.
ki so dobili 100 sµg/kg pegfilgrastima po 1. ciklusu kemoterapije z vinkristinom, doksorubicinom in ciklofosfamidom (VAdriaC/IE), so pri mlajših otrocih, starih od 0 do 5 let, ugotovili dolgotrajnejšo hudo nevtropenijo (nevtrofilci < 0,5 x 109) (8,9 dni) kot pri starejših otrocih, starih od 6 do 11 let (6 dni) in 12 do 21 let (3,7 dni) in pri odraslih.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobni podatki o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
You may take Ziextenzo out of the refrigerator and keep it at room temperature (not above 35 °C) for no longer than 120 hours.
Zdravilo Ziextenzo smete vzeti iz hladilnika in ga hraniti pri sobni temperaturi (do 35 °C) največ 120 ur dolgo.
• Do not inject into areas where the skin is tender, bruised, red, scaly or hard.
• Ne injicirajte v predele, kjer je koža občutljiva,
Solution for injection 1 pre-filled syringe with automatic needle guard containing 0.6 mL solution for injection.
Ena napolnjena injekcijska brizga z avtomatskim ščitnikom igle, ki vsebuje 0,6 ml raztopine za injiciranje.
Each pack contains 1 glass pre-filled syringe with a rubber plunger stopper, a plunger rod, an attached stainless steel needle and needle cap.
Vsaka škatla vsebuje 1 stekleno napolnjeno injekcijsko brizgo z gumijastim batnim zamaškom, batom,
Solution for injection (injection) Clear, colourless to slightly yellowish solution for injection.
Bistra, brezbarvna do rahlo rumenkasta raztopina za injiciranje.
A higher frequency of serious adverse reactions in younger children aged 0-5 years (92%) has been observed compared to older children aged 6-11 and 12-21 years respectively (80% and 67%) and adults.
Pri mlajših otrocih, starih od 0 do 5 let, so ugotovili večjo pogostnost resnih neželenih reakcij (92 %) kot pri starejših otrocih, starih od 6 do 11 (80 %) in 12 do 21 let (67 %)
Your Ziextenzo pre-filled syringe with needle guard
Vaša injekcijska brizga Ziextenzo s ščitnikom igle
Remove the pre-filled syringe from the blister.
Napolnjeno injekcijsko brizgo odstranite iz pretisnega omota.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S
In this configuration the needle guard is NOT ACTIVATED and the pre-filled syringe is ready for use
V tej konfiguraciji ščitnik igle NI AKTIVIRAN,
Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment has 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.
One 6 mg dose (a single pre-filled syringe) of Ziextenzo 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 Ziextenzo, ki je dana vsaj 24 ur po citotoksični kemoterapiji.
• Inflammation of the 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).
Acute respiratory distress syndrome2; Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis) Haemoptysis
pljučne neželene reakcije (intersticijska pljučnica, pljučni edem, pljučni infiltrati in pljučna fibroza)
If you use more Ziextenzo than you should contact your doctor, pharmacist or nurse.
Če uporabite več zdravila Ziextenzo, kot bi smeli, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1%
Incidenca febrilne nevtropenije je bila nižja pri bolnicah, ki so dobivale pegfilgrastim, kot pri tistih, ki so dobivale placebo (1 % v primerjavi s 17 %, p < 0,001).
Thrombocytopenia1 Leukocytosis1
Bolezni krvi in limfatičnega sistema trombocitopenija1 levkocitoza1
Device READY TO BE USED
Pripomoček PRIPRAVLJEN ZA
Preparing the Ziextenzo pre-filled syringe ready for use
napolnjena injekcijska brizga pa je pripravljena za uporabo
Only a solution that is clear and colourless to slightly yellowish should be injected.
Injicirati smete samo raztopino, ki je bistra in brezbarvna do rahlo rumenkasta.
How to use the Ziextenzo pre-filled syringe
Kako uporabiti napolnjeno injekcijsko brizgo z zdravilom Ziextenzo
Elevations in lactate dehydrogenase and alkaline phosphatase1;
Preiskave zvišanje laktatdehidrogenaze in alkalne fosfataze1; prehodno zvišanje jetrnih funkcijskih testov za ALT ali AST1
Ziextenzo 6 mg solution for injection in pre-filled syringe
Ziextenzo 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
The youngest age group (0-5 years) had a higher mean exposure to pegfilgrastim (AUC) (± Standard Deviation) (47.9 ± 22.5 mcg·hr/ml) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 mcg hr/ml and 29.3 ± 23.2 mcg·hr/ml, respectively) (see section 5.1).
± 22,5 µg·h/ml) kot med otroci, starimi od 6 do 11 (22,0 ± 13,1 µg·h/ml) in od 12 do 21 let (29,3 ± 23,2 µg·h/ml) (glejte poglavje 5.1).
Package leaflet: Information for the user Ziextenzo 6 mg solution for injection in pre-filled syringe pegfilgrastim ▼This medicine is subject to additional monitoring.
Navodila za uporabo: Informacije za uporabnika Ziextenzo 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi pegfilgrastim
Bone pain
Glava bata
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-aminotransferazo (ALT) ali aspartat-aminotransferazo (AST).
MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS BLISTER
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
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
EXPIRY DATE
dan študije
How to store Ziextenzo
Shranjevanje zdravila Ziextenzo
Stop using Ziextenzo 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 Ziextenzo in nemudoma poiščite zdravniško pomoč.
Ziextenzo 6 mg solution for injection in pre-filled syringe pegfilgrastim
Ziextenzo 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi pegfilgrastim
Talk to your doctor, pharmacist or nurse before using Ziextenzo:
Pred začetkom uporabe zdravila Ziextenzo se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
Unless your doctor directs you otherwise, you must stop breast-feeding if you use Ziextenzo.
Če uporabljate zdravilo Ziextenzo, morate prenehati dojiti, razen če vam zdravnik ne naroči drugače.
Storage of the Ziextenzo pre-filled syringe
Shranjevanje napolnjene injekcijske brizge
Posology
UPORABO
The safety and efficacy of pegfilgrastim 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,
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora sindrom akutne dihalne stiske2;
Sodium hydroxide (for pH adjustment) Water for injections
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi ledocetna kislina sorbitol (E 420) polisorbat 20 natrijev hidroksid (za prilagoditev pH) voda za injekcije
Comtan Comtan
Jakost
Film-coated tablet Film-coated tablet
Stična ovojnina Velikost pakiranja
MA (EU) number Invented name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size bottle (HDPE)
Številka (EU) dovoljenja za promet
100 tablets 60 tablets
Farmacevtska oblika Pot uporabe
The maximum dose is 500 micrograms every two weeks.
Največji odmerek je 500 mikrogramov vsaka dva tedna.
What measures are being taken to ensure the safe and effective use of Besremi?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Besremi?