natgillin/translations-raw huggingface dataset:
The frequency of all hypersensitivity reactions was estimated from clinical trial data as very common in CRF patients.
Učestalost svih reakcija preosjetljivosti je procijenjena iz podataka kliničkog ispitivanja kao vrlo česta kod bolesnika s kroničnim zatajenjem bubrega.
Aranesp should be administered by the subcutaneous route to patients with anaemia (e.g. haemoglobin concentration ≤ 10 g/dL (6.2 mmol/L)) in order to increase haemoglobin to not greater than 12 g/dL (7.5 mmol/L).
Kod bolesnika s anemijom (primjerice, hemoglobin ≤ 10 g/dl (6,2 mmol/l)) Aranesp treba primjenjivati supkutanim putem da bi se hemoglobin povisio na vrijednost koja nije veća od 12 g/dl (7,5 mmol/l).
For paediatric patients ≥ 1 year of age, in the maintenance phase, Aranesp may continue to be administered as a single injection once weekly or once every two weeks.
U fazi održavanja, za pedijatrijske bolesnike u dobi od 1 godine i starije, može se nastaviti s primjenom lijeka Aranesp kao pojedinačne injekcije jednom tjedno ili jednom svaka 2 tjedna.
Aranesp is a clear, colourless or slightly pearly solution for injection in a pre-filled syringe.
Aranesp je bistra, bezbojna ili blago biserna otopina za injekciju u napunjenoj štrcaljki.
Aranesp 25 micrograms solution for injection in vial Aranesp 40 micrograms solution for injection in vial Aranesp 60 micrograms solution for injection in vial Aranesp 100 micrograms solution for injection in vial Aranesp 200 micrograms solution for injection in vial Aranesp 300 micrograms solution for injection in vial darbepoetin alfa
Aranesp 25 mikrograma otopina za injekciju u bočici Aranesp 40 mikrograma otopina za injekciju u bočici Aranesp 60 mikrograma otopina za injekciju u bočici Aranesp 100 mikrograma otopina za injekciju u bočici Aranesp 200 mikrograma otopina za injekciju u bočici Aranesp 300 mikrograma otopina za injekciju u bočici darbepoetin alfa
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE CARTON WITHOUT TRAY
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA NAPUNJENE ŠTRCALJKE BEZ PODLOŠKA
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
- Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with epoetin treatment.
- Prijavljene su ozbiljne reakcije na koži, uključujući Stevens-Johnsonov sindrom (SJS) i toksičnu epidermalnu nekrolizu (TEN), povezane s liječenjem epoetinom.
On a clean, well-lit work surface, place the new pre-filled syringe and the other supplies.
Položite novu napunjenu štrcaljku i ostali pribor na čistu i dobro osvjetljenu radnu površinu.
NAME OF THE MARKETING AUTHORISATION HOLDER Amgen
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Amgen
• Keep pre-filled syringes out of the sight and reach of children
• Čuvajte napunjenu štrcaljku izvan pogleda i dosega djece.
Do not use this medicine if you notice the pre-filled syringe contents are cloudy or there are particles in it.
Ovaj lijek se ne smije primijeniti ako primijetite da je sadržaj napunjene brizgalice mutan ili sadrži vidljive čestice.
c Rash adverse reactions includes PT rash, rash pruritic, rash generalised, rash papular, erythema, exfoliative rash, rash maculo-papular, rash vesicular as well as rash pustular from SOC Infections and Infestations.
c Nuspojave osipa uključuju sljedeće preporučene pojmove: osip, pruritični osip, generalizirani osip, papularni osip, eritem, eksfolijativni osip, makulopapularni osip, vezikularni osip i pustularni osip iz klasifikacije organskih sustava „Infekcije i infestacije“.
Aranesp (SureClick) is available in packs containing 1 or 4 pre-filled pens.
Aranesp (SureClick) je dostupan u pakovanjima od 1 ili 4 napunjene brizgalice u blisteru.
Aranesp is supplied ready for use in a vial.
Aranesp je dostupan spreman za primjenu u bočici.
Syringe label Used syringe barrel
Etiketa na štrcaljki Iskorišteni spremnik štrcaljke
Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment.
Prijavljene su teške nuspojave na koži (SCARs, engl. severe cutaneous adverse reactions) uključujući Stevens-Johnsonov sindrom (SJS) i toksičnu epidermalnu nekrolizu (TEN), koje mogu biti po život opasne ili smrtonosne, povezane s liječenjem epoetinom.
Aranesp is available in packs of 1 or 4 pre-filled syringes.
Aranesp je dostupan u pakiranjima od 1 ili 4 napunjene štrcaljke.
Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 micrograms solution for injection in pre-filled pen
Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 mikrograma otopina za injekciju u napunjenoj brizgalici
Do not store the pre-filled pen in extreme heat or cold. For example, avoid storing in your car glove box or boot.
Primjerice, izbjegavajte čuvanje brizgalice u pretincu ili prtljažniku Vašeg automobila.
This has been predominantly reported in patients with CRF treated subcutaneously.
Ovo je predominantno zabilježeno kod bolesnika s kroničnim zatajenjem bubrega liječenih supkutano.
A pharmacokinetic study in patients with chemotherapy-induced anaemia treated with 6.75 mcg/kg darbepoetin alfa administered SC every
Farmakokinetičko ispitivanje kod bolesnika s anemijom induciranom kemoterapijom liječenih sa 6,75 µg/kg darbepoetina alfa primijenjenog supkutano svaka 3 tjedna u kombinaciji s kemoterapijom, omogućilo je potpuno određivanje terminalnog poluvijeka života.
Uncommon1
Manje često1
4 single use pre-filled syringes.
4 napunjene štrcaljke za jednokratnu uporabu.
Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 micrograms solution for injection in pre-filled syringe
Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 mirograma otopina za injekciju u napunjenoj štrcaljki
Pack size of 1 or 4 pre-filled syringes.
Veličina pakiranja: 1 ili 4 napunjene brizgalice.
Sodium phosphate monobasic
Samoprimjena lijeka Aranesp brizgalicom
The initial every other week dose of Aranesp (mcg/every other week) can be determined by dividing the total cumulative dose of r-HuEPO administered over a two-week period by 240.
Početna doza lijeka Aranesp primijenjena jednom svaka 2 tjedna (μg/svaki drugi tjedan) može se odrediti dijeljenjem ukupne kumulativne doze r-HuEPO primijenjene kroz period od 2 tjedna s 240.
Aranesp is supplied ready for use in a pre-filled pen.
Aranesp je dostupan spreman za primjenu u napunjenoj brizgalici.
You should contact your doctor, nurse or pharmacist if this does happen.
Dogodi li se to, morate se obratiti svojem liječniku, medicinskoj sestri ili ljekarniku.
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician's evaluation of the individual patient's clinical course and condition is necessary.
Simptomi anemije i njene posljedice mogu varirati ovisno o dobi, spolu i sveukupnoj težini bolesti.
SJS/TEN, erythema multiforme, blistering, skin exfoliation
Stevens-Johnsonov sindrom (SJS)/toksična epidermalna nekroliza (TEN), multiformni eritem, stvaranje mjehura, ljuštenje kože
If the rise in haemoglobin is greater than 2 g/dL (1.25 mmol/L) in four weeks reduce the dose by approximately 25%.
Ako je porast hemoglobina veći od 2 g/dl (1,25 mmol/l) u četiri tjedna, smanjite dozu za otprilike 25%.
• The grey needle cap is missing or not securely attached.
• Ukoliko nema sivog pokrova za iglu ili izgleda kao da nije dobro pričvršćen.
Do not shake the pre-filled pen.
Ne tresite napunjenu brizgalicu.
Dialysis vascular access thrombosisd
Tromboza u vaskularnom pristupu za dijalizud
4 single use vials
4 bočice za jednokratnu uporabu
Keep the container in the outer carton in order to protect from light.
Čuvati spremnik u vanjskom pakiranju radi zaštite od svjetlosti.
The pre-filled syringe contains either 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 or 500 micrograms of darbepoetin alfa.
Napunjena brizgalica sadrži 10, 15, 20, 30, 40, 50, 60, 80, 100, 130,150, 300, ili 500 mikrograma darbepoetina alfa.
Do not recycle pre-filled syringes or throw them into household waste B Examine the injection site.
Nemojte reciklirati iskorištene štrcaljke ili ih bacati u kućni otpad.
The initial every other week dose of Aranesp (mcg/every other week) can be determined by dividing the total cumulative dose of r-HuEPO administered over a two-week period by 200.
Početna doza lijeka Aranesp koja se daje svaka 2 tjedna (μg/svaki drugi tjedan) može se odrediti dijeljenjem ukupne kumulativne doze r-HuEPO-a primijenjene tijekom 2 tjedna s 200.
• The pen contains dry natural rubber, which is made from latex, within the grey cap. Tell your healthcare provider if you are allergic to latex.
• Brizgalica sadrži osušenu prirodnu gumu, izrađenu od lateksa, u sivom pokrovu.
Aranesp 25 micrograms solution for injection in vial Each vial contains 25 micrograms of darbepoetin alfa in 1 mL (25 mcg/mL).
Aranesp 25 mikrograma otopina za injekciju u bočici Svaka bočica sadrži 25 mikrograma darbepoetina alfa u 1 ml (25 µg/ml).
Aranesp is a clear, colourless or slightly pearly solution for injection in vial.
Aranesp je bistra, bezbojna ili blago biserna otopina za injekciju u bočici.
INFORMATION IN BRAILLE Aranesp 130 syringe
16. PODACI NA BRAILLEOVOM PISMU Aranesp 130 štrcaljka
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE CARTON WITH TRAY
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S NAPUNJENIM ŠTRCALJKAMA S PODLOŠKOM
Used plunger
Upotrebljeni klip
If the rise in haemoglobin is greater than 2 g/dL (1.25 mmol/L) in 4 weeks, the dose should be reduced by 25 to 50%.
Ako je porast hemoglobina veći od 2 g/dl (1,25 mmol/l) u četiri tjedna, dozu se mora smanjiti za 25 do
The initial weekly dose of Aranesp (mcg/week) can be determined by dividing the total weekly dose of r-HuEPO (IU/week) by 200.
Početna tjedna doza lijeka Aranesp (μg/tjedan) može se odrediti dijeljenjem ukupne tjedne doze r-HuEPO-a (i.j./tjedan) s 200.
Injection site bruising
Krvarenje na mjestu injiciranja
For all adult and paediatric patients ≥ 1 year of age with chronic renal failure, Aranesp pre-filled pen is given as a single injection, under your skin (subcutaneous).
Svim odraslim i pedijatrijskim bolesnicima u dobi od 1 godine i starijima s kroničnim zatajenjem bubrega, Aranesp se daje kao jedna injekcija potkožno (supkutano) ili u venu (intravenski).
Upper arm
Nadlaktica Trbuh
Stroke was reported as common in CRF patients in TREAT (see section 5.1).
Moždani udar je prijavljen kao čest kod bolesnika s kroničnim zatajenjem bubrega u TREAT (vidjeti dio 5.1).
Do not remove the grey cap from the pre-filled pen until you are ready to inject.
Nemojte skidati sivi pokrov s napunjene brizgalice sve dok niste spremni injicirati.
In clinical studies, an increased risk of death, serious cardiovascular or cerebrovascular events including stroke, and vascular access thrombosis was observed when ESAs were administered to target a haemoglobin of greater than 12 g/dL (7.5 mmol/L).
Kod bolesnika s kroničnim zatajenjem bubrega, koncentracija održavanja hemoglobina ne smije prijeći gornju granicu preporučene ciljne koncentracije hemoglobina u dijelu 4.2. U kliničkim ispitivanjima povećani rizik od smrti, ozbiljnih kardiovaskularnih ili cerebrovaskularnih događaja uključujući moždani udar i vaskularnu trombozu na mjestu primjene su primijećeni kada su LSE primjenjivani radi postizanja ciljne koncentracije hemoglobina više od 12 g/dl (7,5 mmol/l).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING VIAL CARTON
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S BOČICAMA
EU/1/01/185/111 4 Pack
EU/1/01/185/111 pakiranje od 4
Pack size of 1 or 4 vials.
Veličina pakiranja: 1 ili 4 bočice.
Aranesp 15 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 1.42 mg of sodium in 0.375 mL.
Aranesp 15 mikrograma otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 1,42 mg natrija u 0,375 ml.
Aranesp 500 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 3.79 mg of sodium in 1 mL.
Aranesp 500 mikrograma otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 3,79 mg natrija u 1 ml.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NAPUNJENE ŠTRCALJKE BEZ PODLOŠKA
Do not remove the grey needle cap from the pre-filled syringe until you are ready to inject.
Ne uklanjajte sivi pokrov s napunjene štrcaljke sve dok niste spremni injicirati.
Aranesp 25 micrograms solution for injection in vial 1 mL solution for injection (25 mcg/mL darbepoetin alfa) in a type 1 glass vial with fluoropolymer laminated elastomeric stopper and an aluminium seal with flip-off dust cover.
Aranesp 25 mikrograma otopina za injekciju u bočici 1 ml otopine za injekciju (25 µg/ml darbepoetina alfa) u bočici od stakla tipa 1 s elastomernim čepom laminiranim fluoropolimerom i aluminijskim prstenom s „flip-off“ poklopcem.
The initial weekly paediatric dose of Aranesp (mcg/week) can be determined by dividing the total weekly dose of r-HuEPO (IU/week) by 240.
Početna tjedna doza lijeka Aranesp (μg/tjedan) za djecu može se odrediti dijeljenjem ukupne tjedne doze r-HuEPO-a (i.j./tjedan) s 240.
c Thromboembolic events adverse reaction includes PT embolism arterial, thrombophlebitis, thrombosis, venous thrombosis limb.
tromboflebitis, tromboza, venska tromboza ekstremiteta.
INFORMATION IN BRAILLE Aranesp 500 syringe
16. PODACI NA BRAILLEOVOM PISMU Aranesp 500 štrcaljka
INFORMATION IN BRAILLE Aranesp 80 syringe
16. PODACI NA BRAILLEOVOM PISMU Aranesp 80 štrcaljka
INFORMATION IN BRAILLE Aranesp 10 syringe
16. PODACI NA BRAILLEOVOM PISMU Aranesp 10 štrcaljka
Do not touch the injection site before injecting Choose a different site each time you give yourself an injection.
Birajte svaki put drugo mjesto gdje si dajete injekciju.
STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 mL vial contains 25 micrograms darbepoetin alfa.
NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica od 1 ml sadrži 25 mikrograma darbepoetina alfa.
INFORMATION IN BRAILLE Aranesp 15 syringe
16. PODACI NA BRAILLEOVOM PISMU Aranesp 15 štrcaljka
INFORMATION IN BRAILLE Aranesp 20 syringe
16. PODACI NA BRAILLEOVOM PISMU Aranesp 20 štrcaljka
Aranesp 15 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 15 micrograms of darbepoetin alfa in 0.375 mL (40 mcg/mL).
Aranesp 15 mikrograma otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 15 mikrograma darbepoetina alfa u 0,375 ml (40 μg/ml).
Aranesp 130 micrograms solution for injection pre-filled pen EU/1/01/185/072 - 1 pack
Aranesp 130 mikrograma otopina za injekciju u napunjenoj brizgalici EU/1/01/185/072 - pakiranje od 1
Aranesp 20 micrograms solution for injection pre-filled pen EU/1/01/185/047 - 1 pack
Aranesp 20 mikrograma otopina za injekciju u napunjenoj brizgalici EU/1/01/185/047 - pakiranje od 1
INFORMATION IN BRAILLE Aranesp 150 syringe
16. PODACI NA BRAILLEOVOM PISMU Aranesp 150 brizgalica
Aranesp 300 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 2.27 mg of sodium in 0.6 mL.
Aranesp 300 mikrograma otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 2,27 mg natrija u 0,6 ml.
If the rise in haemoglobin is greater than 2 g/dL (1.25 mmol/L) in four weeks reduce the dose by approximately 25%, depending on the rate of increase.
Ako je porast hemoglobina veći od 2 g/dl (1,25 mmol/l) u četiri tjedna, smanjite dozu za otprilike 25%, ovisno o brzini porasta hemoglobina.
Aranesp 200 micrograms solution for injection in vial Each vial contains 200 micrograms of darbepoetin alfa in 1 mL (200 mcg/mL).
Aranesp 200 mikrograma otopina za injekciju u bočici Svaka bočica sadrži 200 mikrograma darbepoetina alfa u 1 ml (200 µg/ml).
d Oedema: includes PT Oedema Peripheral, Oedema, Generalised Oedema, Oedema due to Cardiac Disease, Face oedema e Injection site pain adverse reaction includes PT injection site pain, administration site pain, catheter site pain, infusion site pain and vessel puncture site pain.
e Nuspojava bol na mjestu injiciranja uključuje sljedeće preporučene pojmove: bol na mjestu injiciranja, bol na mjestu primjene, bol na mjestu katetera, bol na mjestu infuzije i bol na mjestu punkcije vene.
Aranesp 25 micrograms solution for injection in vial.
Aranesp 25 mikrograma otopina za injekciju u bočici.
Aranesp 100 micrograms solution for injection in vial Each vial contains 100 micrograms of darbepoetin alfa in 1 mL (100 mcg/mL).
Aranesp 100 mikrograma otopina za injekciju u bočici Svaka bočica sadrži 100 mikrograma darbepoetina alfa u 1 ml (100 µg/ml).
Do not use this medicine after the expiry date which is stated on the carton and on the pre-filled syringe label after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici napunjene štrcaljke iza „Rok valjanosti“/EXP.
Aranesp 60 micrograms solution for injection in vial Each vial contains 60 micrograms of darbepoetin alfa in 1 mL (60 mcg/mL).
Aranesp 60 mikrograma otopina za injekciju u bočici Svaka bočica sadrži 60 mikrograma darbepoetina alfa u 1 ml (60 µg/ml).
It is normal to see a drop of liquid at the end of the needle or yellow safety guard.
Na vrhu igle ili žutog sigurnosnog štitnika može se naći kap tekućine, što je normalno.
Aranesp 15 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 15 micrograms of darbepoetin alfa in 0.375 mL (40 mcg/mL).
Aranesp 15 mikrograma otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica sadrži 15 mikrograma darbepoetina alfa u 0,375 ml (40 µg/ml).
EU/1/01/185/107 4 Pack
EU/1/01/185/107 pakiranje od 4
Aranesp 300 micrograms solution for injection pre-filled pen EU/1/01/185/055 - 1 pack
Aranesp 300 mikrograma otopina za injekciju u napunjenoj brizgalici EU/1/01/185/055 - pakiranje od 1
EU/1/01/185/032 4 Pack Blister
EU/1/01/185/032 pakiranje od 4
Aranesp 200 micrograms solution for injection vial EU/1/01/185/108 1 Pack
Aranesp 200 mikrograma otopina za injekciju u bočici EU/1/01/185/108 pakiranje od 1
INFORMATION IN BRAILLE Aranesp 40 syringe
16. PODACI NA BRAILLEOVOM PISMU Aranesp 40 štrcaljka
Aranesp 500 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 3.79 mg of sodium in 1 mL.
Aranesp 500 mikrograma otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica sadrži 3,79 mg natrija u 1 ml.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Čuvati napunjenu štrcaljku u vanjskom pakiranju radi zaštite od svjetlosti.
Aranesp 40 micrograms solution for injection pre-filled pen EU/1/01/185/049 - 1 pack
Aranesp 40 mikrograma otopina za injekciju u napunjenoj brizgalici EU/1/01/185/049 - pakiranje od 1
Rash/erythemae
Osip/eriteme
MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/071
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/185/071
Aranesp 15 micrograms solution for injection in pre-filled pen Each pre-filled pen contains 1.42 mg of sodium in 0.375 mL.
Aranesp 15 mikrograma otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica sadrži 1,42 mg natrija u 0,375 ml.
H Firmly push the pre-filled pen down onto your skin until it stops moving.
H Čvrsto pritisnite napunjenu brizgalicu prema dolje koliko ide.
Aranesp 130 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 2.46 mg of sodium in 0.65 mL.
Aranesp 130 mikrograma otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 2,46 mg natrija u 0,65 ml.
Aranesp 80 micrograms solution for injection pre-filled pen EU/1/01/185/052 - 1 pack
Aranesp 80 mikrograma otopina za injekciju u napunjenoj brizgalici EU/1/01/185/052 - pakiranje od 1
Aranesp 40 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 40 micrograms of darbepoetin alfa in 0.4 mL (100 mcg/mL).
Aranesp 40 mikrograma otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 40 mikrograma darbepoetina alfa u 0,4 ml (100 μg/ml).
Aranesp 25 micrograms solution for injection in vial Each vial contains 3.79 mg of sodium.
Aranesp 25 mikrograma otopina za injekciju u bočici Svaka bočica sadrži 3,79 mg natrija.
Aranesp 500 micrograms solution for injection pre-filled pen EU/1/01/185/056 - 1 pack
Aranesp 500 mikrograma otopina za injekciju u napunjenoj brizgalici EU/1/01/185/056 - pakiranje od 1
Aranesp 200 micrograms solution for injection in vial.
Aranesp 200 mikrograma otopina za injekciju u bočici.
1 single use pre-filled syringe.
1 napunjena štrcaljka za jednokratnu uporabu.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA NAPUNJENOJ ŠTRCALJKI S PODLOŠKOM
Aranesp 30 micrograms solution for injection pre-filled pen EU/1/01/185/048 - 1 pack
Aranesp 30 mikrograma otopina za injekciju u napunjenoj brizgalici EU/1/01/185/048 - pakiranje od 1
When your syringe has been removed from the refrigerator and left at room temperature for approximately 30 minutes before injection it must either be used within 7 days or disposed of.
Jednom kad se štrcaljka izvadi iz hladnjaka i ostavi prije injiciranja na sobnoj temperaturi približno 30 minuta, mora se ili primijeniti u roku 7 dana ili zbrinuti.
INFORMATION IN BRAILLE Aranesp 300 syringe
16. PODACI NA BRAILLEOVOM PISMU Aranesp 300 brizgalica
Aranesp 15 micrograms solution for injection pre-filled pen EU/1/01/185/046 - 1 pack
Aranesp 15 mikrograma otopina za injekciju u napunjenoj brizgalici EU/1/01/185/046 - pakiranje od 1
Do not reuse the pre-filled syringe
Nemojte ponovno upotrebljavati iskorištenu štrcaljku.
STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 mL vial contains 60 micrograms darbepoetin alfa.
NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica od 1 ml sadrži 60 mikrograma darbepoetina alfa.
NAME OF THE MEDICINAL PRODUCT Aranesp 25 micrograms solution for injection in vial Darbepoetin alfa
Aranesp 25 mikrograma otopina za injekciju u bočici darbepoetin alfa
Aranesp 150 micrograms solution for injection pre-filled pen EU/1/01/185/054 - 1 pack
Aranesp 150 mikrograma otopina za injekciju u napunjenoj brizgalici EU/1/01/185/054 - pakiranje od 1
Aranesp 25 micrograms solution for injection vial EU/1/01/185/100 1 Pack
Aranesp 25 mikrograma otopina za injekciju u bočici EU/1/01/185/100 pakiranje od 1
INFORMATION IN BRAILLE Aranesp 30 syringe
16. PODACI NA BRAILLEOVOM PISMU Aranesp 30 štrcaljka
STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 mL vial contains 200 micrograms darbepoetin alfa.
NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica od 1 ml sadrži 200 mikrograma darbepoetina alfa.
INFORMATION IN BRAILLE Aranesp 130 pen
16. PODACI NA BRAILLEOVOM PISMU Aranesp 130 brizgalica
Aranesp 30 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 30 micrograms of darbepoetin alfa in 0.3 mL (100 mcg/mL).
Aranesp 30 mikrograma otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 30 mikrograma darbepoetina alfa u 0,3 ml (100 μg/ml).
Aranesp 300 micrograms solution for injection in vial Each vial contains 300 micrograms of darbepoetin alfa in 1 mL (300 mcg/mL).
Aranesp 300 mikrograma otopina za injekciju u bočici Svaka bočica sadrži 300 mikrograma darbepoetina alfa u 1 ml (300 µg/ml).
Aranesp 80 micrograms solution for injection in pre-filled syringe Each pre-filled syringe contains 80 micrograms of darbepoetin alfa in 0.4 mL (200 mcg/mL).
Aranesp 80 mikrograma otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 80 mikrograma darbepoetina alfa u 0,4 ml (200 μg/ml).
STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 mL vial contains 40 micrograms darbepoetin alfa.
NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica od 1 ml sadrži 40 mikrograma darbepoetina alfa.