natgillin/translations-raw huggingface dataset:
Once-per-cycle dosing of lipegfilgrastim was investigated in two pivotal randomised, double-blind clinical studies in patients undergoing myelosuppressive chemotherapy.
Odmerjanje lipegfilgrastima enkrat na cikel so preučili v dveh osrednjih randomiziranih, dvojno slepih kliničnih študijah pri bolnikih, zdravljenih z mielosupresivno kemoterapijo.
If you use more Lonquex than you should, talk to your doctor.
Če ste uporabili večji odmerek zdravila Lonquex, kot bi smeli Če ste uporabili večji odmerek zdravila Lonquex, kot bi smeli, se posvetujte z zdravnikom.
You will normally inject your dose of Lonquex approximately 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.
Običajno si boste odmerek zdravila Lonquex injicirali približno 24 ur po zadnjem odmerku kemoterapije ob koncu vsakega cikla kemoterapije.
The onset of pulmonary symptoms such as cough, fever and dyspnoea in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function together with an increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS) (see section 4.8).
Pojav pljučnih simptomov kot so kašelj, zvišana telesna temperatura in dispneja v povezavi z radiološkimi znaki pljučnih infiltratov in poslabšanjem delovanja pljuč skupaj z zvišanjem števila nevtrofilcev so lahko predhodni znaki sindroma akutne dihalne stiske pri odraslih (Acute Respiratory
Open the blister and take the pre-filled syringe out of the blister (see picture 1).
Odprite pretisni omot in napolnjeno injekcijsko brizgo vzemite ven iz pretisnega omota (glejte sliko 1).
Inject the liquid into the tissue slowly and evenly, always keeping your skin pinched.
Tekočino si počasi in enakomerno injicirajte v tkivo, pri tem pa ves čas držite kožo.
Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely with other medicines like this one (e.g. filgrastim, lenograstim or pegfilgrastim of the group of G-CSFs).
Pri bolnikih z rakom so redko poročali o vnetju aorte (velike žile, ki prenaša kri od srca po telesu) z drugimi zdravili, kot je to (npr. filgrastim, lenograstim ali pegfilgrastim skupine G-CSF).
In the case of overdose, WBC and platelet count should be performed regularly and spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
V primeru prevelikega odmerjanja je treba redno spremljati število belih krvnih celic in trombocitov ter skrbno nadzirati velikost vranice (npr. s kliničnim pregledom, z ultrazvokom).
Regular monitoring of the platelet count and haematocrit is recommended.
Priporoča se redno spremljanje števila trombocitov in hematokrita.
• The other ingredients (excipients) are glacial acetic acid, sodium hydroxide , sorbitol (E420), polysorbate 20 and water for injections.
- Druge sestavine zdravila (pomožne snovi) so ledocetna kislina, natrijev hidroksid, sorbitol (E420), polisorbat 20 in voda za injekcije.
Capillary leak syndrome has been reported after administration of G-CSF or derivatives and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration.
Neželeni učinki, povezani z žiljem Po uporabi G-CSF ali derivatov so poročali o sindromu kapilarne prepustnosti, za katerega so značilni hipotenzija, hipoalbuminemija, edemi in hemokoncentracija.
If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.
Če ste negotovi glede samoinjiciranja ali če imate kakšna vprašanja, se za pomoč obrnite na svojega zdravnika ali medicinsko sestro.
Lipegfilgrastim may also cause reversible thrombocytopenia (see section 4.8).
Lipegfilgrastim lahko povzroči tudi reverzibilno trombocitopenijo (glejte poglavje 4.8).
Each pre-filled syringe contains 30 mg sorbitol.
Ena napolnjena injekcijska brizga vsebuje 30 mg sorbitola.
The recommended dose is one pre-filled syringe (6 mg lipegfilgrastim) once per chemotherapy cycle.
Priporočeni odmerek je Priporočeni odmerek je ena napolnjena injekcijska brizga (6 mg lipegfilgrastima) enkrat na cikel kemoterapije.
In 3 studies (XM22-01, XM22-05, XM22-06) in healthy volunteers, the maximum blood concentration was reached after a median of 30 to 36 hours and the average terminal half-life ranged from approximately 32 to 62 hours after a single subcutaneous injection of 6 mg lipegfilgrastim.
V 3 študijah (XM22-01, XM22-05, XM22-06) z zdravimi prostovoljci je bila največja koncentracija v krvi dosežena po mediani 30 do 36 ur, povprečni končni razpolovni čas pa je bil v razponu od približno 32 do 62 ur po subkutanem injiciranju enega odmerka 6 mg lipegfilgrastima.
Δ LS mean (least square mean difference lipegfilgrastim - placebo), CI and p-value out of multivariate Poisson regression analysis
Δ povprečje LS (povprečna razlika najmanjših kvadratov lipegfilgrastim - placebo), IZ in vrednost p iz multivariantne Poissonove regresijske analize
Excipients: Glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 20 and water for injections.
Pomožne snovi: ledocet, natrijev hidroksid, sorbitol (E420), polisorbat 20 in voda za injekcije.
Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the pre-filled syringe after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki napolnjene injekcijske brizge poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
What Lonquex is and what it is used for What you need to know before you use Lonquex How to use Lonquex
Kaj je zdravilo Lonquex in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Lonquex Kako uporabljati zdravilo Lonquex Možni neželeni učinki
If you forget to use Lonquex
Če ste pozabili uporabiti zdravilo Lonquex
In such circumstances Lonquex should be discontinued at the discretion of the physician and appropriate treatment given.
Lonquex po presoji zdravnika prekiniti in bolnika ustrezno zdraviti.
There is no experience with overdose of lipegfilgrastim.
Izkušenj s prevelikim odmerjanjem lipegfilgrastima ni.
• Never put the syringes that you have used into your normal household rubbish bin.
- Uporabljenih injekcijskih brizg nikoli ne odložite v koš, ki ga uporabljate za odlaganje ostalih gospodinjskih odpadkov.
Lipegfilgrastim is a covalent conjugate of filgrastim with a single methoxy polyethylene glycol (PEG) molecule via a carbohydrate linker consisting of glycine, N-acetylneuraminic acid and N-acetylgalactosamine.
Lipegfilgrastim je kovalentni konjugat filgrastima z eno samo molekulo metoksipolietilenglikola (PEG), z veznim ogljikovim hidratom, sestavljenim iz glicina, N-acetilnevraminske kisline in
Incidence (%) 95 % CI
Incidenca (%) 95-% IZ
Lonquex contains the active substance lipegfilgrastim.
Zdravilo Lonquex vsebuje učinkovino lipegfilgrastim.
It could be a consequence of a pulmonary disorder (see section4 “Possible side effects”).
To je lahko posledica bolezni pljuč (glejte poglavje 4, "Možni neželeni učinki").
Do not attempt to give Lonquex to yourself without this training.
Brez teh napotkov si ne poskušajte zdravila Lonquex dati sami.
Dispose of this medicine as instructed by your doctor, pharmacist or nurse.
To zdravilo zavrzite v skladu z navodili svojega zdravnika, farmacevta ali medicinske sestre.
Skin reactions such as erythema and rash may occur.
Pojavijo se lahko kožne reakcije, kot sta eritem in izpuščaj.
It could be a consequence of a spleen disorder (see section4 “Possible side effects”).
To je lahko posledica bolezni vranice (glejte poglavje 4, "Možni neželeni učinki").
• if you have a cough, fever and difficulty breathing.
- če kašljate, imate zvišano telesno temperaturo ali težave z dihanjem.
How you should inject yourself
Kako si sami daste injekcijo
After a single subcutaneous injection of 6 mg lipegfilgrastim during the fourth cycle, the mean maximum blood concentration of 149 ng/ml was reached after a median tmax of 8 hours and the mean terminal half-life was approximately 34 hours.
Po enem subkutanem injiciranju 6 mg lipegfilgrastima v četrtem ciklu je bila povprečna najvišja koncentracija v krvi 149 ng/ml dosežena po 8 urnem medianem tmax, povprečni končni razpolovni čas pa je bil približno 34 ur.
Open the blister and take the pre-filled syringe out of the blister.
Odprite pretisni omot in napolnjeno injekcijsko brizgo vzemite ven iz pretisnega omota.
Lonquex is a solution for injection (injection) in pre-filled syringe with a fixed injection needle in a blister.
Zdravilo Lonquex je raztopina za injiciranje (injekcija) v napolnjeni injekcijski brizgi s pritrjeno injekcijsko iglo v pretisnem omotu.
The safety and efficacy of Lonquex have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression, e.g. nitrosoureas.
Varnosti in učinkovitosti zdravila Lonquex niso ocenili pri bolnikih, ki prejemajo kemoterapijo, povezano z odloženo mielosupresijo, npr. derivate nitrozosečnine.
If you have any problems, please ask your doctor or nurse for help and advice.
Če imate kakršne koli težave, prosite za pomoč in nasvet svojega zdravnika ali medicinsko sestro.
• the abdomen (see grey areas in picture 3) avoiding the skin directly surrounding the navel.
- trebuh (glejte sive predele na sliki 3), pri čemer se izognite koži neposredno okoli popka.
In a study of toxicity to reproduction and development in rabbits, an increased incidence of post-implantation loss and abortion has been observed at high doses of lipegfilgrastim, likely owing to
V študiji vpliva na sposobnost razmnoževanja in razvoja pri kuncih so pri visokih odmerkih lipegfilgrastima opazili večjo incidenco izgube po ugnezdenju in abortusov, kar je verjetno posledica poudarjenega farmakološkega učinka, ki je specifičen za kunce.
• the abdomen (see grey areas in picture 4) avoiding the skin directly surrounding the navel.
- trebuh (glejte sive predele na sliki 4), pri čemer se izognite koži neposredno okoli popka.
Lipegfilgrastim appears to be mainly eliminated by neutrophil-mediated clearance, which becomes saturated at higher doses.
Zdi se, da se lipegfilgrastim iz telesa izloča v glavnem z očistkom, sproženim z nevtrofilci, ki se pri večjih odmerkih zasiči.
EU/1/13/856/001 1 pre-filled syringe with safety device EU/1/13/856/002 1 pre-filled syringe
EU/1/13/856/001 1 napolnjena injekcijska brizga z varnostnim pripomočkom
• Headache.
- glavobol
No adverse events directly attributable to leukocytosis have been reported.
O neželenih učinkih, ki jih je mogoče pripisati neposredno levkocitozi, niso poročali.
Mean ± SD (d) Δ LS mean 95 % CI
Povprečje ± SD (d) Δ povprečje LS
A WBC count should be performed at regular intervals during therapy owing to the clinical effects of lipegfilgrastim and the potential for leukocytosis.
Med zdravljenjem je treba v rednih presledkih spremljati število belih krvnih celic zaradi kliničnih učinkov lipegfilgrastima in možnosti za levkocitozo.
These have generally occurred in patients suffering from advanced malignant diseases, having sepsis, taking multiple chemotherapy medicinal products or undergoing apheresis (see section 4.4).
Ti primeri so se na splošno pojavili pri bolnikih z napredovalimi malignimi boleznimi, sepso, uporabo več zdravil za kemoterapijo ali zdravljenih z aferezo
Most serious side effects
Najbolj resni neželeni učinki
What Lonquex is and what it is used for What Lonquex is
Kaj je zdravilo Lonquex in za kaj ga uporabljamo Kaj je zdravilo Lonquex
In a phase 1 study of 21 children aged between 2 and 16 years with Ewing family of tumours or rhabdomyosarcoma, lipegfilgrastim was administered as a single subcutaneous dose of 100 μg/kg (up to a maximum of 6 mg, which is the fixed dose for adults) 24 hours after the end of the last chemotherapy treatment in week 1 of the regimen.
V študiji faze 1 pri 21 otrocih, starih med 2 in 16 let s tumorji Ewingove družine ali rabdomiosarkomom, so lipegfilgrastim dajali v obliki enega subkutanega odmerka 100 μg/kg (do največ 6 mg, kar je točno določeni odmerek za odrasle) 24 ur po koncu zadnjega zdravljenja s kemoterapijo v 1. tednu sheme zdravljenja.
The solution is injected subcutaneously (SC).
Raztopina se injicira subkutano (s.c.).
What Lonquex looks like and contents of the pack
Izgled zdravila Lonquex in vsebina pakiranja
• Put used syringes into the puncture-proof container and keep this container out of the sight and reach of children.
- Uporabljene injekcijske brizge dajte v vsebnik, odporen na vbode, vsebnik hranite zunaj pogleda in dosega otrok.
Breast-feeding should be discontinued during treatment with Lonquex.
Med zdravljenjem z zdravilom Lonquex je treba prenehati z dojenjem.
Solution for injection in pre-filled syringe (injection) Clear, colourless solution
raztopina za injiciranje v napolnjeni injekcijski brizgi (injekcija) bistra, brezbarvna raztopina
No pharmacokinetic data are available in patients ≥ 75 years.
Farmakokinetični podatkih za bolnike, stare 75 let ali več,
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and local tolerance.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri enkratnem odmerku in ponavljajočih se odmerkih in študij lokalne tolerance ne kažejo posebnega tveganja za človeka.
While the plunger is still pressed all the way down, remove the needle from the skin (see picture 10).
Medtem ko pritiskate na bat, izvlecite iglo iz kože (glejte sliko 10).
Disinfect the injection site on the skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 7).
Kožo na mestu injiciranja razkužite z alkoholno krpico in kožo primite med palec in kazalec, vendar je ne stiskajte (glejte sliko 7).
A post-authorisation safety study XM22-ONC-40041 was conducted to collect data of disease progression and mortality in patients with advanced squamous or non-squamous cell lung cancer receiving lipegfilgrastim in addition to the platinum-based chemotherapy.
Razmerje obetov (lipegfilgrastim/placebo), IZ in vrednost p iz multivariantne logistične regresijske analize Izvedli so študijo varnosti XM22-ONC-40041 za pridobitev podatkov o napredovanju bolezni in smrtnosti pri bolnikih z napredovalim ploščatoceličnim ali neskvamoznim rakom pljuč, ki so prejemali lipegfilgrastim poleg kemoterapije na podlagi platine.
Hypokalaemia has been reported (see section 4.4).
Poročali so o hipokaliemiji (glejte poglavje 4.4).
One 6 mg dose of lipegfilgrastim (a single pre-filled syringe of Lonquex) is recommended for each chemotherapy cycle, given approximately 24 hours after cytotoxic chemotherapy.
Za vsak cikel kemoterapije se priporoča en 6 mg odmerek lipegfilgrastima (ena napolnjena injekcijska brizga zdravila Lonquex), približno 24 ur po citotoksični kemoterapiji.
Avoid vigorous shaking.
Ne stresajte sunkovito.
Hold the syringe and gently remove the cover from the needle without twisting.
Držite injekcijsko brizgo in nežno in brez sukanja potegnite pokrovček z igle.
After subcutaneous injection of 6 mg lipegfilgrastim at three different sites (upper arm, abdomen and thigh) in healthy volunteers, the bioavailability (peak concentration and area under the curve [AUC]) was lower after subcutaneous injection in the thigh compared to subcutaneous injection in the abdomen and in the upper arm.
Po subkutanem injiciranju 6 mg lipegfilgrastima v tri različne predele (nadlaket, trebuh in stegno) zdravim prostovoljcem je bila biološka uporabnost (največja koncentracija in površina pod krivuljo
Disinfect the injection site on the skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 6).
Kožo na mestu injiciranja razkužite z alkoholno krpico in kožo primite med palec in kazalec, vendar je ne stiskajte (glejte sliko 6).
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE UČINKOVINE IN IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
Musculoskeletal pains*
Zelo pogosti mišično-skeletna bolečina*
These pulmonary adverse reactions may also include pulmonary oedema, pulmonary infiltrates, pulmonary fibrosis, respiratory failure or ARDS (see section 4.4).
Ti neželeni učinki na pljuča lahko vključujejo tudi pljučni edem, pljučne infiltrate, pljučno fibrozo,
Injection site reactions such as injection site induration and injection site pain may occur.
Pojavijo se lahko reakcije na mestu injiciranja, kot sta zatrdlina ali bolečina na mestu injiciranja.
Injection site reactions*
Občasni reakcije na mestu injiciranja*
Limited patient data indicate that the pharmacokinetics of lipegfilgrastim in elderly patients (65 - 74 years) is similar to that in younger patients.
Starejši bolniki Omejeni podatki o bolnikih kažejo, da je farmakokinetika pegfilgrastima pri starejših bolnikih (65
Urinalysis monitoring is recommended (see section 4.8).
Priporočljivo je spremljanje urina z analizo (glejte poglavje 4.8).
Elderly patients
Posebne populacije Starejši bolniki
Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported (see section 4.4).
Poročali so o neželenih učinkih na pljuča, še zlasti o intersticijski pljučnici (glejte poglavje 4.4).
In a study (XM22-04) in patients with non-small cell lung cancer receiving chemotherapy consisting of cisplatin and etoposide, the mean maximum blood concentration of 317 ng/ml was reached after a median tmax of 24 hours and the mean terminal half-life was approximately 28 hours after a single subcutaneous injection of 6 mg lipegfilgrastim during the first cycle of chemotherapy.
V študiji (XM22-04) z bolniki z nedrobnoceličnim rakom pljuč, ki so prejemali kemoterapijo, sestavljeno iz cisplatina in etopozida, je bila največja koncentracija v krvi 317 ng/ml dosežena po medianem tmax 24 ur, povprečni končni razpolovni čas pa je bil približno 28 ur po enem subkutanem injiciranju 6 mg lipegfilgrastima v prvem ciklu kemoterapije.
The active substance is a covalent conjugate of filgrastim** with methoxy polyethylene glycol (PEG) via a carbohydrate linker.
Učinkovina je kovalentni konjugat filgrastima** z metoksipolietilenglikolom (PEG) z veznim ogljikovim hidratom.
• if you get left upper abdominal pain or pain at the tip of your shoulder.
- če začutite bolečino v zgornjem levem delu trebuha ali bolečino v konici rame.
Very common
Zelo pogosti navzea*
• Coughing up blood.
- izkašljevanje krvi
Pulmonary adverse reactions*, Pulmonary Haemorrhage
Občasni neželeni učinki na pljuča*, pljučna hemoragija
Patients were randomised 1:1 to receive 6 mg lipegfilgrastim or 6 mg pegfilgrastim.
Bolniki so bili randomizirani v razmerju 1:1 v skupino, ki je prejemala 6 mg lipegfilgrastima ali v skupino, ki je prejemala 6 mg pegfilgrastima.
Granulocyte-colony stimulating factor can promote growth of myeloid cells and some non-myeloid cells in vitro.
Bolniki z mieloično levkemijo ali mielodisplastičnimi sindromi Granulocitne kolonije stimulirajoči faktor lahko spodbudi rast mieloičnih celic in nekaterih nemieloičnih celic in vitro.
• The active substance is lipegfilgrastim.
- Učinkovina je lipegfilgrastim.
Water for injections
Priprava na injiciranje
Hypokalaemia may occur (see section 4.8).
Hipokaliemija Pojavi se lahko hipokaliemija (glejte poglavje 4.8).
Renal and urinary disorders - Glomerulonephritis (see section 4.4)
- glomerulonefritis (glejte poglavje 4.4)
Generally asymptomatic cases of splenomegaly have been reported after administration of lipegfilgrastim (see section 4.8) and infrequent cases of splenic rupture, including fatal cases, have been reported after administration of G-CSF or derivatives (see section 4.8).
Po uporabi lipegfilgrastima (glejte poglavje 4.8) so poročali o na splošno asimptomatskih primerih splenomegalije in po uporabi G-CSF ali derivatov so poročali občasnih primerih rupture vranice,
No lipegfilgrastim therapy should be commenced in these patients because of the risk of cross-reaction.
Zaradi tveganja navzkrižne reakcije zdravljenja z lipegfilgrastimom pri teh bolnikih ne smete uvesti.
Name and address of the manufacturers responsible for batch release
Ime in naslov izdelovalcev, odgovornih za sproščanje serij Teva Biotech GmbH
Splenomegaly, generally asymptomatic, has been reported (see section 4.4).
Poročali so o običajno asimptomatski splenomegaliji (glejte poglavje 4.4).
Sodium.
natrij
• Allergic reactions such as skin rash, raised itchy areas of skin and serious allergic reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the face have been reported uncommonly (may affect up to 1 in 100 people).
- Občasno (pojavijo se lahko pri največ 1 od 100 bolnikov) so poročali o alergijskih reakcijah, kot so kožni izpuščaj, izbočeni srbeči predeli kože in resne alergijske reakcije z oslabelostjo, padcem krvnega tlaka, težavami z dihanjem in oteklostjo obraza.
The safety of lipegfilgrastim has been evaluated based on results from clinical studies including 506 patients and 76 healthy volunteers treated at least once with lipegfilgrastim.
506 bolnikov in 76 zdravih prostovoljcev, ki so vsaj enkrat dobili lipegfilgrastim.
With the syringe pointing upwards, expel all air from the syringe by pushing the plunger slowly upwards.
Injekcijsko brizgo držite v pokončnem položaju, počasi potiskajte bat navzgor in tako iztisnite ves zrak iz injekcijske brizge.
Put everything you need within easy reach (the Lonquex pre-filled syringe, an alcohol wipe, a piece of gauze bandage or a sterile gauze swab and the puncture-proof container).
Vse, kar potrebujete, položite na doseg roke (napolnjeno injekcijsko iglo z zdravilom Lonquex, alkoholno krpico, kos gaze ali sterilni zloženec in vsebnik, odporen na vbode).
The study showed non-inferiority of 6 mg lipegfilgrastim to 6 mg pegfilgrastim for the primary endpoint, duration of severe neutropenia (DSN) in the first cycle of chemotherapy (see table 2).
Študija je pokazala, da 6 mg lipegfilgrastima v primerjavi s 6 mg pegfilgrastima v prvem ciklu kemoterapije ni bilo slabših glede primarnega opazovanega dogodka,
In a phase 1 study (see section 5.1), using a 10 mg/ml solution for subcutaneous injection specifically developed for the paediatric studies, the mean maximum blood concentrations (Cmax) were 243 ng/ml in the 2 to <6-year group, 255 ng/ml in the 6 to <12-year group and 224 ng/ml in the 12 to <18-year group after a single subcutaneous injection of 100 μg/kg (maximum 6 mg) lipegfilgrastim with the first cycle of chemotherapy.
specifično razvite za pediatrične študije, povprečne največje koncentracije v krvi (Cmax) 243 ng/ml v skupini 2 do < 6 let, 255 ng/ml v skupini 6 do < 12 let in 224 ng/ml v skupini 12 do < 18 let po enem subkutanem injiciranju 100 μg/kg (največ 6 mg) lipegfilgrastima s prvim ciklom kemoterapije.
Increased risk of disease progression or death was not observed with lipegfilgrastim.
Z lipegfilgrastimom niso opazili povečanega tveganja za napredovanje bolezni ali smrt.
DSN
THN
Put everything you need within easy reach (the Lonquex pre-filled syringe, an alcohol wipe and a piece of gauze bandage or a sterile gauze swab).
Vse, kar potrebujete, položite na doseg roke (napolnjeno injekcijsko iglo z zdravilom Lonquex, alkoholno krpico in kos gaze ali sterilni zloženec).
Nausea was very commonly observed in patients receiving chemotherapy.
Pri bolnikih, ki so prejemali kemoterapijo, so zelo pogosto poročali o navzei.
Press the injection site with a piece of gauze bandage or a sterile gauze swab for several seconds.
S kosom gaze ali sterilnega zloženca nekaj sekund pritiskajte na mesto injiciranja.
Excessive shaking may aggregate lipegfilgrastim, rendering it biologically inactive.
Pretirano stresanje lahko povzroči agregacijo lipegfilgrastima,
In 2 studies (XM22-02 and XM22-03) in patients with breast cancer receiving chemotherapy consisting of doxorubicin and docetaxel, mean maximum blood concentrations of 227 and 262 ng/ml were reached after median times to maximum concentration (tmax) of 44 and 48 hours.
sestavljeno iz doksorubicina in docetaksela, sta bili povprečni največji koncentraciji v krvi 227 in 262 ng/ml doseženi po medianem času do maksimalne koncentracije (tmax) 44 in 48 ur.