FrancophonIA/ELRC3.0 huggingface dataset:
English: It could be a consequence of a pulmonary disorder (see section4 “Possible side effects”).
Slovenian: To je lahko posledica bolezni pljuč (glejte poglavje 4, "Možni neželeni učinki").
English: Do not attempt to give Lonquex to yourself without this training.
Slovenian: Brez teh napotkov si ne poskušajte zdravila Lonquex dati sami.
English: Dispose of this medicine as instructed by your doctor, pharmacist or nurse.
Slovenian: To zdravilo zavrzite v skladu z navodili svojega zdravnika, farmacevta ali medicinske sestre.
English: Skin reactions such as erythema and rash may occur.
Slovenian: Pojavijo se lahko kožne reakcije, kot sta eritem in izpuščaj.
English: It could be a consequence of a spleen disorder (see section4 “Possible side effects”).
Slovenian: To je lahko posledica bolezni vranice (glejte poglavje 4, "Možni neželeni učinki").
English: • if you have a cough, fever and difficulty breathing.
Slovenian: - če kašljate, imate zvišano telesno temperaturo ali težave z dihanjem.
English: How you should inject yourself
Slovenian: Kako si sami daste injekcijo
English: 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.
Slovenian: 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.
English: Open the blister and take the pre-filled syringe out of the blister.
Slovenian: Odprite pretisni omot in napolnjeno injekcijsko brizgo vzemite ven iz pretisnega omota.
English: Lonquex is a solution for injection (injection) in pre-filled syringe with a fixed injection needle in a blister.
Slovenian: Zdravilo Lonquex je raztopina za injiciranje (injekcija) v napolnjeni injekcijski brizgi s pritrjeno injekcijsko iglo v pretisnem omotu.
English: The safety and efficacy of Lonquex have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression, e.g. nitrosoureas.
Slovenian: Varnosti in učinkovitosti zdravila Lonquex niso ocenili pri bolnikih, ki prejemajo kemoterapijo, povezano z odloženo mielosupresijo, npr. derivate nitrozosečnine.
English: If you have any problems, please ask your doctor or nurse for help and advice.
Slovenian: Če imate kakršne koli težave, prosite za pomoč in nasvet svojega zdravnika ali medicinsko sestro.
English: • the abdomen (see grey areas in picture 3) avoiding the skin directly surrounding the navel.
Slovenian: - trebuh (glejte sive predele na sliki 3), pri čemer se izognite koži neposredno okoli popka.
English: 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
Slovenian: 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.
English: • the abdomen (see grey areas in picture 4) avoiding the skin directly surrounding the navel.
Slovenian: - trebuh (glejte sive predele na sliki 4), pri čemer se izognite koži neposredno okoli popka.
English: Lipegfilgrastim appears to be mainly eliminated by neutrophil-mediated clearance, which becomes saturated at higher doses.
Slovenian: Zdi se, da se lipegfilgrastim iz telesa izloča v glavnem z očistkom, sproženim z nevtrofilci, ki se pri večjih odmerkih zasiči.
English: EU/1/13/856/001 1 pre-filled syringe with safety device EU/1/13/856/002 1 pre-filled syringe
Slovenian: EU/1/13/856/001 1 napolnjena injekcijska brizga z varnostnim pripomočkom
English: • Headache.
Slovenian: - glavobol
English: No adverse events directly attributable to leukocytosis have been reported.
Slovenian: O neželenih učinkih, ki jih je mogoče pripisati neposredno levkocitozi, niso poročali.
English: Mean ± SD (d) Δ LS mean 95 % CI
Slovenian: Povprečje ± SD (d) Δ povprečje LS
English: A WBC count should be performed at regular intervals during therapy owing to the clinical effects of lipegfilgrastim and the potential for leukocytosis.
Slovenian: Med zdravljenjem je treba v rednih presledkih spremljati število belih krvnih celic zaradi kliničnih učinkov lipegfilgrastima in možnosti za levkocitozo.
English: 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).
Slovenian: Ti primeri so se na splošno pojavili pri bolnikih z napredovalimi malignimi boleznimi, sepso, uporabo več zdravil za kemoterapijo ali zdravljenih z aferezo
English: Most serious side effects
Slovenian: Najbolj resni neželeni učinki
English: What Lonquex is and what it is used for What Lonquex is
Slovenian: Kaj je zdravilo Lonquex in za kaj ga uporabljamo Kaj je zdravilo Lonquex
English: 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.
Slovenian: 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.
English: The solution is injected subcutaneously (SC).
Slovenian: Raztopina se injicira subkutano (s.c.).
English: What Lonquex looks like and contents of the pack
Slovenian: Izgled zdravila Lonquex in vsebina pakiranja
English: • Put used syringes into the puncture-proof container and keep this container out of the sight and reach of children.
Slovenian: - Uporabljene injekcijske brizge dajte v vsebnik, odporen na vbode, vsebnik hranite zunaj pogleda in dosega otrok.
English: Breast-feeding should be discontinued during treatment with Lonquex.
Slovenian: Med zdravljenjem z zdravilom Lonquex je treba prenehati z dojenjem.
English: Solution for injection in pre-filled syringe (injection) Clear, colourless solution
Slovenian: raztopina za injiciranje v napolnjeni injekcijski brizgi (injekcija) bistra, brezbarvna raztopina
English: No pharmacokinetic data are available in patients ≥ 75 years.
Slovenian: Farmakokinetični podatkih za bolnike, stare 75 let ali več,
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and local tolerance.
Slovenian: 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.
English: While the plunger is still pressed all the way down, remove the needle from the skin (see picture 10).
Slovenian: Medtem ko pritiskate na bat, izvlecite iglo iz kože (glejte sliko 10).
English: 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).
Slovenian: Kožo na mestu injiciranja razkužite z alkoholno krpico in kožo primite med palec in kazalec, vendar je ne stiskajte (glejte sliko 7).
English: 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.
Slovenian: 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.
English: Hypokalaemia has been reported (see section 4.4).
Slovenian: Poročali so o hipokaliemiji (glejte poglavje 4.4).
English: 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.
Slovenian: Za vsak cikel kemoterapije se priporoča en 6 mg odmerek lipegfilgrastima (ena napolnjena injekcijska brizga zdravila Lonquex), približno 24 ur po citotoksični kemoterapiji.
English: Avoid vigorous shaking.
Slovenian: Ne stresajte sunkovito.
English: Hold the syringe and gently remove the cover from the needle without twisting.
Slovenian: Držite injekcijsko brizgo in nežno in brez sukanja potegnite pokrovček z igle.
English: 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.
Slovenian: 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
English: 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).
Slovenian: Kožo na mestu injiciranja razkužite z alkoholno krpico in kožo primite med palec in kazalec, vendar je ne stiskajte (glejte sliko 6).
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC BIOLOŠKE UČINKOVINE IN IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
English: Musculoskeletal pains*
Slovenian: Zelo pogosti mišično-skeletna bolečina*
English: These pulmonary adverse reactions may also include pulmonary oedema, pulmonary infiltrates, pulmonary fibrosis, respiratory failure or ARDS (see section 4.4).
Slovenian: Ti neželeni učinki na pljuča lahko vključujejo tudi pljučni edem, pljučne infiltrate, pljučno fibrozo,
English: Injection site reactions such as injection site induration and injection site pain may occur.
Slovenian: Pojavijo se lahko reakcije na mestu injiciranja, kot sta zatrdlina ali bolečina na mestu injiciranja.
English: Injection site reactions*
Slovenian: Občasni reakcije na mestu injiciranja*
English: Limited patient data indicate that the pharmacokinetics of lipegfilgrastim in elderly patients (65 - 74 years) is similar to that in younger patients.
Slovenian: Starejši bolniki Omejeni podatki o bolnikih kažejo, da je farmakokinetika pegfilgrastima pri starejših bolnikih (65
English: Urinalysis monitoring is recommended (see section 4.8).
Slovenian: Priporočljivo je spremljanje urina z analizo (glejte poglavje 4.8).
English: Elderly patients
Slovenian: Posebne populacije Starejši bolniki
English: Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported (see section 4.4).
Slovenian: Poročali so o neželenih učinkih na pljuča, še zlasti o intersticijski pljučnici (glejte poglavje 4.4).
English: 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.
Slovenian: 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.
English: The active substance is a covalent conjugate of filgrastim** with methoxy polyethylene glycol (PEG) via a carbohydrate linker.
Slovenian: Učinkovina je kovalentni konjugat filgrastima** z metoksipolietilenglikolom (PEG) z veznim ogljikovim hidratom.
English: • if you get left upper abdominal pain or pain at the tip of your shoulder.
Slovenian: - če začutite bolečino v zgornjem levem delu trebuha ali bolečino v konici rame.
English: Very common
Slovenian: Zelo pogosti navzea*
English: • Coughing up blood.
Slovenian: - izkašljevanje krvi
English: Pulmonary adverse reactions*, Pulmonary Haemorrhage
Slovenian: Občasni neželeni učinki na pljuča*, pljučna hemoragija
English: Patients were randomised 1:1 to receive 6 mg lipegfilgrastim or 6 mg pegfilgrastim.
Slovenian: 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.
English: Granulocyte-colony stimulating factor can promote growth of myeloid cells and some non-myeloid cells in vitro.
Slovenian: Bolniki z mieloično levkemijo ali mielodisplastičnimi sindromi Granulocitne kolonije stimulirajoči faktor lahko spodbudi rast mieloičnih celic in nekaterih nemieloičnih celic in vitro.
English: • The active substance is lipegfilgrastim.
Slovenian: - Učinkovina je lipegfilgrastim.
English: Water for injections
Slovenian: Priprava na injiciranje
English: Hypokalaemia may occur (see section 4.8).
Slovenian: Hipokaliemija Pojavi se lahko hipokaliemija (glejte poglavje 4.8).
English: Renal and urinary disorders - Glomerulonephritis (see section 4.4)
Slovenian: - glomerulonefritis (glejte poglavje 4.4)
English: 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).
Slovenian: 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,
English: Lonquex 6 mg injection lipegfilgrastim
Slovenian: Lonquex 6 mg injekcija lipegfilgrastim s.c.
English: No lipegfilgrastim therapy should be commenced in these patients because of the risk of cross-reaction.
Slovenian: Zaradi tveganja navzkrižne reakcije zdravljenja z lipegfilgrastimom pri teh bolnikih ne smete uvesti.
English: Name and address of the manufacturers responsible for batch release
Slovenian: Ime in naslov izdelovalcev, odgovornih za sproščanje serij Teva Biotech GmbH
English: Splenomegaly, generally asymptomatic, has been reported (see section 4.4).
Slovenian: Poročali so o običajno asimptomatski splenomegaliji (glejte poglavje 4.4).
English: Sodium.
Slovenian: natrij
English: • 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).
Slovenian: - 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.
English: 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.
Slovenian: 506 bolnikov in 76 zdravih prostovoljcev, ki so vsaj enkrat dobili lipegfilgrastim.
English: With the syringe pointing upwards, expel all air from the syringe by pushing the plunger slowly upwards.
Slovenian: Injekcijsko brizgo držite v pokončnem položaju, počasi potiskajte bat navzgor in tako iztisnite ves zrak iz injekcijske brizge.
English: 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).
Slovenian: 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).
English: 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).
Slovenian: Študija je pokazala, da 6 mg lipegfilgrastima v primerjavi s 6 mg pegfilgrastima v prvem ciklu kemoterapije ni bilo slabših glede primarnega opazovanega dogodka,
English: 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.
Slovenian: 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.
English: Increased risk of disease progression or death was not observed with lipegfilgrastim.
Slovenian: Z lipegfilgrastimom niso opazili povečanega tveganja za napredovanje bolezni ali smrt.
English: DSN
Slovenian: THN
English: 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).
Slovenian: Vse, kar potrebujete, položite na doseg roke (napolnjeno injekcijsko iglo z zdravilom Lonquex, alkoholno krpico in kos gaze ali sterilni zloženec).
English: Nausea was very commonly observed in patients receiving chemotherapy.
Slovenian: Pri bolnikih, ki so prejemali kemoterapijo, so zelo pogosto poročali o navzei.
English: Press the injection site with a piece of gauze bandage or a sterile gauze swab for several seconds.
Slovenian: S kosom gaze ali sterilnega zloženca nekaj sekund pritiskajte na mesto injiciranja.
English: Excessive shaking may aggregate lipegfilgrastim, rendering it biologically inactive.
Slovenian: Pretirano stresanje lahko povzroči agregacijo lipegfilgrastima,
English: 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.
Slovenian: 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.
English: Do not pick up the pre-filled syringe by the plunger or needle cover.
Slovenian: Napolnjene injekcijske brizge ne dvigujte za bat ali pokrovček igle.
English: Thrombocytopenia and leukocytosis have been reported (see section 4.4).
Slovenian: Poročali so o trombocitopeniji in levkocitozi (glejte poglavje 4.4).
English: The first pivotal (phase III) clinical study XM22-03 was an active-controlled study in 202 patients with stage II-IV breast cancer receiving up to 4 cycles of chemotherapy consisting of doxorubicin and docetaxel.
Slovenian: 202 bolnikoma z rakom dojke stopnje II-IV, ki so prejemali do 4 cikle kemoterapije, sestavljene iz doksorubicina in docetaksela.
English: Glomerulonephritis has been reported in patients receiving filgrastim, lenograstim or pegfilgrastim.
Slovenian: Pri bolnikih, ki so prejemali filgrastim, lenograstim ali pegfilgrastim, so poročali o glomerulonefritisu.
English: **Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor [G-CSF]) is produced in Escherichia coli cells by recombinant DNA technology.
Slovenian: granulocyte-colony stimulating factor]) je pridobljen s tehnologijo rekombinantne DNA v celicah Escherichiae coli.
English: • Reduction in blood platelets, which increases risk of bleeding or bruising.
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) - zmanjšanje števila krvnih ploščic, kar poveča tveganje za krvavitve ali modrice
English: Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported mostly in cancer patients undergoing chemotherapy after administration of G-CSF or derivatives (see section 4.4 and section 4.8).
Slovenian: Zlasti pri bolnikih z rakom, ki so prejemali kemoterapijo, so po uporabi G-CSF ali derivatov poročali o sindromu kapilarne prepustnosti, ki je lahko smrtno nevaren, če ni zdravljen takoj; glejte poglavje 4.4 in poglavje 4.8.
English: • Damage to the tiny filters inside your kidneys (glomerulonephritis; see section 2 under
Slovenian: poškodujejo drobne filtre v ledvicah (glomerulonefritis; glejte poglavje 4, "Možni neželeni učinki").
English: A trend towards a decrease in lipegfilgrastim exposure was observed with increase in weight.
Slovenian: Z višanjem telesne mase so opazili trend proti nižanju izpostavljenosti lipegfilgrastimu.
English: Lipegfilgrastim is metabolised via intra- or extracellular degradation by proteolytic enzymes.
Slovenian: Lipegfilgrastim se presnavlja z znotrajcelično in zunajcelično razgradnjo s pomočjo proteolitičnih encimov.
English: When to use Lonquex
Slovenian: Kdaj uporabljati zdravilo Lonquex
English: Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after administration of lipegfilgrastim (see section 4.8).
Slovenian: Po dajanju lipegfilgrastima so poročali o neželenih učinkih na pljuča, še zlasti o intersticijski pljučnici (glejte poglavje 4.8).
English: Each pre-filled syringe contains 6 mg lipegfilgrastim.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 6 mg lipegfilgrastima.
English: • Low blood levels of potassium, which can cause muscle weakness, twitching or abnormal heart rhythm.
Slovenian: - kožne reakcije, kot je rdečina ali izpuščaj - nizka raven kalija v krvi, kar povzroča mišično oslabelost, trzanje ali nenormalen srčni ritem - bolečine v prsnem košu
English: After a single subcutaneous injection of 6 mg lipegfilgrastim during the fourth cycle, the maximum blood concentrations were lower than observed in the first cycle (mean values 77 and 111 ng/ml) and were reached after median tmax of 8 hours.
Slovenian: Po enem subkutanem injiciranju 6 mg lipegfilgrastima v četrtem ciklu so bile največje koncentracije v krvi nižje kot v prvem ciklu (povprečni vrednosti 77 in
English: Filgrastim is an un-glycosylated recombinant methionyl human G-CSF.
Slovenian: Filgrastim je neglikozilirani rekombinantni metionil humani
English: How to use Lonquex
Slovenian: Kako uporabljati zdravilo Lonquex
English: Patients with renal or hepatic impairment
Slovenian: Bolniki z ledvično in jetrno okvaro
English: How Lonquex works
Slovenian: Kako deluje zdravilo Lonquex
English: Each pre-filled syringe contains 6 mg lipegfilgrastim in 0.6 ml solution.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 6 mg lipegfilgrastima v 0,6 ml raztopine.
English: • Dispose of the full puncture-proof container as instructed by your doctor, pharmacist or nurse.
Slovenian: - Poln vsebnik, odporen na vbode, odvrzite v skladu z navodili, ki ste jih dobili pri svojem zdravniku, farmacevtu ali medicinski sestri.
English: Leukocytosis may occur (see section 4.8).
Slovenian: Pojavi se lahko levkocitoza (glejte poglavje 4.8).
English: Talk to your doctor, pharmacist or nurse BEFORE using Lonquex
Slovenian: PRED začetkom uporabe zdravila Lonquex se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: Sickle cell crisis has been associated with the use of G-CSF or derivatives in patients with sickle cell anaemia (see section 4.8).
Slovenian: Bolniki s srpastocelično anemijo Srpastocelična kriza je povezana z uporabo G-CSF ali derivatov pri bolnikih s srpastocelično anemijo