FrancophonIA/ELRC3.0 huggingface dataset:
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: 4.1 Therapeutic indications
Slovenian: 4.3 Kontraindikacije
English: These could be symptoms of condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body (see section 4).
Slovenian: To so lahko simptomi motnje, imenovane »sindrom kapilarne prepustnosti«, ki povzroči puščanje krvi iz drobnih krvnih žilic v telesu (glejte poglavje 4);
English: 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.
Slovenian: Običajni odmerek je ena 6-miligramska subkutana (podkožna) injekcija z uporabo napolnjene injekcijske brizge, ki jo morate prejeti vsaj 24 ur po zadnjem odmerku kemoterapije na koncu vsakega cikla kemoterapije.
English: *Sodium acetate is formed by titrating glacial acetic acid with sodium hydroxide.
Slovenian: * Natrijev acetat nastane s titracijo ledocetne kisline z natrijevim hidroksidom.
English: Other warnings
Slovenian: Druga opozorila
English: Preclinical data from conventional studies of repeated dose toxicity revealed the expected pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, extramedullary haematopoiesis and splenic enlargement.
Slovenian: Predklinični podatki na osnovi običajnih študij toksičnosti pri ponavljajočih odmerkih so razkrili pričakovane farmakološke učinke, ki so zajemali zvišanje števila levkocitov, mieloidno hiperplazijo v kostnem mozgu, ekstramedularno hematopoezo in povečanje vranice.
English: • If you have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung infiltration)
Slovenian: • če ste nedavno imeli hudo okužbo pljuč (pljučnico), tekočino v pljučih (pljučni edem), vnetje pljuč (intersticijsko pljučno bolezen) ali nenormalen izvid rentgenskega slikanja pljuč (pljučne infiltrate);
English: A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain.
Slovenian: Na diagnozo rupture vranice moramo biti pozorni pri bolnikih, ki poročajo o bolečini v zgornjem levem delu trebuha ali v predelu lopatice.
English: Concomitant use of pegfilgrastim with any chemotherapy medicinal product has not been evaluated in patients.
Slovenian: Sočasne uporabe pegfilgrastima s katerim koli kemoterapevtskim zdravilom pri bolnikih niso ovrednotili.
English: In rat studies, it was shown that pegfilgrastim may cross the placenta.
Slovenian: V študijah, opravljenih na podganah, se je izkazalo, da lahko pegfilgrastim prehaja skozi placento.
English: • serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).
Slovenian: • resne alergijske reakcije, vključno z anafilaksijo (slabost, padec krvnega tlaka, težave z dihanjem,
English: Clean the injection site with an alcohol wipe.
Slovenian: Mesto injiciranja očistite z alkoholnim robčkom.
English: Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for pegfilgrastim to filgrastim in patients with de novo acute myeloid leukaemia (AML) (see section 5.1).
Slovenian: Omejeno število kliničnih podatkov kaže na primerljiv učinek na čas do okrevanja od hude nevtropenije za pegfilgrastim oziroma filgrastim pri bolnikih z de novo akutno mieloično levkemijo (AML) (glejte poglavje 5.1).
English: In the absence of growth factor support, this regimen has been reported to result in a mean duration of grade 4 neutropenia of 5 to7 days, and a 30-40 % incidence of febrile neutropenia.
Slovenian: Poročajo, da je ta odmerna shema v odsotnosti podpore s strani rastnega faktorja povzročila nevtropenijo 4. stopnje, ki je povprečno trajala od 5 do 7 dni, in 30- do 40-odstotno incidenco febrilne nevtropenije.
English: These could be symptoms of an uncommon (may affect up to 1 in 100 people) condition called “Capillary Leak Syndrome”, which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.
Slovenian: To so lahko simptomi občasne motnje (pojavi se lahko pri 1 od 100 oseb), imenovane »sindrom kapilarne prepustnosti«, ki povzroči puščanje krvi iz drobnih krvnih žilic v telesu in zahteva nujno zdravniško pomoč.
English: Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ pegfilgrastim should be administered at least 24 hours after administration of cytotoxic chemotherapy.
Slovenian: Zaradi možne občutljivosti hitro se delečih mieloidnih celic za citotoksično kemoterapijo je treba pegfilgrastim dovajati vsaj 24 ur po dovajanju citotoksične kemoterapije.
English: OTHER Juta Pharma GmbH
Slovenian: Juta Pharma GmbH
English: • The expiry date printed on the label has passed the last day of the month shown.
Slovenian: • je že pretekel zadnji dan meseca, navedenega kot datum izteka roka uporabnosti, ki je natisnjen na nalepki.
English: (≥ 1/1,000 to
Slovenian: Občasni (≥1/1.000 do
English: The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. c-reactive protein and white blood cell count).
Slovenian: Simptomi so vključevali zvišano telesno temperaturo, bolečine v trebuhu, splošno slabo počutje, bolečine v hrbtu in zvišane označevalce vnetja (npr. število C-reaktivnega proteina in belih krvničk).
English: If you use more Grasustek than you should If you use more Grasustek than you should contact your doctor, pharmacist or nurse.
Slovenian: Če ste uporabili večji odmerek zdravila Grasustek, kot bi smeli Če uporabite več zdravila Grasustek, kot bi smeli, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
English: Urinalysis monitoring is recommended.
Slovenian: Priporočljivo je izvesti analizo urina.
English: • bleeding from the lung (pulmonary haemorrhage)
Slovenian: • krvavitev iz pljuč (pljučna hemoragija).
English: 13 24941 Flensburg Germany
Slovenian: 24941 Flensburg
English: Paediatric population The safety and efficacy of pegfilgrastim in children has not yet been established.
Slovenian: Varnost in učinkovitost pegfilgrastima pri otrocih še ni bila dokazana.
English: Iceland
Slovenian: Ísland
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 6 mg dose, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 6-miligramski odmerek, kar pomeni, da je praktično »brez natrija«.
English: Grasustek left at room temperature for more than 72 hours should be discarded.
Slovenian: Zdravilo Grasustek, ki je bilo sobni temperaturi izpostavljeno dlje kot za 72 ur, je treba zavreči.
English: Pegfilgrastim should not be administered to patients with a history of hypersensitivity to pegfilgrastim or filgrastim.
Slovenian: Pegfilgrastim se ne sme dajati bolnikom z znano preobčutljivostjo na pegfilgrastim ali filgrastim.
English: 4.4 Special warnings and precautions for use Traceability In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
English: • pain at the site of injection.
Slovenian: • bolečina na mestu injiciranja;
English: There are no or limited amount of data from the use of pegfilgrastim in pregnant women.
Slovenian: Podatkov o uporabi pegfilgrastima pri nosečnicah ni oziroma so ti omejeni.
English: ** The concentration is 20 mg/ml if the PEG moiety is included.
Slovenian: **Če je vključen še delež PEG, je koncentracija 20 mg/ml.
English: − The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections (see section 2).
Slovenian: − Druge sestavine so natrijev acetat, sorbitol (E420), polisorbat 20 in voda za injekcije (glejte poglavje 2).
English: Grasustek 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).
Slovenian: Zdravilo Grasustek 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).
English: Sweet's syndrome (acute febrile dermatosis)1,2;
Slovenian: Sweetov sindrom (akutna febrilna dermatoza)
English: -Release the plunger until the needle is covered and then remove the syringe from the injection site
Slovenian: - Sproščajte bat, dokler igla ni prekrita, nato pa iglo odstranite z mesta injiciranja.
English: In all cases, call your doctor or healthcare provider.
Slovenian: V vsakem od teh primerov se posvetujte s svojim zdravnikom ali izvajalcem storitev zdravstvenega varstva.
English: • increased spleen size.
Slovenian: • povečana vranica;
English: Very common side effects (may affect more than 1 in 10 people) • bone pain.
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 oseb): • bolečine v kosteh.
English: Reversible, mild to moderate elevations in uric acid and alkaline phosphatase, with no associated clinical effects, were uncommon; reversible, mild to moderate elevations in lactate dehydrogenase, with no associated clinical effects, were uncommon in patients receiving pegfilgrastim following cytotoxic chemotherapy.
Slovenian: Reverzibilno, blago do zmerno zvišanje sečne kisline in alkalne fosfataze brez pridruženih kliničnih učinkov se je pojavilo občasno; reverzibilno, blago do zmerno zvišanje laktatne dehidrogenaze brez pridruženih kliničnih učinkov se je pojavilo občasno pri bolnikih, ki so po citotoksični kemoterapiji prejemali pegfilgrastim.
English: • swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
Slovenian: • oteklost ali zabuhlost, ki jo lahko spremlja manj pogosto odvajanje urina, težko dihanje, oteklost trebuha in občutek polnosti ter splošen občutek utrujenosti.
English: Turn the plunger to move the label into a position where you can remove the syringe label.
Slovenian: Obrnite bat, da se nalepka igle obrne v položaj, v katerem jo lahko nato odstranite.
English: The overall rate of febrile neutropenia was 9 % of patients treated with pegfilgrastim and 18 % of patients treated with filgrastim (difference 9 %, 95 % CI of-16.8 %,-1.1 %).
Slovenian: Celotna pogostost febrilne nevtropenije je bila pri bolnikih, zdravljenih s pegfilgrastimom, 9 %, pri bolnikih, zdravljenih s filgrastimom, pa 18 % (razlika 9 %, 95-odstotni IZ je -16,8 %, -1,1 %).
English: Elevations in lactate dehydrogenase and alkaline phosphatase Transient elevations in LFTs for ALT or AST1
Slovenian: Preiskave zvišanje laktatdehidrogenaze in alkalne fosfataze1; prehodno zvišanje jetrnih funkcijskih testov za ALT ali
English: Single doses of 300 μg/kg have been administered subcutaneously to a limited number of healthy volunteers and patients with non-small cell lung cancer without serious adverse reactions.
Slovenian: Omejeno število zdravih prostovoljcev in bolnikov z nedrobnoceličnim pljučnim rakom je prejelo subkutane posamične odmerke 300 μg/kg brez resnih neželenih učinkov.
English: Capillary leak syndrome has been reported after granulocyte-colony stimulating factor administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration.
Slovenian: Po uporabi granulocitne kolonije spodbujajočega faktorja so poročali o sindromu kapilarne prepustnosti, za katerega so značilni hipotenzija, hipoalbuminemija, edemi in hemokoncentracije.
English: Preclinical safety data
Slovenian: Predklinični podatki o varnosti
English: • cutaneous vasculitis (inflammation of the blood vessels in the skin).
Slovenian: • kožni vaskulitis (vnetje krvnih žil v koži);
English: General The safety and efficacy of pegfilgrastim have not been investigated in patients receiving high dose chemotherapy.
Slovenian: Varnost in učinkovitost pegfilgrastima nista raziskani pri bolnikih, ki prejemajo kemoterapijo v velikih odmerkih.
English: Method of administration Grasustek is injected subcutaneously.
Slovenian: Zdravilo Grasustek se injicira subkutano.
English: Excipients: Sorbitol (E420), polysorbate 20, sodium acetate, water for injections.
Slovenian: SEZNAM POMOŽNIH SNOVI Pomožne snovi: sorbitol (E420), polisorbat 20, natrijev acetat, voda za injekcije.
English: Alvogen d.o.o.
Slovenian: Hrvatska Alvogen d.o.o.
English: Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Slovenian: Faktor, ki spodbuja rast granulocitnih kolonij, lahko spodbudi rast mieloičnih celic in vitro; podobni učinki bi se lahko pojavili pri nekaterih nemieloičnih celicah in vitro.
English: Pegfilgrastim should be permanently discontinued in patients with clinically significant hypersensitivity.
Slovenian: Pegfilgrastim je treba dokončno ukiniti pri bolnikih, pri katerih je prišlo do klinično pomembnih preobčutljivostnih reakcij.
English: Regular monitoring of platelet count and haematocrit is recommended.
Slovenian: Priporoča se redno spremljanje števila trombocitov in hematokrita.
English: The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1% versus 17 %, p < 0.001).
Slovenian: Pojav febrilne nevtropenije je bil nižji pri bolnicah, ki so dobivale pegfilgrastim, kot pa pri tistih, ki so dobivale placebo (1 % v primerjavi s 17 %, p <0,001).
English: Pegfilgrastim appears to be mainly eliminated by neutrophil mediated clearance, which becomes saturated at higher doses.
Slovenian: Zdi se, da se pegfilgrastim izloča v glavnem z očistkom, ki ga sprožijo nevtrofilci in ki se pri večjih odmerkih nasiti.
English: The symptoms can include fever, abdominal pain, malaise, back pain and increased inflammatory markers.
Slovenian: Simptomi lahko vključujejo zvišano telesno temperaturo, bolečine v trebuhu, splošno slabo počutje, bolečine v hrbtu in zvišane označevalce vnetja.
English: The syringes are provided with an automatic needle safety guard.
Slovenian: Brizge so na voljo z avtomatičnim ščitnikom igle.
English: Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain)
Slovenian: Bolezni mišično- bolečina v mišično-skeletna skeletnega sistema in vezivnega tkiva kosteh bolečina (mialgija, artralgija, bolečina v okončini, bolečina v hrbtu, mišičnoskeletna bolečina, bolečina v vratu)
English: Warning/Precaution: DO NOT twist the needle cover or touch the needle or plunger.
Slovenian: Opozorilo/previdnostni ukrep: Pokrovčka igle NE SUKAJTE in se ne dotikajte igle ali bata.
English: • are pregnant or breast-feeding
Slovenian: • ste noseči ali dojite;
English: Bucharest, Romania Tel: +40 21 318 0377
Slovenian: Tel: +40 21 318 0377
English: You may take Grasustek out of the refrigerator and keep it at room temperature (not above 30 °C) for no longer than 3 days.
Slovenian: Zdravilo Grasustek smete vzeti iz hladilnika in ga pri sobni temperaturi (pod 30 °C) hraniti največ 3 dni.
English: Driving and using machines Grasustek has no or negligible effect on the ability to drive or use machines.
Slovenian: Zdravilo Grasustek nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Do not remove the grey needle cap from the pre-filled syringe until you are ready to inject.
Slovenian: Ne odstranite sivega pokrovčka igle z napolnjene injekcijske brizge, dokler niste pripravljeni na injiciranje.
English: 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.
Slovenian: 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 življenjsko nevaren, če se ne zdravi takoj; glejte poglavje 4.4 in poglavje »Opis izbranih neželenih učinkov« spodaj.
English: With the exception of the youngest age group (0 5 years), the mean AUC in paediatric subjects appeared similar to that for adult patients with high-risk stage II-IV breast cancer and receiving 100 μg/kg pegfilgrastim after the completion of doxorubicin/docetaxel (see sections 4.8 and
Slovenian: Razen v najmlajši starostni skupini (od 0-5 let) je bila povprečna AUC pri pediatričnih bolnikih podobna kot pri odraslih bolnicah z visoko tveganim rakom na dojki v II.-IV. stadiju, ki so prejele 100 µg/kg pegfilgrastima po dokončanju doksorubicina/docetaksela
English: If you become pregnant during Grasustek treatment, please inform your doctor.
Slovenian: Če med zdravljenjem z zdravilom Grasustek zanosite, o tem obvestite zdravnika.
English: • allergic-type reactions, including redness and flushing, skin rash, and raised areas of the skin that itch.
Slovenian: • reakcije alergijske vrste, vključno s pordelostjo in zardevanjem, izpuščaji na koži in dvignjenimi predeli kože, ki srbijo;
English: • if you have any of the following or combination of the following side effects: ­ swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
Slovenian: • če se vam pojavi kateri od naslednjih neželenih učinkov ali kombinacija teh neželenih učinkov: ­ oteklost ali zabuhlost, ki jo lahko spremlja manj pogosto odvajanje urina, težko dihanje, oteklost trebuha in občutek polnosti ter splošen občutek utrujenosti.
English: Cases of capillary leak syndrome have been reported in the post marketing setting with granulocyte colony-stimulating factor use.
Slovenian: V obdobju po trženju zdravila so poročali o primerih sindroma kapilarne prepustnosti med uporabo granulocitne kolonije spodbujajočega faktorja.
English: Only a solution that is clear and colourless should be injected.
Slovenian: Injicirati se sme le raztopina, ki je bistra in brezbarvna.
English: − The active substance is pegfilgrastim.
Slovenian: − Učinkovina je pegfilgrastim.
English: Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk (see section 4.8).
Slovenian: Bolj ogroženi utegnejo biti bolniki z nedavno anamnezo pljučnih infiltratov ali pljučnice (glejte poglavje 4.8).
English: Grasustek is a clear, colourless solution for injection in pre-filled syringe (6 mg/0.6 ml).
Slovenian: Zdravilo Grasustek je bistra, brezbarvna raztopina za injiciranje v napolnjeni injekcijski brizgi (6 mg/0,6 ml).
English: Excipient(s) with known effect Each pre-filled syringe contains 30 mg sorbitol (E 420) (see section 4.4).
Slovenian: Ena napolnjena injekcijska brizga vsebuje 30 mg sorbitola (E 420) (glejte poglavje 4.4).
English: 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).
Slovenian: 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 dneva, v skupini s filgrastimom pa 1,8 dneva (razlika 0,03 dneva, 95-odstotni IZ je -0,36, 0,30).
English: Avoid injecting into areas with scars or stretch marks.
Slovenian: Izognite se injiciranju v predele, kjer imate brazgotine ali strije.
English: Important: Read the package leaflet before handling the pre-filled syringe.
Slovenian: Pomembno: pred ravnanjem z napolnjeno injekcijsko brizgo preberite priloženo navodilo.
English: Over the entire study, the rate of febrile neutropenia was 13 % of pegfilgrastim-treated patients compared with 20 % of filgrastim-treated patients (difference 7 %, 95 % CI of-19 %, 5 %).
Slovenian: V celotni študiji je bila pogostost febrilne nevtropenije pri bolnikih, zdravljenih s pegfilgrastimom, 13 %, pri bolnikih, zdravljenih s filgrastimom, pa 20 % (razlika 7 %, 95-odstotni IZ je -19 %, 5 %).
English: Warning/Precaution: Check there is no loose fragment or fluid inside the pack.
Slovenian: Opozorilo/previdnostni ukrep: Prepričajte se, da v pakiranju ni kakega koščka ali tekočine.
English: Pharmacokinetic properties
Slovenian: Farmakokinetične lastnosti
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij Juta Pharma GmbH
English: These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medicinal products or undergoing apheresis (see section
Slovenian: Ti primeri so se v splošnem pojavili pri bolnikih z napredovalimi malignimi boleznimi, sepso, bolnikih, ki so uporabljali več zdravil za kemoterapijo, ali bolnikih, ki so se zdravili z aferezo (glejte poglavje 4.4).
English: Pack size of one pre-filled syringe with automatic needle guard (0.6 ml) and supplied in a dispensing pack containing one syringe.
Slovenian: Pakiranje z eno napolnjeno brizgo z avtomatičnim ščitnikom igle (0,6 ml) je na voljo v razdeljevalnem pakiranju, ki vsebuje eno brizgo.
English: Splenomegaly, generally asymptomatic, is uncommon.
Slovenian: Občasen neželeni učinek je splenomegalija, praviloma asimptomatska.
English: For further instructions on how to inject yourself with Grasustek, please read the section at the end of this leaflet.
Slovenian: Nadaljnja navodila za samoinjiciranje zdravila Grasustek si preberite v poglavju na koncu tega Navodila za uporabo.
English: Pre-filled syringe (Type I glass), with a (butyl) rubber stopper and a stainless steel needle with automatic needle guard.
Slovenian: Napolnjena injekcijska brizga (steklo tipa I) z (butilnim) gumijastim zamaškom in igla iz nerjavečega jekla z avtomatičnim ščitnikom igle.
English: In one study (n = 157), which used a 6 mg fixed dose of pegfilgrastim the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.8 days compared with 1.6 days in the filgrastim group (difference 0.23 days, 95 % CI -0.15, 0.63).
Slovenian: V eni študiji (n = 157), v kateri so uporabili stalni odmerek 6 mg pegfilgrastima, je bilo srednje trajanje nevtropenije 4. stopnje v skupini s pegfilgrastimom 1,8 dneva, v skupini s filgrastimom pa 1,6 dneva (razlika 0,23 dneva, 95-odstotni IZ je -0,15, 0,63).
English: Step 4: Finish
Slovenian: 4. korak: Zaključek
English: The incidence of hospitalisations and Intra Venous anti-infective use associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group compared with placebo (1 % versus 14 %, p < 0.001; and 2 % versus 10 %, p < 0.001).
Slovenian: antiinfekcijske terapije, povezanih s klinično diagnozo febrilne nevtropenije, kot med prejemnicami placeba (1 % v primerjavi s 14 %, p <0,001, ter 2 % v primerjavi z 10 %, p <0,001).
English: various stages of renal impairment, including end-stage renal disease, had no impact on the pharmacokinetics of pegfilgrastim.
Slovenian: Različne stopnje okvare ledvic, vključno s končno odpovedjo ledvic, v odprti študiji posamičnega odmerka (n = 31) niso vplivale na farmakokinetiko pegfilgrastima.