natgillin/translations-raw huggingface dataset:
Tevagrastim is a ‘biosimilar' medicine.
Zdravilo Tevagrastim je podobno biološko zdravilo.
What is Tevagrastim?
Kaj je zdravilo Tevagrastim?
How has Tevagrastim been studied?
Kako je bilo zdravilo Tevagrastim raziskano?
What is Tevagrastim used for?
Za kaj se zdravilo Tevagrastim uporablja?
The full EPAR for Tevagrastim can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Tevagrastim je na voljo tukaj.
How is Tevagrastim used?
Kako se zdravilo Tevagrastim uporablja?
How does Tevagrastim work?
Kako zdravilo Tevagrastim deluje?
A main measure of effectiveness was a reduction of at least 90% in PASI scores.
Glavno merilo učinkovitosti je bilo znižanje ocene PASI za vsaj 90 %.
It has few side effects.
Ima le malo neželenih učinkov.
Further information on Tremfya can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Tremfya so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The recommended dose is 100 mg as a single dose, followed by a further dose after 4 weeks and then 100 mg every 8 weeks.
Priporočeni odmerek je 100 mg v enkratnem odmerku, čemur sledi naslednji odmerek čez štiri tedne, nato pa 100 mg vsakih osem tednov.
Tremfya received a marketing authorisation valid throughout the EU on 10 November 2017.
Za zdravilo Tremfya je bilo 10. novembra 2017 izdano dovoljenje za promet, veljavno po vsej EU.
After 16 weeks, about 71% of patients (588 out of 825) receiving Tremfya had a reduction of at least 90% in PASI scores, compared with 48% (282 out of 582) of those receiving adalimumab and under 3% (11 out of 422) receiving placebo.
Po 16 tednih se je ocena PASI znižala za vsaj 90 % pri približno 71 % (588 od 825) bolnikov, ki so prejemali zdravilo Tremfya, pri 48 % (282 od 582) bolnikov, ki so prejemali adalimumab, in pri manj kot 3 % (11 od 422) bolnikov, ki so prejemali placebo.
Patients are likely to continue treatment with Tremfya because it is injected every 8 weeks (after the first 4 weeks) and patients can inject it themselves, making it convenient to use.
Bolniki bodo zdravljenje z zdravilom Tremfya verjetno nadaljevali, saj se injicira vsakih osem tednov (po prvih štirih tednih), bolniki pa si ga lahko injicirajo tudi sami, zato je priročno za uporabo.
What measures are being taken to ensure the safe and effective use of Tremfya?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tremfya?
The most common side effects with Tremfya (which may affect more than 1 in 10 people) are infections in the nose and throat.
Najpogostejši neželeni učinki zdravila Tremfya (ki se lahko pojavijo pri več kot 1 bolniku od 10) so okužbe nosu in žrela.
As for all medicines, data on the use of Tremfya are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Tremfya stalno spremljajo.
The Agency considered that Tremfya is effective and longer-term studies have shown that it remains effective with continued use.
Menila je, da je zdravilo Tremfya učinkovito, dolgoročne študije pa so dokazale, da ostaja učinkovito tudi pri neprekinjeni uporabi.
Other information about Tremfya
Druge informacije o zdravilu Tremfya
An overview of Tremfya and why it is authorised in the EU
Pregled zdravila Tremfya in zakaj je odobreno v EU
Side effects reported with Tremfya are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Tremfya, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What benefits of Tremfya have been shown in studies?
Kakšne koristi zdravila Tremfya so se pokazale v študijah?
Why is Tremfya authorised in the EU?
Zakaj je bilo zdravilo Tremfya odobreno v EU?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tremfya have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Tremfya upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
PASI is a measure of disease severity and area of skin affected.
Ocena PASI je merilo resnosti bolezni in prizadete površine kože.
The third study involved 871 patients who were treated with ustekinumab (another medicine used for treating psoriasis).
Tretja študija je vključevala 871 bolnikov, ki so se zdravili z ustekinumabom (drugim zdravilom za zdravljenje psoriaze).
After training, patients may inject Tremfya themselves if the doctor considers it appropriate.
Bolniki si lahko po opravljenem usposabljanju zdravilo Tremfya injicirajo sami, če zdravnik meni, da je to primerno.
The active substance in Tremfya, guselkumab, is a monoclonal antibody (a type of protein) which is designed to attach to interleukin 23 and block its activity.
Učinkovina v zdravilu Tremfya, guselkumab, je monoklonsko protitelo (vrsta beljakovine), ki je zasnovano tako, da se pritrdi na interlevkin 23 in zavira njegovo delovanje.
Patients whose psoriasis did not improve sufficiently after 16 weeks either received Tremfya or continued treatment with ustekinumab for at least 24 weeks.
Bolniki, pri katerih se psoriaza po 16 tednih ni dovolj izboljšala, so začeli prejemati zdravilo Tremfya ali pa so nadaljevali zdravljenje z ustekinumabom, in sicer vsaj 24 tednov.
What is Tremfya and what is it used for?
Kaj je zdravilo Tremfya in za kaj se uporablja?
For more information about using Tremfya, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Tremfya glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What are the risks associated with Tremfya?
Kakšna tveganja so povezana z zdravilom Tremfya?
It is used in adults with moderate to severe disease for whom treatments applied to the skin are not suitable.
Uporablja se pri odraslih bolnikih z zmerno ali resno obliko bolezni, pri katerih zdravila za nanos na kožo niso primerna.
Tremfya must not be used in patients who have an ongoing infection that the doctor considers important.
Zdravila Tremfya ne smejo uporabljati bolniki z obstoječo okužbo, ki jo je zdravnik ocenil za resno.
By blocking the action of interleukin 23, guselkumab reduces inflammation and symptoms associated with the disease.
Guselkumab z zaviranjem delovanja interlevkina 23 zmanjša vnetje in simptome, povezane z boleznijo.
Three main studies involving 2,700 adults found Tremfya effective for treating moderate to severe plaque psoriasis in patients for whom treatments applied to the skin did not work well enough.
V treh glavnih študijah, ki so vključevale 2 700 odraslih, so ugotovili, da je zdravilo Tremfya učinkovito pri zdravljenju zmerne do hude psoriaze s plaki pri bolnikih, pri katerih zdravila za nanos na kožo niso dovolj učinkovita.
The European Medicines Agency decided that Tremfya's benefits are greater than its risks in the treatment of moderate and severe plaque psoriasis, and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so pri zdravljenju zmerne in hude psoriaze s plaki koristi zdravila Tremfya večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Tremfya is a medicine that acts on the immune system and is used to treat plaque psoriasis, a disease causing red, scaly patches on the skin.
Zdravilo Tremfya deluje na imunski sistem in se uporablja za zdravljenje psoriaze s plaki, tj. bolezni, ki povzroča rdeče, luskaste zaplate na koži.
The first two studies compared Tremfya with adalimumab (another medicine used for treating psoriasis) and placebo (a dummy treatment).
V prvih dveh študijah so zdravilo Tremfya primerjali z adalimumabom (drugim zdravilom za zdravljenje psoriaze) in placebom (zdravilom brez učinkovine).
It is injected under the skin in an area that is clear of psoriasis.
Injicira se pod kožo v predel brez psoriaze.
During this period, symptoms of psoriasis improved to a greater extent in patients receiving Tremfya than in those remaining on ustekinumab.
V tem času so se simptomi psoriaze bolj izboljšali pri bolnikih, ki so prejemali zdravilo Tremfya, kot pri bolnikih, ki so še naprej prejemali ustekinumab.
Improvement in psoriasis symptoms was maintained beyond 48 weeks with Tremfya treatment.
Izboljšanje simptomov psoriaze pri zdravljenju z zdravilom Tremfya se je ohranilo več kot 48 tednov.
Tremfya can only be obtained with a prescription and should be used under the supervision of a doctor experienced in diagnosing and treating plaque psoriasis.
Predpisovanje in izdaja zdravila Tremfya je le na recept, zdravilo pa se mora uporabljati pod nadzorom zdravnika, ki ima izkušnje z diagnosticiranjem in zdravljenjem psoriaze s plaki.
Tremfya is available as a solution for injection in pre-filled syringes or pens.
Zdravilo Tremfya je na voljo v obliki raztopine za injiciranje v napolnjeni injekcijski brizgi ali peresniku.
How does Tremfya work?
Kako zdravilo Tremfya deluje?
How is Tremfya used?
Kako se zdravilo Tremfya uporablja?
Tremfya contains the active substance guselkumab.
Zdravilo Tremfya vsebuje učinkovino guselkumab.
These T cells, which are part of the body's immune system (the body's natural defences), are involved in causing inflammation that is linked to the formation of plaque psoriasis.
Interlevkin 23 je prenašalec sporočil, ki nadzoruje rast in dozorevanje nekaterih vrst celic T. Te celice T, ki so del imunskega sistema telesa (naravne obrambe telesa), sodelujejo pri povzročanju vnetja, povezanega z nastankom psoriaze s plaki.
Very rare to < 1/10)
Zelo redki do < 1/10)
For more information, see section 5.1
Za več informacij glejte poglavje 5.1.
B PUSH the plunger with slow and constant pressure until you feel or hear a “snap”.
B POTISKAJTE bat počasi in s stalnim pritiskom povsem do konca, dokler ne začutite ali zaslišite “tlesk”.
Carefully pull the needle cap straight out and away from your body.
B Skrbno potegnite pokrovček igle naravnost z nje in proč od vašega telesa.
The concentration is 10 mg/mL based on protein only**.
Koncentracija je 10 mg/ml na podlagi beljakovine same**.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness
Znotraj posamezne skupine pogostnosti so neželeni učinki navedeni po padajoči resnosti.
- nausea and headaches.
- siljenje na bruhanje in glavoboli.
The frequency category was estimated from a statistical calculation based upon 1,576 patients receiving pegfilgrastim in nine randomised clinical trials.
Kategorija pogostnosti je ocenjena s statističnim izračunom na podlagi podatkov o 1576 bolnikih, ki so prejemali pegfilgrastim v devetih randomiziranih kliničnih preskušanjih.
Calle García Ximénez, nº3-1º 31002 Pamplona (Navarra) Spain
Calle García Ximénez, nº3-1º 31002 Pamplona (Navarra) Španija
Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from AML.
Posebno pozornost je treba nameniti razlikovanju diagnoze blastne transformacije kronične mieloidne levkemije od AML.
2 This adverse reaction was identified through post-marketing surveillance but not observed in randomised, controlled clinical trials in adults that supported the marketing authorisation.
2 Ti neželeni učinki so bili ugotovljeni med spremljanjem v obdobju trženja zdravila, niso pa jih opažali v randomiziranih, kontroliranih kliničnih preskušanjih pri odraslih, ki so podpirala pridobitev dovoljenja za promet.
The trade name and the batch number of the administered product should be clearly recorded in the patient file.
Tržno ime in številko serije uporabljenega zdravila je treba jasno dokumentirati v bolnikovo kartoteko.
Outer area of upper arm (only if someone else is giving you the injection).
• zunanji del nadlakti (le v primeru, če vam injekcijo da kdo drug).
Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30° C) it must either be used within 4 days or disposed of.
Ko injekcijsko brizgo vzamete iz hladilnika in le-ta doseže sobno temperaturo (pod 30 °C), jo morate v 4 dneh porabiti ali pa zavreči.
Medicines should be disposed of in accordance with local requirements.
Zdravilo odvrzite v skladu z lokalnimi predpisi.
Do not use this medicine after the expiry date which is stated on the carton and on the syringe label after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki injekcijske brizge poleg oznake “EXP”.
Common cases of leukocytosis (White Blood Count [WBC] > 100 × 109/L) have been reported (see section 4.4).
Pogosto so poročali o primerih levkocitoze (število belih krvničk > 100 x 109/l) (glejte poglavje 4.4).
to < 1/100)
do < 1/100)
However, the long-term effects of Pegfilgrastim Mundipharma have not been established in AML; therefore, it should be used with caution in this patient population.
Vendar dolgoročni učinki zdravila Pegfilgrastim Mundipharma pri AML niso ugotovljeni, zato ga je treba pri tej populaciji bolnikov uporabljati previdno.
It is important to tell your doctor if you: - are pregnant; - think you may be pregnant; or
- menite, da bi lahko bili noseči, ali - načrtujete zanositev.
Therefore, physicians should use caution when prescribing Pegfilgrastim Mundipharma in patients with sickle cell trait or sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicinal product with splenic enlargement and vaso-occlusive crisis.
Zato morajo biti zdravniki previdni, kadar predpisujejo zdravilo Pegfilgrastim Mundipharma bolnikom s srpastocelično dispozicijo ali s srpastocelično anemijo, spremljati morajo ustrezne klinične parametre in laboratorijski status in biti pozorni na morebitno povezavo tega zdravila z zvečanjem vranice in vazookluzivno krizo.
Its important to keep the skin pinched when injecting.
Pomembno je, da držite kožo med injiciranjem stisnjeno.
Your doctor has given you Pegfilgrastim Mundipharma to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.
Vaš zdravnik vam je predpisal zdravilo Pegfilgrastim Mundipharma, da bi spodbudilo vaš kostni mozeg (tisti del kosti, ki izdeluje krvničke) k izdelavi več belih krvničk, ki pomagajo vašemu telesu boriti se proti okužbam.
As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Tako kot pri drugih hematopoetičnih rastnih faktorjih so tudi pri G-CSF pokazali, da in vitro spodbuja humane endotelijske celice.
If leukocyte counts exceed 50 × 109/L after the expected nadir, this medicinal product should be discontinued immediately.
Če število levkocitov po pričakovanem najmanjšem številu preseže 50 x 109/l, je treba nemudoma prenehati z zdravljenjem s tem zdravilom.
to < 1/1,000)
do < 1/1.000)
• The needle cap is missing or not securely attached.
• pokrovček igle manjka ali ni trdno nameščen.
The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and musculoskeletal pain (common).
Neželena učinka, o katerih so najpogosteje poročali, sta bila bolečina v kosteh (zelo pogosti [> 1/10]) in mišičnoskeletna bolečina (pogosti).
Turn the plunger to move the label into a position where you can remove the syringe label
Obrnite bat tako, da nalepko premaknete na mesto, s katerega jo boste lahko odstranili.
Healthcare professionals only
Samo za zdravstveno osebje
Accidental exposure to freezing temperatures for two periods of less than 72 hours each does not adversely affect the stability of Pegfilgrastim Mundipharma.
Nehotena izpostavitev temperaturam pod lediščem za največ dve obdobji, od katerih nobeno ne traja dlje kot 72 ur, nima negativnega vpliva na stabilnost zdravila Pegfilgrastim Mundipharma.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Pegfilgrastim Mundipharma therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Pegfilgrastim Mundipharma, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
In order to improve the traceability of biologic medicinal products, the name and the batch number of the administered product should be clearly recorded.
Za izboljšanje sledljivosti bioloških zdravil morata biti v bolnikovi kartoteki jasno dokumentirana ime in številka serije prejetega zdravila.
Pegfilgrastim Mundipharma left at room temperature for more than 96 hours should be discarded.
Zdravilo Pegfilgrastim Mundipharma, ki je bilo na sobni temperaturi več kot 96 ur, je treba zavreči.
- serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).
- resne alergijske reakcije, vključno z anafilaksijo (slabotnost, padec krvnega tlaka, težave z dihanjem, otekanje obraza).
Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area) (see section 5.3).
Pegfilgrastim ni vplival na sposobnost razmnoževanja ali plodnost podganjih samcev ali samic pri kumulativnih tedenskih odmerkih, ki so približno 6-krat do 9-krat višji od priporočenega odmerka za človeka (na podlagi telesne površine) (glejte poglavje 5.3).
Pegfilgrastim Mundipharma is for use in adults aged 18 and over.
Zdravilo Pegfilgrastim Mundipharma je namenjeno uporabi pri odraslih, starih 18 ali več let.
• Pegfilgrastim Mundipharma is given as an injection into the tissue just under the skin (subcutaneous injection).
• Zdravilo Pegfilgrastim Mundipharma se daje kot injekcija v tkivo tik pod kožo (subkutano injiciranje).
Pegfilgrastim is a covalent conjugate of recombinant human G-CSF (r-metHuG-CSF) with a single 20 kd polyethylene glycol (PEG) molecule.
Pegfilgrastim je kovalenten konjugat rekombinantnega humanega G-CSF (r-metHuG-CSF) z eno samo molekulo 20 kd polietilenglikola (PEG).
Belly, except for a 5 cm (2-inch) area right around your belly button.
trebuh (razen v predelu 5 cm okrog popka).
In such circumstances Pegfilgrastim Mundipharma should be discontinued at the discretion of the physician and the appropriate treatment given (see section 4.8).
V takih primerih je treba zdravilo Pegfilgrastim Mundipharma po presoji zdravnika prenehati dajati in poskrbeti za ustrezno zdravljenje (glejte poglavje 4.8).
Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim.
Na splošno so primeri glomerulonefritisa izzveneli po zmanjšanju odmerka ali prenehanju uporabe filgrastima ali pegfilgrastima.
Human granulocyte colony stimulating factor (G-CSF) is a glycoprotein, which regulates the production and release of neutrophils from the bone marrow.
Faktor, ki stimulira humane granulocitne kolonije (G-CSF), je glikoprotein, ki uravnava nastajanje nevtrofilcev in njihovo sproščanje iz kostnega mozga.
Pulmonary hemorrhage
hemoptiza pljučna krvavitev
Pegfilgrastim Mundipharma has no or negligible effect on the ability to drive or use machines.
Zdravilo Pegfilgrastim Mundipharma nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
It is important to push down through the “snap” to deliver your full dose.
Pomembno je, da potisnete vse do “tleska“, saj le tako injicirate celotni odmerek.
Before you use a Pegfilgrastim Mundipharma pre-filled syringe with automatic needle guard, read this important information:
Pred uporabo zdravila Pegfilgrastim Mundipharma v napolnjeni injekcijski brizgi z avtomatskim ščitnikom igle preberite te pomembne informacije:
Your doctor will check your blood and urine regularly as Pegfilgrastim Mundipharma can harm the tiny filters inside your kidneys (glomerulonephritis).
Zdravnik vam bo redno kontroliral kri in urin, kajti zdravilo Pegfilgrastim Mundipharma lahko okvari drobne filtre v ledvicah (povzroči glomerulonefritis).
Uncommonly, cases have resulted in respiratory failure or Acute Respiratory Distress Syndrome (ARDS), which may be fatal (see section 4.4).
Občasno so ti primeri povzročili respiratorno insuficienco ali sindrom akutne dihalne stiske (ARDS - Acute Respiratory Distress Syndrome), ki sta lahko smrtna (glejte poglavje 4.4).
The pharmacokinetics of pegfilgrastim were studied in 37 paediatric patients with sarcoma, who received 100 μg/kg pegfilgrastim after the completion of VAdriaC/IE chemotherapy.
Farmakokinetiko pegfilgrastima so raziskali pri 37 pediatričnih bolnikih s sarkomom, ki so po dokončanju kemoterapije z VAdriaC/IE dobili 100 μg/kg pegfilgrastima.
Pegfilgrastim Mundipharma may be exposed to room temperature (not above 30º C) for a maximum single period of up to 96 hours.
Zdravilo Pegfilgrastim Mundipharma sme biti izpostavljeno sobni temperaturi (ne nad 30 °C) za enkratno obdobje, ki ne sme preseči 96 ur.
Pegfilgrastim Mundipharma may be used if it is accidentally frozen for two periods of less than 72 hours each.
Zdravilo Pegfilgrastim Mundipharma je mogoče uporabiti, če je bilo nehote zamrznjeno za največ dve obdobji, od katerih nobeno ni trajalo dlje kot 72 ur.
The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. C-reactive protein and white blood cell count).
Simptomi, ki so se pojavili, vključujejo zvišano telesno temperaturo, bolečine v trebuhu, slabo počutje, bolečine v hrbtu in zvišane vrednosti vnetnih označevalcev (npr. C-reaktivnega proteina in števila belih krvnih celic).
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.
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 zvečanje vranice.
Figure 1: Profile of median pegfilgrastim serum concentration and absolute neutrophil count (ANC) in chemotherapy treated patients after a single 6 mg injection
Profil mediane serumske koncentracije pegfilgrastima in absolutnega števila nevtrofilcev (ANC - Absolute Neutrophil Count) pri bolnikih, zdravljenih s kemoterapijo, po eni sami 6-miligramski injekciji
This medicinal product contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg/mL.
To zdravilo vsebuje 30 mg sorbitola v eni napolnjeni injekcijski brizgi, kar je enako 50 mg/ml.
The safety and efficacy of Pegfilgrastim Mundipharma administration in de novo AML patients aged < 55 years with cytogenetics t (15;17) have not been established.
Varnost in učinkovitost uporabe zdravila Pegfilgrastim Mundipharma pri bolnikih z de novo AML, mlajših od 55 let in s citogenetiko t(15;17), nista ugotovljeni.
Splenomegaly and splenic ruptura
Splenomegalija in ruptura vranice
The usual dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled syringe and it should be given at least 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.
Običajni odmerek je ena 6-miligramska subkutana injekcija (podkožna injekcija) z uporabo napolnjene injekcijske brizge, ki jo morate prejeti vsaj 24 ur po zadnjem odmerku kemoterapije na koncu vsakega cikla kemoterapije.
Each pre-filled syringe contains 30 mg sorbitol (E420).
Ena napolnjena injekcijska brizga vsebuje 30 mg sorbitola (E 420).
Rare side effects (may affect up to 1 in 1,000 people) - Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) - vnetje aorte (velike žile, ki prenaša kri od srca po telesu), glejte poglavje 2.