natgillin/translations-raw huggingface dataset:
Bevacizumab has been shown to be embryotoxic and teratogenic when administered to rabbits.
23 Bevacizumab se je pri kuncih pokazal kot embriotoksičen in teratogen.
23 Adverse foetal outcomes were observed at all tested doses, of which the lowest dose resulted in average serum concentrations approximately 3 times larger than in humans receiving 5 mg/ kg every 2 weeks.
Od teh je najnižji odmerek sprožil približno 3- krat višje povprečne serumske koncentracije kot odmerek 5 mg/ kg pri ljudeh, ki so ga prejemali vsaka dva tedna.
A concentration dependent degradation profile of bevacizumab was observed when diluted with glucose solutions (5%).
Če so bevacizumab razredčili s 5 -% raztopino glukoze, so opazili od koncentracije odvisen razpad tega zdravila.
Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 30°C in sodium chloride 9 mg/ ml (0.9%) solution for injection.
Kemična in fizikalna stabilnost v 0, 9 -% (9 mg/ ml) raztopini natrijevega klorida za injiciranje med uporabo je bila dokazana do 48 ur pri temperaturi 2 °C do 30 °C.
From a microbiological point of view, the product should be used immediately.
Če ga ne uporabite takoj po pripravi, je uporabnik odgovoren za čas in pogoje shranjevanja pred uporabo.
If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Hranjenje navadno ne sme biti daljše od 24 ur pri temperaturi 2 °C do 8 °C, razen če je bila raztopina pripravljena v kontroliranih in validiranih aseptičnih pogojih.
Single-use vial (Type I glass) with a butyl rubber stopper containing 100 mg of bevacizumab in 4 ml of concentrate for solution for infusion.
Viala za enkratno uporabo (steklo tipa I) z gumijastim zamaškom, ki vsebuje 100 mg bevacizumaba v 4 ml koncentrata za raztopino za infundiranje.
Single-use vial (Type I glass) with a butyl rubber stopper containing 400 mg of bevacizumab in 16 ml of concentrate for solution for infusion.
Viala za enkratno uporabo (steklo tipa I) z gumijastim zamaškom, ki vsebuje 400 mg bevacizumaba v 16 ml koncentrata za raztopino za infundiranje.
Pack of 1 vial containing 4 ml.
Pakiranje po 1 vialo, ki vsebuje 4 ml.
Pack of 1 vial containing 16 ml.
Pakiranje po 1 vialo, ki vsebuje 16 ml.
Avastin does not contain any antimicrobial preservative; therefore, care must be taken to ensure the sterility of the prepared solution.
Zdravilo Avastin ne vsebuje konzervansov, zaradi česar moramo paziti na sterilnost pripravljene raztopine.
Avastin should be prepared by a healthcare professional using aseptic technique.
Zdravilo Avastin mora pripraviti zdravstveno osebje v aseptičnih pogojih.
Withdraw the necessary amount of bevacizumab and dilute to the required administration volume with 0.9% sodium chloride solution for injection.
Odvzemite potrebno količino bevacizumaba in jo do ustreznega volumna za administracijo razredčite z 0, 9 -% raztopino
24 Discard any unused portion left in a vial, as the product contains no preservatives.
Koncentracija končne raztopine bevacizumaba mora biti od 1, 4 do 16, 5 mg/ ml.
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Zdravila za parenteralno dajanje je treba pred uporabo vizualno pregledati, saj ne smejo vsebovati delcev ali biti razbarvana.
No incompatibilities between Avastin and polyvinyl chloride or polyolefine bags or infusion sets have been observed.
Med Avastinom in polivinil kloridom ali poliolefinskimi vrečkami ali infuzijskimi seti ni bilo inkompatibilnosti.
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW Velika Britanija
EU/ 1/ 04/ 300/ 001 – 100 mg/ 4 ml vial EU/ 1/ 04/ 300/ 002 – 400 mg/ 16 ml vial
EU/ 1/ 04/ 300/ 001 – 100 mg/ 4 ml viala EU/ 1/ 04/ 300/ 002 – 400 mg/ 16 ml viala
12 January 2005
12. januar 2005
25 ANNEX II
25 DODATEK II
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
26 A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
1 DNA Way South San Francisco, CA 94080-4990 USA
1 DNA Way, South San Francisco, CA 94080- 4990 ZDA
1 Antibody Way Oceanside, CA 92056 USA
1 Antibody Way Oceanside, CA 92056 ZDA
1, D-79639 Grenzach-Wyhlen Germany
Roche Pharma AG Emil- Barell- Str. 1, D- 79639 Grenzach- Wyhlen Nemčija
● CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
Medicinal product subject to restricted medical prescription (See Annex:
Izdaja zdravila je le pod omejenimi pogoji in na recept (Glejte Dodatek I:
● CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt za obvladovanje tveganja Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, ki je bil sprejet v različici 4. 0 načrta za obvladovanje tveganja (RMP - Risk Management Plan), predstavljenem v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnih posodobitvah RMP, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
27 ● Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached ● At the request of the EMEA
27 Poleg tega je treba posodobljen načrt za obvladovanje tveganja predložiti: • kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja • v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja) • na zahtevo Evropske agencije za zdravila (EMEA).
28 ANNEX III
28 DODATEK III
30 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
30 PODATKI NA ZUNANJI OVOJNINI
CARTON
Škatla
Avastin 25 mg/ ml concentrate for solution for infusion Bevacizumab
Avastin 25 mg/ ml koncentrat za raztopino za infundiranje bevacizumab
Each vial contains 100 mg bevacizumab.
Vsaka viala vsebuje 100 mg bevacizumaba.
Concentrate for solution for infusion 100 mg 1 vial of 4 ml
koncentrat za raztopino za infundiranje 100 mg 1 viala (4 ml)
For intravenous use after dilution Read the package leaflet before use
Za intravensko uporabo po razredčitvi Pred uporabo preberite priloženo navodilo!
Do not freeze Keep the vial in the outer carton
Shranjujte v hladilniku (2 °C - 8 °C) Ne zamrzujte Vialo shranjujte v zunanji ovojnini
32 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
32 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL
Viala
33 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
33 PODATKI NA ZUNANJI OVOJNINI
Each vial contains 400 mg bevacizumab.
Vsaka viala vsebuje 400 mg bevacizumaba.
Concentrate for solution for infusion 400 mg 1 vial of 16 ml
koncentrat za raztopino za infundiranje 400 mg 1 viala (16 ml)
EU/ 1/ 04/ 300/ 002
EU1/ 04/ 300/ 002
35 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
35 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
What Avastin is and what it is used for 2.
Kaj je zdravilo Avastin in za kaj ga uporabljamo 2.
Before you use Avastin 3.
Kaj morate vedeti, preden boste uporabili zdravilo Avastin 3.
How to use Avastin 4.
Kako uporabljati zdravilo Avastin 4.
How to store Avastin 6.
Shranjevanje zdravila Avastin 6.
WHAT AVASTIN IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO AVASTIN IN ZA KAJ GA UPORABLJAMO
Avastin is a medicine used for the treatment of advanced cancer in the large bowel, i. e., in the colon or rectum.
Zdravilo Avastin uporabljamo za zdravljenje napredovalega raka debelega črevesa in danke.
Avastin is also used for the treatment of metastatic breast cancer.
Zdravilo Avastin uporabljamo tudi za zdravljenje metastatskega raka dojk.
When used for patients with breast cancer, it will be administered with a chemotherapy called paclitaxel.
Kadar ga uporabljamo za bolnike z rakom dojk, ga dajemo skupaj s kemoterapijo, imenovano paklitaksel.
Avastin is also used for the treatment of advanced non-small cell lung cancer.
Zdravilo Avastin uporabljamo tudi za zdravljenje napredovalega nedrobnoceličnega raka pljuč.
Avastin is also used for treatment of advanced kidney cancer.
Zdravilo Avastin uporabljamo tudi za zdravljenje napredovalega raka ledvičnih celic.
When used for patients with kidney cancer, it will be administered with another type of medicine called an interferon.
Kadar ga uporabljamo pri bolnikih z rakom ledvičnih celic, ga dajemo skupaj z drugim zdravilom, ki se imenuje interferon.
Avastin contains the active substance bevacizumab, which is a humanised monoclonal antibody.
Zdravilo Avastin vsebuje zdravilno učinkovino bevacizumab, ki je humanizirano monoklonsko protitelo.
Monoclonal antibodies are proteins which specifically recognise and bind to other unique proteins in the body.
Monoklonska protitelesa so beljakovine, ki specifično prepoznajo in se vežejo na točno določeno drugo beljakovinsko molekulo v telesu.
VEGF causes blood vessels to grow within tumours, these blood vessels provide the tumour with nutrients and oxygen.
VEGF v tumorjih omogoča rast krvnih žil, ki tumor preskrbujejo s hrano in kisikom.
Once bevacizumab is bound to VEGF, it stops VEGF working properly.
Ko se bevacizumab veže na VEGF, onemogoči njegovo delovanje.
This has the effect of preventing tumour growth by blocking the growth of the blood vessels providing the nutrients and oxygen to the tumour.
To prepreči rast tumorja tako, da zavira rast krvnih žil, ki ga oskrbujejo s hrano in kisikom.
Each pack of Avastin concentrate for solution for infusion contains one vial.
Vsako pakiranje zdravila Avastin, koncentrata za raztopino za infundiranje, vsebuje eno vialo.
This vial contains either 4 ml or 16 ml of a slightly opaque, colourless to pale brown sterile liquid concentrate.
Viala vsebuje 4 ml ali 16 ml rahlo motnega, brezbarvnega do svetlo rjavega sterilnega tekočega koncentrata.
The concentrate must be diluted before use to make a solution for intravenous infusion.
Za pripravo raztopine za intravensko infuzijo je treba koncentrat predhodno razredčiti.
38 2.
38
- you are allergic (hypersensitive) to bevacizumab or to any of the other ingredients of Avastin.
- če ste alergični na (preobčutljivi za) celične produkte ovarija kitajskega hrčka (CHO – Chinese
- you are allergic (hypersensitive) to Chinese hamster ovary (CHO) cell products or to other
Hamster Ovary) ali druga rekombinantna humana ali humanizirana monoklonska protitelesa,
- you have cancer in your brain which has not been treated.
- če imate rak na možganih, ki ni bil zdravljen,
- you are pregnant.
- če ste noseči.
Take special care with Avastin:
Bodite posebno pozorni pri uporabi zdravila Avastin:
- if you have conditions causing inflammation inside the abdomen (e. g. diverticulitis, stomach
- če imate stanje, ki povzroča trebušno vnetje (npr. divertikulitis, želodčno razjedo, s
ulcers, colitis associated with chemotherapy), as it is possible that Avastin may increase the risk of developing holes in the gut wall.
kemoterapijo povezan kolitis), ker je možno, da lahko zdravilo Avastin poveča tveganje za pojav preluknjanja stene črevesja,
- if you are going to have an operation, if you have had major surgery within the last 28 days or if
- če boste operirani, če je od nedavne večje operacije minilo manj kot 28 dni in če se vaša rana po
you still have an unhealed wound following surgery, you should not receive this medicine as Avastin can increase the risk of bleeding or increase the risk of problems with wound healing after surgery.
V teh primerih zdravila Avastin ne smete prejeti, ker lahko poveča tveganje za krvavitve ali poveča tveganje za težave pri celjenju ran po operaciji.
- if you have high blood pressure which is not well controlled with blood pressure medicines as
- če imate visok krvni tlak, ki ga je težko nadzorovati z zdravili proti zvišanemu krvnemu tlaku,
Avastin can increase the incidence of high blood pressure.
ker lahko zdravilo Avastin poveča incidenco visokega krvnega tlaka.
Your doctor should make sure that your blood pressure is under control before starting Avastin treatment.
Vaš zdravnik mora poskrbeti, da bo vaš krvni tlak pred začetkom zdravljenja z zdravilom Avastin ustrezno uravnan.
- if you have high blood pressure, as you may have a higher risk of having protein in your urine.
- če imate visok krvni tlak, ker vas lahko spremlja večje tveganje za pojav beljakovin v seču,
- if you are over 65 years old and also have had blood clots in your arteries (a type of blood
- če ste starejši od 65 let in ste v preteklosti imeli krvne strdke v arterijah (tip krvne žile), ker
vessel) in the past, as these factors can increase the risk of further blood clots in the arteries.
lahko oboje zveča tveganje za pojav novih krvnih strdkov v arterijah,
- if you or your family tend to suffer from bleeding problems or you are taking medicines to thin
- če ste vi ali vaša družina nagnjeni k težavam zaradi krvavitev ali če jemljete zdravila za redčenje
the blood for the treatment of blood clots.
krvi za zdravljenje krvnih strdkov,
- if you have been coughing or spitting blood or had any bleeding in your lungs.
- če ste kašljali, izpljuvali kri ali krvaveli v pljučih,
- if you have ever received anthracyclines (for example doxorubicin, a specific type of
- če ste kadarkoli prejeli antracikline (na primer doksorubicin, specifična vrsta kemoterapije, ki jo
chemotherapy used to treat some cancers) or had radiotherapy to your chest, or if you have heart disease as Avastin can increase the risk of developing a weak heart.
uporabljajo pri zdravljenju nekaterih vrst raka), če so vam obsevali prsni koš ali če imate srčno bolezen, ker lahko zdravilo Avastin poveča tveganje za opešanje srca.
Please consult your doctor, even if these statements were applicable to you at any time in the past.
Prosimo, da se posvetujete s svojim zdravnikom, če so se te navedbe na vas nanašale kdajkoli v preteklosti.
Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Uporaba drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Please tell your doctor if you have recently received, or are receiving, radiotherapy.
Prosimo, obvestite svojega zdravnika, če ste pred kratkim prejeli ali prejemate radioterapijo.
Pregnancy and breast feeding You must not use this medicine if you are pregnant.
Nosečnost in dojenje Če ste noseči, tega zdravila ne smete prejemati.
Tell your doctor straightaway if you are pregnant, become pregnant during treatment with this medicine, or plan to become pregnant in the near future.
Svojemu zdravniku takoj povejte, če ste noseči, če ste med zdravljenjem z zdravilom Avastin zanosili ali če v kratkem načrtujete zanositev.
You must not breast-feed your baby during treatment with Avastin and for at least 6 months after the last dose of Avastin, as this medicine may interfere with the growth and development of your baby.
Med zdravljenjem z zdravilom Avastin in še najmanj 6 mesecev po njegovem zadnjem odmerku otroka ne smete dojiti, ker bi lahko vplivalo na rast in razvoj vašega otroka.
39 Ask your doctor or pharmacist for advice before taking any medicine.
Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.
Avastin has not been shown to impair your ability to drive or to use any tools or machines.
39 Vpliv na sposobnost upravljanja vozil in strojev Za zdravilo Avastin se ni izkazalo, da bi vplivalo na vašo sposobnost za vožnjo ali uporabo orodij oziroma strojev.
HOW TO USE AVASTIN
KAKO UPORABLJATI ZDRAVILO AVASTIN
Dosage and frequency of administration The dose of Avastin needed depends on your body weight and the kind of cancer to be treated.
Odmerjanje in pogostnost dajanja Potrebni odmerek zdravila Avastin je odvisen od telesne mase in vrste raka, ki ga zdravimo.
The recommended dose is 5, 7.5, 10 or 15 mg per kilogram of your body weight.
Priporočeni odmerek je 5; 7, 5; 10 ali 15 mg na kilogram vaše telesne mase.
Your doctor will prescribe a dose of Avastin that is right for you.
Zdravnik vam bo predpisal ustrezni odmerek zdravila Avastin, ki ga boste prejeli enkrat na 2 ali 3 tedne.
You will be treated with Avastin once every 2 or 3 weeks.
Število infuzij, ki jih boste prejeli, je odvisno od vašega odziva na zdravljenje.
The number of infusions that you receive will depend on how you are responding to treatment; you should continue to receive this medicine until Avastin fails to stop your tumour growing.
Z zdravljenjem morate nadaljevati, dokler se ne bo izkazalo, da zdravilo Avastin ni moglo več zaustaviti rasti tumorja.
Method and route of administration Avastin is a concentrate for solution for infusion.
Način in pot dajanja Zdravilo Avastin je koncentrat za raztopino za infundiranje.
Depending on the dose prescribed for you, some or all of the contents of the Avastin vial will be diluted with saline solution before use.
Odvisno od odmerka, ki vam ga je predpisal zdravnik, je treba del ali vso vsebino viale zdravila Avastin pred uporabo razredčiti s solno raztopino.
A doctor or nurse will give you this diluted Avastin solution by intravenous infusion.
Zdravnik ali medicinska sestra vam bosta razredčeno raztopino zdravila Avastin dala z intravensko infuzijo.
The administration of Avastin should be temporarily discontinued:
Dajanje tega zdravila je treba začasno opustiti:
- if you develop severe high blood pressure requiring treatment with blood pressure medicines,
- če se pojavi zelo visok krvni tlak, ki ga je treba zdraviti z zdravili proti zvišanemu krvnemu
- if you have problems with wound healing following surgery,
- če imate težave s celjenjem ran po operaciji,
- if you undergo surgery.
- če boste operirani,
The administration of Avastin should be permanently discontinued if you develop:
ali dokončno opustiti, če se pojavijo:
- severe high blood pressure which cannot be controlled by blood pressure medicines; or a
- zelo visok krvni tlak, ki ga ni mogoče uravnati z zdravili za zdravljenje zvišanega krvnega tlaka,
sudden severe rise in blood pressure,
ali če se krvni tlak nenadoma zelo zviša,
- presence of protein in your urine accompanied by swelling of your body,
- beljakovine v seču, ki jih spremlja otekanje telesa,
- a hole in your gut wall,
- predrtje stene črevesja,
- an abnormal tube-like connection or passage between the windpipe and the gullet, or between
- neobičajna povezava ali prehod, podoben cevi, med sapnikom in požiralnikom ali med
internal organs and skin or other tissues that are not normally connected, and are judged by your doctor to be severe,
notranjimi organi in kožo ali drugimi tkivi, ki normalno niso povezani in jih vaš zdravnik oceni kot resne,
- a blood clot in your arteries,
- krvni strdek v arterijah,
- a blood clot in the veins of your lungs,
- krvni strdek v venah pljuč,
- any severe bleeding.
- kakršnakoli huda krvavitev.
If too much Avastin is given:
Če ste prejeli večji odmerek zdravila Avastin, kot bi ga smeli:
- you may develop a severe migraine.
- lahko dobite hudo migreno.
If this happens you should talk to your doctor or pharmacist
Če se to zgodi, se takoj posvetujte s svojim zdravnikom ali
immediately.
farmacevtom.
If a dose of Avastin is missed:
Če je bil odmerek zdravila Avastin izpuščen:
- your doctor will decide when you should be given your next dose of Avastin.
- bo vaš zdravnik odločil o tem, kdaj boste prejeli naslednji odmerek tega zdravila.
You should
O tem se
discuss this with your doctor.
pogovorite s svojim zdravnikom.
Like all medicines, Avastin can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi Avastin neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Side effects described as very common were experienced in more than 1 in 10 patients.
Opisani neželeni učinki, kot zelo pogosti, so se pojavili pri več kot 1 od 10 bolnikov.
Side effects described as common were experienced by up to 1 in 10 patients.
Opisani neželeni učinki, kot pogosti, so se pojavili pri do 1 od 10 bolnikov.
You should seek help immediately if you suffer from any of the below mentioned side effects.
Če imate kateregakoli od spodaj naštetih neželenih učinkov, nemudoma poiščite zdravniško pomoč.
The common (up to 1 in 10 patients) most serious side effects are:
Pogosti (pri do 1 od 10 bolnikov) najbolj resni neželeni učinki so:
- perforation of the gut,
- perforacija črevesja,
- bleeding, including bleeding in the lungs in patients with non-small cell lung cancer,
- krvavitev, vključno s krvavitvijo v pljučih pri bolnikih z nedrobnoceličnim rakom pljuč,
- blocking of the arteries by a blood clot,
- zamašitev arterij s krvnim strdkom,
- blocking of the veins in the lungs by a blood clot
- zamašitev ven v pljučih s krvnim strdkom
The severe side effects, which may be very common (more than 1 in 10 patients), include:
Hudi neželeni učinki, ki so lahko zelo pogosti (pri več kot 1 od 10 bolnikov), vključujejo:
- high blood pressure,
- visok krvni tlak,
- problems with wound healing after surgery,
- težave s celjenjem ran po operaciji,
- feeling of numbness or tingling in hands or feet.
- občutek otrplosti ali zbadanja v dlaneh ali nogah,
- decreased number of cells in the blood, including white cells that help to fight against infections,
- zmanjšano število krvnih celic, vključno z belimi krvnimi celicami, ki pomagajo pri boju proti
and cells that help the blood to clot,
okužbam in celicami, ki pomagajo strjevati kri,
- lack of energy or tiredness.
- pomanjkanje energije ali utrujenost,
- nausea and vomiting.
- slabost in bruhanje.
The severe side effects which may be common (up to 1 in 10 patients), include:
Hudi neželeni učinki, ki so lahko pogosti (pri do 1 od 10 bolnikov), vključujejo:
- decreased number of cells in the blood, these include white cells (which may occur with a fever),
- zmanjšano število krvnih celic: belih celic (ob tem se lahko pojavi zvišana telesna temperatura)
and red cells,
in rdečih celic,
- bleeding associated with the tumour,
- krvavitev povezano s tumorjem,
- lack of energy,
- pomanjkanje energije,
- abdominal pain,
- bolečino v trebuhu,
- dry mouth in combination with thirst and/ or reduced or darkened urine,
- suha usta v kombinaciji z žejo in/ ali manjšim izločanjem seča ali temnejši seč,
- diarrhoea,
- drisko,
- pain, including headache,
- bolečino, vključno z glavobolom,
- blood clots in the veins of the legs or difficulties in getting the blood to clot,
- krvne strdke v venah nog ali težave pri strjevanju krvi,
- localised pus collection,
- lokalizirano nabiranje gnoja,
- infection, and in particular infection in the blood or bladder,
- okužbo, še posebej krvi ali mehurja,
- reduced blood supply to the brain or stroke,
- zmanjšan dotok krvi v možgane ali kap,
- blood clots in the arteries, which can lead to a stroke and a heart attack,
- krvne strdke v arterijah, ki lahko vodijo do kapi ali srčnega napada,
- falling asleep or fainting
- bolezensko zaspanost in omedlevico,
- problems with the heart with breathing difficulties,
- težave s srcem skupaj s težavami z dihanjem,
- nose bleed,
- krvavitev iz nosu,