natgillin/translations-raw huggingface dataset:
95 / 100 (95)
95 / 100 95/ 100) (95) 8. 0 8, 0 (95
Hazard ratio = 1.07 (95% CI:
60% Razmerje ogroženosti = 1, 07 (95% IZ:
0.77, 1.48)
0, 77- 1, 48) 50%
0%
0% 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 tednov tedni Ogroženi preiskovanci:
Subjects at risk:
Ogroženi preiskovanci:
16 18 20 22 24 26 28 30 32
Vectibix+NPO
9 6 6 5 5 5
5 5 5 5 4 4 4
5 4 4 4 4 2 2 2 2 2 2 1 1
1 77 10 966 5 5 5 5 4 4 4 4 2 2 2 2 2 2 1 1
BSC Alone
Samo NPO
22 22 10 10
22 10 10
The PACCE study:
Študija PACCE:
In this randomised, open label, controlled clinical trial, chemotherapy (oxaliplatin or irinotecan) and bevacizumab were given with and without panitumumab in the first line treatment of patients with metastatic colorectal cancer.
V tem randomiziranem, odprtem, kontroliranem kliničnem preskušanju so v terapiji prve izbire pri bolnikih z metastatskim kolorektalnim rakom uporabljali kemoterapijo (oksaliplatin ali irinotekan) in bevacizumab s panitumumabom ali brez njega.
Panitumumab treatment was discontinued due to a statistically significant reduction in PFS in patients receiving panitumumab observed in an interim analysis.
Zdravljenje s panitumumabom so prekinili, ker je bilo na vmesni analizi ugotovljeno statistično značilno skrajšanje preživetja brez napredovanja med bolniki, ki so dobivali panitumumab.
The hazard ratio for PFS was 1.44 (95% CI:
Razmerje ogroženosti za preživetje brez napredovanja je bilo 1, 44 (95% IZ:
Median PFS was 8.8 (95% CI:
Mediano preživetje brez napredovanja je bilo v kraku s panitumumabom 8, 8 (95% IZ:
8.3, 9.5) and 10.5 (95% CI 9.4, 12.0) months in the panitumumab and the non-panitumumab arm, respectively.
9, 4, 12, 0) mesecev.
There was an increase in mortality in the Vectibix arm.
Umrljivost v kraku z Vectibixom se je povečala.
The hazard ratio for overall survival was 1.56 (95% CI:
Razmerje ogroženost za celotno preživetje je bilo 1, 56 (95% IZ:
Median overall survival was 18.4 (95% CI:
Mediano celotno preživetje je bilo v kraku s panitumumabom 18, 4 (95% IZ:
13.8, not estimable) in the panitumumab arm and not estimable in the non-panitumumab arm.
13, 8, neocenljivo), v kraku brez panitumumaba pa ni bilo ocenljivo.
This medicinal product has been authorised under a “ conditional approval” scheme.
Zdravilo je pridobilo "pogojno dovoljenje za promet".
This means that further evidence on this medicinal product is awaited, in particular data are required to confirm the effect in patients with wild-type KRAS tumours which is currently supported by a retrospective analysis.
To pomeni, da se pričakujejo dodatni dokazi o zdravilu, zlasti podatki, potrebni za potrditev učinka pri bolnikih s tumorji z divjim tipom KRAS, ki ga trenutno potrjuje retrospektivna analiza.
Further evidence is also awaited regarding the effect of panitumumab in combination with chemotherapy on PFS in patients with wild-type KRAS tumours.
Dodatni dokazi se pričakujejo tudi o učinku panitumumaba v kombinaciji s kemoterapijo na preživetje brez napredovanja pri bolnikih s tumorji z divjim tipom KRAS.
Studies investigating this effect are currently ongoing.
Študije, ki raziskujejo ta učinek, trenutno potekajo.
5.2 Pharmacokinetic properties
Vectibix, apliciran kot edino
Vectibix administered as a single agent or in combination with chemotherapy exhibits nonlinear pharmacokinetics.
sredstvo v kombinaciji s kemoterapijo, ima nelinearno farmakokinetiko.
Following a single-dose administration of panitumumab as a 1-hour infusion, the area under the concentration-time curve (AUC) increased in a greater than dose-proportional manner and clearance (CL) of panitumumab decreased from 30.6 to 4.6 ml/ day/ kg as the dose increased from 0.75 to 9 mg/ kg.
Po uporabo posamičnega odmerka panitumumaba v 1- urni infuziji se je površina pod krivuljo koncentracije po času (AUC) povečala bolj kot sorazmerno odmerku, očistek panitumumaba pa se je ob povečanju odmerka od 0, 75 na 9 mg/ kg zmanjšal s 30, 6 na 4, 6 ml/ dan/ kg.
However, at doses above 2 mg/ kg, the AUC of panitumumab increases in an approximately dose-proportional manner.
Toda ob odmerkih nad 2 mg/ kg se AUC panitumumaba povečuje približno sorazmerno odmerku.
Following the recommended dose regimen (6 mg/ kg given once every 2 weeks as a 1-hour infusion), panitumumab concentrations reached steady-state levels by the third infusion with mean (± SD) peak and trough concentrations of 213 ± 59 and 39 ± 14 mcg/ ml, respectively.
39 ± 14 µg/ ml.
The mean (± SD) AUC0-tau and CL were 1306 ± 374 mcg• day/ ml and 4.9 ± 1.4 ml/ kg/ day, respectively.
Povprečna (± SO) AUC0– tau je bila 1306 ± 374 µg• dan/ ml, povprečni (± SO) očistek pa 4, 9 ± 1, 4 ml/ kg/ dan.
3.6 to 10.9 days).
Eliminacijski razpolovni čas je bil približno 7, 5 dneva (razpon: od 3, 6 do 10, 9 dneva).
10 A population pharmacokinetic analysis was performed to explore the potential effects of selected covariates on panitumumab pharmacokinetics.
10 Za proučitev možnih učinkov izbranih sospremenljivk na farmakokinetiko panitumumaba je bila narejena analiza populacijske farmakokinetike.
Results suggest that age, gender, tumour type, race, hepatic function, renal function, chemotherapeutic agents, and EGFR expression in tumour cells had no apparent impact on the pharmacokinetics of panitumumab.
Rezultati kažejo, da starost, spol, vrsta tumorja, rasa, delovanje jeter, delovanje ledvic, zdravila za kemoterapijo in ekspresija EGFR na tumorskih celicah nimajo opaznega vpliva na farmakokinetiko panitumumaba.
No clinical studies have been conducted to examine the pharmacokinetics of panitumumab in patients with renal or hepatic impairment.
Kliničnih študij za proučitev farmakokinetike panitumumaba pri bolnikih z okvaro ledvic ali jeter ni bilo.
No age-related differences in pharmacokinetics of panitumumab were observed in clinical studies in patients 26 to 85 years of age.
V kliničnih študijah pri bolnikih, starih od 26 do 85 let, niso ugotovili starostno pogojenih razlik v farmakokinetiki panitumumaba.
Skin rash and diarrhoea were the major findings observed in repeat-dose toxicity studies of up to 26 weeks duration in cynomolgus monkeys.
V študijah toksičnosti ponavljajočih se odmerkov, trajajočih do 26 tednov pri opicah cynomolgus, ki so dobivale panitumumab v odmerkih do približno 6- kratne izpostavljenosti ob priporočenem odmerku za človeka, sta bili glavni opaženi spremembi osip na koži in driska.
The skin rash and diarrhoea observed in monkeys are considered related to the pharmacological action of panitumumab and are consistent with the toxicities observed with other anti-EGFR inhibitors.
Osip na koži in driska, opažena pri opicah, veljata za povezana s farmakološkim delovanjem panitumumaba in se skladata s toksičnimi učinki, ugotovljenimi z drugim zaviralci anti- EGFR.
Studies to evaluate the mutagenic and carcinogenic potential of panitumumab have not been performed.
Študij za oceno mutagenosti in kancerogenosti panitumumaba ni bilo.
Panitumumab has been shown to cause foetal abortions and/ or foetal deaths in cynomolgus monkeys when administered during the period of organogenesis at doses approximately equivalent to the recommended human dose.
Dokazano je, da panitumumab povzroča splave plodov in/ ali smrt plodov, če je pri opicah cynomolgus uporabljen med obdobjem organogeneze v odmerkih, približno enakovrednih priporočenemu odmerku za človeka.
Formal male fertility studies have not been conducted; however, microscopic evaluation of male reproductive organs from repeat-dose toxicity studies in cynomolgus monkeys at doses up to approximately 5-fold the human dose on a mg/ kg basis, revealed no differences compared to control male monkeys.
Vendar mikroskopski pregled reproduktivnih organov samcev opic cynomolgus v študijah ponavljajočih se odmerkov z odmerki, ki so bili do približno 5- kratnik odmerka za človeka (na podlagi mg/ kg), ni pokazal razlik v primerjavi s kontrolnimi samci.
Fertility studies conducted in female cynomolgus monkeys showed that panitumumab may produce prolonged menstrual cycle and/ or amenorrhea and reduced pregnancy rate which occurred at all doses evaluated.
Študije plodnosti pri samicah opic cynomolgus so pokazale, da lahko panitumumab povzroči podaljšan menstruacijski ciklus in/ ali amenorejo ter zmanjša delež nosečnosti, kar se je dogajalo pri vseh ocenjevanih odmerkih.
No pre- and post-natal development animal studies have been conducted with panitumumab.
Študije antenatalnega in postnatalnega razvoja pri živalih ob uporabi panitumumaba niso bile izvedene.
All patients should be advised regarding the potential risk of panitumumab on pre- and post-natal development prior to initiation of Vectibix therapy.
Vsem bolnikom morate pred začetkom zdravljenja z Vectibixom pojasniti možno tveganje, ki ga panitumumab pomeni za antenatalni in postnatalni razvoj.
6.1 List of excipients
Seznam pomožnih snovi 6. 1
Sodium chloride Sodium acetate trihydrate Acetic acid, glacial (for pH-adjustment) Water for injection.
Natrijev klorid Natrijev acetat trihidrat Ledocetna kislina (za uravnavanje pH) Voda za injekcije
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zdravila ne smete mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6. 6.
Vectibix does not contain any antimicrobial preservative or bacteriostatic agent.
11 Vectibix ne vsebuje nobenih antimikrobnih konzervansov ali bakteriostatikov.
The product should be used immediately after dilution.
Zdravilo treba uporabiti takoj po razredčenju.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should be no longer than 24 hours at 2°C to 8°C.
Če ni uporabljeno takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas običajno ne sme presegati 24 ur pri temperaturi od 2 °C do 8 °C.
Single-use vial (type I glass) with an elastomeric stopper, aluminium seal and flip-off plastic cap.
Viala za posamično uporabo (steklo tipa I) z elastomernim zamaškom, aluminijsko zaporo in plastično snemno zaporko.
One vial contains:
Ena viala vsebuje:
100 mg of panitumumab in 5 ml, 200 mg panitumumab in 10 ml, or 400 mg panitumumab in 20 ml of concentrate for solution for infusion.
100 mg panitumumaba v 5 ml, 200 mg panitumumaba v 10 ml ali 400 mg panitumumaba v 20 ml koncentrata za raztopino za infundiranje.
Pack of 1 vial containing 5 ml.
Pakiranje z 1 vialo s 5 ml.
Pack of 1 vial containing 10 ml.
Pakiranje z 1 vialo z 10 ml.
Pack of 1 vial containing 20 ml.
Pakiranje z 1 vialo z 20 ml.
Vectibix should be diluted in 0.9% sodium chloride injection by healthcare professional using aseptic technique.
Vectibix mora razredčiti zdravstveni delavec; za razredčenje je treba uporabiti 0, 9% raztopino natrijevega klorida za injiciranje in upoštevati je treba aseptični postopek.
Withdraw the necessary amount of Vectibix for a dose of 6 mg/ kg.
Izvlecite potrebno količino Vectibixa za odmerek 6 mg/ kg.
Dilute in a total volume of 100 ml.
Razredčite v skupni količini 100 ml.
The final concentration should not exceed 10 mg/ ml.
Končna koncentracija ne sme preseči 10 mg/ ml.
Doses higher than 1000 mg should be diluted in 150 ml 0.9% sodium chloride injection (see section 4.2).
Odmerke, večje od 1000 mg, morate razredčiti v 150 ml 0, 9% raztopine natrijevega klorida za injiciranje (glejte poglavje 4. 2).
No incompatibilities have been observed between Vectibix and 0.9% sodium chloride injection in polyvinyl chloride bags or polyolefin bags.
Inkompatibilnosti med Vectibixom in 0, 9% raztopino natrijevega klorida za injiciranje v polivinilkloridnih ali poliolefinskih vrečkah niso ugotovili.
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Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Farmakovigilančni sistem Imetnik dovoljenja za promet mora zagotoviti ustrezno delovanje sistema farmakovigilance, kot je opisano v različici 3 predstavljeni v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, pred in med trženjem z zdravilom.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3 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 o obvladovanju tveganja Imetnik dovoljenja za promet se zavezuje, da bo opravil študije in dodatne farmakovigilančne dejavnosti, podrobno navedene v farmakovigilančnem načrtu, kot je dogovorjeno v skladu z različico 3 Načrta o obvladovanju tveganja (NOT), predstavljenega v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom, ter vsemi morebitnimi poznejšimi posodobitvami NOT, dogovorjenimi z Odborom za zdravila za ljudi (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Po smernicah CHMP o sistemih upravljanja s tveganji za zdravila za ljudi je treba posodobljeni NOT vložiti hkrati z naslednjim periodičnim posodobljenim varnostnim poročilom (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Poleg tega je treba posodobljeni NOT vložiti: • kadar so prejete nove informacije, ki bi lahko vplivale na veljavno specifikacijo varnosti, farmakovigilančni načrt ali dejavnosti za minimizacijo tveganja, • v 60 dneh po tem, ko je bil dosežen pomemben mejnik (farmakovigilančni ali za minimizacijo tveganja), • na zahtevo EMEA.
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile: • To ensure the availability of KRAS test kit by 30 November 2007 • To provide a Statistical Analysis Plan describing the analysis of wild-type KRAS subpopulation for 20050181 and 20050203 studies.
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednji program študij, katerih rezultati služijo kot osnova za vsakoletno ponovno oceno razmerja med koristmi in tveganji: • do 30. novembra 2007 zagotoviti dostopnost testnega kompleta KRAS • pripraviti Statistični Analizni Plan, ki bo opisoval analize divjega tipa KRAS podskupin študij 20050181 in 20050203.
Vectibix 20 mg/ ml concentrate for solution for infusion Panitumumab
Vectibix 20 mg/ ml koncentrat za raztopino za infundiranje Panitumumab
Each vial contains 200 mg panitumumab.
Ena viala vsebuje 200 mg panitumumaba.
Each vial contains 400 mg panitumumab.
Ena viala vsebuje 400 mg panitumumaba.
Sodium chloride, sodium acetate trihydrate, acetic acid (glacial), water for injections
Natrijev klorid, natrijev acetat trihidrat, ledocetna kislina, voda za injekcije
Vectibix will only be administered by a health care professional and is not required to have Braille on the packaging (EC Guidance concerning the Braille requirements for labelling and the package leaflet [Article 56a of Directive 2001/ 83/ EC as amended]).
Vectibix bodo aplicirali samo zdravstveni delavci, zato na ovojnini niso potrebni podatki v Braillovi pisavi (Navodila ES o zahtevah glede Braillove pisave na označevanju in navodilu za uporabo [Člen 56a direktive 2001/ 83/ EC z vsemi spremembami]).
20 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
20 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Vectibix 20 mg/ ml sterile concentrate Panitumumab IV
Vectibix 20 mg/ ml sterilen koncentrat Panitumumab i. v.
Vectibix 20 mg/ ml concentrate for solution for infusion panitumumab
Vectibix 20 mg/ ml koncentrat za raztopino za infundiranje Panitumumab
It may harm them, even if their symptoms are the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim. • Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
What Vectibix is and what it is used for 2.
Kaj je zdravilo Vectibix in za kaj ga uporabljamo 2.
Before you use Vectibix 3.
Kaj morate vedeti, preden boste uporabili zdravilo Vectibix 3.
How to use Vectibix 4.
Kako uporabljati zdravilo Vectibix 4.
How to store Vectibix 6.
Shranjevanje zdravila Vectibix 6.
WHAT VECTIBIX IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO VECTIBIX IN ZA KAJ GA UPORABLJAMO
Vectibix is used in the treatment of metastatic colorectal carcinoma (cancer of the bowel) after failure of chemotherapy (medicines used to treat cancer) treatment.
Vectibix uporabljamo za zdravljenje metastatskega kolorektalnega karcinoma (raka na debelem črevesju), če zdravljenje s kemoterapijo (zdravili proti raku) ni bilo uspešno.
Vectibix is for use in adults 18 years and over.
Vectibix je namenjen uporabi pri odraslih bolnikih, starih 18 let in več.
Vectibix contains the active substance panitumumab, which belongs to a group of medicines called monoclonal antibodies.
Vectibix kot zdravilno učinkovino vsebuje panitumumab, ki spada v skupino zdravil, imenovanih monoklonska protitelesa.
BEFORE YOU USE VECTIBIX
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO VECTIBIX
Do not use Vectibix
Ne uporabljajte zdravila Vectibix
• if you are allergic (hypersensitive) to panitumumab or any of the other ingredients of Vectibix.
• če ste alergični na (preobčutljivi za) panitumumab ali katerokoli sestavino zdravila Vectibix.
Take special care with Vectibix
Bodite posebno pozorni pri uporabi zdravila Vectibix
Before starting treatment with Vectibix, please tell your doctor or nurse if you:
Pred začetkom zdravljenja z zdravilom Vectibix zdravniku ali medicinski sestri povejte, če:
• have previously had or have evidence of interstitial pneumonitis (swelling of the lungs causing coughing and difficulty breathing) or pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath);
• ste kdaj imeli ugotovljen intersticijski pnevmonitis (vnetje pljuč, ki povzroča kašelj in težko dihanje) ali pljučno fibrozo (brazgotinjenje in zadebelitve v pljučih s kratko sapo),
23 Your doctor will check your blood levels of several substances such as magnesium, and other electrolyte levels such as calcium and potassium in your blood before you start Vectibix treatment.
23 Pred začetkom zdravljenja z zdravilom Vectibix vam bo zdravnik naredil preiskave krvi, s katerimi bo preveril koncentracijo različnih snovi, npr. magnezija in drugih elektrolitov (npr. kalcija in kalija), v krvi.
If these levels are too low, your doctor may prescribe you appropriate supplements.
Če bodo te koncentracije prenizke, vam bo zdravnik morda predpisal ustrezne dodatke.
During treatment with Vectibix
Med zdravljenjem z zdravilom Vectibix
You may experience dermatologic toxicities (skin reactions), if these worsen or become intolerable please tell your doctor or nurse immediately.
Pojavijo se vam lahko dermatološki toksični učinki (kožne reakcije); če se poslabšajo ali postanejo nevzdržni, nemudoma obvestite zdravnika ali medicinsko sestro.
Your doctor will ask you to come in for tests to monitor hypomagnesaemia (low magnesium levels in the blood) and hypocalcaemia (low calcium levels in the blood) periodically during your treatment, and for up to 8 weeks after you have finished your treatment.
Zdravnik vam bo naročil, da morate med zdravljenjem in še 8 tednov po koncu zdravljenja redno prihajati na preiskave krvi, ki pokažejo, ali imate hipomagneziemijo (nizko koncentracijo magnezija v krvi) ali hipokalciemijo (nizko koncentracijo kalcija v krvi).
Vectibix has not been tested in pregnant women.
Vectibix ni preizkušen pri nosečnicah.
Vectibix could affect your ability to stay pregnant.
Vectibix lahko neugodno vpliva na zmožnost za ohranitev nosečnosti.
If you are a woman of child bearing potential, you should use suitable methods of contraception during treatment with Vectibix and for 6 months after the last dose.
Če ste ženska v rodni dobi, morate med zdravljenjem z zdravilom Vectibix in še 6 mesecev po zadnjem odmerku uporabljati primerno kontracepcijsko zaščito.
Do not breast-feed your baby during treatment with Vectibix and for 3 months after the last dose.
Med zdravljenjem z zdravilom Vectibix in še 3 meseca po zadnjem odmerku ne dojite.
HOW TO USE VECTIBIX
KAKO UPORABLJATI ZDRAVILO VECTIBIX
Vectibix will be administered in a healthcare facility under the supervision of a doctor experienced in the use of anti-cancer medicines.
Vectibix boste dobili v zdravstveni ustanovi, pod nadzorstvom zdravnika, izkušenega z uporabo zdravil proti raku.
Vectibix is administered intravenously (into a vein) with an infusion pump (a device that gives a slow injection).
Vectibix se daje intravensko (v veno) z infuzijsko črpalko (napravo, ki omogoča počasno injiciranje).
The recommended dose of Vectibix is 6 mg/ kg (milligrams per kilogram of body weight) given once every two weeks.
Priporočeni odmerek Vectibixa je 6 mg/ kg (miligramov na kilogram telesne mase) enkrat na dva tedna.
Like all medicines, Vectibix can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Vectibix neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
24 Very common side effects (seen in more than 1 in 10 people who take Vectibix) were: • pruritis (itching); erythaema (redness of skin); rash; skin exfoliation (flaking skin); dry skin; skin fissures (cracks in the skin); • paronychia (infection of a nail bed); • diarrhoea; • fatigue (extreme tiredness); • nausea and vomiting; • cough; dyspnoea (breathing difficulties).
Zelo pogosti neželeni učinki (pojavijo se pri več kot 1 od 10 bolnikov, ki dobivajo Vectibix) so: • pruritus (srbenje), eritem (pordelost kože), osip, eksfoliacija kože (luščenje kože), suha koža, fisure na koži (razpoke na koži), • paronihija (okužba nohtne posteljice), • driska, • izčrpanost (izredna utrujenost), • slabost v želodcu in bruhanje, • kašelj, dispneja (težave z dihanjem).
Common side effects (seen in more than 1, but less than 10 in 100 people taking Vectibix) were: • infusion type reactions (which may include signs and symptoms such as chills; and/ or pyrexia (fever or high temperature); • hypomagnesaemia (low magnesium levels in the blood); • hypocalcaemia (low calcium levels in the blood); • hypokalaemia (low potassium levels in the blood); • dehydration; • headache; • conjunctivitis (eye inflammation); growth of eyelashes and increased lacrimation (flow of tears); ocular hyperaemia (redness of the eye); dry eye; eye pruritus (itchy eyes); • pulmonary embolism (blood clot in the lung); • stomatitis (mouth ulcers and cold sores); mucosal inflammation (inflammation of the mouth); dry mouth; • onycholysis (loosening of the nails); • hypertrichosis (excess hair growth); alopecia (hair loss); • nasal dryness.
Pogosti neželeni učinki (pojavijo se pri več kot 1, a manj kot 10 od 100 bolnikov, ki dobivajo Vectibix) so: • infuzijske reakcije (ki lahko vključujejo znake in simptome, kot so mrzlica in/ ali zvišana telesna temperatura), • hipomagneziemija (nizka koncentracija magnezija v krvi), • hipokalciemija (nizka koncentracija kalcija v krvi), • hipokaliemija (nizka koncentracija kalija v krvi), • dehidracija, • glavobol, • konjunktivitis (vnetje očesne veznice), rast trepalnic in močnejše solzenje, hiperemija očesa (pordelost očesa), suho oko, srbenje oči, • pljučna embolija (krvni strdek v pljučih), • stomatitis (razjede v ustih in ocvirki), vnetje ustne sluznice, suhost ust, • oniholiza (odstopanje nohtov), • hipertrihoza (čezmerna rast dlak), alopecija (izpadanje las), • suhost nosu.
Important information about some of the ingredients of Vectibix
Pomembne informacije o nekaterih sestavinah zdravila Vectibix