natgillin/translations-raw huggingface dataset:
Other medicines and Olanzapine Glenmark Europe Only take other medicines while you are on Olanzapine Glenmark Europe if your doctor tells you that you can. You might feel drowsy if Olanzapine Glenmark Europe is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Druga zdravila in zdravilo Olanzapin Glenmark Europe Med zdravljenjem z zdravilom Olanzapin Glenmark Europe jemljite druga zdravila samo, če vam zdravnik pove, da smete.
MARKETING AUTHORISATION NUMBER(S) EU/1/09/588/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/588/001
Respiratory, thoracic and mediastinal disorders Epistaxis9
Bolezni dihal, prsnega koša in mediastinal nega prostora
Olanzapine Glenmark Europe 10 mg: yellow coloured circular flat bevelled edge orodispersible tablets with ‘OL' debossed on one side and ‘D' debossed on other side.
Olanzapin Glenmark Europe 10 mg: rumena, okrogla, ploščata tableta z zaobljenim robom, z oznako 'OL' na eni strani in oznako 'D' na drugi strani.
Excipient with known effect: Each orodispersible tablet contains 0.23 mg of aspartame For the full list of excipients, see section 6.1
Pomožne snovi z znanim učinkom: Ena orodisperzibilna tableta vsebuje 0,23 mg aspartama.
MARKETING AUTHORISATION NUMBER(S) EU/1/09/588/007
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/588/007
- Weight gain has been seen in patients taking Olanzapine Glenmark Europe.
Pri bolnikih, ki so jemali zdravilo Olanzapin Glenmark Europe, so opazili porast telesne teže.
Olanzapine Glenmark Europe 15 mg: yellow coloured circular flat bevelled edge orodispersible tablets with ‘OL' debossed on one side and ‘E' debossed on other side.
Olanzapin Glenmark Europe 15 mg: rumena, okrogla, ploščata tableta z zaobljenim robom, z oznako 'OL' na eni strani in oznako 'E' na drugi strani.
EU/1/09/588/001 EU/1/09/588/002
EU/1/09/588/007 EU/1/09/588/008 EU/1/09/588/009
Yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘D' debossed on one side.
Rumene, okrogle, ploščate tablete z zaobljenim robom, z oznako 'OL' na eni strani in oznako 'D' na drugi strani.
Olanzapine Glenmark Europe 20 mg orodispersible tablets Olanzapine
Olanzapin Glenmark Europe 20 mg orodisperzibilne tablete olanzapin
NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark Europe 20 mg orodispersible tablets
IME ZDRAVILA Olanzapin Glenmark Europe 20 mg orodisperzibilne tablete
The frequency terms listed are defined as follows: Very common (≥1/10), common (≥ 1/100 to < 1/10 %), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the data available).
Našteti izrazi pogostnosti so definirani kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), ni znano (ocena ni možna iz danih podatkov).
Olanzapine Glenmark Europe 5 mg orodispersible tablets Olanzapine
Olanzapin Glenmark Europe 5 mg orodisperzibilne tablete olanzapin
NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark Europe 10 mg orodispersible tablets
IME ZDRAVILA Olanzapin Glenmark Europe 10 mg orodisperzibilne tablete
Olanzapine Glenmark Europe 15 mg orodispersible tablets Olanzapine
Olanzapin Glenmark Europe 15 mg orodisperzibilne tablete olanzapin
• Abnormal rhythms of the heart.
• motnje srčnega ritma,
Olanzapine Glenmark Europe 10 mg orodispersible tablets Olanzapine
Olanzapin Glenmark Europe 10 mg orodisperzibilne tablete olanzapin
NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark Europe 15 mg orodispersible tablets
IME ZDRAVILA Olanzapin Glenmark Europe 15 mg orodisperzibilne tablete
NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark Europe 5 mg orodispersible tablets
IME ZDRAVILA Olanzapin Glenmark Europe 5 mg orodisperzibilne tablete
- The active substance is olanzapine - Each Olanzapine Glenmark Europe orodispersible tablet contains, 5 mg, 10 mg, 15 mg, or
Ena orodisperzibilna tableta zdravila Olanzapin Glenmark Europe vsebuje 5 mg, 10 mg, 15 mg ali 20 mg olanzapina.
• Prostate problems
• težave pri mokrenju,
STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 10 mg olanzapine.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena orodisperzibilna tableta vsebuje 10 mg olanzapina.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 15 mg Olanzapine Excipient with known effect: Each orodispersible tablet contains 0.69 mg of aspartame For the full list of excipients, see section 6.1
Pomožne snovi z znanim učinkom: Ena orodisperzibilna tableta vsebuje 0,69 mg aspartama.
High Gamma Glutamyltransferase
Visoka raven gamaglutamiltransfe raze10
STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 15 mg olanzapine.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena orodisperzibilna tableta vsebuje 15 mg olanzapina.
Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported very rarely (≥ 0.01% and < 0.1%) when olanzapine is stopped abruptly.
Relo redko (≥ 0,01 % in < 0,1 %) so pri nenadni prekinitvi zdravljenja z olanzapinom poročali o akutnih simptomih, kot so znojenje, nespečnost, tresenje, občutek tesnobe, slabost ali bruhanje.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 20 mg olanzapine Excipient with known effect: Each orodispersible tablet contains 0.92 mg of aspartame For the full list of excipients, see section 6.1
Pomožne snovi z znanim učinkom: Ena orodisperzibilna tableta vsebuje 0,92 mg aspartama.
STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 20 mg olanzapine
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena orodisperzibilna tableta vsebuje 20 mg olanzapina.
STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 5 mg olanzapine.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena orodisperzibilna tableta vsebuje 5 mg olanzapina.
• Dry mouth.
• vnetje trebušne slinavke,
Urinary hesitation11
okvaro jeter)11
Olanzapine Glenmark Europe 20 mg orodispersible tablets 17.
Olanzapin Glenmark Europe 20 mg orodisperzibilne tablete
The CHMP noted there was inadequate information in several areas of the application, including on the manufacture of the medicine, its testing in humans and animals and its safety.
Odbor CHMP je poudaril, da so bile informacije na več področjih vloge pomanjkljive, vključno z informacijami o proizvodnji zdravila, njegovem preskušanju pri ljudeh in živalih ter njegovi varnosti.
In its letter notifying the Agency of the withdrawal of the application, the company stated that it would be unable to provide requested data on the medicine's manufacture within the required time frame.
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da v zahtevanem časovnem okviru ne bi mogla zagotoviti potrebnih podatkov o proizvodnji zdravila.
Once attached to these receptors, it damages the walls of the blood vessels supplying the tumours, thereby helping to slow down the growth of the cancer.
Po vezavi na te receptorje poškoduje stene žil, ki oskrbujejo tumorje, in tako pomaga upočasniti rast raka.
The medicine was intended for those patients whose cancer has worsened within 6 months of treatment with cancer medicines including pemetrexed.
Zdravilo naj bi bilo namenjeno bolnikom, pri katerih se je rak v šestih mesecih zdravljenja z zdravili za zdravljenje raka, vključno s pemetreksedom, poslabšal.
With regard to the medicine's effectiveness, the main study did not show convincingly that Zafiride was better than placebo at prolonging lives in the intended patients.
Kar zadeva učinkovitost zdravila, z glavno študijo ni bilo prepričljivo dokazano, da je zdravilo Zafiride boljše od placeba pri podaljševanju življenja pri bolnikih, ki jim je zdravilo namenjeno.
The company's application included results from a main study in 400 patients which looked at how long patients lived when treated with Zafiride in combination with other cancer medicines.
Vloga družbe je vključevala rezultate glavne študije pri 400 bolnikih, v kateri so proučevali, kako dolgo so živeli bolniki, zdravljeni z zdravilom Zafiride v kombinaciji z drugimi zdravili za zdravljenje raka.
Zafiride was expected to be used for treating adults with advanced malignant pleural mesothelioma, a cancer of the lining of the lungs usually caused by exposure to asbestos.
Zdravilo Zafiride naj bi se uporabljalo za zdravljenje odraslih z napredovalim malignim plevralnim mezoteliomom, rakom pljučne sluznice, ki ga običajno povzroči izpostavljenost azbestu.
What is Zafiride?
Kaj je zdravilo Zafiride?
On 1 June 2017, MolMed S.p.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zafiride for the treatment of advanced malignant pleural mesothelioma.
je 1. junija 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Zafiride, namenjenim zdravljenju napredovalega malignega plevralnega mezotelioma.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes using Zafiride.
Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Zafiride.
Zafiride is a medicine containing the active substance NGR-human tumour necrosis factor alpha.
Zdravilo Zafiride vsebuje zdravilno učinkovino NGR-humani tumorje nekrotizirajoči faktor alfa.
Zafiride was compared with placebo (a dummy treatment), and all patients in the study had previously been treated with pemetrexed-based chemotherapy.
Zdravilo Zafiride so primerjali s placebom (zdravilom brez zdravilne učinkovine), vsi bolniki v študiji pa so bili predhodno zdravljeni s kemoterapijo na osnovi pemetrekseda.
Zafiride was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 3 June 2008 for malignant mesothelioma.
Zdravilo Zafiride je bilo dne 3. junija 2008 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje malignega mezotelioma.
What was Zafiride expected to be used for?
Za kaj naj bi se zdravilo Zafiride uporabljalo?
The active substance in Zafiride is thought to work by attaching to targets called CD13 and TNF receptors, found on new blood vessels forming around tumours.
Zdravilna učinkovina zdravila Zafiride naj bi delovala tako, da se veže na tarče, imenovane receptorji CD13 in TNF, ki se nahajajo na novih žilah, ki nastajajo okrog tumorjev.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Zafiride did not outweigh its risks.
Zato je odbor CHMP ob umiku vloge menil, da koristi zdravila Zafiride ne odtehtajo z njim povezanih tveganj.
Based on the review of the data, at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that Zafiride could not be approved for the second-line treatment of advanced malignant pleural mesothelioma in patients whose disease had worsened within 6 months of treatment with pemetrexed.
Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Zafiride ni mogoče odobriti za zdravljenje druge izbire napredovalega malignega plevralnega mezotelioma pri bolnikih, pri katerih se je bolezen v šestih mesecih zdravljenja s pemetreksedom poslabšala.
How does Zafiride work?
Kako zdravilo Zafiride deluje?
This summary was last updated in 08-2019.
Povzetek je bil nazadnje posodobljen 08-2019.
The usual recommended infusion time is approximately 60 minutes.
Priporočeni čas infundiranja znaša približno 60 minut.
Here are some of the main results from these studies:
V nadaljevanju so podani nekateri najpomembnejši izsledki iz teh študij.
This was switched to a full marketing authorisation on 15 January 2015.
To je bilo 15. januarja 2015 spremenjeno v običajno dovoljenje za promet.
Further information on Vectibix can be found on the Agency's website ema.europa.eu/ medicines/human/EPAR/vectibix.
Nadaljnje informacije o zdravilu Vectibix so na voljo na spletni strani agencije: ema.europa.eu/ medicines/human/EPAR/vectibix.
As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Ker je podjetje predložilo dodatne zahtevane informacije, je bilo dovoljenje za promet spremenjeno iz pogojnega v običajno.
The recommended dose of Vectibix is 6 mg per kilogram body weight given once every two weeks.
Priporočeni odmerek zdravila Vectibix znaša 6 mg na kilogram telesne mase, daje pa se enkrat na dva tedna.
The European Medicines Agency decided that Vectibix's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Vectibix večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
As a result, these tumour cells can no longer receive the messages transmitted via EGFR that they need to grow and spread to other parts of the body.
Tako te tumorske celice ne morejo več sprejemati sporočil, ki se prenašajo prek EGFR, in sicer da morajo rasti in se širiti na druge dele telesa.
Vectibix was originally given ‘conditional authorisation' because there was more evidence to come about the medicine.
Zdravilo Vectibix je prvotno pridobilo „pogojno dovoljenje za promet“, ker je bilo pričakovanih še več dokazov o zdravilu.
This is because growth of these types of cells does not depend on EGFR and they can continue to grow uncontrollably even when EGFR is blocked.
Rast tovrstnih celic namreč ni odvisna od EGRF, zato lahko nenadzorovano rastejo tudi, ko je EGFR zaviran.
What measures are being taken to ensure the safe and effective use of Vectibix?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vectibix?
As for all medicines, data on the use of Vectibix are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Vectibix stalno spremljajo.
Vectibix received a conditional marketing authorisation valid throughout the EU on 3 December 2007.
Za zdravilo Vectibix je bilo 3. decembra 2007 izdano pogojno dovoljenje za promet, veljavno po vsej EU.
It should only be started after the presence of wild-type RAS has been confirmed by an experienced laboratory using a validated test method.
Uvede se lahko le potem, ko je bila v laboratoriju z izkušnjami na tem področju s pomočjo odobrene testne metode potrjena prisotnost divjega tipa RAS.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vectibix 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 Vectibix upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
An overview of Vectibix and why it is authorised in the EU
Pregled zdravila Vectibix in zakaj je odobreno v EU
It must not be used in patients with interstitial pneumonitis or pulmonary fibrosis (lung diseases).
Prav tako se ne sme uporabljati pri bolnikih z intersticijskim pnevmonitisom ali pljučno fibrozo (obolenjem pljuč).
Other information about Vectibix
Druge informacije o zdravilu Vectibix
Side effects reported with Vectibix are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Vectibix, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Patients in this study (there was no comparator treatment) lived for an average of 11.2 months without their disease getting worse.
Bolniki v tej študiji (primerjalnega zdravila ni bilo) so živeli v povprečju 11,2 meseca brez poslabšanja bolezni.
For more information about using Vectibix, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Vectibix glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effects with Vectibix (in more than 2 patients in 10) were diarrhoea, nausea (feeling sick), vomiting, constipation, abdominal pain (stomach ache), tiredness, fever, lack of appetite, paronychia (nail bed infection), rash, acneiform dermatitis (skin inflammation resembling acne), pruritus (itching), erythema (reddening of the skin) and dry skin.
Najpogostejši neželeni učinki zdravila Vectibix (opaženi pri več kot 2 bolnikih od 10) so driska, navzeja (slabost), bruhanje, zaprtje, bolečine v trebuhu, utrujenost, zvišana telesna temperatura, pomanjkanje teka, zanohtnica (okužba nohtne posteljice), izpuščaj, akneiformni dermatitis (vnetje kože, ki je podobno aknam), pruritus (srbenje), eritem (pordelost kože) in suha koža.
The dose may need to be modified if severe skin reactions occur and treatment stopped if the reaction does not get better.
Ob pojavu resnih kožnih reakcij bo treba odmerek morda prilagoditi ali zdravljenje prekiniti, če reakcije ne izzvenijo.
It contains the active substance panitumumab.
Vsebuje učinkovino panitumumab.
In studies, 93% of the patients receiving Vectibix had side effects affecting the skin, although most of these were mild or moderate.
V študijah so se pri 93 % bolnikov, ki so prejemali zdravilo Vectibix, pojavili neželeni učinki, ki so prizadeli kožo, vendar pa jih je bila večina blagih ali zmernih.
Treatment with Vectibix should be supervised by a doctor who has experience in the use of cancer therapy.
Zdravljenje z njim mora nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje rakavih obolenj.
What is Vectibix and what is it used for?
Kaj je zdravilo Vectibix in za kaj se uporablja?
What benefits of Vectibix have been shown in studies?
Kakšne koristi zdravila Vectibix so se pokazale v študijah?
It was later confirmed that benefit is limited only to patients with wildtype RAS tumours.
Kasneje je bilo potrjeno, da so koristi omejene samo na bolnike z divjim tipom gena RAS v tumorjih.
Patients given these combinations lived for an average of 14.8 months and 12.8 months respectively without their disease getting worse.
Bolniki, ki so prejemali ti kombinaciji so v povprečju živeli 14,8 meseca oziroma 12,8 meseca brez poslabšanja bolezni.
This study involved patients with either wild-type or mutant RAS whose disease had got worse despite treatments that included a fluoropyrimidine, oxaliplatin and irinotecan.
V tej študiji so sodelovali bodisi bolniki z divjim tipom RAS ali mutiranim RAS, katerih bolezen se je poslabšala kljub zdravljenjem, ki so vključevala fluoropirimidin, oksaliplatin in irinotekan.
Several bowel cancer studies have shown that Vectibix is effective at prolonging life or slowing disease progression in patients with ‘wild-type' RAS tumours that have spread.
Več študij rakavih obolenj debelega črevesa je pokazalo, da je zdravilo Vecitibix učinkovito pri podaljševanju življenja ali upočasnjevanju slabšanja bolezni pri bolnikih z divjo vrsto RAS tumorjev, ki so se razširili.
What are the risks associated with Vectibix?
Kakšna tveganja so povezana z zdravilom Vectibix?
Why is Vectibix approved?
Zakaj je bilo zdravilo Vectibix odobreno?
The studies show Vectibix can be effective when used alone and together with the standard chemotherapy regimens FOLFOX (a combination of fluorouracil with folinic acid and the cancer medicine oxaliplatin) or FOLFIRI (fluorouracil with folinic acid and a different cancer medicine, irinotecan).
Študije kažejo, da je zdravilo Vectibix lahko učinkovito, kadar se uporabi samostojno ali skupaj s standardnima kemoterapevtskima shemama FOLFOX (kombinacija fluorouracila s folno kislino in zdravila za zdravljenje raka oksaliplatina) ali FOLFIRI (kombinacija fluorouracila s folno kislino in drugega zdravila za zdravljenje raka, irinotekana).
Vectibix must not be used in patients who have had a severe or life-threatening hypersensitivity (allergic) reaction to panitumumab or any of the other ingredients in the past.
Zdravila Vectibix ne smejo uporabljati osebe, ki so v preteklosti imele življenjsko nevarno preobčutljivostno (alergijsko) reakcijo na panitumumab ali katero koli drugo sestavino zdravila.
Patients receiving Vectibix also had a longer period of time without their disease getting worse: 6.4 months versus 4.6 months.
Tudi čas preživetja bolnikov brez poslabšanja bolezni se je po prejemanju zdravila Vectibix podaljšal: 6,4 meseca v primerjavi s 4,6 meseca.
Vectibix is available for infusion (drip) into a vein.
Zdravilo Vectibix je na voljo za infundiranje (kapalno infuzijo) v veno.
Panitumumab does not seem to work against tumour cells that contain mutated (abnormal) RAS genes.
Zdi se, da panitumumab ne deluje proti tumorskim celicam, ki vsebujejo mutirani (nenormalni) gen RAS.
For the full list of side effects of Vectibix, see the package leaflet.
Za celoten seznam neželenih učinkov zdravila Vectibix glejte navodilo za uporabo.
Vectibix is a medicine for treating colorectal (bowel) cancer that has spread to other parts of the body.
Zdravilo Vectibix je zdravilo za zdravljenje rakavega obolenja debelega črevesa in danke, ki se je razširilo na druge dele telesa.
Vectibix is used alone or with other cancer medicines in patients with a type of tumour that has normal (‘wild-type') copies of a gene known as RAS.
Uporablja se samostojno ali skupaj z drugimi zdravili za zdravljenje raka pri bolnikih z vrsto tumorja, ki ima nemutirane (tj. divjega tipa) kopije gena, znanega kot RAS.
• Patients with wild-type tumours who received Vectibix alone had no disease progression for an average of 16 weeks in a study of 463 patients, compared with 8 weeks in those who did not receive Vectibix and only had supportive care.
• V študiji s 463 bolniki z divjim tipom tumorja se pri tistih, ki so prejemali zdravilo Vectibix samostojno, bolezen ni poslabšala v povprečju 16 tednov, v primerjavi z osmimi tedni pri tistih, ki niso prejemali zdravila Vectibix in so imeli samo podporno zdravljenje.
Vectibix can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Vectibix je le na recept.
The active substance in Vectibix, panitumumab, is a monoclonal antibody, a type of protein that has been designed to attach to and block a target called EGFR on certain cells, including some tumour cells.
Učinkovina v zdravilu Vectibix, panitumumab, je monoklonsko protitelo, vrsta beljakovine, ki je bilo zasnovano tako, da na površini rakavih celic in v nekaterih tumorjih, prepozna prijemališče, imenovano EGFR, se veže nanj in ga zavre.
How does Vectibix work?
Kako zdravilo Vectibix deluje?
How is Vectibix used?
Kako se zdravilo Vectibix uporablja?
• Around 73% of patients given Vectibix plus FOLFIRI and 78% of those given Vectibix with FOLFOX had some reduction in signs of cancer in a study of 80 previously untreated patients.
• V študiji, ki je zajemala 80 predhodno nezdravljenih bolnikov, so se pri okoli 73 % bolnikov, ki so prejemali zdravilo Vectibix skupaj s shemo FOLFIRI, in 78 % tistih, ki so prejemali zdravilo Vectibix skupaj s shemo FOLFOX, znaki raka nekoliko zmanjšali.
• Patients receiving Vectibix in combination with FOLFOX lived for an average of 10.1 months without the disease getting worse in a study of 1,183 previously untreated patients compared with 7.9 months for those receiving FOLFOX alone.
• V študiji, ki je zajemala 1 183 predhodno nezdravljenih bolnikov, so tisti, ki so prejemali zdravilo Vectibix v kombinaciji s shemo FOLFOX v povprečju živeli 10,1 meseca brez poslabšanja bolezni, v primerjavi s 7,9 meseca pri tistih, ki so prejemali samo shemo FOLFOX.
Vectibix must not be used with oxaliplatin-containing chemotherapy in patients whose tumour contains the mutated RAS gene or for whom the RAS status is not known.
Zdravilo Vectibix se pri bolnikih, pri katerih ni bilo potrjeno, da njihovi tumorji vsebujejo mutirani gen RAS, ali pri katerih stanje gena RAS ni znano, ne sme uporabljati skupaj s kemoterapijo, ki vsebuje oksaliplatin.