natgillin/translations-raw huggingface dataset:
Vemlidy tenofovir alafenamide
Vemlidy tenofoviralafenamid
What is Vemlidy and what is it used for?
Što je Vemlidy i za što se koristi?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vemlidy have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Vemlidy nalaze se u sažetku opisa svojstava i u uputi o lijeku.
It is not intended to provide practical advice on how to use Vemlidy.
Svrha sažetka nije davati praktične savjete o primjeni lijeka Vemlidy.
Other information about Vemlidy
Ostale informacije o lijeku Vemlidy
This result was similar to that in patients taking another form of tenofovir (tenofovir disoproxil fumarate) where 93% had very low viral DNA levels.
Taj rezultat sličan je onom u bolesnika koji su dobivali drugi oblik tenofovira (tenofovirdizoproksil fumarat), kada je 93 % bolesnika imalo vrlo niske razine virusnog DNK-a.
Vemlidy is an antiviral medicine for treating chronic (long-term) hepatitis B, an infectious disease that affects the liver.
Vemlidy je protuvirusni lijek za liječenje kroničnog (dugotrajnog) hepatitisa B, zarazne bolesti koja zahvaća jetru.
Vemlidy reduces levels of hepatitis B virus in most patients.
Lijek Vemlidy smanjuje razinu virusa hepatitisa B u većine bolesnika.
For more information about treatment with Vemlidy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o liječenju lijekom Vemlidy pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
It contains the active substance tenofovir alafenamide.
Sadrži djelatnu tvar tenofoviralafenamid.
What are the risks associated with Vemlidy?
Koji su rizici povezani s lijekom Vemlidy?
In a second study of 875 patients with ‘e-antigen positive' chronic hepatitis, 64% of patients taking Vemlidy and 67% of those taking tenofovir disoproxil fumarate had very low levels of viral DNA after 48 weeks.
U drugom ispitivanju, koje je obuhvatilo 875 bolesnika s kroničnim hepatitisom B pozitivnih na antigen e, 64 % bolesnika koji su dobivali lijek Vemlidy i 67 % bolesnika koji su dobivali tenofovirdizoproksil fumarat imalo je vrlo niske razine virusnog DNK-a nakon 48 tjedana liječenja.
It is converted in the body into its active compound tenofovir, which blocks the activity of reverse transcriptase, an enzyme made by the hepatitis B virus that allows it to reproduce itself in the cells it has infected.
U tijelu se pretvara u aktivni spoj tenofovir koji onemogućuje djelovanje reverzne transkriptaze, enzima koji virus hepatitisa B stvara i omogućuje mu da se množi u stanicama koje je zarazio.
Vemlidy suppresses levels of hepatitis B virus in the body, and its effectiveness is comparable to that of another tenofovir medicine (tenofovir disoproxil fumarate).
Lijek Vemlidy smanjuje razinu virusa hepatitisa B u tijelu, a njegova djelotvornost usporediva je s djelotvornošću drugog lijeka koji sadrži tenofovir (tenofovirdizoproksil fumarat).
Why is Vemlidy approved?
Zašto je lijek Vemlidy odobren?
Vemlidy can only be obtained with a prescription.
Lijek Vemlidy izdaje se samo na recept.
In addition, Vemlidy is effective at a lower dose than tenofovir disoproxil fumarate and may lead to reduced side effects in the kidneys and bones.
Osim toga, lijek Vemlidy učinkovit je pri manjoj dozi u odnosu na tenofovirdizoproksil fumarat i mogao bi imati blaže nuspojave povezane s bubrezima i kostima.
In a study of 426 patients with ‘e-antigen negative' chronic hepatitis, 94% of patients on Vemlidy had very low levels of viral DNA after 48 weeks of treatment.
U ispitivanju koje je obuhvatilo 426 bolesnika s kroničnim hepatitisom B negativnih na antigen e, 94 % bolesnika koji su dobivali lijek Vemlidy imalo je vrlo niske razine virusnog DNK-a nakon 48 tjedana liječenja.
For practical information about using Vemlidy, patients should read the package leaflet or contact their doctor or pharmacist.
Praktične informacije o primjeni lijeka Vemlidy bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
With regard to its risks, the side effects of Vemlidy are manageable.
U pogledu rizika, nuspojave lijeka Vemlidy moguće je kontrolirati.
For the full list of side effects and restrictions see the package leaflet.
Potpuni popis nuspojava i ograničenja potražite u uputi o lijeku.
What benefits of Vemlidy have been shown in studies?
Koje su koristi lijeka Vemlidy dokazane u ispitivanjima?
How does Vemlidy work?
Kako djeluje Vemlidy?
The active substance in Vemlidy, tenofovir alafenamide, works by stopping the hepatitis B virus in the liver from multiplying.
Djelatna tvar u lijeku Vemlidy, tenofoviralafenamid, djeluje zaustavljajući umnožavanje virusa hepatitisa B u jetri.
How is Vemlidy used?
Kako se Vemlidy koristi?
These reactions usually regress within one week.
Te se reakcije uglavnom povlače za tjedan dana.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
Ako bol potraje više od 12 sati nakon pregleda, potražite ponovo medicinsku pomoć.
Dogs (pregnant bitches)
Psi (gravidne kuje).
Special warnings for each target species:
Posebna upozorenja za svaku od ciljanih vrsta:
Accidental injection is dangerous
Slučajno ubrizgavanje je opasno.
Second injection: 1 to 2 weeks before the expected date of whelping.
Druga injekcija: 1 do 2 tjedna prije očekivanog datuma koćenja.
These are rare and appropriate symptomatic treatment should be administered.
One su rijetke i potrebno je primijeniti odgovarajuće simptomatsko liječenje.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/
Revaccination: during each pregnancy, according to the same schedule.
Docjepljivanje: tijekom svakog graviditeta, prema istom rasporedu.
Hypersensitivity reactions may occur.
Mogu se javiti reakcije preosjetljivosti.
Shelf life of the veterinary medicinal product as packaged for sale: 24 months.
Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju : 24 mjeseca.
Pharmacotherapeutic group : Inactivated viral vaccines ATCvet code: QI07AA06
Farmakoterapijska grupa : inaktivirana virusna vakcina ATCvet kod: QI07AA06
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Ne postoje dostupni podaci o neškodljivosti i djelotvornosti ovog cjepiva kada se primjenjuje s bilo kojim drugim veterinarsko medicinskim proizvodom.
This veterinary medicinal product contains mineral oil.
Ovaj veterinarsko medicinski proizvod sadrži mineralno ulje.
Solvent : homogeneous white emulsion
Otapalo: homogena bijela emulzija.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
SADRŽAJ, TEŽINA, VOLUMEN IL BROJ DOZA
Date of first authorisation: 26.03.2001 Date of last renewal: 18.04.2006
Datum posljednjeg produljenja odobrenja: 18.04.2006.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after “EXP”.
Ne koristiti ovaj veterinarsko medicinski proizvod poslije isteka roka valjanosti naznačenog na naljepnici iza „EXP“.
This vaccine is specifically indicated during pregnancy.
Ovo cjepivo je posebno indicirano tijekom graviditeta.
Following reconstitution of the powder with the solvent, inject one dose (1ml) of the vaccine via the subcutaneous route, according to the following schedule:
Nakon rekonstitucije praha s otapalom injicirajte jednu dozu (1 ml) cjepiva subkutano, u skladu sa sljedećim rasporedom cijepljenja:
EU/2/01/029/001 10 doses: powder (10 bottles) + solvent (10 bottles) EU/2/01/029/002 50 doses: powder (50 bottles) + solvent (50 bottles) EU/2/01/029/003 1 dose: powder (1 bottle) + solvent (1 bottle)
EU/2/01/029/001 10 doza: prah (10 bočica) + otapalo (10 bočica) EU/2/01/029/002 50 doza: prah (50 bočica) + otapalo (50 bočica) EU/2/01/029/003 1 doza: prah (1 bočica) + otapalo (1 bočica)
QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance :
KVALITATIVNI I KVANTITATIVNI SASTAV Djelatna tvar
Pregnancy: This vaccine is specifically indicated during pregnancy.
Graviditet: Ovo cjepivo posebno je indicirano tijekom graviditeta.
First injection: Either during heat or 7 -10 days after the presumed date of mating.
Prva injekcija: bilo u tijeku tjeranja ili 7 -10 dana nakon vjerojatnog parenja.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle
OSNOVNI PODACI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA
EXP {month/year} Once reconstituted use immediately.
EXP {mjesec/godina} Jednom rekonstituirano odmah upotrijebiti.
Once reconstituted use immediately.
Jednom rekonstituirano upotrijebiti odmah.
Polyoxyethylene fatty acids Ether of fatty alcohols and of polyols Triethanolamine
Polioksietilenske masne kiseline Eter masnih kiselina i poliola Trietanolamin
Aseptically reconstitute the contents of the powder with the solvent supplied with this vaccine.
Aseptično rekonstituirajte sadržaj u formi praha s otapalom isporučenim uz ovo cjepivo.
The reconstituted content shall be a milky emulsion.
Rekonstituirano cjepivo treba biti emulzija mliječne boje.
Type I glass bottle containing powder for 1-dose and glass bottle containing 1-ml of solvent.
I koja sadrži prah za 1 dozu i staklena bočica koja sadrži 1 ml otapala.
Dextran 40
Dekstran 40
Manufacturer responsible for batch release: MERIAL, Laboratoire Porte des Alpes, Rue de l'Aviation, 69800 Saint Priest, France
Proizvođač odgovoran za puštanje serije u promet: MERIAL, Laboratoire Porte des Alpes, Rue de l'Aviation, 69800 Saint Priest, Francuska
Do not mix with any other veterinary medicinal product except the solvent supplied for use with the veterinary medicinal product.
Ne miješati ni s jednim drugim veterinarsko medicinskim proizvodom osim s isporučenim otapalom za ovaj veterinarsko medicinski proizvod.
Light paraffin oil
Lako parafinsko ulje
No undesirable effects other than those mentioned in the “Adverse reactions” section have been observed after the administration of several doses.
Nisu primijećeni neželjeni učinci nakon primjene nekoliko doza cjepiva osim onih već spomenutih u odjeljku "Nuspojave".
Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Nehotična injekcija/samoinjiciranje može prouzročiti jaku bol i otok, naročito ako se injicira u zglob prsta, a u rijetkim slučajevima može rezultirati gubitkom zahvaćenog prsta ukoliko nije pružena hitna medicinska pomoć.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE C. STATEMENT OF THE MRLs
UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE C. IZVJEŠĆE O MRL
Casein hydrolysate Collagen hydrolysate Salts
Kazein hidrolizat Kolagen hidrolizat Soli
Special precautions to be taken by the person administrating the veterinary medicinal product to animals:
Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama:
Box of 2 x 1 bottle, 2 x 10 bottles and 2 x 50 bottles.
Kutija s 2 x 1 bočicom, 2 x 10 bočica i 2 x 50 bočica.
4.5 Special precautions for use Special precautions for use in animals
4.5 Posebne mjere opreza za primjenu Posebne mjere opreza za primjenu na životinjama
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
13. RIJEČI “ SAMO ZA PRIMJENU NA ŽIVOTINJAMA ” I UVJETI ILI OGRANIČENJA
Purified subunit vaccine for the active immunisation of pregnant bitches to induce passive immunity in puppies against herpesvirus-induced fatal neonatal disease.
Pročišćeno subjedinično cjepivo za aktivnu imunizaciju gravidnih kuja i pasivnu imunost štenaca protiv smrtne neonatalne bolesti izazvane herpes virusom.
In order for immunity to be conferred to the puppies, sufficient intake of colostrum is required
Kako bi se prenijela imunost na štenad, potreban je dostatan unos kolostruma
In order for immunity to be conferred to the puppies, sufficient intake of colostrum is required.
Kako bi se prenijela imunost na štenad, potreban je dostatan unos kolostruma.
Active immunisation of bitches to prevent mortality, clinical signs and lesions in puppies resulting from canine herpes virus infections acquired in the first few days of life through passive immunity.
Aktivna imunizacija kuja za sprečavanje smrtnosti, kliničkih znakova i lezija u štenadi koje su posljedica infekcije herpes virusom pasa zaraženih u prvih nekoliko dana života, zaštita štenadi preko pasivnog imuniteta.
Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
HITNO je potreban, stručni kirurški pregled koji može zahtijevati preventivnu inciziju i irigaciju injiciranog područja, napose u području jagodice prsta i tetiva.
Overdose:
Predoziranje:
Powder and solvent for emulsion for injection.
Prašak i otapalo za emulziju za injekciju.
10 doses: powder (10 bottles) + solvent (10 bottles) 50 doses: powder (50 bottles) + solvent (50 bottles)
1 doza: prah (1 bočica) + otapalo (1 bočica) 10 doza: prah (10 bočica) + otapalo (10 bočica) 50 doza: prah (50 bočica) + otapalo (50 bočica)
The vaccine may commonly cause transient oedema at the site of injection.
Cjepivo može često prouzročiti prolazni edem na mjestu uboda.
- common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
- manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja)
Shelf life after reconstitution: use immediately
Rok valjanosti poslije rekonstitucije: primijeniti odmah.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja tretmana)
Per 1-ml dose: Canine herpesvirus (F205 strain) antigens ............................................... 0.3 to 1.75 µg* *expressed in µg of gB glycoproteins
Po dozi od 1 ml: antigeni herpes virusa pasa (soj F205) ..................................................0,3 do 1,75 μg*
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Ukoliko ste nehotično samoinjicirali ovaj proizvod, potražite hitnu medicinsku pomoć čak i ako je injicirana vrlo mala količina, a sa sobom ponesite uputu o VMP.
Eurican Herpes 205 solvent
Eurican Herpes 205 otapalo
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ BIOLOŠKI DJELATNE(IH) TVARI I PROIZVOĐAČ ODGOVORAN
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
12. POSEBNE MJERE OPREZA ZA ODLAGANJE NEUPOTREBLJENIH PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit.
U slučaju nehotičnog injiciranja ovim proizvodom, čak ako je injicirana i vrlo mala količina, ona može prouzročiti intenzivno oticanje, koje može rezultirati ishemičnom nekrozom i čak gubitkom prsta.
Name and address of the manufacturer responsible for batch release
Naziv i adresa proizvođača odgovornog za puštanje serije u promet MERIAL
Eurican Herpes 205 powder for injection
Eurican Herpes 205 prašak za injekciju
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
PROIZVOĐAČ BIOLOŠKI DJELATNE(IH) TVARI I PROIZVOĐAČ
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of 2 x 1 bottle, 2 x 10 bottles and 2 x 50 bottles
Kutija s 2 x 1 bočicom, 2 x 10 bočica i 2 x 50 bočica
Light paraffin oil ......................................................................................................... 224.8 to 244.1 mg For the full list of excipients, see section 6.1.
Lako parafinsko ulje ............................................................................................224,8 do 244,1 mg
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja tretmana) - česte (više od 1 ali manje od 10 životinja na 100 životinja)
Abortion and premature parturition can occur as a result of CHV infection in bitches, the protection of the bitch against infection has not been studied for this vaccine.
Zaštita kuje od infekcije nije proučavana za ovo cjepivo.
Eurican Herpes 205 powder and solvent for emulsion for injection.
Eurican Herpes 205 prašak i otapalo za emulziju za injekciju.
PACKAGE LEAFLET FOR: Eurican Herpes 205 powder and solvent for emulsion for injection
UPUTA O VMP ZA : Eurican Herpes 205 prašak i otapalo za emulziju za injekciju
Eurican Herpes 205 powder and solvent for emulsion for injection
Eurican Herpes 205 prašak i otapalo za emulziju za injekciju
The bottles are closed with a butyl elastomer closure and sealed with an aluminium cap Box of 2 x 1 bottle, 2 x 10 bottles and 2 x 50 bottles.
Bočice su zatvorene čepom od butil elastomera i aluminijskom kapicom.
Powder and solvent for emulsion for injection Lyophilisate : white pellet.
Liofilizat: bijela peleta.
Packaging Content Package size
Pakovanje Sadržaj
Further information can be found here:
Dodatne informacije možete pronaći ovdje:
It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Ova tvrtka može zatražiti ponovno ispitivanje mišljenja u roku od 15 dana od primitka obavijesti o ovom negativnom mišljenju.
ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
ema.europa.eu/Find medicine/Human medicines/Rare disease designations
The company provided data in experimental models from the scientific literature.
Tvrtka je dostavila podatke iz eksperimentalnih modela koji su dostupni iz znanstvene literature.
The main measure of effectiveness was based on how long the patients lived without their cancer symptoms reappearing or until death.
Glavna mjera djelotvornosti temeljila se na tome koliko su dugo bolesnici preživjeli bez ponovnog pojavljivanja simptoma raka ili do smrti.
EMA/249530/2015 EMEA/H/C/002772
24. travnja 2015. EMA/372536/2015 EMEA/H/C/002772
What is Lympreva?
Što je Lympreva?
The CHMP also had some concerns regarding some aspects of the manufacture and quality control of the medicine.
CHMP bio je također u određenoj mjeri zabrinut zbog pojedinih aspekata proizvodnog postupka i kontrole kvalitete lijeka.
It was to be available as a suspension for injection under the skin.
Trebao je biti dostupan kao supenzija za potkožnu injekciju.
The company also presented the results of one main study involving a total of 177 adults with follicular lymphoma who had responded to induction treatment with an established therapy known as PACE (prednisone, doxyrubicin, cyclophosphamide, and etoposide) and who had no sign of their disease.
Tvrtka je također dostavila rezultate jednog glavnog ispitivanja koje je obuhvatilo ukupno 177 odraslih osoba s folikularnim limfomom koji je odgovorio na uvodnu terapiju s utvrđenom terapijom poznatom kao PACE (prednizon, doksirubicin, ciklofosfamid i etopozid) te koji nisu imali znakove svoje bolesti.
The CHMP considered that the way the main study was designed and carried out was inadequate to allow the Committee to establish the medicine's benefit.
CHMP je zaključio da je način na koji je osmišljeno i provedeno glavno ispitivanje ne omogućuje Odboru utvrđivanje koristi lijeka.
In addition, the effectiveness of Lympreva following induction treatment with the current standard of care (the so-called ‘anti-CD20' therapies) has not been demonstrated.
Nadalje, nije utvrđena djelotvornost lijeka Lympreva nakon uvodne terapije s aktualnim standardom skrbi (takozvanih "anti-CD20" terapija).
On 23 April 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Lympreva, intended for the treatment of patients with follicular non-Hodgkin's lymphoma.
Dana 23. travnja 2015., Odbor za lijekove za humanu uporabu (CHMP) usvojio je negativno mišljenje, preporučujući odbijanje odobrenja za stavljanje lijeka u promet za lijek Lympreva, koji je namijenjen liječenju bolesnika s folikularnim ne-Hodgkinovim limfomom.
Therefore, at that point in time, the CHMP was of the opinion that the benefits of Lympreva did not outweigh its risks and recommended that it be refused marketing authorisation.
Stoga, u tom trenutku CHMP bio je mišljenja da koristi lijeka Lympreva ne nadmašuju njegove rizike, te je preporučio da se odbije izdavanje odobrenja za stavljanje lijeka u promet.
Lympreva is a medicine that contains the active substance dasiprotimut-T.
Lympreva je lijek koji sadrži djelatnu tvar dasiprotimut-T.
Lympreva was expected to be given to patients whose signs of disease had disappeared following an ‘induction' treatment, to maintain the complete disappearance of symptoms of cancer.
Očekivano je da će se Lympreva primjenjivati u bolesnika čiji su znakovi bolesti nestali nakon "uvodnog" liječenja kako bi se zadržao potpuni nestanak simptoma raka.
What was Lympreva expected to be used for?
Za što se Lympreva trebao koristiti?
Refusal of the marketing authorisation for Lympreva (dasiprotimut-T)
Odbijanje odobrenja za stavljanje u promet lijeka Lympreva (dasiprotimut-T)
Refusal of the marketing authorisation for Lympreva (dasiprotimut-T) EMA/249530/2015
Odbijanje odobrenja za stavljanje u promet lijeka Lympreva (dasiprotimut-T) EMA/372536/2015
Lympreva is a type of ‘cancer immunotherapy' medicine, a medicine designed to stimulate the patient's immune system (the body's natural defences) so that it attacks and kills the cancer cells.
Lympreva je tip "antitumorskog imunoterapijskog" lijeka, lijeka koji je razvijen za stimulaciju imunosnog sustava (prirodne obrane tijela) bolesnika tako da napada i ubija stanice raka.
The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes with Lympreva.
Tvrtka je obavijestila CHMP da nema tekućih kliničkih ispitivanja ili programa milosrdnog davanja lijeka Lympreva.
Lympreva is prepared individually for each patient from a sample of their own lymphoma cells.
Lympreva se priprema zasebno za svakog bolesnika iz uzorka njihovih vlastitih stanica limfoma.
When injected into the patient's body, these lymphoma-specific proteins are expected to stimulate certain components of the immune system to attack and kill the lymphoma cells.
Ako se ubrizgaju u tijelo bolesnika, očekuje se da će ovi proteini specifični za limfom stimulirati određene komponente imunosnog sustava koje napadaju i ubijaju stanice limfoma.
It was expected to be used in combination with another medicine called granulocyte macrophage colony-stimulating factor (GM-CSF).
Očekuje se da će se koristiti u kombinaciji s drugim lijekom naziva faktor stimulacije kolonije granulocita i makrofage.
How is Lympreva expected to work?
Kako je Lympreva trebao djelovati?