natgillin/translations-raw huggingface dataset:
Primary vaccination: 2 injections of one dose (2 ml) - From the age of 96 days, with an interval of 3 weeks between injections to achieve duration of immunity over 6 months.
Primarno cepljenje: 2 injekciji enega odmerka (2ml) - Od 96. dneva starosti v razmiku 3 tednov za zagotovitev trajanja imunosti 6 mesecev.
In case of accidental self-injection only a minor injection site reaction is expected.
V primeru nenamernega samo-injiciranja lahko pride do blage reakcije na mestu injiciranja.
Package sizes:
Velikosti pakiranja:
Special warnings for the target species
Posebna opozorila za vsako ciljno živalsko vrsto
Maternally-derived immunity in the piglets interacts with antibody induction.
Maternalna imunost pujskov vpliva na indukcijo protiteles.
PACKAGE LEAFLET FOR:
NAVODILO ZA UPORABO ZA:
Pregnancy and lactation: The vaccine can be used during pregnancy and lactation.
Brejost in laktacija: Lahko se uporablja v obdobju brejosti in laktacije.
PROHIBITION OF SALE; SUPPLY AND/OR USE
PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Ni smiselno.
or - Between the age of 56 and 96 days, with an interval of 3 weeks between injections to achieve duration of immunity over 4 months.
Ali - Med 56. in 96. dnem starosti v razmiku 3 tednov za zagotovitev trajanja imunosti 4 mesece.
Read the package leaflet before use.
IM Pred uporabo preberite navodilo za uporabo.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA SPROŠČANJE SERIJ V EGP, ČE STA RAZLIČNA
GMNU = Geometric mean of neutralizing units induced in Guinea pigs after twice immunisation with 0.5 ml of this vaccine.
GMNU = Geometrijska sredina neutralizirajočih enot induciranih pri budrah po dvakratni imunizaciji z 0,5 ml tega cepiva
MANUFACTURER'S BATCH NUMBER
IZDELOVALČEVA ŠTEVILKA SERIJE Lot:
Strains of inactivated Influenza A virus/swine/ Bakum/IDT1769/2003 (H3N2)
Sevi inaktiviranega virusa Influenca A /prašiči/ Bakum/IDT1769/2003 (H3N2)
The vaccine stimulates an active immunity against Swine Influenza A virus subtypes H1N1, H3N2 and H1N2.
Cepivo sproži nastanek aktivne imunosti proti virusu influence A prašičev, subtip H1N1, H3N2 in H1N2.
Active immunisation of pigs from the age of 56 days onwards including pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection.
Aktivna imunizacija prašičev od 56 dneva starosti naprej, vključno z brejimi svinjami, proti influenci prašičev, ki jo povzročajo podtipi H1N1, H3N2 in H1N2, za zmanjšanje kliničnih znakov in prisotnosti virusa v pljučih po okužbi.
A booster is possible at each stage of pregnancy and lactation.
Revakcinacija je možna v vseh obdobjih brejosti in laktacije.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box for 20ml, 50 ml, 100 ml
PODATKI NA ZUNANJI OVOJNINI Škatla za 20 ml, 50 ml, 100 ml
STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGEIH SESTAVIN
A transient slight swelling may occur on very rare occasions after vaccination at the site of injection, regressing within 2 days.
Na mestu injiciranja se lahko v zelo redkih primerih pojavi manjša prehodna oteklina, ki običajno mine v 2 dneh.
SPECIAL WARNING(S), IF NECESSARY
POSEBNO(A) OPOZORILO(A)
Date of first authorisation: 14/01/2010 Date of last renewal : DD/MM/YYYY
Datum podaljšanja dovoljenja za promet: DD/MM/LLLL
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št.
Gripovac 3 suspension for injection for pigs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Gripovac 3 suspenzija za injiciranje za prašiče
Suspension for injection
FARMACEVTSKA OBLIKA Suspenzija za injiciranje
Active immunisation of pregnant sows after finished primary immunisation by administration of a single dose 14 days prior to farrowing to develop high colostral immunity which provides clinical protection of piglets for at least 33 days after birth.
Aktivna imunizacija brejih svinj po zaključeni primarni imunizaciji z dajanjem enega odmerka 14 dni pred prasitvijo, za doseganje visoke kolostralne imunosti, ki pujske ščiti vsaj 33 dni po rojstvu.
Flanged caps
Zaporke: Zarobljene zaporke
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY AND USE
B POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
Immunologicals, Inactivated viral vaccines
Farmakoterapevtska skupina: cepiva, inaktivirana virusna cepiva Oznaka ATC vet:
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
Thiomersal
Pomožna snov: Tiomersal
When vaccination is performed 14 days prior to farrowing with one dose (2 ml), it provides maternally-derived immunity to the piglets which protects them from clinical signs of influenza at least until day 33 after birth.
S cepljenjem 14 dni pred prasitvijo je zagotovljena maternalna imunost, ki pujske ščiti pred kliničnimi znaki influence vsaj do 33. dneva po prasitvi.
Incompatibilities: Do not mix with any other medicinal product.
Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili za uporabo v veterinarski medicini.
100 ml (50 doses)
50 ml (25 odmerkov)
20 ml (10 doses), 50 ml (25 doses), 100 ml (50 doses)
VELIKOST PAKIRANJA 20 ml (10 odmerkov), 50 ml (25 odmerkov), 100 ml (50 odmerkov)
When a single dose of the vaccine is administered 14 days prior to farrowing as a booster to previously vaccinated sows, the vaccine stimulates active immunity in order to provide maternally-derived immunity to the progeny against Swine Influenza A virus subtypes H1N1, H3N2 and H1N2.
Po dajanju enega poživitvenega odmerka cepiva predhodno cepljenim svinjam 14 dni pred prasitvijo, cepivo povzroči nastanek aktivne imunosti in zagotovi maternalno imunost potomcem proti influenci prašičev A, podtip H1N1, H3N2 in H1N2.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSČANJE SERIJE
PET vials: 20 ml Polyethylene terephthalate (PET) vials, clear 50 ml PET vials, clear
PET viale: 20 ml polietilen tereftalatne (PET) prozorne viale
MARKETING AUTHORISATION NUMBER(S)
IMETNIK(I) DOVOLJENJ(A) ZA PROMET
Disposal: read package leaflet
Odstranjevanje: preberite navodilo za uporabo.
Gilts and sows:
Mladice in svinje:
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDARVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Zero days
Nič dni.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial of 100 ml
PODATKI NA STIČNI OVOJNINI Steklena viala s 100 ml
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov izdelovalca zdravila, odgovornega za sproščanje serije
Adjuvant:
Pujski:
EU/2/09/102/003 EU/2/09/102/006
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/09/102/003
Target species
CILJNE ŽIVALSKE VRSTE Prašiči
Cardboard box with 1 glass or PET vial of 10 doses (20 ml), 25 doses (50 ml) or 50 doses (100 ml) with a rubber stopper and flanged cap.
Škatlica z 1 stekleno vialo ali PET vialo z 10 odmerki (20 ml), 25 odmerki (50 ml) ali 50 odmerki (100 ml) z gumijastim zamaškom in zarobljeno zaporko.
Amounts to be administered and administration route
4.9 Odmerjanje in pot uporabe
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 20 ml (10 odmerkov),
Shelf-life
Rp-Vet.
QUALITATIVE AND QUANTITATIVE COMPOSITION
6.5 Vrsta ovojnine in vsebina
Special precautions for the disposal of unused veterinary medicinals product or waste materials derived from the use of such products
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial of 20 ml and 50 ml
Steklena viala z 20 ml in 50 ml
CLINICAL PARTICULARS 4.1.
4.1 Ciljne živalske vrste
QUANTITY OF THE ACTIVE SUBSTANCE(S)
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI Vsak odmerek (2ml) vsebuje:
Withdrawal period: zero days
KARENCA Karenca: Nič dni
For animal treatment only.To be supplied only on veterinary prescription.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: V primeru nenamernega samo-injiciranja lahko pride do blage reakcije na mestu injiciranja.
For intramuscular use.
NAČIN IN POT(I) UPORABE Intramuskularna uporaba.
100 ml PET vials, clear
50 ml PET prozorne viale 100 ml PET prozorne viale
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
This summary was last updated in 12-2011.
Povzetek je bil nazadnje posodobljen 12-2011.
They may also block the multiplication of viruses.
Morda tudi zavirajo razmnoževanje virusov.
These contain between 1 and 50 million international units (IU) per millilitre.
Te oblike vsebujejo od 1 do 50 milijonov mednarodnih enot na mililiter.
The exact way that they work in cancer and viral diseases is not fully understood, but it is thought that they act as immunomodulators (substances that modify how the immune system works).
Natančen način njihovega delovanja pri raku in virusnih boleznih ni v celoti znan, vendar se domneva, da delujejo kot imunomodulatorji (snovi, ki spreminjajo način delovanja imunskega sistema).
Doctors should take this risk into account when deciding whether to treat a patient before adulthood.
Zdravniki morajo upoštevati to tveganje pri odločanju o uvedbi zdravljenja, preden bolnik odraste.
The European Commission granted a marketing authorisation valid throughout the European Union for IntronA on 9 March 2000.
Evropska komisija je dovoljenje za promet z zdravilom IntronA, veljavno po vsej Evropski uniji, odobrila dne 9. marca 2000.
Other information about IntronA
Druge informacije o zdravilu IntronA
Interferon alfa-2b has been available in the European Union (EU) for the treatment of various diseases for a number of years.
Interferon alfa-2b je v Evropski uniji (EU) že več let na voljo za zdravljenje različnih bolezni.
The full EPAR for IntronA can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo IntronA je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
To so naravne snovi, ki jih telo proizvaja za obrambo pred okužbami, ki jih povzročajo virusi.
Because IntronA is linked to side effects such as depression, patients must be closely monitored during treatment.
Ker je zdravilo IntronA povezano z neželenimi učinki, kot je depresija, je treba bolnike med zdravljenjem pozorno spremljati.
IntronA is generally given three times per week but the injection can be given more frequently in CML and melanoma.
Zdravilo IntronA se navadno daje trikrat tedensko, injekcijo pa je pri CML in melanomih mogoče dajati pogosteje.
This is a summary of the European public assessment report (EPAR) for IntronA.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo IntronA.
The Committee for Medicinal Products for Human Use (CHMP) decided that IntronA's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila IntronA večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
For more information about treatment with IntronA, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom IntronA preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The dose and duration of treatment depend on the disease being treated and the response of the patient, with doses ranging from 2 to 20 million IU per square metre of body surface area (calculated using the patient's height and weight).
Odmerek in trajanje zdravljenja sta odvisna od zdravljene bolezni in odziva bolnika, pri čemer se odmerki gibljejo v razponu od 2 do 20 milijonov mednarodnih enot na kvadratni meter telesne površine (ki se izračuna na podlagi bolnikove telesne višine in mase).
What benefit has IntronA shown during the studies?
Kakšne koristi je zdravilo IntronA izkazalo med študijami?
It is usually used in combination with ribavirin (an antiviral medicine);
Običajno se uporablja v kombinaciji z ribavirinom (protivirusnim zdravilom);
IntronA is used for the treatment of the following diseases:
Zdravilo IntronA se uporablja za zdravljenje naslednjih bolezni:
Because interferon alfa 2b has been used in the EU for a number of years, the company presented the results of studies from the published literature, as well as from studies of its use with cytarabine in CML and studies of IntronA used alone (in adults) or with ribavirin (in patients from three years of age) for the treatment of long-term hepatitis C. The main measures of effectiveness were the number of patients who responded to treatment in the hepatitis studies and how long the patients survived in the cancer studies.
Ker se interferon alfa-2b v EU uporablja že vrsto let, je družba predložila rezultate študij iz objavljene literature, kot tudi iz študij o njegovi uporabi v kombinaciji s citarabinom pri CML in študij zdravila IntronA, uporabljenega samostojno (pri odraslih) ali v kombinaciji z ribavirinom (pri bolnikih, starejših od treh let) pri zdravljenju dolgotrajnega hepatitisa C. Glavni merili učinkovitosti sta bili število bolnikov, ki se je odzvalo na zdravljenje v študijah hepatitisa, in čas preživetja bolnikov v študijah raka.
It is generally given by injection under the skin, but in melanoma it can also be given by infusion.
Navadno se daje kot injekcija pod kožo, pri melanomih pa jo je mogoče dajati tudi kot infuzijo.
IntronA in combination with ribavirin is also linked to weight loss and reduced growth in children and adolescents.
Zdravilo IntronA v kombinaciji z ribavirinom je tudi povezano z izgubljanjem telesne mase in zmanjšano telesno rastjo pri otrocih in mladostnikih.
Treatment with IntronA should be started by a doctor who has experience in the management of the disease it is being used for.
Zdravljenje z zdravilom IntronA mora uvesti zdravnik, ki ima izkušnje z zdravljenjem bolezni, za katero se uporablja.
In adults, the most common side effects with IntronA used with or without ribavirin (seen in more than 1 patient in 10) are pharyngitis (sore throat), viral infection, leucopenia (low white blood cell counts), loss of appetite, depression, insomnia (difficulty sleeping), anxiety, emotional lability (mood swings), agitation, nervousness, dizziness, headache, impaired concentration, dry mouth, blurred vision, dyspnoea (difficulty breathing), coughing, nausea (feeling sick) or vomiting, abdominal pain (stomach ache), diarrhoea, stomatitis (inflammation of the lining of the mouth), dyspepsia (heartburn), alopecia (hair loss), pruritus (itching), dry skin, rash, increased sweating, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the site of the injection including inflammation, fatigue (tiredness), rigors (shaking chills), pyrexia (fever), flu-like symptoms, asthenia (weakness), irritability, chest pain, malaise (feeling unwell) and weight loss.
Pri odraslih so najpogostejši neželeni učinki zdravila IntronA v kombinaciji z ribavirinom ali brez njega (opaženi pri več kot 1 bolniku izmed 10) faringitis (vneto žrelo), virusna okužba, levkopenija (nizko število belih krvničk), izguba teka, depresija, nespečnost (težave s spanjem), anksioznost, čustvena labilnost (nihanje razpoloženja), tesnoba, živčnost, omotica, glavobol, motnje koncentracije, suha usta, zamegljen vid, dispneja (oteženo dihanje), kašelj, navzeja (slabost) ali bruhanje, bolečine v trebuhu, driska, stomatitis (vnetje ustne sluznice), dispepsija (zgaga), alopecija (izpadanje las), pruritus (srbenje), suha koža, izpuščaji, povečano znojenje, mialgija (bolečine v mišicah), artralgija (bolečine v sklepih), mišično-skeletne bolečine (bolečine v mišicah in kosteh), reakcije na mestu injiciranja, vključno z vnetjem, utrujenost, mrzlica (drgetanje), pireksija (zvišana telesna temperatura), gripi podobni simptomi, astenija (šibkost), razdražljivost, bolečina v prsih, občutek neugodja (slabo počutje) in izguba telesne mase.
IntronA is used to maintain anticancer effects in patients who have responded to previous treatment with anticancer medicines;
Zdravilo IntronA se uporablja za vzdrževanje protirakavih učinkov pri bolnikih, ki so se odzvali na predhodno zdravljenje z zdravili proti raku;
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for IntronA.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo IntronA, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Patients can inject themselves once they have been trained appropriately.
Bolniki si lahko po ustreznem usposabljanju zdravilo injicirajo sami.
• carcinoid tumour (a tumour of the endocrine system that produces hormones);
• karcinoidnega tumorja (tumorja endokrinega sistema, ki proizvaja hormone);
It must not be used in patients who have had severe heart disease or certain immune system disorders, in patients who are taking medicines that suppress the immune system, in hepatitis patients who have liver cirrhosis (scarring) that is causing symptoms or who have recently received medicines that affect the immune system, or in children or adolescents with a history of severe mental illness, particularly severe depression, thoughts about committing suicide or suicide attempts.
Zdravilo se ne sme uporabljati pri bolnikih, ki so imeli hudo obolenje srca ali določene motnje imunskega sistema, pri bolnikih, ki jemljejo zdravila za zaviranje delovanja imunskega sistema, pri bolnikih s hepatitisom, ki imajo cirozo (brazgotinjenje) jeter, ki povzroča simptome, ali so nedavno prejemali zdravila, ki vplivajo na imunski sistem, ali pri otrocih ali mladostnikih z anamnezo hude duševne bolezni, še posebno hude depresije, samomorilnih misli ali poskusa samomora.
• long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in patients aged three years and older.
• dolgotrajnega hepatitisa C (bolezni jeter, ki je posledica okužbe z virusom hepatitisa C) pri bolnikih, starih tri leta ali več.
• long-term hepatitis B (a disease of the liver due to infection with the hepatitis B virus) in adults (aged 18 years and older);
• dolgotrajnega hepatitisa B (bolezni jeter, ki je posledica okužbe z virusom hepatitisa B) pri odraslih (starih 18 let ali več);
It is available as a powder and solvent that are made up into a solution for injection or infusion (drip into a vein), and as a readyto-use solution for injection in a vial or in a multidose pen.
Na voljo je kot prašek in vehikel za pripravo raztopine za injiciranje ali infudiranje (kapalne infuzije v veno) in kot predhodno pripravljena raztopina za injiciranje v viali ali večodmernem peresniku.
The studies showed that IntronA is effective in the diseases for which it can be used.
Študije so pokazale, da je zdravilo IntronA učinkovito pri zdravljenju bolezni, za katere je namenjeno.
IntronA must not be used in patients with severe kidney or liver disease, epilepsy or other central nervous system problems, or thyroid disease that is not controlled.
Zdravilo IntronA se ne sme uporabljati pri bolnikih s hudo boleznijo ledvic ali jeter, epilepsijo ali drugimi motnjami delovanja osrednjega živčnega sistema ali nenadzorovano boleznijo ščitnice.
EPAR summary for the public interferon alfa 2b
Povzetek EPAR za javnost interferon alfa-2b
IntronA was also shown to be effective in treating hepatitis C in adults when it was used with or without ribavirin, and in younger patients when used with ribavirin.
Zdravilo IntronA je bilo učinkovito tudi pri zdravljenju hepatitisa C pri odraslih v kombinaciji z ribavirinom ali brez njega ter pri mlajših bolnikih v kombinaciji z ribavirinom.
What is the risk associated with IntronA?
Kakšna tveganja so povezana z zdravilom IntronA?
• malignant melanoma (a type of skin cancer affecting cells called melanocytes).
• malignih melanomov (vrste kožnega raka, ki prizadene celice, imenovane melanociti).
In children and adolescents receiving IntronA in combination with ribavirin, side effects were similar to adults, although anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell), hypothyroidism (underactive thyroid gland) and reduced growth were also seen in more than 1 patient in 10.
Pri otrocih in mladostnikih, ki so prejemali zdravilo IntronA v kombinaciji z ribavirinom, so bili neželeni učinki podobni kot pri odraslih, čeprav so anemijo (nizko število rdečih krvničk), nevtropenijo (nizko raven nevtrofilcev, vrste belih krvničk), hipotiroidizem (zmanjšano funkcijo ščitnice) in zmanjšano telesno rast ugotovili pri več kot 1 bolniku izmed 10.
The interferon alfa-2b in IntronA is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce interferon alfa-2b.
Interferon alfa-2b, ki ga vsebuje zdravilo IntronA, se proizvaja po metodi, znani kot „tehnologija rekombinantne DNK“: pri kateri bakterija prejme gen (DNK), s katerim lahko tvori interferon alfa-2b.
In CML, more patients who received IntronA with cytarabine were still alive after three years than patients who only received IntronA.
Pri CML je bilo po treh letih še vedno živih več bolnikov, ki so prejemali zdravilo IntronA v kombinaciji s citabirinom, kot bolnikov, ki so prejemali samo zdravilo IntronA.
The replacement interferon alfa-2b acts in same way as naturally produced interferon alpha.
Nadomestni interferon alfa-2b deluje enako kot naravno proizvedeni interferon alfa.
Why has IntronA been approved?
Zakaj je bilo zdravilo IntronA odobreno?
IntronA should not be used in people who may be hypersensitive (allergic) to interferon alfa 2b or any of the other ingredients.
Zdravila IntronA se ne sme uporabljati pri ljudeh, ki utegnejo biti preobčutljivi za (alergični na) interferon alfa-2b ali katero koli drugo sestavino.
IntronA can be used in combination with cytarabine (an anticancer medicine) in the first year;
Zdravilo IntronA je v prvem letu mogoče uporabljati v kombinaciji s citarabinom (zdravilom proti raku) v prvem letu;
IntronA is used after surgery in patients whose melanoma could come back.
Zdravilo IntronA se uporablja po operaciji pri bolnikih, pri katerih obstaja možnost, da se melanomi znova pojavijo.
IntronA is a medicine that contains the active substance interferon alfa-2b.
IntronA je zdravilo, ki vsebuje zdravilno učinkovino interferon alfa-2b.
IntronA is used as an add-on to anticancer treatments;
Zdravilo IntronA se uporablja kot dodatek zdravilom proti raku;
The active substance in IntronA, interferon alfa-2b, belongs to the group ‘interferons'.
Zdravilna učinkovina zdravila IntronA, interferon alfa-2b, spada v skupino interferonov.
For the full list of all side effects reported with IntronA, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila IntronA, glejte navodilo za uporabo.