natgillin/translations-raw huggingface dataset:
Very common side effects (may affect more than 1 in 10 people): - feeling depressed, irritability, trouble falling asleep or staying asleep, feeling anxious or nervous, difficulty concentrating, mood swings, - headache, dizziness, tired feeling, shaking chills, fever, flu-like symptoms, virus infection,
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): - depresija, razdražljivost, težave z uspavanjem ali zbujanje, tesnoba ali živčnost, težave s koncentracijo, nihanje razpoloženja, - glavobol, omotica, občutek utrujenosti, mrzlica s tresenjem, zvišana telesna temperatura, gripi podobni simptomi, virusna okužba, šibkost, - oteženo dihanje, faringitis (vneto grlo), kašelj,
The following treatment-related adverse reactions were reported in adults in clinical trials or through post-marketing surveillance in patients treated with peginterferon alfa-2b, including PegIntron monotherapy or PegIntron/ribavirin.
Med zdravljenjem so v času kliničnih preizkušanj ali v obdobju spremljanja zdravila na trgu pri odraslih bolnikih zdravljenih s peginterferonom alfa-2b, vključno z monoterapijo z zdravilom PegIntron ali s kombinirano terapijo z zdravilom PegIntron in ribavirinom poročali o naslednjih neželenih učinkih, povezanih z zdravljenjem.
Dental and periodontal disorders, which may lead to loss of teeth, have been reported in patients receiving PegIntron and ribavirin combination therapy.
Pri bolnikih, ki so prejemali zdravilo PegIntron z ribavirinom v kombinirani terapiji, so poročali o boleznih zob in obzobnega tkiva, ki lahko vodijo do izgube zob.
- pain in joints and muscles, muscle and bone pain.
bolečine v kosteh, mišična šibkost
if you are a girl or a woman of childbearing age who is taking ribavirin: you must have a negative pregnancy test before treatment, each month during treatment, and for the 4 months after treatment is stopped.
Test nosečnosti mora biti pri vas negativen pred zdravljenjem, vsak mesec med zdravljenjem in še 4 mesece po zaključku zdravljenja.
How to store PegIntron
Shranjevanje zdravila PegIntron
PegIntron 50 micrograms powder and solvent for solution for injection EU/1/00/131/001
PegIntron 50 mikrogramov prašek in vehikel za raztopino za injiciranje EU/1/00/131/001
PegIntron 100 micrograms powder and solvent for solution for injection EU/1/00/131/011
PegIntron 100 mikrogramov prašek in vehikel za raztopino za injiciranje EU/1/00/131/011
PegIntron 50 micrograms - vial of powder
PegIntron 50 mikrogramov - viala praška
PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 80 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 100 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 120 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 150 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
PegIntron 50 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku PegIntron 80 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku PegIntron 100 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku PegIntron 120 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku PegIntron 150 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku peginterferon alfa-2b
Careful co-administration of thioridazine with the product (PegIntron) is recommended.
Pri sočasni uporabi tioridazina z zdravilom PegIntron je potrebna previdnost.
PegIntron contains sucrose
Zdravilo PegIntron vsebuje saharozo
PegIntron 100 micrograms - vial of powder
PegIntron 100 mikrogramov - viala praška
PegIntron 50 micrograms powder and solvent for solution for injection PegIntron 80 micrograms powder and solvent for solution for injection PegIntron 100 micrograms powder and solvent for solution for injection PegIntron 120 micrograms powder and solvent for solution for injection PegIntron 150 micrograms powder and solvent for solution for injection peginterferon alfa-2b
PegIntron 50 mikrogramov prašek in vehikel za raztopino za injiciranje PegIntron 80 mikrogramov prašek in vehikel za raztopino za injiciranje PegIntron 100 mikrogramov prašek in vehikel za raztopino za injiciranje PegIntron 120 mikrogramov prašek in vehikel za raztopino za injiciranje PegIntron 150 mikrogramov prašek in vehikel za raztopino za injiciranje peginterferon alfa-2b
PegIntron 50 micrograms powder and solvent for solution for injection PegIntron 80 micrograms powder and solvent for solution for injection PegIntron 100 micrograms powder and solvent for solution for injection PegIntron 120 micrograms powder and solvent for solution for injection PegIntron 150 micrograms powder and solvent for solution for injection
PegIntron 50 mikrogramov prašek in vehikel za raztopino za injiciranje PegIntron 80 mikrogramov prašek in vehikel za raztopino za injiciranje PegIntron 100 mikrogramov prašek in vehikel za raztopino za injiciranje PegIntron 120 mikrogramov prašek in vehikel za raztopino za injiciranje PegIntron 150 mikrogramov prašek in vehikel za raztopino za injiciranje
Both the Metavir score and Ishak grade decreased among subjects treated with PegIntron in combination with ribavirin.
Pri preiskovancih, zdravljenih z zdravilom PegIntron v kombinaciji z ribavirinom, sta se zmanjšali tako ocena po Metavirju kot ocena po Ishaku.
EU/1/00/131/008 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/009 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
EU/1/00/131/008 (4 viale praška, 4 ampule vehikla) EU/1/00/131/009 (4 viale praška, 4 ampule vehikla, 4 injekcijske brizge, 8 injekcijskih igel, 4 čistilni tamponi)
The pharmacokinetics of PegIntron have not been evaluated in patients with severe hepatic dysfunction.
Okvara jeter Pri bolnikih s hudo jetrno okvaro farmakokinetike zdravila PegIntron niso ocenjevali.
The following treatment-related adverse reactions were reported in the study in children and adolescent patients treated with PegIntron in combination with ribavirin.
V študiji pri otrocih in mladostnikih, zdravljenih z zdravilom PegIntron v kombinaciji z ribavirinom, so poročali o naslednjih z zdravljenjem povezanih neželenih učinkih.
EU/1/00/131/003 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/004 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
EU/1/00/131/003 (4 viale praška, 4 ampule vehikla) EU/1/00/131/004 (4 viale praška, 4 ampule vehikla, 4 injekcijske brizge, 8 injekcijskih igel, 4 čistilni tamponi)
Package inserts of theophylline should be referred to when co-administering with the product (PegIntron)
Pri sočasni uporabi z zdravilom PegIntron je treba upoštevati navodilo za uporabo teofilina.
PegIntron 80 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
PegIntron 80 mikrogramov prašek in vehikel za raztopino za injiciranje Eno vialo se rekonstituira z 0,7 ml vode za injekcije za dajanje do 0,5 ml raztopine.
Pen label - PegIntron 120 micrograms powder and solvent for solution for injection in pre-filled pen
Nalepka na peresniku - PegIntron 120 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku
Pen label - PegIntron 150 micrograms powder and solvent for solution for injection in pre-filled pen
Nalepka na peresniku - PegIntron 150 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku
Metabolism of thioridazine is suppressed by inhibitory action of the product (PegIntron) on CYP2D6.
Zaviralni učinek zdravila PegIntron na CYP2D6 upočasni presnovo tioridazina.
Also see SmPCs for ribavirin and boceprevir if PegIntron is to be administered in combination therapy in patients with chronic hepatitis C.
Pri uporabi zdravila PegIntron v kombinirani terapiji pri bolnikih s kroničnim hepatitisom C glejte tudi SmPC za ribavirin in boceprevir.
EU/1/00/131/011 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/012 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)
EU/1/00/131/011 (1 viala praška, 1 ampula vehikla) EU/1/00/131/012 (1 viala praška, 1 ampula vehikla, 1 injekcijska brizga, 2 injekcijski igli, 1 čistilni tampon)
Pen label - PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen
Nalepka na peresniku - PegIntron 50 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku
st dose reduction of PegIntron is to 40 g/m 2/week, 2
Začetni odmerek 60 g/m2/teden zmanjšate na 40 g/m2/teden in nato na
Carton 150 micrograms powder and solvent for solution for injection in pre-filled pen
PegIntron 150 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku
Discard the PegIntron pre-filled pen (CLEARCLICK) with any solution that is left in it after you give yourself the injection.
Morebitno raztopino, ki po injiciranju zdravila še ostane v PegIntron napolnjenem injekcijskem peresniku (CLEARCLICK), zavrzite.
PegIntron 80 micrograms powder for injection peginterferon alfa-2b
PegIntron 80 mikrogramov prašek za injekcijo peginterferon alfa-2b s.c.
EU/1/00/131/006 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/007 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)
EU/1/00/131/006 (1 viala praška, 1 ampula vehikla) EU/1/00/131/007 (1 viala praška, 1 ampula vehikla, 1 injekcijska brizga, 2 injekcijski igli, 1 čistilni tampon)
EU/1/00/131/047 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/048 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/050 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/1/00/131/047 (1 peresnik, 1 injekcijska igla in 2 čistilna tampona) EU/1/00/131/048 (4 peresniki, 4 injekcijske igle in 8 čistilnih tamponov) EU/1/00/131/050 (12 peresnikov, 12 injekcijskih igel in 24 čistilnih tamponov)
The plasma half-life of PegIntron is prolonged compared with nonpegylated interferon alfa-2b.
V primerjavi z nepegiliranim interferonom alfa-2b je njegova razpolovna doba v plazmi daljša.
PegIntron 150 micrograms powder and solvent for solution for injection Each vial contains 150 micrograms of peginterferon alfa-2b measured on a protein basis.
PegIntron 150 mikrogramov prašek in vehikel za raztopino za injiciranje Ena viala vsebuje 150 mikrogramov peginterferona alfa-2b, merjeno na proteinski osnovi.
EU/1/00/131/016 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/017 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)
EU/1/00/131/016 (1 viala praška, 1 ampula vehikla) EU/1/00/131/017 (1 viala praška, 1 ampula vehikla, 1 injekcijska brizga, 2 injekcijski igli, 1 čistilni tampon)
PegIntron 150 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
PegIntron 150 mikrogramov prašek in vehikel za raztopino za injiciranje Eno vialo se rekonstituira z 0,7 ml vode za injekcije za dajanje do 0,5 ml raztopine.
PegIntron 120 micrograms powder and solvent for solution for injection Each vial contains 120 micrograms of peginterferon alfa-2b measured on a protein basis.
PegIntron 120 mikrogramov prašek in vehikel za raztopino za injiciranje Ena viala vsebuje 120 mikrogramov peginterferona alfa-2b, merjeno na proteinski osnovi.
PegIntron 80 micrograms powder and solvent for solution for injection Each vial contains 80 micrograms of peginterferon alfa-2b measured on a protein basis.
PegIntron 80 mikrogramov prašek in vehikel za raztopino za injiciranje Ena viala vsebuje 80 mikrogramov peginterferona alfa-2b, merjeno glede na beljakovine.
HCV/HIV Co-infected patients
Bolniki, sočasno okuženi s HCV / HIV
HCV/HIV co-infected patients
Bolniki, sočasno okuženi s HCV/HIV
PegIntron 120 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
PegIntron 120 mikrogramov prašek in vehikel za raztopino za injiciranje Eno vialo se rekonstituira z 0,7 ml vode za injekcije za dajanje do 0,5 ml raztopine.
EU/1/00/131/035 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/036 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/038 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/1/00/131/035 (1 peresnik, 1 injekcijska igla in 2 čistilna tampona) EU/1/00/131/036 (4 peresniki, 4 injekcijske igle in 8 čistilnih tamponov) EU/1/00/131/038 (12 peresnikov, 12 injekcijskih igel in 24 čistilnih tamponov)
PegIntron 120 micrograms powder for injection peginterferon alfa-2b
PegIntron 120 mikrogramov prašek za injekcijo peginterferon alfa-2b s.c.
Pen label - PegIntron 80 micrograms powder and solvent for solution for injection in pre-filled pen
Nalepka na peresniku - PegIntron 80 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku
EU/1/00/131/043 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/044 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/046 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/1/00/131/043 (1 peresnik, 1 injekcijska igla in 2 čistilna tampona) EU/1/00/131/044 (4 peresniki, 4 injekcijske igle in 8 čistilnih tamponov) EU/1/00/131/046 (12 peresnikov, 12 injekcijskih igel in 24 čistilnih tamponov)
EU/1/00/131/021 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/022 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)
EU/1/00/131/021 (1 viala praška, 1 ampula vehikla) EU/1/00/131/022 (1 viala praška, 1 ampula vehikla, 1 injekcijska brizga, 2 injekcijski igli, 1 čistilni tampon)
nd dose reduction of PegIntron is to 0.5 µg/kg/week.
Če je potrebno, lahko še drugič zmanjšate odmerek zdravila PegIntron, in sicer na 0,5 µg/kg/teden.
EU/1/00/131/039 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/040 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/042 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/1/00/131/039 (1 peresnik, 1 injekcijska igla in 2 čistilna tampona) EU/1/00/131/040 (4 peresniki, 4 injekcijske igle in 8 čistilnih tamponov) EU/1/00/131/042 (12 peresnikov, 12 injekcijskih igel in 24 čistilnih tamponov)
PegIntron 50 micrograms powder for injection peginterferon alfa-2b
PegIntron 50 mikrogramov prašek za injekcijo peginterferon alfa-2b s.c.
PegIntron 100 micrograms powder and solvent for solution for injection Each vial contains 100 micrograms of peginterferon alfa-2b measured on a protein basis.
PegIntron 100 mikrogramov prašek in vehikel za raztopino za injiciranje Ena viala vsebuje 100 mikrogramov peginterferona alfa-2b, merjeno na proteinski osnovi.
Pen label - PegIntron 100 micrograms powder and solvent for solution for injection in pre-filled pen
Nalepka na peresniku - PegIntron 100 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku
EU/1/00/131/001 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/002 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)
EU/1/00/131/001 (1 viala praška, 1 ampula vehikla) EU/1/00/131/002 (1 viala praška, 1 ampula vehikla, 1 injekcijska brizga, 2 injekcijski igli, 1 čistilni tampon)
PegIntron 150 micrograms powder for injection peginterferon alfa-2b
PegIntron 150 mikrogramov prašek za injekcijo peginterferon alfa-2b s.c.
PegIntron 100 micrograms powder for injection peginterferon alfa-2b
PegIntron 100 mikrogramov prašek za injekcijo peginterferon alfa-2b s.c.
PegIntron 150 micrograms powder and solvent for solution for injection Each vial contains 150 micrograms of peginterferon alfa-2b as measured on a protein basis.
PegIntron 150 mikrogramov prašek in vehikel za raztopino za injiciranje Ena viala vsebuje 150 mikrogramov peginterferona alfa-2b, merjeno glede na beljakovine.
PegIntron 50 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
PegIntron 50 mikrogramov prašek in vehikel za raztopino za injiciranje Eno vialo se rekonstituira z 0,7 ml vode za injekcije za dajanje do 0,5 ml raztopine.
PegIntron 50 micrograms powder and solvent for solution for injection Each vial contains 50 micrograms of peginterferon alfa-2b measured on a protein basis.
PegIntron 50 mikrogramov prašek in vehikel za raztopino za injiciranje Ena viala vsebuje 50 mikrogramov peginterferona alfa-2b, merjeno glede na beljakovine.
PegIntron 100 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
PegIntron 100 mikrogramov prašek in vehikel za raztopino za injiciranje Eno vialo se rekonstituira z 0,7 ml vode za injekcije za dajanje do 0,5 ml raztopine.
st dose reduction of PegIntron is to 1 µg/kg/week.
Opomba 2: Pri odraslih bolnikih je prvo zmanjšanje odmerka zdravila PegIntron na 1 µg/kg/teden.
- Break off the top of the ampoule of solvent.
- Odlomite vrh ampule z vehiklom.
EU/1/00/131/031 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/032 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/034 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/1/00/131/031 (1 peresnik, 1 injekcijska igla in 2 čistilna tampona) EU/1/00/131/032 (4 peresniki, 4 injekcijske igle in 8 čistilnih tamponov) EU/1/00/131/034 (12 peresnikov, 12 injekcijskih igel in 24 čistilnih tamponov)
PegIntron 120 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
PegIntron 120 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku peginterferon alfa-2b
PegIntron 80 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
PegIntron 80 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku peginterferon alfa-2b
PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
PegIntron 50 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku peginterferon alfa-2b
PegIntron 150 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
PegIntron 150 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku peginterferon alfa-2b
Common side effects (may affect up to 1 in 10 people): - fungal infection, common cold, cold sores, pharyngitis (sore throat), sinusitis, ear infection, coughing, throat pain, feeling cold, eye pain, - decrease in blood clotting cells called platelets, that may result in easy bruising and spontaneous bleeding, swollen glands (swollen lymph nodes), blood thyroid tests abnormalities, decrease in thyroid gland activity, which may make you feel tired, depressed, increase your sensitivity to cold and other symptoms, - wanting or attempting to harm yourself aggressive behaviour, agitation, anger, mood changes, nervousness or restlessness, depression, feeling anxious, trouble falling asleep or staying asleep, emotional instability, poor quality sleep, feeling sleepy, disturbance in attention.
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): - glivične okužbe, navaden prehlad, herpesni izpuščaji, faringitis (vnetje grla), sinusitis, okužba ušes, kašelj, bolečine v grlu, občutek mrazenja, očesne bolečine, - zmanjšanje števila celic za strjevanje krvi, ki jim pravimo trombociti, kar lahko vodi do nagnjenosti k nastanku podplutb in spontanih krvavitev, otekle žleze (otekle bezgavke), nenormalni izvidi krvnih preiskav delovanja žleze ščitnice, zmanjšanje delovanja žleze ščitnice, ki lahko povzroči utrujenost, depresijo, povečanje občutljivosti na mraz in druge simptome,
PegIntron 150 micrograms powder and solvent for injection peginterferon alfa-2b
PegIntron 150 mikrogramov prašek in vehikel za raztopino za injiciranje peginterferon alfa-2b
PegIntron 100 micrograms powder and solvent for injection peginterferon alfa-2b
PegIntron 100 mikrogramov prašek in vehikel za raztopino za injiciranje peginterferon alfa-2b
PegIntron 50 micrograms powder and solvent for injection peginterferon alfa-2b
PegIntron 50 mikrogramov prašek in vehikel za raztopino za injiciranje peginterferon alfa-2b
Please refer to the ribavirin SmPC for capsules or oral solution when PegIntron is to be used in combination with ribavirin.
Če bo bolnik zdravilo PegIntron uporabljal sočasno z ribavirinom, prosimo, glejte SmPC za ribavirin trde kapsule ali peroralno raztopino.
PegIntron 80 micrograms powder and solvent for injection peginterferon alfa-2b
PegIntron 80 mikrogramov prašek in vehikel za raztopino za injiciranje peginterferon alfa-2b
PegIntron 100 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
PegIntron 100 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku peginterferon alfa-2b
PegIntron 120 micrograms powder and solvent for injection peginterferon alfa-2b
PegIntron 120 mikrogramov prašek in vehikel za raztopino za injiciranje peginterferon alfa-2b
EU/1/00/131/015 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/028 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/1/00/131/028 (12 vial praška, 12 ampul vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov)
EU/1/00/131/025 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/030 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/1/00/131/030 (12 vial praška, 12 ampul vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov)
EU/1/00/131/010 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/027 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/1/00/131/027 (12 vial praška, 12 ampul vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov)
EU/1/00/131/023 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/024 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)
EU/1/00/131/024 (4 viale praška, 4 ampule vehikla, 4 injekcijske brizge, 8 injekcijskih igel, 4 čistilni tamponi)
EU/1/00/131/020 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/029 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/1/00/131/029 (12 vial praška, 12 ampul vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov)
Dose reduction of PegIntron in children and adolescents is accomplished by modifying the recommended dose in a two-step process from the original starting dose of 60 g/m 2/week, to 40 g/m 2/week, then to 20 g/m 2/week, if needed.
Pri otrocih in mladostnikih je prvo zmanjšanje odmerka zdravila PegIntron na 40 µg/m2/teden in drugo zmanjšanje odmerka zdravila PegIntron na 20 µg/m2/teden.
Both active substances have been available in the European Union (EU) as separate preparations for a number of years.
Obe zdravilni učinkovini sta v Evropski uniji (EU) v obliki ločenih pripravkov na voljo že vrsto let.
The European Commission granted a marketing authorisation valid throughout the European Union for Omidria on 28 July 2015.
Evropska komisija je dovoljenje za promet z zdravilom Omidria, veljavno po vsej Evropski uniji, izdala 28. julija 2015.
Other information about Omidria
Druge informacije o zdravilu Omidria
What measures are being taken to ensure the safe and effective use of Omidria?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Omidria?