Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

fresenius kabi ab - soya-bean oil refined; glucosum; alaninum inn; arginine; aspartic acid; glutamic acid; glycine; histidinum inn; isoleucinum inn; leucinum inn; lysinum inn; methioninum inn; phenylalaninum inn; proline; serine; threoninum inn; tryptophanum inn; tyrosinum inn; valine; natrii glycerophosphas; magnesii sulfas; kalii chloridum; sodium acetate trihydrate; calcium chloride dihydrate - innrennslislyf, fleyti

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

baxter holding b.v.* - magnesii chloridum; natrii chloridum; sodium hydrogen carbonate; kalii chloridum; dinatrii hydrogenophosphas - blóðskilunar-/blóðsíunarlausn - 22 mmól/l

Evrópusambandið - íslenska - EMA (European Medicines Agency)

zoetis belgium sa - raðbrigða raðbrigða svínavírus (cpcv) 1-2, óvirkt - Ónæmisfræðilegar upplýsingar - svín (smágrísir) - virk bólusetningar svín yfir aldri þrjár vikur gegn svín circovirus tegund 2 (pcv2) til að draga úr veiru hlaða í blóði og eitilfruma vefja, og sár í eitilfruma vefja í tengslum við pcv2 sýkingu, eins og til að draga úr klínískum merki - þar á meðal tap daglega þyngdaraukningu, og dauðsföll í tengslum við eftir að venja multisystemic að sóa heilkenni.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

zoetis belgium - inactivated mycoplasma hyopneumoniae, strain p-5722-3, inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2a open reading frame 2 (orf2) protein, inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2b orf2 protein - Ónæmissjúkdómar fyrir suidae - svín (fyrir fitandi) - active immunisation of pigs against porcine circovirus type 2 to reduce viral load in blood and lymphoid tissues, fecal shedding and the lesions in lymphoid tissues associated with pcv2 infection. protection was demonstrated against porcine circovirus types 2a, 2b and 2d. active immunisation of pigs against mycoplasma hyopneumoniae to reduce the lung lesions associated with mycoplasma hyopneumoniae infection.  onset of immunity (both vaccination schedules): 3 weeks after (the last) vaccination.  duration of immunity (both vaccination schedules): 23 weeks after (the last) vaccination.  in addition, vaccination has been shown to reduce body weight gain losses under field conditions.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - Æxlishemjandi lyf - vegzelma in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. vegzelma in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. sjá nánar í kafla 5 til að fá nánari upplýsingar varðandi húðþéttni vaxtarþáttar viðtaka 2 (her2). vegzelma in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with vegzelma in combination with capecitabine. nánari upplýsingar um her2 stöðu, sjá kafla 5. vegzelma, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer (nsclc) other than predominantly squamous cell histology. vegzelma, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent nsclc with epidermal growth factor receptor (egfr) activating mutations (see section 5. vegzelma, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. vegzelma, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. vegzelma, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (vegf) inhibitors or vegf receptor–targeted agents. vegzelma in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. vegzelma, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

eco animal health europe limited - týlvalósín - antiinfectives fyrir almenn nota, sýklalyf fyrir almenn nota makrólíða - pheasants; chicken; turkeys; pigs - pigstreatment og methaphylaxis svín enzootic lungnabólgu;meðferð svín fjölgunar enteropathy (ileitis);meðferð og methaphylaxis svín blóðkreppusótt. chickenstreatment og methaphylaxis um sjúkdóma í öndunarfærum tengslum við r gallisepticum í hænur. pheasantstreatment um sjúkdóma í öndunarfærum tengslum við r gallisepticum. turkeystreatment um sjúkdóma í öndunarfærum tengslum við tylvalosin viðkvæm stofnum ornithobacterium rhinotracheale í kalkúna.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

elanco gmbh - valnemulin - antiinfectives fyrir almenn nota - pigs; rabbits - pigsthe meðferð og koma í veg fyrir svín blóðkreppusótt. meðferð á klínískum einkennum um slímhúð í æð (ileitis). forvarnir gegn klínískum einkennum um kólesterólkyrningafæð (ristilbólga) þegar sjúkdómurinn hefur verið greindur í hjörðinni. meðferð og forvarnir gegn smitandi lungnabólgu í svínum. við ráðlagða skammtinn 10-12 mg / kg líkamsþyngdar eru lungnaskemmdir og þyngdartap, en sýking með mycoplasma hyopneumoniae er ekki útrunnin. rabbitsreduction dauðsfalla á braust dýrafarsóttarfræðilega kanína enteropathy (ÁÐur). meðferð skal hafin snemma í braustinni þegar fyrsta kanínan hefur verið greind með sjúkdómnum klínískt.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

biontech manufacturing gmbh - single-stranded, 5’-capped messenger rna produced using a cell-free in vitro transcription from the corresponding dna templates, encoding the viral spike (s) protein of sars-cov-2 - covid-19 virus infection - bóluefni - comirnaty 30 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older.  comirnaty 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty original/omicron ba. 1 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against covid-19. comirnaty original/omicron ba. 4-5 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty original/omicron ba. 4-5 (5/5 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years.  comirnaty original/omicron ba. 4-5 (1. 5/1. 5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years.  comirnaty omicron xbb. 5 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in individuals 12 years of age and older. comirnaty omicron xbb. 5 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 10 micrograms/dose dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in children aged 5 to 11 years. comirnaty omicron xbb. 5 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent covid-19 caused by sars-cov-2, in infants and children aged 6 months to 4 years. notkun þetta bóluefni ætti að vera í samræmi við opinbera tillögur.

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

ge healthcare as - acidum gadotericum inn - stungulyf, lausn í áfylltri sprautu - 0,5 mmól/ml

Evrópusambandið - íslenska - EMA (European Medicines Agency)

zoetis belgium sa - óvirkja blátunguveiru, sermigerð 1 - Ónæmisfræðilegar upplýsingar - nautgripir - virkt ónæmisaðgerð nautgripa frá 2½ mánaða aldri til að koma í veg fyrir veirublæði af völdum blátunguveiru, sermisgerð 1. upphaf ónæmis: 15 dögum eftir að grunnbólusetningarferlið er lokið. lengd ónæmis: 12 mánuðir.