Euroopan unioni - suomi - EMA (European Medicines Agency)

pfizer ireland pharmaceuticals - keftaroliinifosamiili - community-acquired infections; skin diseases, infectious; pneumonia - systeemiset bakteerilääkkeet, - zinforo is indicated for the treatment of the following infections in neonates, infants, children, adolescents and adults: , complicated skin and soft tissue infections (cssti), community-acquired pneumonia (cap) , consideration should be given to official guidance on the appropriate use of antibacterial agents.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international nv - darunaviiri, cobicistat, emtrisitabiini, tenofoviiri alafenamide - hiv-infektiot - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - symtuza on tarkoitettu hoito immuunikatoviruksen virus tyyppi 1 (hiv‑1) tartunnan aikuisille ja nuorille (alle 12-vuotiaat ja vanhemmat kanssa kehon paino on vähintään 40 kg). genotypic testing should guide the use of symtuza.

Euroopan unioni - suomi - EMA (European Medicines Agency)

virbac s.a. - halofuginonipitoisuudet - antiprototsooisia - vasikka, vastasyntynyt - in new born calves:- prevention of diarrhoea due to diagnosed cryptosporidium parvum, in farms with history of cryptosporidiosis,administration should start in the first 24 to 48 hours of age- reduction of diarrhoea due to diagnosed cryptosporidium parvum. antamisen tulisi alkaa 24 tunnin kuluessa ripulin alkamisesta. kummassakin tapauksessa ookystien erittymisen väheneminen on osoitettu.

Euroopan unioni - suomi - EMA (European Medicines Agency)

pfizer europe ma eeig - talazoparib - rintojen kasvaimet - antineoplastiset aineet - talzenna on tarkoitettu monoterapiana aikuispotilaille, joilla on ituradan brca1/2-mutaatioita, joilla on her2-negatiivinen paikallisesti edennyt tai metastasoitunut rintasyöpä. patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. potilaat, joilla on hormoni-reseptori (hr)-positiivinen rintasyöpä olisi pitänyt käsitellä ennen hormonitoimintaan perustuva hoito, tai katsotaan sopimattomaksi hormonitoimintaan perustuva hoito.

Euroopan unioni - suomi - EMA (European Medicines Agency)

d&a pharma - natriumoksibaatti - substance withdrawal syndrome; alcohol abstinence - muut hermoston huumeet - substitution treatment for alcohol dependence within a framework of careful medical supervision along with continuous psychosocial support and social rehabilitation. treatment should be initiated only in patients resistant to existing interventions or in patients for whom existing therapies are contra-indicated or not recommended.

Euroopan unioni - suomi - EMA (European Medicines Agency)

virbac s.a. - tulatromysiini - systeemiseen käyttöön tarkoitetut antibakteerit - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. taudin läsnäolo karjassa olisi perustettava ennen metafylaktista hoitoa. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. taudin läsnäolo karjassa olisi perustettava ennen metafylaktista hoitoa. the product should only be used if pigs are expected to develop the disease within 2–3 days. lampaat: tarttuvan pododermatiitin (jalkajuhla) alkuvaiheen hoito, johon liittyy virulentti dichelobacter nodosus, joka vaatii systeemistä hoitoa.

Euroopan unioni - suomi - EMA (European Medicines Agency)

ceva santé animale - tulatromysiini - systeemiseen käyttöön tarkoitetut antibakteerit - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. taudin läsnäolo karjassa olisi perustettava ennen metafylaktista hoitoa. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. taudin läsnäolo karjassa olisi perustettava ennen metafylaktista hoitoa. the product should only be used if pigs are expected to develop the disease within 2–3 days. lampaat: tarttuvan pododermatiitin (jalkajuhla) alkuvaiheen hoito, johon liittyy virulentti dichelobacter nodosus, joka vaatii systeemistä hoitoa.

Euroopan unioni - suomi - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - arseenitrioksidi - leukemia, promyelocytic, akuutti - antineoplastiset aineet - arsenic trioxide medac is indicated for induction of remission, and consolidation in adult patients with:newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (apl) (white blood cell count, ≤ 10 x 10³/μl) in combination with all-trans-retinoic acid (atra)relapsed/refractory apl (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (pml/rarα) gene. vastausprosentti muita akuutin myelooisen leukemian alatyyppien mukaan arseenitrioksidi ei ole tutkittu.

Euroopan unioni - suomi - EMA (European Medicines Agency)

samsung bioepis nl b.v. - bevasitsumabi - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastiset aineet - aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. aybintio in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. lisätietoja ihmisen epidermaalisen kasvutekijäreseptorin 2 (her2) tilasta on kohdassa 5. 1 of the smpc. aybintio 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 anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with aybintio in combination with capecitabine. lisätietoja her2-tilasta on kohdassa 5. 1 of the smpc. aybintio, 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 other than predominantly squamous cell histology. aybintio, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. 1 of the smpc). aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. aybintio, 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. 1 of the smpc). aybintio, 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 vegf inhibitors or vegf receptor targeted agents. aybintio, in combination with 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. 1 of the smpc). aybintio, 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. 1 of the smpc).

Euroopan unioni - suomi - EMA (European Medicines Agency)

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - immunosuppressantit - idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. the use of idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.