United States - English - NLM (National Library of Medicine)

bimeda, inc. - chloramphenicol (unii: 66974fr9q1) (chloramphenicol - unii:66974fr9q1) - chloramphenicol 250 mg - indications : chloramphenicol tablets are recommended for oral treatment of the following conditions in dogs: - bacterial pulmonary infections caused by susceptible microorganisms such as: staphylococcus aureus , streptococcus pyogenes and brucella bronchiseptica . - infections of the urinary tract caused by susceptible microorganisms such as: escherichia coli , proteus vulgaris , corynebacterium renale , streptococcus spp., and hemolytic staphylococcus . - enteritis caused by susceptible microorganisms such as: e. coli , proteus spp., salmonella spp., and pseudomonas spp. - infections associated with canine distemper caused by susceptible microorganisms such as: b. bronchiseptica , e. coli , p. aeruginosa , proteus spp., shigella spp. and neisseria catarrhalis . additional adjunctive therapy should be used when indicated. most susceptible infectious disease organisms will respond to chloramphenicol therapy in three to five days when the recommended dosage regimen is followed. if no response to chloram

European Union - English - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - leflunomide - arthritis, rheumatoid - selective immunosuppressants - leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (dmard).recent or concurrent treatment with hepatotoxic or haematotoxic dmards (e.g. methotrexate) may result in an increased risk of serious adverse reactions, therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.moreover, switching from leflunomide to another dmard without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

Malta - English - Medicines Authority

aristo pharma gmbh wallenroder straße 8–10, 13435, berlin, germany - tadalafil - film-coated tablet - tadalafil 5 mg - urologicals

Malta - English - Medicines Authority

aristo pharma gmbh wallenroder straße 8–10, 13435, berlin, germany - tadalafil - film-coated tablet - tadalafil 10 mg - urologicals

Malta - English - Medicines Authority

aristo pharma gmbh wallenroder straße 8–10, 13435, berlin, germany - tadalafil - film-coated tablet - tadalafil 20 mg - urologicals

Singapore - English - HSA (Health Sciences Authority)

mylan pharmaceuticals pte. ltd. - azelastine hcl - spray - 1 mg/ml - azelastine hcl 1 mg/ml

European Union - English - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - capecitabine - colorectal neoplasms - antineoplastic agents - capecitabine medac is indicated for the adjuvant treatment of patients following surgery of stage-iii (dukes’ stage-c) colon cancer.capecitabine medac is indicated for the treatment of metastatic colorectal cancer.capecitabine medac is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.capecitabine medac in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. previous therapy should have included an anthracycline.capecitabine medac is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

European Union - English - EMA (European Medicines Agency)

medac - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; leukemia, myelogenous, chronic, bcr-abl positive; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome - protein kinase inhibitors - imatinib medac is indicated for the treatment of:paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment;paediatric patients with ph+cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase;adult and paediatric patients with ph+cml in blast crisis;adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+all) integrated with chemotherapy;adult patients with relapsed or refractory ph+all as monotherapy;adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement;adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery.the effect of imatinib on the outcome of bone marrow transplantation has not been determined.in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp.the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited. except in newly diagnosed chronic phase cml, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

United States - English - NLM (National Library of Medicine)

meda pharmaceuticals - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152), sodium bicarbonate (unii: 8mdf5v39qo) (bicarbonate ion - unii:hn1zra3q20), sodium sulfate (unii: 0ypr65r21j) (sodium sulfate anhydrous - unii:36kcs0r750) - polyethylene glycol 3350 240 g in 4 l - colyte® with flavor packs is indicated for bowel cleansing prior to colonoscopy or barium enema x-ray examination. colyte is contraindicated in the following conditions: colyte® (co-light) with flavor packs (peg-3350 & electrolytes for oral solution) read this instructions for use before you start taking colyte. this information does not take the place of talking with your healthcare provider about your medical condition or your treatment. how should i take colyte? colyte can be taken with or without a flavor pack. if you use a flavor pack, complete steps 1 through 8. if you do not use a flavor pack, throw away the flavor packs and complete steps 4 through 8. step 1:  remove the cap from the colyte bottle. step 2:  tear open 1 flavor pack of your choice and pour contents into the colyte bottle. throw away the unused flavor pack. step 3:  replace the cap on the colyte bottle. shake the colyte bottle well to mix the contents of the flavor pack into the powder. step 4:  remove the cap from the colyte bottle.

United States - English - NLM (National Library of Medicine)

meda pharmaceuticals inc. - felbamate (unii: x72rbb02n8) (felbamate - unii:x72rbb02n8) - felbamate 400 mg - felbatol® is not indicated as a first line antiepileptic treatment (see warnings ). felbatol® is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. if these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgement, felbatol® can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with lennox-gastaut syndrome in children. felbatol® is contraindicated in patients with known hypersensitivity to felbatol®, its ingredients, or known sensitivity to other carbamates. it should not be used in patients with a history of any blood dyscrasia or hepatic dysfunctio