Европейски съюз - английски - EMA (European Medicines Agency)

schering-plough europe - posaconazole - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimycotics for systemic use - posaconazole sp is indicated for use in the treatment of the following fungal infections in adults (see section 5.1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products;- oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.posaconazole sp is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who areat high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.

Канада - английски - Health Canada

teva canada limited - salbutamol (salbutamol sulfate) - metered-dose aerosol - 100mcg - salbutamol (salbutamol sulfate) 100mcg - selective beta 2-adrenergic agonists

САЩ - английски - NLM (National Library of Medicine)

lake erie medical & surgical supply dba quality care products llc - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol 90 ug - proair hfa inhalation aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. proair hfa inhalation aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. proair hfa inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other proair hfa inhalation aerosol components. rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate [see warnings and precautions (5.6 )] . teratogenic effects: pregnancy category c: there are no adequate and well-controlled studies of proair hfa inhalation aerosol or albuterol sulfate in pregnant women. during worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients treated with albuterol. some of the mothers were tak

САЩ - английски - NLM (National Library of Medicine)

remedyrepack inc. - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol 90 ug

САЩ - английски - NLM (National Library of Medicine)

baxalta us inc. - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k), human thrombin (unii: 6k15abl77g) (human thrombin - unii:6k15abl77g) - fibrinogen human 90 mg in 1 ml - artiss is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age. artiss is not indicated for hemostasis. do not inject artiss directly into blood vessels. intravascular application of artiss may result in life-threatening thromboembolic events. do not use artiss in individuals with a known hypersensitivity to aprotinin and/or hypersensitivity to any of the active substances or excipients (see warnings/precautions, hypersensitivity/allergic/anaphylactic reactions (5.1) and adverse reactions, overall adverse reactions (6.1)). pregnancy category c animal reproduction studies have not been conducted with artiss. it is also not known whether artiss can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. some viruses, such as parvovirus b19, are particularly difficult to remove or inactivate at this time. parvovirus b19 most seriously affects pregnant women (f

САЩ - английски - NLM (National Library of Medicine)

fibrocell technologies, inc. - azficel-t (unii: 022461sr75) (azficel-t - unii:022461sr75) - azficel-t 15000000 in 1 ml - lavivtm is an autologous cellular product indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. the safety and efficacy of laviv for areas other than the nasolabial folds have not been established. the efficacy of laviv beyond six months has not been established. - allogeneic use if laviv is administered to a patient who is not the individual whose skin was used to produce the laviv, serious immunological reactions can occur. each vial of laviv has a unique patient identifier to assist in ensuring that there is no mismatch. - severe hypersensitivity reactions serious hypersensitivity reactions, including anaphylaxis, can occur in patients with known hypersensitivity to the ingredients in laviv. do not use laviv in patients allergic to gentamicin, amphotericin, dimethyl sulfoxide (dmso), or material of bovine origin. - active infection injecting laviv into areas with skin infections can lead to local or systemic infection. pregnancy category c. animal reprodu

Великобритания - английски - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme ltd - posaconazole - oral suspension - 40mg/1ml

САЩ - английски - NLM (National Library of Medicine)

rpk pharmaceuticals, inc. - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol 90 ug - proair hfa inhalation aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. proair hfa inhalation aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. proair hfa inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other proair hfa inhalation aerosol components. rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate [see warnings and precautions (5.6) ] . teratogenic effects: pregnancy category c: there are no adequate and well-controlled studies of proair hfa inhalation aerosol or albuterol sulfate in pregnant women. during worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients treated with albuterol. some of the mothers were tak

САЩ - английски - NLM (National Library of Medicine)

baxalta us inc. - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - fibrinogen human 90 mg in 1 ml - artiss is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age. artiss is not indicated for hemostasis. do not inject artiss directly into blood vessels. intravascular application of artiss may result in life-threatening thromboembolic events. do not use artiss in individuals with a known hypersensitivity to aprotinin and/or hypersensitivity to any of the active substances or excipients (see warnings/precautions, hypersensitivity/allergic/anaphylactic reactions (5.1) and adverse reactions, overall adverse reactions (6.1)). pregnancy category c animal reproduction studies have not been conducted with artiss. it is also not known whether artiss can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. some viruses, such as parvovirus b19, are particularly difficult to remove or inactivate at this time. parvovirus b19 most seriously affects pregnant women (f

САЩ - английски - NLM (National Library of Medicine)

h.j. harkins company, inc. - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - 1.1 bronchospasm albuterol sulfate hfa inhalation aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. 1.2 exercise-induced bronchospasm albuterol sulfate hfa inhalation aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. albuterol sulfate hfa inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other albuterol sulfate hfa inhalation aerosol components. rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate [see warnings and precautions (5.6)]. 8.1 pregnancy pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications during pregnancy. for more information, contact the mothers to baby pregnancy studies conducted by the organization of teratology