Irlanda - anglès - HPRA (Health Products Regulatory Authority)

instituto grifols s.a. - human coagulation factor viii - powder and solvent for solution for injection - 250 international unit(s) - blood coagulation factors; coagulation factor viii

Irlanda - anglès - HPRA (Health Products Regulatory Authority)

instituto grifols s.a. - human coagulation factor viii - powder and solvent for solution for injection - 500 international unit(s) - blood coagulation factors; coagulation factor viii

Irlanda - anglès - HPRA (Health Products Regulatory Authority)

instituto grifols s.a. - human plasma protein - solution for infusion - 50 gram(s)/litre - blood substitutes and plasma protein fractions; albumin

Irlanda - anglès - HPRA (Health Products Regulatory Authority)

instituto grifols s.a. - human albumin - solution for infusion - 200 gram(s)/litre - blood substitutes and plasma protein fractions; albumin

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

vantive pty ltd - 58130 - haemodialysis system, institutional - the device is intended for use in continuous renal replacement therapy (crrt) for patients with acute renal failure and/or fluid overload, therapeutic plasma exchange therapy (tpe) for patients with diseases where removal of plasma components is indicated, or haemoperfusion for patients with conditions where immediate removal of substances by adsorption is indicated.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

b braun australia pty ltd - 58130 - haemodialysis system, institutional - this device is an extracorporeal blood purification system.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

fresenius medical care australia pty ltd - 58131 - haemodialysis system, institutional/home-use - the device is used for the extracorporeal blood treatment of patients suffering from renal insufficiency.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

fresenius medical care australia pty ltd - 58131 - haemodialysis system, institutional/home-use - the device is designed for extracorporeal blood purification procedures.

Estats Units - anglès - NLM (National Library of Medicine)

mylan institutional inc. - isoniazid (unii: v83o1voz8l) (isoniazid - unii:v83o1voz8l) - isoniazid 300 mg - isoniazid tablets, usp are recommended for all forms of tuberculosis in which organisms are susceptible. however, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. single-drug treatment of active tuberculosis with isoniazid or any other medication, is inadequate therapy. isoniazid tablets, usp are recommended as preventive therapy for the following groups, regardless of age. (note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parenthesis): - persons with human immunodeficiency virus (hiv) infection (greater than or equal to 5 mm) and persons with risk factors for hiv infection whose hiv infection status is unknown but who are suspected of having hiv infection. preventive therapy may be considered for hiv infected persons who are tuberculin-negative but belong to groups in which the prevalence of tuberculosis infection is high. candidates for preventive therapy who have hiv infection should have a minimum of 12 months of therapy. - close contacts of persons with newly diagnosed infectious tuberculosis (greater than or equal to 5 mm). in addition, tuberculin-negative (less than 5 mm) children and adolescents who have been close contacts of infectious persons within the past 3 months are candidates for preventive therapy until a repeat tuberculin skin test is done 12 weeks after contact with the infectious source. if the repeat skin test is positive (greater than 5 mm), therapy should be continued. - recent converters, as indicated by a tuberculin skin test (greater than or equal to 10 mm increase within a 2-year period for those less than 35 years old; greater than or equal to 15 mm increase for those greater than or equal to 35 years of age). all infants and children younger than 4 years of age with a greater than 10 mm skin test are included in this category. - persons with abnormal chest radiographs that show fibrotic lesions likely to represent old healed tuberculosis (greater than or equal to 5 mm). candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly. - intravenous drug users known to be hiv-seronegative (greater than 10 mm). - persons with the following medical conditions that have been reported to increase the risk of tuberculosis (greater than or equal to 10 mm): silicosis; diabetes mellitus; prolonged therapy with adrenocorticosteroids; immunosuppressive therapy; some hematologic and reticuloendothelial diseases, such as leukemia or hodgkin’s disease; end-stage renal disease; clinical situations associated with substantial rapid weight loss or chronic undernutrition (including: intestinal bypass surgery for obesity, the postgastrectomy state [with or without weight loss], chronic peptic ulcer disease, chronic malabsorption syndromes and carcinomas of the oropharynx and upper gastrointestinal tract that prevent adequate nutritional intake). candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly. additionally, in the absence of any of the above risk factors, persons under the age of 35 with a tuberculin skin test reaction of 10 mm or more are also appropriate candidates for preventive therapy if they are a member of any of the following high-incidence groups: - foreign-born persons from high-prevalence countries who never received bcg vaccine. - medically underserved low-income populations, including high-risk racial or ethnic minority populations, especially blacks, hispanics and native americans. - residents of facilities for long-term care (e.g., correctional institutions, nursing homes and mental institutions). children who are less than 4 years old are candidates for isoniazid preventive therapy if they have greater than 10 mm induration from a ppd mantoux tuberculin skin test. finally, persons under the age of 35 who a) have none of the above risk factors (1 to 6); b) belong to none of the high-incidence groups; and c) have a tuberculin skin test reaction of 15 mm or more, are appropriate candidates for preventive therapy. the risk of hepatitis must be weighed against the risk of tuberculosis in positive tuberculin reactors over the age of 35. however, the use of isoniazid is recommended for those with the additional risk factors listed above (1 to 6) and on an individual basis in situations where there is likelihood of serious consequences to contacts who may become infected. isoniazid is contraindicated in patients who develop severe hypersensitivity reactions, including drug-induced hepatitis; previous isoniazid-associated hepatic injury; severe adverse reactions to isoniazid such as drug fever, chills, arthritis; and acute liver disease of any etiology.

Estats Units - anglès - NLM (National Library of Medicine)

mylan institutional inc. - sulindac (unii: 184sns8vuh) (sulindac - unii:184sns8vuh) - sulindac 200 mg - carefully consider the potential benefits and risks of sulindac tablets, usp and other treatment options before deciding to use sulindac tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings). sulindac tablets are indicated for acute or long-term use in the relief of signs and symptoms of the following: - osteoarthritis - rheumatoid arthritis * - ankylosing spondylitis - acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis) - acute gouty arthritis * the safety and effectiveness of sulindac have not been established in rheumatoid arthritis patients who are designated in the american rheumatism association classification as functional class iv (incapacitated, largely or wholly bedridden, or confined to wheelchair; little or no self-care). sulindac tablets are contraindicated in patients with known hypersensitivity to sulindac or the excipients (see