Israel - English - Ministry of Health

csl behring ltd., israel - factor xiii - powder and solvent for solution for injection/solution for infusion - factor xiii 200 - 320 iu - coagulation factor xiii - coagulation factor xiii - fibrogammin is indicated for adult and paediatric patients • for prophylactic treatment of congenital fxiii deficiency and • for peri-operative management of surgical bleeding with congentital fxiii deficiency. fibrogammin is furthermore indicated • for haemorrhagic diatheses caused completely or in part by acquired fxiii deficiency • for supportive therapy in case of disturbance in wound healing, especially in ulcus cruris, after large surgery or injuries.

Israel - English - Ministry of Health

csl behring ltd., israel - factor xiii - powder and solvent for solution for injection/solution for infusion - factor xiii 1250 iu - coagulation factor xiii - coagulation factor xiii - fibrogammin is indicated for adult and paediatric patients • for prophylactic treatment of congenital fxiii deficiency and • for peri-operative management of surgical bleeding with congentital fxiii deficiency. fibrogammin is furthermore indicated • for haemorrhagic diatheses caused completely or in part by acquired fxiii deficiency • for supportive therapy in case of disturbance in wound healing, especially in ulcus cruris, after large surgery or injuries.

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

merus labs international inc. - gemifloxacin mesylate (unii: x4s9f8rl01) (gemifloxacin - unii:okr68y0e4t) - gemifloxacin 320 mg - factive is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. (see dosage and administration and clinical studies. ) acute bacterial exacerbation of chronic bronchitis (abecb) caused by streptococcus pneumoniae, haemophilus influenzae, haemophilus parainfluenzae, or moraxella catarrhalis . because fluoroquinolones, including factive, have been associated with serious adverse reactions (see warnings ) and for some patients abecb is self-limiting, reserve factive for treatment of abecb in patients who have no alternative treatment options. community-acquired pneumonia (of mild to moderate severity) caused by streptococcus pneumoniae (including multi-drug resistant strains [mdrsp])*, haemophilus influenzae, moraxella catarrhalis, mycoplasma pneumoniae, chlamydia pneumoniae, or klebsiella pneumoniae . *mdrsp: multi-drug resistant s

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

vansen pharma inc. - gemifloxacin mesylate (unii: x4s9f8rl01) (gemifloxacin - unii:okr68y0e4t) - gemifloxacin 320 mg - factive is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. (see dosage and administration and clinical studies . ) acute bacterial exacerbation of chronic bronchitis caused by streptococcus pneumoniae, haemophilus influenzae, haemophilus parainfluenzae, or moraxella catarrhalis . community-acquired pneumonia (of mild to moderate severity) caused by streptococcus pneumoniae (including multi-drug resistant strains [mdrsp])*, haemophilus influenzae, moraxella catarrhalis, mycoplasma pneumoniae, chlamydia pneumoniae, or klebsiella pneumoniae . *mdrsp: multi-drug resistant streptococcus pneumoniae , includes isolates previously known as prsp (penicillin-resistant streptococcus pneumoniae ), and are strains resistant to two or more of the following antibiotics: penicillin (mic ≥2 μg/ml), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines and trimethoprim/sulfamethoxazole. to reduce the development

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

gemini laboratories, llc - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - estradiol 0.5 mg - . limitation of use when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered. limitation of use when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered. activella is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding - known, suspected, or history of breast cancer - known, past or suspected estrogen-dependent neoplasia - active dvt, pe, or history of these conditions - active arterial thromboembolic disease (for example stroke and mi), or a history of these conditions - known anaphylactic reaction or angioedema or hypersensitivity to activella - known liver impairment or disease - known protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders - known or suspected

Ireland - English - HPRA (Health Products Regulatory Authority)

gsk vaccines s.r.l. - meningococcal group c oligosaccharide; corynebacterium diphtheriae crm197 protein - suspension for injection in pre-filled syringe - 10 - meningococcal vaccines; other meningococcal polyvalent purified polysaccharides antigen - meningococcal vaccines - active immunisation of children from 2 months of age, adolescents and adults, for the prevention of invasive disease caused by neisseria meningitidis group c.

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

oscient pharmaceuticals - gemifloxacin mesylate (unii: x4s9f8rl01) (gemifloxacin - unii:okr68y0e4t) - tablet - 320 mg - factive is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. (see dosage and administration and clinical studies . ) acute bacterial exacerbation of chronic bronchitis caused by streptococcus pneumoniae, haemophilus influenzae, haemophilus parainfluenzae, or moraxella catarrhalis . community-acquired pneumonia (of mild to moderate severity) caused by streptococcus pneumoniae (including multi-drug resistant strains [mdrsp])*, haemophilus influenzae, moraxella catarrhalis, mycoplasma pneumoniae, chlamydia pneumoniae, or klebsiella pneumoniae . *mdrsp: multi-drug resistant streptococcus pneumoniae , includes isolates previously known as prsp (penicillin-resistant streptococcus pneumoniae ), and are strains resistant to two or more of the following antibiotics: penicillin (mic ≥2 μg/ml), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines and trimethoprim/sulfamethoxazole. to reduce the development

Malta - English - Medicines Authority

pfizer hellas s.a. 243 messoghion ave., neo psychiko 15451, athens, greece - neisseria meningitidis, polysaccharide group, tetanus toxoid - suspension for injection - neisseria meningitidis polysaccharide group c tetanus toxoid - vaccines

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - meningococcal polysaccharide group w135, quantity: 10 microgram; meningococcal polysaccharide group c, quantity: 10 microgram; meningococcal polysaccharide group a, quantity: 10 microgram; meningococcal polysaccharide group y, quantity: 10 microgram - injection, solution - excipient ingredients: sodium acetate; tetanus toxoid; sodium chloride; water for injections - menquadfi is indicated for active immunisation for the prevention of invasive meningococcal disease caused by neisseria meningitidis serogroups a, c, w and y.,the use of menquadfi should be in accordance with official recommendations.

Canada - English - Health Canada

oscient pharmaceuticals corporation - gemifloxacin (gemifloxacin mesylate) - tablet - 320mg - gemifloxacin (gemifloxacin mesylate) 320mg - quinolones