Israel - English - Ministry of Health

ilex medical ltd, israel - follitropin alfa - solution for injection - follitropin alfa 600 iu/ml - follitropin alfa - in adult women• anovulation (including polycystic ovarian disease, pcod) in women who have been unresponsive to treatment with clomiphene citrate.• stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (art) such as in vitro fertilisation (ivf), gamete intra-fallopian transfer (gift) and zygote intra-fallopian transfer (zift).• follitropin alfa in association with a luteinising hormone (lh) preparation is recommended for the stimulation of follicular development in women with severe lh and fsh deficiency. inclinical trials these patients were defined by an endogenous serum lh level < 1.2 iu/l.in adult men• follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hcg) therapy

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

alphapharm pty ltd - cefalexin monohydrate, quantity: 52.6 mg/ml (equivalent: cefalexin, qty 50 mg/ml) - oral liquid, powder for - excipient ingredients: sodium lauryl sulfate; allura red ac; methylcellulose; dimeticone 350; xanthan gum; pregelatinised maize starch; sucrose; flavour - indications as at 24 february 2004: ibilex is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: respiratory tract infections caused by s. pneumoniae and group a beta-haemolytic streptococci (penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. ibilex is generally effective in the eradication of streptococci from nasopharynx; however, substantial data establishing the efficacy of ibilex in the subsequent prevention of rheumatic fever are not available at present.) bacterial sinusitis caused by streptococci, s. pneumoniae and s. aureus (methicillin-sensitive only) otitis media due to s. pneumoniae, staphylococci; skin and soft tissue infections caused by staphlococci anr/or streptococci; genitourinary tract infections, including acute prostatic caused by e. coli, p. mirabilis, and klebsiella sp. the effectiveness of ibilex in the treatment of bacterial infections of the brain and spinal column has not been established and ibilex is not indicated in these conditions. note: appropriate culture and susceptibility test should be initiated prior to and during therapy to determine susceptibility of the causative organism to ibilex. renal function studies should be performed when indicated

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

alphapharm pty ltd - cefalexin monohydrate, quantity: 26.3 mg/ml (equivalent: cefalexin, qty 25 mg/ml) - oral liquid, powder for - excipient ingredients: sodium lauryl sulfate; allura red ac; methylcellulose; dimeticone 350; xanthan gum; pregelatinised maize starch; sucrose; flavour - indications as at 24 february 2004: ibilex is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: respiratory tract infections caused by s. pneumoniae and group a beta-haemolytic streptococci (penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. ibilex is generally effective in the eradication of streptococci from nasopharynx; however, substantial data establishing the efficacy of ibilex in the subsequent prevention of rheumatic fever are not available at present.) bacterial sinusitis caused by streptococci, s. pneumoniae and s. aureus (methicillin-sensitive only) otitis media due to s. pneumoniae, staphylococci; skin and soft tissue infections caused by staphlococci anr/or streptococci; genitourinary tract infections, including acute prostatic caused by e. coli, p. mirabilis, and klebsiella sp. the effectiveness of ibilex in the treatment of bacterial infections of the brain and spinal column has not been established and ibilex is not indicated in these conditions. note: appropriate culture and susceptibility test should be initiated prior to and during therapy to determine susceptibility of the causative organism to ibilex. renal function studies should be performed when indicated

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

alphapharm pty ltd - cefalexin monohydrate, quantity: 526 mg (equivalent: cefalexin, qty 500 mg) - capsule, hard - excipient ingredients: titanium dioxide; quinoline yellow; gelatin; magnesium stearate; patent blue v; dimeticone 350; microcrystalline cellulose; carmellose sodium - indications as at 24 february 2004: ibilex is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: respiratory tract infections caused by s. pneumoniae and group a beta-haemolytic streptococci (penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. ibilex is generally effective in the eradication of streptococci from nasopharynx; however, substantial data establishing the efficacy of ibilex in the subsequent prevention of rheumatic fever are not available at present.) bacterial sinusitis caused by streptococci, s. pneumoniae and s. aureus (methicillin-sensitive only) otitis media due to s. pneumoniae, staphylococci; skin and soft tissue infections caused by staphlococci anr/or streptococci; genitourinary tract infections, including acute prostatic caused by e. coli, p. mirabilis, and klebsiella sp. the effectiveness of ibilex in the treatment of bacterial infections of the brain and spinal column has not been established and ibilex is not indicated in these conditions. note: appropriate culture and susceptibility test should be initiated prior to and during therapy to determine susceptibility of the causative organism to ibilex. renal function studies should be performed when indicated

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

alphapharm pty ltd - cefalexin monohydrate, quantity: 263 mg (equivalent: cefalexin, qty 250 mg) - capsule, hard - excipient ingredients: gelatin; dimeticone 350; magnesium stearate; titanium dioxide; patent blue v; quinoline yellow; microcrystalline cellulose; carmellose sodium - indications as at 24 february 2004: ibilex is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: respiratory tract infections caused by s. pneumoniae and group a beta-haemolytic streptococci (penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. ibilex is generally effective in the eradication of streptococci from nasopharynx; however, substantial data establishing the efficacy of ibilex in the subsequent prevention of rheumatic fever are not available at present.) bacterial sinusitis caused by streptococci, s. pneumoniae and s. aureus (methicillin-sensitive only) otitis media due to s. pneumoniae, staphylococci; skin and soft tissue infections caused by staphlococci anr/or streptococci; genitourinary tract infections, including acute prostatic caused by e. coli, p. mirabilis, and klebsiella sp. the effectiveness of ibilex in the treatment of bacterial infections of the brain and spinal column has not been established and ibilex is not indicated in these conditions. note: appropriate culture and susceptibility test should be initiated prior to and during therapy to determine susceptibility of the causative organism to ibilex. renal function studies should be performed when indicated

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

sandoz pty ltd - candesartan cilexetil, quantity: 32 mg; hydrochlorothiazide, quantity: 12.5 mg - tablet - excipient ingredients: iron oxide yellow; lactose monohydrate; povidone; carrageenan; magnesium stearate; croscarmellose sodium; iron oxide red; iron oxide black; maize starch - the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

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

sandoz pty ltd - hydrochlorothiazide, quantity: 25 mg; candesartan cilexetil, quantity: 32 mg - tablet - excipient ingredients: carrageenan; povidone; lactose monohydrate; magnesium stearate; croscarmellose sodium; iron oxide black; titanium dioxide; maize starch; iron oxide red - the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

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

sandoz pty ltd - candesartan cilexetil, quantity: 16 mg; hydrochlorothiazide, quantity: 12.5 mg - tablet - excipient ingredients: magnesium stearate; carrageenan; lactose monohydrate; maize starch; iron oxide red; croscarmellose sodium; povidone; iron oxide yellow - the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

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

amneal pharma australia pty ltd - hydrochlorothiazide, quantity: 12.5 mg; candesartan cilexetil, quantity: 16 mg - tablet, uncoated - excipient ingredients: magnesium stearate; carmellose calcium; maize starch; lactose monohydrate; macrogol 8000; hyprolose; iron oxide red - the treatment of hypertension. treatment should not be initiated with these fixed dose combinations.

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

amneal pharma australia pty ltd - hydrochlorothiazide, quantity: 12.5 mg; candesartan cilexetil, quantity: 32 mg - tablet, uncoated - excipient ingredients: magnesium stearate; maize starch; macrogol 8000; lactose monohydrate; carmellose calcium; hyprolose; iron oxide yellow - the treatment of hypertension. treatment should not be initiated with these fixed dose combinations.