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

arrotex pharmaceuticals pty ltd - calcium carbonate, quantity: 1.2492 g (equivalent: calcium, qty 500 mg) - tablet - excipient ingredients: magnesium stearate; hypromellose; sodium lauryl sulfate; dibasic sodium phosphate; monobasic sodium phosphate; titanium dioxide; croscarmellose sodium; macrogol 8000; polydextrose; indigo carmine aluminium lake; pregelatinised maize starch - alendronate/vitamin d3 and calcium composite pack is indicated for the treatment of:,? osteoporosis* in select patients where vitamin d and calcium supplementation is recommended,* prior to treatment, osteoporosis must be confirmed by: ? the finding of low bone mass of at least 2 standard deviations below the gender specific mean for young adults or by ? the presence of osteoporotic fracture

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

arrotex pharmaceuticals pty ltd - calcium carbonate, quantity: 1.2492 g (equivalent: calcium, qty 500 mg) - tablet - excipient ingredients: magnesium stearate; hypromellose; sodium lauryl sulfate; dibasic sodium phosphate; monobasic sodium phosphate; titanium dioxide; croscarmellose sodium; macrogol 8000; polydextrose; indigo carmine aluminium lake; pregelatinised maize starch - alendronate/vitamin d3 and calcium composite pack is indicated for the treatment of:,? osteoporosis* in select patients where vitamin d and calcium supplementation is recommended,* prior to treatment, osteoporosis must be confirmed by: ? the finding of low bone mass of at least 2 standard deviations below the gender specific mean for young adults or by ? the presence of osteoporotic fracture

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

arrotex pharmaceuticals pty ltd - calcium carbonate, quantity: 1.2492 g (equivalent: calcium, qty 500 mg) - tablet - excipient ingredients: hypromellose; magnesium stearate; sodium lauryl sulfate; dibasic sodium phosphate; monobasic sodium phosphate; titanium dioxide; croscarmellose sodium; macrogol 8000; polydextrose; indigo carmine aluminium lake; pregelatinised maize starch - alendronate/vitamin d3 and calcium composite pack is indicated for the treatment of:,? osteoporosis* in select patients where vitamin d and calcium supplementation is recommended,* prior to treatment, osteoporosis must be confirmed by: ? the finding of low bone mass of at least 2 standard deviations below the gender specific mean for young adults or by ? the presence of osteoporotic fracture

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

arrotex pharmaceuticals pty ltd - calcium carbonate, quantity: 1.2492 g (equivalent: calcium, qty 500 mg) - tablet - excipient ingredients: magnesium stearate; hypromellose; sodium lauryl sulfate; dibasic sodium phosphate; monobasic sodium phosphate; titanium dioxide; croscarmellose sodium; macrogol 8000; polydextrose; indigo carmine aluminium lake; pregelatinised maize starch - alendronate/vitamin d3 and calcium composite pack is indicated for the treatment of:,? osteoporosis* in select patients where vitamin d and calcium supplementation is recommended,* prior to treatment, osteoporosis must be confirmed by: ? the finding of low bone mass of at least 2 standard deviations below the gender specific mean for young adults or by ? the presence of osteoporotic fracture

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

merck sharp & dohme (australia) pty ltd - alendronate sodium,calcium carbonate,colecalciferol -

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

merck sharp & dohme (australia) pty ltd - alendronate sodium,calcium carbonate,colecalciferol -

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

viatris pty ltd - mesalazine, quantity: 250 mg - tablet, enteric coated - excipient ingredients: microcrystalline cellulose; povidone; sodium carbonate; purified talc; titanium dioxide; iron oxide red; colloidal anhydrous silica; calcium stearate; glycine; iron oxide yellow; methacrylic acid copolymer; macrogol 6000; triethyl citrate - indications as at 12 september 1990: treatment of acute inflammatory large bowel disease. maintenance therapy of crohns colitis and ulcerative colitis in patients sensitive to sulfasalazine.

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

seqirus pty ltd - tapentadol hydrochloride, quantity: 291.2 mg (equivalent: tapentadol, qty 250 mg) - tablet, modified release - excipient ingredients: iron oxide red; iron oxide yellow; microcrystalline cellulose; propylene glycol; macrogol 6000; lactose monohydrate; hypromellose; magnesium stearate; purified talc; iron oxide black; titanium dioxide; colloidal anhydrous silica - palexia sr is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. palexia sr is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. palexia sr is not indicated as an as-needed (prn) analgesia.

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

arrotex pharmaceuticals pty ltd - ciprofloxacin hydrochloride, quantity: 277.5 mg (equivalent: ciprofloxacin, qty 250 mg) - tablet, film coated - excipient ingredients: maize starch; colloidal anhydrous silica; microcrystalline cellulose; purified talc; sodium starch glycollate type a; magnesium stearate; titanium dioxide; hypromellose; macrogol 400 - the treatment of infections caused by susceptible organisms in the conditions listed below: - urinary tract infections - gonorrhoeal urethritis and cervicitis - gastroenteritis, - bronchial infections - skin and skin structure infections - bone and joint infections - chronic bacterial prostatitis of mild to moderate severity. note: 1. typhoid and paratyphoid infections and infections due to multiresistant staphylococcus aureus are excluded from the above due to insufficient data. 2. because gram-positive organisms are generally less sensitive to ciprofloxacin, it may not be the drug of choice in case with gram- positive infections, such as pneumonia due to streptococcus pneumoniae. 3. chronic bacterial prostatitis should be demonstrated by microbiological evidence localising infection to the prostate. strains of neisseria gonorrhoea resistant to ciprofloxacin have been reported in australia. appropriate culture and susceptibility tests should be performed before treatment in order to determine organism susceptibility to ciprofloxacin and after treatment as warranted by the clinical condition. therapy with ciprofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. ciprofloxacin is suitable to treat mixed infections caused by susceptible strains of both gram-negative and gram-positive aerobic bacteria. if anaerobic organisms are suspected as accompanying aetiological agents, additional therapy should be considered.

Ireland - English - HPRA (Health Products Regulatory Authority)

norbrook laboratories (ireland) limited - amoxicillin trihydrate; potassium clavulanate - tablet - 250 mg/tablet - amoxicillin and enzyme inhibitor