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

alphapharm pty ltd - ciprofloxacin hydrochloride, quantity: 555 mg (equivalent: ciprofloxacin, qty 500 mg) - tablet, film coated - excipient ingredients: crospovidone; pregelatinised maize starch; maize starch; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; macrogol 8000; triacetin; polydextrose - c-flox is indicated for 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. inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolised bacillus anthracis. ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. 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. c-flox 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. consideration should be given to available official guidance on the appropriate use of antibacterial agents.

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

alphapharm pty ltd - ciprofloxacin hydrochloride, quantity: 277.5 mg (equivalent: ciprofloxacin, qty 250 mg) - tablet, film coated - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; maize starch; crospovidone; pregelatinised maize starch; titanium dioxide; hypromellose; macrogol 8000; triacetin; polydextrose - for the treatment of infections caused by susceptible organisms in the following conditions: - 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.- inhalational anthrax (post-exposure). to reduce the incidence or progression of disease following exposure to aerosolised bacillus anthracis. ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. note:1. typhoid and paratyphoid infections and infections due to multi-resistant 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. c-flox 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. consideration should be given to available official guidance on the appropriate use of antibacterial agents.

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

strides pharma science pty ltd - ciprofloxacin hydrochloride, quantity: 294.586 mg (equivalent: ciprofloxacin, qty 250 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; sodium starch glycollate type a; povidone; magnesium stearate; titanium dioxide; hypromellose; macrogol 400 - ciprofloxacin is indicated for 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. inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis. ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. note: typhoid and paratyphoid infections and infections due to multi-resistant staphylococcus aureus are excluded from the above due to insufficient data. because gram-positive organisms are generally less sensitive to ciprofloxacin, it may not be the drug of choice in cases with gram-positive infections, such as pneumonia due to streptococcus pneumoniae. 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 aetiologic agents, additional therapy should be considered.

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

amneal pharma australia pty ltd - ciprofloxacin hydrochloride, quantity: 294.586 mg (equivalent: ciprofloxacin, qty 250 mg) - tablet, film coated - excipient ingredients: povidone; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; sodium starch glycollate type a; titanium dioxide; hypromellose; macrogol 400 - ciprofloxacin is indicated for 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. inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis. ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. note: typhoid and paratyphoid infections and infections due to multi-resistant staphylococcus aureus are excluded from the above due to insufficient data. because gram-positive organisms are generally less sensitive to ciprofloxacin, it may not be the drug of choice in cases with gram-positive infections, such as pneumonia due to streptococcus pneumoniae. 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 aetiologic agents, additional therapy should be considered.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

a a h pharmaceuticals ltd - zinc oxide - cutaneous cream - 320mg/1gram

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

j m loveridge ltd - zinc oxide - cutaneous cream - 320mg/1gram

Malta - English - Medicines Authority

fresenius kabi limited - chromic chloride; copper chloride; ferric chloride; manganese chloride; potassium iodide; sodium fluoride; sodium molybdate dihydrate; sodium selenite; zinc chloride - concentrate for solution for infusion - chromic chloride 5.33 µg/ml; copper chloride 0.10 mg; ferric chloride 0.54 mg; manganese chloride 19.8 µg; potassium iodide 16.6 µg; sodium fluoride 0.21 mg; sodium molybdate dihydrate 4.85 µg; sodium selenite 17.3 µg; zinc chloride 1.05 mg - blood substitutes and perfusion solutions

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

abbvie pty ltd - levobupivacaine hydrochloride, quantity: 1.436 mg; levobupivacine, quantity: 1.25 mg - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium chloride; sodium hydroxide - adults - pain management. continuous epidural infusion, for post operative and labour analgesia.

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

abbvie pty ltd - levobupivacaine hydrochloride, quantity: 8.449 mg/ml (equivalent: levobupivacine, qty 7.5 mg/ml) - injection, solution - excipient ingredients: sodium hydroxide; sodium chloride; water for injections; hydrochloric acid - adults levobupivacaine is indicated in adults for: surgical anaesthesia: major: epidural (including for caesarean section), intrathecal, peripheral nerve block minor: local infiltration, oral, peribulbar block in ophthalmic surgery. pain management: continuous epidural infusion, single or multiple bolus administration for post-operative, labour or chronic pain. for continuous epidural analgesia, levobupivacaine may be administered in combination with epidural fentanyl, morphine or clonidine. children levobupivacaine is indicated in children greater than 6 months of age, for infiltration analgesia (ilioinguinal/iliohypogastric blocks). after careful consideration to alternative concentrations, the 7.5mg/ml concentration of levobupivacine may be considered for those procedures requiring a dense block with low volume. the 7.5mg/ml concentration should not be considered for paediatric use.

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

abbvie pty ltd - levobupivacaine hydrochloride, quantity: 5.633 mg/ml (equivalent: levobupivacine, qty 5 mg/ml) - injection, solution - excipient ingredients: water for injections; sodium hydroxide; sodium chloride; hydrochloric acid - adults levobupivacaine is indicated in adults for: surgical anaesthesia: major: epidural (including for caesarean section), intrathecal, peripheral nerve block minor: local infiltration, oral, peribulbar block in ophthalmic surgery. pain management: continuous epidural infusion, single or multiple bolus administration for post-operative, labour or chronic pain. for continuous epidural analgesia, levobupivacaine may be administered in combination with epidural fentanyl, morphine or clonidine. children levobupivacaine is indicated in children greater than 6 months of age, for infiltration analgesia (ilioinguinal/iliohypogastric blocks). after careful consideration to alternative concentrations, the 7.5mg/ml concentration of levobupivacine may be considered for those procedures requiring a dense block with low volume. the 7.5mg/ml concentration should not be considered for paediatric use.