Malta - angļu - Medicines Authority

abbott laboratories limited - clarithromycin 250 mg - film-coated tablet

Īrija - angļu - HPRA (Health Products Regulatory Authority)

mylan ire healthcare limited - clarithromycin - film-coated tablet - 250 milligram(s) - macrolides; clarithromycin - antibacterial for systemic use, macrolide - it is indicated for the treatment of infections due to susceptible organisms. such infections include: 1. lower respiratory tract infections (e.g. bronchitis, pneumonia). 2. upper respiratory tract infections (e.g. pharyngitis, sinusitis). 3. skin and soft tissue infections (e.g. folliculitis, cellulitis, erysipelas). 4. disseminated or localised mycobacterial infections due to mycobacterium avium or mycobacterium intracellulare. localised infections due to mycobacterium chelonae, mycobacterium fortuitum or mycobacterium kansasii. 5. clarithromycin is indicated for the prevention of disseminated mycobacterium avium complex infection in hivinfected patients with cd4 lymphocyte counts less than or equal to 100/mm3. 6. clarithromycin in the presence of acid suppression is indicated for the eradication of h. pylori, resulting in decreased recurrence of duodenal ulcer. (see further information).

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - clarithromycin, quantity: 250 mg - tablet, film coated - excipient ingredients: sorbitan mono-oleate; pregelatinised maize starch; titanium dioxide; povidone; propylene glycol; hypromellose; silicon dioxide; sorbic acid; stearic acid; purified talc; hyprolose; quinoline yellow; vanillin; magnesium stearate; croscarmellose sodium; microcrystalline cellulose - klacid (clarithromycin) is indicated for use in adults and children older than 12 years for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro-organisms in the conditions listed below: 1. acute streptococcal pharyngitis; 2. community acquired pneumonia due to chlamydia pneumoniae, mycoplasma pneumoniae, legionella pneumophila and streptococcus pneumoniae; 3. uncomplicated skin and skin structure infections due to staphylococcus aureus or streptococcus pyogenes; 4. disseminated or localised mycobacterial infections due to mycobacterium avium or mycobacterium intracellulare and skin and skin structure infections due to mycobacterium chelonae. clarithromycin should be used in combination with other antimycobacterial agents. 5. prevention of disseminated mycobacterium avium complex infection in hiv-infected adults with cd4 lymphocyte counts of < 75 cells/cubic mm. (see precautions) disseminated infection due to mycobacterium avium complex should be excluded by a negative blood culture prior to commencement of prophylaxis. 6. acute bacterial exacerbation of chronic bronchitis due to haemophilus influenzae, moraxella catarrhalis or streptococcus pneumoniae; 7. combination therapy for the treatment of peptic ulcer disease associated with helicobacter pylori infection. klacid (clarithromycin) is indicated for use in children for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro-organisms in the conditions listed below: 1. acute streptococcal pharyngitis and tonsillitis caused by streptococcus pyogenes; 2. community acquired pneumonia including infections due to chlamydia pneumoniae, mycoplasma pneumoniae and legionella pneumophila; 3. skin and skin structure infections (eg impetigo); 4. disseminated or localised infections due to mycobacterium avium or mycobacterium intracellulare in immunocompromised children, including those with hiv infection or aids. 5. acute otitis media. note: 1. penicillins are the drug of first choice in the treatment of acute otitis media. 2. penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections including prophylaxis of rheumatic fever. clarithromycin appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx, however substantial data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present. 3. there is insufficient evidence of efficacy to support the use of klacid in acute bronchitis in young children. 4. the data presented on infections of skin and skin structure were confined largely to mild to moderate infections such as impetigo.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - clarithromycin, quantity: 500 mg - tablet, film coated - excipient ingredients: sorbic acid; hypromellose; hyprolose; sorbitan mono-oleate; vanillin; purified talc; silicon dioxide; stearic acid; quinoline yellow; propylene glycol; povidone; croscarmellose sodium; titanium dioxide; magnesium stearate; microcrystalline cellulose - klacid (clarithromycin) is indicated for use in adults and children older than 12 years for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro-organisms in the conditions listed below: 1. acute streptococcal pharyngitis; 2. community acquired pneumonia due to chlamydia pneumoniae, mycoplasma pneumoniae, legionella pneumophila and streptococcus pneumoniae; 3. uncomplicated skin and skin structure infections due to staphylococcus aureus or streptococcus pyogenes; 4. disseminated or localised mycobacterial infections due to mycobacterium avium or mycobacterium intracellulare and skin and skin structure infections due to mycobacterium chelonae. clarithromycin should be used in combination with other antimycobacterial agents. 5. prevention of disseminated mycobacterium avium complex infection in hiv-infected adults with cd4 lymphocyte counts of < 75 cells/cubic mm. (see precautions) disseminated infection due to mycobacterium avium complex should be excluded by a negative blood culture prior to commencement of prophylaxis. 6. acute bacterial exacerbation of chronic bronchitis due to haemophilus influenzae, moraxella catarrhalis or streptococcus pneumoniae; 7. combination therapy for the treatment of peptic ulcer disease associated with helicobacter pylori infection. klacid (clarithromycin) is indicated for use in children for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro-organisms in the conditions listed below: 1. acute streptococcal pharyngitis and tonsillitis caused by streptococcus pyogenes; 2. community acquired pneumonia including infections due to chlamydia pneumoniae, mycoplasma pneumoniae and legionella pneumophila; 3. skin and skin structure infections (eg impetigo); 4. disseminated or localised infections due to mycobacterium avium or mycobacterium intracellulare in immunocompromised children, including those with hiv infection or aids. 5. acute otitis media. note: 1. penicillins are the drug of first choice in the treatment of acute otitis media. 2. penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections including prophylaxis of rheumatic fever. clarithromycin appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx, however substantial data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present. 3. there is insufficient evidence of efficacy to support the use of klacid in acute bronchitis in young children. 4. the data presented on infections of skin and skin structure were confined largely to mild to moderate infections such as impetigo.

Īrija - angļu - HPRA (Health Products Regulatory Authority)

viatris healthcare limited - clarithromycin - film-coated tablet - macrolides; clarithromycin

Īrija - angļu - HPRA (Health Products Regulatory Authority)

viatris healthcare limited - clarithromycin - film-coated tablet - macrolides; clarithromycin

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - dasatinib propylene glycol, quantity: 116 mg (equivalent: dasatinib, qty 100 mg) - tablet, film coated - excipient ingredients: hydrogenated castor oil; lactose; silicon dioxide; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; titanium dioxide; hypromellose; triacetin - dasatinib dr.reddy's is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase. ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. ? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib dr.reddy's is indicated for the treatment of paediatric patients with: ? ph+ cml in the chronic phase. ? newly diagnosed ph+ all in combination with chemotherapy.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - dasatinib propylene glycol, quantity: 23.2 mg (equivalent: dasatinib, qty 20 mg) - tablet, film coated - excipient ingredients: lactose; croscarmellose sodium; triacetin; hydrogenated castor oil; magnesium stearate; titanium dioxide; silicon dioxide; microcrystalline cellulose; hypromellose - dasatinib dr.reddy's is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase. ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. ? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib dr.reddy's is indicated for the treatment of paediatric patients with: ? ph+ cml in the chronic phase. ? newly diagnosed ph+ all in combination with chemotherapy.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - dasatinib propylene glycol, quantity: 81.2 mg (equivalent: dasatinib, qty 70 mg) - tablet, film coated - excipient ingredients: silicon dioxide; croscarmellose sodium; magnesium stearate; triacetin; titanium dioxide; microcrystalline cellulose; lactose; hydrogenated castor oil; hypromellose - dasatinib dr.reddy's is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase. ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. ? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib dr.reddy's is indicated for the treatment of paediatric patients with: ? ph+ cml in the chronic phase. ? newly diagnosed ph+ all in combination with chemotherapy.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - dasatinib propylene glycol, quantity: 58 mg (equivalent: dasatinib, qty 50 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; hydrogenated castor oil; magnesium stearate; hypromellose; titanium dioxide; lactose; triacetin; silicon dioxide - dasatinib dr.reddy's is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase. ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. ? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib dr.reddy's is indicated for the treatment of paediatric patients with: ? ph+ cml in the chronic phase. ? newly diagnosed ph+ all in combination with chemotherapy.