European Union - English - EMA (European Medicines Agency)

laboratorios hipra s.a - live ge- tk- double-gene-deleted bovine herpes virus type 1, strain ceddel: 106.3–107.3 ccid50 - immunologicals - cattle - for the active immunisation of cattle from three months of age against bovine herpes virus type 1 (bohv-1) to reduce the clinical signs of infectious bovine rhinotracheitis (ibr) and field virus excretion.onset of immunity: 21 days after completion of the basic vaccination scheme.duration of immunity: 6 months after completion of the basic vaccination scheme

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - potassium clavulanate 128mg equivalent to clavulanic acid 100 mg (based on 82% potency +5% overage);  ; ticarcillin sodium 3.838 g equivalent to ticarcillin 3 g (based on 82% potency +5% overage) - powder for injection - active: potassium clavulanate 128mg equivalent to clavulanic acid 100 mg (based on 82% potency +5% overage)   ticarcillin sodium 3.838 g equivalent to ticarcillin 3 g (based on 82% potency +5% overage) - the treatment of infections caused by susceptible strains of organisms in the conditions listed below: - septicaemia (including bacteraemia) - lower respiratory tract infections - bone and joint infections - skin and skin structure infections - urinary tract infections - gynaecological infections - surgical prophylaxis appropriate culture and susceptibility tests should be performed in order to isolate and identify organisms causing infection and to determine their susceptibility to timentin. susceptibility to timentin will vary with geography and time and local succeptibility data should be consulted where available. in certain infections, when the causative organisms are unknown, timentin may be administered in conjunction with an aminoglycoside as initial therapy. as soon as results of culture and susceptibility tests become available, antimicrobial therapy should be adjusted as indicated. may be administered perioperatively (preoperatively, intraoperatively and postoperatively) to patients undergoing vaginal hysterectomy, abdominal surgery, and colorectal surgery when there is a significant risk of postoperative infection or where occurrence of postoperative infection is considered to be especially serious.

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

inova pharmaceuticals (australia) pty ltd - phenoxymethylpenicillin, quantity: 500 mg - capsule, hard - excipient ingredients: erythrosine; titanium dioxide; sunset yellow fcf; brilliant blue fcf; magnesium stearate; gelatin; indigo carmine; allura red ac; quinoline yellow aluminium lake; iron oxide black; sd alcohol 3-a - penicilin v potassium is indicated in the treatment of mild to moderately severe infections due to penicillin v sensitive micro-organisms. therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. note: severe pneumonia, empyema, bacteraemia, pericarditis, meningitis and arthritis should not be treated with penicillin v during the acute stage. indicated surgical procedures should be performed.

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

laboratoires delbert - potassium clavulanate; ticarcillin sodium - powder for solution for infusion - 200mg ; 3gram

European Union - English - EMA (European Medicines Agency)

zoetis belgium sa - inactivated bluetongue virus, serotype 1 - immunologicals - cattle - active immunisation of cattle from 2½ months of age for the prevention of viraemia caused by bluetongue virus, serotype 1.onset of immunity: 15 days after completion of the primary vaccination course.duration of immunity: 12 months.

European Union - English - EMA (European Medicines Agency)

zoetis belgium sa - inactivated bluetongue virus, serotype 1, strain btv-1/alg2006/01 e1 rp, inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02 - bluetongue virus, immunologicals, immunologicals for bovidae, cattle, inactivated viral vaccines - cattle - active immunisation of cattle from 3 months of age for the prevention* of viraemia caused by bluetongue virus (btv), serotypes 1 and 8.*(cycling value (ct) ≥ 36 by a validated rt-pcr method, indicating no presence of viral genome).

European Union - English - EMA (European Medicines Agency)

zoetis belgium - inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02 - immunologicals - cattle - active immunisation of cattle from three months of age for the prevention of viraemia caused by bluetongue virus, serotype 8.

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

inova pharmaceuticals (australia) pty ltd - phenoxymethylpenicillin, quantity: 250 mg - capsule, hard - excipient ingredients: brilliant blue fcf; magnesium stearate; titanium dioxide; erythrosine; sunset yellow fcf; carbon black; gelatin; indigo carmine; allura red ac; quinoline yellow aluminium lake; iron oxide black; sd alcohol 3-a - treatment of mild to moderately severe infections due to penicillin v sensitive micro-organisms. therapy should be guided by bacteriological studies ( including sensitivity tests) and by clinical response. note: severe pneumonia, empyema, bacteraemia, pericarditis, meningitis and arthritis should not be treated with penicillin v during the acute stage. indicated surgical procedures should be performed. the following infections will usually respond to adequate dosage of penicillin v: streptococcal infections( without bacteraemia). mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. note: streptococci in groups a,c,g,h,l and m are very sensitive to penicillin. other groups, including group d (enterococcus) are resistant. pneumococcal infections. mild to moderately severe infections of the respiratory tract. staphylococcal infections-penicillin v sensitive. mild infections of the skin and soft tissues. note: reports indicate an increasing number of strains of staphylococci resistant to penicillin v, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. fusospirochetosis (vincent's gingivitis and pharyngitis)-mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. note: reports indicate an increasing number of strains of staphylococci resistant to penicillin v, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. fusospirochetosis( vincent's gingivitis and pharyngitis)-mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. note; necessary dental care should be accomplished in infections involving the gum tissue. medical conditions in which oral penicillin therapy is indicated as prophylaxis: for the prevention of recurrence following rheumatic fever and/or chorea-prophylaxis with oral penicillin on a continuing basis has proven bacterial endocarditis in patients with congenital and/or rheumatic heart lesions who are to undergo dental procedures or minor upper respiratory tract surgery or instrumentation. prophylaxis should be instituted on the day of the procedure and for 2 or more days following. patients who have a past history of rheumatic fever and are receiving continuous prophylaxis may harbour increased numbers of penicillin-resistant organisms; use of another prophylactic anti-infective agent should be considered. if penicillin is to be used in these patients at surgery, penicillin may be re-instituted as a prophylactic measure against the hazards of surgically induced bacteraemia. note: oral penicillin should not be used as a adjunctive prophylaxis for genito-urinary instrumentation or surgery, lower intestinal tract surgery, sigmoidoscopy and complications of childbirth.

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

merck sharp & dohme (australia) pty ltd - mycobacterium bovis (bacillus calmette and guerin (bcg) strain), quantity: 200000000 cfu - injection, powder for - excipient ingredients: citric acid monohydrate; ferric ammonium citrate; strong ammonia solution; purified water; asparagine; magnesium sulfate heptahydrate; zinc formate dihydrate; lactose monohydrate; dibasic potassium phosphate; glycerol - onco tice is used as a treatment of primary or recurrent carcinomain situ of the urinary bladder. onco tice is also used after transurethral resection for the prevention or recurrence of high grade and/or relapsing superficial papillary transitional cell carcinoma of the urinary bladder (viz papillary carcinoma stage ta or t1 - grades 1, 2, or 3) indications as at 3 october 2001: oncotice is used as a treatment ofthe urinary bladder. oncotice is also used after transurethral resection for the prevention of recurrence of high grade and/or relapsing superficial papillary transitional cell carinoma of the urinary bladder (viz papillary carcinoma stage ta (grade 2 or 3) or t1 (grade 1, 2, or 3). oncotice is only recommended for stage ta grade 1 tumours, when there is judged to be a high risk of tumour recurrence is considered likely. inidications as at 24 april 2002: oncotice is used as a treatment of primary of recurrent carcinoma in situ (cid) of the urinary bladder. oncotice is also used after transurethral resection for the prevention of recurrence of high grade and/or relapsing superficial papillary transitional cell carcinoma of the urinary bladder (viz papillary carcinoma stage ta (grade 2 or 3) or t1 (grade 1, 2, or 3). oncotice is only reccommended for stage ta grade 1 tumours, when there is judged to be a high risk of tumour recurrence.

Singapore - English - HSA (Health Sciences Authority)

sa dental supply pte ltd - dental - relief acp oral care gel is indicated for relief of discomfort from dentin sensitivity. the product works by forming a layer of calcium phosphate and potassium nitrate on teeth