PHARMAKOE PTE. LTD.

**4.1 Therapeutic indications** PANNEXIA tablets are indicated for: - Symptomatic relief of osteoarthritis (OA), - Rheumatoid arthritis (RA), - Symptomatic relief of ankylosing spondylitis (AS), - Pain and signs of inflammation associated with acute gouty arthritis, - Treatment of acute pain, including that related to primary dysmenorrhea and minor dental procedures. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient’s overall risks, taking into consideration other available therapeutic options. (see sections 4.3, 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

<p><strong>4.1 Therapeutic indications</strong><br> PANNEXIA tablets are indicated for:</p> <ul class="dash"> <li>Symptomatic relief of osteoarthritis (OA),</li> <li>Rheumatoid arthritis (RA),</li> <li>Symptomatic relief of ankylosing spondylitis (AS),</li> <li>Pain and signs of inflammation associated with acute gouty arthritis,</li> <li>Treatment of acute pain, including that related to primary dysmenorrhea and minor dental procedures.</li> </ul> <p>The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient&rsquo;s overall risks, taking into consideration other available therapeutic options. (see sections 4.3, 4.4 &ndash; <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>

<p><strong>Indications</strong><br> Severe infections caused by cefotaxime-susceptible pathogens;<br> Infections</p> <ul class="dash"> <li>of the respiratory tract, including nose and throat</li> <li>of the ear</li> <li>of the kidneys and urinary tract,</li> <li>of the skin and soft tissues</li> <li>of the bones and joints,</li> <li>of the genital organs including gonorrhoea,</li> <li>of the abdominal region</li> </ul> <p>Sepsis, endocartitis, meningitis: for perioperative prophylaxis in patients who are at increased risk from infection, and for the prophylaxis of infections in patients with reduced resistance. Cefotaxime is generally effective against the following pathogens: Staphylococci, aerobic and anaerobic streptococci, Streptococcus pneumonia, Neisseria spp., Haemophilus influenzae, Eschericha coli, Citrobacter spp., Salmonella spp., Klebsiella spp., Enterobacter areogenes, Serratia spp., indole-positive and indole-negative Proteus spp., Yersinia entercolitica, Clostridium spp., and Bacteroides spp.<br> Pathogens with varying susceptibility are: Streptococcus faecalis, Enterobacter colacae, Pseudomonas aeruginosa, and Bacteroides fragilis.<br> There are not yet sufficient clinical experience with Salmonella typhi and parathyphi A and B infections. Cefotaxime is not effective against Treponema pallidum and Clostridium difficile.</p> <p>Combination therapy: In severe, life-threatening infections, the combination of Cefotaxime with aminoglycosides is indicated without awaiting the results of sensitivity tests. The two preparations must be administered separately.<br> Infections with Pseudomonas aeruginosa may require concomitant treatment with other antibiotics effective against Pseudomonas.</p>

<p><strong>Indications</strong><br> Severe infections caused by cefotaxime-susceptible pathogens;<br> Infections</p> <ul class="dash"> <li>of the respiratory tract, including nose and throat</li> <li>of the ear</li> <li>of the kidneys and urinary tract,</li> <li>of the skin and soft tissues</li> <li>of the bones and joints,</li> <li>of the genital organs including gonorrhoea,</li> <li>of the abdominal region</li> </ul> <p>Sepsis, endocartitis, meningitis: for perioperative prophylaxis in patients who are at increased risk from infection, and for the prophylaxis of infections in patients with reduced resistance. Cefotaxime is generally effective against the following pathogens: Staphylococci, aerobic and anaerobic streptococci, Streptococcus pneumonia, Neisseria spp., Haemophilus influenzae, Eschericha coli, Citrobacter spp., Salmonella spp., Klebsiella spp., Enterobacter areogenes, Serratia spp., indole-positive and indole-negative Proteus spp., Yersinia entercolitica, Clostridium spp., and Bacteroides spp.<br> Pathogens with varying susceptibility are: Streptococcus faecalis, Enterobacter colacae, Pseudomonas aeruginosa, and Bacteroides fragilis.<br> There are not yet sufficient clinical experience with Salmonella typhi and parathyphi A and B infections. Cefotaxime is not effective against Treponema pallidum and Clostridium difficile.</p> <p>Combination therapy: In severe, life-threatening infections, the combination of Cefotaxime with aminoglycosides is indicated without awaiting the results of sensitivity tests. The two preparations must be administered separately.<br> Infections with Pseudomonas aeruginosa may require concomitant treatment with other antibiotics effective against Pseudomonas.</p>

<p><strong>Therapeutic indications</strong></p> <p>Mepronem is indicated for treatment, in adults and children, of the following infections caused by single or multiple bacteria sensitive to meropenem.</p> <ul class="dash"> <li>Pneumonias and Nosocomial Pneumonias</li> <li>Urinary Tract Infections</li> <li>Intra-abdominal Infections</li> <li>Gynaecological Infections, such as endometritis and pelvic inflammatory disease</li> <li>Skin and Skin Structure Infections</li> <li>Meningitis</li> <li>Septicaemia</li> <li>Empiric treatment, for presumed infections in adult patients with febrile neutropenia, used as monotherapy or in combination with anti-viral or anti-fungal agents.</li> </ul> <p>Mepronem has proved efficacious alone or in combination with other antimicrobial agents in the treatment of polymicrobial infections.</p> <p>There is no experience in paediatric patients with neutropenia or primary or secondary immunodeficiency.</p>

<p>INDICATIONS</p> <p>TREATMENT<br> The activity of IMCIL against an unusually broad spectrum of pathogens makes it particularly useful in the treatment of polymicrobic and mixed aerobic/anaerobic infections, as well as initial therapy prior to the identification of the causative organisms. IMCIL is indicated for the treatment of the following infections due to susceptible organisms:</p> <ul> <li>Intra-abdominal infections</li> <li>Lower respiratory tract infections</li> <li>Gynecological infections</li> <li>Septicemia</li> <li>Genitourinary tract infections</li> <li>Bone and joint infections</li> <li>Skin and soft tissue infections</li> <li>Endocarditis</li> </ul> <p>IMCIL is indicated for the treatment of mixed infections caused by susceptible strains of aerobic and anaerobic bacteria. The majority of these mixed infections are associated with contamination by fecal flora or flora originating from the vagina, skin, and mouth. In these mixed infections, Bacteroides fragilis is the most commonly encountered anaerobic pathogen and is usually resistant to aminoglycosides, cephalosporins and penicillins. However, Bacteroides fragilis is usually susceptible to IMCIL.<br> Imipenem and Cilastatin injection has demonstrated efficacy against many infections caused by aerobic and anaerobic gram-positive and gram-negative bacteria resistant to the cephalosporins, including cefazolin, cefoperazone, cephalothin, cefoxitin, cefotaxime, moxalactam, cefamandole, ceftazidime, and ceftriaxone. Similarly, many infections caused by organisms resistant to aminoglycosides (gentamicin, amikacin, tobramycin) and/or penicillins (ampicillin, carbenicillin, penicillin-G, ticarcillin, piperacillin, azlocillin, mezlocillin) responded to treatment with Imipenem and Cilastatin injection.<br> IMCIL is not indicated for the treatment of meningitis.</p>

<p><strong>Therapeutic indications</strong><br> ROVALUX is indicated for patients with primary hypercholesterolaemia and mixed dyslipidaemia (including Fredrickson Type IIa, IIb; and heterozygous familial hypercholesterolaemia) as an adjunct to diet when response to diet and exercise is inadequate.</p> <p>ROVALUX is indicated to treat patients with primary dysbetalipoproteinaemia (Fredrickson Type III hyper lipoproteinaemia) as an adjunct to diet when response to diet and exercise is inadequate.</p> <p>ROVALUX reduces elevated LDL-cholesterol, total cholesterol and triglycerides and increases HDL-cholesterol, thereby enabling most patients to achieve relevant treatment guidelines.</p> <p>Rosuvastatin also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C, total C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I ratios and increases ApoA-I.<br> Rosuvastatin is also indicated in patients with homozygous familial hypercholesterolaemia, either alone or as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis).<br> Primary prevention of cardiovascular disease: Rosuvastatin is indicated in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age &ge; 50 years old in men and &ge; 60 years old in women, hsCRP &ge; 2 mg/L, and the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease.</p> <p>Rosuvastatin is indicated to:</p> <ul> <li>reduce the risk of stroke</li> <li>reduce the risk of myocardial infarction</li> <li>reduce the risk of arterial revascularization procedures</li> </ul> <p>Rosuvastatin is indicated in children and adolescents 10 to 17 years of age as an adjunct to diet to reduce Total-C, LDL-C and ApoB levels in adolescent boys and girls, who are at least one year postmenarche, 10&ndash;17 years of age with heterozygous familial hypercholesterolaemia if after an adequate trial of diet therapy the following findings are present: LDL-C &gt; 190 mg/dL or &gt; 160 mg/dL and there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors. Paediatric studies were conducted mainly in the non-Asian population and data on Asian children/adolescents is limited.</p>

**2.1. Therapeutic Indication(s)** Infections caused by pathogens sensitive to Cyrosef, e.g.: - Sepsis; - Meningitis; - Disseminated Lyme Borreliosis (early and late stages of the disease); - Abdominal Infections (peritonitis, infections of the biliary and gastrointestinal tracts); - Infections of the bones, joints, soft tissue, skin and of wounds; - Infections in patients with impaired defense mechanisms; - Renal and urinary tract infections; - Respiratory tract infections, particularly pneumonia, and ear, nose and throat infections; - Genital infections, including gonorrhea. And perioperative prophylaxis of infections.