APOTHECA MARKETING PTE LTD

**4.1 Therapeutic indications** Adult patients Plerixafor 20 mg/mL Solution for Injection is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4.2). Paediatric patients (1 to less than 18 years) Plerixafor 20 mg/mL Solution for Injection is indicated in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either: - pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with GCSF (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or - who previously failed to collect sufficient haematopoietic stem cells (see section 4.2).

**4.1 Therapeutic indications** Irinotecan is indicated for the treatment of patients with advanced colorectal cancer. - In combination with 5-fluorouracil (5-FU) and folinic acid (FA) in patients without prior chemotherapy for advanced cancer. - As a single agent in patients who have failed an established treatment regimen containing 5-FU.

**Therapeutic indications** Anastrozole is indicated for the: Treatment of advanced breast cancer in postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. Efficacy has not been demonstrated in oestrogen receptor negative patients unless they had a previous positive clinical response to tamoxifen.

**Therapeutic indications** Treatment of erectile dysfunction (ED) in adult males. In order for tadalafil to be effective for the treatment of ED, sexual stimulation is required. Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). If Tadalafil is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks. Treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (ED/BPH). Tadalafil is not indicated for use by women.

<p><strong>Therapeutic indications</strong></p> <p>Treatment and control of benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce prostate size, reduce the risk of acute urinary retention, and reduce the need for BPH-related surgery.</p> <p>In addition, Dutasteride in combination with the alpha-blocker tamsulosin is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.</p>

**4.1 Therapeutic indications** BORTEBIN (Bortezomib) for Injection is indicated as part of combination therapy for the treatment of patients with previously untreated multiple myeloma. BORTEBIN (Bortezomib) for Injection is indicated as monotherapy for the treatment of patients with multiple myeloma who have received at least 1 prior therapy. BORTEBIN (Bortezomib) for Injection is indicated as monotherapy for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy. BORTEBIN (Bortezomib) for Injection in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

**Therapeutic indications** Hypertension Losartan Potassium is indicated for the treatment of hypertension. Hypertensive Patients with Left Ventricular Hypertrophy Losartan Potassium is indicated for the reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy (see RACE). Renal Protection in Type 2 Diabetic Patients with Proteinuria Losartan Potassium is indicated to delay the progression of renal disease as measured by a reduction in the incidence of doubling of serum creatinine and end stage renal disease (need for dialysis or renal transplantation), and to reduce proteinuria.

**Therapeutic indications** Hypertension Losartan Potassium is indicated for the treatment of hypertension. Hypertensive Patients with Left Ventricular Hypertrophy Losartan Potassium is indicated for the reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy (see RACE). Renal Protection in Type 2 Diabetic Patients with Proteinuria Losartan Potassium is indicated to delay the progression of renal disease as measured by a reduction in the incidence of doubling of serum creatinine and end stage renal disease (need for dialysis or renal transplantation), and to reduce proteinuria.

<p><strong>4.1 Therapeutic indications</strong><br> Meronem IV 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>Meronem IV 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>