Powder for infusion 25mg, 100mg

First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate.

Indolent non-Hodgkin’s lymphomas as monotherapy in patients who have progressed during or within 6 months following treatment with rituximab or a rituximab containing regimen.

Front line treatment of multiple myeloma (Durie-Salmon stage II with progress or stage III) in combination with prednisone for patients older than 65 years who are not eligible for autologous stem cell transplantation and who have clinical neuropathy at time of diagnosis precluding the use of thalidomide or bortezomib containing treatment.

Powder for solution for injection 15,000IU indicated for the treatment of

• Squamous cell carcinoma (SCC) of the head and neck, external genitalia and cervix
• Hodgkin’s lymphoma
• Non-Hodgkin’s lymphoma of intermediate and high malignancy in Adults
• Testis carcinoma (seminoma and non-seminoma)

Solution for infusion 20mg/1ml, 80mg/4ml, 140mg/7ml 

Taxceus (docetaxel) in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:

• operable node-positive breast cancer
• operable node-negative breast cancer

Taxceus is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.

Taxceus in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.

Taxceus in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.

Taxceus in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.

Taxceus in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Concentrate for solution for infusion 50mg, 150mg, 450mg indicated for the treatment of

• Advanced ovarian carcinoma of epithelial origin 
• a. First line therapy
• b. Second line therapy, after other treatments have failed. 
• Small-cell carcinoma of the lung

Solution for infusion 10mg/5ml, 50mg/25ml, 200mg/100ml

Doxorubicin is a cytotoxic medicinal product that is indicated in the following neoplastic conditions:

Small-cell lung cancer (SCLC), Breast cancer, Recurrent ovarian carcinoma, Systemic treatment of local advanced or metastasized bladder carcinoma, Intravesical prophylaxis of recurrences of superficial bladder carcinoma following transurethral resection, Neoadjuvant and adjuvant therapy of osteosarcoma, Advanced soft-tissue sarcoma in adults, Ewing’s sarcoma, Hodgkin’s disease, Non-Hodgkin’s lymphoma, Acute lymphatic leukaemia, Acute myeloblastic leukaemia, Advanced multiple myeloma, Advanced or recurrent endometrial carcinoma.

Solution for injection 10mg/5ml, 50mg/25ml, 200mg/100ml

Epirubicin is used in the treatment of a range of neoplastic conditions including:

• Carcinoma of the breast
• Advanced ovarian cancer
• Gastric cancer
• Small cell lung cancer

When administered intravesically, epirubicin has been shown to be beneficial in the treatment of:

• Papillary transitional cell carcinoma of the bladder
• Carcinoma-in-situ of the bladder
• Intravesical prophylaxis of recurrences of superficial bladder carcinoma following transurethral resection.

Solution for infusion 100mg/5ml, 500mg/25ml

Etoposide is indicated for the management of:

• testicular tumours in combination with other chemotherapeutic agents
• small cell lung cancer, in combination with other chemotherapeutic agents
• monoblastic leukaemia (AML M5) and acute myelomonoblastic leukaemia (AML M4) when standard therapy has failed (in combination with other chemotherapeutic agents).

Solution for injection

25mg/ml – 2500mg/100ml

50mg/ml – 500mg/10ml, 1000mg/20ml, 2500mg/50ml, 500mg/100ml

Fluorouracil Injection, 25mg/ml and 50 mg/ml solution for injection, may be used alone or in combination, for its palliative action in the management of common malignancies particularly cancer of the colon and breast, either as single agent or in combination with other cytotoxic agents.

Powder for solution for infusion 38 mg/ml. 200mg, 1000mg, 1500mg 

Gemcitabine is indicated for the treatment of locally advanced or metastatic bladder cancer in combination with cisplatin.

Gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas.  

Gemcitabine, in combination with cisplatin is indicated as first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Gemcitabine monotherapy can be considered in elderly patients or those with performance status 2.

Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, first-line therapy. 

Gemcitabine, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated.

Solution for infusion 40mg/2ml, 100mg/5ml, 300mg/15ml

Irinotecan medac is indicated for the treatment of patients with advanced colorectal cancer

• as a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen.
• in combination with 5-fluorouracil and folinic acid in patients without prior chemotherapy for advanced disease.

Irinotecan medac in combination with cetuximab is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer after failure of irinotecan-including cytotoxic therapy.

Irinotecan medac in combination with 5-fluorouracil, folinic acid and bevacizumab is indicated for first-line treatment of patients with metastatic carcinoma of the colon or rectum.

Solution for infusion 50mg, 100mg, 200mg

Oxaliplatin medac is used in combination with 5-fluorouracil (5-FU) and folinic acid (FA) for:

• adjuvant treatment of stage III (Dukes’ C) colon carcinoma after complete removal of the primary tumour,
• the treatment of metastasising colorectal carcinoma.

Solution for  infusion 30mg/5ml, 100mg/16.7ml, 300mg/50ml

Ovarian carcinoma

For first-line treatment of carcinoma of the ovary, paclitaxel is indicated in combination with cisplatin in patients with advanced disease or a residual tumour (> 1 cm) following laparotomy.

For second-line treatment of carcinoma of the ovary, paclitaxel is indicated for treatment of metastatic carcinoma of the ovary after failure of standard therapy with platinum-containing preparations.

Breast carcinoma

As adjuvant treatment paclitaxel is indicated in treatment of node-positive breast carcinoma after anthracycline and cyclophosphamide (AC) treatment. Adjuvant treatment with paclitaxel should be considered as an alternative to prolonged AC treatment.

Paclitaxel is indicated as initial treatment of locally advanced or metastatic breast carcinoma either in combination with anthracycline in patients in whom anthracycline treatment is suitable or in combination with trastuzumab, in patients who over-express HER-2 at a level of 3+ as determined by immunohistochemistry methods and to patients in whom anthracycline treatment is not suitable (see sections 4.4 and 5.1).

Paclitaxel is indicated as a single agent for treatment of metastatic breast carcinoma in patients in whom standard anthracycline therapy has failed or in whom anthracycline therapy is not suitable.

Advanced non-small-cell lung carcinoma

Paclitaxel, in combination with cisplatin, is indicated for treatment of non-small-cell lung carcinoma (NSCLC) in patients who are not candidates for potentially curative surgery and/or radiotherapy.

AIDS-related Kaposi’s sarcoma

Paclitaxel is indicated for the treatment of patients with advanced AIDS-related Kaposi´s sarcoma (KS) who have failed prior liposomal anthracycline therapy.

Solution for injection 15mg/5ml, 30mg/10ml, 60mg/20ml, 90mg/30ml

Treatment of conditions associated with increased osteoclast activity:

• Tumour-induced hypercalcaemia
• Osteolytic lesions in patients with bone metastases associated with breast cancer
• Multiple myeloma stage III

Capsules 5mg, 20mg, 100mg, 140mg, 180mg, 250mg

Temomedac (temozolomide) capsules is indicated for the treatment of:

• adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
• children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

Solution for infusion 1mg/1ml, 4mg/4ml

Topotecan monotherapy is indicated for the treatment of:

• patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.
• patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.
• Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.