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The Ciproxin 250 mg/5 mL oral suspension is indicated for the treatment of the following infections (see sections 4.4 and 5.1). Special attention should be paid to available information on resistance to ciprofloxacin before commencing therapy. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Adults • Lower respiratory tract infections due to Gram-negative bacteria - exacerbation of chronic obstructive pulmonary disease. In exacerbation of chronic obstructive pulmonary disease Ciprofloxacin should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections. - broncho-pulmonary infections in cystic fibrosis or in bronchiectasis - pneumonia • Chronic suppurative otitis media • Acute exacerbation of chronic sinusitis especially if these are caused by Gram-negative bacteria • Urinary tract infections - Uncomplicated acute cystitis. In uncomplicated acute cystitis Ciprofloxacin should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections. - Acute pyelonephritis - Complicated urinary tract infections - Bacterial prostatitis • Genital tract infections - gonococcal uretritis and cervicitis due to susceptible Neisseria gonorrhoeae - epididymo-orchitis including cases due to susceptible Neisseria gonorrhoeae - pelvic inflammatory disease including cases due to susceptible Neisseria gonorrhoeae • Infections of the gastro-intestinal tract (e.g. travellers' diarrhoea) • Intra-abdominal infections • Infections of the skin and soft tissue caused by Gram-negative bacteria • Malignant external otitis • Infections of the bones and joints • Prophylaxis of invasive infections due to Neisseria meningitidis • Inhalation anthrax (post-exposure prophylaxis and curative treatment) Ciprofloxacin may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. Children and adolescents • Broncho-pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis • Complicated urinary tract infections and acute pyelonephritis • Inhalation anthrax (post-exposure prophylaxis and curative treatment) Ciprofloxacin may also be used to treat severe infections in children and adolescents when this is considered to be necessary. Treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents (see sections 4.4 and 5.1).

Hyaluronidase can be used to enhance permeation of subcutaneous or intramuscular injections, local anaesthetics and subcutaneous infusions and to promote resorption of excess fluids and blood in the tissues.

Takeda announced that the FDA has approved Gammagard Liquid[Immune Globulin Infusion (Human) 10% solution] as an intravenous immunoglobulin (IVIG) therapy to improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy (CIDP)

Sodium Chloride 0.45% Solution for Infusion is indicated for the treatment of hypertonic extracellular dehydration or hypovolaemia in cases where the intake of fluids and electrolytes by normal routes is not possible. It can also be used as a vehicle or diluent of compatible medicinal products.

Noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see section 5.1): - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy . Noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (GVHD) and who are at high risk of developing invasive fungal infections. Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis.

Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion is indicated for the treatment of patients with advanced colorectal cancer: • In combination with 5-fluorouracil and folinic acid in patients without prior chemotherapy for advanced disease, • As a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen. Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion in combination with cetuximab is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild- type metastatic colorectal cancer, who had not received prior treatment for metastatic disease or after failure of irinotecan-including cytotoxic therapy. (see section 5.1) Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion 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. Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion in combination with Capecitabine with or without bevacizumab is indicated for first – line treatment of patients with metastatic colorectal carcinoma.

Noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see section 5.1): - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy . Noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high-risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (GVHD) and who are at high-risk of developing invasive fungal infections. Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis.

Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency). Fabrazyme is indicated in adults, children and adolescents aged 8 years and older.

Treatment of clinical vitamin C deficiency states not amenable to dietary supply or oral replacement therapy. Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion is indicated in adults.

The product is used for rehydration only when diluted. Before administration, the concentrate must be diluted and thoroughly mixed with a larger volume of fluid.