Section 3 : Deletion of - freeze dried powder in a glass vial for reconstitution and administration by infusion, injection or instillation.
Section 4.3 : Addition of - Patients who have previously had a hypersensitivity or idiosyncratic reaction to bleomycin
Section 4.4 : Addition of - High oxygen concentrations should be used with caution in these cases - at end of first paragraph.
Addition of - When Bleomycin has been administered pre-operatively, reduced oxygen concentrations should be used during operation and post operatively.
Addition of – Patients treated previously or concurrently with radiation to the chest may develop more frequent or severe toxicity.
Addition of – Bleomycin should be used with caution in patients with significant renal impairment as clearance may be reduced and toxicity increased
(see Section 4.2 “Posology and Method of Administration”
Addition of – Bleomycin should be used with caution in patients with severe heart disease.
Section 4.5 Addition of – The following clinical incompatibilities have been noted:- Cytotoxics possibly reduce the absorption of phenytoin. Concommitant use of bleomycin with clozapine should be avoided due to an increased risk of agranulocytosis.
Section 4.8 Addition of – The most frequently observed adverse reactions in 1613 patients receiving bleomycin were pulmonary manifestations such as interstitial pneumonia or pulmonary fibrosis (10.2%), sclerosis of skin, pigmentation (40.6%), fever and rigors (39.8%), alopecia (29.5%), anorexia and weight decrease (28.7%), general malaise (16.0%), nausea and vomiting (14.6%), stomatitis (13.3%) and nail changes (11.2%).
Haematologic:
Common Haemorrhage
Uncommon Leukopenia
Nervous:
Common Headache
Uncommon Dizziness
Respiratory:
Very common Interstitial pneumonia and pulmonary fibrosis
Gastrointestinal:
Very common Anorexia, weight decrease, nausea and vomiting and stomatitis
Common Angular stomatitis
Uncommon Diarrhoea
Hepatic:
Uncommon Hepatic disturbances
Skin:
Very common Hypertrophy of the skin, pigmentation, alopecia and deformation and discolouration of the nail
Common Rash, urticaria and erythroderma associated with fever
Renal and Urinary:
Uncommon Oligurea, micturition pain, polyuria and feeling of residual urine
General Disorders and Administration Site Conditions:
Very common Fever, rigors and malaise
Uncommon Pain at the tumour site
Hypertrophy of the venous wall and narrowing of the venous lumen when given by intravenous injection
Induration when given by intramuscular or local injection
Addition of - During postmarketing surveillance the following events have been reported: sepsis, pancytopenia, thrombocytopenia, anaemia, neutropenia, chest pain, myocardial infarction, Raynaud’s syndrome, embolism, thrombosis and digital ischaemia.
Section 5 Addition of – ATC code: LO1D C01, other cytotoxic antibiotics
Section 5.3 Added - 5.3 Preclinical safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.
Section 9 Changed to 03/07/2006
Section 10 Changed to 03/07/2006
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