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The Pharmaceutical Journal Vol 264 No 7088 p450
March 18, 2000 Products

Prescription products

Thiotepa SPC changes

Wyeth has revised the summary of product characteristics for Thiotepa 15mg injection. The contraindication section has been extended to include "patients with a known hypersensitivity to this preparation". A warning about possible carcinogenicity has been added to the special warnings and precautions section. Also, under this section, advice to monitor white blood cells and platelet levels has been added, as well as a caution in patients with existing hepatic, renal and bone marrow damage. The following statement has been added to the undesirable effects section: "Death from septicaemia and haemorrhage has occurred as a direct consequence of haematopoietic suppression. There have been fatal cases of bone marrow depression from systemically absorbed drug following intravesical administration". Other side effects added to this section are: fatigue, weakness, allergic reactions, contact dermatitis, abdominal pain, dizziness, blurred vision, conjunctivitis, amenorrhoea and interference with spermatogenesis. The statement "Thiotepa may be removed using dialysis" has been added to the overdose section. Wyeth has also reworded some parts of the posology and methods of administration section in order to clarify the dosing instructions. The company says that none of the dosing schedules has been changed.