SPC changes
AmBisome injection
The summary of product
characteristics for AmBisome (liposomal amphotericin) injection (Gilead
Sciences) has been updated. The shelf-life of the product has been extended
from 30 to 36 months. The special precautions section for unopened vials
now states: Do not store above 25C.
Tramadol injection
The summary of product characteristics for tramadol
hydrochloride 100mg/2ml (Sterwin Medicines) has been amended. The section
on posology and administration now indicates that the product should be
administered by the intravenous route only. The intramuscular route has
been excluded.
Novartis Pharmaceuticals
Novartis Pharmaceuticals has updated the summaries
of product characteristics for the following products:
• Estracombi (combination pack containing Estraderm
TTS 50 and Estragest [estradiol, norethisterone acetate] TTS) patches
• Estraderm (estradiol) MX patches
• Estraderm TTS patches
• Estrapak 50 (combination pack containing Estraderm
TTS 50 and norethisterone acetate tablets)
• Menorest (17b-estradiol) patches
Changes have been made to the special warnings and
precautions for use section with regard to the advice given to doctors
for managing patients on hormone replacement therapy. Patient information
leaflets have also been updated.
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