SPC changes
Cozaar-Comp
The summary of product characteristics for Cozaar-Comp (45.8mg losartan
and 12.5mg hydrochlorothiazide; Merck Sharp & Dohme) now includes
an additional indication for the treatment of hypertension in patients
with left ventricular hypertrophy. It states that there is no evidence
that losartan reduces the risk of stroke in black hypertensive patients
with left ventricular hypertrophy. See SPC.
Gliadel Implant
The summary of product characteristics for Gliadel Implant (carmustine;
Link Pharmaceuticals) 7.7mg now includes an additional indication in
newly diagnosed high grade malignant glioma as an adjunct to surgery
and radiotherapy. It is recommended that a maximum of eight implants
is placed if the size and shape of the resection cavity allows it.
The SPC also now includes adverse events relating to this indication.
See SPC.
Sinthrome
The summary of product characteristics for Sinthrome (acenocoumarol;
Alliance) has been updated to include additional interactions with
other medicinal products and other forms of interaction. See SPC.
Zevalin
The summary of product characteristics for Zevalin (ibritumomab tiuxetan;
Schering) now states that the shelf life of Zevalin is three years.
See SPC.
Back to Top
|
The
Pharmaceutical Journal