SPC changes
Decapeptyl SR
The summary of product characteristics for Decapeptyl SR (triptorelin)
11.25mg now includes an additional indication for endometriosis (Ipsen).
The dose for this indication is one intramuscular injection administered
every three months. The treatment must be initiated in the first five
days of the menstrual cycle. The maximum duration of treatment should
be six months (two injections). The SPC also advises that non-hormonal
contraception should be used throughout treatment and for three months
after the last injection. The SPC now states that Decapeptyl SR should
be used with caution in women with known metabolic bone disease. See
SPC.
Nuvelle Continuous
The summary of product characteristics for Nuvelle Continuous (estradiol
[as hemihydrate] and norethisterone acetate) has been updated (Schering
Health Care). Its shelf-life is now 36 months and it is now presented
only in packs of 3 x 28 tablets. See SPC.
Sustiva
The summaries of product characteristics for Sustiva (efavirenz) hard
capsules, oral solution and 600mg tablets have been updated (Bristol-Myers
Squibb). They now warn that in HIV-infected patients with severe immune
deficiency at the time of initiation of combination antiretroviral
therapy, an inflammatory reaction to asymptomatic or residual opportunistic
pathogens may arise. See SPCs.
Videx
The summaries of product characteristics for Videx (didanosine) tablets
and Videx EC capsules have been updated to include information concerning
immune reactivation syndrome and additional adverse events (Bristol-Myers
Squibb).
They now state that in HIV-infected patients with severe immune deficiency
at the time of institution of combination antiretroviral therapy, an
inflammatory reaction to asymptomatic or residual opportunistic pathogens
may arise and cause serious clinical conditions or aggravation of symptoms.
They also state that abnormal serum amylase, alkaline phosphatase and
creatine phosphokinase should be investigated. See SPCs.
Velosef
The summaries of product characteristics for Velosef capsules and syrup
have been updated (Bristol-Myers Squibb). The contraindication in patients
suffering from porphyria has been removed. See SPCs.
Back to Top
|
The
Pharmaceutical Journal