SPC Changes
Plavix new indication
The licensed indications for Plavix (clopidogrel) have been extended (Sanofi-Synthelabo).
Plavix is additionally indicated for the prevention of atherothrombotic
events in patients suffering from non-ST segment elevation acute coronary
syndrome (unstable angina or non Q-wave myocardial infarction) in combination
with aspirin. In these patients treatment should be initiated with a single
300mg loading dose and then continued at 75mg once a day (with aspirin
75–325mg daily). Clinical trial data support use up to 12 months,
and the maximum benefit was seen at three months. The special warnings
and precautions section states that blood count determination and/or other
appropriate testing should be promptly considered whenever clinical symptoms
suggestive of bleeding arise during treatment. Information from the CURE
study has been added to the undesirable effects and the pharmacodynamics
properties sections. See SPC.
Dovobet ointment
The summary of product characteristics for Dovobet (calcipotriol) ointment
has been updated (Leo Pharmaceuticals). It now states that Dovobet ointment
should be applied to the affected area once daily. See SPC.
Begrivac influenza vaccine
The summary of product characteristics for Begrivac (suspension of formaldehyde-inactivated
influenza virus) vaccine has been updated to include the following viral
strain for this season (Wyeth Pharmaceuticals): B/Hong Kong/330/2001-like
strain (B/Shangdong/7/97).
CellCept range
The interactions section of the summary of product characteristics for
CellCept (mycophenolate mofetil) capsules, tablets, oral suspension and
solution for infusion now includes additional information regarding an
interaction between mycophenolate mofetil and ciclosporin A (Roche Products).
See SPC.
Cymevene capsules
The summary of product characteristics for Cymevene (ganciclovir) capsules
has been updated (Roche Products). The shelf-life has been extended from
three to four years. The special precautions for storage section now states:
“No special precautions.” See SPC.
Eucardic tablets
The summary of product characteristics for Eucardic (carvedilol) tablets
has been revised (Roche Products). Eucardic is contraindicated in patients
with second and third degree AV heart block unless a permanent pacemaker
is in place. Information on catecholamine depletion and ciclosporin concentrations
has been added to the interactions section. Breast-feeding is not recommended
during administration of carvedilol. The following have been added to
the undesirable effects section for the indication of chronic heart failure:
leucopenia has been reported in isolated cases; hypoglycaemia and worsening
of blood glucose control in patients with pre-existing diabetes mellitus;
headache, asthenia (including fatigue); syncope (including presyncope);
dermatitis and increased sweating. For the indications of hypertension
and angina, the following have been added: asthenia; PVD; angina pectoris
(including chest pain); dermatitis; increased sweating and isolated cases
of allergic reactions have been reported. See SPC.
Zenapax infusion
The summary of product characteristics for Zenapax (daclizumab) infusion
has been updated to include paediatric prescribing information (Roche
Products). The following adverse events occurred more frequently in paediatric
patients than in adults: diarrhoea, postoperative pain, fever, vomiting,
hypertension, pruritus and infections of the upper respiratory tract and
urinary tract. See SPC.
|
