Cher e-medien,
La situation de retrait de medicaments pour le SIDA en Afirque du Sud est
resumee par le Newsletter de l'Association de Pharmacien sud Africain No.
119 ci-joint (Anglais).
En resume, nous pouvons dire que c'est Ranbaxy (SA) (Pty), apres
consultation avec Medicine Control Council (MCC), institution Sud Africain
responsable de l'enregistrement de medicament, qui avait volontairement
decide de retirer du marche Sud Africain ! ! tous ses
produits/HIV-AIDS-DRUGS enregistres par MCC-South Africa.(respect de la loi
! ! ! !).
Les autres generiques enregistres par MCC-SA et produits par d'autres
Compagnies sont substitues à la place de ceux de Ranbaxy et jusqu' à
present, il ne se pose pas encore le probleme de rupture de stock ou de
substitution.
Regards
Philippe S Longhe
Regulatory Affairs Pharmacist
Adcock Ingram Limited
Tel: +27 11 709 9375
Fax: +27 11 709 9339
Portable: +27 72 532 5541
e-mail: philippe.longhe@tigerbrands.com
Urgent Medicine Recall
Ranbaxy (SA) (Pty) Ltd in consultation with the Medicines Control Council
(MCC) is voluntarily recalling all batches of the following products
marketed by Thembalami Pharmaceuticals (Pty) Ltd:
Lamaid 150 tablets (lamivudine 150mg)
Nevran 200 tablets (nevirapine 200mg)
Zidaid 300 tablets (zidovudine 300mg)
Avocomb tablets (lamivudine 150mg + zidovudine 300mg)
Anomalies in data handling and non-compliance with Good Clinical and
Laboratory Practices have been confirmed by Ranbaxy Laboratories Limited,
India, hence the studies for these products can no longer be used as an
unequivocal proof of bio-equivalence. Work on new bio-equivalence studies
has been initiated, and the data will be submitted to the regulatory
authorities as soon as possible.
In view of the above, Ranbaxy believes that the responsible action is to
recall the products from the South African market. All batches of the
above-mentioned products must be returned either to your wholesaler (if
purchased through a wholesaler) or alternatively to Adcock Ingram Healthcare
(Pty) Ltd, Distribution Centre, Isando, for a credit with immediate effect.
Healthcare professionals are requested to contact all patients using these
products, to explain the situation to them, and to make alternative therapy
available as soon as possible. Patients are strongly urged to continue with
current therapy (although withdrawn) until an equivalent alternative can be
substituted. A fixed drug combination may be considered.
Particular attention should be given to patients who appear, on clinical
evaluation, not to have been responding to therapy. Patients should also
specifically be asked about possible adverse effects related to their
antiretroviral therapy. In addition, it may be necessary to review CD4
counts, viral loads and other markers of treatment progress. If viral
resistance to any of the components of the patient's antiretroviral therapy
is suspected, this should be investigated.
Suspected adverse drug reactions should be reported to the National Adverse
Drug Event Monitoring Centre (NADEMC). Telephone: 021-447 1618; Fax: 021-448
6181.
For further information or assistance, please call:
Ms Deloise Raubenheimer (Managing Director)
012-643 2008
Dr Thys Kruger (Medical Director)
012-643 2009
Mrs Susan Heritage (Regulatory & Quality Assurance Pharmacist) 012-643 2033
Cipralex 10 mg Tablets
Lundbeck has requested that members should be informed that the active
ingredient in Cipralex is escitalopram, for which there is no generic
equivalent. It is therefore inappropriate to substitute Cipralex with a
generic citalopram product.
Visit our website at www.pssa.org.za for more information.
Your Society, the PSSA, working for you!
U Vereniging, die AVSA, tot u diens!
Mokgatlo. PSSA, ho isa tshebeletsong ya hao!