Fillable Information sheet for prednisolone sodium phosphate oral liquid (Pharmaceutical Management Agency)

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Information sheet for prednisolone sodium phosphate oral liquid (Pharmaceutical Management Agency)

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Country of origin: NEW-ZEALAND
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1
Information sheet for prednisolone sodium phosphate oral liquid
(Redipred)
With the withdrawal of the GSK’s brand of betamethasone (Betnesol) 0.5mg dispersible tablet
from the market, an alternative oral corticosteroid is available for patients over 12 years of
age, prednisolone sodium phosphate (Redipred) oral liquid, 5mg per ml, 30ml. As this product
does not have an indication for use as a mouthwash for oropharyngeal lesions, it is only available
pursuant to Section 29 of the Medicines Act for patients where there is no suitable alternative,
and it cannot currently be funded through the Pharmaceutical Schedule.
The Named Patient Pharmaceutical Assessment (NPPA) Policy provides a mechanism for individual
patients to receive funding consideration for medicines not listed in the Pharmaceutical Schedule
(either at all or for their clinical circumstances). However, NPPA funding would not generally be
available to those who do not meet the NPPA Policy principles.
PHARMAC has the discretion to consider applications to fund pharmaceuticals outside of the NPPA
Policy and PHARMAC has decided to allow patient specific applications for the funding of Redipred
for a small number of patients with certain disorders affecting the oral mucosa, who need to be
treated with an oral corticosteroid.
Applications on the following form are to be made by a relevant specialist.
Approvals will generally be granted for a fixed period of one year.
2
Application form for
prednisolone sodium
phosphate oral liquid
Application (check boxes where appropriate)
Patient has oropharyngeal lesions
Other (please describe)
Medicine and Dosage detail
s
Brand: Redipred
Form: Oral liquid
Strength: 5mg per ml
Pharmacode: 317659
Dosage required:
Nominated pharmacy
Where will supplies be obtained if approval of this treatment is granted?
Name:
DHB:
Address:
Phone:
Patient Details
Details of Applying Practitioner
Last name:
Last name:
First Name:
First name:
Address:
Address:
Gender: Phone:
Date of Birth:
Facsimile: NZMC#:
NHI No:
Email address:
NPPA Coordinator
PHARMAC
PO Box 10-254
WELLINGTON
Phone: 0800 660 050, option 2
Fax: 09 523 6870
Email: nppa@pharmac.govt.nz
3
Signature of Medical Practitioner: ____________________________________
Date of Request: __________________________________________________
Prednisolone sodium phosphate is not approved by Medsafe as an oral mouthwash
Patient consent has been obtained for the use of a medicine being obtained under Section 29 and used
for a non-registered indication.
Information about the use of unapproved medicines and the obligations of the prescriber for use of an
unapproved medicine can be found on the Medsafe website:
https://www.medsafe.govt.nz/profs/RIss/unapp.asp
Applicant is aware of unapproved regulatory status of Prednisolone sodium phosphate and has met the
requirements of the Medicines Act 1981 in regard to prescribing Prednisolone sodium phosphate for this
patient, including patient (or legal guardian) consent.
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Information sheet for prednisolone sodium phosphate oral liquid (Pharmaceutical Management Agency)

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Completed 11 November 2020

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