Medicines go through an assessment and approval process before they can be supplied in
New Zealand. This is to ensure that the medicines supplied meet the required standards of
quality and are safe and effective. These are known as approved medicines.
Sometimes your healthcare professional (prescriber) may need to use an unapproved medicine or an approved medicine in a new way.
If this is the case, the prescriber must explain to you what is being prescribed and why, and
you must give your consent if you agree. This is required under the Code of Health and
Disability Services Consumers' Rights.
If you agree to be given an unapproved medicine (sometimes called a section 29 medicine),
information about the supply must be held by the manufacturer or importer, and a subset of this sent to Medsafe, Ministry of Health. Your prescriber will tell you about this.
Section 29 medicines are manufactured, compounded or imported by a pharmacist in a pharmacy.
The intravenous infusion you are receiving today is an elective service, and further research is needed to confirm its effectiveness for medical purposes. The LAB and its clinicians have informed you about the potential side effects, which are rare but can be serious, such as
Anaphylaxis—a severe allergic reaction to the infused drug. Although this is uncommon, it’s important to recognize
the symptoms, which include difficulty breathing, swelling of the lips or mouth, and the formation of a rash.
Common expected side effects include nausea, vomiting, dizziness or light-headedness, and hot flushes. If you experience any of these symptoms, please inform us immediately so we can adjust
your infusion accordingly.
Our clinician may request blood test results for screening purposes at the same time of your infusion or prior to your infusion. It is important you disclose your full medical conditions including history or
known allergy reactions.
By signing this consent form, you have been advised of the adverse effects of the infusions, have been provided information regarding the infusion, and have been advised of the purpose and procedure of the intravenous infusion.
