Medical Mandates
Mandatory Statement
Botox®, Prescription Medicine
For the treatment of frown lines and crow’s feet round the eyes Botox® has risks and benefits. Ask your
doctor if Botox is right for you Botulinum toxin type A 50, 100, 200 Units. For product information check
with your doctor or Consumer Medicine Information on www.medsafe.govt.nz Click for further
details. Allergan, Auckland.
Juvederm Ultra™ & Ultra Plus™, Medical Device. Class III For the filling of medium size and deep facial
wrinkles by injection into the skin. Juvederm™ has risks and benefits. Ask your doctor if Juvederm is
right for you Volume (mL) 0.8mL Volume (mL) 1.0m hyaluronic acid + lidocaine. For product information
check with your doctor or from product details with the supplier. Click for further details. Allergan,
Auckland.
Restylane®, Medical Device Class III to smooth facial wrinkles and enhance lips by restoring volume and
fullness. Restylane® has risk and benefits Ask your doctor if Restylane is right for you For product
information check with your doctor or from product details with the supplier. Click for further details.
Stabilised Hyaluronic Acid 20mg/Ml. Galderma, Australia, Sydney or distributor Healthcare Logistics,
Auckland.
Dysport®, Prescription Medicine For the treatment of frown lines and crow’s feet round the eyes.
Dysport® has risks and benefits. Ask your doctor if Dysport is right for you Botulinum toxin type A 300 or
500 Ipsen Units For product information check with your doctor or Consumer Medicine Information on
www.medsafe.govt.nz . Click for further details Galderma, Auckland.
Belotero® Medical Device Class III to smooth facial wrinkles and folds, correct facial atrophic scars,
restore or enhance the lips or restore facial volume Belotero has risk and benefits Ask your doctor if
Belotero is rightfor you For product information check with your doctor or from product details with the
supplier. Click for further details. Contains Sodium Hyaluronate Gel. Merz, Sydney. Distributed by
Healthcare Logistics, Auckland
Xeomin® (incobotulinum toxin ) Prescription Medicine for the treatment of upper facial lines: glabellar
frown lines, crow’s feet round the eyes, horizontal forehead lines Xeomin has risks and benefits. Ask your
doctor if Xeomin is right for you (incobotulinum toxin A, purified Botulinum toxin type A 50 Units
and 100 Units For product information check with your doctor or Consumer Medicine Information on
www.medsafe.govt.nz . Click for further details Merz, Sydney. Distributed by Healthcare Logistics,
Auckland
​
Profhilo® Medical Device Class III. For the redefinition and
laxity remodelling where skin laxity is a
problem. Profhilo has risks and benefits Contains low & high molecular weight hyaluronic acid (64mg /2ml)
As your doctor if Profhilo is right for you
For product information check with your doctor or from product
details with the supplier Accelagen Pty Ltd. Whanganui
BELOTERO® Revive is an injectable resorbable implant intended to treat early-signs of photodamaged
skin via rehydration of dry and very dry skin and smoothening of superficial fine lines. Belotero® Revive is
indicated for treatment of early signs of photodamaged facial skin, as characterised by dehydration and
presence of superficial fine lines. BELOTERO® Revive should not be used on patients: with known
hypersensitivity to any of the components; presenting with a general infection or an active auto-immune
disease; in an area with permanent dermal filler or inflamed/ infected skin due to immunological, allergic,
bacterial, fungal or viral causes; into blood vessels, glabellar or nose region; under 18 years of age; in
pregnancy or lactation; others. BELOTERO® Revive is precautioned in patients: with history of severe
multiple allergies or anaphylactic shock; prone to hypertrophic scars/keloids or streptococcal diseases;
with unhealed aesthetic treatments; on anti-coagulation, anti-platelet, or thromobolytic medications; with
epilepsy, impaired cardiac conditions, severely impaired hepatic function or severe renal dysfunction or
porphyria, others - see full Instructions for Use before prescribing for full safety information, available by
calling 0800 822 310 or https:// merzaustralia.com.au/products/.This medical device must be
administered by a Healthcare Professional.
SKINVIVE by JUVÉDERM® is not for people who have a history of severe allergic reactions or allergies
to any of its ingredients, including lidocaine. Tell your specialist if you have a history of scarring or taking
medicines that decrease the body's immune response or that can prolong bleeding Certain medicines and
procedures may increase the risk of infection, inflammation, bleeding, or bruising at the injection site.
Common side effects were lumps/bumps, swelling, redness, pain, itching, bruising, and discoloration.
Additionally, there have been reports outside of the US of inflammation, nodules, unsatisfactory result or
loss of/no improvement, allergic reaction, anxiety, blood vessel blockage, infection, dry skin,
increase/decrease in sensation, and abscess. There is a rare risk of unintentional injection into a blood
vessel with all dermal fillers which can cause vision abnormalities, blindness, stroke, temporary scabs, or
permanent scarring. Delayed-onset inflammation and infection at the injection site are events associated
with dermal filler injection. Talk to your licensed specialist and for additional information, including
Important Safety Information, visit www.skinvivebyjuvederm.com.
Mandatory Statement
SUNEKOS containing hyaluronic acid and amino acids is a class III medical device that modifies the
structure of mature skin, restoring volume, filling wrinkles and folds in the skin and in scar sites. Sunekos
has risks and benefits. Sunekos should not be used on patients: with known hypersensitivity to any of its
components; presenting with a general infection, inflammation or irritation in the area to be treated; or in
patients predisposed to coagulation disorders. A local reaction may rarely occur, caused by
hypersensitisation phenomena, with symptoms that include oedema and sensation of burning and/or
itching. These reactions normally resolve within two days. Consult your healthcare professional to see if
Sunekos is right for you. For more information refer to the instructions for use. New Zealand Sponsor:AA-
Med Pty LtdDistributed by:Xytide Biotech NZ Pty LTD
GENERIC MANDATORY
Toxin - Botulinum toxin injections are prescription medicines for the treatment of frown lines, horizontal
forehead lines and crow's feet around the eyes. Botulinum toxin injections have risks and benefits. Ask
your doctor if botulinum toxin injections are right for you. For further information ask your doctor or go to
www.medsafe.govt.nz.
Dermal Filler - Dermal filler injections are Medical devices for the treatment of loss of volume in the skin.
Dermal fillers have risks and benefits. Ask your doctor if dermal filler injections are is right for you. For
further information ask your doctor or go to www.medsafe.govt.nz