Dysport® is a prescription medicine containing Clostridium Botulinum Type A toxin complex for injection. It is used for the treatment of frown lines and excessive sweating. It should be administered only by trained medical professionals. Cautions: people with defective neuro-muscular transmission disorders, infection at site of injection, pregnancy and lactation. Possible side effects include headaches, pain, burning or redness at injection site, local muscle weakness including drooping eye lids, lack of feeling or nausea, or compensatory sweating in other skin areas. Talk to your specialist about the benefits/risks of this procedure. A charge applies. Dysport® treatment lasts about four months and after this time further courses of treatment may be necessary. Speak to your specialist about your own situation. Healthcare Logistics, Auckland. Distributed in NZ byHealthcare Logistics, 58 Richard Pearse Drive, Airport Oaks, Mangere 2022, NZ. Phone:1800 144 944 (AUS) 0800 174 104 (NZ) Fax: +61 (2) 9986 1699. Sponsor: Ipsen Pty Ltd,Level 2, Building 4, Brandon Office Park, 540 Springvale Road, Glen Waverley, Victoria3150 Australia. Distributed by Galderma Australia Pty Ltd for the glabellar lines andlateral canthal lines indications only. Dysport® is a trademark of Ipsen Pty Ltd. Galdermatrademark is owned by Galderma Holding S.A.
Xeomin ® (Incobotulinumtoxin A)The below mandatory information must accompany any use of the Xeomin name orbranding in consumer advertising. The below text cannot be edited or changed in any form. Anyadvertising conducted by the customer utilising the Xeomin name or branding must be consistentwith the approved Data Sheet available from www.medsafe.govt.nz and any applicable advertisingstandards/regulations. Merz does not take any responsibility if this text is altered in any way. Merzreserves the right to request changes or updates to these mandatories at any time.Xeomin is a purified botulinum toxin type A free from complexing proteins. It is used to improve thelook of upper facial lines including frown lines between the eyebrows (glabellar lines), wrinkles atthe side of eyes (crows feet) and horizontal forehead lines.Xeomin ® (Incobotulinumtoxin A) 50, 100 Units is a Prescription Medicine. Indications: In adults, forthe treatment of cervical dystonia; blepharospasm; spasticity of the upper limb; upper facial lines:glabellar frown lines, lateral periorbital lines (crow’s feet), horizontal forehead lines. Xeomin hasboth risks and benefits, consult your doctor if Xeomin is right for you. Further information on therisks and benefits of Xeomin can be found in the Consumer Medicine Information (CMI) availablefrom www.medsafe.govt.nz or by calling 0800 822 310. Use strictly as directed. If symptomscontinue or you have side effects, see your doctor, pharmacist or health care professional. Commonside effects include: Headaches; nausea; tenderness, swelling, redness, numbness or bruising of theskin; dry eye; heavy feeling of eyelid/eyebrow/forehead; face/brow not symmetrical, droppingeyelids/eyebrows. Serious Side effects are rare and include allergic reactions. Xeomin is an unfundedmedicine, prescription charge will apply. Normal doctor charges will still apply.Copyright © 2019. Pharmacy Retailing NZ Limited t/a Health Care Logistics (HCL). 58 Richard PearseDrive, Mangere, Auckland 2022 All rights reserved. Xeomin ® and Merz Aesthetics are registeredtrademarks of Merz Pharma GMbH & Co. KGaA
Please read the Consumer Medicines Information for further detailsat www.medsafe.govt.nz
JUVEDERM ULTRA®, JUVEDERM ULTRA PLUS® injectable gels are Prescription Medicines containing 24 mg/mL cross-linked hyaluronic acid. They are used for the filling of medium size and deep facial wrinkles by injection into the skin and for creating definition and volume in the lips. They should be administered only by trained medical professionals. Talk to your specialist about the benefits/risks of this procedure in appearance medicine. Cautions: Use in an area that has been treated with another dermal filler. People with autoimmune disease; or who are pregnant, breastfeeding, age under 18; or have an increased susceptibility to keloid formation and hypertrophic scarring. Possible Side Effects: Injection site inflammatory reactions (redness/swelling /itching/pain on pressure); induration or nodules; discolouration; weak filling effect. If you have any side effects or concerns speak to your doctor.
JUVÉDERM® Injectable Gel Fillers Important Information
JUVÉDERM® VOLUMA™ XC injectable gel is for deep injection in the cheek area to correct age-related volume loss and for augmentation of the chin region to improve the chin profile in adults over 21.
JUVÉDERM® VOLLURE™ XC and JUVÉDERM® XC injectable gels are for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. JUVÉDERM® VOLLURE™ XC injectable gel is for adults over 21.
JUVÉDERM® VOLBELLA™ XC injectable gel is for injection into the lips for lip augmentation and for correction of perioral lines in adults over 21.
JUVÉDERM® Ultra XC injectable gel is for injection into the lips and perioral area for lip augmentation in adults over 21.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive any JUVÉDERM® formulation?
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products.
What precautions should my doctor advise me about?
- Minimize strenuous exercise and exposure to extensive sun or heat within the first 24 hours following treatment. Exposure to any of these may cause temporary redness, swelling, and/or itching at the injection site
- Tell your doctor if you are pregnant or breastfeeding. The safety of these products for use during pregnancy or while breastfeeding has not been studied
- The safety of JUVÉDERM® VOLUMA™ XC has not been studied in patients under 35 years or over 65 years for cheek augmentation, or under 22 years and over 80 years for chin augmentation. The safety of JUVÉDERM® VOLLURE™ XC and JUVÉDERM® VOLBELLA™ XC has not been studied in patients under 22 years, and the safety of JUVÉDERM® XC and JUVÉDERM® Ultra XC has not been studied in patients under 18 years
- The safety and effectiveness of JUVÉDERM VOLUMA® XC in areas other than the cheek area, JUVÉDERM® XC and JUVÉDERM VOLLURE™ XC for areas other than facial wrinkles and folds, and JUVÉDERM® Ultra XC and JUVÉDERM VOLBELLA® XC in areas other than the lips and perioral area have not been established in clinical studies
- JUVÉDERM® VOLUMA™ XC is intended for use in the chin and cheek areas. JUVÉDERM® VOLLURE™ XC and JUVÉDERM® XC are intended for use in facial wrinkles and folds. JUVÉDERM® VOLBELLA™ XC and JUVÉDERM® Ultra XC are intended for use in the lips and perioral area. The safety and effectiveness for treatment in other areas have not been established in clinical studies
- Tell your doctor if you have a history of excessive scarring (thick, hard scars) or pigmentation disorders. The safety of JUVÉDERM® products has not been studied in these patients and may result in additional scars or changes in pigmentation
- Tell your doctor if you are on therapy used to decrease the body’s immune response (immunosuppressive therapy). Use may result in an increased risk of infection
- Tell your doctor before treatment if you are using substances that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners. As with any injection, this may result in increased bruising or bleeding at the injection site
- Patients who experience skin injury near the site of injection may be at a higher risk for adverse events
- JUVÉDERM® VOLUMA™ XC was not studied in patients with significant loose skin of the chin, neck, or jaw
- The effect of JUVÉDERM® VOLUMA™ XC injection into the chin on facial hair growth has not been studied
What are possible side effects?
The most commonly reported side effects with JUVÉDERM® injectable gels included redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA™ XC, dryness was also reported. For JUVÉDERM® VOLUMA™ XC, most side effects resolved within 2 to 4 weeks. For JUVÉDERM® VOLLURE™ XC, JUVÉDERM® XC, and JUVÉDERM® Ultra XC injectable gels, most resolved within 14 days or less. For JUVÉDERM® VOLBELLA™ XC, most resolved within 30 days or less. These side effects are consistent with other facial injection procedures.
Most side effects will resolve with time. Your doctor may choose to treat side effects persisting over 30 days with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid).
One of the risks with these products is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin.
As with all skin injection procedures, there is a risk of infection.
Visit Juvederm.com or talk to your doctor for more information. To report a side effect with any JUVÉDERM® product, please call Allergan at 1-800-433-8871.
Note: Juvederm® treatment lasts from about 12-24 months.
Allergan New Zealand Ltd. PO Box 1873 Auckland 1140, New Zealand
Restylane® Kysse is a sterile, biodegradable, viscoelastic, non-pyrogenic, clear, colorless, flexible
and homogeneous gel composed of hyaluronic acid of bacterial origin, with a moderate lifting
capacity. Restylane® Kysse is crosslinked with BDDE (1,4-butanediol diglycidylether). The product
has a sodium hyaluronate concentration of 20 mg/mL in phosphate buffered saline at pH 7 and
contains 3 mg/mL lidocaine hydrochloride.
2 INTENDED USE/INDICATIONS
Restylane® Kysse is indicated for injection into the lips for lip augmentation and the correction of
upper perioral rhytids in patients over the age of 21.
• Restylane® Kysse is contraindicated for patients with severe allergies such as manifested by a
history of anaphylaxis or history or presence of multiple severe allergies.
• Restylane® Kysse may contain trace amounts of gram-positive bacterial proteins and is
contraindicated for patients with a history of allergies to such material.
• Restylane® Kysse contains lidocaine and is contraindicated for patients with a history of allergies
to such material or other amide type anesthetics.
• Introduction of Restylane® Kysse into the vasculature may lead to embolization, occlusion of the
vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers, for example
inject the product slowly and apply the least amount of pressure necessary. Rare but serious
adverse events associated with the intravascular injection of soft tissue fillers in the face have
been reported and include temporary or permanent vision impairment, blindness, cerebral
ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying
facial structures. Immediately stop the injection if a patient exhibits any of the following
symptoms, including changes in vision, signs of a stroke, blanching of the skin or unusual pain
during or shortly after the procedure. Patients should receive prompt medical attention and
possibly evaluation by an appropriate health care professional specialist should an intravascular
injection occur (see Health Care Professional Instructions).
• Defer use of Restylane® Kysse at specific sites in which an active inflammatory process (skin
eruptions such as cysts, pimples, rashes, or hives) or infection is present until the process has
• Restylane® Kysse must not be implanted into blood vessels and should not be used in vascular
rich areas. Localized superficial necrosis and scarring may occur after injection in or near
vessels, such as in the lips. It is thought to result from the injury, obstruction, or compromise of
blood vessels. Special caution should be taken if the patient has undergone a prior surgical
procedure in the planned treatment area.
• Delayed onset inflammatory papules have been reported following the use of dermal fillers.
Inflammatory papules should be considered and treated as a soft tissue infection. For additional
information please see Adverse Events section.
• Restylane® Kysse is packaged for single-patient use. Do not resterilize. Do not use if package is
open or damaged.
• Restylane® Kysse is to be used as supplied. Modification or use of the product outside the
Directions for Use may adversely impact the sterility, homogeneity, and performance of the
• In order to minimize the risks of potential complications, this product should only be used by
health care professionals who have appropriate training, experience, and who are knowledgeable
about the anatomy at and around the site of injection.
• Health care professionals are encouraged to discuss all potential risks of soft tissue injection with
their patients prior to treatment and ensure that patients are aware of signs and symptoms of
• The recommended maximum injected volume per subject and treatment is 6 mL (i.e., 3 mL for
lips and 3 mL for perioral area).
• As with all transcutaneous procedures, dermal filler implantation carries a risk of infection.
Standard precautions associated with injectable materials should be followed.
• Avoid injecting Restylane® Kysse into areas in close proximity to permanent implants, as this
could potentially aggravate latent adverse events or interfere with the aesthetic outcome of the
treatment. Limited data is available on injecting Restylane® Kysse into an area where an implant
other than hyaluronic acid has been placed.
• Post inflammatory pigmentation changes may occur after dermal filler injections in people with
dark skin (Fitzpatrick Type IV-VI).
• Injections of Restylane® Kysse into patients with a history of previous herpetic eruption may be
associated with reactivation of the herpes.
• Restylane® Kysse should be used with caution in patients on immunosuppressive therapy.
• Restylane® Kysse should be used with caution in patients with bleeding disorders.
• Patients who are using substances that can prolong bleeding (such as aspirin, nonsteroidal
anti-inflammatory drugs, and warfarin) may, as with any injection, experience increased bruising
or bleeding at treatment sites.
• The safety of Restylane® Kysse with concomitant dermal therapies such as epilation, UV
irradiation, or laser, mechanical or chemical peeling procedures has not been evaluated in
controlled clinical trials. If laser treatment, chemical peeling or any other procedure based on
active dermal response is considered after treatment with Restylane® Kysse, there is a possible
risk of eliciting an inflammatory reaction at the implant site. This also applies if Restylane®
Kysse is administered before the skin has healed completely after such a procedure.
• Patients should minimize exposure of the treated area to excessive sun, UV lamp exposure and
extreme cold weather at least until any initial swelling and redness has resolved.
• The safety of Restylane® Kysse for use during pregnancy, in breastfeeding females or in patients
under 22 years has not been established.
• Individual variation and treatment area may affect the bio-degradation of Restylane® Kysse,
product remnants may remain in the tissue even when the clinical effect has returned to baseline.
• Failure to comply with the needle attachment instructions could result in needle disengagement
and/or product leakage at the Luer lock and needle hub connection.
• After use, treatment syringes and needles may be potential biohazards. Handle and dispose of
these items in accordance with accepted medical practice and applicable local, state, and federal
• Restylane ®Kysse injectable gel is a clear, colorless gel without particulates. In the event that the
content of a syringe shows signs of separation and/or appears cloudy, do not use the syringe.
• Restylane® Kysse should not be mixed with other products before implantation of the device.
• Considerations should be given to the total dose of lidocaine administered if dental block or
topical administration of lidocaine is used concurrently. High doses of lidocaine (more than 400
mg) can cause acute toxic reactions manifesting as symptoms affecting the central nervous
system and cardiac conduction.
• Lidocaine should be used with caution in subjects receiving agents structurally related to amidetype anesthetics, e.g. certain anti-arrhythmics, since the systemic toxic effects can be additive.
• Lidocaine should be used with caution in patients with epilepsy, impaired cardiac conduction,
severely impaired hepatic function or severe renal dysfunction.