BOTOX® (Botulinum toxin type-A) IMPORTANT INFORMATION
BOTOX® Botulinum toxin type-A is a prescription only medicine that is injected into muscles only by physicians with appropriate qualifications, and expertise in the treatment and the use of the required equipment. BOTOX is approved in several therapeutics and aesthetics indications. Among the approved indications related to Skin, BOTOX is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines seen at maximum frown, crow’s feet lines seen at maximum smile and/or forehead lines seen at maximum eyebrow elevation when the severity of the facial lines has an important psychological impact in adult patients.
For full list of approved indications, please refer to the Summary of Product Characteristics
IMPORTANT SAFETY INFORMATION
The below information is only related to the aesthetics indications approved for BOTOX®, For more details, please refer to the
Summary of Product Characteristics
BOTOX® may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX®:
If you have any difficulty in breathing, swallowing, or speaking after receiving botox, contact your doctor immediately.
If you experience hives, swelling including swelling of the face or throat, wheezing, feeling faint and shortness of breath, contact your doctor immediately.
Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing.
BOTOX® dosing units are not the same as, or comparable to, any other botulinum toxin product.
There has not been a confirmed serious case of spread of toxin effect when BOTOX® has been used at the recommended dose to treat frown lines, crow’s feet lines, and/or forehead lines.
BOTOX® may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX®. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Serious and/or immediate allergic reactions have been reported. They include : itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.
Do not receive BOTOX® if you: are allergic to any of the ingredients in BOTOX® (see
Package Information Leaflet for ingredients); had an allergic reaction to any other botulinum toxin product.
Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX®.
Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; have trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX can harm your unborn baby); are breast-feeding or plan to (it is not known if BOTOX® passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® in the past.
Tell your doctor if you have received any other botulinum toxin product in the last 4 months (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.
Other side effects of BOTOX® include: dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids and eyebrows, swelling of your eyelids and dry eyes.
For more information refer to the
Package Information Leaflet or talk with your doctor.
To report a Side Effect or Adverse Event please contact PV.MEA@abbvie.com
JUVÉDERM® COLLECTION OF FILLERS IMPORTANT INFORMATION
All products are with lidocaine which is meant to reduce the patient’s pain during treatment.
Juvéderm® VOLUX™ is an injectable implant intended to restore and create volume of the face.
Juvéderm® VOLUMA® with Lidocaine is an injectable implant intended to restore volume of the face.
Juvéderm® VOLBELLA® with Lidocaine is an injectable implant used for the treatment of any fine lines and medium-sized skin depressions due to conditions such as premature aging. Juvéderm® VOLBELLA® with Lidocaine can also be used for enhancement and pouting of the lips to correct structural defects such as asymmetry, contour deformities, volume loss... Juvéderm® VOLBELLA® with Lidocaine is intended to be used via superficial or mid-dermis injection or lips mucosa injection by an authorized medical practitioner.
Juvéderm® VOLIFT® with Lidocaine is an injectable implant intended for the treatment of any deep skin depressions due to conditions such as premature aging. Juvéderm® VOLIFT® with Lidocaine can also be used for face contouring and volume restoration to correct facial structural defects such as asymmetry, contour deformities, volume loss in the lips, cheeks, chin, lower face. Juvéderm® VOLIFT® with Lidocaine is intended to be used via deep dermis or lips mucosa injection by an authorized medical practitioner.
Juvéderm® VOLITE™ is an injectable implant used for the treatment, by filling, of superficial cutaneous depressions such as fine lines and for additional improvement of skin quality attributes such as hydration and elasticity. Juvéderm® VOLITE™ is intended for intra-dermal injection by an authorized medical practitioner in accordance with local applicable regulation.
Juvéderm® ULTRA 3 is an injectable implant used for filling mid and/or deep depressions of the skin via mid and/or deep dermis injection, as well as for lip definition and enhancement.
Juvéderm® ULTRA 4 is an injectable implant used for filling any deep depressions of the skin via deep dermis injection, as well as for lip enhancement and cheekbone augmentation.
IMPORTANT SAFETY INFORMATION
JUVÉDERM® has undergone extensive clinical testing. Your healthcare practitioner will ask about your medical history to determine if JUVÉDERM® products are appropriate for you.
Tell your healthcare practitioner if you have:
Severe allergies with a history of anaphylaxis, multiple severe allergies, allergies to hyaluronic acid or other filler products, or allergies to lidocaine or other local anesthetics.
A history of autoimmune disease, recurrent sore throats, rheumatic fever, epilepsy, or porphyria.
The following are important treatment considerations for you to discuss with your healthcare practitioner before treatment to help avoid unsatisfactory results and complications:
You are currently taking medications which prolong bleeding, such as acetylsalicylic acid (aspirin), non-steroidal anti-inflammatory drugs or anticoagulants – as with any injection, you may experience prolonged bleeding. You should inform your healthcare practitioner about any medications you are currently taking.
You have recently had other skin surface treatments (such as laser treatment, skin peels or dermabrasion) or have previously used fillers.
You have skin infections or inflammation such as acne or cold sores.
You scar frequently.
You are pregnant or breastfeeding, or you are under the age of 18 years (under 21 years if treating the lips), as the safety of JUVÉDERM® products has not been established for that age.
Potential side effects associated with JUVÉDERM® products include temporary injection-site reactions such as redness, swelling, itching, pain, firmness, bumps, bruising, and discoloration. These reactions may occur immediately or may be delayed and may last for up to a week. Injections in the lips may cause more swelling and bruising due to the unique physiology of this area. As with any injection, there is a risk of infection. This is not a complete list of side effects. If inflammatory reactions persist for more than one week, or if any other side effects develop, seek medical attention as soon as possible.
For more information, check the Directions for Use for the related brand, visit juvederm-mena or talk to your healthcare provider. To report a side effect with any JUVÉDERM® product, please contact ProductSurveillance_EAME@abbvie.com
Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.
COOLSCULPTING®
The CoolSculpting® System, also labeled as the ZELTIQ® System or the ZELTIQ® Breeze System (system), is a non-invasive cooling and heating device that applies controlled cooling or heating to a treatment site on the patient’s skin.
Uses of the system in cooling mode include: Fat layer reduction through cold-assisted lipolysis. Minimizing pain and thermal injury during laser and dermatological treatments. Acting as a local anesthetic for procedures that induce minor local discomfort.
The system can also provide localized thermal therapy (hot or cold) to minimize pain for post-traumatic and/or post-surgical pain and to temporarily relieve minor aches and pains and muscle spasms.
The optional massage function can also be used for temporary: Relief of minor muscle aches, pain, and spasm. Improvement in local circulation. Reduction in the appearance of cellulite.
IMPORTANT SAFETY INFORMATION
These procedures are not for everyone. You should not be treated with CoolSculpting® if you suffer from cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
Tell your doctor if you have any medical conditions including recent surgery, pre-existing hernia, and any known sensitivities or allergies.
During the procedure you may experience sensations of pulling, tugging, mild pinching, intense cold, tingling, stinging, aching, and cramping at the treatment site. These sensations subside as the area becomes numb.
Following the procedure, typical side effects include temporary redness, swelling, blanching, bruising, firmness, tingling, stinging, tenderness, cramping, aching, itching, or skin sensitivity, and sensation of fullness in the back of the throat after submental or submandibular area treatment.
The CoolSculpting® procedure is not for everyone. You should not have the CoolSculpting® procedure if you suffer from cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
Tell your doctor if you have any medical conditions including recent surgery, pre-existing hernia, and any known sensitivities or allergies.
Rare side effects may also occur. These rare and very rare adverse events have the following incidence rates (approximate occurrences per number of treatments): paradoxical hyperplasia (1/3000 [0.033%]); late-onset pain (1/6000 [0.017%]); severe pain (1/6000 [0.017%]); hyperpigmentation (1/11000 [0.009%]); freeze burn (1/15000 [0.006%]); treatment area demarcation (1/20000 [0.005%]); vasovagal symptoms (1/30000 [0.003%]); subcutaneous induration (1/30000 [0.003%]); cold panniculitis (1/60000 [0.002%]) and hernia (1/185000 [0.001%]).1,2
CoolSculpting® may cause a visible enlargement in the treated area, which may develop 2 to 5 months after treatment and requires surgical intervention for correction.
The CoolSculpting® procedure is not a treatment for obesity.3 CoolSculpting® is not a weight-loss procedure and should not replace a healthy diet and active lifestyle.
The suitability of CoolSculpting® treatment on an individual patient basis should always be considered as part of the assessment and consultation process. CoolSculpting® is not suitable for all patients. Please see CoolSculpting® full Important Safety Information for additional information and prior to the procedure. Patient results may vary.
To learn more about CoolSculpting® please visit www.coolsculpting-mena.com for further information. Images are for illustrative purposes only. Registration of the website may vary between the MENA countries. Adverse events should be reported to your local regulatory authority and Allergan Aesthetics office.
PLSProductSurveillanceteam@abbvie.com
1. Allergan Inc. CoolSculpting® system user manual. BRZ-101-TUM-EN4-K. August 2020.
2. Allergan Inc. CoolSculpting® Important Safety Information (ISI) November 2021. Available at: https://www.coolsculpting.com/important-safety-information [Accessed
November 2021];
3. FDA 510(K) Summary Document. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/K172144.pdf [Accessed November 2021]
