Nuceiva 50 unidades polvo para soluciÓn inyectable

Label: information for the user

NUCEIVA 50 Units powder for injectable solution

type A botulinum toxin

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this label. See section 4.

NUCEIVA contains the active ingredient botulinum toxin type A.

It prevents muscle contraction, causing temporary paralysis. It acts by blocking nerve impulses to the muscles into which it has been injected.

NUCEIVA is used to temporarily improve the appearance of vertical wrinkles between the eyebrows. It is used in adults under 65 years of age in whom facial wrinkles have a significant psychological impact.

Do not use NUCEIVA:

• if you are allergic to botulinum toxin type A or to any of the other components of this medication (listed in section 6);
• if you have myasthenia gravis or Lambert-Eaton syndrome (chronic diseases that affect the muscles);
• if you have an infection or inflammation at the proposed injection sitesbetween the eyebrows and above them (as indicated in figure 1).

Warnings and precautions

Very rarely, adverse effects possibly related to the spread of botulinum toxin from the injection site (e.g., muscle weakness, difficulty swallowing, or entry of food or liquids into the respiratory tract) may occur. Patients receiving the recommended doses may experience excessive muscle weakness.

The injection has been associated with localized pain, inflammation/swelling, abnormal sensitivity (paresthesia), decreased sensitivity (hypoesthesia), tenderness to the touch, skin eruption (erythema), localized infection, hemorrhage, and/or hematomas. Pain and/or anxiety related to the needle have led to vasovagal responses, such as pallor, nausea, sweating, blurred vision, rapid heart rate, dizziness, and/or a temporary decrease in blood pressure that causes dizziness or fainting.

Visit your doctor immediatelyif you find it difficult to swallow, speak, or breathe after treatment.

• This medication is not recommended for patients who have had difficulty swallowing (dysphagia) and breathing recently or in the past, as it would prevent safe administration of the medication in the doctor's opinion.
• Administering the medication too frequently or in excess may cause the formation of antibodies. The formation of antibodies may prevent botulinum toxin type A from acting even for other uses.
• Very rarely, an allergic reaction may occur after injection of botulinum toxin.

Among the symptoms are skin reactions, such as urticaria, itching, and red or pale skin, swelling of the eyes, lips, mouth, or throat, weak and rapid pulse, dizziness, and wheezing or shortness of breath

• Eye drooping may occur after treatment.

Inform your doctor if:

• you have had problems with previous injections of botulinum toxin;
• you do not observe any significant improvement in wrinkles one month after the first treatment cycle;
• you have certain diseases that affect the nervous system (such as amyotrophic lateral sclerosis or motor neuropathy);
• there is inflammation at the proposed injection site;
• the muscles to be injected are weak or deteriorated;
• you have a bleeding disorder, as the injection may cause hematomas.

Children and adolescents

This medication is not recommended for use in individuals under 18 years of age.

Other medications and NUCEIVA

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This medication is not recommended for use with aminoglycoside antibiotics, spectinomycin, or other medications that affect nerve impulses to the muscle.

Inform your doctor if you have recently been injected with a medication containing botulinum toxin (the active ingredient of NUCEIVA), as this may excessively increase the effect ofthis medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

This medication is not recommended for use during pregnancy or in women capable of becoming pregnant who do not use contraceptive methods.

This medicationis not recommended for use in breastfeeding women.

Driving and operating machinery

Debility, dizziness, and visual disturbances associated with this medication may make driving or operating machinery hazardous. Do not drive or operate machinery until these effects have disappeared.

NUCEIVA contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially

«sodium-free».

The unit doses of NUCEIVA are not interchangeable with those used for other botulinum toxin preparations.

This medicationshould only be injected by doctors with the necessary qualifications and experience in the treatment of frown lines between the eyebrows.

The usual dose of NUCEIVA is 20 Units. You will be injected with the recommended volume of 0.1 milliliters (ml) (4 Units) ofthis medicationin each of the 5 injection sites.

The improvement in the depth of the wrinkles between the eyebrows usually occurs a few days after treatment.

The interval between treatments will be decided by your doctor.

How NUCEIVA is injected

This medicationis injected into the muscles (intramuscularly), directly into the affected area between the eyebrows and above them.

Once reconstituted, NUCEIVA should only be used to treat a single patient during a single session.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Generally, adverse effects appear in the first days after injection and are transient. Most adverse effects are of mild or moderate intensity.

If you have any difficulty breathing, swallowing, or speaking after receiving this medication, contact your doctor immediately.

If you experience hives, swelling, including swelling of the face or throat, wheezing, feeling of weakness, and shortness of breath, contact your doctor immediately, as these may be symptoms of an allergic reaction.

The probability of experiencing an adverse effect is described in the following categories:

Reporting Adverse Effects

If you experience adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this prospectus. You can also report them directly through the national notification system included in Appendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Store in the refrigerator(between 2°C and 8°C)

Keep out of sight and reach of children.

Unopened vial

Do not use this medication after the expiration date that appears on the vial and the box after CAD.

Composition of NUCEIVA

• The active principle is: 50 Units of botulinum toxin type A.
• The other components are human albumin and sodium chloride.

Appearance of the product and contents of the package

NUCEIVA is presented in the form of a white powder for injectable solution in a transparent glass vial.

Each package contains 1 vial.

Holder of the marketing authorization and Manufacturers

Evolus Pharma B.V.

Apollolaan 151

1077 AR Amsterdam

Netherlands

For more information about this medication, please contact the local representative of the marketing authorization holder.

Last review date of this leaflet: May 2024.

THIS INFORMATION IS INTENDED ONLY FOR MEDICAL PROFESSIONALS OR HEALTHCARE PROFESSIONALS:

The Units of botulinum toxinare not interchangeable from one product to another. The recommended doses in Units are different from those of other botulinum toxin preparations.

The reconstitution must be performed in accordance with good clinical practices, especially with regard to aseptic technique. NUCEIVA is reconstituted with sodium chloride 9 mg/ml (0.9%) for injectable solution. 1.25 ml of sodium chloride 9 mg/ml (0.9%) for injectable solution is drawn up in a syringe to obtain a reconstituted injectable solution in a concentration of 4 Units/0.1 ml.

The central part of the rubber stopper must be cleaned with alcohol. Inject the diluent slowly into the vial with a needle through the rubber stopper and gently rotate the vial to avoid bubble formation. The vial must be discarded if the vacuum is not introduced into the vial. Once reconstituted, the injectable solution must be visually inspected before use to ensure that it is a transparent and colorless solution free of particles.

NUCEIVA reconstituted (50 Units/1.25 ml) is injected with a sterile 30-gauge needle. Four units (4 U/0.1 ml) are administered at each of the 5 injection sites (see Figure 1): 2 injections in each corrugator muscle (inferior and superior inner face) and 1 injection in the procer muscle, representing a total dose of 20 Units.

Figure 1 Injection sites

To reduce the complication of ptosis, the following measures should be taken:

• Avoid injecting near the superior palpebral elevator, especially in patients with large brow depressor complexes.
• Corrugator lateral injections should be applied at least 1 cm above the supraorbital bone.
• Ensure that the injected volume/dose is exact and, if possible, kept to a minimum.

Procedure for safe disposal of vials, syringes, and materials used:

Immediately after use, the unused reconstituted NUCEIVA injectable solution remaining in the vial or syringe must be inactivated, before disposal, with 2 ml of 0.5% or 1% available chlorine solution or sodium hypochlorite solution. After inactivation, dispose of in accordance with local requirements.

Vials, syringes, and used materials must not be emptied and must be disposed of in suitable containers and disposed of in accordance with local regulations.

Recommendations in case of accident during manipulation of botulinum toxin:

In case of an accident while handling the product, whether in a vacuum-dried state or reconstituted, the following appropriate measures should be applied immediately.

• Toxin is very sensitive to heat and certain chemicals.

• Spills should be cleaned with an absorbent material soaked in a sodium hypochlorite solution (bleach) in the case of the vacuum-dried product or with a dry absorbent material if the product is already reconstituted.

• Contaminated surfaces should be cleaned with an absorbent material soaked in a sodium hypochlorite solution (bleach) and then dried.

• If a vial is broken, carefully collect the glass fragments and clean the product as indicated above, avoiding cuts to the skin.

• In case of splashes, wash with a sodium hypochlorite solution and thoroughly rinse with plenty of water.

• In case of splashing in the eyes, wash them well with plenty of water or an eye wash solution.

• If the operator is injured (cut, punctured), follow the above steps and take the necessary medical measures depending on the injected dose.

These use, handling, and disposal instructions must be followed strictly.