RELFYDESS 100 U/ML Инъекционный раствор

Содержание инструкции

1. Relfydess
   1. What is Relfydess and what is it used for
   2. What you need to know before using Relfydess
   3. How to use Relfydess
   4. Possible side effects
   5. How to store Relfydess
   6. Contents of the pack and other information

Relfydess

100units/mL, injectable solution
type A botulinum toxin
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Relfydess is and what it is used for
• 2. What you need to know before using Relfydess
• 3. How to use Relfydess
• 4. Possible side effects
• 5. How to store Relfydess
• 6. Contents of the pack and other information

1. What is Relfydess and what is it used for

Relfydess contains the active substance botulinum toxin A, which causes muscle relaxation.
It works by inhibiting nerve impulses to the muscles into which it is injected, preventing the muscles from
contracting.
Relfydess is used to temporarily improve the appearance of vertical wrinkles between the eyebrows
of moderate to severe grade (glabellar lines) and wrinkles at the outer corners of the eyes of moderate to
severe grade (lateral canthal lines, also known as crow's feet). It is used in
adults under 65 years of age in whom these facial wrinkles have a significant impact on their
well-being.

2. What you need to know before using Relfydess

Do not administer an injection of Relfydess if:

• you are allergic to botulinum toxin or to any of the other ingredients of this medicine (listed in section 6).
• you have an infection at the proposed injection sites.
• you suffer from myasthenia gravis, Eaton Lambert syndrome or amyotrophic lateral sclerosis (chronic diseases that affect the muscles)

Warnings and precautions
Consult your doctor before undergoing an injection of Relfydess if:

• you suffer from any disease that affects the nervous system
• you are debilitated with lack of strength and energy

• you have difficulty breathing
• you have difficulty swallowing food or frequently experience food or drinks entering your airways causing coughing or choking
• you have had side effects from previous botulinum toxin injections and/or have not experienced significant improvement in your wrinkles after the last treatment
• you have inflammation at the proposed injection site(s)
• you have eye problems, including drooping eyelids and dry eyes
• the muscles at the proposed injection site are weak or show signs of wasting
• you suffer from a bleeding disorder, meaning that you continue to bleed for longer than normal, or are taking medicines to thin the blood (anticoagulants)

This information will help the healthcare professional make an informed decision about the risks and benefits of treatment.

Warnings and precautions
Adverse effects likely related to the spread of the toxin effect away from the injection site have been very rarely reported with botulinum toxin (e.g. difficulty swallowing, coughing and choking during swallowing, difficulty speaking or breathing). These symptoms have been reported from hours to weeks after injection.
Seek immediate medical attention if you experience difficulty swallowing, speaking or breathing.
The use of Relfydess may cause dry eyes. If you experience symptoms of dry eyes (e.g. eye irritation, light sensitivity or visual changes), consult your doctor.
Repeated treatment with botulinum toxin may lead to muscle atrophy due to temporary paralysis of the treated muscles.
Too frequent use or higher doses of botulinum toxins can lead to the formation of antibodies. The formation of neutralizing antibodies may reduce the effectiveness of treatment.

Children and adolescents
Relfydess is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Relfydess
Tell your doctor if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking the following medicines, as they may increase the effect of Relfydess:

• certain antibiotics used to treat infections (e.g. aminoglycosides)
• other muscle relaxants
• other medicines containing botulinum toxin.

Pregnancy and breastfeeding
If you are pregnant, or if you are breastfeeding, if you suspect or are planning a pregnancy, ask your doctor for advice before using this medicine.
Relfydess should not be used during pregnancy, if you are of childbearing potential and not using contraception, or if you are breastfeeding.

Driving and using machines
Following treatment with Relfydess you may experience temporary visual disturbances or muscle weakness.
If you suffer from these, do not drive or use machines.

Relfydess contains potassium, sodium and polysorbate.
This medicine contains potassium, less than 1 mmol (39 mg) per 150 unit vial, i.e. essentially “potassium-free”.
This medicine contains less than 1 mmol (23 mg) of sodium per 150 unit vial, i.e. essentially “sodium-free”.
This medicine contains 1.6 mg of polysorbate 80 per 150 unit vial, equivalent to 1.1 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Relfydess

Relfydess must be administered exclusively by a healthcare professional with appropriate qualifications and
experience for this treatment and who has the necessary equipment. Relfydess will be
administered as injections into the muscles at the intended site.
The dose units of Relfydess are not interchangeable with those used for other preparations based on
botulinum toxin.
The recommended dose for Relfydess is:

• For vertical wrinkles between the eyebrows: 50 units (0.5 mL), injected as 10 units (0.1 mL) at each of the 5 injection points on the forehead, in the area above the nose and eyebrows.
• For wrinkles at the outer corner of the eyes: 60 units (0.6 mL), injected as 10 units (0.1 mL) at each of the 6 injection points. The 6 injection points include 3 injections in each of the crow's feet areas, both right and left.
• For combined treatment: the same doses are recommended, namely 50 units for glabellar wrinkles and 60 units for lateral canthal wrinkles, with a total dose of 110 units (1.1 mL).

The effect of the treatment should be visible within a few days of the injection and may last up to
6 months. The interval between Relfydess treatments will be decided by the doctor. Treatment should not
be performed more frequently than every 3 months.

If you receive too much Relfydess
Since this medicine will be administered by a qualified and experienced professional, it is
unlikely that an excessive amount of this medicine will be administered. However, if you are
administered more Relfydess than you need, muscles other than those injected may begin to
weaken. Excessive doses can cause difficulty swallowing and speaking and breathing problems.
This may not happen immediately. If this occurs, contact your doctor
immediately. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are mild or moderate and occur within the first month after the injection and are temporary.

Seek urgent medical attention if you experience the following symptoms, which have been reported
very rarely:

• difficulty breathing, swallowing or speaking.
• swelling, including swelling of the face or throat, hives, wheezing, feeling faint and shortness of breath. This may mean you are having an allergic reaction to Relfydess.

Tell your doctor if you notice any of the following side effects:
Common (may affect up to 1 in 10 people)

• Reactions at the injection site such as bruising, pain, itching, redness, swelling, discomfort, hypersensitivity, warmth.
• Headache
• Drooping of the upper eyelid.

Uncommon (may affect up to 1 in 100 people)

• Muscle weakness
• Muscle contraction
• Drooping of the eyebrow
• Allergic reaction, such as asthma or widespread hives
• Local allergic reaction, such as hives
• Blurred vision
• Dry eye
• Eye fatigue
• Swelling of the eyelids.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Relfydess

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the vial in the outer packaging to
protect it from light.
The unopened vial can be brought to room temperature at 25°C and protected from light. The
stability of Relfydess (unopened vial) has been demonstrated for up to 24 hours at room temperature.

6. Contents of the pack and other information

What Relfydess contains

• The active substance is type A botulinum toxin, 100 units/mL. One vial contains 150 units in 1.5 mL of solution.
• The other excipients are: disodium hydrogen phosphate dihydrate, disodium phosphate dihydrate, potassium chloride, sodium chloride, polysorbate 80, L- tryptophan and water for injections (see section 2 Relfydess contains potassium, sodium and polysorbate).

Description of the appearance of Relfydess and contents of the pack
Relfydess is a clear injectable solution, from colourless to pale yellow (injection). It is available in
packs of 1 or 10 glass vials containing 1.5 mL of injectable solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ipsen Pharma
65 quai Georges Gorse
92100 Boulogne Billancourt
France
Local Representative:
Galderma Italia S.p.A.
Via Manara Luciano, 15
20122 Milano

Manufacturer:
Q-Med AB
Seminariegatan 21
752 28 Uppsala
Sweden
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The following information is intended exclusively for doctors or healthcare professionals:
Dosage and method of administration:
Relfydess must only be administered by healthcare professionals with appropriate qualifications and experience
in treatment and with the necessary equipment, in accordance with local guidelines and regulations.
The potency units are specific to Relfydess and are not interchangeable with those of other
botulinum toxin-based preparations.
Relfydess is ready for use with a concentration of 10 units per 0.1 mL and no reconstitution is
required
Each vial must be used for a single patient during a single treatment session. Any residual product after treatment must be discarded
The dosage and treatment intervals depend on the assessment of the individual patient's response, but must not exceed the maximum permitted doses and a minimum interval of 12 weeks.
In order to improve the traceability of biological medicinal products, the name and batch number of the
medicinal product administered must be clearly recorded.

Special precautions for disposal and handling
Instructions for use, handling and disposal must be followed strictly.

RECOMMENDATIONS FOR DISPOSAL OF CONTAMINATED MATERIALS
Immediately after use and before disposal, unused Relfydess (which may be
present in the vial or syringe) must be inactivated with a diluted solution of sodium hypochlorite (0.1% NaOCl) or sodium hydroxide solution (1% NaOH). Vials, syringes and used materials must not be emptied and must be disposed of in appropriate containers and in accordance with
local regulations.

RECOMMENDATIONS IN CASE OF ACCIDENTS DURING HANDLING
OF BOTULINUM TOXIN

• Any product spills must be eliminated with dry and absorbent material. The material must be disposed of in accordance with current local regulations.
• Contaminated surfaces must be cleaned using a diluted solution of sodium hypochlorite or sodium hydroxide and then dried.
• If a vial breaks, proceed as indicated above, carefully collecting the glass fragments and drying the product, taking care not to injure yourself.
• If the product comes into contact with the skin, wash the affected area with soap and water.
• If the product comes into contact with the eyes, rinse thoroughly with plenty of water or with an ophthalmic solution for eye washing.
• If the product comes into contact with a wound, cut or skin lesion, rinse thoroughly with plenty of water and seek medical attention.

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