ICATIBANT 30 mg Инъекционный Раствор В Преднаполненном Шприце

Содержание инструкции

1. Icatibant Aguettant 30 mg injectable solution in pre-filled syringe
   1. What is Icatibant Aguettant and what is it used for
   2. What you need to know before using Icatibant Aguettant
   3. How to use Icatibant Aguettant
   4. Possible side effects
   5. How to store Icatibant Aguettant
   6. Contents of the pack and other information

Icatibant Aguettant 30 mg injectable solution in pre-filled syringe

icatibant

Generic medicine
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.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• 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 Icatibant Aguettant is and what it is used for
• 2. What you need to know before you use Icatibant Aguettant
• 3. How to use Icatibant Aguettant
• 4. Possible side effects
• 5. How to store Icatibant Aguettant
• 6. Contents of the pack and other information

1. What is Icatibant Aguettant and what is it used for

Icatibant Aguettant contains the active ingredient Icatibant.
Icatibant Aguettant is used for the treatment of symptoms of hereditary angioedema (HAE) in adults,
adolescents and children starting from 2 years of age.
In HAE, the levels in the blood of a substance called bradykinin increase, which causes symptoms such as
swelling, pain, nausea and diarrhoea.
Icatibant Aguettant blocks the activity of bradykinin and therefore stops the progression of symptoms of an
HAE attack.

2. What you need to know before using Icatibant Aguettant

Do not use Icatibant Aguettant

• if you are allergic to Icatibantt or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before using Icatibant Aguettant:

• if you suffer from angina (reduced blood flow to the heart muscle)
• if you have had a recent stroke

Some of the side effects associated with Icatibant Aguettant are similar to the symptoms of the condition you have.
Immediately inform your doctor if you find that the symptoms of the attack worsen
after the administration of Icatibant Aguettant.
Also:

• You or the person who cares for you must have been trained in the technique of subcutaneous injection (under the skin) before self-administering/administering Icatibant Aguettant.
• Immediately after self-administration of Icatibant Aguettant or administration of Icatibant Aguettant by the person who cares for you during a laryngeal attack (upper airway obstruction), you must seek medical assistance at a healthcare facility.
• If your symptoms have not resolved after self-administration or after being given an injection of Icatibant Aguettant, consult a doctor to receive additional injections of Icatibant Aguettant. For adult patients, a maximum of 2 additional injections may be given within 24 hours.

Children and adolescents
The use of Icatibant Aguettant is not recommended in children under 2 years of age or weighing less than 12
kg because it has not been studied in these patients.

Other medicines and Icatibant Aguettant
Tell your doctor if you are taking, have recently taken or might take any other medicines.
No interactions with other medicines are known for Icatibant Aguettant. If you are taking a medicine known
as an angiotensin converting enzyme (ACE) inhibitor (for example, captopril,
enalapril, ramipril, quinapril, lisinopril), which is used to lower blood pressure or for other
reasons, tell your doctor before taking Icatibant Aguettant.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor for advice before starting to take this medicine.
If you are breastfeeding, you should not breastfeed for 12 hours after the last administration of Icatibant
Aguettant.

Driving and operating machinery
Do not drive or operate machinery if you feel tired or dizzy after an HAE attack or
after the administration of Icatibant Aguettant.

Icatibant Aguettant contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per pre-filled syringe, i.e.
essentially ‘sodium-free’.

3. How to use Icatibant Aguettant

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor.
If you have never received Icatibant Aguettant before, the first dose of Icatibant Aguettant will be
injected by your doctor or a nurse. The doctor will advise you when it is possible to return home. After
discussing with your doctor or nurse and being trained in the subcutaneous injection technique
(under the skin), during an attack of HAE you can self-administer, or the person who takes care of you
can administer to you, Icatibant Aguettant. It is important that Icatibant Aguettant is injected via
subcutaneous route (under the skin) at the first sign of an angioedema attack. The healthcare professional who
follows you will teach you and the person assisting you how to inject Icatibant Aguettant safely for

When and how often to use Icatibant Aguettant?
The doctor has established the exact dose of Icatibant Aguettant and will indicate how often to use it.

Adults

• The recommended dose of Icatibant Aguettant is one injection (3 ml, 30 mg) administered subcutaneously (under the skin) at the first sign of an angioedema attack (for example, increased swelling of the skin, especially at the level of the face and neck, or increasing abdominal pain).
• If you do not feel an improvement in symptoms after 6 hours, consult a doctor to receive additional injections of Icatibant Aguettant. For adults, a maximum of 2 additional injections can be administered within 24 hours.
• Do not administer more than 3 injections within a 24-hour period and, if more than 8 injections are necessaryin a month, consult a doctor.Children and adolescents in the age group 2-17 years
• The recommended dose of Icatibant Aguettant is one subcutaneous injection (under the skin) of 1 ml up to a maximum of 3 ml depending on body weight at the first sign of symptoms of an angioedema attack (for example, increased swelling of the skin, especially at the level of the face and neck, increasing abdominal pain).
• For the specific dose to be injected, see the instructions for use section.
• If you are unsure of which dose to inject, consult your doctor, pharmacist or nurse.
• If your symptoms worsen or you do not experience any relief, seek immediate medical attention.How should Icatibant Aguettant be administered?Icatibant Aguettant is intended for use by subcutaneous injection (under the skin). Each syringe must be used only once.

Icatibant Aguettant should be injected with a short needle into the fatty tissue, under the skin of the abdomen (stomach).
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

The following are step-by-step instructions for:

• self-administration (adults)
• administration to adults, adolescents or children over 2 years of age (withminimum body weight of 12 kg) by a caregiver or healthcareprofessional.The instructions include the following main steps:
• 1) General information 2a) Preparation of the syringe for children and adolescents (age 2-17 years) weighing 65 kg or less 2b) Preparation of the syringe and needle for injection (all patients)
• 3) Preparation of the injection site
• 4) Injection of the solution
• 5) Disposal of the injection kit

Step-by-step injection instructions

• 1) General information
• Before starting the process, clean the work (surface) area to be used.
• Wash your hands with soap and water.
• Open the tray by detaching the seal.
• Remove the pre-filled syringe from the tray.
• By unscrewing, remove the cap from the end of the pre-filled syringe.
• After unscrewing the cap, place the syringe on a flat surface.

2a) Preparation of the syringe for
children and adolescents (age 2-17 years) weighing 65 kg or less
Important information for healthcare professionals and caregivers:
When the dose is less than 30 mg (3 ml), the following materials are required to extract the appropriate dose (see below):
a) Pre-filled syringe of Icatibant Aguettant (containing the icatibant solution)
b) Connector (adapter)
c) 3 ml graduated syringe

The volume in ml needed for the injection must be drawn into an empty 3 ml graduated syringe
(see table below).

Table 1: Dosage regimen for children and adolescents
Body weightDose (Injection Volume)
12-25 kg 10 mg (1.0 ml)
26-40 kg 15 mg (1.5 ml)
41-50 kg 20 mg (2.0 ml)
51-65 kg 25 mg (2.5 ml)
Patients weighing more than 65 kgwill use the entire contents of the pre-filled syringe (3 ml).

If you are unsure of the volume of solution to withdraw, consult your doctor, pharmacist or
nurse.

• 1) Remove the caps from both ends of the connector.

Avoid touching the ends of the connector and the tips of the syringes to prevent
contamination.

• 2) Screw the connector onto the pre-filled syringe.
• 3) Attach the graduated syringe to the other end of the connector, making sure both connections are securely fastened.

Transfer the icatibant solution into the graduated syringe:

• 1) To start transferring the icatibant solution, lower the plunger of the pre-filled syringe (all the way to the left in the figure below).

• 2) If the icatibant solution does not transfer into the graduated syringe, gently pull the plunger of the graduated syringe until the icatibant solution begins to flow into it (see figure below).

• 3) Continue to lower the plunger of the pre-filled syringe until the necessary injection volume (dose) is transferred into the graduated syringe. For dosage information see table 1. If there is air in the graduated syringe:
• Turn the connected syringes upside down so that the pre-filled syringe is on top (see figure below).

• Lower the plunger of the graduated syringe so that the air is re-transferred into the pre-filled syringe (this step may need to be repeated several times).
• Withdraw the necessary volume of icatibant solution.
• 4) Detach the pre-filled syringe and the connector from the graduated syringe.
• 5) Dispose of the pre-filled syringe and connector in a sharps container.

2b) Preparation of the syringe and needle for injection:
All patients (adults, adolescents and children)

• Remove the cap containing the needle from the blister pack.
• Peel off the film from the cap (the needle must still be in the cap).

• Hold the syringe firmly. Carefully attach the needle to the pre-filled syringe containing the colorless solution.
• Screw the pre-filled syringe onto the needle while it is still in the cap.
• Remove the needle from the cap by pulling the syringe but without pulling the plunger.
• The syringe is now ready for injection.

• 3) Preparation of the injection site

• Choose the injection site, which should be a skin fold on the abdomen about 5-10 cm located to the right or left below the navel. The area should be at least 5 cm away from any scars. Do not choose an area that is bruised, swollen or painful.
• Clean the injection site by rubbing it with a cotton ball soaked in alcohol and let it dry.
• 4) Injection of the solution

• Hold the syringe between two fingers of one hand with your thumb on the plunger.
• Make sure there are no air bubbles in the syringe by pushing the plunger until the first drop appears on the tip of the needle.

• Hold the syringe at an angle of 45-90 degrees to the skin, with the needle pointing towards the injection point.
• Holding the syringe in one hand, use the other to gently hold a skin fold between your thumb and fingers at the previously disinfected injection point.
• Keeping the skin fold, bring the syringe and quickly insert the needle into the fold.
• Slowly push the plunger of the syringe with a firm hand until all the liquid has been injected and the syringe is empty.
• Push slowly: the injection should take about 30 seconds.
• Release the skin fold and gently remove the needle.
• 5) Disposal of the injection kit

• Dispose of the syringe, needle and its cap in the appropriate container for disposing of waste that could injure others if not handled properly.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Almost all patients treated with Icatibant Aguettant have a reaction at the injection site
(such as skin irritation, swelling, pain, itching, erythema and a burning sensation). These effects
are usually mild and resolve on their own without the need for further treatment.

Very common(may affect more than 1 in 10 people):
Further reactions at the injection site (feeling of compression, bruising, loss of sensation and/or
numbness, swollen and itchy rash, and warmth).

Common(may affect up to 1 in 10 people):
Feeling unwell
Headache
Dizziness
Fever
Itching
Skin rashes
Skin redness
Abnormal liver function tests

Not known(frequency cannot be estimated from available data):
Urticaria
Tell your doctor immediately if you notice that the symptoms of the attack worsen after administration of
Icatibant Aguettant.
If any side effect occurs, including any not listed in this leaflet, please tell your
doctor.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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 Icatibant Aguettant

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 after “Exp”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice that the syringe or needle packaging is damaged or if there are
evident signs of deterioration, for example if the solution is cloudy, if it contains floating particles
or if the colour of the solution has changed.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Icatibant Aguettant contains

• The active substance is icatibant. Each pre-filled syringe contains 30 milligrams of icatibant (as acetate).
• The excipients are sodium chloride, glacial acetic acid and sodium hydroxide (for pH adjustment) and water for injections.

Description of the appearance of Icatibant Aguettant and contents of the pack
Icatibant Aguettant is presented as a clear and colourless injectable solution, in a 3 ml glass pre-filled syringe.
The pack also includes a hypodermic needle.
Icatibant Aguettant is available in a single pack, containing one pre-filled syringe and one needle, or in a
multipack, containing three pre-filled syringes and three needles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France

Manufacturer
Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France

Wessling Hungary Kft.
Anonymus Utca.6,
1045 Budapest,
Hungary

Wessling GmbH
Johann-Krane-Weg 42,
48149 Münster,
Germany

Other sources of information
More detailed information on this medicine is available on the website of the Italian Medicines Agency