Icatibanto cipla 30 mg … – інструкція – Іспанія

Інструкція із застосування Icatibanto cipla 30 mg solucion inyectable en jeringa precargada efg

Introduction

Leaflet: information for the user

Icatibant Cipla 30 mg injectable solution in pre-filled syringe EFG

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Icatibanto Cipla and what is it used for

Icatibanto Cipla contains the active ingredient icatibanto.

This medication is used for the treatment of symptoms of hereditary angioedema (HAE) in adults, adolescents, and children over 2 years old.

In HAE, blood concentrations of a substance called bradykinin increase, producing symptoms such as swelling, pain, nausea, and diarrhea.

Icatibanto blocks bradykinin activity and thereby slows the progression of HAE symptoms during an episode.

2. What you need to know before starting to use Icatibant Cipla

No use Icatibanto Cipla

If you are allergic to icatibant or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor before starting to use Icatibanto Cipla:

If you have angina pectoris (reduced blood flow to the heart).
If you have recently had a stroke.

The side effects related to icatibant are similar to the symptoms of your own disease. Consult your doctor immediately if you notice that the symptoms of the crisis worsen after you are administered this medication.

Additionally:

You or your caregiver must learn the technique of subcutaneous injection (under the skin) before self-administering or having your caregiver administer this medication to you.
Immediately after self-administering Icatibanto Cipla or having your caregiver administer it to you while experiencing a laryngeal crisis (obstruction of the upper airway), you must seek medical attention at a medical institution.
If your symptoms do not resolve after an injection of Icatibanto Cipla self-administered or administered by your caregiver, you must consult your doctor about the administration of additional injections of this medication. In adult patients, up to 2 additional injections may be administered within a 24-hour period.

Children and Adolescents

This medication is not recommended for use in children under 2 years of age or weighing less than 12 kg, as it has not been studied in these patients.

Other Medications and Icatibanto Cipla

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

No interactions of Icatibanto Cipla with other medications are known. If you are taking an angiotensin-converting enzyme inhibitor (ACEI) (e.g., captopril, enalapril, ramipril, quinapril, lisinopril) to reduce blood pressure or for any other reason, inform your doctor before using this medication.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor before starting to use this medication.

If you are breastfeeding, do not breastfeed your child for 12 hours after the last administration of this medication.

Driving and Operating Machines

Do not drive or operate machines if you feel tired or dizzy due to an AEH crisis or after using this medication.

Icatibanto Cipla contains sodium

This medication contains less than 1 mmol (23 milligrams) of sodium per syringe, making it essentially "sodium-free".

3. How to use Icatibant Cipla

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

If you have never received Icatibanto Cipla before, the first dose must always be injected by medical or nursing staff. Your doctor will discharge you when they consider it safe for you to go home.

After analyzing it with your doctor or nurse, and after learning the technique for subcutaneous injections (under the skin), you or the person caring for you can administer this medication if you have an acute AEH attack.

It is essential to inject Icatibanto Cipla subcutaneously (under the skin) as soon as you notice an acute angioedema attack. Healthcare staff will teach you and the person caring for you how to inject this medication safely, following the prospectus instructions.

When and how often should you use Icatibanto Cipla?

Your doctor has determined the exact dose of this medication and will tell you how often to use it.

Adults

The recommended dose of Icatibanto Cipla is one injection (3 ml, 30 mg) administered subcutaneously (under the skin) as soon as you notice the acute angioedema attack (for example, with increased skin swelling, especially on the face and neck, or increased abdominal pain).
If you do not notice an improvement in symptoms, after 6 hours, you should seek medical advice on the administration of additional Icatibanto Cipla injections. In adults, up to 2 additional injections can be administered within 24 hours.
You should not receive more than 3 injections in a 24-hour period and if you need more than 8 injections in a month, consult your doctor.

Children and adolescents aged 2 to 17 years

The recommended dose of this medication is one injection of 1 ml up to a maximum of 3 ml based on body weight administered subcutaneously (under the skin) as soon as symptoms of an acute angioedema attack occur (for example, increased skin swelling, especially on the face and neck, or increased abdominal pain).
See the usage instructions section to see the dose you should inject.
If you are unsure about the dose you should inject, consult your doctor, pharmacist, or nurse.
If your symptoms worsen or do not improve, you should seek immediate medical advice.

How should Icatibanto Cipla be administered?

Icatibanto Cipla is administered via subcutaneous injection (under the skin). Each syringe should be used only once.

This medication is injected with a short needle into the fatty tissue located under the skin of the abdomen (lower abdomen).

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

The following step-by-step instructions are intended for:

Self-administration (adults)
Administration by a caregiver or healthcare professional for adults, adolescents, or children over 2 years old (who weigh at least 12 kg).

The instructions include the following main steps:

1)General information

2a)Preparation of the syringe for children and adolescents (2-17 years) who weigh 65 kg or less

2b)Preparation of the syringe and needle for injection (all patients)

Preparation of the injection site
Injection of the solution
Disposal of injection materials

Step-by-step instructions for injection

1) General information

Clean the work surface area to be used before starting the process.
Wash your hands with water and soap
Remove the preloaded syringe from the packaging
Unscrew and remove the cap from the end of the preloaded syringe
Leave the preloaded syringe once the cap has been unscrewed

2a) Preparation of the syringe for children and adolescents (2-17 years) who weigh 65 kg or less:

Important information for healthcare professionals and caregivers:

When the dose is less than 30 mg (3 ml), the following equipment is needed to extract the correct dose (see information below):

Preloaded syringe of Icatibanto Cipla (with icatibanto solution)
Connector (adapter)
3 ml graduated syringe

The required injection volume in ml must be prepared in a 3 ml graduated syringe (see table below).

Table 1: Dosage schedule for children and adolescents

Body weight	Injection volume
12 kg to 25 kg	1.0 ml
26 kg to 40 kg	1.5 ml
41 kg to 50 kg	2.0 ml
51 kg to 65 kg	2.5 ml

Patients who weighmore than 65 kgwill use the entire contents of the preloaded syringe (3 ml).

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

Remove the caps from both ends of the connector.

Avoid touching the connector ends and syringe tips to prevent contamination.

Attach the connector to the preloaded syringe.

Connect the graduated syringe to the other end of the connector, ensuring both connections fit securely.

Transfer the icatibanto solution to the graduated syringe:

To initiate the transfer of the icatibanto solution, push the plunger of the preloaded syringe (on the left side of the image below).

If the icatibanto solution does not start to transfer to the graduated syringe, pull slightly on the plunger of the graduated syringe until the icatibanto solution starts to flow into the graduated syringe (see the image below).

Continue pushing the plunger of the preloaded syringe until the required injection volume (dose) is transferred to the graduated syringe. See Table 1 for dosage information.

If there is air in the graduated syringe:

Turn the connected syringes so that the preloaded syringe is on top (see the image below).

Push the plunger of the graduated syringe to transfer the air back into the preloaded syringe (this step may need to be repeated several times).
Extract the required volume of icatibanto solution.

Remove the preloaded syringe and connector from the graduated syringe.

Dispose of the preloaded syringe and connector in the sharp objects container.

	2b) Preparation of the syringe and needle for injection: All patients (adults, adolescents, and children)
	Remove the needle cap from the packaging Remove the seal from the needle cap (the needle should remain inside the cap) Hold the syringe firmly. Carefully connect the needle to the preloaded syringe with the colorless solution. Secure the preloaded syringe to the needle, still fixed in the cap Pull the syringe to remove the needle from the cap. Do not pull the plunger. The syringe is now ready for injection
3) Preparation of the injection site
Select the injection site. The injection site should be a skin fold on the abdomen, approximately 5-10 cm (2-4 inches) below the navel, to one or the other side. The area should be at least 5 cm (2 inches) away from any scars. Do not choose an area with hematomas, inflammation, or pain. Clean the injection site by rubbing with an alcohol wipe, and let it dry.
4) Injection of the solution
Hold the syringe between two fingers, with your thumb on the end of the plunger
Verify that there is no air in the syringe, by pressing the plunger until the first drop appears at the tip of the needle Hold the syringe with the needle pointing at the skin at an angle of 45 to 90 degrees Hold the syringe in one hand, with the other hand take a skin fold between your thumb and fingers, on the previously cleaned area Hold the skin fold, bring the syringe close, and quickly insert the needle into the skin fold Slowly push the plunger with firm pressure, until all the fluid has been injected into the skin and no liquid remains in the syringe Push slowly, so that the process takes approximately 30 seconds Release the skin fold and remove the needle gently
5) Disposal of injection materials
Dispose of the syringe, needle, and cap in the sharp objects container intended for disposal of objects that can harm others if not handled correctly.

4. Possible Adverse Effects

Like all medications, this medication may produce adverse effects, although not everyone will experience them. Almost all patients who receive Icatibanto Cipla notice a reaction at the injection site (such as skin irritation, inflammation, pain, itching, skin redness, and burning). These effects are usually mild and improve without the need for additional treatment.

Inform your doctor immediately if you observe that the symptoms of the crisis worsen after receiving this medication.

Very Frequent(may affect more than 1 in 10 people):

Additional reactions at the injection site (sensation of pressure, bruising, decreased sensitivity and/or numbness, increased skin rash with itching and heat).

Frequent(may affect up to 1 in 10 people):

Nausea
Headache
Dizziness
Fever
Itching
Rash
Skin redness
Abnormal liver function tests

Unknown Frequency(cannot be estimated from available data):

Hives (urticaria)

Reporting Adverse Effects

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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

5. Conservation of Icatibant Cipla

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Do not freeze.

Do not use this medication if you observe that the syringe or needle container is damaged or if you observe visible signs of deterioration; for example, if the solution is cloudy, if it contains floating particles or if the solution color has changed.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

6. Contents of the packaging and additional information

Composition of Icatibanto Cipla

The active ingredient is icatibanto. Each pre-filled syringe contains 30 milligrams of icatibanto (in the form of acetate). Each milliliter of solution contains 10 mg of icatibanto
The other components are sodium chloride, glacial acetic acid, sodium hydroxide (for pH adjustment) and water (see section 2).

Appearance of the product and contents of the package

Icatibanto Cipla is presented as a transparent and colorless injectable solution in a 3 ml pre-filled syringe made of glass. The package contains a hypodermic needle.

Icatibanto Cipla is available in a single pre-filled syringe with a needle or in a multiple package of three pre-filled syringes with three needles.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cipla Europe NV

De Keyserlei 58-60, Box 19,

2018 Antwerp, Belgium

Responsible for manufacturing

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola PLA 3000

Malta

Eurofins PROXY Laboratories (PRX)

Archimedesweg 25 2333 CM Leiden

Netherlands

Local representative

Cipla Europe NV subsidiary in Spain,

C/Guzmán el Bueno, 133 Edif Britannia 28003 Madrid, Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany	Icatibant Cipla 30 mg Injection Solution i.e. Pre-filled Syringe
Denmark	Icatibant Cipla
Spain	Icatibanto Cipla 30 mg injectable solution in pre-filled syringe EFG
Norway	Icatibant Cipla

Last review date of this leaflet:September 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)