Package Leaflet: Information for the User

Riastap 1g

Powder for solution for injection and for infusion

Human fibrinogen

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• Ifyou experience any side effects, consult your doctor or pharmacist,even if they are not listed in this leaflet. See section 4.

1. What Riastap is and what it is used for

2. What you need to know before using Riastap

3. How to use Riastap

4. Possible side effects

5. Storage of Riastap

6. Contents of the pack and additional information

What is Riastap?

Riastap contains human fibrinogen, which is an important protein for blood coagulation. The

lack of fibrinogen implies that the blood does not coagulate as quickly as it should, which causes an increased tendency to suffer from hemorrhages. The substitution of human fibrinogen by Riastap repairs the coagulation mechanism.

How is Riastap used?

Riastap is used for the treatment of hemorrhages in patients with congenital fibrinogen deficiency (hypo or afibrinogenemia) with a tendency to bleed.

The following sections contain information that your doctor should consider before administering Riastap to you.

Do not use Riastap:

• if you are allergic to human fibrinogen or to any of the other components of this medication (listed in section 6).

Inform your doctor if you are allergic to any medication or food.

Warnings and precautions:

• If you have had allergic reactions to Riastap in the past. You should take antihistamines and corticosteroids as prophylaxis if your doctor recommends it.

corticosteroids as prophylaxis if your doctor recommends it.

• When allergic reactions or anaphylactic reactions (severe allergic reaction that produces severe respiratory difficulties or dizziness) occur.The administration of Riastap should be interrupted immediately (e.g., by interrupting the injection).

immediately (e.g., by interrupting the injection).

• Due to a high risk of forming blood clots in a blood vessel (thrombosis), particularly:

– in the case of high or repeated doses,

– if you have had a heart attack (history of coronary artery disease or myocardial infarction),

– if you suffer from liver disease,

– if you have recently undergone surgery (postoperative patients),

– if you are about to undergo surgery (preoperative patients),

– in newborns (neonates),

– if you have a higher than normal risk of forming blood clots (patients at risk of developing thromboembolic phenomena or disseminated intravascular coagulation).

Your doctor will have to carefully weigh the benefits of treatment with Riastap against the risks of these complications.

Viral safety

When manufacturing medications prepared from human blood or plasma, certain measures are taken to prevent the transmission of infections to patients. These measures include:

• the careful selection of blood and plasma donors to ensure that donors at risk of carrying infections are excluded, and
• the analysis of each individual donation and plasma mixtures to search for signs of viruses and infections.

Additionally, manufacturers of these products include the necessary measures during the processing of blood or plasma to inactivate or eliminate viruses. Despite these measures, when administering medications prepared from human blood or plasma, it is not possible to completely rule out the possibility of transmitting infections. This applies to any emerging or unknown viruses or other types of infections.

The measures taken are considered effective for encapsulated viruses such as human immunodeficiency virus (HIV, AIDS virus), hepatitis B virus, and hepatitis C virus (liver inflammation), and for non-encapsulated viruses such as hepatitis A virus (liver inflammation) and parvovirus B19.

Your doctor may recommend that you be vaccinated against hepatitis A and B if you regularly or repeatedly receive medications prepared from human plasma.

It is strongly recommended that each time Riastap is administered, the date of administration, the batch number, and the injected volume be recorded.

Administration of Riastap with other medications

• Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medication.
• Riastap should not be mixed with other medications, except for those mentioned in the section "This information is intended solely for healthcare professionals".

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.
• During pregnancy and breastfeeding, Riastap should only be administered if clearly indicated.

Driving vehicles and operating machinery

The influence of Riastap on the ability to drive and operate machinery is negligible or insignificant.

Important information about some of the ingredients in Riastap

Riastap contains up to 164 mg (7.1 mmol) of sodium per vial. This corresponds to 11.5 mg (0.5 mmol) of sodium per kilogram of patient body weight if the recommended initial dose of 70 mg/kg body weight is administered. Please note this if you are following a sodium-controlled diet.

Treatment must be initiated and supervised by a doctor with experience in this type of disorders.

Dosage

The amount of human fibrinogen needed and the duration of treatment depend on:

• The severity of your illness
• The location and intensity of the bleeding
• Your clinical condition

If you take more Riastap than you should

During treatment, your doctor must regularly check your blood coagulation status. In case of overdose, the risk of developing thromboembolic complications increases.

Method of administration

If you have more questions about the use of this product, consult your doctor or pharmacist (see the section "This information is intended solely for healthcare professionals").

Like all medications,this medicationcan produce adverse effects, although not all peopleexperience them.

Please inform your doctor immediately:

• if any adverse effect appears
• if you notice any adverse effect not described in this leaflet.

The following adverse effect occursvery frequently(can affectmore than 1 in 10 patients):

• Increased body temperature

The following adverse effect has been observed infrequently (can affect up to 1 in 100 patients):

• Asudden allergic reaction(such as skin redness, erythema all over the body, blood pressure drop, respiratory difficulty).

The following adverse effect has been observed frequently (can affect up to 1 in 10 patients, however, the incidence was higher in patients who did not receive fibrinogen):

• Risk of increased blood clot formation(see section 2 "What you need to know before starting to use Riastap").

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects not appearing in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

.

• Keep out of reach and sight of children.
• Do not use Riastap after its expiration date, which is included on the label and carton packaging.
• Do not store at a temperature above 25 °C.
• Do not freeze.
• Store the vial in its outer packaging to protect it from light.
• The reconstituted solution must be used immediately.
• If the reconstituted solution is not administered immediately, storage at room temperature (max. +25 ºC) should not exceed an 8-hour period.
• Do not refrigerate the solution after reconstitution.

Composition of Riastap

The active principle is:

Fibrinogen human (1 g/vial; after reconstitution with 50 ml of water for injectable preparations, approx. 20 mg/ml).

If you want more information, see the section " This information is intended solely for healthcare professionals ".

The other ingredients are:

Human albumin, sodium chloride, L-arginine chloride, sodium citrate dihydrate, sodium hydroxide (to adjust the pH).

See the last paragraph of section 2. " Important information about some of the ingredients of Riastap ".

Appearance of Riastap and packaging contents

Riastap is presented in the form of a white powder.

After reconstitution with water for injectable preparations, the solution obtained must be transparent or slightly opalescent, i.e., it may shine when placed under light, but it must not contain any type of particles.

Presentation

1 g vial (Figure 1)

1. A vial containing 1 g of human fibrinogen
2. Pall ® needle filter
3. Mini-Spike ® aspiration needle

Figure 1

Marketing authorization holder and manufacturer

CSL Behring GmbH

Emil_von_Behring_Strasse 76

35041 Marburg

Germany

Local representative:

CSL Behring, S.A.

c/ Tarragona 157, 18th floor

08014 Barcelona

Spain

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

Riastap 1 g powder for solution for injection/infusion United Kingdom

Riastap 1g, poudre pour solution injectable/perfusion France

Riastap 1g prašek za raztopino za injiciranje ali infundiranje Slovenia

Riastap 1 g Germany, Ireland

Riastap Belgium, Cyprus, Denmark, Finland, Greece, Iceland, Italy, Luxembourg, Malta, Norway, Poland, Slovakia, Spain, Sweden

Last review date of this leaflet: December 2023

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/

This information is intended solely for healthcare professionals:

Dosage

The level of fibrinogen (functional) must be determined in order to calculate the individual dose and the amount and frequency of administration, which must be calculated for each patient through periodic measurement of the fibrinogen level in plasma and continuous monitoring of the patient's clinical situation and other substitutive therapies applied.

The normal level of fibrinogen in plasma is within the range of 1.5 - 4.5 g/l. The critical level of fibrinogen in plasma below which there is a possibility of bleeding is approximately 0.5 - 1.0 g/l. In the case of major surgery, it is essential to control the substitution therapy through coagulation tests.

Initial dose

If the patient's fibrinogen level is unknown, the recommended dose is 70 mg per kg of body weight, administered intravenously.

Subsequent doses

In mild cases (e.g. nasal bleeding, intramuscular hemorrhage or menorragia) the level to be achieved is 1 g/l, which must be maintained for at least three days. In important cases (e.g. head trauma or intracranial hemorrhage) the level to be achieved is 1.5 g/l, which must be maintained for seven days.

Dose of fibrinogen = [Target level (g/l) - measured level (g/l)]

(mg/kg of body weight) 0.017 (g/l per mg/kg of body weight)

Dosage for neonates, infants and children

There are limited data from clinical studies on the dose of Riastap in children. As a result of these studies, as well as extensive clinical experience with products containing fibrinogen, the recommended doses in the treatment of children are the same as those recommended for adults.

Method of administration

General instructions

• The reconstitution and transfer must be performed in aseptic conditions.
• Before administration, the reconstituted solutions must be visually inspected for foreign particles and discoloration.
• The solution must be practically colorless or yellowish, clear or slightly opalescent and have a neutral pH. Do not use turbid or particle-containing solutions.

Reconstitution

• Warm the solvent and powder in the vials without opening to room temperature or body temperature (not exceeding 37 °C).
• Riastap must be reconstituted with water for injectable preparations (50 ml, not included).
• Wash your hands or use gloves before reconstituting the product.
• Remove the capsule from the Riastap vial, exposing the central surface of the perfusion stopper.
• Treat the surface of the perfusion stopper with an antiseptic and let it dry.
• Transfer the solvent with a suitable transfer device to the perfusion vial, favoring the complete humidification of the powder.
• Gently agitate the vial until the powder is completely dissolved and the solution is ready for administration. Avoid vigorous agitation, as this would lead to the formation of foam. Generally, the powder dissolves in approximately 5 minutes. It should not take more than 15 minutes to dissolve completely.

• Open the plastic blister containing the Mini-Spike ® aspiration needle provided with Riastap (Figure 2).

Figure 2

• Take the provided aspiration needle and insert it into the stopper of the vial with the reconstituted product (Figure 3).

Figure 3

• After inserting the aspiration needle, remove the cap. After removing the cap, do not touch the exposed surface.
• Open the blister containing the Pall ® needle filter provided with Riastap (Figure 4).

Figure 4

• Attach the syringe to the filter (Figure 5).

Figure 5

• Attach the syringe with the mounted filter to the aspiration needle (Figure 6).

Figure 6

• Aspirate the reconstituted product into the syringe (Figure 7).

Figure 7

• Cuando haya terminado, remove the filter, the aspiration needle and the empty vial from the syringe , dispose of them properly and continue with the administration in the usual manner.
• The reconstituted product must be administered immediately through a separate injection/infusion line.
• Be careful not to allow blood to enter the syringes containing the product.

Administration

For intravenous administration, at room temperature, it is recommended to use a standard infusion kit.

Inject or infuse the reconstituted solution slowly intravenously at a comfortable rate for the patient.

The injection or infusion rate should not exceed 5 ml per minute.