RIASTAP 1 g POWDER FOR INJECTABLE SOLUTION OR INFUSION

2. What you need to know before you use Riastap

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 medicine (listed in section 6).

Tell your doctor if you are allergic to any medicine 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.

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

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

• in case of administration of a high dose or repeated doses,
• if you have had a heart attack (history of coronary artery disease or myocardial infarction),
• if you have 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 blood clots (patients with a risk of thromboembolic events or disseminated intravascular coagulation).

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

Viral safety

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

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

In addition, manufacturers of these products include measures during blood or plasma processing to inactivate or remove viruses. Despite these measures, when medicines are administered that are made from human blood or plasma, the possibility of transmitting infections cannot be completely excluded. This applies to any emerging or unknown virus or other types of infections.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV, the AIDS virus), hepatitis B virus, and hepatitis C virus (liver inflammation), and for non-enveloped 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 medicines made from human plasma.

It is strongly recommended that every time Riastap is administered, a record is kept of the date of administration, the batch number, and the volume injected.

Taking Riastap with other medicines

• Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
• Riastap should not be mixed with other medicines, except those mentioned in the section "This information is intended for healthcare professionals only".

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
• During pregnancy and breastfeeding, Riastap should only be used if clearly indicated.

Driving and using machines

Riastap has no or negligible influence on the ability to drive and use machines.

Important information about some of the ingredients of 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 body weight of the patient, if the recommended initial dose of 70 mg/kg body weight is administered. Please note this if you are on a controlled sodium diet.

3. How to use Riastap

Treatment should be initiated and supervised by a doctor experienced in the treatment of this type of disorder.

Dosage

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

• the severity of your disease
• the location and intensity of the bleeding
• the patient's clinical situation

If you take more Riastap than you should

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

Method of administration

If you have any further questions on the use of this product, ask your doctor or pharmacist (see the section "This information is intended for healthcare professionals only").

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Please tell your doctor immediately:

• if you get any side effects
• if you notice any side effects not listed in this leaflet.

The following side effect is very common (may affect more than 1 in 10 people):

• Increased body temperature

The following side effect has been observed uncommonly (may affect up to 1 in 100 people):

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

The following side effect has been observed frequently (may affect up to 1 in 10 people, 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 you use Riastap").

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

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5. Storage of Riastap

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

6. Further information

Composition of Riastap

The active substance is:

Human fibrinogen (1 g/vial; after reconstitution with 50 ml of water for injections, approx. 20 mg/ml).

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

The other ingredients are:

Human albumin, sodium chloride, L-arginine hydrochloride, sodium citrate dihydrate, sodium hydroxide (for pH adjustment).

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

Appearance of Riastap and contents of the pack

Riastap is presented as a white powder.

After reconstitution with water for injections, the solution obtained should be clear or slightly opalescent, i.e., it may shine when held against the light, but it should not contain any particles.

Presentation

1 g pack (Figure 1)

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

Figure 1

Marketing authorisation 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 medicine is authorised in the Member States of the European Economic Area under the following names:

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

Riastap 1g, powder for solution for injection/infusion 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

Date of last revision of this leaflet:December 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.es/

This information is intended for healthcare professionals only:

Dosage

The level of fibrinogen (functional) should be determined in order to calculate the individual dose and the amount and frequency of administration, which should 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 substitute 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 risk of bleeding is approximately 0.5 - 1.0 g/l. In case of major surgery, control of substitution therapy by coagulation tests is essential.

Initial dose

If the patient's fibrinogen level is not known, the recommended dose is 70 mg per kg of body weight, administered intravenously.

Subsequent doses

In mild cases (e.g., nosebleeds, muscle hemorrhage, or menorragia), the level to be achieved is 1 g/l, which should be maintained for at least three days. In severe cases (e.g., head trauma or intracranial hemorrhage), the level to be achieved is 1.5 g/l, which should be maintained for seven days.

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

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

Dosing for neonates, infants, and children

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

Method of administration

General instructions

• Reconstitution and transfer should be performed under aseptic conditions.
• Before administration, the reconstituted solutions should be visually inspected for foreign particles and discoloration.
• The solution should be practically colorless or yellowish, clear or slightly opalescent, and have a neutral pH. Do not use cloudy solutions or those containing deposits.

Reconstitution

• Allow the solvent and powder in the vials to reach room temperature or body temperature (not above 37°C) without opening.
• Riastap should be reconstituted with water for injections (50 ml, not included).
• Wash your hands or use gloves before reconstituting the product.
• Remove the cap from the Riastap vial, exposing the central surface of the infusion stopper.
• Treat the surface of the infusion stopper with an antiseptic and let it dry.
• Transfer the solvent with a suitable transfer device into the vial, ensuring complete wetting of the powder.
• Gently swirl the vial until the powder is completely dissolved and the solution is ready for administration. Avoid vigorous shaking as this may cause foam formation. The powder usually 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 aspiration needle provided 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 filter needle provided with Riastap (Figure 4).

Figure 4

• Screw the syringe onto the filter (Figure 5).

Figure 5

• Screw the syringe with the mounted filter onto the aspiration needle (Figure 6).

Figure 6

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

Figure 7

• When finished, 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 should be administered immediately through a separate injection/infusion line.
• Be careful not to let blood enter the syringes containing the product.

Administration

For intravenous administration, at room temperature, the use of a standard infusion kit is recommended. Inject or infuse the reconstituted solution slowly intravenously at a comfortable speed for the patient. The injection or infusion rate should not exceed 5 ml per minute.