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RIASTAP 1G POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): HUMAN FIBRINOGEN

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pbF1069_Riastap_28_148x630 12.02.2014 06:21 Seite 1

Package Leaflet: Information for the user

Riastap 1 g
Powder for solution for injection / infusion.
Human fibrinogen
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
• If you get any of side effects talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Riastap is and what it is used for
What you need to know before you use Riastap
How to use Riastap
Possible side effects
How to store Riastap
Contents of the pack and other information

1. What Riastap is and what it is used for
What is Riastap?
Riastap contains human fibrinogen which is a protein important for blood clotting (coagulation). Lack of
fibrinogen means that the blood does not clot as quickly as it should, which results in an increased tendency
of bleeding. The replacement of human fibrinogen with Riastap will correct the coagulation defect.

What is Riastap used for?
Riastap is used for treatment of bleeding in patients with a congenital lack of fibrinogen (hypo- or
afibrinogenaemia) with bleeding tendency.

2. What you need to know before you use Riastap
The following sections contain information that your doctor should consider before you are given Riastap.

Do not use Riastap:
• if you are allergic to human fibrinogen or any of the other ingredients of this medicine listed in section 6..
Please inform your doctor if you are allergic to any medicine or food.

Warnings and precautions:
• if you have experienced allergic reactions to Riastap in the past. You should take antihistamines and
corticosteroids prophylactically if advised by your doctor.
• when allergic or anaphylactic-type reactions occur (a serious allergic reaction that causes severe difficulty
in breathing or dizziness). The administration of Riastap should be stopped immediately
(i.e. discontinue injection).
• because of an increased risk of blood clots in a blood vessel (thrombosis), particularly:
– in case of a high dose or repeated dosing
– if you have had a heart attack (a history of coronary heart disease or myocardial infarction)
– if you suffer from liver disease
– if you have just had surgery (patients postoperatively)
– if you will be having surgery soon (patients preoperatively)
– in newborn infants (neonates)
– if you are more likely to suffer from blood clots than normal (patients at risk of thromboembolic
phenomena or disseminated intravascular coagulation)
Your doctor will consider carefully the benefit of treatment with Riastap compared with the risk of these
complications.

Virus safety
When medicines are made from human blood or plasma, certain measures are put in place to prevent
infections being passed on to patients. These include:
• careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded,
and
• the testing of each donation and pools of plasma for signs of virus/infections.
Manufacturers of these products also include steps in the processing of the blood or plasma that can
inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma
are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any
unknown or emerging viruses 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 (inflammation of the liver), and for the
non-enveloped hepatitis A virus (inflammation of the liver).
The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Parvovirus B19 infection may be serious:
– for pregnant women (infection of the unborn child) and
– for individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell
disease or haemolytic anaemia).
Your doctor may recommend that you consider vaccination against hepatitis A and B if you
regularly/repeatedly receive human plasma-derived products.
It is strongly recommended that every time that Riastap is given, your doctor should record the date of
administration, the batch number and the injected volume.

Other medicines and Riastap
• Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
• Riastap must not be mixed with other medicinal products except those mentioned in section “The following
information is intended for healthcare professionals only / Reconstitution”.

Pregnancy and breast-feeding
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
• During pregnancy and breast-feeding Riastap should be given only if it is clearly needed.

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 in Riastap

F1069 G28 A

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The following information is intended for healthcare professionals only
Posology
The (functional) fibrinogen level should be determined in order to calculate individual dosage and the amount
and frequency of administration should be determined on an individual patient basis by regular measurement
of plasma fibrinogen level and continuous monitoring of the clinical condition of the patient and other
replacement therapies used.
Normal plasma fibrinogen level is in the range of 1.5 – 4.5 g/l. The critical plasma fibrinogen level below
which haemorrhages may occur is approximately 0.5 – 1.0 g/l. In case of major surgical intervention, precise
monitoring of replacement therapy by coagulation assays is essential.
Initial Dose
If the patient’s fibrinogen level is not known, the recommended dose is 70 mg per kg body weight
administered intravenously.
Subsequent Dose
The target level (1 g/l) for minor events (e.g. epistaxis, intramuscular bleeding, or menorrhagia) should be
maintained for at least three days. The target level (1.5 g/l) for major events (e.g. head trauma, or intracranial
haemorrhage) should be maintained for seven days.
Dose of fibrinogen
(mg/kg body weight)

=

[Target level (g/l) - measured level (g/l)]
0.017 (g/l per mg/kg body weight)

Dosage for neonates, infants and children
Limited data from clinical studies regarding the dosage of Riastap in children are available. Resulting from
these studies, as well as from long lasting clinical experience with fibrinogen products, dosage
recommendations in the treatment of children are the same as for adults.

Method of Administration
General instructions
• Reconstitution and withdrawal should be carried out under aseptic conditions.
• Reconstituted products should be inspected visually for particulate matter and discoloration prior to
administration.
• The solution should be almost colourless to yellowish, clear to slightly opalescent and of neutral pH. Do not
use solutions that are cloudy or have deposits.
Reconstitution
• Warm both the solvent and the powder in unopened vials to room or body temperature (not above 37 °C).
• Riastap should be reconstituted with water for injections (50 ml, not provided).
• Remove the cap from the Riastap vial to expose the central portions of the infusion stoppers.
• Treat the surface of the infusion stopper with antiseptic solution and allow it to dry.
• Transfer the solvent into the vial using an appropriate transfer device. Ensure complete wetting of the
powder.
• Gently swirl the vial until the powder is reconstituted and the solution is ready for administration.
Avoid strong shaking which causes formation of foam. The powder should be completely reconstituted
within 15 minutes (generally 5 to 10 minutes).
• Reconstituted product should be administered immediately by a separate injection/infusion line.
• Take care that no blood enters syringes filled with product.
Any unused product or waste material should be disposed of in accordance with local requirements.
Administration
A standard infusion set is recommended for intravenous application of the reconstituted solution at room
temperature. The reconstituted solution should be injected or infused slowly at a rate which the patient finds
comfortable. The injection or infusion rate should not exceed approx. 5 ml per minute.

mit Perforation

Riastap contains up to 164 mg (7.1 mmol) sodium per vial. This correlates with 11.5 mg (0.5 mmol) sodium
per kg body weight of the patient if the recommended initial dose of 70 mg/kg body weight is applied. Please
take this into account if you are on a controlled sodium diet.

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3. How to use Riastap
Treatment should be initiated and supervised by a physician who is experienced in 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 site and intensity of the bleeding,
• your clinical condition.

If you use more Riastap than you should
Your doctor should regularly check your blood clot status during the treatment. In case of overdosage, the risk
of development of thromboembolic complications is enhanced.

Method of administration
If you have any further questions on the use of this product, ask your doctor or pharmacist (see section
“The following information is intended for medical or healthcare professionals only” ).

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Please contact your doctor immediately:
• if any of the side effects occur
• if you notice any side effects not listed in this leaflet.
The following side effects have been observed rarely (affects 1 to 10 users in 10,000):
• Increase in body temperature
• A sudden allergic reaction (such as reddening of the skin, skin rash over the whole body, fall in blood
pressure, difficulty in breathing).
The following side effects have been observed very rarely (affects less than 1 user in 10,000):
• Risk of increased formation of blood clots (see section 2 "Take special care with Riastap" ).

Reporting of side effects
If you get any side effects, talk to your doctor or healthcare professional. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects,
you can help provide more information on the safety of this medicine.
UK:
Ireland:
Yellow Card Scheme.
FREEPOST
Website:
Pharmacovigilance Section
www.mhra.gov.uk/yellowcard
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Ireland.
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie

5. How to store Riastap








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 and carton.
Do not store above 25 °C.
Do not freeze.
Keep the vial in the outer carton, in order to protect from light.
The reconstituted product should preferably be used immediately.
If the reconstituted product is not administered immediately, storage shall not exceed 8 hours at room
temperature (max. +25 °C).
• The reconstituted product should not be stored in the refrigerator.

6. Contents of the pack and other information
What Riastap contains
The active substance is:
Human fibrinogen (1 g/vial; after reconstitution with 50 ml of water for injections approx. 20 mg/ml).
See section “The following information is intended for healthcare professionals only” for further information.
The other ingredients are:
Human albumin, sodium chloride, L-arginine hydrochloride, sodium citrate, sodium hydroxide (for pH
adjustment).
See last paragraph of section 2."Important information about some of the ingredients of Riastap".

What Riastap looks like and contents of the pack
Riastap is presented as a white powder.
After reconstitution with water for injections the product should be clear or slightly opalescent, i.e. it might
sparkle when held up to the light but must not contain any obvious particles.

Presentation
Pack with 1 g
1 vial containing 1 g human fibrinogen

Marketing Authorisation Holder and Manufacturer
CSL Behring GmbH
Emil-von-Behring-Strasse 76
35041 Marburg
Germany

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mit Perforation

This leaflet was last revised in 02/2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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