1 g Powder for solution for injection/infusion
human fibrinogen
What Riastap is and what it is used for
What is Riastap?
Ripstop contains human fibrinogen, which is a protein that is important for the blood to coagulate (coagulate). Lack of fibrinogen prevents the blood from coagulating as quickly as it should, resulting in an increased tendency for bleeding. By replacing human fibrinogen with Riastap, the coagulation disorder can be corrected.
What is Riastap used for?
Ripstop is used to treat bleeding in patients who have a congenital deficiency of fibrinogen (hypo- or afibrinogenemia) with an increased risk of bleeding.
What you need to know before using Ripstop
The following sections contain information that your doctor should consider before receiving 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). Tell your doctor if you are allergic to any medicine or any food.
Warnings and Precautions:
- if you have had allergic reactions to Riastap before. If your doctor advises you to, you should take antihistamines and corticosteroids for prevention.
- in case of an allergic or anaphylactic reaction (a severe allergic reaction that causes great difficulty in breathing or dizziness). The use of Riastap should be discontinued immediately (ie discontinue the infusion ).
- as there is an increased risk of blood clots ( thrombosis ), especially:
- at high doses or in repeated dosing
- if you have had a heart attack (previously had heart disease or heart attack)
- if you have any liver disease
- if you have just undergone surgery ( postoperative patient)
- if you will be operated on soon ( preoperative patient)
- in newborns
- if you have a higher-than-normal risk of developing blood clots (patients at risk of thromboembolic events or disseminated intravascular coagulation).
Your doctor will carefully consider the benefits of Riastap treatment compared to the risk of the above complications.
Virus security
When medicines are made from human blood or plasma, special measures are taken to prevent the transmission of infection to patients. This includes:
- a careful selection of blood and plasma donors to ensure that people at risk of being carriers are excluded, and
- testing of individual donations and plasma pools for signs of virus/infection.
Manufacturers of these products also include steps in the handling of blood and plasma that can inactivate or secrete any viruses. Nevertheless, the risk of transmission of infection can not be completely ruled out when drugs made from human blood or plasma are given. This also applies to unknown or new viruses and other types of infection.
The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus ( HIV which causes AIDS ), hepatitis B and hepatitis C virus ( inflammation of the liver), and against non-enveloped viruses such as hepatitis A ( inflammation of the liver).
The measures may be of limited value against non-enveloped viruses such as parvovirus B19.
Parvovirus B19 infection can be serious
- for pregnant women ( fetal infection ) and
- people with a weakened immune system or with certain types of anemia (eg sickle cell anemia or hemolytic anemia ).
Your doctor may suggest vaccination against hepatitis A and B if you are regularly / repeatedly treated with human plasma-derived preparations.
It is strongly recommended that the date of administration, batch number, and injected volume be recorded each time you receive Riastap.
Other medicines and Riastap
- Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
- Riastap should not be mixed with other medicines other than those mentioned in the section “The following information is intended for healthcare professionals only” under “Preparation”.
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 taking this medicine.
- Riastap should only be given during pregnancy and breastfeeding if your doctor deems it necessary.
Driving and using machines
Riastap has no or negligible effect on your ability to drive or use machines.
Riastap contains sodium
Riastap contains up to 164 mg sodium (7.1 mmol) per vial, which is equivalent to 11.5 mg (0.5 mmol) sodium per kg body weight if the recommended starting dose of 70 mg/kg body weight is used. This should be considered if you have been prescribed a low-salt diet.
How to use Riastap
Treatment should be initiated and supervised by a physician experienced in this type of treatment.
Dosage
The amount of human fibrinogen you need and how long you should be treated depends on:
- how severe your illness is
- where the bleeding occurred and how severe it is
- your general condition.
If you use more Riastap than you should
Your doctor should regularly check your coagulation status during treatment. In the event of an overdose, the risk of developing thromboembolic complications increases.
If you have used more Riastap than prescribed or if a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.
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” ).
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately:
- if any of the side effects occur
- if you notice any side effects not mentioned in this information.
The following side effects have been observed in very common cases (may affect more than 1 user in 10):
- Elevated body temperature
The following side effects have been observed in less common cases (may affect up to 1 in 100 people):
- Sudden allergic reaction (such as redness of the skin, rash all over the body, drop in blood pressure, difficulty breathing).
The following side effects have been observed in common cases (may affect up to 1 in 10 people; however, the incidence was higher in patients receiving fibrinogen):
- Increased risk of blood clots (see section 2 “What you need to know before using Riastap”).
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.
- Store in a refrigerator (2 ° C-8 ° C).
- Do not freeze.
- Keep the vial in the outer carton. Sensitive to light.
- The reconstituted solution should be used immediately.
- If the reconstituted solution is not used immediately, it must be stored at room temperature (maximum 25 ° C) and the solution must be used within 8 hours.
- The reconstituted solution should not be stored in the refrigerator.
Contents of the package and other information
Content declaration
The active substance is:
Human fibrinogen (1 g / vial; after reconstitution with 50 ml of water for injections approximately 20 mg/ml).
See section “The following information is intended for healthcare professionals only” for further information.
Other ingredients are:
Human albumin, sodium chloride, L-arginine hydrochloride, sodium citrate, and sodium hydroxide (for pH adjustment).
See the last paragraph in section 2. ” Riastap contains sodium “.
What the medicine looks like and the contents of the pack
Riastap is a white powder.
After reconstitution with water for injections, the solution should be clear or slightly opalescent, ie the solution may shine when held against the light but should not contain any visible particles.
Packaging
A 1 g pack contains (Figure 1):
- A vial containing 1 g of human fibrinogen
- Filter: Pall ® spray filter
- Retractable nail: Mini-Spike ® retractable nail
Marketing Authorization Holder and Manufacturer:
CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany
This medicinal product is authorized under the European Economic Area under the names:
| Riastap 1 g powder for solution for injection/infusion | UK |
| Riastap 1g, powder for injectable/perfusion solution | France |
| Riastap 1g prescription for injection or infusion | Slovenia |
| Riastap 1 g | Germany, Ireland |
| Riastap | Belgium, Cyprus, Denmark, Finland, Greece, Iceland, Italy, Luxembourg, Malta, Norway, Poland, Slovakia, Spain, Sweden |