1 g Powder and solvent for solution for injection/infusion
Human fibrinogen
1. What Fibryga is and what it is used for
What Fibryga is
Fibrous contains human fibrinogen, which is a protein that is important for the blood to coagulate (coagulate). Lack of fibrinogen means that the blood does not clot as well as it should, which leads to an increased tendency to bleed. By replacing the body’s own fibrinogen with Fibryga, you can correct the coagulation disorder.
What Fibryga is used for
Fiber bridge is used for:
– to treat bleeding and as prophylaxis (preventive treatment) in surgical procedures in patients who have an increased risk of bleeding due to a congenital deficiency of fibrinogen (hypo- or afibrinogenemia).
– to replace fibrinogen in patients with uncontrolled severe bleeding and acquired fibrinogen deficiency during surgery.
2. What you need to know before using Fibryga
Do not use Fibryga
- if you are allergic to human fibrinogen or any of the other ingredients of this medicine (listed in section 6).
- if you have previously had allergic reactions to Fibryga.
Tell your doctor if you are allergic to any medicine.
Warnings and cautions
Talk to your doctor or pharmacist before using Fibryga.
Risk of blood clots
Your doctor should evaluate the benefits of this medicine against the risk of blood clots, especially if:
– you have been given a high dose or repeated dose of this medicine
– you have had a heart attack (previously had coronary heart disease or heart attack)
– you have a liver disease
– you have recently undergone surgery (postoperative patients)
– you will undergo an operation (preoperative patients)
– in newborns (neonatal)
– you are likely to have blood clots or coagulation problems in blood vessels (patients at risk for thromboembolic events or multiple intravascular coagulation ).
To monitor the risk, your doctor may ask you to undergo further coagulation tests.
Allergic reactions or reactions of the anaphylactic type
All drugs, which like Fibryga are made from human blood (contain proteins ) and are injected into a vein ( intravenously ), can cause allergic reactions. If you have previously had allergic reactions to Fibryga, your doctor will advise you on the need for allergy medicine.
Your doctor will inform you of the warning signs of allergic or anaphylactic reactions.
Be aware of early signs of allergic reactions (hypersensitivity) such as:
hives
– skin rash
– pressure over the chest
– wheezing
– low blood pressure,
or anaphylactic reaction (when any or all of the above symptoms develop rapidly and are intense).
If they occur, the injection/infusion of Fibryga should be stopped immediately (ie discontinue injection one).
Virus security
When medicines are prepared from human blood or plasma, certain measures are taken to prevent the transmission of infection to patients. These include:
– careful selection of blood and plasma donors to ensure that people at risk – for being carriers – are excluded
testing of individual donations and plasma pools for signs of viruses/infections
inclusion of steps in the management of blood/plasma that can inactivate or eliminate viruses.
Despite these measures, the risk of transmission of infection can not be completely ruled out when using drugs prepared from human blood or plasma. This also applies to new, hitherto unknown viruses or other types of infection.
The measures taken are considered effective for enveloped viruses, such as human immunodeficiency virus ( HIV ), hepatitis B virus, and hepatitis C virus, as well as for non-enveloped hepatitis A virus. Measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Parvovirus B19 infection can be serious in pregnant women ( fetal infection ) and in people with weakened immune systems or who have certain types of anemia (eg sickle cell anemia or abnormal red blood cell breakdown ).
It is strongly recommended that you write down the product name and batch number each time you receive Fibryga to maintain a register of which batches are used.
Your doctor may recommend that you consider being vaccinated against hepatitis A and B if you regularly / repeatedly receive fibrinogen products from human plasma.
Children and young people
There are no special or additional warnings or precautions for children and adolescents.
Other drugs and Fibryga
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Fibryga must not be mixed with other medicines other than those mentioned in the section “The following information is intended for healthcare professionals / Preparations only”.
Pregnancy, breastfeeding, and fertility
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. This product should only be used during pregnancy or breast-feeding on the advice of a doctor or pharmacist.
Driving and using machines
Fiber bridge has no or negligible effect on the ability to drive vehicles and use machines.
Fibrous contains sodium
This medicine contains up to 132 mg of sodium (the main ingredient in table salt/table salt) per bottle. This corresponds to 6.6% of the maximum recommended daily intake of sodium for adults. Take this into account if you have been prescribed a low-salt diet.
3. How to use Fibryga
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
Fibrous is given as an intravenous infusion ( infusion into a vein) by healthcare professionals.
Dose and dosing regimen will depend on:
– your weight the
the severity of the disease
where the bleeding occurred or
the type of operation and
– your state of health
Use for children and adolescents
The use of Fibryga in children and adolescents ( intravenously ) does not differ from the use in adults.
If you use too much Fibryga
To avoid the risk of overdose, your doctor will take regular blood tests to measure your fibrinogen levels.
In case of overdose, the risk of abnormal blood clots may increase.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Method of administration
This medicine should be injected or infused into veins after reconstitution with the diluent provided. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately:
- if you get any side effects (see below)
- if you notice any side effects not mentioned in this leaflet
The following side effects have been reported with Fibryga and other fibrinogen products (affects an unknown number of users):
- Allergic or anaphylactic-type reactions: skin reactions (see section 2 “Warnings and precautions”)
- Cardiovascular reactions: thromboembolism, pulmonary embolism thrombophlebitis (see section 2 “Warnings and precautions”)
- Increased body temperature
If you experience any of the above symptoms, consult a doctor as soon as possible.
Reporting of side effects ar
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.
The Medical Products Agency
Box 26
751 03 Uppsala
5. How to store Fibryga
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. The expiration date is the last day of the specified month.
Do not store above 25 ° C. Do not freeze. Store the bottle in the outer carton. Sensitive to light.
The powder should only be dissolved just before injection/infusion. The stability of the reconstituted solution has been demonstrated for 24 hours at room temperature (max. 25 ° C). However, to prevent contamination, the solution should be used immediately and only once. The reconstituted solution must not be stored in the refrigerator or freezer.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is human fibrinogen.
- Fibroga contains 1 g human fibrinogen per vial or 20 mg/ml human fibrinogen after reconstitution with the supplied diluent (50 ml water for injections ).
- The other ingredients are L-arginine hydrochloride, glycine, sodium chloride, and sodium citrate (dihydrate).
What the medicine looks like and the contents of the pack
Fibryga is delivered as a powder and diluent for injection/infusion, a solution provided in glass bottles.
The powder is white or pale yellow and moisture-absorbing, which also appears as a crumbled dry substance.
The diluent is clear and colorless.
The prepared solution is almost colorless and slightly opalescent.
Fiber bridge is sold in a package that contains:
- 1 vial of powder for solution for injection/infusion
- 1 vial of diluent (water for injections)
- 1 Octajet transfer set
- 1 particle filter
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Octapharma AB
Lars Forssells gata 23
75 Stockholm
Manufacturer
Octapharma Pharmazeutika Produktionsges.mbH
Oberlaaer Strasse 235, 1100 Vienna, Austria
Octapharma AB
Lars Forssells gata 23, 75 Stockholm
This medicinal product is authorized under the European Economic Area under the names:
Fibers: Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Ireland, Iceland, Italy, Croatia, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, United Kingdom, Czech Republic, Germany, Hungary, Austria
Fibrema: Slovenia