FIBROGAMMIN Powder and solvent for solution for injection Ref.[9446] Active ingredients: Coagulation factor XIII

In patients with known allergies to the product, with symptoms such as generalised urticaria, rash, a fall in blood pressure, dyspnoea, antihistamines and corticosteroids may be administered prophylactically.

Allergic-type hypersensitivity reactions are possible with Fibrogammin. If symptoms of hypersensitivity (such as hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis) occur, the Fibrogammin infusion should be discontinued immediately. In case of shock, the current medical standards for shock treatment should be implemented.

In cases of fresh thromboses caution should be exercised on account of the fibrin-stabilising effect of Factor XIII.

Immunogenicity

Development of inhibitory antibodies against FXIII has been detected in patients receiving Fibrogammin. Therefore, patients should be monitored for possible development of inhibitory antibodies. The presence of inhibitory antibodies may manifest as an inadequate response to treatment. If expected plasma FXIII activity levels are not attained, or if breakthrough bleeding occurs during prophylaxis, FXIII inhibitory antibody concentrations should be measured.

Note for diabetic patients

Fibrogammin contains glucose (24 mg per 250 IU). When administering a dose of 40 IU/kg body weight to a patient with 75 kg body weight, a maximum of 288 mg glucose will be supplied.

Note for patients on a low sodium diet

Fibrogammin contains 124.4 to 195.4 mg (5.41 to 8.50 mmol) sodium per dose (40 IU/body weight – for average of 70 kg), if the recommended dose (2800 IU = 44.8 ml) is applied. To be taken into consideration in patients on a controlled sodium diet.

Virus safety

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) and for the non-enveloped viruses hepatitis A and parvovirus B19.

It is strongly recommended that whenever Fibrogammin is administered to a patient, the product name and batch number are recorded in order to maintain a link between the patient and the batch of the product.

Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived factor XIII products.

No interaction studies have been performed.

Pregnancy

Limited data on the clinical use of Fibrogammin in pregnancy did not show any negative effects on the course of gestation and the peri- or postnatal development. The use of Fibrogammin may be considered during pregnancy, if necessary.

Breastfeeding

There are no data on the excretion of Fibrogammin into human milk. However, based on its large molecular size excretion into milk is unlikely and due to its proteinaceous character, absorption of intact molecules by the infant is also unlikely. Therefore, Fibrogammin can be used during breastfeeding.

Fertility

There are no data regarding effects of Fibrogammin on fertility.

No studies on the effects on the ability to drive and use machines have been performed.

The following adverse reactions are based on post-marketing experience.

Tabulated list of adverse reactions

The table presented below is according to the MedDRA system organ classification. Frequencies have been evaluated according to the following convention:

very common: ≥1/10, common: ≥1/100 and <1/10, uncommon: ≥1/1,000 and <1/100, rare: ≥1/10,000 and <1/1,000, very rare: <1/10,000.

Immune System Disorders

Rare: Allergoid-anaphylactoid reactions (like generalised urticaria, rash, fall in blood pressure, dyspnoea)

Very rare: Development of inhibitors to FXIII

General Disorders and Administration Site Conditions

Rare: Rise in temperature

If allergoid-anaphylactoid reactions occur, the administration of Fibrogammin has to be discontinued immediately and an appropriate treatment initiated. The current medical standards for shock treatment are to be observed.

Paediatric population

The safety profile for paediatric patients is no different from that of adults in clinical studies.

For safety with respect to transmissible agents, see section 4.4.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the UK Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Fibrogammin must not be mixed with other medicinal products, diluents, or solvents except those mentioned in section 6.6 and should be administered by a separate infusion line.