The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.Source: electronic medicines compendium (emc), DatapharmActive substance: factor xiiiOfficial document: view the original leaflet on emc →Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

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Fibrogammin 250 / 1250 IU Powder and solvent for solution for injection or infusion

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Factor xiii may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Factor xiii

Source: electronic medicines compendium (emc)

Official leaflet: Read the PIL on emc

What it is and what it is used for

FOR Fibrogammin (Factor XIII) is a product made from human plasma (this is the liquid part of the blood). It is used to prevent or stop the bleeding that you might get because of a lack of factor XIII in your blood, a condition that you have had from birth. Factor XIII is needed for the formation of blood clots which help bleeding to stop and helps slow healing wounds to heal more quickly.

2. BEFORE YOU USE FIBROGAMMIN Do not use Fibrogammin

If you are allergic to any of the ingredients (see section 6). If you are unsure about this, ask your doctor. Take special care with Fibrogammin
If you experience any signs of an allergic reaction to Fibrogammin (for example a rash, tight chest, wheezing or feeling dizzy), stop injecting the product immediately and contact your doctor.
You should visit your doctor or haemophilia treatment centre regularly to ensure that your dose is correct. The doctor may wish to carry out some tests to make sure that you are getting the right amount.
If your bleeding is not being controlled with Fibrogammin, tell your doctor immediately. You may have developed an inhibitor (an antibody which can cancel out the effects of factor XIII) and your doctor may wish to carry out more tests to confirm this. Note: After repeated treatment, patients should be carefully monitored for the development of inhibitors to Factor XIII by appropriate clinical observation and laboratory tests.

•

If you have ever had a blood clot (thrombosis), you should ask your doctor for advice. See section 4 for signs of a thrombosis.

Taking or using other medicines There are no medicines that are known to react with Fibrogammin. However, if you are taking another medicine and are concerned, please ask your doctor or haemophilia nurse. Fibrogammin must not be mixed with other medicinal products except those mentioned in section 3 and should be administered by a separate infusion line. Pregnancy and breast-feeding If you are pregnant or planning a family soon, or if you are breast-feeding, ask your doctor for advice before using this product. Driving and using machines No studies on the effects on the ability to drive and use machines have been performed. Important information about some of the ingredients of Fibrogammin Fibrogammin contains up to 189 mmol/L sodium (17/87 mg per 250/1250 IU vial). Please take this into account if you are on a sodium (salt) controlled diet as you may need to cut down on the salt in your diet. Fibrogammin contains 24/120 mg glucose per 250/1250 IU vial. Please take this into account if you have diabetes. Important safety information related to infections When medicines are made from human blood, steps are taken to prevent virus infections being passed on to the patient. These steps include:

Careful selection of blood donors to ensure that those at risk of carrying infections are excluded,
Testing of each donation for signs of infection,
Steps in the manufacture to inactivate or remove viruses. The measures taken are considered effective for enveloped viruses such as HIV, hepatitis B and C and for the non-enveloped viruses hepatitis A and parvovirus B19. However, there is still a small chance of an infection being passed on to the patient. This may include a new virus or other type of infection. Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived factor XIII products. Every time you receive a dose of Fibrogammin, it is important to note the name and batch number of the medicine (shown on the carton) in order to maintain a record of the batches used.

How to take it

FIBROGAMMIN

The amount of factor XIII you need will depend on several factors, such as your weight, the severity of your condition, the site and severity of bleeding or the need to prevent bleeding during an operation or investigation. Fibrogammin is given by injection or infusion into a vein. If you have been prescribed Fibrogammin to use at home, your doctor or haemophilia centre nurse will make sure that you are shown how to inject it and how much to use. If you are in any doubt about injecting Fibrogammin, go back to your doctor or haemophilia centre for more advice and training before attempting to treat yourself. Follow the directions given to you by your doctor or haemophilia nurse. You can also use the directions given below as a guide. Directions for preparing and administering Fibrogammin Wash your hands thoroughly using soap and warm water. Warm the Fibrogammin powder and liquid (Water for Injections) vials to room temperature without opening either container. You can do this by leaving them to stand at room temperature for about an hour after taking them out of the fridge or if you need them quickly, hold them in your hands for a few minutes. DO NOT expose the containers to direct heat or stand them on a radiator. They must not be heated above body temperature (37o C). Ensure that product and solvent vial flip caps are removed and the stoppers are treated with an antiseptic solution and allowed to dry, prior to opening the Mix2Vial package. 1. Open the Mix2Vial package by peeling off the lid. Do not remove the Mix2Vial from the blister package! 1

2. Place the solvent vial on an even, clean surface and hold the vial tight. Take the Mix2Vial together with the blister package and push the spike of the blue adapter end straight down through the solvent vial stopper. 3. Carefully remove the blister package from the Mix2Vial set by holding at the rim and pulling vertically upwards. Make sure that you only pull away the blister package and not the Mix2Vial set.

4. Place the product vial on an even and firm surface. Invert the solvent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the product vial stopper. The solvent will automatically flow into the product vial.

5. With one hand grasp the product-side of the Mix2Vial set and with the other hand, grasp the solvent-side and unscrew the set counter-clockwise carefully into two pieces. Discard the solvent vial with the blue Mix2Vial adapter attached. 5 6. Gently swirl the product vial with the transparent adapter attached until the substance is fully dissolved. Do not shake. 6 7. Draw air into an empty, sterile syringe. While the product vial is upright, connect the syringe to the Mix2Vial's Luer Lock fitting by screwing clockwise. Inject air into the product vial.

7 Once you have made up the solution according to the instructions above, it should be used immediately in order to avoid microbial contamination. Do not freeze the reconstituted solution. Withdrawal and application 8. While keeping the syringe plunger pressed, turn the system upside down and draw the solution into the syringe by pulling the plunger back slowly.

9. Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial adapter from the syringe by unscrewing counter-clockwise.

9 The solution should be clear or slightly opalescent. After filtering/withdrawal the reconstituted product should be inspected visually for particulate matter and discoloration prior to administration. Do not use solutions which are cloudy or contain residues (deposits/particles). Care should be taken that no blood enters the syringe filled with product, as there is a risk that the blood could coagulate in the syringe and fibrin clots could therefore be administered to the patient. In case more than one vial of Fibrogammin is required, it is possible to pool several vials of Fibrogammin for a single infusion via a commercially available infusion device. The Fibrogammin solution must not be diluted. The reconstituted solution should be administered into a separate injection / infusion line (provided with the product) by slow intravenous injection, at a rate note exceeding 4 ml per minute. Any unused solution should be left in the vial or syringe. Dispose of all vials, needles, syringes and antiseptic swabs as you have been told. Do not throw them away with your household rubbish. If you use more Fibrogammin than you should No cases of overdose have been reported. If you forget to use Fibrogammin Inject your normal dose as soon as you remember and then continue as instructed by your doctor or haemophilia nurse.

Possible side effects

Like all medicines, Fibrogammin can cause side effects, although not everybody gets them. Rare side effects (affect less than 1 in 1,000 people):

Rise in temperature
Rash, itchy swellings on the skin (hives)
Low blood pressure which could make you feel faint or dizzy
Difficulty breathing

Fibrogammin could increase your risk of a thrombosis. Symptoms of a thrombosis include:

Unusual pain or swelling in your legs
Sudden sharp pain in your chest
Sudden difficulty breathing
An unusual, severe or long-lasting headache
Dizziness or fainting If you have any of these symptoms, stop your injection immediately and contact your doctor. If you notice that your Fibrogammin is less effective than usual, contact your doctor or haemophilia centre immediately. 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 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 By reporting side effects, you can help provide more information on the safety of this medicine.

5. STORING FIBROGAMMIN Store in a fridge at 2 oC to 8 oC, in the original packaging. Do not freeze. Keep out of the sight and reach of children. Do not use Fibrogammin after the expiry date on the carton.

6. FURTHER INFORMATION What Fibrogammin contains The active substance is:

250/1250 International Units (IU) human plasma coagulation factor XIII Other ingredients are:
human albumin
glucose monohydrate
sodium chloride
traces of sodium hydroxide may be present, (used for pH adjustment). Presentations

Pack with 250 IU 1 vial with powder 1 vial with 4 ml Water for Injections 1 filter transfer device 20/20 Administration set (inner box): 1 disposable 5 ml syringe 1 venipuncture set 2 alcohol swabs 1 non-sterile plaster Pack with 1250 IU 1 vial with powder 1 vial with 20 ml Water for Injections 1 filter transfer device 20/20 (Mix2Vial) Administration set (inner box): 1 disposable 20 ml syringe 1 venipuncture set 2 alcohol swabs 1 non-sterile plaster Bottles of product and liquid may appear partly empty but this is normal and does not mean that there is the wrong amount of powder or solution. Marketing Authorisation Holder and Manufacturer CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: United Kingdom CSL Behring UK Ltd. Tel: +44 (0)1444 447405 This leaflet was last revised in 06/2018.

Frequently asked questions about Fibrogammin 250 / 1250 IU Powder and solvent for solution for injection or infusion

How do I take Fibrogammin 250 / 1250 IU Powder and solvent for solution for injection or infusion?

Fibrogammin 250 / 1250 IU Powder and solvent for solution for injection or infusion comes as injection containing 1250iu. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Fibrogammin 250 / 1250 IU Powder and solvent for solution for injection or infusion?

The active substance in Fibrogammin 250 / 1250 IU Powder and solvent for solution for injection or infusion is factor xiii.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Fibrogammin 250 / 1250 IU Powder and solvent for solution for injection or infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Fibrogammin 250 / 1250 IU Powder and solvent for solution for injection or infusion without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Source: electronic medicines compendium (emc), Datapharm
Active substance: factor xiii
Official document: view the original leaflet on emc →

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Factor xiii (1 medicine)

See every medicine containing this substance, or browse the full A–Z of active substances.

⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+

Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Fibrogammin is indicated for adult and paediatric patients.

Congenital deficiency of Factor XIII and resultant haemorrhagic diathesis, haemorrhages and disturbances in wound healing.

4.2. Posology and method of administration

Posology

1 ml is equivalent to 62.5 IU, and 100 IU are equivalent to 1.6 ml, respectively.

Important: The amount to be administered and the frequency of administration should always be orientated towards clinical efficacy in the individual case.

Dosage

The dosing regimen should be individualised based on body weight, laboratory values, and the patient's clinical condition.

Routine prophylaxis dosing schedule for treatment of congenital FXIII deficiency

Initial dose

• 40 International Units (IU) per kg body weight

• The injection rate should not exceed 4 ml per minute.

Subsequent dosing

• Dosing should be guided by the most recent trough FXIII activity level, with dosing every 28 days (4 weeks) to maintain a trough FXIII activity level of approximately 5 to 20%.

• Recommended dosing adjustments of ± 5 IU per kg should be based on trough FXIII activity levels as shown in Table 1 and the patient's clinical condition.

• Dosing adjustments should be made on the basis of a specific, sensitive assay used to determine FXIII levels.

An example of dose adjustment using the standard Berichrom® FXIII activity assay is outlined in Table 1 below.

Table 1: Dose adjustment using the Berichrom® FXIII activity assay

Factor XIII Activity Trough Level (%)

Dosage Change

One trough level of <5%

Increase by 5 units per kg

Trough level of 5% to 20%

No change

Two trough levels of >20%

Decrease by 5 units per kg

One trough level of >25%

Decrease by 5 units per kg

The potency expressed in units is determined using the Berichrom® FXIII activity assay, referenced to the current International Standard for Blood Coagulation Factor XIII, Plasma. Therefore, a unit is equivalent to an International Unit.

Prophylaxis prior to surgery

After the patient's last routine prophylactic dose, if a surgery is scheduled:

• Between 21 and 28 days later – administer the patient's full prophylaxis dose immediately prior to surgery and the next prophylactic dose should be given 28 days later.

• Between 8 and 21 days later – an additional dose (full or partial) may be administered prior to surgery. The dose should be guided by the patient's FXIII activity levels and clinical condition and should be adjusted according to the half-life of Fibrogammin.

• Within 7 days of last dose – additional dosing may not be needed.

Adjustments to dosing may be different from these recommendations and should be individualised, based on FXIII activity levels and the patient's clinical condition. All patients should be monitored closely during and after surgery.

It is recommended to monitor the increase in FXIII-activity with a FXIII assay. In the case of major surgery and severe haemorrhage, the aim is to obtain values within the normal range for healthy people, i.e. 0.7 -1.4 IU/ml.

Paediatric population

The posology and method of administration in children and adolescents is based on body weight and is therefore generally based on the same guidelines as for adults. The dose and/or frequency of administration for each individual should always be guided by the clinical effectiveness and FXIII activity levels. (Please also refer to sections 5.1 and 5.2.)

Elderly population

The posology and method of administration in elderly people (> 65 years) has not been established in clinical studies.

Method of administration

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

After reconstitution the solution should be clear or slightly opalescent. The preparation should be warmed to room or body temperature before administration. Slowly inject or infuse intravenously into a separate injection/infusion line (provided with the product) at a rate which the patient finds comfortable. The injection or infusion rate should not exceed approximately 4ml per minute.

Observe the patient for any immediate reaction. If any reaction takes place that might be related to the administration of Fibrogammin, the rate of infusion should be decreased or the infusion stopped, as required by the clinical condition of the patient.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

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.

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6. Fertility, pregnancy and lactation

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.

4.7. Effects on ability to drive and use machines

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

4.8. Undesirable effects

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.

MedDRA Standard System Organ Class

Adverse Reaction

Frequency

Immune System Disorders

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

Rare

Development of inhibitors to FXIII

Very rare

General Disorders and Administration Site Conditions

Rise in temperature

Rare

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

4.9. Overdose

No cases of overdose have been reported.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

⚠ Not the same combination. This medicine contains Factor xiii. The products below do not contain exactly the same set of active substances — they are not direct substitutes.

OCTANATE 50 UI/ml prescription partial — not the same combinationFACTOR VIII DE COAGULARE · injection / infusion
BERIATE 250 UI prescription partial — not the same combinationFACTOR VIII DE COAGULARE · injection / infusion
BERIATE 500 UI prescription partial — not the same combinationFACTOR VIII DE COAGULARE · injection / infusion
BERIATE 1000 UI prescription partial — not the same combinationFACTOR VIII DE COAGULARE · injection / infusion
BERIATE 2000 UI prescription partial — not the same combinationFACTOR VIII DE COAGULARE · injection / infusion
BERIPLEX P/N 500 UI prescription partial — not the same combinationCOMBINATII (FACTORI DE COAGULARE) · injection / infusion

Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako