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FIBROGAMMIN 250/1250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): FACTOR XIII

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FIBROGAMMIN® 250/1250 IU
Powder and solvent for injection or infusion
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again. If you have further questions, please ask
your doctor or your haemophilia nurse. This medicine has been prescribed for you
personally and you should not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
IN THIS LEAFLET:
1. What Fibrogammin is and what it is used for
2. Before you use Fibrogammin
3. How to use Fibrogammin
4. Possible side effects
5. Storing Fibrogammin
6. Further information
1.

WHAT FIBROGAMMIN IS AND WHAT IT IS USED 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.

3.

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:
F4659 G28 A

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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.

SUMMARY OF PRODUCT CHARACTERISTICS
1.

5

6. Gently swirl the product vial with the transparent adapter
attached until the substance is fully dissolved. Do not shake.
2.

6

HOW TO USE 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.

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.

8

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.

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.

2

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.

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.

N

PATIENT INFORMATION LEAFLET

• Careful selection of the 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.

3

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.

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 by a separate injection/infusion line by
slow intravenous injection, at a rate not 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.

NAME OF THE MEDICINAL PRODUCT
Fibrogammin 250/1250 IU
Powder and solvent for solution for injection or infusion
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Fibrogammin is a purified concentrate of blood coagulation
factor XIII (FXIII). It is derived from human plasma and is presented as a white powder.
Each vial contains nominally 250 or 1250 IU human plasma coagulation factor XIII.
Fibrogammin contains approximately 62.5 IU/ml (250 IU/4 ml or 1250/20 ml) of
human plasma coagulation factor XIII when reconstituted with 4 ml or 20 ml water
for injections, respectively.
The specific activity of Fibrogammin is approximately 3.1 – 13.3 IU/mg protein.
Excipients with known effect: Sodium (as chloride and hydroxide): 2.78 to 4.36 mg/ml
(120 to 189 mmol/L)
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Powder and solvent for solution for injection/infusion.
White powder and clear, colourless solvent.
4. CLINICAL PARTICULARS
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.

4

2

3

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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 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
fibrinstabilising 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.
8

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 Interactions 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 Rare
reactions (like generalised
urticaria, rash, fall in
blood pressure, dyspnoea)
Development of
inhibitors to FXIII

General Disorders and
Administration Site
Conditions

Very rare

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
4.9 Overdose
No cases of overdose have been reported.

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PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antihaemorrhagics
ATC code: B02B D07
Biochemically, factor XIII acts as transglutaminase.
Factor XIII connects the amino group of lysine with glutamine via its enzymatic
function (transamidase activity), thereby leading to the cross-linking of fibrin
molecules. This is the final stage of blood coagulation. Fibrin cross-linking and
stabilisation promote the penetration of fibroblasts and support wound healing.
Paediatric population
In clinical studies that included subjects with congenital FXIII deficiency <18 years
old, the prophylactic administration with Fibrogammin every 28 days was successful
in maintaining trough FXIII activity levels of approximately 5% to 20%.
5.2 Pharmacokinetic properties
Distribution
The product is administered intravenously, and is thus immediately bioavailable
resulting in a plasma concentration corresponding to the applied dose.
Elimination
In patients with congenital factor-XIII-deficiency the biological half-life of
Fibrogammin was determined to be 6.6 ± 2.29 days (mean ± SD).
Fibrogammin is metabolised in the same way as is the endogenous coagulation
factor XIII.
An overview of pharmacokinetic parameters (adult population/18 years and older) is
given in the following table:
Parameters
AUCss 0 - ∞ (units/hr/ml)
Css max (units/ml)*
Css min (units/ml)*
Tmax (hr)
T½ [days]
CL [ml/hr/kg]
Vss [ml/kg]
MRT [days]

Median (min-max)
182.9 (133.5-300.2)
0.9 (0.6-1.2)
0.07 (0.0-0.16)
1.2 (0.7-4.2)
7.8 (3.1-11.02)
0.22 (0.13-0.30)
49.4 (31.65-62.91)
11.7 (5.7-17.02)

AUCss (0-∞): Area under the plasma concentration curve from time 0 to infinity at steady state
*100% activity corresponds to 1 unit/ml
Css max: Peak concentration at steady state
Css min: Trough concentration at steady state
Tmax: Time to peak concentration
T½: Half-life
CL: Clearance
Vss: Volume of distribution at steady state
MRT: Mean residence time

Paediatric population
Of the 188 unique subjects in the Factor XIII concentrate (human) clinical studies,
117 were subjects <18 years of age at the time of enrolment (1 month to <2 years,
n=17; 2 to <12 years, n=62; 12 to <16 years, n=30; 17 to 18 years, n=8).
In the pharmacokinetic study PK 2002, 5 of the 14 subjects ranged in age from
2 to <18 years (2 – 11 years, n=3; 12 – 16 years, n=2; 17 – 18 years, n=0).
Subjects less than 16 years had a shorter half-life and faster clearance (half-life:
5.7±1.00 days; clearance: 0.291±0.12 ml/hr/kg) compared to adults (half-life:
7.1±2.74 days, clearance: 0.22±0.07 ml/hr/kg).
The product has a shorter half-life and faster clearance in children compared to adults.
However, since across all age groups dosing is individually determined by subject
weight and adjusted by trough FXIII activity, no specific age related dosing is
needed.

6.2 Incompatibilities
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.

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.

6.3 Shelf life
3 years
Do not use after the expiry date given on the pack and container.
Do not freeze reconstituted solution.
Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C.
From a microbiological point of view, unless the method of opening and reconstitution
precludes the risk of microbial contamination, the product should be used
immediately. If not used immediately, storage times and conditions are the
responsibility of the user.

4

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.

6.4 Special precautions for storage
Store in a refrigerator (+2 to +8 °C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
6.5 Nature and contents of container
Vials:
250 IU
Powder: injection vial of colourless glass, sealed with a bromobutyl rubber stopper,
aluminium cap and plastic disc.
Solvent (Water for Injections): vial of colourless glass
1250 IU
Powder: injection vial of colourless glass, sealed with a bromobutyl rubber stopper,
aluminium cap and plastic disc.
Solvent (Water for Injections): vial of colourless glass.
Presentations:
Pack with 250 IU
1 vial with powder
1 vial with 4 ml Water for Injections
1 filter transfer device 20/20 (Mix2Vial)
Pack with 1250 IU
1 vial with powder
1 vial with 20 ml Water for Injections
1 filter transfer device 20/20 (Mix2Vial)
6.6 Special precautions for disposal and other handling
General instructions
• The solution should be clear or slightly opalescent. After filtering/withdrawal (see
below) the reconstituted product should be inspected visually for particulate matter
and discoloration prior to administration.
• Reconstitution and withdrawal must be carried out under aseptic conditions.
• Do not use solutions which are cloudy or contain residues (deposits/particles).
Reconstitution:
Bring the solvent to room temperature. Ensure 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

5.3 Preclinical safety data
The proteins contained in Fibrogammin are sourced from human plasma and act like
human plasma proteins.
Single and repeated dose toxicity studies in animals did not reveal a toxic potential
for Fibrogammin.
Studies on reproduction and embryo-foetal development have not been conducted.
6.

N

5.

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.

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

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.

8

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

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 by a separate injection / infusion line
by slow intravenous injection, at a rate not exceeding 4 ml per minute.
Any unused product or waste material should be disposed of in accordance with local
requirements.
7.

*see also section 4.4

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, (see
details below). By reporting side effects, you can help provide more information on the
safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
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

8.

Marketing Authorisation Holder and Manufacturer
CSL Behring GmbH
Emil-von-Behring-Strasse 76
35041 Marburg, Germany
This leaflet was last revised in 07/2015.

MARKETING AUTHORISATION NUMBER(S)
PL 15036/0006

9.

Other ingredients are:
• human albumin
• glucose monohydrate
• sodium chloride
• traces of sodium hydroxide may be present, (used for pH adjustment).
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
CSL Behring GmbH
Emil-von-Behring-Strasse 76
35041 Marburg, Germany

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
22 June 1998 / 30 October 2003

2

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.

POSSIBLE SIDE EFFECTS

Like all medicines, Fibrogammin can cause side effects, although not everybody gets them.

What Fibrogammin contains
The active substance is:
• 250/1250 International Units (IU) human plasma coagulation factor XIII

PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Powder
Human albumin
Glucose monohydrate
Sodium chloride*
Sodium hydroxide (for pH adjustment)

4.

10. DATE OF REVISION OF THE TEXT
September 2015

Solvent:
Water for Injections
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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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