GAMUNEX 100 mg /Ml Infusion Solution

Зміст інструкції

1. Gamunex
   1. What is Gamunex and what is it used for
   2. What you need to know before using Gamunex
   3. How to use Gamunex
   4. Possible side effects
   5. How to store Gamunex
   6. Contents of the pack and other information

Gamunex

100 mg/ml solution for infusion
normal human immunoglobulin (IVIg)

Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Gamunexis and what it is used for
• 2. What you need to know before you use Gamunex
• 3. How to use Gamunex
• 4. Possible side effects
• 5. How to store Gamunex
• 6. Contents of the pack and other information

1. What is Gamunex and what is it used for

What is Gamunex

Gamunexcontains normal human immunoglobulin (antibodies) in the form of a highly
purified protein extracted from human plasma (a part of the blood of donors). This medicine belongs
to the group of medicines called intravenous immunoglobulins, used in the treatment of conditions in
which the body's defense system against diseases does not function correctly.

What is Gamunex used forGamunex
Treatment of adults, children and adolescents (0-18 years) who do not have a sufficient level of
antibodies (replacement therapy), such as:

• Patients with primary immunodeficiency syndromes (PID), a congenital antibody deficiency
• Patients with acquired immunodeficiency (AIDS) with severe or recurrent infections, ineffective antimicrobial treatment and who have a demonstrated inability to produce specificantibodies or serum IgG levels < 4 g/L Treatment of adults, children and adolescents (0-18 years) who have been exposed to measles or are at risk of exposure to measles and in whom active vaccination against measles is not indicated or not recommended.

Treatment of adults, children and adolescents (0-18 years) with certain autoimmune disorders
(immunomodulation). There are groups:

• Primary immune thrombocytopenia (ITP), a condition in which the amount of platelets in the bloodstream is very reduced. Platelets represent an important part of the coagulation process and a reduction in their number can cause unwanted bleeding and bruising. The medicine is also used in patients at high risk of bleeding, or before surgery, to correct the platelet count.
• Guillain-Barré syndrome, in which the immune system damages the nerves and prevents them from functioning properly.
• Kawasaki disease (in this case together with therapy with acetylsalicylic acid), a childhood disease in which the blood vessels (arteries) of the body widen.
• Chronic inflammatory demyelinating polyneuropathy (CIDP), a rare and progressive disease that causes weakness of the limbs, numbness, pain and fatigue.
• Multifocal motor neuropathy (MMN), a rare disease that causes a slow progressive weakening of the limbs, without sensory loss.

2. What you need to know before using Gamunex

Do not useGamunex

• If you are allergic to normal human immunoglobulin or to any of the other ingredients of this medicine (listed in section 6).
• If you do not have enough immunoglobulin A (IgA) in your blood and have developed antibodies against IgA.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Gamunex.
Infusion reactions and hypersensitivity
Some undesirable effects may be related to the infusion rate. Therefore, the recommended
infusion rate must be followed (see “Information for healthcare professionals” at the end
of this leaflet).
Some undesirable effects may occur more frequently:

• in case of a high infusion rate,
• in patients with total lack of gammaglobulins or low levels of gammaglobulins (agammaglobulinemia or hypogammaglobulinemia) with or without IgA deficiency,
• in patients receiving normal human immunoglobulin for the first time, or, in rare cases, when the immunoglobulin-based product is changed or after a prolonged interval without treatment.

It is often possible to avoid potential complications by checking:

• that you are not hypersensitive to human immunoglobulin, by initially administering Gamunexslowly.
• that you are carefully monitored to detect any symptoms during the infusion period. In particular, if you are receiving human immunoglobulin for the first time, if the immunoglobulin-based product is changed or if you have not received treatment for a certain period, you must be kept under observation to detect possible undesirable effects during the first infusion and for the following hour. If undesirable effects occur, the infusion rate must be reduced or the infusion must be stopped until the symptoms disappear. If the symptoms persist even after stopping the infusion, appropriate treatment must be started. In case of a shock reaction (anaphylactic shock with severe reduction in blood pressure), treatment with the medicine must be stopped immediately and current standard medical therapy for shock must be initiated.

Patients with kidney problems and other risk factors
Cases of impaired kidney function and acute renal failure have been reported in connection
with the administration of intravenous immunoglobulins. You are particularly at risk if
you have some risk factors, such as pre-existing impaired kidney function
(renal insufficiency), diabetes (diabetes mellitus) or reduced blood volume (hypovolemia). Other
conditions considered risk factors are overweight, concomitant treatment with
medicines that have harmful effects on the kidneys and/or an age over 65 years. In any case, the
following precautions must be taken:

• Drink sufficient fluids to ensure adequate fluid intake before starting therapy,
• the doctor must check urine production and measure kidney function,
• do not use concomitant medicines that increase urine production (loop diuretics). The infusion rate in your case must be as low as possible and the immunoglobulin product must be used at the lowest possible concentration. If impaired renal function occurs, the doctor will consider whether to discontinue treatment with immunoglobulins.

Hemolysis (abnormal breakdown of red blood cells)
It is commonly reported that immunoglobulins increase the risk of destruction of red blood cells
(hemolysis) in both adults and children. If you have been given high doses of IVIg in
a single day or over several days and your blood type is A, B or AB and/or you have a
underlying inflammatory disease, you may have an increased risk of red blood cell
destruction (hemolysis).
In post-marketing reports, high-dose IVIg indications in children, particularly Kawasaki disease, are associated with a higher
reporting rate of hemolytic reactions compared to other IVIg indications in children.
Consult your doctor if you develop paleness (pale skin), lethargy (feeling of weakness), dark urine,
shortness of breath or palpitations (rapid heartbeat).
Isolated cases of impaired kidney function/renal failure related to
hemolysis with fatal outcome have been reported.
Safety information with reference to infections
When medicines are derived from human blood or plasma, certain measures are taken to
prevent the transmission of infections to patients. These include:

• careful selection of blood and plasma donors, to ensure the exclusion of donors at risk of carrying infections,
• testing of each donation and plasma pool for signs of viruses/infections,
• adoption of procedures during the processing of blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of transmitting an infection cannot be completely excluded. This also applies to any unknown or emerging viruses or other types of infections.

The measures taken are considered effective for enveloped viruses, such as the human immunodeficiency virus (HIV), the hepatitis B virus and the hepatitis C virus. These measures
may be of limited value against non-enveloped viruses, such as the hepatitis A virus and/or
parvovirus B19. Immunoglobulins have not been associated with hepatitis A or parvovirus
B19 infections, possibly because the antibodies against these infections contained in the product have a protective effect.
This medicine contains less than 1 mmol of sodium (23 mg) per single dose (up to a maximum of
2 g/kg), i.e. is essentially “sodium-free”.
It is strongly recommended that you record the
name and batch number of the product each time you receive a dose of this medicine in order to keep a record of the batches used.

Other medicines andGamunex
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
You should avoid the concomitant use of medicines that increase water excretion from the body
(loop diuretics) during treatment with Gamunex.
Effects on vaccines: Gamunexmay reduce the effectiveness of some types of vaccines (live attenuated virus vaccines). In case of rubella, mumps and varicella, a period of up to 3 months must elapse between the
administration of this product and the administration of these vaccines. In case of measles, such
period must be extended up to 1 year.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
Dizziness or other reactions may sometimes occur, which may affect your ability to drive
vehicles and use machines. If such symptoms occur, wait until they resolve before driving
vehicles or using machines.

3. How to use Gamunex

Gamunexis injected into a vein (intravenous administration) by the doctor.
The dose administered depends on the disease and body weight and will be determined by the doctor
(see the section “Information for healthcare professionals” at the end of this leaflet).
At the beginning of the infusion, Gamunexwill be administered to you slowly. If you feel well, the doctor
may gradually increase the infusion rate.

If you stop taking Gamunex
If treatment with this medicine is stopped, your clinical condition may worsen. Contact
the doctor responsible for the treatment if you wish to discontinue therapy with this
medicine prematurely.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In rare and isolated cases, the following side effects have been reported with preparations based on immunoglobulins. Seek medical attention immediately if any of the following side effects occur during or after the infusion:

• A sudden drop in blood pressure and, in isolated cases, anaphylactic shock (whose signs, among others, are skin rash, low blood pressure, fast or irregular heartbeat, wheezing, coughing, sneezing and difficulty breathing), even if you have not shown an allergic reaction in a previous administration.
• Cases of temporary non-infectious meningitis (whose signs are headache, fear or intolerance to light, stiff neck).
• Cases of temporary reduction of red blood cells in the blood (hemolytic anemia / reversible hemolysis).
• Cases of temporary skin reactions.
• Increased serum creatinine levels (a test that measures kidney function) and/or acute renal failure (whose signs are back pain, fatigue, decreased urine output).
• Thromboembolic events, such as myocardial infarction (feeling of tightness in the chest with a sensation of a too-fast heartbeat), stroke (weakness of the facial, arm or leg muscles, problems speaking or understanding others while they are speaking), pulmonary embolism (shortness of breath, chest pain and fatigue), deep vein thrombosis (pain and swelling in a limb).
• Cases of acute transfusion-related lung injury (TRALI), which causes hypoxia (lack of oxygen), difficulty breathing, rapid breathing, bluish discoloration of the skin or mucous membranes, fever and low blood pressure. In clinical studies conducted with Gamunex, the following side effects have been observed:

The following side effects have been common (may affect up to 1 in 10 infusions):

• headache
• fever

The following side effects have been uncommon (may affect up to 1 in 100 infusions):

• dizziness
• urticaria (hives, redness, itching of the skin)
• pruritus
• skin rash
• nausea
• vomiting
• high blood pressure
• sore throat
• cough
• nasal congestion
• wheezing
• joint pain
• back pain
• flu-like illness
• fatigue
• chills
• asthenia (weakness)
• muscle pain The following side effects have been rare (may affect up to 1 in 1,000 infusions):
• hemolytic anemia (destruction of red blood cells)
• shortness of breath
• sinusitis
• skin peeling
• anxiety
• decreased hemoglobin
• indigestion
• bruising
• redness
• musculoskeletal stiffness
• palmar erythema (redness of the palms of the hands)
• aphonia (inability to produce sounds with the voice)
• decreased number of white blood cells
• dermatitis (skin inflammation) or contact dermatitis
• abdominal pain
• diarrhea
• low blood pressure
• neck pain
• musculoskeletal pain
• chest pain
• discomfort
• injection site reaction
• urethritis (pain or difficulty urinating)
• upper respiratory viral infection (diseases caused by an acute infection affecting the upper respiratory tract, including nose, nasal sinuses, throat)
• lymphocytosis (increase in a particular type of white blood cells)
• hypersensitivity (allergic reaction)
• eye sensitivity to light
• hypertensive crisis (acute increase in blood pressure)
• hyperemia (increased blood flow)
• hemoglobinuria (presence of the blood protein that carries oxygen in excessively high concentrations in the urine)
• increased blood pressure
• presence of free hemoglobin (hemoglobin circulating outside red blood cells)
• increased erythrocyte sedimentation rate (increase in the rate of sedimentation of red blood cells in a tube)

What countermeasures should be taken if side effects occur?
If side effects occur, the infusion rate should be reduced or the infusion should be suspended until the symptoms disappear. If the symptoms persist even after stopping the infusion, appropriate treatment should be started.
In case of a severe hypersensitivity reaction with a decrease in blood pressure and dyspnea up to the point of a severe generalized allergic reaction (anaphylactic shock), the use of this medicine must be stopped immediately and appropriate countermeasures must be taken.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Gamunex

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 package and vial. The
period of validity is 3 years.
Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the vial in the outer
packaging.
The medicine may be stored in the outer packaging for a single period of a maximum of
6 months at room temperature (not exceeding 25°C). In this case, the period of validity of the
medicine expires after 6 months, regardless of the original expiry date. The new date of
expiry must be noted on the outer packaging. In any case, the new expiry date must not
be later than the expiry date printed on the package. Subsequent refrigeration is not possible.
Once the individual vials have been opened, the contents must be used immediately. Any
residue must be discarded. Further storage is not permitted, even in a refrigerator, due to the
possible invasion by microbes.

6. Contents of the pack and other information

What Gamunex contains
The active ingredient is normal human immunoglobulin (IVIg). One ml of this medicine contains
100 mg of protein with at least 98% of IgG in water for injections.
One 10 ml vial contains: 1 g of normal human immunoglobulin
One 50 ml vial contains: 5 g of normal human immunoglobulin
One 100 ml vial contains: 10 g of normal human immunoglobulin
One 200 ml vial contains: 20 g of normal human immunoglobulin
One 400 ml vial contains: 40 g of normal human immunoglobulin
The percentage of IgG subclasses is approximately: 62.8% (IgG1), 29.7% (IgG2), 4.8% (IgG3),
2.7% (IgG4). The maximum content in IgA is 84 micrograms/ml.
The other components are glycine and water for injections.

Description of the appearance ofGamunexand contents of the pack

Gamunexis a solution for infusion. The solution is from clear to slightly opalescent and
colourless or pale yellow.

Gamunexis available in packs of 10 ml, 50 ml, 100 ml, 200 ml and 400 ml. The box contains a

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Grifols Deutschland GmbH
Colmarer Straße 22
60528 Frankfurt
Germany
Tel.:+49 69/660 593 100

Manufacturer:
Instituto Grifols, S.A.
Can Guasc, 2 – Parets del Vallès
08150 Barcelona
Spain

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) with the following denominations:
Austria, Belgium, Cyprus, Ireland, Germany, Luxembourg, Netherlands, Poland, Portugal, United
Kingdom (Northern Ireland): Gamunex 10% 100 mg/ml
Czech Republic, Denmark, Finland, France, Hungary, Italy, Norway, Slovakia, Spain,
Sweden: Gamunex 100 mg/ml
Greece: Gaminex 10% 100 mg/ml
 -----------------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for healthcare professionals

Use only clear or slightly opalescent, colourless or pale yellow infusion solutions, free of

particles - do not shake. Before infusion, bring Gamunex to room or body temperature

(if possible, in a water bath at a temperature not exceeding 37°C).
The vials are equipped with a label-hook (Fig. 1) After inserting the infusion set (Fig. 2), turn the vial upside down and fold the ring part of the label (Fig. 3). Press firmly with your fingersto create a foldon each side where the ring part joins the rest of the label (Fig. 4). Hang the vial on the infusion pole via the resulting ring (Fig. 5).

Fig. 1 Fig. 2 Fig. 3 Fig. 4 Fig. 5

Dosage and method of administration
The dose and dosage regimen depend on the indication.
It may be necessary to individualise the dose for each patient, based on the clinical response. The dose based on body weight may require adjustment in underweight or overweight patients. The dosage regimens below are provided as a guideline.
The recommended dosage is summarised in the following table

Method of administration
For intravenous use.
Normal human immunoglobulin must be infused intravenously at an initial rate of
0.6 - 1.2 ml/kg/hour for 0.5 hours. If an adverse reaction occurs, the rate of
administration must be reduced or the infusion stopped. If well tolerated, the rate of administration may
be gradually increased to a maximum of 4.8 - 8.4 ml/kg/hour.

Paediatric population
Since the dosage for each indication is given based on body weight and adjusted based on the clinical outcome of the aforementioned conditions, the dosage in children and adolescents
(0-18 years) is not different from that of adults.

Gamunex must not be mixed with other infusion solutions and with other medicinal products. If

dilution is necessary before infusion, a 50 mg/ml glucose solution may be used for this purpose. Do not dilute with saline solutions.

The simultaneous administration of Gamunex and heparin via a single-lumen delivery device must be avoided.

Gamunex infusion lines can be flushed with 50 mg/ml glucose solution or sodium chloride (9 mg/ml) solution, but not with heparin.

The heparin lock through which Gamunex was administered must be flushed with

50 mg/ml glucose solution or sodium chloride (9 mg/ml) solution, but not with heparin.