GAMTEN 100 mg /Ml Infusion Solution

Зміст інструкції

1. Gamten
   1. What is Gamten and what is it used for
2. Gamten can also be used in the treatment of the following autoimmune diseases
   1. What you need to know before using Gamten
   2. How to use Gamten
   3. Possible side effects
   4. How to store Gamten
   5. Contents of the pack and other information

Gamten

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

Read this leaflet carefully before you start to use this medicine because 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 their
symptoms are the same as yours, as it may be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Gamten and what is it used for

What is Gamten
Gamten is a normal human immunoglobulin (IgG) solution (i.e., a solution of human antibodies) to be administered intravenously (i.e., by infusion into a vein). Immunoglobulins are normal constituents of the human body and contribute to the defenses of your body's immune system. Gamten contains all IgG activities found in the normal population. Adequate doses of this medicine can intervene on abnormally reduced IgG levels, bringing them back into the normal range.
Gamten has a broad spectrum of antibodies against various infectious agents.

What is Gamten used for
Gamten is used as replacement therapy in children, adolescents (0-18 years of age) and adults in several patient groups:

• Patients with congenital antibody deficiency (primary immunodeficiency syndromes such as agammaglobulinemia and congenital hypogammaglobulinemia, common variable immunodeficiency, severe combined immunodeficiencies).
• Patients with an acquired antibody deficiency (secondary immunodeficiency) caused by specific diseases and/or treatments and who experience severe or recurrent infections.

Gamten can be used for the treatment of susceptible 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.

Gamten can also be used in the treatment of the following autoimmune diseases

(immunomodulation):

• In patients with immune thrombocytopenia (ITP), a condition in which platelets are destroyed and their number is therefore reduced, and who present a high risk of bleeding or need to correct the platelet count before surgery.
• In patients with Kawasaki disease, a condition that leads to inflammation of various organs.
• In patients with Guillain Barré syndrome, a condition that leads to inflammation of certain parts of the nervous system.
• In patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a disease that leads to chronic inflammation of peripheral parts of the nervous system causing muscle weakness and/or numbness mainly in the legs and arms.
• In patients with multifocal motor neuropathy (MMN), a disease characterized by asymmetrical, slowly progressive weakness of the limbs without loss of sensation.
• In adult patients with dermatomyositis (DM) in the active phase, a disease involving inflammation of the muscles and skin changes. Typical symptoms are symmetrical and progressive muscle weakness and characteristic skin changes, such as a rash on different parts of the body (e.g. eyelids, cheeks, nose, back, elbows, knuckles) and scaly, rough, dry skin. Gamten can be used in patients treated with immunosuppressive drugs, such as corticosteroids, or when these drugs are contraindicated or poorly tolerated.

2. What you need to know before using Gamten

Do not use Gamten

• if you are allergic to human immunoglobulin or to any of the other ingredients of Gamten (listed in section 6).
• if you have a deficiency of immunoglobulin A (IgA deficiency) and have developed antibodies against IgA-type immunoglobulins. Warnings and precautionsTalk to your doctor or pharmacist before using Gamten. It is strongly recommended to record, with each administration of Gamten, the name and lot number of the product to maintain traceability of the lot used. Some adverse reactions may occur more frequently:
• in case of high infusion rate
• when you receive Gamten for the first time or, in rare cases, when a long time has passed since the previous infusion
• when you have an untreated infection or underlying chronic inflammation If an adverse reaction occurs, the administration rate should be reduced or the infusion itself should be stopped. The treatment required for the adverse event will depend on the nature and severity of the undesirable effect. Circumstances and conditions that increase the risk of developing adverse effects
• Very rarely, after the administration of Gamten, thromboembolic events such as heart attack, stroke and obstruction of a deep vein, for example in the calves or a blood vessel in the lungs, may occur. This type of event occurs more commonly, although very rarely, in patients with risk factors such as obesity, advanced age, high blood pressure, diabetes, dermatomyositis, previous events of the same type, prolonged periods of immobilization and taking certain hormones (e.g. the contraceptive pill). Ensure that fluid intake is balanced; also, Gamten should be administered as slowly as possible,
• If you have had kidney problems in the past or if you have some risk factors such as diabetes, overweight or are over 65 years of age, Gamten should be administered as slowly as possible, as cases of acute renal failure have been reported, although very rarely, in patients who present these risk factors. Also inform your doctor if any of the above circumstances have occurred in the past.
• Patients with blood type A, B or AB, as well as patients suffering from some inflammatory diseases are at higher risk of red blood cell destruction by the administered immunoglobulins (hemolysis).

When may it be necessary to slow down or stop the infusion?

• Severe headaches and neck stiffness may rarely occur within a few hours to 2 days after treatment with Gamten.
• Allergic reactions are rare, but can induce anaphylactic shock, even in patients who had tolerated previous treatments. A sudden drop in blood pressure or shock can be consequences of an anaphylactic reaction.
• In very rare cases, acute lung injury associated with transfusion (TRALI) may occur after receiving immunoglobulins including Gamten. This will lead to an accumulation of fluid not related to cardiac causes in the air spaces of the lungs. You will recognize TRALI by the onset of severe difficulty breathing, normal heart function and increased body temperature (fever). Symptoms usually appear within 1-6 hours after administration of the treatment.

Immediately inform your doctor or healthcare professional if you notice these reactions during or after
the infusion of Gamten. They will decide whether to reduce the infusion rate or stop it
completely, or if further action is necessary.

• Sometimes immunoglobulin solutions like Gamten can cause a decrease in the number of white blood cells. Normally, this condition resolves spontaneously within 1-2 weeks.

Viral safety
When medicines are prepared from human blood or plasma, certain
measures are taken to prevent the risk of transmitting infections to patients. These measures include:

• careful selection of blood and plasma donors to ensure exclusion of subjects at risk of carrying infectious diseases;
• examination of each donation and plasma pools to check for signs of viruses/infections;
• procedures introduced by manufacturers in the processing of blood or plasma that can inactivate or remove viruses. Despite these measures, when administering medicines prepared from human blood or plasma, it is not possible to completely exclude the possibility of transmitting infectious diseases. This also applies to viruses of unknown or emerging nature 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. The measures taken may have limited value against non-enveloped viruses, such as the hepatitis A virus and parvovirus B19. Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, probably because the antibodies against these infections contained in the medicine are protective.

Children and adolescents
There are no specific or additional warnings or precautions applicable to children and adolescents.

Other medicines and Gamten
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicines, including over-the-counter medicines, or if you have been
given a vaccination in the last three months.
The infusion line can be flushed before and after the administration of Gamten with 0.9% saline solution or with a 5% dextrose solution.
Concomitant use of loop diuretics should be avoided.
Gamten may impair the effectiveness of vaccines with live attenuated viruses, such as measles, rubella,
mumps and varicella.
Therefore, an interval of 3 months must be respected after the administration of the product before
performing a vaccination with live attenuated virus vaccines. In the case of measles, this
period of reduced efficacy may persist for up to 1 year.

Effects on blood tests
In case of blood tests after the administration of Gamten, inform the person performing the
collection or the doctor that you have been given normal human immunoglobulin solution,
as this treatment may affect the test results.
Blood sugar tests
Some types of blood glucose monitoring systems (so-called glucometers) incorrectly interpret
the maltose contained in Gamten as glucose. This condition can
lead to falsely elevated blood glucose readings during an infusion and for about 15 hours after the end of the infusion, and consequently to inappropriate insulin administration, which causes hypoglycemia (i.e. low blood sugar levels) that can endanger the patient's life.
In addition, actual hypoglycemia cases may be overlooked if the hypoglycemic state
is masked by falsely elevated glucose readings.

Therefore, when administering Gamten or other products containing maltose, blood glucose levels
must be measured with test systems that use a specific method for
glucose. Systems based on the glucose-dehydrogenase-pyrroloquinoline quinone (GDH PQQ) method or the colorimetric glucose-oxidoreductase method should not be used.
You must carefully read the information on the product of the glucose test system, including that of the test strips, so as to determine whether the system is
suitable for use with parenteral products containing maltose. If in doubt, consult your
treating physician to determine whether the glucose test system you are using is suitable for
use with parenteral products containing maltose.

Gamten with food, drinks and alcohol
No effects have been observed. Adequate
hydration should be provided before the infusion during the use of Gamten.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using any medicine.
The safety of use of this medicine during pregnancy in humans has not been
evaluated in controlled clinical studies, therefore it should be administered only with extreme caution in
pregnant or breastfeeding women. Immunoglobulin-based products have been shown to
cross the placenta, increasingly during the third trimester of pregnancy. Clinical experience with immunoglobulins suggests that no adverse effects on the course of
pregnancy or on the fetus and newborn are to be expected.
Immunoglobulins are excreted in breast milk. No adverse effects on
newborns/infants are expected.
Clinical experience with immunoglobulins suggests that no harmful effects on
fertility are to be expected.

Driving and operating machinery
Gamten does not alter or negligibly alters the ability to drive vehicles and operate machinery.
However, patients who experience adverse reactions during treatment should wait for
these to resolve before driving vehicles or operating machinery.

Gamten contains sodium
100 ml of this medicine contains 69 mg of sodium (the main component of table/cooking salt), equivalent to 3.45% of the recommended maximum daily intake of 2 g of
sodium with the diet for an adult.
This should be taken into consideration by patients who are following a diet with
controlled sodium content.

3. How to use Gamten

It is your doctor’s responsibility to decide whether and in what dose Gamten should be administered to you.
Gamten is administered by healthcare professionals as an intravenous infusion (infusion into a
vein). The dose and dosage schedule depend on the indication and may need to be
personalized for each patient.

• If you have any doubts about the use of this product, consult your doctor or pharmacist.

Use in children and adolescents
The administration (intravenous) of Gamten in children and adolescents (0-18 years) is not
different from the administration in adults.

If you receive more Gamten than you should
An overdose is very unlikely to occur, because Gamten is generally administered
under medical supervision. However, if you should receive more Gamten than you
should, your blood may become too thick (hyperviscous) and this may increase the risk of
developing clots. This can happen especially in patients at risk, such as the elderly or
patients with heart or kidney disease. Make sure to maintain adequate hydration.
Inform your doctor if you have any known medical conditions.

If you forget to use Gamten
Consult your doctor to discuss how to proceed.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the side effects listed below ( all very rareand may affect up to 1 infusion in 10,000) contact your doctor as soon as possible.
In some cases, your doctor may need to stop treatment and reduce the dose or discontinue treatment:

• swelling of the face, tongue and tracheawhich can cause considerable difficulty breathing;
• sudden allergic reactionwith shortness of breath, rash, wheezing and low blood pressure;
• strokewhich can cause weakness and/or loss of sensation on one side of the body;
• heart attackcausing chest pain;
• thrombuscausing pain and swelling of the limbs;
• pulmonary embolismcausing chest pain and shortness of breath;
• anemiacausing shortness of breath or paleness;
• severe nephropathywhich can cause failure to excrete urine;
• a lung diseasecalled acute transfusion-related acute lung injury (TRALI) which causes difficulty breathing, bluish discoloration of the skin, fever, and a decrease in blood pressure;
• severe headachein combination with any of the following symptoms: stiff neck, drowsiness, fever, sensitivity to light, nausea, vomiting (these may be signs of meningitis). If you experience any of the symptoms listed above, contact your doctor as soon as possible.

The following side effects have also been reported with this medicine:

Common side effects(may affect up to 1 infusion in 10):

• Hypersensitivity (allergic reaction)
• Headache
• Nausea
• Changes in blood pressure
• Fever

Uncommon side effects(may affect up to 1 infusion in 100):

• Deficiency of various types of blood cells
• Changes in heart rate
• Vomiting
• Stroke
• Dizziness
• Sensation of tingling or prickling on the skin
• Tremor
• Blurred vision
• Blood clots in blood vessels
• Blockage of a deep vein
• Blockage of a pulmonary artery
• Back pain
• Chest pain
• Joint or muscle pain
• Involuntary muscle contraction
• Pain in legs or arms
• Breathing difficulties
• Chills
• Feeling tired, unwell or generally weak
• Fluid accumulation in the tissues of the limbs
• Skin reactions at the injection site
• Abnormal blood test results (relating to liver function or red blood cells)

Other side effects that have not been observed in clinical trials, but have been reported are:

• Fluid overload
• Sodium too low in the blood
• Feeling agitated, anxious, confused or nervous
• Migraine
• Speech disorders
• Loss of consciousness
• Reduced sense of touch or sensitivity
• Sensitivity to light
• Weakened vision
• Angina pectoris
• Palpitations
• Temporary bluish discoloration of the lips or other areas of the skin
• Circulatory collapse or shock
• Venous inflammation
• Pale skin
• Cough
• Pulmonary edema (fluid accumulation in the lungs)
• Bronchospasm (difficulty breathing or wheezing)
• Respiratory failure
• Lack of oxygen in the blood
• Diarrhea, abdominal pain
• Urticaria, itchy skin
• Skin redness
• Skin rash
• Skin peeling
• Skin inflammation
• Hair loss
• Muscle weakness or stiffness
• Severe painful muscle contractions
• Neck pain
• Kidney pain
• Skin swelling (edema)
• Facial flushing, increased sweating
• Chest discomfort
• Flu-like symptoms
• Feeling cold or hot
• Sleepiness
• Burning sensation
• Incorrect values of blood glucose measurements

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist or nurse. You can also report side effects directly through the national reporting system at the website:
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 Gamten

Keep this medicine out of the sight and reach of children.
Do not use Gamten after the expiry date which is stated on the label and the packaging.
Store in a refrigerator (2 °C - 8 °C). Keep the container in the outer packaging, in order
to protect it from light. Do not freeze.
The product may be removed from the refrigerator for a single period of up to 9 months and stored at
a temperature ≤ 25 °C, without however exceeding the expiry date. At the end of this period, the
product must not be refrigerated again and must be disposed of. The date on which the product was
removed from the refrigerator must be indicated on the outer packaging.
After first opening, the medicine must be used immediately.
Do not use Gamten if you notice that the solution is cloudy, shows deposits or has assumed a strong
coloration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Gamten contains:
The active substance is normal human immunoglobulin (human antibodies) at a
concentration of 100 mg/ml (at least 95% is immunoglobulin G).
The other components are maltose and water for injections.

Description of Gamten and contents of the pack:
Gamten is a solution for infusion and is available in a vial (2g/20ml) or bottles (5g/50ml,
6g/60ml, 10g/100ml, 20g/200ml, 30g/300ml).
Pack sizes:
2 g in 20 ml
5 g in 50 ml
6 g in 60 ml
10 g in 100 ml
20 g in 200 ml
3 x 10 g in 3x100 ml
3 x 20 g in 3x200 ml
30 g in 300 ml
The solution is clear or slightly opalescent, colourless or pale yellow.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
OCTAPHARMA ITALY S.p.A.
Via Cisanello, 145
56100 Pisa
Italy

Manufacturers:
Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Strasse 235, A-1100 Vienna, Austria
Octapharma AB
SE-112 75 Stockholm, Sweden

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following names:
Austria, Czech Republic, Denmark, Finland,
France, Hungary, Latvia, Norway, Portugal,
Slovenia, Sweden:
Octagam 100 mg/ml
Belgium, Bulgaria, Cyprus, Estonia, Germany,
Iceland, Lithuania, Luxembourg, Malta, Netherlands,
Poland, Romania, Slovakia, United
Kingdom (Northern Ireland):
Octagam 10%
Italy: Gamten
Spain: Octagamocta 100 mg/ml

The following information is intended exclusively for physicians or healthcare professionals:

• The product must be brought to room or body temperature before use.
• The solution must be clear or slightly opalescent, colourless or pale yellow.
• Do not use solutions that are turbid or contain precipitates.
• Any unused product or waste material must be disposed of in accordance with current regulations.
• This medicinal product must not be mixed with other medicinal products.
• To flush any product that may remain in the infusion line at the end of the infusion, flush the line with 0.9% sodium chloride solution or 5% dextrose solution.