• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Gamunex^®10% is and what it is used for
2. What you need to know before you use Gamunex^®10%
3. How to use Gamunex^®10%
4. Possible side effects
5. How to store Gamunex^®10%
6. Contents of the pack and other information

Gamunex^® 10% contains human normal immunoglobulin (antibodies) as highly purified protein extracted from human plasma (part of the blood of donors). This medicine belongs to the group of medicines called intravenous immunoglobulins. These are used to treat conditions where the body’s defence system against disease is not working properly.

Treatment of adults, children and adolescents (0-18 years) who do not have sufficient antibodies (replacement therapy) such as:

• Patients with primary immunodeficiency syndromes (PID), an inborn lack of antibodies
• Patients with acquired immunodeficiency (SID) with severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure or serum IgG level of <4 g/l

Treatment of susceptible adults, children and adolescents (0-18 years) who have been exposed to measles or are at risk of measles exposure and in whom active vaccination against measles is not indicated or not advised.

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

• Primary immune thrombocytopenia (ITP), a condition where the number of platelets in the blood stream is greatly reduced. Platelets form an important part of the clotting process and a reduction in their numbers may cause unwanted bleeding and bruising. The product is also used in patients at high risk of bleeding or prior to surgery to correct the platelet count.
• Guillain-Barré-Syndrome, where the immune system damages the nerves and hinders them from working properly.
• Kawasaki disease (in this case in conjunction with acetylsalicylic acid therapy), an illness in children where the blood vessels (arteries) in the body become enlarged.
• Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a rare and progressive disease causing limb weakness, numbness, pain and fatigue.
• Multifocal motor neuropathy (MMN), a rare disease causing slowly progressive limb weakness without sensory loss.

Treatment of adults aged 18 years or older with:

• Severe acute exacerbations of myasthenia gravis. Myasthenia gravis is a disease that causes muscle weakness; exacerbations mainly affect swallowing, speaking and breathing.

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

Talk to your doctor, pharmacist or nurse before using Gamunex^®10%.

Infusion reactions and hypersensitivity

Certain side effects may be related to the rate of infusion. The recommended infusion rate should therefore be followed (see “Information intended for healthcare professionals” at the end of this leaflet).

Certain side effects may occur more frequently:

• in case of high infusion rate,
• in patients with a complete lack of gammaglobulins or low gammaglobulin levels (agammaglobulinaemia or hypogammaglobulinaemia) with or without IgA deficiency,
• in patients who are receiving human normal immunoglobulin for the first time or, in rare cases, when the immunoglobulin product is switched or after a prolonged interval without treatment.

Potential complications can often be avoided by ensuring:

• that you are not hypersensitive to human immunoglobulin by having Gamunex^®10% initially infused slowly,
• that you are carefully monitored for any symptoms throughout the infusion period. In particular, if you are receiving human immunoglobulin for the first time, if you have been switched from a different immunoglobulin or if you have not received treatment for some time, you should be monitored for possible side effects during the first infusion and for one hour afterwards.

If side effects occur, the infusion rate should be reduced or the infusion should be suspended until the symptoms have disappeared. If the symptoms persist even after suspending the infusion, suitable treatment should be commenced. In the event of a shock reaction (anaphylactic shock with a severe fall in blood pressure), treatment with the product should be stopped immediately and the current standard medical treatment for shock should be implemented.

Patients with a kidney problem and other risk factors

Cases of kidney function disorders and acute kidney failure have been reported in connection with administration of intravenous immunoglobulins. You are particularly at risk if you have certain risk factors such as pre-existing impairment of kidney function (renal insufficiency), diabetes (diabetes mellitus) or a reduced blood volume (hypovolaemia). Other circumstances considered to be risk factors are if you are overweight or are being treated simultaneously with medicines that have harmful effects on the kidneys and/or if you are over the age of 65. The following precautions should be taken by you in any case:

• Please, drink enough to ensure adequate fluid intake prior to commencement of therapy,
• Your doctor should control your urine output and measure kidney function,
• Please, do not use simultaneously certain medicines that increase urine output (loop diuretics).

The infusion rate in your case should be as low as possible and the immunoglobulin product should be used at the lowest feasible concentration. If a kidney function disorder occurs, your doctor will consider discontinuing the immunoglobulin treatment.

Haemolysis (abnormal breakdown of red blood cells)

It is commonly reported that immunoglobulins increase the risk of destruction of red blood cells (haemolysis) in both adults and children. If you were administered high doses of IVIg either on one day or over several days and are blood type A, B or AB and/or have an underlying inflammatory condition you may be at increased risk for red blood cell destruction (haemolysis).

In post-marketing reports it is observed that IVIg high-dose indications in children, particularly Kawasaki disease, are associated with an increased reporting rate of haemolytic reactions compared to other IVIg indications in children.

You should seek medical attention should you develop pallor (turn pale), lethargy (feeling weak), dark urine, shortness of breath or palpitations (fast heart rate).

Isolated cases of haemolysis-related kidney dysfunction/kidney failure with fatal outcome have occurred.

Information on safety with respect to infections

When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include:

• careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded,
• the testing of each donation and pools of plasma for signs of virus/infections,
• the inclusion of steps in the processing of the 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 passing on infection cannot be totally 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 human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus. The measures taken may be of limited value against non-enveloped viruses such as 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, which are contained in the product, are protective.

This medicinal product contains less than 1 mmol sodium (23 mg) per single dose (up to a maximum of 2g/kg), i.e. essentially ‘sodium free’.

It is strongly recommended that every time you receive a dose of this medicine, the name and batch number of the product are recorded in order to maintain a record of the batches used.

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 the excretion of water from your body (loop diuretics) during treatment with Gamunex^®10%.

Effects on vaccines: Gamunex^®10% may reduce the effectiveness of certain types of vaccines (live attenuated virus vaccines). In case of rubella, mumps and varicella a period of up to 3 months should elapse after receiving this medicine and before receiving these vaccines. In case of measles, the period is up to 1 year.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Dizziness or other reactions can sometimes occur and might affect the ability to drive and use machines. If this happens, you should wait for these to resolve before driving or operating machines.

If treatment with this medicine is stopped, your clinical condition may worsen. Please talk to the doctor in charge of your treatment if you wish to end treatment with this medicine prematurely.

If side effects occur, the infusion rate should be reduced or the infusion should be suspended until the signs of the effects have disappeared. If the signs persist even after suspending the infusion, suitable treatment should be initiated.

In the event of a severe hypersensitivity reaction with a fall in blood pressure and dyspnoea to the point even of a severe generalised allergic reaction (anaphylactic shock), use of this medicine should be ceased immediately and appropriate countermeasures should be initiated.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: 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.

The active substance is human normal immunoglobulin (IVIg). One ml of this medicine contains 100 mg protein with an IgG content of at least 98% in water for injections.

One vial of 10 ml contains: 1 g of human normal immunoglobulin

One vial of 50 ml contains: 5 g of human normal immunoglobulin

One vial of 100 ml contains: 10 g of human normal immunoglobulin

One vial of 200 ml contains: 20 g of human normal immunoglobulin

One vial of 400 ml contains: 40 g of human normal immunoglobulin

The percentage of IgG subclasses is approximately 62.8% (IgG₁), 29.7% (IgG₂), 4.8% (IgG₃), 2.7% (IgG₄).

The maximum IgA content is 84 micrograms/ml.

The other ingredients are glycine and water for injection.

Gamunex® 10% is a solution for infusion. The solution is clear to slightly opalescent and colourless or pale yellow.

Gamunex^®10% is available in pack sizes of 10 ml, 50 ml, 100 ml, 200 ml and 400 ml. The carton contains a vial made of glass with a stopper (chlorobutyl), a tear-off hanger label and a package leaflet.

Marketing authorisation holder:

Manufacturer: