Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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. 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.

What is in this leaflet

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

Do not use Octagam 10%:

• if you are allergic to human immunoglobulin or any of the other ingredients contained in Octagam 10% (listed in section 6).
• if you have a deficiency of immunoglobulin A (IgA deficiency) and if you have developed antibodies against immunoglobulins of the type IgA.

Warnings and precautions

Talk to your doctor or pharmacist before using Octagam 10%.

It is strongly recommended that every time you receive a dose of Octagam 10% the name and batch number of the product are recorded in order to maintain a record of the batches used.

Certain adverse reactions may occur more frequently:

• in case of high rate of infusion
• when you receive Octagam 10% for the first time or, in rare cases, when there has been a long interval since the previous infusion.
• when you have an untreated infection or an underlying chronic inflammation

In the case of an adverse reaction, either the rate of administration must be reduced or the infusion must be stopped. The treatment of the adverse event required will depend on the nature and severity of the side effect.

Circumstances and conditions increasing the risk of having side effects

• Thromboembolic events such as heart attack, stroke, and obstructions of a deep vein for example in the calves or of a blood vessel in the lung may occur very rarely after administration of Octagam 10%. These types of events occur more commonly, although very rarely, in patients with risk factors, such as obesity, advanced age, high blood pressure, diabetes, previous occurrences of such events, prolonged periods of immobilisations, and intake of certain hormones (e.g. the pill). Ensure a balanced fluid intake; moreover Octagam 10% should be administered as slowly as possible.
• If you had kidney problems in the past or if you have certain risk factors like diabetes, overweight, or age over 65, Octagam 10% should be administered as slowly as possible because cases of acute kidney failure have been reported in patients, although very rarely, with such risk factors. Tell your doctor, even when any of the above-mentioned circumstances had happened to you in the past.
• Patients with blood group A, B or AB as well as patients with certain inflammatory conditions have a higher risk of red blood cells being destroyed by the administered immunoglobulins (called haemolysis).

When may slowing or stopping the infusion be required?

• Strong headaches and neck stiffness may rarely occur several hours to 2 days following Octagam 10% treatment.
• Allergic reactions are rare, but can induce an anaphylactic shock, even in patients who had tolerated the previous treatments.
• In very rare cases transfusion-related acute lung injury (TRALI) can occur after receiving immunoglobulins including Octagam 10%. This will lead to non-heart related accumulation of fluid in the air spaces of the lungs. You will recognize TRALI by severe difficulty in breathing, normal heart function and increased body temperature (fever). Symptoms typically appear within 1 to 6 hours after receiving treatment.

Tell your doctor or healthcare professional immediately if you notice such reactions during or after the infusion of Octagam 10%. He or she will decide whether to decrease the infusion rate or to stop the infusion completely or if further measures are necessary.

• Sometimes immunoglobulin solutions such as Octagam 10% can trigger a decrease in the number of white blood cells. Normally this condition resolves spontaneously within 1-2 weeks.

Virus safety

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
• testing of each donation and pools of plasma for signs of virus/infections
• steps included by the manufacturers 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 encapsulated viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus.

The measures taken may be of limited value against non-encapsulated viruses such as hepatitis A virus and 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.

Children and adolescents

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

Other medicines and Octagam 10%

The infusion line may be flushed before and after administration of Octagam 10% with either normal saline or 5% dextrose in water.

Concomitant use of loop diuretics should be avoided.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, or if you have received a vaccination in the last three months.

Octagam 10% may impair the effect of live attenuated virus vaccines such as measles, rubella, mumps and varicella.

After administration of this product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to 1 year.

Effects on blood tests

If you have a blood test after receiving Octagam 10%, please inform the person taking your blood or your doctor that you have received a human normal immunoglobulin solution, as this treatment may affect the results.

Blood Glucose Testing

Some types of blood glucose testing systems (so called glucometers) falsely interpret the maltose contained in Octagam 10% as glucose. This may result in falsely elevated glucose readings during an infusion and for a period of about 15 hours after the end of the infusion and, consequently, in the inappropriate administration of insulin, resulting in life-threatening hypoglycaemia (i.e. a decreased blood sugar level).

Also, cases of true hypoglycaemia may go untreated if the hypoglycaemic state is masked by falsely elevated glucose readings.

Accordingly, when administering Octagam 10% or other maltose-containing products, the measurement of blood glucose must be done with a test-system using a glucose-specific method. Systems based on the glucose dehydrogenase pyrroloquinolinequinone (GDH PQQ) or glucose-dye-oxidoreductase methods should not be used.

Review carefully the product information of the blood glucose testing system, including that of the test strips, to determine if the system is appropriate for use with maltose-containing parenteral products. If any uncertainty exists, please ask your treating physician to determine if the glucose testing system you are using is appropriate for use with maltose-containing parenteral products.

Octagam 10% with food, drink and alcohol

No effects have been observed. While using Octagam 10% adequate hydration before infusion should be taken into account.

Pregnancy, breast-feeding and fertility

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 any medicine.

The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers. Immunoglobulin preparations have been shown to cross the placenta, increasingly during the third trimester. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.

Immunoglobulins are excreted into human milk. No negative effects on the breastfed newborns/infants are anticipated.

Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.

Driving and using machines

Octagam 10% has no or negligible influence on the ability to drive and use machines. However, patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines.

Octagam 10% contains sodium

100 mL of this medicinal product contains 69 mg sodium (main component of cooking/table salt). This is equivalent to 3.45% of the recommended maximum daily intake of 2 g sodium for an adult.

To be taken into consideration by patients on a controlled sodium diet.

Use in children and adolescents

The administration (intravenously) of Octagam 10% in children and adolescents (0-18 years) does not differ from the administration in adults.

Reporting of side effects

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 (for details see below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store

What Octagam 10% contains

• The active substance is human normal immunoglobulin (human antibodies) 100 mg/ml (at least 95% is immunoglobulin G).
• The other ingredients are maltose and water for injections.

What Octagam 10% looks like and contents of the pack

Octagam 10% is a solution for infusion and is available in vials (2g/20ml) or bottles (5g/50ml, 6g/60ml, 10g/100ml, 20g/200ml).

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 3 x 100 ml

3 x 20 g in 3 x 200 ml

The solution is clear or slightly opalescent, colourless or slightly yellow.

Not all pack sizes may be marketed.

Marketing authorisation holder

Manufacturers

This medicinal product is authorised in the member states of the EEA under the following names:

Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, United Kingdom: Octagam

Italy: Gamten

Spain Octagamocta