SCL7

PATIENT INFORMATION LEAFLET

subgam

human normal immunoglobulin |— 160 g/L sterile solution

Please read all of this leaflet carefully before using this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, please ask your doctor.

•    This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Is this leaflet hard to see or read? Phone 020 8258 2200 In this leaflet:

1.    What Subgam is and what it is used for

2.    Before you are given Subgam

3.    How you are given Subgam

4.    Possible side effects

5.    How to store Subgam

6.    Further information

1.    what subgam is and what it is used for

This product is a solution containing antibodies. It is prepared from blood plasma from screened donors and then virally inactivated during manufacture.

It is used to protect you against a variety of infections when you have insufficient levels of your own antibodies. This is because you have a condition that prevents you from making your own antibodies, called antibody deficiency. Your doctor will explain further why this medicine has been given to you.

Subgam is given by injection just under the skin (subcutaneously) or in some cases into a muscle (intramuscular) such as the buttocks or thigh. Your doctor or nurse will give you the injection or instruct you in how to inject yourself.

2.    before you are given subgam

You must NOT be given this medicine if you are:

•    suffering from any blood disorders which interfere with clotting as this medicine may cause severe bruising where injected.

•    allergic to any of the ingredients in this product (seeSection 6 ‘Further Information’ for a list of these).

Special care must be taken with Subgam if you:

•    develop an allergic reaction (see Section 4 ‘Possible Side Effects’ for a list of these). If you suffer from any of these, or just feel unwell, tell your doctor.

•    suffer from a blood disorder. Inform your doctor before this medicine is injected. This product may not be suitable for you.

Taking other medicines

•    Please tell your doctor if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.

This solution for injection must not be mixed with other medicinal products for injection.

Important information about some of the ingredients of Subgam sterile solution

The sodium content of this product is approximately the same value as that found in your blood.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, think you may be pregnant or are breast-feeding before this medicine is injected.

Driving and using machines

There are no known effects of this product on your ability to drive or operate machinery.

Please note

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, and for the nonenveloped hepatitis A and parvovirus B19 viruses.

3.    how you are given subgam

Subgam must not be injected into a vein. It must be injected slowly just under the skin, but may be injected by a doctor or nurse into a large muscle such as the buttocks or thigh. This product may be injected by yourself. Injection of this product under the skin requires a device called a syringe driver and your doctor or nurse will train you in its use. You will only be allowed to inject yourself just under the skin. Doses

At the start of treatment at least 0.2-0.5 g/kg body weight may be given. When normal levels of antibodies have been reached in your blood stream, the regular dose will be about 100 mg/kg usually weekly.

Your doctor will advise you on the dose and dose frequency for you which might mean having a blood test to measure the amount of antibodies in your blood.

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

For disposal - see Section 5.

If you are given too much or too little Subgam sterile solution

You must inform your doctor if you think any of the above has happened. If you are given too little then you will need to be given more. If you are given too much this is unlikely to be a problem for you.

4. possible side effects

As with all medicines, Subgam may cause side effects, although not everybody gets them and they do not usually occur with every injection.

Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and in some cases a shock reaction resulting in a fall in blood pressure and difficulty in breathing.

Some short term discomfort at the site of injection such as swelling, hardening around the injection site, soreness, redness, itching, bruising, rash and feeling hot to touch may be experienced. With injections into a muscle there may be some pain and tenderness where the injection was given.

Very common side effects (more than 1 in 10 people have experienced):

•    Headache

•    Inflammation at the injection site

Common side effects (more than 1 in 100 people have experienced):

•    Stomach problems such as tummy ache, diarrhoea , feeling sick and being sick

•    Mouth ulcers    • Anxiety

•    Dizziness    • Migraine

•    Tingling    • Shivering, feeling cold,    fever

•    Wheezy breathing, asthma attack

•    Pain or tightness in the chest

•    Muscle or joint stiffness, joint pain

•    Tiredness

•    Rash, sweating, itchy skin, skin flushing

•    Raised blood pressure

If you have any of the above or feel unwell at all STOP the injection and tell your doctor.

5. how to store subgam

•    Keep out of the reach and sight of children.

•    The medicine should be stored in its carton to protect it from light, in the refrigerator (2-8°C). DO NOT FREEZE. Short periods (up to

1 week) of storage at room temperature (25°C), in the dark, will not damage the product. Product that has been stored out of a fridge for one period of up to one week at temperatures up to 25°C may be returned to the fridge with no change to the expiry date.

•    The medicine must not be used after the expiry date which is printed as “EXP” on the containers (the expiry date refers to the last day of the month stated).

•    The medicine must not be used if it is cloudy or any small bits can be seen in it.

Disposal

After injection of the correct dose, your doctor or nurse will dispose of any solution that remains, along with used syringes, needles and containers. If you are using this medicine at home ask your doctor for a container to dispose material in and take the container back to your doctor when full.

Medicines should not be disposed of via wastewater or household waste.

What Subgam contains

The active substance is immunoglobulin containing a normal variety of antibodies (160 g/L which is equal to 160 mg/mL).

The other ingredients are: glycine, sodium chloride, sodium acetate and small quantities of sodium hydroxide, hydrochloric acid and polysorbate 80.

What Subgam looks like and the contents of the pack

Subgam is a clear to slightly cloudy, colourless to pale yellow sterile solution, available as single dose glass vials containing 750 mg or 1500 mg of antibodies. The volume that contains these stated quantities is overprinted on the label. These vials are closed with a synthetic rubber stopper, held on by an aluminium ring and flip off cover.

Marketing Authorisation Holder and manufacturer

Bio Products Laboratory Limited

Dagger Lane

Elstree

Hertfordshire, WD6 3BX United Kingdom

Marketing Authorisation Number, PL 08801/0050 This leaflet was last approved in, November 2012

For further information or if you have any questions about the use of this product, please contact BPL via the Marketing Department at the address above or through info@bpl.co.uk.

August 2014

Bio Products Laboratory Limited

Dagger Lane, Elstree, Herts., WD6 3BX, U.K. Tel: +44 (0)20 8957 2200

PATIENT INFORMATION LEAFLET    sclzb

subgam

human normal immunoglobulin 160 g/L sterile solution

Please read all of this leaflet carefully before using this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, please ask your doctor.

•    This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Is this leaflet hard to see or read? Phone 020 8258 2200

In this leaflet:

1.    What Subgam is and what it is used for

2.    Before you are given Subgam

3.    How you are given Subgam

4.    Possible side effects

5.    How to store Subgam

6.    Further information

This product is a solution containing antibodies. It is prepared from blood plasma from screened donors and then virally inactivated during manufacture.

It is used to protect you against a variety of infections when you have insufficient levels of your own antibodies. This is because you have a condition that prevents you from making your own antibodies, called antibody deficiency. Your doctor will explain further why this medicine has been given to you.

Subgam is given by injection just under the skin (subcutaneously) or in some cases into a muscle (intramuscular) such as the buttocks or thigh. Your doctor or nurse will give you the injection or instruct you in how to inject yourself.

2.    before you are given subgam

You must NOT be given this medicine if you are:

•    suffering from any blood disorders which interfere with clotting as this medicine may cause severe bruising where injected.

•    allergic to any of the ingredients in this product (see Section 6 'Further Information’ for a list of these).

Special care must be taken with Subgam if you:

•    develop an allergic reaction (see Section 4 'Possible Side Effects’ for a list of these). If you suffer from any of these, or just feel unwell, tell your doctor.

•    suffer from a blood disorder. Inform your doctor before this medicine is injected. This product may not be suitable for you.

Taking other medicines

•    Please tell your doctor if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.

This solution for injection must not be mixed with other medicinal products for injection.

Important information about some of the ingredients of Subgam sterile solution

The sodium content of this product is approximately the same value as that found in your blood.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, think you may be pregnant or are breast-feeding before this medicine is injected.

Driving and using machines

There are no known effects of this product on your ability to drive or operate machinery.

Please note

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, and for the nonenveloped hepatitis A and parvovirus B19 viruses.

3.    how you are given subgam

Subgam must not be injected into a vein. It must be injected slowly just under the skin, but may be injected by a doctor or nurse into a large muscle such as the buttocks or thigh. This product may be injected by yourself. Injection of this product under the skin requires a device called a syringe driver and your doctor or nurse will train you in its use. You will only be allowed to inject yourself just under the skin.

Doses

At the start of treatment at least 0.2-0.5 g/kg body weight may be given. When normal levels of antibodies have been reached in your blood stream, the regular dose will be about 100 mg/kg usually weekly.

Your doctor will advise you on the dose and dose frequency for you which might mean having a blood test to measure the amount of antibodies in your blood.

It is strongly recommended that every time you receive a dose of Subgam the name and batch number of the product are recorded in order to maintain a record of the batches used. For disposal - see Section 5.

If you are given too much or too little Subgam sterile solution

You must inform your doctor if you think any of the above has happened. If you are given too little then you will need to be given more. If you are given too much this is unlikely to be a problem for you.

4. possible side effects

As with all medicines, Subgam may cause side effects, although not everybody gets them and they do not usually occur with every injection.

Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and in some cases a shock reaction resulting in a fall in blood pressure and difficulty in breathing.

Some short term discomfort at the site of injection such as swelling, hardening around the injection site, soreness, redness, itching, bruising, rash and feeling hot to touch may be experienced. With injections into a muscle there may be some pain and tenderness where the injection was given.

Very common side effects (more than 1 in 10 people have experienced):

•    Headache

•    Inflammation at the injection site

Common side effects (more than 1 in 100 people have experienced):

•    Stomach problems such as tummy ache, diarrhoea , feeling sick and being sick

•    Mouth ulcers    •    Anxiety

•    Dizziness    •    Migraine

•    Tingling    •    Shivering,    feeling cold,    fever

•    Wheezy breathing,    asthma attack    •    Pain or tightness    in    the    chest

•    Muscle or joint stiffness, joint pain    •    Tiredness

•    Rash, sweating, itchy skin, skin flushing • Raised blood pressure

If you have any of the above or feel unwell at all STOP the injection and tell your doctor.

5.    how to store subgam

•    Keep out of the reach and sight of children.

•    The medicine should be stored in its carton to protect it from light, in the refrigerator (2-8°C). DO NOT FREEZE. Short periods (up to 1 week) of storage at room temperature (25°C), in the dark, will not damage the product. Product that has been stored out of a fridge for one period of up to one week at temperatures up to 25°C may be returned to the fridge with no change to the expiry date.

•    The medicine must not be used after the expiry date which is printed as “EXP” on the containers (the expiry date refers to the last day of the month stated).

•    The medicine must not be used if it is cloudy or any small bits can be seen in it.

Disposal

After injection of the correct dose, your doctor or nurse will dispose of any solution that remains, along with used syringes, needles and containers. If you are using this medicine at home ask your doctor for a container to dispose material in and take the container back to your doctor when full.

Medicines should not be disposed of via wastewater or household waste.

6.    further information

What Subgam contains

The active substance is immunoglobulin containing a normal variety of antibodies (160 g/L which is equal to 160 mg/mL).

The other ingredients are: glycine, sodium chloride, sodium acetate and small quantities of sodium hydroxide, hydrochloric acid and polysorbate 80.

What Subgam looks like and the contents of the pack

Subgam is a clear to slightly cloudy, colourless to pale yellow sterile solution, available as single dose glass vials containing 750 mg or 1500 mg of antibodies. The volume that contains these stated quantities is overprinted on the label. These vials are closed with a synthetic rubber stopper, held on by an aluminium ring and flip off cover.

Marketing Authorisation Holder and manufacturer

Bio Products Laboratory Limited

Dagger Lane

Elstree

Hertfordshire, WD6 3BX United Kingdom

Marketing Authorisation Number, PL 08801/0050 This leaflet was last approved in, November 2012

For further information or if you have any questions about the use of this product, please contact BPL via the Marketing Department at the address above or through info@bpl.co.uk.

Version SCL7B

Bio Products Laboratory Limited,

Dagger Lane, Elstree, Herts., WD6 3BX, U.K. Tel: +44 (0)20 8957 2200