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SUBGAM HUMAN NORMAL IMMUNOGLOBULIN SOLUTION 160G/L SOLUTION FOR INJECTION

Active substance(s): HUMAN NORMAL IMMUNOGLOBULIN

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Package leaflet: Information for the patient

Subgam® 160 mg/ml
solution for injection
human normal immunoglobulin

1. What Subgam is and what it is used for
This product is a solution containing antibodies. It is prepared from human 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). Your doctor or nurse will give you the injection or instruct you in how to inject yourself.

2. What you need to know before you use Subgam
Do not use Subgam:
• if you are allergic to human immunoglobulins or to any of the other ingredients of this medicine (listed in section 6)
• if you are suffering from any blood disorders which interfere with clotting as this medicine may cause severe bruising where injected
• into a blood vessel (intravenously)
Check with your doctor if you think this applies to you.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Subgam:
• as an allergic reaction could occur even if you have not had one before and even if you have used the product before (see section 4 “Possible side effects” for a list
of likely symptoms). If you suffer from any of these, or just feel unwell tell your doctor, pharmacist or nurse
• as Subgam should be used under close medical supervision if you have a lack of immunoglobulin A (IgA) with anti-IgA antibodies as allergic reactions are more
likely to occur
• as rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactic reaction including shock, even in patients who have tolerated
previous treatment with human normal immunoglobulin. It is advisable that you are observed for at least 20 minutes after each infusion
• if you have particular blood disorders in addition to antibody deficiency, this product may not be suitable for you. Make sure your doctor, pharmacist or nurse is
aware
• if you develop severe headache, neck stiffness, drowsiness, fever, dislike of light (photophobia), nausea and vomiting after an infusion, tell your doctor or nurse
immediately as these may be symptoms of aseptic meningitis syndrome
• if you need a blood test, tell your doctor or nurse that you are taking Subgam as it may interfere with some blood (serological) tests
• if you develop pain, swelling and unusual warmth of a limb, sudden shortness of breath and chest pain worsening on deep breathing, numbness or weakness on
one side, difficulty with speaking or confusion, contact your doctor or nurse immediately as these may indicate a blood clot
• as some medicines may increase the risk of a blood clot, tell your doctor, pharmacist or nurse of all the medicines you are taking
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,
– 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, hepatitis C virus and nonenveloped viruses such as hepatitis A and parvovirus B19 viruses.
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.
It is strongly recommended that every time you receive a dose of Subgam, the name and batch number of the medicine are recorded in order to maintain a record of
the batches used.
Children and adolescents
The listed warnings and precautions apply to both adults and children.
Other medicines and Subgam
Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines including those obtained without a prescription.
Tell your doctor or nurse about your treatment with Subgam if any vaccination is being planned.
You must not mix other medicines with Subgam.
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 this medicine is injected.
Driving and using machines
The ability to drive and operate machines may be impaired by some adverse reactions associated with Subgam. If you experience adverse reactions during treatment,
wait for these to resolve before driving or operating machines.
Subgam contains sodium
This medicinal product contains up to 0.2 mmol (4.6 mg) sodium per ml. To be taken into consideration by patients on a controlled sodium diet.

3. How to use Subgam
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Subgam must not be injected into a vein. It must be injected slowly just under the skin. 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
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.
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.
If you use more Subgam than you should
If you think that you have used more Subgam than you should, speak to your doctor, pharmacist or nurse as soon as possible.

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BPL 16052 29.11.17 Proof FIFTEEN Size: 215x290mm BPL PO: P25586 Colours: Black Blue Pan 274 Grey Pan 430

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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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Subgam is and what it is used for
2. What you need to know before you use Subgam
3. How to use Subgam
4. Possible side effects
5. How to store Subgam
6. Contents of the pack and other information

If you forget to use Subgam
Do not take a double dose to make up for a forgotten dose. If you think that you have missed a dose speak to your doctor, pharmacist or nurse as soon as possible.
If you stop using Subgam
You are more likely to have more infections, some of which may be severe. Therefore, speak to your doctor, pharmacist or nurse if you think you ought to stop Subgam.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with Subgam.
Rarely (may affect up to 1 in 1,000 people) human normal immunoglobulins may cause an allergic reaction (for example, sudden fall in blood pressure, dizziness,
lightheadedness, fast heart rate, chest pain, blurred vision) and in some cases shock (loss of consciousness). Stop using the medicine immediately and tell your
doctor or nurse straight away.
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. This local reaction is very common at the start of treatment but reduces as further injections are given.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme: Website: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Subgam
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 containers after “EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 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.
Keep the vial in the outer carton in order to protect from light.
Do not use this medicine if it is cloudy or if 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other information
What Subgam contains
– The active substance is human normal immunoglobulin. One ml contains 160 mg of human plasma protein, of which at least 95% is immunoglobulin type G (IgG).
– This medicine contains trace elements of IgA (not more than 0.064 milligrams/ml).
– The other ingredients are: glycine, sodium chloride, sodium acetate and polysorbate 80.
What Subgam looks like and the contents of the pack
Subgam is a clear or colourless to slightly pearl-like (opalescent) solution, available as single dose glass vials containing 750 mg or 1500 mg of antibodies.
Presentations
Subgam 750 mg
1 vial 5 ml solution for injection
Or
Subgam 1500 mg
1 vial 10 ml solution for injection
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Bio Products Laboratory Ltd.,
Elstree,
WD6 3BX.
United Kingdom
Marketing Authorisation Number PL 08801/0050
For any information about this medicine, please contact the Marketing Authorisation Holder. Please e-mail: medinfo@bpl.co.uk
This leaflet was last revised in November 2017.
Version 9

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BPL 16052 29.11.17 Proof FIFTEEN Size: 215x290mm BPL PO: P25586 Colours: Black Blue Pan 274 Grey Pan 430

8pt Text

Very common (may affect more than 1 in 10 people):
• Headache
• Inflammation at the injection site
Common (may affect up to 1 in 10 people):
• Stomach problems such as tummy ache, diarrhoea, feeling sick and being sick
• Mouth ulcers
• Dizziness
• Anxiety
• Tingling
• Migraine
• 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
Additional side effects in children and adolescents
Frequency, type and severity of adverse reactions in children are the same as in adults.

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Further information

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