GAMMANORM 165 MG/ML SOLUTION FOR INJECTION

Active substance: IMMUNOGLOBULIN NORMAL

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165 mg/ml

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Gammanorm is an immunoglobulin and contains antibodies against bacteria and viruses. Antibodies
protect the body and increase its resistance to infections. The purpose of this
treatment is to attain normal antibody levels.

1. WHAT GAMMANORM IS AND WHAT IT IS USED FOR

1. What Gammanorm is and what it is used for
2. Before you use Gammanorm
3. How to use Gammanorm
4. Possible side effects
5. How to store Gammanorm
6. Further information

In this leaflet:

- 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 symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

Read all of this leaflet carefully before you start using this medicine.

Human Normal Immunoglobulin

solution for injection

PACKAGE LEAFLET: INFORMATION FOR THE USER

B.860.002.UK

2014.03.31 / 135 x 380 mm / B.860.002.UK_GTP_06

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B.860.002.UK

Note: Every time you receive a dose of Gammanorm you should record
the name and batch number of the product in order to maintain a record of the batch used.

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 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.

Take special care with Gammanorm
- Tell your doctor if you have any other illnesses.
- If Gammanorm is accidentally administered into a blood vessel you could develop shock.
- True hypersensitivity reactions are rare. They can particularly occur in the very rare cases of IgA
deficiency with anti-IgA antibodies and these patients should be treated with caution.
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 the blood and plasma donors
to make sure those at risk of carrying infections are excluded, and the testing of each donation and
pools of plasma for signs of virus/infections.
Manufacturers of these products also include steps in the processing of the blood or plasma that can
inactivate or remove the viruses.
Despite these measures, when medicines prepared from human blood or plasma are administered,
the possibility of passing on infection cannot be totally excluded.

Do not use Gammanorm
- if you are hypersensitive to human normal immunoglobulin or any of the other ingredients of
Gammanorm.
- intravenously (Gammanorm must not be administered into a vein).
- intramuscularly (into a muscle) by yourself. Gammanorm must not be given into a muscle if you have
any bleeding disorders.

2. BEFORE YOU USE GAMMANORM

Gammanorm is used as replacement therapy in adults and children to treat primary immunodeficiency
syndromes such as:
- congenital agammaglobulinaemia and hypogammaglobulinaemia
- common variable immunodeficiency (CVID)
- severe combined immunodeficiency
- IgG subclass deficiencies with recurrent infections
- myeloma or chronic lymphatic leukaemia with severe secondary
hypogammaglobulinaemia and recurrent infections.

Code is a sample

B.860.002.UK

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The treatment will be started off by your doctor who will ensure that you receive training and precise
information on using the pump, injection technique, keeping a treatment diary, and what action to
take in the
event of serious side effects. As soon as you are able to treat yourself, and if no side effects have
arisen during treatment, your doctor may allow you to continue treatment at home.
The dosage and infusion speed will be determined by your doctor, who will adapt the dose especially
for you. Always follow your doctor’s instructions.
This product should be administered subcutaneously (under the skin). In special cases where
Gammanorm cannot be given subcutaneously, it may be administered intramuscularly (into muscle).
An intramuscular injection must be given by a doctor or nurse.
Instructions
Always use Gammanorm exactly as your doctor has told you. You should check with your doctor if
you are not sure.
The product should be at room or body temperature prior to use.
The solution should be clear or semi-translucent. Do not use solution that is cloudy, contains particles,
or has deposits.
Handling instructions:
• Remove the protective cap from the vial and wipe the rubber stopper with alcohol.
• To withdraw Gammanorm, use a sterile syringe and needle or transfer device (e.g. Minispike® or
Medimop® vial adapter).

3. HOW TO USE GAMMANORM

Using other medicines
- Inform your doctor or pharmacist if you are taking, or have recently taken any other
medicines, even over-the-counter ones, or if you have received a vaccination in the
last three months.
- Gammanorm may weaken the effect of all vaccines containing live viruses such as
measles, rubella, mumps, and chicken pox. Following treatment with Gammanorm,
three months should have elapsed before you are vaccinated with any of these
vaccines. Where measles vaccine is concerned, you may need to wait up to a year
following treatment with Gammanorm. It is therefore important that the doctor
carrying out the vaccination is aware that you are having, or have had treatment
with Gammanorm.
- Inform your doctor that you are taking immunoglobulin when you give a blood
sample, as this treatment may affect the results.
Pregnancy and breast-feeding
There is limited experience of usage of Gammanorm during pregnancy and breast-feeding. You should
therefore consult your doctor before use of Gammanorm when you are pregnant or breast-feeding.
Driving and using machines
No effect has been observed upon the ability to drive or operate machinery.
Important information about some of the ingredients of Gammanorm
This medicinal product contains 4.35 mmol (or 100 mg) sodium per dose (40 ml). Please take this into
consideration if you are on a controlled sodium diet.

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31.03.14 21:36

B.860.002.UK_BPT_GTP_Test_06.indd 2

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Trough levels should be measured in order to adjust the dose
and dosage interval.

The dosage regimen using the subcutaneous route should
achieve a sustained level of IgG. A loading dose of at least 0.20.5 g/kg may be required. After steady state IgG levels have
been attained, maintenance doses are administered at repeated
intervals to reach a cumulative monthly dose of the order of
0.4-0.8 g/kg.

The dosage may need to be individualised for each patient
dependent on the pharmacokinetic and clinical response. The
following dosage regimens are given as a guidance.

The treatment should be initiated and monitored under the
supervision of a physician experienced in the treatment of
immunodeficiency.

Replacement therapy

Posology

The following information is intended for medical or healthcare
professionals only:

Fig 1

Inject air into the vial that is equivalent to the amount of Gammanorm
to be withdrawn. Then withdraw Gammanorm from the vial. If
multiple vials are required to achieve the desired dose, repeat this
step (Fig. 1).













Fig 7

Fig 6

Fig 5

Fig 4

Fig 3

Fig 2

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B.860.002.UK

Inject Gammanorm following the manufacturer’s instructions for the
syringe driver (Fig. 7).

Secure the needle in place by applying sterile gauze or a transparent
dressing (Fig. 6).

Gammanorm must not be injected into a blood vessel. To test that no
blood vessel has been accidentally hit, gently pull back on the syringe
plunger and look to see if any blood is flowing back into the tubing
(Fig. 5). If you see any blood, remove and discard the needle and tubing,
gently applying pressure with cotton wool or gauze to where the needle
was inserted. Repeat priming and needle insertion steps using a new
needle, tubing and a new injection site.

Insert the needle under the skin (Fig. 4).

Grasp the skin between two fingers (Fig. 3).

Clean the injection site(s) with antiseptic solution (Fig. 2).

• Follow the manufacturer’s instructions for preparing the syringe driver. Prime the administration
tubing to ensure that no air is left in the tubing by filling the tubing/needle with Gammanorm.



6. FURTHER INFORMATION

Keep out of the reach and sight of children.

5. HOW TO STORE GAMMANORM

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Like all medicines, Gammanorm can cause side effects, although not everybody gets them.
Certain side effects may occur more often in people who are receiving Gammanorm for the first
time or, in rare cases, when changing human normal immunoglobulin products, or when treatment is
suspended for more than eight weeks.
In rare cases, Gammanorm may cause a fall in blood pressure and a severe hypersensitivity reaction
(anaphylactic reaction), even in people who previously tolerated treatment with human normal
immunoglobulin.
In case of a suspected allergy or anaphylactic reaction, which may cause such things as dizziness,
pounding heart, falling blood pressure, breathlessness, itching, and rash, seek medical attention
immediately and follow your doctor’s instructions.
Common side effects (affect 1 to 10 patients of 100):
local reactions at the injection site such as swelling, tenderness, pain, redness, hardening, a sensation
of heat, itching, bruising, or rashes
Rare side effects (affect 1 to 10 patients of 10,000):
low blood pressure, allergic reactions
Very rare side effects (affect less than 1 of 10,000 patients):
headache, dizziness, nausea, vomiting, back pain, joint pains, fever, shaking, tiredness, anaphylactic
shock (severe allergic reaction)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

This leaflet was last approved in 02/2014

Manufacturer
Octapharma AB
SE-112 75 Stockholm
Sweden

Marketing Authorisation Holder
Octapharma Limited
The Zenith Building
26 Spring Gardens
Manchester M2 1AB
United Kingdom.

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31.03.14 21:36

What Gammanorm looks like and contents of the pack
Gammanorm is a clear or slightly opalescent and pale-yellow to light-brown solution for injection
and is available as:
10 ml or 20 ml of solution in a vial (Type I glass) - pack size of 1, 10 or 20.

The other ingredients are:
glycine, sodium chloride, and sodium acetate equivalent to 2.5 mg of sodium per ml, polysorbate 80,
water for injections.

The active substance is:
human normal immunoglobulin 165 mg/ml (at least 95% is immunoglobulin G)

What Gammanorm contains

If you stop using Gammanorm
If you stop injecting Gammanorm the success of your treatment may be at risk. Do not stop your
treatment without consulting your doctor before.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you forget to use Gammanorm
If you forget to inject one dose of Gammanorm do not use a double dose or multiple doses at the
same time to make up for the forgotten dose. Instead inject one dose as soon as possible, then go on
injecting Gammanorm as prescribed by your doctor.

If you use more Gammanorm than you should
The risks of overdosing with Gammanorm are not known. Contact your doctor or Poison Information
Centre if you have taken more Gammanorm than prescribed.

Do not use Gammanorm after the expiry date which is stated on the label and carton after EXP. The
expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Keep the vial in the outer carton.
Within its shelf-life, the product may be stored below 25 °C for up to 2 months. The date of transfer
from the refrigerator and the end of the 2 month period should be recorded on the outer carton.
The product must not be returned to the refrigerator and must be discarded if not used after the
2-month period.
After first opening, the product should be used immediately.
Do not use Gammanorm if the solution is cloudy or contains particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment. Never
discard used syringes with ordinary household waste.

• The injection site should be changed after 5 – 15 ml.
• Multiple injection sites can be used at the same time. Injection sites should be at least 5 cm apart.
• Remove the peel-off label from the Gammanorm vial and use this to complete the patient diary.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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