GAMMANORM 165 MG/ML SOLUTION FOR INJECTION

Active substance: IMMUNOGLOBULIN NORMAL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

165 mg/ml
solution for injection
Human Normal Immunoglobulin

B.860.001.UK

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.
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.
Using other medicines

Read all of this leaflet carefully before you start using this medicine.
- 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.
In this leaflet:
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
1. WHAT GAMMANORM IS AND WHAT IT IS USED FOR

- 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.

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.

Driving and using machines

Gammanorm is used as replacement therapy in adults and children to treat
primary immunodeficiency syndromes such as:

Important information about some of the ingredients of Gammanorm

-

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.

2. BEFORE YOU USE GAMMANORM
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.
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.

B.860.001.UK_BPT_03.indd 1

No effect has been observed upon the ability to drive or operate machinery.

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.

3. HOW TO USE GAMMANORM
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).

06.03.12 05:30



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).

• 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.


Fig 2

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



Fig 3

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



Fig 4

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





Fig 5

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.

Fig 6

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



Fig 7

4. POSSIBLE SIDE EFFECTS
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.

5. HOW TO STORE GAMMANORM
Keep out of the reach and sight of children.
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.

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

• 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.
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.
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 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.

B.860.001.UK_BPT_03.indd 2

What Gammanorm contains
The active substance is:
human normal immunoglobulin 165 mg/ml (at least 95% is immunoglobulin G)
The other ingredients are:
glycine, sodium chloride, and sodium acetate equivalent to 2.5 mg of
sodium per ml, polysorbate 80, water for injections.
What Gammanorm looks like and contents of the pack
Gammanorm is a clear or slightly opalescent and pale-yellow to lightbrown 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.
Marketing Authorisation Holder
Octapharma Limited
The Zenith Building
26 Spring Gardens
Manchester M2 1AB
United Kingdom.
Manufacturer
Octapharma AB
SE-112 75 Stockholm
Sweden
This leaflet was last approved in 02/2012.

06.03.12 05:30

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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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