12014.03.31 /135 x380 m Code is a sample

PACKAGE LEAFLET: INFORMATION FOR THE USER

gammanornrr 165 mg/ml

solution for injection

Human Normal Immunoglobulin

ocla pharma

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 ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

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 aveinj.

■    intramuscularly (into a muscle) byyourself. Gammanorm must not be given into a musde ifyou have any bleeding disorders.

Take special care with Gammanorm

■    Tell your doctor if you have any other illnesses.

■    IfGammanorm 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.

In this leaflet:

1.    What Gammanorm is and what i t 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.WNAT GAMMANORM IS AND WHAT IT IS USED FOR

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.

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 ofvirushnfections

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.

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.

B.860.002.UK

■ pharmacist ifyou are taking, or have recently taken any other -the-counter ones, or ifyou have received a vaccination in the

■    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 wai t 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 ecperi ence of usage of Gammanorm during pregnancy and breast-feeding. You should therefore consultyour doctor before use of Gammanorm when you are pregnant or breast-feeding.

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 contains4.35 mmol (or 100 mg) sodium per dose (40 ml). Please take this into

consideration ifyou are on a controlled sodium diet.

3. HOW TO USE GAMMANORM

The treatment will be started off by your doctor who will ensure thatyou receive training and precise information on using the pump, injection technique keeping a treatment diary, and what action to

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 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).

(860.003.

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

Posologv

Replacement therapy

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

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 dosage regimen using the subcutaneous route should achieve a sustained level of IgG. A loading dose of at least 0.2-0.5 g/kg may be required. After steady state IgG levels have been attained, maintenance doses are administered at repeated

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

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•    The injection site should be changed after 5 -15 ml.

•    Multiple injection sites can be used at the same time. Injection sites should beat leasts cm apart.

•    Remove the peel-off label from the Gammanormvial 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.

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

In rare cases, Gammanorm may cause a fall in blood pressure and a severe hypersensitivity¹ 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 10PT:

local reactions at the injection site such as swelling, tenderness, pain, redness, hardening, a sensation

ofheat, 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.

Do not use Gammanorm after the expiry date which is stated on the label and carton after EXP. The e<pir>> 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 maybe 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.

S. FURTHER INFORMATION What Gammanorm contains

The active substance is:

human normal immunoglobulin 1 65 mgfml (at least 95% is immunoglobulin G) The other ingredients are:

glycine sodium chloride and sodium acetate equivalent to 2.5 mg of sodium water for injections

What Gammanorm looks like and contents oT the pack Gammanorm is a clear or slightly opalescent and pale-yellow to light-browr

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 TheZenith Building 26 Spring Gi

Octapharma Af SE-112 75 Stoc

5. HOW TO STORE GAMMANORM

sight of children.