iMedi.co.uk

Nanogam 50 Mg/Ml Solution For Infusion

Informations for option: Nanogam 50 Mg/Ml Solution For Infusion, show other option
Document: leaflet MAH BRAND_PL 16935-0004 change

Package leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nanogam 50 mg/ml solution for infusion

Human normal immunoglobulin

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 Nanogam is and what it is used for

2.    Before you use Nanogam

3.    How to use Nanogam

4.    Possible side effects

5.    How to store Nanogam

6.    Further information

1. WHAT NANOGAM IS AND WHAT IT IS USED FOR

Nanogam is a solution for infusion which contains the human protein immunoglobulin. Immunoglobulins are antibodies and normal constituents of human blood and they protect you from infections. Nanogam is used to raise antibody levels in your blood when the antibody level is too low or if you need additional antibodies in certain diseases. The administration of antibodies can also have an effect in case of a disrupted immune system.

Nanogam is used for:

Replacement therapy (treatment of patients who do not have sufficient antibodies) in:

•    Primary immunodeficiency syndromes (diseases which are caused by a hereditary disorder of the immune system such as):

-    congenital agammaglobulinemia and hypogammaglobulinemia (complete or partial lack of the immune response caused by a complete or partial deficit of antibodies).

-    common variable immunodeficiency (partial or complete lack of immune response caused by a lack of antibodies by a defective production).

-    severe combined immunodeficiency (complete or partial lack of immune defence because of non-functional antibodies).

-    Wiskott Aldrich syndrome (a hereditary disease in young children, mainly boys, with persistent infections of the airways and skin, eczema and a serious shortage of blood platelets with bleedings).

•    Myeloma (malignant bone marrow tumor) or chronic lymphocytic leukaemia (malignant bleeding disorder) with severe hypogammaglobulinemia caused by an underlying disease (immune disorder) and recurrent infections.

Children with congenital AIDS and who frequently have infections.

Immunomodulation (influencing a disrupted immune system):

•    Idiopathic Thrombocytopenic Purpura (ITP, a bleeding disorder caused by a reduced number of platelets), in children or adults at risk of bleeding or prior to surgery to correct the platelet count.

•    Guillain Barre syndrome (this is a syndrome of unknown cause at which muscle paralysis occur).

•    Kawasaki disease (a very rare disease in children with defects of the skin, mucous membrane, blood vessels of the brain and coronary arteries).

Allogeneic bone marrow transplantation (bone marrow transplantation with bone marrow

derived from another human being).

2. BEFORE YOU USE NANOGAM Do not use Nanogam

•    if you are allergic (hypersensitive) to immunoglobulins or any of the other ingredients of Nanogam.

•    if you have immunoglobulin A (IgA) deficiency with antibodies against IgA. Nanogam contains a small amount of IgA which might cause an allergic reaction.

If an allergic reaction occurs, administration of Nanogam should be discontinued immediately.

Take special care with Nanogam

You will be observed carefully during the infusion period to detect potential adverse reactions. Certain adverse reactions may be related to the rate of infusion, therefore your doctor makes sure that the infusion rate is suitable for you. If you experience a reaction during infusion, tell your doctor immediately. The doctor will decide if the infusion will be discontinued.

Certain adverse reactions may occur more frequently:

•    in case of high rate of infusion.

•    if you have hypo- or agammaglobulinemia (a complete or partial lack of antibodies) with or without IgA deficiency.

•    if you receive Nanogam for the first time.

•    in rare cases, when the human normal immunoglobulin product is replaced by another product or there has been a long interval since the previous infusion.

Risk factors during treatment with Nanogam

Please tell your doctor if any of the following factors concerns you, since these might be risk factors during the treatment with Nanogam. In particular, tell your doctor if you have:

•    renal insufficiency (when your kidneys are not working well).

•    nephrotoxic (toxic for the kidney) medication.

•    diabetes (abnormally high glucose levels in the blood)

•    history of vascular (blood vessel) diseases or thrombosis (formation of a clot inside a blood vessel).

•    hypertension.

•    overweight.

•    diseases which increase blood viscosity (thickness of the blood).

•    hypovolemia (a decrease in circulating blood volume).

•    advanced age (over 65).

While using Nanogam the following should be taken into account

•    adequate hydration before infusion of Nanogam.

•    follow-up of urine output.

•    follow-up of serum creatinine levels (a substance which is an indicator of the activity of the kidneys).

•    avoiding concomitant use of certain diuretics (so called loop diuretics).

Effects on blood tests

If you will have blood tests taken, please tell you doctor that you are using Nanogam, since Nanogam contains antibodies and this may result in misleading positive results in antibody tests.

Using other medicines

Do not mix Nanogam with other medicinal products.

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

Vaccination

Tell your doctor if you have planned to take a vaccination. Nanogam may impair the efficacy of vaccines such as measles, rubella, mumps and varicella. After using Nanogam, an interval of three months should elapse before vaccination with these vaccines. In case of measles, this impairment may persist for up to one year.

Using Nanogam with food and drink

While using Nanogam adequate hydration before infusion should be taken into account.

Pregnancy and breast-feeding

In pregnant women the safety of this medicine has not been investigated. Therefore caution should be taken with pregnant women and women who are breast-feeding. Clinical experience with immunoglobulins indicate that these will not have a harmful effect on the course of a pregnancy nor on the foetus (unborn child) or the newborn.

Immunoglobulins are excreted in breast-milk and can contribute to the transfer of protective antibodies to the newborn.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

No effects on ability to drive or use machines have been observed.

Important information about some of the ingredients of Nanogam

Nanogam contains glucose 50 mg/ml (5 %). Please note this may effect (latent) diabetes or when you are on a low sugar diet. Your doctor will decide if there is a need to monitor your blood glucose levels and a need for insulin, especially if high doses of Nanogam are given.

Special warnings and special precautions for use

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, 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 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 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.

Batch number control:

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

3. HOW TO USE NANOGAM

Nanogam is given to you by your doctor or nurse. Nanogam may be self administered if it is an approved practice in your country and when you have been trained sufficiently. Always use Nanogam exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Bring Nanogam to room or body temperature before use. Start the intravenous infusion of Nanogam as soon as possible after puncturing the stopper.

The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits. Discard any unused solution.

Dosage and route of administration

Nanogam is intended for infusion into a vein. Dosage will vary depending on your condition and weight. If your administer Nanogam yourself your doctor will tell you the dose and infusion rate.

If you use more Nanogam than you should

Overdose may lead to fluid overload and hyperviscosity (an increased thickness of the blood). Tell your doctor immediately.

If you forget to use Nanogam

Tell your doctor immediately and follow his/her instructions. Do not take a double dose to make up for a forgotten dose.

If you stop using Nanogam

If you have any further questions on the use of this product, ask your doctor

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Nanogam can cause side effects, although not everybody gets them.

Occasional side effects

-    chills,

-    headache,

-    fever,

-    vomiting,

-    allergic reactions,

-    nausea,

-    arthralgia (joint pain),

-    low blood pressure,

-    moderate low back pain.

Rare side effects

-    a sudden fall in blood pressure and in isolated cases, anaphylactic shock, even if you have not experienced hypersensitive reactions during previous administrations.

-    reversible aseptic meningitis (meningitis without infection).

-    reversible haemolytic anemia/haemolysis (disruption of red cells).

-    temporary skin reactions.

-    increase in serum creatinine level and/or acute renal failure.

Very rare side effects

-    thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism and deep vein thromboses (obstruction of veins).

5.    HOW TO STORE NANOGAM

Keep Nanogam out of the reach and sight of children.

Store Nanogam in a refrigerator (2°C - 8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light.

Nanogam can be stored at or below 25°C up to six months, for example while travelling, without impairing its efficacy. The date when taken to room temperature should be marked on the package. If not used during six months storage at room temperature the product must be discarded.

Do not use Nanogam after the expiry date which is stated on the label and the carton after EXP.

6. FURTHER INFORMATION

What Nanogam contains

-    The active substance is human normal immunoglobulin for intravenous administration. One ml contains 50 mg immunoglobulin, of which at least 95% is immunoglobulin G (IgG).

-    The other ingredients are glucose and water for injections.

What Nanogam looks like and contents of the pack

Nanogam is a solution for infusion. The solution is a clear or slightly opalescent, colourless or slightly yellowish.

Nanogam is supplied in five pack sizes 20 ml, 50 ml, 100 ml, 200 ml and 400 ml, containing 1 g, 2.5 g, 5 g, 10 g and 20 g of immunoglobulin, respectively. Not all sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Sanquin

Plesmanlaan 125 1066 CX Amsterdam The Netherlands Tel: +31 20 512 3355

This leaflet was last approved on 01.04.2008.

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

Posology and method of administration

Nanogam must only be administered intravenously.

Start the intravenous infusion of Nanogam as soon as possible after puncturing the stopper. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. The in-use storage times would normally not be longer than 24 hours at 2°C - 8°C, unless puncturing has taken place in controlled and validated aseptic conditions.

If you need large quantities of Nanogam, it is also possible to transfer the contents of several vials to an Ethyl Vinyl Acetate container (Clintec® EVA-parenteral nutrition container, Baxter, CE0123). A maximum amount of 800 ml of Nanogam can be transferred to such a container using an aseptic technique. For microbiological reasons, start the infusion as soon as possible after transfer of Nanogam into the EVA-container, but not later than three hours after the transfer.

The dose and dosage depend on the indication. Nanogam is given as an intravenous infusion under controlled circumstances at an initial rate of 0.5 ml/kg/hr for 20 minutes. If well tolerated, the rate of administration may gradually be increased to 1.0 ml/kg/hr for 20 minutes and thereafter increased to a maximum of 3.0 ml/kg/hr for the first time users. In adult patients who receive Nanogam on a regular base with good tolerance, the infusion rate may be increased to a maximum of 7.0 ml/kg/hr.

The dose and dosage regimen is dependent on the indication.

In replacement therapy the dosage may need to be individualized for each patient dependent on the pharmacokinetic and clinical response. The following dosage regimens are given as a guideline.

The dosage recommendations are summarised in the following table:

Indication

Dose

Frequency of injections

Replacement therapy in primary immunodeficiency

starting dose: 0.4 - 0.8 g/kg thereafter: 0.2 - 0.8 g/kg

every 2 - 4 weeks to obtain IgG trough level of at least 4 - 6 g/l

Replacement therapy in secondary immunodeficiency

0.2 - 0.4 g/kg

every 3 - 4 weeks to obtain IgG trough level of at least 4 - 6 g/l

Children with AIDS

0.2 - 0.4 g/kg

every 3 - 4 weeks

Immunomodulation:

Idiopathic Thrombocytopenic Purpura

0.8 -1 g/kg or

on day 1, possibly repeated once within 3 days

0.4 g/kg/d

for 2 - 5 days

Guillain Barre syndrome

0.4 g/kg/d

for 3 - 7 days

Kawasaki disease

1.6 - 2 g/kg or

in several doses for 2 - 5 days in association with acetylsalicylic acid

2 g/kg

in one dose in association with acetylsalicylic acid

Allogeneic bone marrow transplantation

- treatment of infections and prophylaxis of graft versus host disease

0.5 g/kg

every week from seven days before up to 3 months after transplantation

- persistent lack of antibody

0.5 g/kg

every month until antibody levels return

production

to normal

Special precautions

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

Incompatibilities

Nanogam should not be mixed with other medicines.

Instructions for handling and disposal

Bring Nanogam to room or body temperature before use. The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits. Discard any unused solution.