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NANOGAM 50 MG/ML SOLUTION FOR INFUSION

Active substance(s): HUMAN NORMAL IMMUNOGLOBULIN / HUMAN NORMAL IMMUNOGLOBULIN / HUMAN NORMAL IMMUNOGLOBULIN

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ANNEX IIIB
PACKAGE LEAFLET

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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.
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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.
2.
3.
4.
5.
6.

What Nanogam is and what it is used for
Before you use Nanogam
How to use Nanogam
Possible side effects
How to store Nanogam
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 adults, and
children and adolescents (0-18 years) in:
 Primary immunodeficiency syndromes (diseases which are caused by a hereditary disorder
of the immune system) with impaired antibody production.
 Hypogammaglobulinaemia (complete or partial lack of the immune response caused by a
complete or partial deficit of antibodies) and recurrent bacterial infections in patients with
chronic lymphocytic leukaemia (malignant bleeding disorder), in whom prophylactic
antibiotics have failed.
 Hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple
myeloma (malignant bone marrow tumor) patients who have failed to respond to
pneumococcal immunisation.
 Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell
transplantation (HSCT).
 Congenital AIDS with recurrent bacterial infections.

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Immunomodulation (influencing an altered immune system) in adults, and children and
adolescents (0-18 years) in:
 Primary immune thrombocytopenia (ITP, a bleeding disorder caused by a reduced number of
platelets), in patients at high risk of bleeding or prior to surgery to correct the platelet count.
 Guillain Barré syndrome (this is a syndrome of unknown cause in which serious limb
muscle paralysis occurs).
 Kawasaki disease (a very rare disease in children with defects of the skin, mucous
membrane, blood vessels of the brain and coronary arteries).
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
(unwanted side effects). Certain adverse reactions may be related to the rate of infusion, therefore
your doctor should make 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 should 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 applies to 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)

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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 (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.
Fertility, pregnancy and breast-feeding
Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be
expected.
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 are not expected to 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 may contribute to the transfer of protective
antibodies to the newborn.
Ask your doctor or pharmacist for advice before taking any medicine.

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Driving and using machines
The ability to drive and operate machines may be impaired by some adverse reactions associated
with Nanogam. Patients who experience adverse reactions during treatment should wait for these to
resolve before driving or operating machines.
Important information about some of the ingredients of Nanogam
Nanogam contains glucose 50 mg/ml (5 %). Please note this may increase your blood glucose
levels. If you are a diabetic, 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.

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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
- dizziness
- 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)

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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
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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 pale
yellow.
Nanogam is supplied in five pack sizes:
20 ml of solution in a vial containing 1 g of human normal immunoglobulin,
50 ml of solution in a vial containing 2.5 g of human normal immunoglobulin,
100 ml of solution in a vial containing 5 g of human normal immunoglobulin,
200 ml of solution in a vial containing 10 g of human normal immunoglobulin,
400 ml of solution in a vial containing 20 g of human normal immunoglobulin.
Not all sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sanquin Plasma Products B.V.
Plesmanlaan 125
NL-1066 CX Amsterdam
The Netherlands
Tel: +31 20 512 3355
PL No: 45609/0001
This leaflet was last approved in:

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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
Primary immunodeficiency syndromes with
impaired antibody production

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

every 3 - 4 weeks to obtain IgG
trough level of at least 5 - 6 g/l

Hypogammaglobulinaemia and recurrent
bacterial infections in patients with chronic
lymphocytic leukaemia, in whom prophylactic
antibiotics have failed.

0.2 - 0.4 g/kg

every 3 - 4 weeks to obtain IgG
trough level of at least 5 - 6 g/l

Hypogammaglobulinaemia and recurrent
bacterial infections in plateau phase multiple
myeloma patients who have failed to respond to
pneumococcal immunisation.

0.2 - 0.4 g/kg

every 3 - 4 weeks to obtain IgG
trough level of at least 5 - 6 g/l

Hypogammaglobulinaemia in patients after
allogeneic haematopoietic stem cell
transplantation (HSCT).

0.2 - 0.4 g/kg

every 3 - 4 weeks to obtain IgG
trough level above 5 g/l.

Congenital AIDS with recurrent bacterial
infections.

0.2 - 0.4 g/kg

every 3 - 4 weeks

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IMMUNOMODULATION
Primary immune thrombocytopenia (ITP), in
patients at high risk of bleeding or prior to
surgery to correct the platelet count.

Guillain Barré syndrome
Kawasaki disease

0.8 - 1.0 g/kg

on day 1, possibly repeated once
within 3 days

or
0.4 g/kg/d

for 2 - 5 days

0.4 g/kg/d

for 5 days

1.6 - 2.0 g/kg
or
2.0 g/kg

in several doses for 2 - 5 days in
association with acetylsalicylic
acid
in 1 dose in association with
acetylsalicylic acid

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.

Expand Transcript

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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