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OCTAGAM 50MG/ML SOLUTION FOR INFUSION

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

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2017.05.14 • 420 x 340 mm • B.840.000.UK_GTP_13

B.840.000.UK

B.840.000.UK

Code is a sample

B.840.000.UK

B.840.000.UK

PACKAGE LEAFLET: INFORMATION FOR THE USER

Octagam 50 mg/ml can be used in the following inflammatory
diseases:

Octagam 50 mg/ml, solution for infusion

- In adults or children who do not have a sufficient number of
platelets (idiopathic thrombocytopenic purpura), and who have
a high risk of bleeding prior to surgery

Human Normal Immunoglobulin (IVIg)
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
- 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 signs of illnessare
the same as yours.
- If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

- In patients with a disease that leads to inflammation of various
organs (Kawasaki disease)
- In patients with a disease that can lead to inflammation of certain
parts of the nervous system (Guillain Barré syndrome)
- Chronic inflammatory demyelinating polyneuropathy (CIDP,
inflammatory disease of certain parts of the nervous system).
Only limited experience is available of use of intravenous
immunoglobulins in children with CIDP.
2 What you need to know before you use Octagam 50 mg/ml
Do not use Octagam 50 mg/ml:
- if you are allergic to human immunoglobulin or any of the other
ingredients contained in Octagam 50 mg/ml (listed in section 6).

What is in this leaflet
1. What Octagam 50 mg/ml is and what it is used for
2. What you need to know before you use Octagam 50 mg/ml

- if you have a deficiency of immunoglobulin A (IgA deficiency)
with anti-IgA antibodies.

3. How to use Octagam 50 mg/ml
Warnings and precautions

5. How to store Octagam 50 mg/ml

Talk to your doctor or pharmacist before using Octagam 50 mg/ml.

1 What Octagam 50 mg/ml is and what it is used for

In the case of an adverse reaction, either the rate of administration
must be reduced or the infusion must be stopped. The treatment of
the adverse event required will depend on the nature and severity
of the side effect.

What Octagam 50 mg/ml is:

Virus safety

Octagam 50 mg/ml is a human normal immunoglobulin (IgG)
solution (i.e. solution of human antibodies) for intravenous
administration (i.e. infusion into a vein). Immunoglobulins are
normal constituents of the human body and support the immune
defence of your body. Octagam 50 mg/ml contains all IgG activities
which are present in the normal population. Adequate doses of
this medicinal product may restore abnormally low IgG levels to
the normal range.

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:

Octagam 50 mg/ml has a broad spectrum of antibodies against
various infectious agents.
What Octagam 50 mg/ml is used for:
Octagam 50 mg/ml is used
* as replacement therapy in patients who do not have sufficient
amounts of own antibodies.
* in certain inflammatory diseases.

• careful selection of blood and plasma donors to make sure those
at risk of carrying infections are excluded
• testing of each donation and pools of plasma for signs of virus/
infections
• the inclusion of 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.

* to prevent or treat infections after a bone marrow transplantation.

The measures taken may be of limited value against non-enveloped
viruses such as hepatitis A virus and parvovirus B19.

Octagam 50 mg/ml is used as replacement therapy. There are 3
groups of replacement therapy:

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.

- Patients with inborn deficiency of antibodies (primary
immunodeficiency syndromes: congenital agammaglobulinaemia
and
hypogammaglobulinaemia,
common
variable
immunodeficiency, severe combined immunodeficiencies)

It is strongly recommended that every time that you receive a
dose of Octagam 50 mg/ml the name and batch number of the
medicine are recorded in order to maintain a a record of the
batches used.

- Patients with diseases of the blood that lead to a lack of antibodies
and to recurrent infections (Myeloma or chronic lymphatic
leukaemia with severe secondary hypogammaglobulinaemia and
recurrent infections)

Corn allergy

- Patients with congenital AIDS who have repeated bacterial
infections

Octagam 50 mg/ml contains maltose, which is derived from corn.
Allergic reactions have been reported in association with infusion

B.840.000.UK_420x340_GTP_13.indd 1

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on the course of pregnancy, or on the foetus and the neonate are
to be expected.
Immunoglobulins are excreted into the milk and may contribute to
the transfer of protective antibodies to the newborn.

Children and adolescents

Clinical experience with immunoglobulins suggests that no harmful
effects on fertility are to be expected.

There are no specific or additional warnings or precautions
applicable for children and adolescents.

Driving and using machines:

Other medicines and Octagam 50 mg/ml
The infusion line may be flushed before and after administration
of Octagam 50 mg/ml with either normal saline or 5% dextrose in
water.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription, or if you have received a vaccination in the
last three months.
Octagam 50 mg/ml may impair the effect of live viral vaccines such
as measles, rubella, mumps and varicella.
After administration of this product, an interval of 3 months
should elapse before vaccination with live viral vaccines. In the
case of measles, this impairment may persist for up to 1 year.

The ability to drive and operate machines may be impaired by some
adverse reactions associated with Octagam 50 mg/ml. Patients who
experience adverse reactions during treatment should wait for
these to resolve before driving or operating machines.
3 How to use Octagam 50 mg/ml
Your doctor will decide if you need Octagam 50 mg/ml and at
what dose. Octagam 50 mg/ml is administered as an intravenous
infusion (infusion into a vein) by healthcare personnel. The dose
and dosage regimen is dependent on the indication and may need
to be individualised for each patient.
• If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4 Possible side effects

Inform your doctor that you are taking immunoglobulin when you
give a blood sample, as this treatment may affect the results.
Blood Glucose Testing

4. Possible side effects

6. Contents of the pack and other information

of other maltose / corn starch related products. If you have a known
corn allergy, you should either avoid using Octagam 50 mg/ml or
be closely observed for signs and symptoms of hypersensitivity
reactions during the infusion of Octagam 50 mg/ml.

Some types of blood glucose testing systems (so called glucometers)
falsely interpret the maltose contained in Octagam 50 mg/ml as
glucose. This may result in falsely elevated glucose readings during
an infusion and for a period of about 15 hours after the end of the
infusion and, consequently, in the inappropriate administration of
insulin, resulting in lifethreatening hypoglycaemia (i.e. a decreased
blood sugar level).
Also, cases of true hypoglycaemia may go untreated if the
hypoglycaemic state is masked by falsely elevated glucose readings.

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Contact your doctor as soon as possible if you suffer from any of the
serious side effects listed below (all are very rare and may affect up
to 1 in 10,000 people).
In some cases your doctor may need to interrupt treatment and
reduce your dose or stop treatment:

· Swelling of the face, tongue and windpipe that can cause great
difficulty in breathing
· A sudden allergic reaction with shortness of breath, rash,
wheezing and drop of blood pressure

Accordingly, when administering Octagam 50 mg/ml or other maltose
containing products, the measurement of blood glucose must be
done with a test-system using a glucose-specific method. Systems
based on the glucose dehydrogenase pyrroloquinolinequinone
(GDH PQQ) or glucose-dye-oxidoreductase methods should not be
used.

· Stroke that may cause weakness and / or loss of sensation down
one side of the body

Review carefully the product information of the blood glucose
testing system, including that of the test strips, to determine if the
system is appropriate for use with maltose containing parenteral
products. If any uncertainty exists, please ask your treating
physician to determine if the glucose testing system you are using
is appropriate for use with maltose containing parenteral products.

· Severe kidney disorder that may cause you to not pass urine

· Heart attack causing chest pain
· Blood clot causing pain and swelling of limbs
· Blood clot in lung causing chest pain and breathlessness

· Non-infectious (aseptic) meningitis causing severe headache and
neck stiffness
If you experience any of the symptoms above, contact your doctor
as soon as possible.

Octagam 50 mg/ml with food, drink and alcohol
No effects have been observed. While using Octagam 50 mg/ml
adequate hydration before infusion should be taken into account.

The following other side effects have also been reported:
Common side effects (may affect up to 1 in 10 people):

Pregnancy, breast-feeding and fertility

· Hypersensitivity (allergic reaction)

If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking any medicine.

· Headache

The safety of this medicinal product for use in human pregnancy
has not been established in controlled clinical trials and therefore
should only be given with caution to pregnant women and breastfeeding mothers. Immunoglobulin preparations have been shown
to cross the placenta, increasingly during the third trimester. Clinical
experience with immunoglobulins suggests that no harmful effects

· Feeling tired

3

· Nausea
· Fever
· Skin reactions at injection site
Uncommon side effects (may affect up to 1 in 100 people):
· Eczema

4

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B.840.000.UK

· Back pain

Reporting of side effects

Marketing authorisation holder:

· Chest pain

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the national reporting system.
By reporting side effects you can help provide more information on
the safety of this medicine.

OCTAPHARMA Limited
The Zenith Building
26 Spring Gardens
Manchester
M2 1AB
United Kingdom
Tel: +44 161 837 3770
Fax: +44 161 837 3799

· Chills
Very rare side effects (may affect up to 1 in 10,000 people):
· haemolytic anaemia (Destruction of and resulting lack of red
blood cells; this side effect may be increased in individuals
receiving high doses, that have blood group A, B or AB and / or
an underlying inflammatory disease)
· Lack of white blood cells

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

· Fluid overload
· Too low sodium in blood
· Feeling agitated, anxious, confused or nervous
· Migraine

5 How to store Octagam 50 mg/ml
Keep this medicine out of the sight and reach of children.

· Speech disorder

Do not use Octagam 50 mg/ml after the expiry date which is stated
on the label and the carton.

· Loss of consciousness
· Dizziness

Store below 25°C. Do not freeze. Keep container in the outer carton
in order to protect from light.

· Tingling sensation in skin
· Reduced sense of touch or sensation
· Sensitivity to light
· Involuntary muscle contractions
· Impaired vision
· Angina pectoris

Do not use Octagam 50 mg/ml if you notice that the solution is
cloudy, has deposits or is coloured intensively.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help to protect the environment.

· Palpitations
6 Contents of the pack and other information

· Changes in heart beat
· Temporary bluish lips or other parts of skin
· Circulatory collapse or shock

What Octagam 50 mg/ml contains:

· Changes in blood pressure

- The active substance is human normal immunoglobulin 50 mg/ml
(at least 95% is immunoglobulin G).

· Vein inflammation

- The other ingredients are maltose and water for injections.

· Pale color of the skin

- Components used in the packaging of Octagam 50 mg/ml are
latexfree.

· Cough
· Breathing disorders
· Pulmonary oedema (accumulation of fluid in the lung)
· Bronchospasm (difficulty in breathing or wheezing)
· Respiratory failure
· Lack of oxygen in the blood
· Vomiting, diarrhoea, abdominal pain
· Hives, skin itching
· Skin rash
· Peeling of the skin
· Inflammation of the skin
· Hair loss
· Pains in joints or muscles
· Muscle weakness or stiffness
· Strong painful muscle contraction
· Neck pain, pain in legs or arms
· Kidney pain
· Swelling of the skin (oedema)

Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Strasse 235, A-1100 Vienna, Austria
Tel: +43 1 61032 0
Fax: +43 1 61032 9300
Octapharma S.A.S.
70-72 rue de Marèchal Foch, BP 33,
F-67380 Lingolsheim, France
Tel: +33 3 88 78 89 89
Fax +33 3 88 78 89 78
Octapharma AB
SE-112 75 Stockholm, Sweden
Tel: +46 8 566 430 00
Fax: +46 8 133045
This medicinal product is authorised in the member states of the
EEA under the following names:
Finland:

OCTAGAM, 50 mg/ml, infuusioneste, liuos

Iceland:

OCTAGAM, 50 mg/ml innrennslislyf, lausn.

Italy:

OCTAGAM, Soluzione per infusione da 50 mg/ml

Spain:

Octagamocta, 50 mg/ml solución para perfusión

What Octagam 50 mg/ml looks like and contents of the pack:

United Kingdom: OCTAGAM 50 mg/ml, solution for infusion

Octagam 50 mg/ml is a solution for infusion and is available in vials
(2g/20 ml) or bottles (2.5 g/50 ml, 5 g/100 ml, 10 g/200 ml,

This leaflet was last approved in 05/2017

25 g/500 ml).
The following information is intended for medical or healthcare
professionals only:

Pack sizes:

· Redness of skin

Manufacturers:

1g

in

20 ml

2.5 g

in

50 ml

5g

in

100 ml

10 g

in

200 ml

2 x 10 g

in

2 x 200 ml

3 x 10 g

in

3 x 200 ml

25 g

in

500 ml

• The product should be brought to room or body temperature
before use.
• The solution should be clear to slightly opalescent and colourless
to slightly yellow.
• Do not use solutions that are cloudy or have deposits.
• Filtration of Octagam 50 mg/ml is not required

Not all pack sizes may be marketed.
The solution is clear or slightly opalescent, colourless or slightly
yellow.

· Flushing, increased sweating
· Chest discomfort

• Any unused product or waste material should be disposed of in
accordance with local requirements.
• This medicinal product should not be mixed with other
medicinal products.
• The infusion line may be flushed before and after administration
of Octagam 50 mg/ml with either normal saline or 5% dextrose
in water.

· Flu-like symptoms
· Feeling cold or hot or generally unwell and weak
· Drowsiness
· Burning sensation
· Abnormalities in blood test reports of liver function
· False readings for blood sugar measurements

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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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