INTRAGAM

Main information

  • Trade name:
  • INTRAGAM P immunoglobulin-normal (human) 3g/50mL for intravenous use injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • INTRAGAM P immunoglobulin-normal (human) 3g/50mL for intravenous use injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 68632
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

68632

INTRAGAM P immunoglobulin-normal (human) 3g/50mL for intravenous use injection vial

ARTG entry for

Medicine Registered

Sponsor

CSL Behring Australia Pty Ltd

Postal Address

189-209 Camp Road,BROADMEADOWS, VIC, 3047

Australia

ARTG Start Date

28/05/1999

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. INTRAGAM P immunoglobulin-normal (human) 3g/50mL for intravenous use injection vial

Product Type

Single Medicine Product

Effective date

21/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Intragam P is indicated in replacement Immunoglobulin G (IgG) therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with

severe secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections.

INDICATIONS AS AT 21 JULY 2000: Replacement IgG therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe

secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections.

Immunomodulatory therapy in: idiopathic thrombocytopenic purpura (ITP), in adults or children at high risk of bleeding or prior to surgery to correct

platelet count; allogenic bone marrow transplantation; Kawasaki disease. INDICATIONS AS AT 25 FEBRUARY 2003: For replacement immunoglobulin

G (IgG) therapy in: Primary immunodeficiency; Myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and

recurrent infections, and; Congenital acquired immune deficiency syndrome with recurrent infections. For immunomodulatory therapy in: Idiopathic

thrombocytopenic purpura (ITP) in adults or children at high risk of bleeding or prior to surgery to correct platelet count; Allogeneic bone marrow

transplantation; Kawasaki disease, and; Guillain-Barre Syndrome (GBS).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

2 Years

Store at 2 to 8

degrees Celsius

Not recorded

Refrigerate

Do not Freeze

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

50mL x 1

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Injection, solution

Route of Administration

Intravenous

Visual Identification

A clear colourless solution.

Active Ingredients

normal immunoglobulin

60 mg/mL

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 01.12.2017 at 06:32:42 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Intragam P AU CMI 14.00 (Supplied)

Page 1 of 4

Intragam

®

P

Human Normal Immunoglobulin, solution for intravenous infusion.

Consumer Medicine Information

What is in this leaflet

This leaflet answers some

common questions about

Intragam

P. It does not contain

complete information about

Intragam

P. It does not take the

place of talking to your doctor.

If you have any concerns

about using this medicine, ask

your doctor. Follow your

doctor’s advice even if it is

different from what this leaflet

says.

Please read this leaflet

carefully and keep it for

future reference.

The information in this leaflet is

subject to change. Please check

with your doctor whether there

is any new information about

this medicine that you should

know since you were last

treated.

What Intragam

®

P is

used for

Intragam

P is manufactured

from human plasma (the liquid

component of blood)

collected

by the Australian Red Cross

Blood Service. Intragam

P is

used for patients who need

replacement of antibodies which

form part of our immune system

and can provide protection

against some infections.

Intragam

P is also used in

diseases when the immune

system is overactive, these are

called autoimmune disorders.

Ask your doctor if you have any

questions about why

Intragam

P has been prescribed

for you. Your doctor will have

assessed the risks and benefits

for you associated with the use

of this medicine.

Before you are given

Intragam

®

P

Intragam

P must not be used

if you have a history of allergy

to human immunoglobulin

products. Tell your doctor if

you have allergies to any other

medicines, or if you have ever

had an allergic reaction to an

injection.

Tell your doctor also if you:

have previously been

advised that you have

Immunoglobulin A (IgA)

deficiency

have previously been

advised that you have

kidney disease

have a history of heart, or

blood vessel disease, or

blood clots, have thick

blood, have been immobile

for some time. Also tell the

doctor what medicine you

are using as some

medicines, such as those

that contain the hormone

estrogen (for example, birth

control pills), may increase

your risk of developing a

blood clot.

have previously been

treated with

immunoglobulin products

have previously been

advised that you have

diabetes

have blood group A, B or

are taking or using any

other medicines. These

include medicines bought

from pharmacies,

supermarkets and health

food stores.

have any other medical

conditions

are pregnant or

breast-feeding

become pregnant during

your treatment

have had any vaccination

within the last two weeks or

intend to receive one in the

next three months.

Intragam P AU CMI 14.00 (Supplied)

Page 2 of 4

If you want further information,

consult your doctor.

How to use

Intragam

®

P

Your doctor will determine the

dose(s) of Intragam

P that you

will receive. Your doctor will

give you Intragam

P as an

infusion, that is, an injection

given slowly into the vein.

Side effects

Along with their intended

effects, blood products

occasionally cause unwanted

effects, some of which are

serious. Unwanted effects are

more common with the first

dose of Intragam

P. Individuals

may react differently to similar

doses of the same product. This

applies to Intragam

P. Most

minor effects are related to the

rate of infusion and disappear

when the rate is slowed down.

Effects associated

with Intragam

®

P

During a clinical trial with

Intragam

P in patients who

needed replacement of

antibodies, some patients

experienced headache, migraine,

nausea, dizziness or faintness,

and tiredness. Reduced red

blood cells and iron stores and

reduced white blood cells were

also reported.

During another clinical trial with

Intragam

P in patients with an

overactive immune system, who

received larger doses of

Intragam

P, some patients

experienced headache, nausea,

vomiting, shivering, fever,

drowsiness, hot flushes, muscle

pain, abdominal pain, allergic

reactions, reddening of the face

or neck, a hot feeling or redness

at the site of the injection and

increased blood pressure.

Reduced red and white blood

cells were also reported.

Effects associated

with similar products

Unwanted effects which may

occur include stomach pain,

headache, chest tightness,

flushed or pale face, feeling hot

or unwell, shortness of breath or

breathing difficulty, skin rash,

itching, general redness,

swelling, faintness, dizziness,

nausea or vomiting or a hot

feeling or redness at the site of

the injection. Should any of

these effects develop during

infusion, the doctor will take

appropriate action.

Some patients may develop

delayed unwanted effects such

as nausea, vomiting, chest pain,

chills or shivering, dizziness,

aching legs or joint pain. These

effects may occur after the

infusion has stopped but usually

within 24 hours.

A condition called aseptic

meningitis syndrome has been

reported to occur infrequently in

association with infusions

similar to Intragam

P. It

usually begins within several

hours to two days following

treatment. The signs include

severe headache, neck stiffness,

drowsiness, fever, inability to

stand bright light, painful eye

movements, and nausea and

vomiting. The condition

reverses without ill effects when

treatment is stopped.

There have been reports that the

kidneys, liver and blood vessels

(thrombosis) may be affected

with infusions similar to

Intragam

P. These occurrences

are extremely rare.

If you experience any of the

mentioned effects or any other

abnormal signs after treatment,

contact your doctor

immediately.

Contact your doctor

immediately if you experience

any of these symptoms at any

time: fever, loss of appetite,

extreme tiredness, dizziness,

paleness of skin, stomach pain,

jaundice (yellow skin and eyes),

dark urine, joint pain, skin

rashes, shortness of breath, chest

pain, weakness or numbness on

one side of the body and

pain/tenderness,

swelling/discolouration of an

arm or leg.

Intragam

P can interfere with

some live vaccines (e.g. measles

and polio), even up to three

months later. Advise your

doctor if you are to receive other

Intragam P AU CMI 14.00 (Supplied)

Page 3 of 4

vaccines within three months of

receiving Intragam

About blood products

This product is made from

human plasma obtained from

voluntary donors. When

products are made from human

blood and injected into you, it is

possible that viruses or other

substances could be present in

the product and cause an illness.

These could be viruses such as

hepatitis, human

immunodeficiency virus (HIV),

or parvovirus B19 and

theoretically the

Creutzfeldt-Jakob Disease

(CJD) agent. There could also

be other infectious agents some

of which may not yet have been

discovered.

To reduce the risk of this

happening, extra steps are taken

when manufacturing this

product. Strict controls are

applied when selecting blood

donors and donations. The

product is specially treated to

remove and kill certain viruses.

This special treatment is

considered effective against

viruses known as enveloped

viruses such as HIV and

hepatitis B and C viruses, and

the non-enveloped virus,

hepatitis A. These procedures

may be of limited value against

the non-enveloped virus,

parvovirus B19. However, the

product contains specific

antibodies directed against

parvovirus B19. Parvovirus B19

is a virus causing respiratory

irritation, commonly affecting

children.

Despite the measures taken, the

risk of viral and other agents’

infectivity cannot be totally

eliminated.

Vaccines are available against

some of these viruses and your

doctor will be able to help you

decide whether it is worthwhile

having any of those vaccines.

Please discuss the risks and

benefits of this product with

your doctor.

Interference with

glucose estimations

The maltose present in

Intragam

P may interfere with

some blood glucose

measurements, resulting in the

overestimation of blood glucose

results. If this glucose

measurement is used to guide

treatment, hypoglycaemia may

occur. Only certain glucose tests

have been implicated, so when

monitoring glucose levels

consult your doctor to ensure

that maltose does not interfere

with the blood glucose reading

of the test you are using.

Infusion of Intragam

P may

also result in elevated levels of

glucose in the urine for a short

period of time.

If you want further information,

or if you are worried about any

other symptoms after the

infusion, consult your doctor.

Overdose

Administering a larger than

recommended dose may lead to

thickening of the blood and

expansion of the blood volume,

particularly in elderly patients

and patients with kidney

problems.

Storing Intragam

®

P

Store at 2°C to 8°C (Refrigerate.

Do not freeze). Once removed

from refrigeration, store below

25°C and use within 3 months.

Protect from light.

Do not use after the expiry date.

Further information

Intragam

P can only be

obtained on a doctor’s

prescription. This leaflet does

not contain the complete

information about Intragam

If you require further

information about Intragam

and your treatment generally, or

if you have any questions or are

not sure about something in this

leaflet, consult your doctor.

Product description

What it looks like

Intragam

P is a clear,

colourless, non-viscous (not

thick) solution. It is available in

glass bottles.

Intragam P AU CMI 14.00 (Supplied)

Page 4 of 4

Ingredients

In each vial of Intragam

P is a

sterile solution containing 6%

blood proteins of which at least

98% is immunoglobulins. It also

contains 10% maltose (a sugar).

Manufacturer

Intragam

P is manufactured in

Australia by:

CSL Behring (Australia) Pty Ltd

ABN 48 160 734 761

189–209 Camp Road

Broadmeadows VIC 3047

Australia

Distributor

Australian Red Cross Blood

Service

Date of most recent

amendment

July 2015

Australian Register Numbers

10 mL: AUST R 68635

50 mL: AUST R 68632

200 mL: AUST R 68633

Registered trademark of CSL

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