labelling item intragam p au cmi 10 00 (supplied)

7/30/2019 Labelling Item Intragam P AU CMI 10 00 (Supplied)

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Intragam P, Australia, CMI, 10.00 (supplied) Page 1 of 3

Intragam

PHuman normal immunoglobulin for intravenous infusion

Consumer Medicine Information

10 mL: AUST R 68635

50 mL: AUST R 68632200 mL: AUST R 68633

What is in this leaflet

This leaflet answers somecommon questions about

Intragam P. It does not containcomplete information aboutIntragam

P. It does not take the

place of talking to your doctor. Ifyou have any concerns aboutusing this product,ask yourdoctor. Follow your doctor'sadvice even if it is different fromwhat this leaflet says.

Please read this leafletcarefully and keep it forfuture reference. However,the information in this leaflet issubject to change. Pleasecheck with your doctor whetherthere is any new informationabout this product that youshould know since you were

last treated with this product.

What IntragamP is usedfor

Intragam

P is manufacturedfrom human plasma (the liquidcomponent of blood) collectedby the Australian Red CrossBlood Service. Intragam

P is

used for patients who need

replacement of antibodieswhich form part of our immunesystem and can provideprotection against someinfections. Intragam

P is also

used in diseases when theimmune system is overactive,these are called autoimmunedisorders.

Ask your doctor if you have anyquestions about whyIntragam

P has been

prescribed for you. Your doctorwill have assessed the risksand benefits for you associatedwith the use of this product.

Before your doctor givesyou IntragamP

Intragam

P must not beused if you have a history ofallergy to humanimmunoglobulin products.Tell your doctor if you haveallergies to any othermedicines, or if you haveever had an allergic reactionto an injection.

Tell your doctor also if you: have previously been advised

that you have ImmunoglobulinA (IgA) deficiency

have previously been advisedthat you have kidney disease

have a previous history ofclotting in blood vessels(thrombosis)

have previously been treatedwith immunoglobulin products

have previously been advisedthat you have diabetes

are taking or using any othermedicines. These includemedicines bought frompharmacies, supermarketsand health food stores

have any other medicalconditions

are pregnant or breast-feeding

become pregnant during yourtreatment

have had any vaccination withinthe last two weeks or intend toreceive one in the next threemonths.

If you want further information,consult your doctor.

How to use IntragamP

Your doctor will determine the

dose(s) of Intragam P that youwill receive. Your doctor will give

you Intragam P as an infusion,that is, an injection given slowlyinto the vein.

Unwanted effects

Along with their intended effects,blood products occasionallycause unwanted effects, some ofwhich are serious. Unwantedeffects are more common withthe first dose of Intragam

P.

Individuals may react differentlyto similar doses of the sameproduct. This applies toIntragam

P. Most minor effects

are related to the rate of infusionand disappear when the rate isslowed down.

Effects Associated with

IntragamP

During a clinical trial withIntragam

P in patients who

needed replacement ofantibodies, some patients


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experienced headache,migraine, nausea, dizziness orfaintness, and tiredness.Reduced red blood cells andiron stores and reduced whiteblood cells were also reported.

During another clinical trial withIntragam

P in patients with an

overactive immune system,who received larger doses ofIntragam

P, some patients

experienced headache,nausea, vomiting, shivering,fever, drowsiness, hot flushes,muscle pain, abdominal pain,allergic reactions, reddening ofthe face or neck, a hot feelingor redness at the site of theinjection and increased bloodpressure. Reduced red andwhite blood cells were also

reported.

Effects Associated with

Similar Produc ts

Unwanted effects which mayoccur include stomach pain,headache, chest tightness,flushed or pale face, feeling hotor unwell, shortness of breathor breathing difficulty, skinrash, itching, general redness,swelling, faintness, dizziness,nausea or vomiting or a hotfeeling or redness at the site ofthe injection. Should any ofthese effects develop duringinfusion, the doctor will takeappropriate action.

Some patients may developdelayed unwanted effects suchas nausea, vomiting, chestpain, chills or shivering,dizziness, aching legs or jointpain. These effects may occurafter the infusion has stopped

but usually within 24 hours.

A condition called asepticmeningitis syndrome has beenreported to occur infrequentlyin association with infusionssimilar to Intragam

P. It

usually begins within severalhours to two days followingtreatment. The signs includesevere headache, neckstiffness, drowsiness, fever,

inability to stand bright light,painful eye movements, andnausea and vomiting. Thecondition reverses without illeffects when treatment isstopped.

There have been reports thatthe kidneys, liver and blood

vessels (thrombosis) may beaffected with infusions similarto Intragam

P. These

occurrences are extremelyrare.

If you experience any of thementioned effects or any otherabnormal signs after treatment,contact your doctorimmediately.

Contact your doctor

immediately if you experienceany of these symptoms at anytime: fever, loss of appetite,extreme tiredness, stomachpain, jaundice (yellow skin andeyes), dark urine, joint painand skin rashes.

Intragam

P can interfere withsome live vaccines (e.g.measles and polio), even up tothree months later. Advise yourdoctor if you are to receive

other vaccines within threemonths of receivingIntragam

P.

This product is made fromhuman plasma obtained fromvoluntary donors. Whenproducts are made fromhuman blood and injected intoyou, it is possible that virusesor other substances could bepresent in the product andcause an illness. These couldbe viruses such as hepatitis,HIV (human immunodeficiencyvirus), or parvovirus B19 andtheoretically the Creutzfeldt-Jakob Disease (CJD) agent.There could also be otherinfectious agents some ofwhich may not yet have beendiscovered.

To reduce the risk of thishappening, extra steps are

taken when manufacturing thisproduct. Strict controls areapplied when selecting blooddonors and donations. Theproduct is specially treated toremove and kill certain viruses.This special treatment isconsidered effective againstviruses known as enveloped

viruses such as HIV andhepatitis B and C viruses, andthe non-enveloped virus,hepatitis A. These proceduresmay be of limited value againstthe non-enveloped virus,parvovirus B19. However, theproduct contains specificantibodies directed againstparvovirus B19. Parvovirus B19is a virus causing respiratoryirritation, commonly affectingchildren.

Despite the measures taken, therisk of viral and other agentsinfectivity cannot be totallyeliminated.

Vaccines are available againstsome of these viruses and yourdoctor will be able to help youdecide whether it is worthwhilehaving any of those vaccines.

Please discuss the risks and

benefits of this product with yourdoctor.

Interference With GlucoseEstimations

The maltose present inIntragam

P may interfere with

some blood glucosemeasurements, resulting in theoverestimation of blood glucose

results. If this glucosemeasurement is used to guidetreatment, hypoglycaemia mayoccur. Only certain glucose testshave been implicated, so whenmonitoring glucose levels consultyour doctor to ensure that maltosedoes not interfere with the bloodglucose reading of the test you areusing. Infusion of Intragam

P may

also result in elevated levels of


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glucose in the urine for a shortperiod of time.

If you want further information, orif you are worried about any othersymptoms after the infusion,consult your doctor.

Overdose

Administering a larger thanrecommended dose may lead tothickening of the blood andexpansion of the blood volume,

particularly in elderly patients andpatients with kidney problems.

How to store Intragam

P

Store at 2C to 8C (Refrigerate.Do not freeze). Once removedfrom refrigeration, store below25C and use within 3 months.Protect from light.

Do not use after the expiry date.

Further Information

Intragam

P can only beobtained on a doctor'sprescription. This leaflet doesnot contain the completeinformation about Intragam P.If you require furtherinformation about Intragam

P

and your treatment generally,or if you have any questions orare not sure about somethingin this leaflet, consult yourdoctor.

Product description

What it looks l ike

Intragam

P is a clear, colourless,non-viscous (not thick) solution. Itis available in glass bottles.

Ingredients

In each vial of Intragam

P is asterile solution containing 6%blood proteins of which at least

98% is immunoglobulins. It alsocontains 10% maltose (a sugar).

Manufacturer/Sponsor

Intragam

P is manufactured inAustralia by:CSL Limited ABN 99 051 588348

189 - 209 Camp RoadBroadmeadows VIC 3047AUSTRALIA

Distr ibuted b y

Australian Red Cross BloodService

This leaflet was updated in:January 2013

Registered trademark of CSL

Limited.

labelling item intragam p au cmi 10 00 (supplied)

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