Human Cytomegalovirus Immunoglobulin, solution for intravenous injection
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about CMV Immunoglobulin-VF. The letters CMV stand for cytomegalovirus, a type of virus. It does not contain complete information about CMV Immunoglobulin-VF. 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 CMV Immunoglobulin-VF is used for
CMV Immunoglobulin-VF is manufactured from human plasma (the liquid component of blood) collected by the Australian Red Cross Blood Service. Donations are selected on the basis that they contain high levels of specific antibody to the cytomegalovirus. CMV Immunoglobulin-VF contains protein substances called antibodies, which can provide protection against cytomegalovirus infection. CMV Immunoglobulin-VF is used to prevent cytomegalovirus infection in specific transplant patients. It may also help in the treatment of cytomegalovirus infection.
Ask your doctor if you have any questions why CMV Immunoglobulin-VF has been prescribed for you. Your doctor will have assessed the risks and benefits associated with the use of this medicine for you.
Before you are given CMV Immunoglobulin-VF
CMV Immunoglobulin-VF 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 advised that you have diabetes
- have blood group A, B or AB
- 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 during the last two weeks or intend to receive one in the next three months.
If you want any further information, consult your doctor.
About blood products
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 human 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. These special treatments are considered effective against viruses known as enveloped viruses such as HIV, hepatitis B virus and hepatitis C virus, and non-enveloped viruses, such as hepatitis A virus and human parvovirus B19. Despite these measures, the risk of viral and other agent’s 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.
How to use CMV Immunoglobulin-VF
Your doctor will determine the dose(s) of CMV Immunoglobulin-VF that you are to receive. Your doctor will give you CMV Immunoglobulin-VF as an infusion, that is, an injection given slowly into the vein.
Along with their intended effects, blood products occasionally cause unwanted effects, some of which can sometimes be serious. Individuals may react differently to similar doses of the same medicine. This applies to CMV Immunoglobulin-VF.
Severe allergic reactions to immunoglobulins are rare. Should a severe allergic reaction occur, the doctor will stop the infusion.
Unwanted effects which may occur include: stomach pain, headache, chest tightness, flushed or pale face, feeling hot, shortness of breath, non-itchy skin rash, itching, faintness, dizziness, nausea or vomiting, or a hot feeling or redness at the site of 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 or aching legs. These effects may occur after the infusion has stopped but usually within 24 hours.
A condition called Aseptic Meningitis Syndrome (AMS) has been reported to occur infrequently in association with infusions similar to CMV Immunoglobulin-VF. 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, or a hot feeling or redness at the site of injection. The condition reverses without ill effects when treatment is stopped.
There have been reports that the kidneys may be affected with infusions similar to CMV Immunoglobulin-VF. 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:
- loss of appetite
- extreme tiredness
- paleness of skin
- stomach pain
- jaundice (yellow skin and eyes)
- dark urine
- joint pains
- skin rashes
- shortness of breath
- chest pain
- pain/tenderness, swelling/discolouration of an arm or leg
- weakness or numbness on one side of the body.
CMV Immunoglobulin-VF 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 vaccines within three months of receiving CMV Immunoglobulin-VF.
Interference with glucose estimations
The maltose present in CMV Immunoglobulin-VF 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.
If you want further information, or if you are worried about any other symptoms after the infusion, consult your doctor.
There is no information available.
Storing CMV Immunoglobulin-VF
Store at 2°C to 8°C (Refrigerate. Do not freeze). Protect from light.
Do not use after the expiry date shown on the label.
CMV Immunoglobulin-VF can only be obtained on a doctor’s prescription. This leaflet does not contain t
complete information about CMV Immunoglobulin-VF. If you require further information about CMV Immunoglobulin-VF and your treatment generally, or if you have any questions or are not sure about something in this leaflet, consult your doctor.
What it looks like
CMV Immunoglobulin-VF is a clear, colourless, non-viscous (not thick) solution. It is available in glass bottles.
In each vial of CMV Immunoglobulin-VF is a sterile solution containing 6% blood proteins of which at least 98% is immunoglobulins. It also contains 10% maltose (a sugar).
CMV Immunoglobulin-VF is manufactured in Australia by:
CSL Behring (Australia) Pty Ltd
ABN 48 160 734 761
189–209 Camp Road
Broadmeadows VIC 3047
Australian Red Cross Blood Service
Date of most recent amendment
Australian Register Number
AUST R 31810
Published by MIMS July 2017