Consumer medicine information

Tetanus Immunoglobulin-VF (for intramuscular injection)

Immunoglobulin, tetanus

BRAND INFORMATION

Brand name

CSL Tetanus Immunoglobulin-VF (for Intramuscular Use)

Active ingredient

Immunoglobulin, tetanus

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Tetanus Immunoglobulin-VF (for intramuscular injection).

What is in this leaflet

This leaflet answers some common questions about Tetanus Immunoglobulin-VF. It does not contain complete information about Tetanus 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 Tetanus Immunoglobulin-VF is used for

Tetanus Immunoglobulin-VF is manufactured from human plasma (the liquid component of blood) collected by Australian Red Cross Lifeblood. Tetanus Immunoglobulin-VF contains protein substances called antibodies which can provide protection against tetanus infection. It is used for the prevention of tetanus in a person who has not recently been immunised against tetanus and who has suffered an injury which could expose them to the tetanus bacteria.

Ask your doctor if you have any questions about why Tetanus Immunoglobulin-VF has been prescribed for you. Your doctor will have assessed the risks and benefits associated with the use of this product for you.

Before you are given Tetanus Immunoglobulin-VF

Make sure you tell your doctor of any reasons you know of why you should not be given this medicine.

You must not be given this medicine if you have:

  • a history of allergy to human immunoglobulin products (allergic reactions may include skin rash, face swelling, wheezing or breathing difficulties) or previously been told you react to any of the ingredients in Tetanus Immunoglobulin-VF (human immunoglobulins or glycine)
  • been told you have antibodies to immunoglobulin A (IgA).

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 ever had a tetanus vaccine injection
  • have previously been advised that you have immunoglobulin A (IgA) deficiency
  • are taking or using any other medicines. These include medicines bought from pharmacies, supermarkets and health food stores.
  • suffer from a blood disorder or blood clotting problem
  • have had any vaccination during the last two weeks
  • have any other medical conditions.

Vaccinations: Please inform your doctor if you are planning to have a vaccination. Tetanus Immunoglobulin-VF may impair the effect of some virus vaccines such as measles, mumps, rubella and chicken pox for a period of at least 6 weeks, and up to 3 months. After receiving this medicine, a period of 3 months should be allowed before vaccination with some virus vaccines. In the case of measles vaccine, this effect may last for up to 1 year. Therefore, your vaccinating doctor should check the effectiveness of the measles vaccination.

Pregnant or lactating women should discuss use of Tetanus Immunoglobulin-VF with their 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 as yet have been discovered.

To reduce the risk of this happening, extra steps are taken when manufacturing this product. Strict controls are applied to the selection of 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. Additionally, the product contains specific antibodies which can provide some protection against 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 Tetanus Immunoglobulin-VF

Your doctor will determine the dose(s) of Tetanus Immunoglobulin-VF that you are to receive. Your doctor will give you the injection. It will be injected into the muscle. If a large volume of product is required, you may receive more than one injection.

Side effects

Along with their intended effects, medicines may cause some unwanted effects, which can sometimes be serious. Furthermore, individual patients may react differently to the same dose of the same medicine. This applies to Tetanus Immunoglobulin-VF.

Reactions are very uncommon after injection with Tetanus Immunoglobulin-VF. However, some pain, redness and stiffness may be apparent at the injection site. This may occur after any large injection into a muscle.

Occasionally mild fever, chills, drowsiness or discomfort may be felt and an itchy rash may develop.

If any of these effects are severe, or if you are worried about any other symptoms after the injection, consult your doctor.

Overdose

The consequences of overdosage are not known.

Storing Tetanus 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.

Further information

Tetanus Immunoglobulin-VF can only be obtained on a doctor’s prescription. This leaflet does not contain the complete information about Tetanus Immunoglobulin-VF. If you require further information about Tetanus Immunoglobulin-VF 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

Tetanus Immunoglobulin-VF is a clear, colourless, viscous (thick) solution. It is available in glass bottles.

Ingredients

Each bottle of Tetanus Immunoglobulin-VF is a sterile solution containing 160 mg/mL blood proteins of which at least 98% is immunoglobulins. It also contains 22.5 mg/mL glycine.

Manufacturer

Tetanus Immunoglobulin-VF 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 Lifeblood

Date of revision

June 2021

Australian Register Number
AUST R 61218

Published by MIMS August 2021

BRAND INFORMATION

Brand name

CSL Tetanus Immunoglobulin-VF (for Intramuscular Use)

Active ingredient

Immunoglobulin, tetanus

Schedule

S4

 

Notes

Distributed by Australian Red Cross Lifeblood

1 Name of Medicine

Human tetanus immunoglobulin.

2 Qualitative and Quantitative Composition

Tetanus Immunoglobulin-VF (for Intramuscular Use) is a sterile, preservative free solution containing 160 mg/mL human plasma protein of which at least 98% is immunoglobulin G (IgG), with a tetanus antitoxin activity of not less than 100 IU/mL.
Tetanus Immunoglobulin-VF (for Intramuscular Use) contains less than 0.5 mg/mL immunoglobulin A (IgA).
The pH value of the ready-to-use solution is 6.6.
Tetanus Immunoglobulin-VF (for Intramuscular Use) is manufactured from human plasma collected by Australian Red Cross Lifeblood.
Tetanus Immunoglobulin-VF (for Intramuscular Use) contains 22.5 mg/mL of glycine.

3 Pharmaceutical Form

Solution for intramuscular injection.

4 Clinical Particulars

4.9 Overdose

The consequences of overdosage are not known.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No genotoxicity studies have been conducted with Tetanus Immunoglobulin-VF (for Intramuscular Use). There have been no reports of such effects associated with the use of CSL's plasma-derived therapeutic medicines.
Carcinogenicity. No carcinogenicity studies have been conducted with Tetanus Immunoglobulin-VF (for Intramuscular Use). There have been no reports of such effects associated with the use of CSL's plasma-derived therapeutic medicines.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Not applicable.
CAS number. None assigned.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes

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