Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about you or your child receiving
this medicine, speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I or my child receiving Verorab?
Verorab contains the active ingredient rabies virus (inactivated). Verorab is a vaccine
used to help prevent rabies infection in people who have been, or are likely to be,
bitten, licked or scratched by an animal that has rabies.
2. What should I know before I or my child receives Verorab?
Do not use if you or your child has ever had an allergic reaction to Verorab or any
of the ingredients listed at the end of the CMI. Do not use if you or your child has
a high temperature or serious illness.
Talk to your doctor if you or your child has any other medical conditions or is taking
any other medicines. Tell your doctor if you are pregnant or plan to become pregnant
or are breastfeeding.
3. What if I or my child is taking other medicines?
Some medicines may interfere with Verorab and affect how it works.
4. How do I or my child receive Verorab?
Verorab is given as an injection, usually into muscle in the upper arm or in the skin,
by a doctor or nurse. Your doctor will decide how many injections you or your child
should have and when they should have them. Carefully follow all of your doctor's
directions.
5. What should I know after I or my child receives Verorab?
|
Things you should do
|
Keep an updated record of you or your child’s vaccinations.
Keep follow-up appointments with your doctor or clinic. It is important to have follow-up
doses of Verorab, and any blood tests, at the correct intervals.
|
|
Looking after your medicine
|
Verorab is usually stored in the doctor's surgery or clinic, or at the pharmacy. However,
if you need to store Verorab:
Keep it where children cannot reach it.
Keep it in the original pack until it is time for it to be given.
Keep it in the refrigerator, between 2°C and 8°C. Do not freeze it.
|
6. Are there any side effects?
Very common side effects include, feeling unwell, headache, sore muscles, pain, redness
or swelling at the injection site, and in babies, irritability, inconsolable crying
and drowsiness. These side effects are mild and short-lived.
Serious side effects include serious allergic reactions. Symptoms include, rash, itchy
swellings, swelling of the face, lips, tongue, or other parts of the body.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient:
Rabies virus (inactivated)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about Verorab. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about you or your child receiving Verorab.
Where to find information in this leaflet:
1. Why am I or my child receiving Verorab?
Verorab contains the active ingredient, rabies virus (inactivated). Verorab is a vaccine used to help prevent rabies infection in people who have been,
or are likely to be, bitten, licked or scratched by an animal that has rabies. Verorab
works by causing your body to protect itself against rabies.
Verorab is used to help prevent rabies infection. However, as with all vaccines, 100%
protection cannot be guaranteed.
2. What should I know before I or my child receives Verorab?
Warnings
Do not receive Verorab if:
you or your child is allergic to Verorab, or any of the ingredients listed at the
end of this leaflet UNLESS they have been bitten or scratched by an animal that has
rabies.
you or your child has a high temperature or serious illness.
Always check the ingredients to make sure you or your child can receive this vaccine.
Check with your doctor if you or your child:
has any other medical conditions such as low immunity due to an illness or treatment
with medicines such as corticosteroids, ciclosporin or cancer treatment (including
radiation therapy).
experience anxiety problems, such as breathing fast, fainting, unusual skin sensations,
before or after receiving needle injections.
ever had an allergic reaction to antibiotics
take any medicines for any other condition, for example antibiotics
During treatment, you or your child may be at risk of developing certain side effects.
It is important you understand these risks and how to monitor for them. See additional
information under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
3. What if I or my child is taking other medicines?
Tell your doctor or pharmacist if you or your child is taking any other medicines,
including any medicines, vitamins or supplements that you buy without a prescription
from your pharmacy, supermarket or health food shop.
Some medicines may interfere with Verorab and affect how it works.
medicines which lower the immune system, such as corticosteroids, ciclosporin or other
medicines used to treat cancer (including radiation therapy).
antirabies immunoglobulin (used to treat confirmed rabies infection).
Verorab can be administered at the same time as a typhoid fever vaccine in 2 separate
injections sites.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you or your child is taking and if these affect Verorab.
4. How do I or my child receive Verorab?
How much to receive
Verorab is given as an injection, usually into muscle in the upper arm or in the skin,
by a doctor or nurse. Your doctor will decide how much Verorab is needed.
When to receive Verorab
Verorab may be given in advance to people at risk of getting rabies. Verorab is also
given to people after they have been exposed to rabies infection.
The usual course is 3 to 5 injections, given at intervals over 1 to 4 weeks.
After one year, depending on the circumstances, a booster injection may be needed.
Further boosters may be needed every few years.
Your doctor will tell you how many injections you or your child should have and when
they should have them. Carefully follow all of your doctor's directions.
If you forget to receive Verorab
If you or your child miss a dose, talk to your doctor and arrange another visit as
soon as possible.
If you or your child receive too much Verorab
Overdose is most unlikely because your doctor or nurse gives the injections. If you
have any concerns, ask your doctor.
5. What should I know after I or my child receives Verorab?
Things you should do
Keep an updated record of you or your child’s vaccinations.
Keep follow-up appointments with your doctor or clinic. It is important to have follow-up
doses of Verorab, and any blood tests, at the correct intervals. This gives the vaccine
the best chance of providing protection against rabies and allows the antibody level
to be measured.
Remind any doctor, dentist or pharmacist you visit that you or your child have received
Verorab.
Looking after your medicine
Verorab is usually stored in the doctor's surgery or clinic, or at the pharmacy. However,
if you need to store Verorab:
Keep it where children cannot reach it.
Keep it in the original pack until it is time for it to be given.
Keep it in the refrigerator, between 2°C and 8°C. Do not freeze it. Freezing destroys
the vaccine.
Getting rid of any unwanted medicine
If you no longer need to use this vaccine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this vaccine after the expiry date.
6. Are there any side effects?
All vaccines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
or your child feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you or your child experience,
you can report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems (Australia) or to Medsafe at
https://nzphvc.otago.ac.nz/reporting/ (New Zealand). By reporting side effects, you can help provide more information on
the safety of this vaccine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
receiving any of your medicines.
7. Product details
This vaccine is only available with a doctor's prescription.
What Verorab contains
Each pack of Verorab contains one vial of vaccine powder and one prefilled syringe.
Vial of Vaccine Powder
|
Active ingredient
(main ingredient)
|
3.25 International Units of rabies virus (inactivated) (WISTAR Rabies PM/WI 38 1503-3M
strain)
|
|
Other ingredients
(inactive ingredients)
|
Maltose
20% albumin solution
Basal Medium Eagle: mixture of mineral salts, vitamins, dextrose and amino-acids including
L-Phenylalanine
Water for injections
Hydrochloric acid and sodium hydroxide
|
|
Potential allergens
|
Neomycin, streptomycin and polymyxin
|
|
Excipient with known effect
|
Phenylalanine (4.1 micrograms)
|
Prefilled syringe
|
Ingredient
|
Sodium Chloride 0.4%
Water for injections
|
Do not receive this vaccine if you or your child is allergic to any of these ingredients.
What Verorab looks like
Your doctor will inject the sterile diluent into the vial to make the liquid for injection.
This liquid is a clear and colourless.
AUST R 371727.
Who distributes Verorab?
Distributed in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Distributed in New Zealand by:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
PO Box 62027
Sylvia Park Auckland 1644
Freecall: 0800 283 684
This leaflet was prepared in October 2023
verorab-ccdsv11-cmiv2-27oct23