Consumer medicine information

Merieux Inactivated Rabies Vaccine (MIRV)

Rabies vaccine

BRAND INFORMATION

Brand name

Merieux Inactivated Rabies Vaccine

Active ingredient

Rabies vaccine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Merieux Inactivated Rabies Vaccine (MIRV).

SUMMARY CMI

Merieux Inactivated Rabies Vaccine (MIRV)

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about you or child receiving this medicine, speak to your doctor or pharmacist.

1. Why am I or my child receiving MIRV?

MIRV contains the active ingredient rabies virus (inactivated). MIRV 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.

For more information, see Section 1. Why am I or my child receiving MIRV? in the full CMI.

2. What should I know before me or my child receives MIRV?

  • Do not use if you or your child has ever had an allergic reaction to MIRV 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.

For more information, see Section 2. What should I know before me or my child receives MIRV? in the full CMI.

3. What if me or my child is taking other medicines?

Some medicines may interfere with MIRV and affect how it works.

A list of these medicines is in Section 3. What if me or my child is taking other medicines? in the full CMI.

4. How do I or my child receive MIRV?

  • MIRV is given as an injection, usually into muscle in the upper arm, by a doctor or nurse. Your doctor will decide how much MIRV is needed.
  • 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.

More instructions can be found in Section 4. How do I or my child receive MIRV? in the full CMI.

5. What should I know after me or my child receives MIRV?

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 MIRV, and any blood tests, at the correct intervals.
  • Remind any doctor, dentist or pharmacist you visit that you or your child has received MIRV.
Looking after your medicineMIRV is usually stored in the doctor's surgery or clinic, or at the pharmacy. However, if you need to store MIRV:
  • 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.

For more information, see Section 5. What should I know after me or my child receives MIRV? in the full CMI.

6. Are there any side effects?

Common side effects include, local reactions at the injection site, headache, nausea, sore, tender, or weak muscles, fever, feeling tired or lack of energy. 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.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

Merieux Inactivated Rabies Vaccine (MIRV)

Active ingredient(s): Rabies virus (inactivated)


Consumer Medicine Information (CMI)

This leaflet provides important information about MIRV. 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 MIRV.

Where to find information in this leaflet:

1. Why am I or my child receiving MIRV?
2. What should I know before me or my child receives MIRV?
3. What if me or my child is taking other medicines?
4. How do I or my child receive MIRV?
5. What should I know after me or my child receives MIRV?
6. Are there any side effects?
7. Product details

1. Why am I or my child receiving MIRV?

MIRV contains the active ingredient, rabies virus (inactivated). MIRV 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. MIRV works by causing your body to protect itself against rabies.

MIRV is used to help prevent rabies infection. However, as with all vaccines, 100% protection cannot be guaranteed.

2. What should I know before me or my child receives MIRV?

Warnings

Do not receive MIRV if:

  • you or your child is allergic to MIRV, 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
    - low immunity due to an illness or treatment with medicines such as corticosteroids, ciclosporin or cancer treatment (including radiation therapy).
    - bleeding problems or bruise easily.
    - experience anxiety problems, such as breathing fast, fainting, unusual skin sensations, before or after receiving needle injections.
    - take any medicines for any other condition

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 me 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 MIRV 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).

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 MIRV.

4. How do I or my child receive MIRV?

How much to receive

  • MIRV is given as an injection, usually into muscle in the upper arm, by a doctor or nurse. Your doctor will decide how much MIRV is needed.

When to receive MIRV

  • MIRV may be given in advance to people at risk of getting rabies. MIRV is also given to people after they have been exposed to rabies infection.
  • The usual course is 3 or 4 injections, given at intervals over 3 or 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 MIRV

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 MIRV

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 me or my child receives MIRV?

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 MIRV, 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 MIRV.

Looking after your medicine

MIRV is usually stored in the doctor's surgery or clinic, or at the pharmacy. However, if you need to store MIRV:

  • 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 or your child 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

Less serious side effectsWhat to do
The following side effects are mild and short-lived.
  • any effects at the injection site, such as pain, redness, swelling, bruising or itching.
  • headache
  • dizziness or light-headedness
  • muscle ache, tenderness or weakness
  • painful or swollen joints
  • “pins and needles”, tingling sensation
  • nausea, vomiting or diarrhea
  • stomach cramps or pain
  • bodily discomfort, feeling unwell
  • tiredness, lack of energy
  • chills
  • fever
  • swollen glands
Speak to your doctor if you or your child have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
The following side effects are rare.
  • signs of allergy such as,
    - rash,
    - itching or pinkish, itchy swellings on the skin (also called hives or nettle rash),
    - swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing.
  • a hypersensitivity reaction associated with the presence of betapropiolactone-altered human albumin in the vaccine.
    - symptoms include fever, swelling, skin rash, enlargement of the lymph nodes
  • numbness or weakness of the arms and legs
  • convulsions
  • swelling or infection of the brain
    - symptoms include headache and fever, progressing to hallucinations, confusion, paralysis of part or all of the body, disturbances of behaviour, speech and eye movements, stiff neck and sensitivity to light
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these 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. 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 MIRV contains

Each pack of MIRV contains one vial of vaccine powder and one prefilled syringe, which contains sterile water.

Vial of Vaccine Powder

Active ingredient
(main ingredient)
Not less than 2.5 International Units of rabies virus (inactivated) (WISTAR Rabies PM/WI 38 1503-3M strain).
Other ingredients
(inactive ingredients)
100-150 micrograms of Neomycin (antibiotic)
up to 70 mg of albumin
Potential allergensNeomycin

Prefilled syringe

Ingredient1 mL of water for injections

Do not receive this vaccine if you or your child is allergic to any of these ingredients.

The manufacture of this product includes exposure to bovine materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.

What MIRV looks like

Your doctor will inject the sterile water into the vial to make the liquid for injection. This liquid is a red to purple-red colour.

AUST R 26675

Who distributes MIRV?

Australia:
sanofi-aventis australia pty ltd
12 - 24 Talavera Road
Macquarie Park NSW 2113 Australia
Tel: 1800 818 806

New Zealand:
sanofi-aventis new zealand limited
Level 8
56 Cawley St
Ellerslie
Auckland
New Zealand
Tel: 0800 283 684

This leaflet was prepared in April 2020
mirv-ccdsv4-5.1-6-cmiv3-28apr20

Published by MIMS July 2020

BRAND INFORMATION

Brand name

Merieux Inactivated Rabies Vaccine

Active ingredient

Rabies vaccine

Schedule

S4

 

1 Name of Medicine

Rabies Virus (Inactivated).

2 Qualitative and Quantitative Composition

Merieux Inactivated Rabies Vaccine (MIRV) is lyophilised, stabilised suspension of inactivated Wistar rabies virus strain PM/W1381503-3M. It is cultured on human diploid cells and inactivated by β-propiolactone. These human diploid cells are a cell line derived from human embryonic lung tissue in the 1960s.
The potency of the reconstituted vaccine is not less than 2.5 IU, the WHO International Standard per dose (1 mL).

Excipient with known effect.

Neomycin.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

The powder is pinkish beige to orangey yellow. After reconstitution with the diluent supplied, MIRV is a clear or slightly opalescent red to purplish red suspension.

4 Clinical Particulars

4.1 Therapeutic Indications

Pre-exposure immunisation in persons at special risk of contracting rabies. Post exposure immunisation against rabies.

4.2 Dose and Method of Administration

One dose consists of 1 mL of vaccine administered by the intramuscular route, in the deltoid area for adults and children or the anterolateral area of the thigh muscle in infants and toddlers.
The vaccination schedule should be adapted in accordance with the circumstances of the exposure and the individual's rabies immune status. For further information, refer to the current Immunisation Handbook.
Product is for single use in one patient on one occasion only. Discard any residue.

Pre-exposure prophylaxis.

Primary vaccination.

3 injections at day 0, day 7, and day 21 or day 28.
For further information about pre-exposure prophylaxis refer to the current Australian Immunisation Handbook.
Regular serology testing of neutralising antibodies is recommended to assess seroconversion of individuals at increased risk of exposure to rabies virus, with a frequency adapted to that risk. When antibody titre is below acceptable level, a booster dose is needed.
According to the Australian Immunisation Handbook, WHO current recommendations state that booster doses are not required for persons who are travelling to, or living in, an area of high rabies risk and who have completed a primary course, either pre- or post-exposure, using currently available cell culture derived vaccine.

Post-exposure prophylaxis.

Post-exposure prophylaxis consists of local treatment of the wound, initiated as soon as possible after an exposure, followed by the administration of the vaccine and of passive immunisation, if indicated.
The vaccination must be administered under medical supervision and should be started as soon as possible after exposure.
The immunisation schedule must be adapted according to the type of contact and the immunisation status of the subject. For further information, refer to the current Australian Immunisation Handbook.
Vaccination of non-immunised individuals.

Administration of immunoglobulin.

In the case of severe types of exposure, rabies immunoglobulin should be given in association with the vaccine for non-immunised individuals:
On day 0, a complementary passive immunisation is required using: Human rabies immunoglobulin (HRIG) 20 IU/kg body weight.
As much as possible should be infiltrated around the wounds. The remainder should be administered by deep intramuscular injection at a site distant from the vaccine injection site. If possible, the vaccine should be injected contra-laterally to the immunoglobulin administration sites.

Administration of vaccine.

Vaccine should be administered on day 0, day 3, day 7 and day 14 (4 injections of 1 mL). The posology is the same for adults and children.
Vaccination of previously immunised individuals (full pre-exposure prophylaxis vaccination confirmed). In this case, administration of immunoglobulin is not required. Two injections of vaccine should be administered at day 0 and day 3.
This schedule should not apply to immunocompromised individuals.
In both previously-immunised and non-immunised individuals, consideration should also be given to the possibility of tetanus and other wound infections, and appropriate measures taken as per the current Australian Immunisation Handbook.

Method of administration.

Preparation.

Instructions for Luer-Lok syringe.

Step 1: Holding the syringe cap in one hand (avoid holding the syringe plunger or barrel), unscrew the tip cap by twisting it counter-clockwise.
Step 2: To attach the needle to the syringe, gently twist the needle clockwise into the syringe until slight resistance is felt.
Reconstitution of vaccine (all syringes). Reconstitute the freeze-dried vaccine by introducing the diluent in the pre-filled syringe into the vial of powder. Gently swirl until complete suspension of the powder is obtained.

Syringe with attached needle.

Withdraw the suspension from the vial into a separate syringe, and administer via intramuscular injection with an appropriate needle for each individual.

Luer-Lok syringe.

Without removing the needle from the vial, unscrew the syringe to eliminate negative pressure (as the vial is sealed under vacuum). Reattach the needle remaining in the vial to the syringe (as per Step 2). Withdraw the suspension from the vial into the syringe. Unscrew the reconstitution needle and replace it with a sterile needle (as per Step 2) of an appropriate size and length for intramuscular injection.
Once reconstituted, the vaccine must be used immediately.
After use, any remaining vaccine and container must be disposed of safely, preferably by heat inactivation or incineration, according to locally agreed procedures.

4.3 Contraindications

Pre-exposure prophylaxis.

Known systemic hypersensitivity reaction to any component of MIRV or after previous administration of the vaccine or a vaccine containing the same components.
Vaccination must be postponed in case of febrile or acute disease.

Post-exposure prophylaxis.

Since rabies infection generally results in death, there are no contraindications to post-exposure vaccination.

4.4 Special Warnings and Precautions for Use

Do not administer intravenously or intradermally.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following administration of the vaccine.
As with any vaccine, vaccination with MIRV may not protect 100% of vaccinated individuals.
The full course of immunisation should be completed in order to obtain efficient antibody response to prevent rabies.

Neomycin.

As each dose may contain undetectable traces of neomycin which is used during vaccine production, caution must be exercised when the vaccine is administered to individuals with hypersensitivity to this antibiotic and other antibiotics of the same class.

Immunocompromised individuals.

In individuals with congenital or acquired immunodeficiency, the immune response to the vaccine may be inadequate.
Therefore, it is recommended to monitor serologically RVNA (Rabies Virus Neutralizing Antibodies) level in such individuals to ensure that an acceptable immune response has been induced. Additional doses should be given as necessary.
Moreover, if post-exposure prophylaxis is needed, only full schedule of vaccination should be administered. In addition, rabies immunoglobulin should be given in association with the vaccine for both categories II and III exposures.

Bleeding disorders.

Because intramuscular injection can cause injection site haematoma, MIRV should not be given to individuals with any bleeding disorder, such as haemophilia or thrombocytopaenia, or to individuals on anticoagulant therapy unless the potential benefits clearly outweighs the risk of administration. If the decision is made to administer MIRV in such individuals, it should be given with caution, with steps taken to avoid the risk of haematoma formation following injection.

Apnoea.

The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.

Anxiety-related reactions.

Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions can occur following, or even before, any vaccination as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance and paresthesia. It is important that procedures are in place to avoid injury from fainting.

Use in the elderly.

MIRV is indicated for use in elderly.

Paediatric use.

MIRV is indicated for use in paediatric population.

Effects on laboratory tests.

Interference of MIRV with laboratory and/or diagnostic tests has not been studied.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Immunosuppressive treatments, including long-term systemic corticosteroid therapy, may interfere with antibody production and cause the failure of the vaccination. It is therefore advisable to perform a serological test (RVNA) level using a Rapid Fluorescent Focus Inhibition Test (RFFIT) 2 to 4 weeks after the last injection.
No clinical data are available regarding the concurrent administration of MIRV with other vaccines.
As rabies immunoglobulin interferes with development of immune response to the vaccine, the recommendation of administration of rabies immunoglobulin must be strictly followed.
Separate injection sites and separate syringes must be used in case of concomitant administration with any other medicinal product, including rabies immunoglobulins.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

MIRV has not been evaluated for impairment of male or female fertility.
(Category B2)

Pre-exposure.

The vaccine has not been studied in animal teratogenicity studies. Data on the use of this vaccine in pregnant women are limited. Therefore, the administration of the vaccine during pregnancy is not recommended.
For the vaccination of individuals at a high risk of exposure, the risk/benefit ratio must be assessed before administering the vaccine.

Post-exposure.

Due to the severity of the disease, pregnancy is not a contraindication.

Pre-exposure.

It is not known whether MIRV is excreted in human milk. Therefore, caution must be exercised when the vaccine is administered to a nursing woman.

Post-exposure.

Due to the severity of the disease, lactation is not a contraindication.

4.7 Effects on Ability to Drive and Use Machines

No studies on the effects on the ability to drive or use machines have been performed.

4.8 Adverse Effects (Undesirable Effects)

Adverse event information is derived from clinical trials and worldwide post-marketing experience.
Within each system organ class the adverse events are ranked under headings of frequency, using the following CIOMS frequency rating: Very common ≥ 10%; Common ≥ 1 and < 10%; Uncommon ≥ 0.1 and < 1%; Rare ≥ 0.01 and < 0.1%; Very rare < 0.01%; Not known (cannot be estimated from available data).

Data from clinical studies.

In clinical studies, more than 1,600 subjects (from less than 1 through 72 years of age) received at least one dose of MIRV.
A pooled analysis has been performed on 4 randomized, controlled, observer-blind clinical studies sharing the same safety standards, integrating data from 401 subjects (113 children and adolescents from 2 through 17 years of age and 288 adults from 18 through 65 years of age). In two studies in adults, the subjects received HRIG concurrently with the first dose of MIRV.
The adverse reactions were generally of mild intensity and appeared within 3 days after vaccination. Most reactions resolved spontaneously within 1 to 3 days after onset. Most frequent adverse reactions events in all age groups were injection site pain, and headache, malaise and myalgia.
Table 1 presents the frequencies of solicited adverse reaction (recorded within 7 days) and unsolicited related adverse events (recorded within 28 days), reported following any dose of MIRV.
For a comprehensive overview of vaccine safety, additional relevant adverse reactions from studies not eligible for pooled safety analysis have been included. Their frequency is estimated based on total number of subjects from clinical development (N = 1674 subjects, including at least 612 children and adolescents). See Table 2.

Data from post-marketing experience.

Based on spontaneous reporting, the following additional adverse events have been reported during the commercial use of MIRV. These events have been very rarely reported, however, exact incidence rate cannot be precisely calculated, their frequency is qualified as "Not known".

Immune system disorders.

Anaphylactic reactions.
Serum sickness type reactions:
These reactions might be associated with the presence of betapropiolactone-altered human albumin in the Human Diploid Cell Vaccine (HDCV).

Nervous system disorders.

Neuropathy.
Convulsion, encephalitis.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems (Australia) or https://nzphvc.otago.ac.nz/reporting/ (New Zealand).

4.9 Overdose

For general advice on overdose management, contact the Poisons Information Centre, telephone number 13 11 26 (Australia) or the National Poisons Centre, 0800 POISON or 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Anti-infectives for systemic use, ATC code: J07BG01.

Mechanism of action.

Following a single deep subcutaneous injection, an antibody response can be detected after a variable period of up to 7 days, in all subjects. Peak antibody levels are reached at about 30 days and then start to decline.

Clinical trials.

No pharmacodynamic studies are performed for vaccines.

5.2 Pharmacokinetic Properties

No pharmacokinetics studies are performed for vaccines.

5.3 Preclinical Safety Data

Genotoxicity.

MIRV has not been evaluated for genotoxic potential.

Carcinogenicity.

MIRV has not been evaluated for carcinogenic potential.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each vial contains, in addition, between 100 and 150 microgram of neomycin and up to 70 mg of albumin.
The manufacture of this product includes exposure to bovine materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.

6.2 Incompatibilities

This vaccine must not be mixed with other medicinal products.

6.3 Shelf Life

36 months when stored at 2° to 8°C.

6.4 Special Precautions for Storage

Store refrigerated (2° to 8°C). Do not freeze. Use immediately after reconstituting the vaccine.

6.5 Nature and Contents of Container

Powder (1 dose) in vial (glass) and 1.0 mL of diluent (water for injection) in pre-filled syringe (glass) with attached needle or pre-filled needlelesss (Luer-lok) syringe with Plastic Rigid Tip Cap.

6.6 Special Precautions for Disposal

After use, any remaining vaccine and container must be disposed of safely, preferably by heat inactivation or incineration, according to locally agreed procedures.

6.7 Physicochemical Properties

No data available.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes