2.5 IU Powder and suspension for injection Rabies vaccine (inactivated)
What Rabies-Imovax is and what it is used for
Rabies-Imovax is a vaccine given to prevent rabies and for pre-treatment after exposure to rabies infection, regardless of age.
Rabies-Imovax is a vaccine that contains a very small amount of inactive rabies virus. When Rabies-Imovax is given, the body’s defense system begins to produce antibodies that protect against rabies.
If you or your child has been exposed to rabies, your doctor or nurse will decide if you or your child should be vaccinated.
If you or your child are at high risk of being infected with rabies shortly, your doctor or nurse may prescribe a series of vaccinations with Rabies-Imovax to prevent the possible onset of rabies.
What you need to know before you get Rabies-Imovax
Do not take Rabies-Imovax if you or your child
- is allergic (hypersensitive) to the active substance or any of the other ingredients of Rabies-Imovax
- has had an allergic reaction after vaccination with Rabies-Imovax
- is ill and has a high fever or some acute illness. The vaccination should be postponed until you or your child has recovered.
Because rabies is a serious illness, your doctor may decide to vaccinate you even though any of the above points apply to you or your child.
Warnings and cautions
Like other vaccines, Rabies-Imovax does not necessarily protect everyone vaccinated.
Tell a doctor, pharmacist, or nurse:
- if you or your child are allergic (hypersensitive) to neomycin or beta-propiolactone, which are used in the production of the vaccine. Small amounts of these substances may be present in the vaccine.
- if you or your child have had vaccination reactions. Your doctor will decide if the vaccination program should continue for you or your child and may refer you or the child for a blood test to find out if you or the child have adequate protection against rabies.
- if you or your child have hemophilia or a low platelet count (a condition characterized by easy bruising or bleeding), the puncture site may bleed.
- if you are taking immunosuppressive drugs (eg corticosteroids ) or have a weakened immune system. Such situations can affect the antibody response to vaccination. Antibody testing should therefore always be performed on patients receiving immunosuppressive therapy or patients with weakened immune systems.
- if your child is younger than 1 year.
- if you or your child have had an allergic reaction to natural rubber (latex). The syringe cover on the pre-filled syringe contains a derivative of latex rubber which may cause a severe allergic reaction.
The doctor or nurse will decide if you or your child should be vaccinated or not.
Other medicines and Rabies-Imovax
Treatments that inhibit the function of the immune system, including long-term systemic corticosteroid therapy, may affect antibody production and lead to failure of vaccination. Therefore, the antibody level should be measured with an antibody test 2–4 weeks after vaccination (see section Warnings and Precautions).
If other medicines, including immunoglobulin for rabies, are to be given at the same time as the Rabies-Imovax vaccine, these preparations must not be drawn into the same syringe or injected at the same site.
As rabies immunoglobulins affect the immune response of the vaccine, recommendations for the administration of rabies immunoglobulins should be followed carefully.
Tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy, breastfeeding, and fertility
Tell your doctor if you are pregnant, think you may be pregnant, or breastfeeding.
There is only limited information on the use of this vaccine in pregnant women. Your doctor will decide if you should be vaccinated or not.
It is unknown whether Rabies-Imovax passes into breast milk. Therefore, consult your doctor about vaccination with Rabies-Imovax if you are breastfeeding.
Fertlitet
The effects of the vaccine on male or female fertility have not been evaluated.
Driving and using machines
The vaccine has no known effects on the ability to drive and use machines.
How to use Rabies-Imovax
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Your doctor or nurse will give you Rabies-Imovax as an injection.
Dosage
The vaccination schedule depends on
- if you or your child have previously been vaccinated with rabies vaccine or not
- if you or your child have been exposed to a rabies-infected or possibly rabies-infected animal
The recommended dose is 1 ml of reconstituted vaccine.
A) Dosage before exposure to rabies (preventive / pre-exposure)
Three vaccines (1 milliliter) are given on different days.
| Injection | Time of injection | Day |
| First | First vaccine dose | 0 |
| Other | 7 days after the first vaccine dose | 7 |
| Third | 21 or 28 days after the first injection | 21 or 28 |
Extra doses, so-called booster doses, should be given by official national recommendations. People at high risk for rabies infection should be tested for antibodies.
B) Dosage when you or your child has received the three above-mentioned injections and has been exposed to a rabies-infected or possibly rabies-infected animal:
Post-exposure treatment should be initiated as soon as possible after exposure to rabies.
Treatment of bites and lacerations should be done immediately or as soon as possible after exposure. The first aid measures recommended involve thorough and immediate rinsing of bites and lacerations, as well as washing with soap, copious amounts of water, povidone-iodine, or another rabies virus killer for at least 15 minutes. The treatment of wounds should be done before administering the rabies vaccine or rabies immunoglobulins if these drugs are to be given.
Administration of a rabies vaccine must be adapted to the type of contact, the person’s vaccination status, and the animal’s rabies status (see Table 1 WHO category for exposure rate).
Table 1: WHO category for exposure rates how larger
| Exposition category | Type of exposure to pets or wild animals suspected or confirmed to have rabies or animals not available for testing | Recommended preventive treatment |
| IN | Touching or feeding animals. Licking on intact skin (no exposure). | None, if reliable medical history exists. a |
| II | Nibble on unprotected skin.Minor lacerations or abrasions without bleeding (exposure). | Give vaccine immediately. Discontinue treatment if the animal is healthy throughout the 10-day b observation period or if laboratory tests, performed using appropriate diagnostic methods, have reliably demonstrated that the animal does not have rabies. Treatment according to exposure category III, in the case of exposure to bats. |
| III | Single or multiple bites or lacerations that have passed through the skin c, contamination of mucous membranes or damaged skin with saliva from animals when licking, exposure to bats (severe exposure). | Give rabies vaccine immediately and rabies immunoglobulins preferably as soon as possible after initiating prophylaxis after exposure. Rabies immunoglobulins can be given as an injection no later than 7 days after the first vaccine dose. Discontinue treatment if the animal has been healthy throughout the 10-day observation period or if laboratory tests, performed using appropriate diagnostic methods, have reliably demonstrated that the animal does not have rabies. |
| a | The treatment can be postponed if a dog or cat that is healthy and that is in or comes from a low-risk area is taken in for observation. | |
| b | This observation period only applies to dogs and cats. Other domestic animals and wild animals, except endangered species suspected of having rabies, should be killed and their tissues examined for the presence of rabies antigen by appropriate laboratory tests. | |
| c | Bites especially in the head, neck, or face area, on the hands and genitals, belong to exposure category III, as these areas have plenty of nerves. |
a. Dosage when you or your child have protection against rabies (have been vaccinated) and have been exposed to a rabies-infected or possibly rabies-infected animal:
Two vaccines are given to the muscle on different days. In this case, rabies immunoglobulins do not need to be given.
| Injection | Time of injection | Day |
| First | As soon as possible | 0 |
| Other | After 3 days | 3 |
B. Dosage when you or your child do not have protection against rabies (have not been vaccinated) but have been exposed to a rabies-infected or possibly rabies-infected animal:
If you or your child have not previously received the Rabies-Imovax vaccine, your doctor or nurse may also give you or your child human rabies immunoglobulin in the form of a syringe with the first vaccine dose, (see exposure category III in Table 1). This substance immediately helps against rabies infection.
For vaccination, either the Essen schedule or the Zagreb schedule are used, see below. Your doctor will decide which option is most suitable for you.
Essen schedule: A total of 4 vaccine syringes (1 milliliter) are given on different days.
| Injection | Time of injection | Day |
| First | First vaccine dose | 0 |
| Other | 3 days after the first vaccine dose | 3 |
| Third | 7 days after the first vaccine dose | 7 |
| Fourth | Between 14 and 28 days after the first injection | 14 to 28 |
Zagreb schedule: A total of 4 vaccine syringes (1 milliliter) are given on different days.
| Injection | Time of injection | Day |
| First and second | First and second vaccine dose (given on different sides of the body, in the upper arm) | 0 |
| Third | 7 days after the first vaccine dose | 7 |
| Fourth | 21 days after the first injection | 21 |
The vaccination schedule must not be interrupted unless, according to the veterinarian’s examination, the animal is found to be non-rabies-infected (observation of the animal and/or laboratory examinations).
C) Use in immunocompromised individuals
- Pre-exposure to rabies (preventive / pre-exposure)For people with a weakened immune system, an examination of the amount of neutralizing antibodies in the blood should be performed 2-4 weeks after vaccination to assess the possible need for an additional vaccine dose.
- After exposure to a rabies-infected or possibly rabies-infected animal immunocompromised individuals, the vaccine should always be given according to the complete vaccination schedule. In categories II and III exposure cases, rabies immunoglobulin should be co-administered with the vaccine (see Table 1).
How the vaccine is given
The doctor or nurse will prepare the vaccine immediately before injection.
The vaccine can only be given in one muscle: in adults and children in the upper arm and infants and toddlers in the thigh muscle. Do not give into a vein ( intravenously ).
Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
The following side effects may occur after vaccination with Rabies-Imovax.
Severe allergic reactions:
Anaphylactic reactions, including shock, may be associated with one or more of the following symptoms:
- itching and rash
- swelling of the face and/or neck
- difficulty breathing, bluish discoloration of the tongue or lips
- low blood pressure, fast and weak pulse, cold skin, dizziness, and possible fainting.
These symptoms usually occur very quickly after injection one. Contact a doctor immediately if you get any of these symptoms when you have already left the place where you received the injection.
Other side effects are
Most side effects occurred within 3 days after injection and disappeared on their own within 1-3 days. Adverse reactions have been reported with the following frequencies:
Very common (may affect more than 1 user in 10)
- general malaise
- headache
- muscle aches
- pain at the puncture site.
Common (may affect up to 1 in 10 people)
- fever
- nausea
- fatigue, unusual weakness
- redness at the puncture site
- swelling at the puncture site
- itching at the puncture site
- bruise at the puncture site.
Uncommon (may affect up to 1 in 100 people)
- allergic reactions that cause skin reactions or breathing problems
- enlarged lymph nodes
- magnet
- diarrhea
- vomiting
- dizziness
- joint pain
- frostbite
- stinging sensation.
Rare (may affect up to 1 in 1,000 people)
- swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing.
Has been reported (occurs in an unknown number of users):
- serum sickness: joint pain, rash, enlarged lymph nodes, and general malaise. These symptoms usually occur 2-4 weeks after injection one.
- swelling of the brain or encephalitis
- cramps
- nerve damage that can cause a decreased sensation, pain, and weakness.
How to store Rabies-Imovax
Keep out of sight and reach of children.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze. Store in the original package. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the carton after (EXP).
The expiration date is the last day of the specified month.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
Note that the person to be vaccinated must tell the doctor or nurse if they have ever had an allergic reaction to the substances listed below.
- The active substance is inactivated rabies virus (virus strain Wistar PM / WI-38 1503-3M), 2.5 IU per dose one (1 ml)
- The other ingredients are human albumin and water for injections
The vaccine may contain very small amounts of the antimicrobial substance betapropiolactone and the antibiotic et neomycin used in the production of the vaccine.
What the medicine looks like and the contents of the pack
Rabies-Imovax is supplied in a disposable glass syringe pack filled with 1 ml water for injection (without additives) and a glass vial containing a dose of vaccine in the form of a lyophilized powder. The powder contains a small amount of phenol red. When the water for injection is added to the lyophilized vaccine, its color changes to pink. The package contains one or two separate needles or is without a needle.
The Rabies-Imovax vaccine is available in a single pack.
Not all types of packaging may be marketed.
Marketing Authorisation Holder
Sanofi Pasteur Europe
14 Henry Vallée Space
69007 Lyon
France
Manufacturer
Sanofi Pasteur
Campus Merieux
1541 Avenue Marcel Merieux
FR-69280 Marcy l’Etoile
France
Local representative:
Sanofi AB
Box 30052
104 25 Stockholm
Tel: +46 8-634 50 00