Powder and solvent for solution for injection in pre-filled syringe
Vaccine against measles, mumps, and rubella, live
What Priorix is and what it is used for
Priorix is a vaccine used in children from 9 months and up, adolescents, and adults to protect against measles, mumps, and rubella.
How Priorix works
When a person is vaccinated with Priorix, the immune system (the body’s natural defense system) produces antibodies that protect the person from becoming infected with viruses that cause measles, mumps, and rubella.
Although Priorix contains live viruses, these viruses are too weak to cause measles, mumps, or rubella in healthy people.
What you need to know before you receive Priorix
Priorix should not be given
- you are allergic to any of the ingredients of this vaccine (listed in section 6). Signs of an allergic reaction may include an itchy rash, shortness of breath, and swelling of the face or tongue.
- you have a known allergy to neomycin (an antibiotic ). Known contact dermatitis (skin rash when the skin comes in direct contact with the allergen, such as neomycin ) should not be a problem but talk to your doctor first.
- you have a severe infection with a high fever. In these cases, the vaccination should be postponed until after recovery. A mild infection such as a cold should not be a problem but talk to your doctor first.
- you have a disease (eg human immunodeficiency virus ( HIV ) or acquired immune deficiency syndrome ( AIDS )) or are taking any medicine that weakens the immune system. Whether you get the vaccine depends on the level of your immune system.
- you are pregnant. In addition, pregnancy should be avoided for 1 month after vaccination.
Warnings and cautions
Talk to your doctor or pharmacist before taking Priorix
- if you have a neurological disease, have had febrile seizures, or if someone else in the family has had seizures. In case of high fever after vaccination, contact your or your child’s doctor immediately for advice
- you have previously had a severe allergic reaction to egg protein
- you have previously had a side effect after vaccination against measles, mumps, or rubella that made it easier to get bruises or prolonged bleeding time (see section 4)
- you have a weakened immune system (eg HIV infection ). You should be carefully monitored as the response to the vaccine may not be sufficient to ensure protection against the disease (see section 2 “Priorix should not be given”).
Fainting can occur (mainly in adolescents) after, or even before, any needle injection. Therefore, tell your doctor or nurse if you have fainted from a previous injection.
If you are vaccinated within 72 hours of contact with someone with measles, Priorix will protect you against the disease to some extent.
Children under 12 months of age
Children who are vaccinated during their first year of life may not receive full protection. The doctor will advise if additional vaccine doses are needed.
As with all vaccines, Priorix may not provide complete protection in all vaccines.
Other medicines and Priorix
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines (or vaccines).
Priorix can be given at the same time as you receive other vaccines such as diphtheria, tetanus, pertussis ( acellular ), Haemophilus influenzae type b, oral or inactivated polio, hepatitis A, hepatitis B vaccine, varicella vaccine, the meningococcal vaccine is serogroup B, meningococcus is serogroup C and meningococcus is serogroups A, C, W-135, and Y and conjugate vaccine against pneumococci. For more information, talk to your doctor or nurse.
A new injection site will be used for each vaccine.
If the vaccines are not given at the same time, an interval of at least one month between the administration of Priorix and other live attenuated vaccines is recommended.
Your doctor may postpone vaccination for at least 3 months if you have recently had a blood transfusion or human antibodies (immunoglobulins).
If a tuberculin test is to be performed, it should be done either before, at the same time, or the earliest 6 weeks after vaccination with Priorix.
Pregnancy, breastfeeding, and fertility
Priorix should not be given to pregnant women.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this vaccine. It is also important that you do not become pregnant within one month of receiving the vaccine. During this time, you should use an effective contraceptive to avoid pregnancy.
In case of accidental vaccination of pregnant women with Priorix, this should not be a reason for abortion.
How to use Priorix
Priorix is injected under the skin or into a muscle, either in the upper arm or on the outside of the thigh.
Priorix is intended for children from 9 months of age and up, adolescents and adults.
The doctor will determine the appropriate time and number of injections to be given to you based on current official recommendations.
The vaccine should never be given to a friend.
Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
In clinical trials with Priorix, the following adverse reactions were reported:
- Very common (these may occur in more than 1 in 10 vaccine doses):
- redness at the injection site
- fever 38 ° C or higher.
- Common (these may occur in up to 1 in 10 vaccine doses):
- pain and swelling at the injection site
- fever above 39.5 ° C
- rash
- the infection you in the upper respiratory tract.
- Uncommon (these may occur in up to 1 in 100 vaccine doses):
- infection in the middle ear
- swollen lymph nodes ( glands in the neck, armpits, and groin)
- loss of appetite
- concern
- persistent crying
- insomnia (insomnia)
- red, irritated, and watery eyes ( conjunctivitis )
- bronchitis
- cough
- swollen tinnitus glands ( glands in the cheek)
- diarrhea
- vomiting.
- Rare (may occur in up to 1 in 1,000 vaccine doses):
- seizures associated with high fever
- allergic reactions.
Following the launch of Priorix, the following side effects have been reported on a few occasions :
- pain in joints and muscles
- spotting or spotting of the skin or bruising more easily than usual due to reduced platelet count
- sudden life-threatening allergic reaction
- infection or inflammation of the brain, spinal cord, and peripheral nerves leading to temporary difficulty walking (instability) and/or temporary loss of control of body movements, inflammation of certain nerves, possibly with anthrax or loss of sensation or loss of normal mobility ( Guillain-Barré syndrome )
- narrowing or blockage of blood vessels
- erythema multiforme (symptoms are red, often itchy spots, similar to measles rash that begins on the arms or legs and sometimes on the face and the rest of the body)
- measles or mumps-like symptoms (including the transient, painful swelling of the testicles and swollen glands in the neck).
How to store Priorix
Keep this vaccine out of the reach and sight of children.
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.
Store and transport cold (2 -C-8 ºC)
Do not freeze.
Store in the original box. Sensitive to light.
The vaccine should be injected immediately after completion. If this is not possible, it should be stored at 2 –C – 8 ºC (in a refrigerator) and used within 8 hours of completion.
Medicines 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 pack and other information
Content declaration
- The active substances are: live attenuated measles virus, mumps virus, and rubella virus.
- Other ingredients are Powder: amino acids, lactose (anhydrous), mannitol, and sorbitol. Diluent: water for injections
What the medicine looks like and the contents of the pack
Priorix is supplied as a powder and solvent for solution for injection (powder in a vial for one dose and diluent in a pre-filled syringe (0.5 ml)) with or without needles in the following pack sizes:
- with 1 separate needle: packs of 20 or 40
- with 2 separate needles: packs of 1, 10, 25 or 100
- without a needle: packages of 1, 10, 20, 25, 40 or 100
Priorix is supplied as a white to slightly light pink powder and a clear colorless diluent (water for injections) for reconstitution of the vaccine.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder / Information provided by:
GlaxoSmithKline AB
Box 516
169 29 Solna
Tel: 08-638 93 00
Email: info.produkt@gsk.com
Manufacturer:
GlaxoSmithKline Biologicals SA
Rue de L’Institut 89
B-1330 Rixensart
Belgium