Powder and solvent for suspension for injection
mumps, rubella and varicella (live).
What ProQuad is and what it is used for
ProQuad is a vaccine containing measles, mumps, rubella, and varicella viruses that have been weakened. When the vaccine is given to a person, the immune system (the body’s natural defense system) will produce antibodies against measles, mumps, rubella, and varicella viruses. The antibodies help protect against diseases caused by these viruses.
ProQuad is given to your child to protect against measles, mumps, rubella, and chickenpox (varicella). The vaccine can be given to people from 12 months of age.
ProQuad can also be given to children from 9 months of age under special conditions (eg to follow national vaccination schedules, outbreak situations, or travel to an area with a high incidence of measles).
Although ProQuad contains live viruses, they are too weak to cause measles, mumps, rubella, or varicella in healthy people.
What you need to know before you get ProQuad
Do not use ProQuad
- if the person to be vaccinated is allergic to any varicella vaccine or measles, mumps, rubella vaccine, or any of the ingredients of this vaccine (listed in section 6) including neomycin.
- if the person to be vaccinated has a blood disease or some type of cancer that affects the immune system.
- if the person to be vaccinated is receiving treatment or taking any medication that may weaken the immune system (except low-dose corticosteroid therapy for asthma or replacement therapy).
- if the person to be vaccinated has a weakened immune system due to illness (including AIDS ).
- if the person is to be vaccinated or the family has a congenital or hereditary immune deficiency if it has not been shown that this person has an adequate immune system.
- if the person to be vaccinated has active untreated tuberculosis.
- if the person to be vaccinated has a disease with a fever exceeding 38.5 ° C; However, low-grade fever alone is not a reason to postpone vaccination.
- if the person to be vaccinated is pregnant (pregnancy should also be avoided 1 month after vaccination, see Pregnancy and breastfeeding).
Warnings and cautions
If the person to be vaccinated has experienced any of the following, talk to your doctor or pharmacist before giving ProQuad:
- An allergic reaction to eggs or to anything that contained eggs.
- Have had allergies or seizures, or if anyone in the family has had this.
- A side effect after vaccination with a vaccine containing measles, mumps, and/or rubella in the form of bruising or longer bleeding time than normal.
- An HIV infection without showing symptoms of HIV disease. Vaccination may then be less effective than for non-infected people (see Do not use ProQuad ).
If you suffer from a coagulation disorder or low platelet count, the injection will occur and will be given under the skin.
In rare cases, it is possible to get chickenpox, including severe chickenpox, from a person who has been vaccinated with ProQuad. This can occur in people who have not previously been vaccinated against chickenpox or had chickenpox, as well as in people who fall into one of the following categories:
- individuals with reduced disease resistance.
- pregnant women who have not had chickenpox or who have not been vaccinated against chickenpox.
- newborns whose mothers have not had chickenpox or who have not been vaccinated against chickenpox.
If possible, individuals vaccinated with ProQuad should try to avoid close contact, for up to 6 weeks after vaccination, with anyone who falls into one of the categories above. Tell your doctor if there is anyone who falls into one of these categories and is expected to come into close contact with the person who has been vaccinated.
As with other vaccines, ProQuad may not provide complete protection for all people who have been vaccinated. In addition, if the person to be vaccinated has already been exposed to measles, mumps, rubella, or varicella viruses, without having already become ill, ProQuad may not be able to prevent the disease from breaking out.
Other drugs and ProQuad
Tell your doctor or pharmacist if the person to be vaccinated is taking or has recently taken any other medicines (or other vaccines).
ProQuad can be given at the same time as other childhood vaccines such as Prevenar and/or hepatitis A vaccine, or vaccines containing diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated poliomyelitis or hepatitis B. Different injection sites will be used for each vaccine.
Your doctor may postpone vaccination for at least 3 months after a blood or plasma transfusion or administration of immunoglobulin (IG), or varicella-zoster immunoglobulin (VZIG). After vaccination with ProQuad, IG or VZIG should not be given until after 1 month, unless your doctor tells you otherwise.
If a tuberculin test is to be performed, it should be done either before, at the same time as, or 4 to 6 weeks after vaccination with ProQuad.
Tell your doctor if the person to be vaccinated has recently been vaccinated or will be vaccinated shortly. Your doctor will decide when ProQuad should be given.
The use of salicylates (eg acetylsalicylic acid, a substance used in many painkillers and antipyretics) should be avoided for 6 weeks after vaccination with ProQuad.
Pregnancy and breastfeeding
ProQuad should not be given to pregnant women. Women of childbearing potential should take the necessary precautions to avoid pregnancy for 1 month after vaccination.
Women who are breastfeeding or intending to breastfeed should tell their doctor. Your doctor will decide if ProQuad should be used.
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.
ProQuad contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.
ProQuad contains potassium
This medicine contains less than 1 mmol (39 mg) potassium per dose, ie it is essentially ‘potassium-free’.
ProQuad contains sorbitol
This medicine contains 16 mg of sorbitol per dose. The additive effects of concomitantly administered drugs containing sorbitol (or fructose) and food intake of sorbitol (or fructose) should be considered.
How to use ProQuad
ProQuad should be injected into the muscle or under the skin either on the outside of the thigh or on the upper arm.
When injected into the muscle, the thigh is usually suitable for smaller children, while the upper arm is a suitable injection site for older individuals.
If the person to be vaccinated suffers from a coagulation disorder or has a low platelet count, the vaccine should be given under the skin as bleeding may occur if given in a muscle.
ProQuad should not be injected directly into a blood vessel.
ProQuad is given by injection as follows:
- Children between 9 and 12 months of age: ProQuad can be given from 9 months of age. To ensure optimal protection against chickenpox and measles, two doses of ProQuad should be given at least three months apart.
- Individuals from 12 months of age and older: To ensure optimal protection against chickenpox, two doses of ProQuad should be given at least one month apart.
The appropriate time and number of injections will be determined by your doctor by official recommendations.
Dilution instructions for healthcare professionals are included at the end of this leaflet.
If you forget to take ProQuad
Your doctor will decide when the missed dose should be given.
Possible side effects
Like all vaccines and medicines, this vaccine can cause side effects, although not everybody gets them.
Allergic reactions (hives) may occur. Some of these reactions can be severe and may cause difficulty breathing or swallowing. If the vaccinated person has an allergic reaction, talk to a doctor immediately.
Other side effects have been reported after administration of ProQuad and some of these are serious, these are:
- Uncommon (may affect up to 1 in 100 people): febrile seizures.
- Rare (may affect up to 1 in 1,000 people): Unsteady gait.
The following other side effects have been reported with the use of ProQuad:
- Very common (may affect more than 1 in 10 people): injection site symptoms including pain/tenderness, redness, fever (38.9 ° C or higher).
- Common (may affect up to 1 in 10 people): injection site symptoms including swelling or bruising; irritability, rash (including measles-like rash, chickenpox-like rash, and injection site rash); upper respiratory tract infection; vomiting and diarrhea.
Other side effects have been reported with the use of at least one of the following vaccines: ProQuad, previous formulations of combined measles, mumps, and rubella vaccine, or formulations with the individual vaccine ingredients manufactured by Merck & Co., Inc., or live varicella vaccine ( Oka / Merck). These side effects include:
- Uncommon (may affect up to 1 in 100 people): cough.
- Rare (may affect up to 1 in 1,000 people): skin infection, chickenpox (varicella).
- Has been reported (occurs in unknown numbers of people): abnormal bleeding or bruising of the skin, swelling of the testicles, tingling of the skin, herpes zoster ( shingles ), encephalitis, encephalitis not caused by a bacterial infection (aseptic meningitis ), severe skin disease, stroke, convulsions without fever, joint pain and/or swelling (which may be transient or chronic ), pneumonia (pneumonia/pneumonitis).
Your doctor has a more complete list of side effects of ProQuad and the vaccine components of ProQuad (the measles, mumps, rubella, and varicella vaccine manufactured by Merck & Co., Inc. and live varicella vaccine (Oka / Merck)).
How to store ProQuad
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 outer carton after EXP. The expiration date is the last day of the specified month.
Store and transport cold (2ºC – 8ºC).
Do not freeze.
Keep the vial in the outer carton. Sensitive to light.
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
After reconstitution , one dose (0.5 ml) contains :
The active substances are:
Live attenuated measles virus 1, strain Enders Edmonston not less than 3.00 log 10 TCID 50 *
Live attenuated mumps virus 1, strain Jeryl Lynn TM (B level) not less than 4.30 log 10 TCID 50 *
Live attenuated rubella virus 2, strain Wistar RA 27/3 not less than 3.00 log 10 TCID 50 *
Live attenuated varicella virus 3, strain Oka / Merck not less than 3.99 logs 10 PFU **
* 50% tissue culture infectious dose
** plaque-forming units
( 1 ) Produced in chicken embryonic cell culture.
( 2 ) Produced in human diploid pulmonary fibroblasts (WI-38).
( 3 ) Produced in human diploid (MRC-5) cells.
Other ingredients are:
Powder
Sucrose, hydrolyzed gelatin, urea, sodium chloride, sorbitol (E420), monosodium glutamate, sodium phosphate, sodium bicarbonate, potassium phosphate, potassium chloride, medium 199 with Hanks salts, MEM, neomycin, phenol red, hydrochloric acid, sodium hydroxide
Diluent
Water for injections.
What the medicine looks like and the contents of the pack
The vaccine is a powder for solution for injection in a single-dose vial, which should be mixed with the diluent provided with the vial of powder.
The powder is a white to pale yellow compact crystalline cake and the diluent is a clear colorless liquid.
ProQuad is available in packs of 1 and 10 pcs. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder: Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN Haarlem, The Netherlands
Manufacturer responsible for batch release: Merck Sharp and Dohme, BV, Waarderweg, 39, NL-2031 BN Haarlem, The Netherlands
Contact the representative of the marketing authorization holder to find out more about this medicine.
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