Proquad polvo y disolvente para suspension inyectable en jeringa precargada

Label: information for the user

ProQuad

Powder and solvent for injectable suspension in pre-filled syringe

Mumps, rubella, measles, and varicella vaccine (live virus)

Read this label carefully before you or your child is vaccinated, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This vaccine has been prescribed only for you or your child, and should not be given to others.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What ProQuad is and how it is used

2.What you need to know before receiving ProQuad

3.How to use ProQuad

4.Possible adverse effects

5.Storage of ProQuad

6.Contents of the package and additional information

ProQuad is a vaccine that contains attenuated viruses of measles, mumps, rubella, and varicella. When the vaccine is administered to a person, the immune system (the body's natural defenses) will create antibodies against the measles, mumps, rubella, and varicella viruses. The antibodies help to protect against infections caused by these viruses.

ProQuad is administered to help protect your child against measles, mumps, rubella, and varicella. The vaccine can be administered to individuals from 12 months of age.

ProQuad can also be administered to children from 9 months of age under special circumstances (to meet national vaccination schedules, in outbreak situations, or when traveling to a region with high prevalence of measles).

Although ProQuad contains live viruses, they are too weak to cause measles, mumps, rubella, or varicella in healthy individuals.

Do not use ProQuad

• If the person to be vaccinated is allergic to any measles, mumps, or rubella vaccine or to any of the other components of this vaccine (listed in section 6), including neomycin.
• If the person to be vaccinated has blood disorders or any type of cancer that affects the immune system.
• If the person to be vaccinated is receiving treatment or taking medication that may weaken the immune system (except low-dose corticosteroid therapy for asthma or hormone replacement therapy).
• If the person to be vaccinated has a weakened immune system due to illness (including HIV/AIDS).
• If the person to be vaccinated has a family history of congenital or hereditary immunodeficiency, unless the person's immune competence has been demonstrated.
• If the person to be vaccinated has active, untreated tuberculosis.
• If the person to be vaccinated has any illness with a fever above 38.5°C; however, a fever below this level is not in itself a reason to delay vaccination.
• If the person to be vaccinated is pregnant (in addition, pregnancy should be avoided for 1 month after vaccination, see Pregnancy and breastfeeding).

Warnings and precautions

If the person to be vaccinated experiences any of the following problems, consult with their doctor or pharmacist before being vaccinated with ProQuad:

• An allergic reaction to eggs or any product containing eggs.
• Personal or family history of allergies or seizures (convulsions).
• An adverse effect after vaccination with measles, mumps, and/or rubella vaccine that involves bruising or prolonged bleeding.
• HIV infection without symptoms of HIV disease. However, vaccination may be less effective than for non-infected individuals (see Do not use ProQuad).

If you have a bleeding disorder or low platelet count, the injection will be administered under the skin.

In rare circumstances, it is possible to contract measles, including severe measles, from a person who has been vaccinated with ProQuad. This can occur in individuals who have not been previously vaccinated against measles or who have not had measles, as well as in individuals who fall into one of the following categories:

• Individuals with a weakened immune system.
• Pregnant women who have never had measles or have not been vaccinated against measles.
• Newborns whose mothers have never had measles or have not been vaccinated against measles.

Whenever possible, individuals who have been vaccinated with ProQuad should attempt to avoid close contact, until 6 weeks after vaccination, with anyone who falls into one of the above categories.Inform your doctor if someone falls into one of the above categories and will be in close contact with the person being vaccinated.

As with other vaccines, ProQuad may not protect all vaccinated individuals completely. Additionally, if the person to be vaccinated has already been exposed to measles, mumps, rubella, or varicella viruses but has not yet developed the disease, ProQuad may not be able to prevent the onset of the disease.

Other medications and ProQuad

Inform your doctor or pharmacist if the person being vaccinated is using or has recently used other medications (or other vaccines).

ProQuad can be administered at the same time as other pediatric vaccines such as Prevnar and/or the hepatitis A vaccine, or with vaccines that contain diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated poliovirus, or hepatitis B. A different injection site will be used for each vaccine.

Your doctor may delay vaccination for at least 3 months after a blood or plasma transfusion or after administration of immunoglobulin (Ig) or varicella-zoster immunoglobulin (IgVZ).After vaccination with ProQuad, Ig or IgVZ should not be administered for 1 month, unless your doctor instructs otherwise.

Any tuberculin test should be performed before, simultaneously with, or 4 to 6 weeks after vaccination with ProQuad.

Inform your doctor if the person being vaccinated has recently received a vaccine or has one scheduled in the near future. Your doctor will determine when ProQuad should be administered.

Salicylates (such as aspirin, a substance present in numerous medications used to relieve pain and reduce fever) should be avoided during the 6 weeks following vaccination with ProQuad.

Pregnancy and breastfeeding

ProQuad should not be administered to pregnant women. Women of childbearing age should take necessary precautions to avoid pregnancy for 1 month after vaccination.

Inform your doctor if you are breastfeeding or plan to breastfeed. Your doctor will decide whether you should receive ProQuad.

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this vaccine.

ProQuad contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

ProQuad contains potassium

This medication contains potassium, less than 1 mmol (39 mg) per dose; this is essentially "potassium-free".

ProQuad contains sorbitol

This medication contains 16 mg of sorbitol per dose.Consider the additive effect of medications containing sorbitol (or fructose) administered concomitantly and the ingestion of sorbitol (or fructose) in the diet.

ProQuad must be injected into the muscle or under the skin, either on the outer surface of the thigh or on the upper part of the arm.

Recommended injection sitesfor muscle injections are the thigh area in young children, while for the rest of the ages, it is preferable to choose the upper part of the arm.

If the person to be vaccinated has a coagulation disorder or low platelet levels, the vaccine must be administered under the skin because bleeding may appear after muscle administration.

ProQuad must not be injected directly into any blood vessel.

ProQuad is administered by injection as follows:

• Children between 9 and 12 months of age:

ProQuad can be administered from 9 months of age. To ensure optimal protection against chickenpox and measles, two doses of ProQuad should be administered with an interval of at least 3 months.

• Individuals 12 months of age and older:

To ensure optimal protection against chickenpox, two doses of ProQuad should be administered with an interval of at least 1 month.

The appropriate time and number of injections will be determined by your doctor in accordance with official recommendations.

Instructions for reconstitution intended for doctors or healthcare professionals are included at the end of the leaflet.

If you forgot to use ProQuad

Your doctor will decide when to administer the missed dose.

Like all vaccines and medications, this vaccinemay cause side effects, although not everyone will experience them.

Allergic reactions (hives) may occur. Some of these reactions can be severe and may include difficulty breathing or swallowing. If the person vaccinated experiences an allergic reaction, call their doctor immediately.

Other side effects have been reported after the administration of ProQuad, and some of them were severe. These included:

• Rare (may affect up to 1 in 100people): febrile seizures.
• Very rare (may affect up to 1 in 1,000people):gait instability.

The following side effects were more frequently reported with the use of ProQuad:

• Very common (may affect more than 1 in 10people): injection site reactions consisting of pain/tenderness/swelling, redness, fever (38.9°C or higher);
• Common (may affect up to 1 in 10people): injection site reactions consisting of swelling or painful rash; irritability; rash (includingrash of the type of measles, rash of the type of varicellaand rash at the injection site); upper respiratory tract infection; vomiting and diarrhea.

Other side effects have been reported with the administration of at least one of the following vaccines: ProQuad, previous formulations of monovalent and combined measles, mumps, and rubella vaccines manufactured byMerckSharp & Dohme LLC, Rahway, NJ 07065, USA.(hereinafter MSD), or Varicella Live Virus Vaccine (Oka/Merck). These adverse events include:

• Rare (may affect up to 1 in 100people): cough
• Very rare(may affect up to 1 in 1,000people): skin infection; varicella.
• Unknown (cannot be estimated from available data):unusual bleeding or painful rash under the skin; inflammation of the testicles; skin tingling, herpes zoster (herpes); encephalitis (inflammation of the brain); aseptic meningitis (inflammation of the membranes covering the brain and spinal cord not caused by a bacterial infection), severe skin alterations; cerebral hemorrhage; afebrile seizures; joint pain and/or swelling (which may be transient or chronic); pneumonia/neumonitis (inflammation of the lungs).

Your doctor has a more comprehensive list of side effects for ProQuad and for the components of ProQuad (measles, mumps, and rubella vaccines manufactured by MSD and Varicella Live Virus Vaccine (Oka/Merck)).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this vaccine out of sight and reach of children.

Do not use this vaccine after the expiration date that appears on the outer packaging after CAD. The expiration date is the last day of the month indicated.

Store and transport refrigerated (between 2°C and 8°C).

Do not freeze.

Store the vial in the outer packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of ProQuad

After reconstitution, one dose (approximately 0.5 ml) contains:

The active ingredients are:

Measles virus 1 strain Enders’ Edmonston (live, attenuated) No less than 3.00 log 10 TCID 50*

Mumps virus 1 strain Jeryl Lynn (Level B) (live, attenuated) No less than 4.30 log 10 TCID 50*

Rubella virus 2 strain Wistar RA 27/3 (live, attenuated) No less than 3.00 log 10 TCID 50*

Varicella virus 3 strain Oka/Merck (live, attenuated) No less than 3.99 log 10 UFP**

* Dose that infects 50% of the histocultures

** Plaque-forming units

(1) Produced in chicken embryo cells.

(2) Produced in human diploid lung fibroblasts (WI-38).

(3) Produced in human diploid cells (MRC-5).

The other components are:

Sugar

Sucrose, hydrolyzed gelatin, urea, sodium chloride, sorbitol (E-420), monosodium glutamate, sodium phosphate, sodium bicarbonate, potassium phosphate, potassium chloride, Hanks' balanced salt solution, MEM, neomycin, phenol red, hydrochloric acid (HCl), and sodium hydroxide (NaOH).

Vehicle

Water for injection.

Appearance of the product and contents of the container

The vaccine is a powder for suspension for injection contained in a single-dose vial, which must be mixed with the vehicle supplied with the powder vial.

The powder is a compact crystalline mass of white to pale yellow color, and the vehicle is a clear, colorless liquid.

ProQuad is available in containers of 1, 10, and 20. Only some container sizes may be marketed.

Marketing authorization holder and manufacturer

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, Netherlands

For more information about this medicinal product, please contact the local representative of the marketing authorization holder.

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:https://www.ema.europa.eu.

This information is intended solely for healthcare professionals:

Before mixing with the vehicle, the vaccine powder is a compact crystalline mass of white to pale yellow color. The vehicle is a clear, colorless liquid. When fully reconstituted, the vaccine is a pale yellow to pinkish liquid.

For the reconstitution of the vaccine, only the vehicle supplied should be used, as it lacks preservatives or other antiviral substances capable of inactivating the vaccine.

It is essential to use a new, sterile syringe and needle for each individual to prevent the transmission of infectious agents from one person to another.

A separate needle should be used for reconstitution and another for injection.

ProQuad should not be mixed in the same syringe with other vaccines.

Instructions for reconstitution

To place the needle, firmly attach it to the end of the syringe and secure it with a twist.

Inject the entire contents of the vehicle from the syringe into the vial containing the powder. Gently agitate to mix thoroughly.

The reconstituted vaccine should be visually inspected for any foreign particles and/or variation in physical appearance before administration. If any of the above are observed, discard the vaccine.

It is recommended that the vaccine be administered immediately after reconstitution, to minimize loss of potency. Discard the reconstituted vaccine if not used within 30 minutes.

Do not freeze the reconstituted vaccine.

Extract the entire contents of the reconstituted vaccine from the vial into a syringe, change the needle, and inject the entire contents subcutaneously or intramuscularly.

Unused products or waste materials should be disposed of in accordance with local requirements.

See also Section 3 How to use ProQuad