PRIORIX 0,5 ML Proszek i rozpuszczalnik do roztworu do wstrzykiwań
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Treść ulotki
- What is Priorix and what is it used for
- What you need to know before you receive Priorix
- How Priorix is administered
- Possible side effects
- How to store Priorix
- Contents of the pack and other information
Priorix, powder and solvent for injectable solution in a pre-filled syringe
Vaccine (live) against measles, mumps, and rubella
Read this leaflet carefully before using this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Never give it to others.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. This leaflet is addressed to the person receiving the vaccine. However, the vaccine can be administered to both adults and children, and therefore the leaflet can also be read for administration to the child.
Contents of this leaflet:
- 1. What Priorix is and what it is used for
- 2. What you need to know before you receive Priorix
- 3. How Priorix is administered
- 4. Possible side effects
- 5. How to store Priorix
- 6. Contents of the pack and other information
1. What is Priorix and what is it used for
Priorix is a vaccine used in children from 9 months of age, adolescents and adults for the prevention of diseases
caused by the measles, mumps and rubella viruses.
How Priorix works
When a person is vaccinated with Priorix, their immune system (the body's natural defense
system) develops antibodies that protect them from infection by the measles, mumps and rubella
viruses.
Even though Priorix contains live viruses, these are too weak to cause measles, mumps or rubella in
healthy people.
2. What you need to know before you receive Priorix
Priorix must not be administered if:
- you are allergic to any of the ingredients of this vaccine (listed in section 6). Signs of an allergic reaction can include itchy rash, shortness of breath and swelling of the face or tongue,
- you have had an allergy to neomycin (an antibiotic agent). A known contact dermatitis (skin rash that appears when the skin is in direct contact with allergens such as neomycin) should not be a problem but you should inform your doctor beforehand,
- you have a serious infection accompanied by a high temperature. In these cases, vaccination will be postponed until recovery. A mild infection such as a cold does not pose a problem, but you should inform your doctor beforehand,
- you have any illness (such as Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)) or are taking medicines that weaken the immune system. Whether or not to administer the vaccine will depend on the level of your immune defenses,
- you are pregnant. In addition, pregnancy should be avoided in the first month after vaccination.
Warnings and precautions
Consult your doctor or pharmacist before receiving Priorix if:
- you have disorders of the central nervous system, a history of convulsions with high fever, or a family history of convulsions. If you develop a high fever following vaccination, please consult your doctor immediately,
- you have had a severe allergic reaction to egg proteins,
- you have, after vaccination against measles, mumps or rubella, experienced easy bruising or bleeding for longer than normal as an undesirable effect (see section 4),
- your immune system is weakened (e.g. due to an HIV infection). You should be closely monitored as the response to the vaccine may not be sufficient to guarantee protection against the disease (see section 2 “Priorix must not be administered if”).
Fainting (especially in adolescents) may occur following, or even before any injection
with a needle. Therefore, inform your doctor or nurse if you have fainted with a previous injection.
If you have been vaccinated within 72 hours of contact with a person affected by measles, Priorix will offer a certain
degree of protection against the disease.
Children under 12 months of age
Children vaccinated in their first year of life may not be fully protected. The doctor
will indicate whether additional doses of vaccine are necessary.
Like all vaccines, Priorix may not fully protect all people who have been vaccinated.
Other medicines and Priorix
Tell your doctor if you are taking, have recently taken or might take any other medicines
(or other vaccines).
Priorix can be given at the same time as other vaccines such as diphtheria, tetanus, pertussis
(acellular), Haemophilus influenzaetype b, oral or inactivated polio, hepatitis A and hepatitis B, varicella, vaccines
meningococcal of serogroup B as well as meningococcal of serogroup C, meningococcal of the
serogroups A, C, W-135 and Y, and pneumococcal conjugate. Consult your doctor or nurse for further
information.
A different injection site will be used for each vaccine.
If not administered simultaneously, an interval of at least one month is recommended between
the administration of Priorix and other live attenuated vaccines.
The doctor may delay vaccination for at least 3 months if you have received blood transfusions or human antibodies
(immunoglobulins).
If a tuberculin test needs to be performed, this should be done before, at the same time or 6
weeks after vaccination with Priorix.
Pregnancy, breastfeeding and fertility
Priorix must not be administered to pregnant women.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before receiving this vaccine. It is also important
to avoid pregnancy in the first month after vaccination. During this period of time you should
use an effective method of contraception to avoid pregnancy.
Accidental vaccination of pregnant women with Priorix should not be a reason for termination of
pregnancy.
Priorix contains sorbitol, para-aminobenzoic acid, phenylalanine, sodium and potassium
This vaccine contains 9 mg of sorbitol per dose.
Priorix contains para-aminobenzoic acid. It may cause allergic reactions (even delayed) and,
exceptionally, bronchospasm.
This vaccine contains 334 micrograms of phenylalanine per dose. Phenylalanine may be harmful to
subjects affected by phenylketonuria, a rare genetic disease that causes the accumulation of phenylalanine because the
body cannot dispose of it correctly.
This vaccine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
This vaccine contains less than 1 mmol of potassium (39 mg) per dose, i.e. essentially ‘potassium-free’
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3. How Priorix is administered
Priorix is administered by subcutaneous or intramuscular injection, in the upper arm or the outer thigh.
Priorix is suitable for children aged 9 months and over, adolescents and adults. The doctor will determine the timing and
number of injections to be administered based on official recommendations.
The vaccine should never be administered intravenously.
4. Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
The side effects that have been observed during clinical trials with Priorix are:
- Very common (may affect more than 1 in 10 doses of the vaccine):
- redness at the injection site
- fever of 38°C or higher
- Common (may affect up to 1 in 10 doses of the vaccine):
- pain and swelling at the injection site
- fever above 39.5°C
- skin rash (spots)
- upper respiratory tract infection
- Uncommon (may affect up to 1 in 100 doses of the vaccine):
- middle ear infection
- swollen lymph nodes (glands in the neck, armpit or groin)
- loss of appetite
- nervousness
- unusual crying
- difficulty sleeping (insomnia)
- redness, irritation and watering of the eyes (conjunctivitis)
- bronchitis
- cough
- swelling of the parotid glands (glands in the cheeks)
- diarrhoea
- vomiting
- Rare (may affect up to 1 in 1,000 doses of the vaccine):
- convulsions accompanied by high fever
- allergic reactions
After marketing of Priorix, the following adverse reactions have been reported in some cases:
- joint and muscle pain
- pinpoint or small spot bleeding, or bruising more frequently than normal due to a decrease in platelets
- sudden allergic reaction that is life-threatening
- infection or inflammation of the brain, spinal cord and peripheral nerves leading to temporary difficulty walking (instability) and/or temporary loss of body movement control, inflammation of some nerves, possibly with tingling or loss of normal sensation or movement (Guillain-Barré syndrome)
- narrowing or blockage of blood vessels
- erythema multiforme (symptoms of which are red spots, often itchy, similar to measles rash, starting on the limbs and sometimes on the face and the rest of the body)
- measles-like and mumps-like symptoms (including transient and painful swelling of the testicles and swelling of the neck glands)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the website
By reporting side effects you can help provide more information on the safety of this
medicine.
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5. How to store Priorix
Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date which is stated on the pack after the wording ‘Exp.’.
Store and transport in a refrigerator (2 C – 8 C).
Do not freeze.
Store in the original packaging to protect the medicine from light.
After reconstitution, the vaccine must be administered immediately. If this is not possible it must
be stored in a refrigerator (2 C – 8 C) and used within 8 hours of reconstitution.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Priorix contains
The active ingredients are: attenuated live measles, mumps and rubella viruses.
The excipients are:
Powder: amino acids (containing phenylalanine), lactose (anhydrous), mannitol (E421), sorbitol (E420), medium
199 (containing phenylalanine, para-aminobenzoic acid, sodium and potassium)..
Solvent: water for injections
Description of Priorix and contents of the pack
Priorix is presented as powder and solvent for injectable solution (powder in a vial for 1 dose and
solvent in a pre-filled syringe (0.5 ml)) with or without needles in the following packs:
- with 2 separate needles: packs of 1 or 10
- without needles: packs of 1 or 10.
Priorix is supplied as a powder ranging in colour from white to slightly pink and a clear, colourless
solvent (water for injections) for reconstitution of the vaccine.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
GlaxoSmithKline S.p.A. Viale dell’Agricoltura, 7 - 37135 Verona - Italy
Manufacturer responsible for batch release
GlaxoSmithKline Biologicals Rue de l’Institut, 89 - 1330 - Rixensart – (Belgium)
Other sources of information
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The following information is intended exclusively for healthcare professionals:
As with all injectable vaccines, in the rare event of an anaphylactic reaction following vaccine administration, appropriate medical supervision and treatment must always be immediately available.
Alcohol and other disinfecting agents should be allowed to evaporate from the skin before injecting
the vaccine, as they may inactivate the attenuated viruses in the vaccine itself.
Priorix must not be administered intravascularly under any circumstances.
In the absence of compatibility studies, the medicinal product must not be mixed with other medicinal products.
The solvent and the reconstituted vaccine must be visually inspected for the presence of
foreign particles and/or changes in physical appearance before reconstitution or administration. If
the above is observed, do not use the solvent or the reconstituted vaccine.
The vaccine must be reconstituted by adding the entire contents of the pre-filled solvent syringe to
the vial containing the powder.
To insert the needle into the syringe, carefully read the instructions in figures 1 and 2. However, the syringe
supplied with Priorix may be slightly different (without threading) from the syringe in the drawing.
In this case, the needle should be inserted without screwing.
Needle
Syringe
Figure 1Figure 2
Always hold the syringe by the body, not by the syringe plunger or the Luer Lock Adapter (LLA), and
keep the needle in line with the syringe (as illustrated in Figure 2). Otherwise, the LLA adapter may
deform and leak.
If the LLA adapter detaches during syringe assembly, a new dose of
vaccine (new syringe and new vial) must be used.
1 Unscrew the syringe protection by rotating it counterclockwise (as shown in Figure 1)
Whether or not the LLA is rotating, follow these steps:
- 2. Attach the needle to the syringe by gently connecting the needle hub to the LLA adapter and rotate a quarter turn clockwise until a click is felt (as shown in Figure 2).
- 3. Remove the needle protection, which may be a little difficult.
- 4. Add the solvent to the powder. The mixture must be shaken well until the powder is completely dissolved in the solvent.
Due to a slight variation in its pH, the colour of the reconstituted vaccine may range from light peach to
fuchsia pink without a decrease in vaccine potency.
Aspirate the entire contents of the vial
- 6. To administer the vaccine, a new needle must be used. Unscrew the needle from the syringe and connect the injection needle, repeating step 2 above.
After reconstitution, the vaccine must be administered immediately. If this is not possible, it must
be stored in a refrigerator (2°C - 8°C) and used within 8 hours of reconstitution.
Unused medicinal product and waste materials derived from such medicinal product should be disposed of in accordance with
current local regulations.
- Kraj rejestracji
- Postać farmaceutycznaPowder and solvent for injectable solution, 0,5 ML
- Kod ATCJ07BD52
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki PRIORIXSubstancja czynna: measles, combinations with mumps and rubella, live attenuatedProducent: MERCK SHARP & DOHME B.V.Bez receptyPostać farmaceutyczna: Powder and solvent for injectable solution, 0.5 MLSubstancja czynna: measles, combinations with mumps, rubella and varicella, live attenuatedProducent: GLAXOSMITHKLINE S.P.A.Wymaga receptyPostać farmaceutyczna: Powder and solvent for injectable solution, 0.5 mlSubstancja czynna: respiratory syncytial virus vaccinesProducent: PFIZER EUROPE MA EEIGWymaga recepty
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PRIORIX wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w PRIORIX jest measles, combinations with mumps and rubella, live attenuated. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
PRIORIX jest produkowany przez GLAXOSMITHKLINE S.P.A.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie PRIORIX jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić PRIORIX w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (measles, combinations with mumps and rubella, live attenuated) to m.in. M-M-RVAXPRO, PRIORIX TETRA, ABRYSVO. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
