Active ingredients: Vaccine (live) anti-measles, anti-mumps, anti-rubella
Priorix, powder and solvent for solution for injection in a pre-filled syringe
Indications Why is Priorix used? What is it for?
Priorix is a vaccine used in children 9 months and older, 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, they are too weak to cause measles, mumps, or rubella in healthy people.
Contraindications When Priorix should not be used
Priorix must not be given if:
- you are allergic to any of the ingredients of this vaccine (listed in section 6). Signs of an allergic reaction may 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 (rash that appears when the skin is in direct contact with allergens such as neomycin) should not be a problem but must first be communicated to the doctor;
- you have a "severe infection accompanied by high body temperature. In these cases, vaccination will be postponed until recovery. A" mild infection such as a cold is not a problem, but you need to tell your doctor first;
- you have any disease (such as Human Immunodeficiency Virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS)) or are taking medicines that weaken the immune system. Whether or not to give you the vaccine will depend on the level of your immune defenses;
- is pregnant. Furthermore, pregnancy should be avoided in the first month following vaccination.
Precautions for use What you need to know before taking Priorix
Talk to a doctor or pharmacist before receiving Priorix if:
- you have central nervous system disorders, a history of seizures with high fever or a family history of seizures. In case of a high fever following vaccination, please consult your doctor immediately; you have had a severe allergic reaction to egg proteins.
- you had an easier side effect of bruising or bleeding for longer than normal after vaccination against measles, mumps or rubella (see section 4)
- you have a weakened immune system (for example, due to an "HIV infection). You must be closely monitored as the response to the vaccine may not be sufficient to ensure protection against the disease (see section 2" Priorix must not be administered if ").
Fainting may occur (especially in adolescents) following, or even before, any needle injection. Therefore tell your doctor or nurse if you fainted with a previous injection.
If you have been vaccinated within 72 hours of contact with a person with measles, Priorix will offer some degree of protection against the disease.
Children under the age of 12 months
Children vaccinated in their first year of life may not be fully protected. Your doctor will indicate if additional doses of the vaccine are needed.
Like all vaccines, Priorix may not fully protect all people who have been vaccinated.
Interactions Which drugs or foods may change the effect of Priorix
Tell your doctor if you are taking, have recently taken or might take any other medicines (or other vaccines).
Priorix can be given to you at the same time as other recommended vaccinations such as diphtheria, tetanus, pertussis, Haemophilus influenzae type b, oral or inactivated polio, hepatitis A and B, meningococcus serotype C conjugate, varicella and pneumococcus 10-valent conjugate.
Injections should be given at different injection sites. Your doctor will inform you about it.
If not administered simultaneously, an interval of at least one month between administration of PRIORIX and other live attenuated vaccines is recommended.
Your doctor may delay vaccination for at least 3 months if you have received transfusions of blood or human antibodies (immunoglobulins).
If tuberculin testing is to be performed this should be done earlier, at the same time or 6 weeks after vaccination with Priorix.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
Priorix must not be administered to pregnant women.
If you are pregnant, think you may be pregnant or are planning to have a baby, or if you are breast-feeding, ask your doctor or pharmacist for advice before receiving this vaccine. It is also important to avoid becoming pregnant in the first month after vaccination. During this time you must use effective contraception to avoid becoming pregnant.
Accidental vaccination of pregnant women with Priorix should not be a reason for pregnancy termination.
Priorix contains sorbitol
If you have been told by your doctor that you have an "intolerance to some sugars, contact your doctor before receiving this vaccine.
Dosage and method of use How to use Priorix: Dosage
Priorix is administered subcutaneously or into the muscle.
Priorix is suitable for children aged 9 months and older, adolescents and adults. Your doctor will determine the timing and number of injections to administer based on official recommendations.
The vaccine should never be administered intravenously.
Side Effects What are the side effects of Priorix
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Side effects that occurred during clinical trials with Priorix are:
Very common (these may occur in more than 1 in 10 doses of the vaccine):
- redness at the injection site
- fever of 38 ° C or higher
Common (these may occur in up to 1 in 10 doses of the vaccine):
- Pain and swelling at the injection site
- fever above 39.5 ° C
- rash (spots)
- upper respiratory tract infection
Uncommon (these may occur in up to 1 in 100 doses of the vaccine):
- middle ear infection
- swollen lymph glands (glands in the neck, armpit or groin)
- loss of appetite
- nervousness
- unusual crying
- inability to sleep (insomnia)
- redness, irritation and watery eyes (conjunctivitis)
- bronchitis
- cough
- swelling of the parotid glands (glands in the cheeks)
- diarrhea
- He retched
Rare (these may occur in up to 1 in 1,000 doses of the vaccine):
- convulsions accompanied by high fever
- allergic reactions
Following marketing of Priorix, the following adverse reactions have been reported on a few occasions:
- pain in the joints and muscles
- pinpoint or patchy bleeding, or bruising more frequently than normal due to a drop in platelets
- sudden, life-threatening allergic reaction
- infection or inflammation of the brain, spinal cord and peripheral nerves resulting in temporary difficulty walking (instability) and / or temporary loss of control of body movements, inflammation of some nerves, possibly with tingling or loss of sensation or normal movement (Guillain-Barré syndrome)
- narrowing or blockage of blood vessels
- erythema multiforme (symptoms of which are red, often itchy, measles-like spots that start in the limbs and sometimes the face and rest of the body)
- measles-like and mumps-like symptoms (including transient, painful swelling of the testicles and swollen glands in the neck)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
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 carton after the entry EXP.
Store and transport refrigerated (2 ° C - 8 ° C).
Do not freeze.
Store in the original package to protect the medicine from light.
After reconstitution, the vaccine should be administered immediately. If this is not possible it must be stored in the refrigerator (2 ° C - 8 ° C) and used within 8 hours of reconstitution.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other information
What Priorix contains
- The active ingredients are: live attenuated viruses for measles, mumps and rubella.
- The other ingredients are: Powder: amino acids, lactose (anhydrous), mannitol, sorbitol.
- Solvent: water for injections
Description of the appearance of Priorix and contents of the package
Priorix is presented as a powder and solvent for solution for injection (powder in a 1 dose vial and solvent 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 needles: packs of 1, 10, 20, 25, 40 or 100
Priorix is supplied as a white to slightly pink powder and clear colorless solvent (water for injections) for reconstitution of the vaccine.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
PRIORIX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 ml) contains:
live attenuated measles virus1 (Schwarz strain) not less than 103.0 CCID50 3
live attenuated mumps virus1 (strain RIT 4385, derived from Jeryl Lynn strain) not less than 103.7 CCID50 3
live attenuated rubella virus2 (Wistar RA 27/3 strain) not less than 103.0 CCID50 3
1 produced in chicken embryonic cells
2 produced in human diploid cells (MRC-5)
3 Infecting Dose 50% of Cell Culture
This vaccine contains traces of neomycin. See section 4.3.
Excipients with known effect:
The vaccine contains 9 mg of sorbitol, see section 4.4.
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Powder and solvent for solution for injection in a pre-filled syringe.
The lyophilized anti-measles, anti-mumps and anti-rubella component is a white to slightly pink powder.
The solvent is a clear, colorless solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
PRIORIX is indicated for the active immunization of children from 9 months of age or older, of adolescents and adults against measles, mumps and rubella.
For use in children between 9 and 12 months of age see sections 4.2, 4.4 and 5.1.
04.2 Posology and method of administration
Dosage
The use of PRIORIX must be based on official recommendations.
Subjects from 12 months of age onwards
The dose is 0.5 ml. A second dose should be administered in accordance with official recommendations.
PRIORIX can be used in individuals who have previously been vaccinated with another monovalent or combined vaccine for measles, mumps and rubella.
Children aged between 9 and 12 months
Babies in their first year of life may not respond sufficiently to vaccine components. In case an epidemiological situation requires vaccinating children in their first year of life (for example: epidemic or travel to endemic regions), a second dose of PRIORIX should be given in the second year of life, preferably within three months after the first dose. Under no circumstances should the dosing interval be less than four weeks (see sections 4.4 and 5.1).
Children younger than 9 months
The safety and efficacy of PRIORIX in children less than 9 months of age have not been established.
Method of administration
PRIORIX is indicated for subcutaneous administration, although it can also be administered by intramuscular injection (see sections 4.4 and 5.1).
The vaccine should preferably be administered subcutaneously in patients with thrombocytopenia or coagulation disorders (see section 4.4).
For instructions on reconstitution of the medicinal product before administration see section 6.6.
04.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or to neomycin. A history of neomycin contact dermatitis is not a contraindication. For hypersensitivity reactions to egg proteins, see section 4.4.
Severe humoral or cellular immunodeficiency (primary or acquired), for example severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection, or an age-specific percentage of CD4 + T cells in infants less than 12 months of age: CD4 +
Pregnancy. Furthermore, pregnancy should be avoided in the first month following vaccination (see section 4.6).
As with other vaccines, administration of PRIORIX should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, such as a cold, should not delay vaccination.
04.4 Special warnings and appropriate precautions for use
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in the event of a rare anaphylactic event following the administration of the vaccine.
Alcohol and other disinfecting agents should be allowed to evaporate from the skin before injecting the vaccine as they can inactivate the attenuated viruses present in the vaccine.
Infants in their first year of life may not respond adequately to vaccine components due to possible interference with maternal antibodies (see sections 4.2 and 5.1).
Due caution should be used when administering PRIORIX to individuals with central nervous system (CNS) disease, susceptibility to febrile seizures or with a family history of seizures. Vaccinates with a history of febrile seizures should be monitored very carefully.
The measles and mumps components of the vaccine are produced in embryonic chicken cell cultures and may therefore contain traces of egg protein. People with a history of anaphylactic, anaphylactoid or other immediate reactions (eg generalized urticaria, swelling of the mouth and throat , difficulty in breathing, hypotension or shock) following egg ingestion may be at increased risk for immediate type hypersensitivity reactions after vaccination, although these types of reactions have been shown to be very rare. Individuals who have experienced anaphylactic reactions after ingestion of eggs should be vaccinated with extreme caution, having adequate treatment for anaphylaxis on hand should such a reaction occur.
Patients with rare hereditary problems of fructose intolerance should not be vaccinated with PRIORIX as it contains sorbitol.
Limited protection against measles can be achieved through vaccination for up to 72 hours after exposure to natural measles.
Syncope (fainting) may occur following, or even before, any vaccination especially in adolescents as a psychogenic response to needle injection. It may be accompanied by various neurological signs such as transient visual disturbances, paraesthesia and tonic-clonic movements of the limbs. during the recovery phase It is important that adequate procedures are in place to avoid injury resulting from fainting.
As with any vaccine, a protective immune response may not be elicited in all vaccines.
PRIORIX SHOULD NOT BE ADMINISTERED BY THE INTRAVASCULAR ROUTE UNDER ANY CIRCUMSTANCES.
Thrombocytopenia
There have been reports of worsening and recurrence of thrombocytopenia in subjects with thrombocytopenia following administration of the first dose of vaccination with live measles, mumps and rubella virus vaccines. MMR-associated thrombocytopenia is rare and generally self-limiting. In patients with ongoing thrombocytopenia or with a history of thrombocytopenia after vaccination with measles, mumps and rubella, the benefit-risk balance of administration of PRIORIX should be carefully considered. These patients should be vaccinated with caution and preferably subcutaneously.
Immunocompromised patients
Vaccination may be considered in patients with selected immunodeficiencies where the benefits outweigh the risks (e.g. patients with asymptomatic HIV, IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease, and complement deficiency disorders).
Immunocompromised patients who have no contraindication for this vaccination (see section 4.3) may not respond as well as immunocompetent patients; therefore, some of these patients may contract measles, mumps or rubella upon contact, despite proper vaccine administration. These patients should be carefully monitored for symptoms of measles, mumps and rubella.
Transmission
The transmission of measles and mumps viruses from vaccinees to susceptible contacts has never been documented. Pharyngeal excretion of measles and rubella viruses is known to occur approximately 7-28 days after vaccination with peak excretion around day 11. However, there is no evidence of transmission of these vaccine viruses excreted to susceptible contacts. Transmission of rubella virus to infants via breast milk and transplacental transmission has been documented with no evidence of clinical disease.
04.5 Interactions with other medicinal products and other forms of interaction
PRIORIX can be administered simultaneously (but at separate injection sites) with any of the following monovalent or combination vaccines [including hexavalent vaccines (DTPa-HBV-IPV / Hib)]: diphtheria-tetanus-acellular pertussis (DTPa) vaccine, vaccine Haemophilus influenzae type b (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), hepatitis A vaccine (HAV), meningococcal serotype C conjugate vaccine (MenC), varicella zoster vaccine (VZV), oral polio vaccine (OPV) and conjugate vaccine 10-valent pneumococcal in accordance with official recommendations.
If not administered simultaneously, an interval of at least one month is recommended between administration of PRIORIX and other live attenuated vaccines.
There are no data to support the use of PRIORIX with any other vaccine.
If tuberculin testing is required, it should be performed before or at the same time as vaccination, as combined measles, mumps and rubella vaccines have been reported to cause temporary depression of skin sensitivity to tuberculin. As this lack of reaction can last up to a maximum of 6 weeks, the tuberculin test should not be performed within this period after vaccination to avoid false negative results.
In individuals who have received human gammaglobulins or blood transfusions, vaccination should be postponed for three months or more (up to 11 months) depending on the dose of human globulin administered, due to the likelihood of vaccine failure due to antibodies to measles , mumps and rubella, acquired passively.
04.6 Pregnancy and breastfeeding
Fertility
PRIORIX has not been evaluated in fertility studies.
Pregnancy
Pregnant women should not be vaccinated with Priorix.
However, no fetal harm has been documented following the administration of measles, mumps or rubella vaccines to pregnant women.
Although a theoretical risk cannot be excluded, no cases of congenital rubella syndrome have been reported in more than 3,500 susceptible women who, at the time of administration of a rubella-containing vaccine, were unknowingly in the early stages of pregnancy. Therefore, accidental vaccination of unknowingly pregnant women with measles, mumps and rubella-containing vaccines should not be a reason for termination of pregnancy.
Pregnancy should be avoided in the first month following vaccination. It is therefore necessary to advise women who intend to become pregnant to postpone it.
Breastfeeding
There is limited experience with PRIORIX during breastfeeding. Studies have shown that postpartum breastfeeding women vaccinated with live attenuated rubella vaccines can secrete the virus into breast milk and pass it on to breastfed infants without evidence of symptomatic disease. Only if the infant is confirmed or suspected to be immunodeficient, the risks and benefits of vaccinating the mother should be weighed (see section 4.3).
04.7 Effects on ability to drive and use machines
PRIORIX has no or negligible influence on the ability to drive and use machines.
04.8 Undesirable effects
Summary of the safety profile
The safety profile presented below is based on a total of approximately 12,000 subjects vaccinated with PRIORIX in clinical studies.
The adverse reactions that may occur following the use of a combined measles, mumps and rubella vaccine correspond to those observed after administration of single or combination monovalent vaccines.
In controlled clinical trials, signs and symptoms were actively monitored during a 42-day follow-up period. Vaccinates were asked to report any clinical events that occurred during the study period.
The most common adverse reactions after administration of PRIORIX were redness at the injection site and fever ≥38 ° C (rectal) or ≥37.5 ° C (axillary / oral).
List of adverse reactions
Adverse reactions reported are listed according to the following frequencies:
Very common: (≥1 / 10)
Common: (≥1 / 100 to
Uncommon: (≥1 / 1,000 to
Rare: (≥1 / 10,000 to
Data from clinical studies
Infections and infestations:
Common: upper respiratory tract infections
Uncommon: otitis media
Disorders of the blood and lymphatic system:
Uncommon: lymphadenopathy
Immune system disorders:
Rare: allergic reactions
Metabolism and nutrition disorders:
Uncommon: anorexia
Psychiatric disorders:
Uncommon: nervousness, unusual crying, insomnia
Nervous system disorders:
Rare: febrile convulsions
Eye disorders:
Uncommon: conjunctivitis
Respiratory, thoracic and mediastinal disorders:
Uncommon: bronchitis, cough
Gastrointestinal disorders:
Uncommon: swelling of the parotid glands, diarrhea, vomiting
Skin and subcutaneous tissue disorders:
Common: skin rash
General disorders and administration site conditions:
Very common: redness at the injection site, fever ≥38 ° C (rectal) or ≥37.5 ° C (axillary / oral)
Common: injection site pain and swelling, fever> 39.5 ° C (rectal) or> 39 ° C (axillary / oral)
In general, the frequency category for adverse reactions was similar for both the first and second vaccine doses. The only exception was injection site pain which was 'Common' after the first dose of vaccine and 'Very common' after the second dose of vaccine.
Data from post-marketing surveillance
The following adverse reactions have been identified on rare occasions during post-marketing surveillance. Since they are reported voluntarily from a population of unknown size, no real estimate of frequency can be provided.
Infections and infestations:
Meningitis, measles-like syndrome, mumps-like syndrome (including orchitis, epididymitis, and mumps).
Disorders of the blood and lymphatic system:
Thrombocytopenia, thrombocytopenic purpura
Immune system disorders:
Anaphylactic reactions
Nervous system disorders:
Encephalitis * cerebellitis, cerebellitis-like symptoms (including transient gait disturbance and transient ataxia), Guillain Barré syndrome, transverse myelitis, peripheral neuritis
Vascular pathologies
Vasculitis
Skin and subcutaneous tissue disorders:
Erythema multiforme
Musculoskeletal and connective tissue disorders:
Arthralgia, arthritis
* Encephalitis has been reported with a frequency of less than 1 in every 10 million doses. The risk of encephalitis following vaccine administration is well below the risk of encephalitis caused by natural diseases (measles: 1 in 1000-2000 cases ; mumps: 2-4 in 1000 cases; rubella: approximately 1 in 6000 cases).
Accidental intravascular administration can result in severe reactions or even shock. Immediate measures depend on the severity of the reaction (see section 4.4).
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address: http://www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
Cases of overdose (up to twice the recommended dose) have been reported during post-marketing surveillance. No adverse reactions occurred in association with overdose.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: viral vaccine, ATC code: J07BD52
Immune response in infants 12 months of age and older
In clinical studies in children aged 12 months to 2 years PRIORIX was highly immunogenic.
Vaccination with a single dose of PRIORIX induces antibodies against measles in 98.1%, against mumps in 94.4% and against rubella in 100% of previously seronegative vaccinates.
Two years after primary vaccination, seroconversion rates were 93.4% for measles, 94.4% for mumps and 100% for rubella.
Although no data on the protective efficacy of PRIORIX are available, immunogenicity is accepted as an indicator of protective efficacy. However, some observational studies report that efficacy against mumps may be lower than the seroconversion rates observed for mumps.
Immune response in 9-10 month old babies
A clinical study enrolled 300 healthy children between the ages of 9 and 10 months at the time of the first vaccine dose. Of these, 147 subjects received PRIORIX and VARILRIX concurrently.
The seroconversion rates for measles, mumps and rubella were 92.6%, 91.5% and 100%, respectively. The reported seroconversion rates following the second dose administered 3 months after the first dose were 100% for measles, 99.2% for mumps and 100% for rubella. Therefore, to offer an optimal immune response, a second dose of PRIORIX should be administered within three months.
Teenagers and adults
The safety and immunogenicity of PRIORIX in adolescents and adults has not been specifically studied in clinical studies.
Route of intramuscular administration
In clinical studies, a limited number of subjects received PRIORIX intramuscularly. The seroconversion rates towards the three components were comparable to those observed after subcutaneous administration.
05.2 Pharmacokinetic properties
Evaluation of pharmacokinetic properties is not required for vaccines.
05.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional safety studies.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Dust:
Amino acids
Lactose (anhydrous)
Mannitol
Sorbitol
Solvent:
Water for injections
06.2 Incompatibility
In the absence of incompatibility studies, this medicinal product must not be mixed with other medicinal products.
06.3 Period of validity
2 years.
The vaccine should be injected immediately after its reconstitution. If this is not possible, it should be stored at 2 ° C - 8 ° C and used within 8 hours of reconstitution.
06.4 Special precautions for storage
Store and transport refrigerated (2 ° C - 8 ° C).
Do not freeze.
Store in the original package to protect the medicine from light.
For storage conditions after reconstitution of the vaccine, see section 6.3.
06.5 Nature of the immediate packaging and contents of the package
Powder in vial (type I glass) with rubber stopper
0.5 ml of solution in pre-filled syringe (type I glass) with rubber plunger, with or without needles in the following pack sizes:
• with separate needle: packs of 20 or 40
• with 2 separate needles: packs of 1, 10, 25 or 100
• without needle: packs of 1, 10, 20, 25, 40 or 100.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
The solvent and the reconstituted vaccine should be visually examined for foreign particles and / or changes in physical appearance prior to administration. If the above is observed, discard the solvent or the reconstituted vaccine.
The vaccine must be reconstituted by adding the entire contents of the pre-filled syringe of solvent to the vial containing the powder.
To insert the needle into the syringe, refer to the drawing below. However, the syringe supplied with Priorix may be slightly different (without thread) than the syringe described in the drawing.
In this case, the needle must be inserted without screwing.
1. While holding the syringe barrel in one hand (avoid holding the syringe plunger), unscrew the syringe cap by turning it counterclockwise.
2. To connect the needle to the syringe, turn the needle in the syringe clockwise until it stops (see illustration).
3. Remove the needle guard, which on occasion can be a bit difficult.
Add the solvent to the powder. After adding the solvent to the powder, the mixture should be well stirred until the powder is completely dissolved in the solvent.
Due to a slight change in its pH, the color of the reconstituted vaccine can vary from light peach to fuchsia pink without diminishing the potency of the vaccine.
Withdraw the entire contents of the vial and administer it.
A new needle must be used to administer the vaccine.
Contact with disinfectants should be avoided (see section 4.4).
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 - 37135 Verona (Italy)
08.0 MARKETING AUTHORIZATION NUMBER
Packaging:
"Powder and solvent for solution for injection in pre-filled syringe" 1 Vial powder + 1 pre-filled syringe of 0.5 ml A.I.C. 034199048
"Powder and solvent for solution for injection in pre-filled syringe" 10 Vials of powder + 10 pre-filled syringes of 0.5 ml A.I.C. 034199051
"Powder and solvent for solution for injection in pre-filled syringe" 20 Vials of powder + 20 pre-filled syringes of 0.5 ml A.I.C. 034199063
"Powder and solvent for solution for injection in pre-filled syringe" 1 Powder vial + 1 0.5 ml solvent pre-filled syringe with 2 A.I.C. 034199075
"Powder and solvent for solution for injection in pre-filled syringe" 10 Vials powder + 10 solvent pre-filled syringes of 0.5 ml with 20 A.I.C. 034199087
"Powder and solvent for solution for injection in pre-filled syringe" 20 Vials powder + 20 solvent pre-filled syringes of 0.5 ml with 20 A.I.C. 034199099
"Powder and solvent for solution for injection in pre-filled syringe" 25 Vials powder + 25 solvent pre-filled syringes of 0.5 ml without A.I.C. 034199164
"Powder and solvent for solution for injection in pre-filled syringe" 40 Vials powder + 40 solvent pre-filled syringes of 0.5 ml without A.I.C. 034199176
"Powder and solvent for solution for injection in pre-filled syringe" 100 Vials powder + 100 solvent pre-filled syringes of 0.5 ml without A.I.C. 034199188
"Powder and solvent for solution for injection in pre-filled syringe" 25 Vials powder + 25 solvent pre-filled syringes of 0.5 ml with 50 A.I.C. 034199190
"Powder and solvent for solution for injection in pre-filled syringe" 100 Vials powder + 100 solvent pre-filled syringes of 0.5 ml with 200 A.I.C. 034199202
"Powder and solvent for solution for injection in pre-filled syringe" 40 Vials powder + 40 solvent pre-filled syringes of 0.5 ml with 40 A.I.C. 034199214
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
22 December 1998 / June 2008
10.0 DATE OF REVISION OF THE TEXT
September 2015
