Active ingredients: Vaccine (adsorbed, with reduced antigen content) diphtheria, tetanus and pertussis (acellular component)
Boostrix, suspension for injection in pre-filled syringe
Indications Why is Boostrix used? What is it for?
Boostrix is a vaccine used as a booster dose in children aged 4 years and older, adolescents and adults for the prevention of three diseases: diphtheria, tetanus, pertussis (whooping cough). The vaccine works by stimulating the body to produce protection (antibodies) against these diseases.
- Diphtheria: diphtheria causes problems especially to the respiratory tract and sometimes to the skin. Generally the airways become inflamed (swollen) causing severe breathing problems and sometimes leading to suffocation. Diphtheria bacteria also release a toxin (poison) that can cause nerve damage, heart problems, and even death.
- Tetanus: Tetanus bacteria enter the body as a result of cuts, scrapes or wounds of the skin. The wounds most at risk of infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure or wood splinters The bacteria release a toxin (poison) that can cause muscle stiffness, painful muscle spasms, seizures, and even death Muscle spasms can be so violent that they cause bone fractures in the spine.
- Whooping cough (whooping cough): Whooping cough is a very contagious disease. The disease affects the airways causing repeated strong coughs that can interfere with normal breathing. The cough is often accompanied by a "whooping inhalation hence the common name of" whooping cough ". The cough can last for 1-2 months or longer. Whooping cough can also cause ear infections, bronchitis which can last for a long time, pneumonia, seizures, brain damage and even death.
None of the ingredients contained in the vaccine can cause diphtheria, tetanus or whooping cough.
Contraindications When Boostrix should not be used
Boostrix should not be given:
- if you or your child have previously had an allergic reaction to Boostrix or any of the other ingredients contained in this vaccine. Signs of an allergic reaction may include itchy skin rash, shortness of breath, swelling of the face or tongue.
- if you or your child have previously had an allergic reaction to any other diphtheria, tetanus or whooping cough (pertussis) vaccine.
- if you or your child have had problems with the nervous system (encephalopathy) within 7 days of previous vaccination with a pertussis vaccine (whooping cough).
- if you or your child have a severe infection with a high fever (over 38 ° C). A mild infection is not a problem, but you need to tell your doctor first.
- if you or your child have experienced a temporary reduction in blood platelets (which increases the risk of bleeding or bruising) or brain or nerve problems after previous vaccination with a diphtheria and / or tetanus vaccine.
Precautions for use What you need to know before taking Boostrix
Talk to your doctor or pharmacist before you or your child receive Boostrix:
- if you or your child have experienced health problems after the previous administration of Boostrix or other vaccines against whooping cough (whooping cough), especially:
- High fever (over 40 ° C) within 48 hours of vaccination
- Collapse or state of shock within 48 hours of vaccination
- Persistent crying, lasting 3 hours or more, occurring within 48 hours of vaccination
- Seizures / convulsions with or without high fever occurring within 3 days of vaccination
- if your child has progressive or undiagnosed brain disease or uncontrolled epilepsy. The vaccine should be given after disease control is achieved
- if you or your child have problems with bleeding or bruising easily
- if you or your child have a tendency to seizures / convulsions from fever or there is a family history of similar events
- if you or your child have long-lasting problems with the immune system of any nature (including HIV infection). In this case, you or your child can receive Boostrix, but the protection against infection after receiving the vaccine may not be comparable to that of children or adults with normal immune responses to infections.
Fainting may occur (especially in adolescents) following, or even before, any needle injection. Therefore tell your doctor or nurse if you or your child fainted from a previous injection.
Like all vaccines, Boostrix may not fully protect people who are vaccinated.
Interactions Which drugs or foods may change the effect of Boostrix
Tell your doctor or pharmacist if you or your child are taking or have recently taken or might take any other medicines, or have recently received any other vaccinations.
Boostrix may not work its best if you or your child are taking medicines that make your immune system less effective at fighting infections.
Warnings It is important to know that:
Pregnancy and breastfeeding
Your doctor will inform you about the possible risks and benefits of receiving Boostrix during pregnancy. It is not known if Boostrix passes into breast milk. Your doctor will inform you about the possible risks and benefits of receiving Boostrix while breastfeeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this vaccine.
Driving and using machines
Boostrix is unlikely to affect the ability to drive or use machines.
Dosage and method of use How to use Boostrix: Dosage
- Boostrix is given as an injection into a muscle.
- The vaccine should never be given into blood vessels.
- You or your child will receive a single injection of Boostrix.
- Your doctor will check whether you or your child have previously received diphtheria, tetanus and / or pertussis vaccines.
- Boostrix can be administered in the event of a suspected tetanus infection, although additional measures, such as appropriate wound dressing and / or administering a tetanus anti-toxin, will need to be taken to reduce the risk of developing the disease.
- Your doctor will inform you about booster vaccinations.
Side Effects What are the side effects of Boostrix
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
As with all injectable vaccines, severe allergic reactions (anaphylactic and anaphylactoid reactions) can occur very rarely (up to 1 in 10,000 doses of the vaccine). These can be recognized by:
- Skin rashes such as itching or blistering
- Swelling of the eyes and face
- Difficulty in breathing or swallowing
- A sudden decrease in blood pressure and loss of consciousness.
These reactions can occur before you leave your doctor's office. However, if you or your child experience any of these symptoms you should contact your doctor immediately.
Side effects that occurred during clinical trials in children aged 4 to 8 years
Very common (may occur in more than 1 in 10 doses of the vaccine):
- Pain, redness and swelling at the injection site
- Irritability
- Drowsiness
- Tiredness
Common (may occur up to 1 in 10 doses of the vaccine):
- Loss of appetite
- Headache
- Fever of 37.5 ° C or more (including fever over 39 ° C)
- Extensive swelling of the vaccinated limb
- Vomiting and diarrhea
Uncommon (may occur up to 1 in 100 doses of the vaccine):
- Upper respiratory tract infection
- Attention disturbances
- Discharge with itchy eyes and crusting (conjunctivitis)
- Skin erythema
- Hard edema where the injection was given
- Ache
Side effects that occurred during clinical trials in adults, adolescents and children aged 10 years and over.
Very common: (may occur in more than 1 in 10 doses of the vaccine)
- Pain, redness and swelling at the injection site
- Headache
- Fatigue
- General malaise
Common: (may occur up to 1 in 10 doses of the vaccine)
- Fever of 37.5 ° C or more
- Dizziness
- Nausea
- Hard edema and abscess at the injection site
Uncommon: (may occur up to 1 in 100 vaccine doses)
- Fever over 39 ° C
- Ache
- Muscle and joint stiffness
- He retched
- Diarrhea
- Joint stiffness, joint pain, muscle pain
- Itching
- Excessive sweating (hyperhidrosis)
- Skin erythema
- Swollen glands in the neck, armpit or groin (lymphadenopathy)
- Sore throat and pain when swallowing (pharyngitis)
- Upper respiratory tract infection
- Cough
- Fainting (syncope)
- Flu-like symptoms, such as fever, sore throat, runny nose, cough and chills
The following side effects have occurred during routine use of Boostrix and are not specific to age group:
- Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
- Collapse or periods of unconsciousness or lack of awareness
- Convulsions (with or without fever)
- Hives (Urticaria)
- Unusual weakness (asthenia)
After administration of the tetanus vaccine, temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often spreading to the chest and face, has been reported very rarely (up to 1 in 10,000 doses of the vaccine). Guillain-Barré syndrome).
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 and on the pre-filled syringe label after the word EXP. The expiry date refers to the last day of the month.
Store in a refrigerator (2 ° C - 8 ° C).
Do not freeze. Freezing ruins the vaccine.
Store in the original package to protect the medicine from light.
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 "> Other Information
What Boostrix contains
- The active ingredients are:
- Diphtheria toxoid not less than 2 International Units (IU) (2.5 Lf)
- Tetanus toxoid not less than 20 International Units (IU) (5 Lf)
- Bordetella pertussis antigens:
- Pertussis toxoid 8 micrograms
- Filamentous Haemagglutinin 8 micrograms
- Pertactin 2.5 micrograms
- Diphtheria, tetanus, tetanus toxoid, filamentous haemagglutinin and pertactin are adsorbed on aluminum hydroxide, hydrate (Al (OH) 3) 0.3 milligrams Al3 +
- and aluminum phosphate (AlPO4) 0.2 milligrams Al3
Aluminum hydroxide and aluminum phosphate are included in this vaccine as adjuvants.
Adjuvants are substances included in some vaccines to accelerate, enhance and / or prolong the protective effect of the vaccine.
The other ingredients are: sodium chloride and water for injections.
Description of what Boostrix looks like and contents of the pack
Suspension for injection in pre-filled syringe.
Boostrix is a slightly milky white liquid contained in a pre-filled syringe (0.5 ml).
Boostrix is available in packs of 1, 10, 20, 25 or 50 with or without needles.
Not all pack sizes may be marketed.
Other sources of information
Detailed information on this medicine is available on the website of the Italian Medicines Agency.
The following information is intended for healthcare professionals only:
- Before use the vaccine should be at room temperature and should be shaken well to obtain a homogeneous cloudy white suspension. Before administration the vaccine should be visually inspected for the absence of particles and / or change in appearance. If any of these phenomena are observed, discard the vaccine.
- Any unused medicine or waste material should be disposed of in accordance with local regulations.
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
BOOSTRIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE VACCINE (ADSORBED, WITH LOW ANTIGEN CONTENT) DIFTERIC, TETANIC AND PERTOXIC (ACELLULAR COMPONENT).
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains:
Diphtheria toxoid1 not less than 2 International Units (IU) (2.5 Lf)
Tetanus toxoid1 not less than 20 International Units (IU) (5 Lf)
Antigens of Bordetella pertussis:
Pertussis toxoid1 8 mcg
Filamentous Haemagglutinin1 8 mcg
Pertactin1 2.5 mcg
1adsorbed on aluminum hydroxide, hydrated (Al (OH) 3) 0.3 milligrams Al3 +
and aluminum phosphate (AlPO4) 0.2 milligrams Al3 +
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Pre-filled syringe
Suspension for injection in pre-filled syringe.
Vial
Suspension for injection
Boostrix is a cloudy white suspension.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Boostrix is indicated for booster vaccination against diphtheria, tetanus and pertussis in individuals from 4 years of age (see section 4.2).
Administration of Boostrix should be based on official recommendations.
04.2 Posology and method of administration
Dosage
A single 0.5 ml dose of the vaccine is recommended.
Boostrix can be given from the age of four onwards.
The use of Boostrix may be considered during the third trimester of pregnancy. For use of the vaccine before the third trimester of pregnancy, see section 4.6.
Boostrix should be administered in accordance with official recommendations and / or local practice regarding the use of vaccines with reduced diphtheria, tetanus and pertussis antigens.
Boostrix can be given to adolescents and adults with unknown vaccination status or incomplete vaccination against diphtheria, tetanus and pertussis as part of a diphtheria, tetanus and pertussis vaccination course. Based on data obtained in adults, two additional doses of a vaccine containing diphtheria and tetanus are recommended, one and six months after the first dose to maximize the vaccine response against diphtheria and tetanus (see section 5.1).
Boostrix can be used in the treatment of wounds at risk of tetanus infection in subjects who have previously received a primary vaccination course against tetanus toxoid and in subjects for whom a booster against diphtheria and pertussis is indicated. Tetanus immunoglobulin should be administered concurrently according to guidelines.
Vaccination against diphtheria, tetanus and pertussis should be repeated at intervals, according to official recommendations (usually 10 years).
Pediatric population
The safety and efficacy of Boostrix in children aged less than 4 years have not been established.
Method of administration
Boostrix is administered by deep intramuscular injection preferably in the deltoid region (see section 4.4).
04.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Hypersensitivity after previous administration of diphtheria, tetanus or pertussis vaccines.
Boostrix is contraindicated in individuals with a history of encephalopathy of unknown etiology occurring within 7 days of previous vaccination with pertussis-containing vaccines. In this case the pertussis vaccination should be stopped and the vaccination course should continue with the diphtheria and tetanus vaccines.
Boostrix should not be administered in subjects who have experienced transient thrombocytopenia or neurological complications (for convulsions or hypotonic-hyporesponsive episodes, see section 4.4) following previous immunization against diphtheria and / or tetanus.
As with other vaccines, administration of Boostrix should be postponed in subjects with severe acute febrile illness. The presence of minor infections is not a contraindication.
04.4 Special warnings and appropriate precautions for use
Vaccination must be preceded by a medical history (with special attention to previous vaccinations and the possible occurrence of undesirable effects).
If you are aware that one of the following events occurs; occurred in temporal relationship with the administration of a vaccine containing pertussis, the decision to administer doses of vaccines containing pertussis should be carefully considered:
- Temperature ≥ 40.0 ° C within 48 hours of vaccination, not due to any other identifiable cause.
- Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination.
- Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination.
- Convulsions with or without fever, occurring within 3 days of vaccination.
There may be circumstances, such as a "high incidence of whooping cough, where the potential benefits outweigh the possible risks."
As with any vaccination, the risk-benefit of immunizing with Boostrix or postponing vaccination in a child with a new onset or progressing severe neurological disorder should be carefully weighed.
As with all injectable vaccines, appropriate medical treatment and assistance should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
Boostrix should be administered with caution to subjects with thrombocytopenia (see section 4.3) or with coagulation disorders as bleeding may occur in these subjects following intramuscular administration. Strong pressure (without rubbing) should be applied to the injection site for at least two minutes.
Boostrix should not be administered intravascularly under any circumstances.
A "history or family history of seizures and a family history of adverse events following a DTP (diphtheria-tetanus-pertussis) vaccination are not contraindications.
Human Immunodeficiency Virus (HIV) infection is not a contraindication. The expected immunological response following vaccination may not occur in immunosuppressed patients.
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 other vaccine, a protective immune response cannot be induced in all vaccines.
04.5 Interactions with other medicinal products and other forms of interaction
Use with other vaccines or immunoglobulins
Boostrix can be administered concomitantly with the human papillomavirus vaccine without any clinically relevant interference with the antibody response to any of the components of either vaccine. Co-administration of Boostrix with other vaccines or with immunoglobulins has not been studied.
Co-administration is unlikely to lead to interference in the immune response.
If concomitant administration of Boostrix with other vaccines or with immunoglobulins is considered necessary, in accordance with common vaccination practices and recommendations, the products should be administered in separate sites.
Use with immunosuppressive treatment
As with other vaccines, patients on immunosuppressive therapy may not respond adequately.
04.6 Pregnancy and breastfeeding
Pregnancy
Safety data from a prospective observational study in which Boostrix was administered to pregnant women during the third trimester (793 pregnancy outcomes) as well as data from passive surveillance when pregnant women were exposed to Boostrix or Polio Boostrix (dTpa-IPV vaccine) in the third and second trimesters, have not demonstrated the occurrence of vaccine-related undesirable effects on pregnancy or the health of the fetus or newborn.
The use of Boostrix may be considered during the third trimester of pregnancy.
There are no human data from prospective clinical studies regarding the use of Boostrix during the first and second trimester of pregnancy. However, as with other inactivated vaccines, vaccination with Boostrix is not expected to harm an unborn baby in any trimester of pregnancy.
The benefits of administering Boostrix during pregnancy should be carefully weighed against the risks.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryofoetal development, parturition or postnatal development (see section 5.3).
Limited data indicate that maternal antibodies may reduce the magnitude of the immune response to some vaccines in infants born to mothers vaccinated with Boostrix during pregnancy. The clinical relevance of this observation is unknown.
Feeding time
The effect of administering Boostrix during breastfeeding has not been evaluated. However, as Boostrix contains inactivated toxoids or antigens, no risks to the breastfed infant are expected. Healthcare professionals should carefully weigh the risks and benefits of administering Boostrix to breastfeeding women.
Fertility
No human data are available from prospective clinical studies. Animal studies do not indicate direct or indirect harmful effects with respect to female fertility (see section 5.3).
04.7 Effects on ability to drive and use machines
The vaccine is unlikely to affect the ability to drive and use machines.
04.8 Undesirable effects
Summary of the safety profile
The safety profile below is based on data from clinical trials in which Boostrix was administered to 839 children (4 to 8 years of age) and 1,931 adults, adolescents and children (10 to 76 years of age). .
The most common adverse events reported following administration of Boostrix in both groups were local reactions at the injection site (pain, redness and swelling), reported by 23.7 - 80.6% of subjects in each study. These effects usually appear during the first 48 hours after vaccination. All resolved without consequences.
Tabular list of adverse reactions
Adverse reactions reported are listed according to the following frequencies:
Very common: (≥1 / 10)
Common: (≥1 / 100,
Uncommon: (≥1 / 1,000,
Rare: (≥1 / 10,000,
Very rare: (
Within each frequency class, undesirable effects are reported in descending order of severity.
• Clinical studies
Reactogenicity after repeated dose
Data on 146 subjects suggest that a slight increase in local reactogenicity (pain, redness, swelling) may be observed with repeated vaccination according to the schedule at 0, 1, 6 months in adults (aged> 40 years).
The data suggest that in subjects who received a first childhood vaccination with diphtheria-tetanus-pertussis (DTP) vaccine, the administration of a second dose as a booster may result in an increase in local reactogenicity.
• Post-marketing surveillance:
As these events have been reported spontaneously, their frequency cannot be reliably estimated.
Following administration of tetanus toxoid-containing vaccines, adverse reactions in the central or peripheral nervous system, including ascending paralysis or even respiratory paralysis (eg Guillain-Barré syndrome), have been reported very rarely.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the Agency's website. Italian Medicines: www.aifa.gov.it/content/segnalazioni-reazioni-avvers e.
04.9 Overdose
Cases of overdose have been reported during post marketing surveillance. Adverse events following overdose, when reported, were similar to those reported with normal vaccine administration.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: bacterial vaccines, pertussis vaccines, ATC code: J07AJ52.
Immune response
Approximately one month after booster vaccination with Boostrix, the following serum protection / seropositivity rates were observed:
Answer: When at the specified time point, a diphtheria and tetanus antibody concentration ≥ 0.1 IU / mL was considered seroprotection and a pertussis antibody concentration ≥ 5 EL.U / mL was considered seropositive.
ATP: Per protocol - includes all eligible subjects, who had received a single booster dose of Boostrix, for whom immunogenicity data was available for at least one antigen at the specified time point.
N = the minimum number of subjects with data available for each antigen.
Comparative studies in adolescents and adults have shown that antibody titers against diphtheria are similar to those obtained with adult-type Td vaccines containing the same antigens as Boostrix one month after vaccination; lower tetanus antibody titers were found compared to adult-type Td vaccines.
Like other adult-type Td vaccines, Boostrix induces higher anti-D and anti-T antibody titers in children and adolescents than in adults.
Persistence of the immune response
The following rates of seroprotection / seropositivity were observed in subjects vaccinated according to the protocol (ATP1), from three to 3.5 years, from 5 to 6 years and from 10 years after a first vaccination with Boostrix:
ATP: Per protocol - includes all eligible subjects, who had received a single booster dose of Boostrix, for whom immunogenicity data was available for at least one antigen at the specified time point.
Answer: When at the specified time point, a diphtheria and tetanus antibody concentration ≥ 0.1 IU / mL was considered seroprotection and a pertussis antibody concentration ≥ 5 EL.U / mL was considered seropositive.
The terms "adult" and "adolescent" reflect the age at which subjects received their first vaccination with Boostrix.
Percentage of subjects with antibody concentrations associated with protection against disease (≥ 0.1 IU / mL by ELISA or ≥ 0.016 IU / mL using an in vitro Vero-cell neutralization test).
N = the minimum number of subjects with data available for each antigen
Effectiveness in protecting against whooping cough
The pertussis antigens contained in Boostrix are an integral part of the pediatric acellular pertussis combined vaccine (Infanrix), for which efficacy after primary vaccination was demonstrated in an efficacy study in family contacts. The antibody titers of all three pertussis components following vaccination with Boostrix are higher than those observed during the efficacy study in family contacts.
Based on these comparisons, Boostrix provides protection against whooping cough, although the degree and duration of protection afforded by the vaccine is not determined.
Immune response after a repeat dose of Boostrix
The immunogenicity of Boostrix administered 10 years after a previous booster dose with antigen-reduced diphtheria, tetanus and acellular pertussis vaccine (s) was evaluated. One month after vaccination> 99% of subjects were seroprotected against diphtheria and tetanus and seropositive against pertussis.
Immune response in subjects with no previous vaccination history or with unknown vaccination history
After administration of one dose of Boostrix to 83 adolescents aged 11 to 18 years, with no previous pertussis vaccination and without diphtheria and tetanus vaccination for the previous 5 years, all subjects were seroprotected against tetanus and diphtheria. The seropositivity rate after one dose ranged from 87% to 100% for the different pertussis antigens.
Following the administration of one dose of Boostrix to 139 adults ≥40 years of age who have not received any vaccine containing diphtheria and tetanus in the past 20 years, more than 98.5% of adults were seropositive to all three pertussis antigens. and 81.5% and 93.4% were seroprotected against diphtheria and tetanus respectively. After the administration of two additional doses one and six months after the first dose, the seropositivity rate was 100% for all and three pertussis antigens and the seroprotection rate for diphtheria and tetanus reached 99.3% and 100% respectively.
05.2 Pharmacokinetic properties
Evaluation of pharmacokinetic properties is not required for vaccines.
05.3 Preclinical safety data
Reproductive toxicology
Fertility
Non-clinical data obtained with Boostrix reveal the absence of a specific risk to humans based on conventional studies of female fertility in rats and rabbits.
Pregnancy
Non-clinical data obtained with Boostrix reveal the absence of a specific risk for humans based on conventional studies of embryofoetal development in rats and rabbits, as well as parturition toxicity and postnatal toxicity in rats (up to the end of the breastfeeding).
Animal toxicology and / or pharmacology
The preclinical data obtained from conventional safety and toxicity studies did not reveal any particular risks for the human species.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Sodium chloride
Water for injections
For adjuvants, see section 2
06.2 Incompatibility
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Store in a refrigerator (2 ° C-8 ° C).
After being removed from the refrigerator, the vaccine is stable for 8 hours at + 21 ° C.
Do not freeze.
Store in the original package to protect the medicine from light.
06.5 Nature of the immediate packaging and contents of the package
Pre-filled syringe
0.5 ml suspension in pre-filled syringes (type I glass) with stopper (butyl rubber) with or without needles in pack sizes of 1, 10, 20, 25 or 50
Vial
0.5 ml suspension in vials (type I glass) with a stopper (butyl rubber) in pack sizes of 1, 10, 20, 25 or 50.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
Before use, the vaccine must be at room temperature and must be shaken well to obtain a white, cloudy, homogeneous suspension. Before administration, the vaccine must be visually inspected for the absence of foreign particles and / or variations. physical appearance. In the event that one of the two phenomena occurs, discard the vaccine.
The medicinal not used and the 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 - Verona
08.0 MARKETING AUTHORIZATION NUMBER
034813067 "suspension for injection in pre-filled syringe" 1 0.5 ml syringe
034813079 "suspension for injection in pre-filled syringe" 10 Syringes of 0.5 ml
034813081 "suspension for injection in pre-filled syringe" 20 syringes of 0.5 ml
034813093 "suspension for injection in pre-filled syringe" 25 Syringes of 0.5 ml
034813105 "suspension for injection in pre-filled syringe" 50 Syringes of 0.5 ml
034813117 "suspension for injection in pre-filled syringe" 1 0.5 ml syringe with 1 needle
034813129 "suspension for injection in pre-filled syringe" 10 0.5 ml syringes with 10 needles
034813131 "suspension for injection in pre-filled syringe" 20 0.5 ml syringes with 20 needles
034813143 "suspension for injection in pre-filled syringe" 25 0.5 ml syringes with 25 needles
034813156 "suspension for injection in pre-filled syringe" 50 syringes of 0.5 ml with 50 needles
034813168 "suspension for injection in pre-filled syringe" 1 0.5 ml syringe with 2 needles
034813170 "suspension for injection in pre-filled syringe" 10 syringes of 0.5 ml with 20 needles
034813182 "suspension for injection in pre-filled syringe" 20 syringes of 0.5 ml with 40 needles
034813194 "suspension for injection in pre-filled syringe" 25 0.5 ml syringes with 50 needles
034813206 "suspension for injection in pre-filled syringe" 50 syringes of 0.5 ml with 100 needles
034813016 "suspension for injection" 1 vial of 0.5 ml
034813028 "suspension for injection" 10 vials of 0.5 ml
034813030 "suspension for injection" 20 vials of 0.5 ml
034813042 "suspension for injection" 25 vials of 0.5 ml
034813055 "suspension for injection" 50 vials of 0.5 ml
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
February 13, 2001 / July 2008
10.0 DATE OF REVISION OF THE TEXT
May 2017
