Active ingredients: Diphtheria vaccine pertussis poliomyelitis ethane
Tetravac, Suspension for injection
Why is Tetravac used? What is it for?
Tetravac is a vaccine. Vaccines are used to protect her from infectious diseases. This vaccine helps protect your baby from diphtheria, tetanus, whooping cough (whooping cough) and polio (polio).
It is given as a primary course of vaccination in infants and for booster vaccination in children who have previously received this vaccine or a similar vaccine.
When a dose of Tetravac is administered, the body's natural defenses will develop protection against these different diseases.
- Diphtheria is an infectious disease that usually affects the throat initially. In the throat, the infection causes pain and swelling that can lead to choking. The bacteria responsible for the disease also produce a toxin (poison) that can damage the heart, kidneys and nerves.
- Tetanus (often referred to as a "clenched jaw") is caused by tetanus bacteria that penetrate through a deep wound. The bacteria produce a toxin (poison) that causes muscle spasms, leading to the inability to breathe with the possibility of suffocation.
- Whooping cough (often called whooping cough) is an "airway infection, which can occur at any age but most frequently affects infants and children. Increasingly intense and close coughs, which can last for several weeks, are characteristic. The cough may be followed by a forced inhalation which produces the characteristic "scream".
- poliomyelitis (often called polio) is a disease caused by viruses that affect the nerves. It can lead to paralysis or muscle weakness, usually in the legs. Paralysis of the muscles that control breathing and swallowing can be fatal.
Important
Tetravac will only help prevent these diseases if they are caused by the same bacteria or viruses used to make the vaccine. Your baby can still get these infectious diseases if they are caused by different viruses or bacteria.
Contraindications When Tetravac should not be used
It is important to tell your doctor, pharmacist or healthcare professional if any of the points below apply to your baby so they can be sure that Tetravac can be given to your baby.
Do not use Tetravac if your child:
- you are allergic to:
- the active substances of Tetravac or any of the excipients of Tetravac (see section 6);
- other vaccines containing any of the substances mentioned in section 6;
- any vaccine that protects against whooping cough.
- have a high fever or acute illness (e.g. fever, sore throat, cough, cold or flu). Vaccination with Tetravac should be postponed until your baby gets better;
- have any active brain disease (developmental encephalopathy);
- have had a severe reaction to any vaccine that protects against whooping cough that has affected the brain.
Precautions for use What you need to know before taking Tetravac
Tell your doctor or healthcare professional before vaccination if:
- Your child is allergic (hypersensitive) to glutaraldehyde, neomycin, streptomycin and polymyxin B, as these substances are used in the manufacture of Tetravac and may still be present in undetectable traces in the vaccine;
- Your baby has problems with his immune system or is receiving immunosuppressive treatment. It is recommended that vaccination be postponed until the disease or treatment ends.Administration of Tetravac to children who have chronic problems with their immune system (including HIV infection) is recommended, but the protection against infection after vaccination may not be as good as that obtained in children with an immune response. in the norm;
- Your child has had a temporary loss of motility and sensation (Guillain-Barré syndrome) or loss of motility, pain and numbness in the arm and shoulder (brachial neuritis) following a previous injection of a vaccine containing the tetanus. Your doctor or healthcare professional will decide whether to give Tetravac to your child;
- Your baby has thrombocytopenia (low platelet levels) or a bleeding disorder (such as haemophilia), as he may be bleeding at the injection site;
- Your child has received a whooping cough vaccine in the past and has experienced any of the following early after the vaccination:
- temperature equal to or above 40 ° C within 48 hours of vaccination not related to other identifiable causes;
- shock-like episodes or paleness, weakness and lack of response to stimuli for a certain period of time or fainting (episodes of hypotonia-hyporesponsiveness or collapse) within 48 hours of vaccination;
- persistent and inconsolable crying lasting more than 3 hours within 48 hours of vaccination;
- fits (convulsions) with or without fever within 3 days of vaccination.
Interactions Which drugs or foods may change the effect of Tetravac
Tetravac can be given at the same time as the Haemophilus influenzae type b (Act-Hib) vaccine. Tetravac can be given at the same time as the combined measles-mumps-rubella vaccine. Your doctor or healthcare professional will administer the two vaccines at different injection sites, using different syringes for each injection.
Tell your doctor, healthcare professional or pharmacist if your child is taking, has recently taken or might take any other medicines.
If there is something you do not understand, ask your doctor, healthcare professional or pharmacist about it.
Warnings It is important to know that:
Pregnancy and breastfeeding
Not applicable as the vaccine is intended for pediatric use only.
Tetravac contains phenylalanine
Tetravac contains phenylalanine which may be harmful to you if you have phenylketonuria (PKU).
Tetravac contains ethanol
Tetravac contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Dosage and method of use How to use Tetravac: Posology
Dosage
For the vaccine to be effective:
- your child will need to receive a number of doses of the vaccine at different times before they reach 2 years of age. Below is the table showing the two different schedules with the times at which these vaccine doses can be administered. Your doctor will decide which program to follow for your baby.
In program 1, the first three doses are administered with an interval of 1-2 months between one administration and the next.
- Your child can also receive Tetravac if he is between the ages of 5 and 12 and has already been vaccinated with any whooping cough vaccine.
Usually a high dose of diphtheria vaccine, such as Tetravac, is used to immunize children under the age of 12. However, in some countries, children under the age of 12 may receive a lower dose of the diphtheria vaccine.
If your child has not received a dose of Tetravac
If your child has not received a scheduled injection, your doctor will decide when to give this dose.
Method of administration
The vaccine must be administered by a physician or healthcare professional who has been trained in the use of vaccines and who is equipped to intervene in the event of any uncommon severe allergic reaction following the injection.
Tetravac is given by injection into the upper thigh or upper arm of your baby. Your doctor or healthcare professional will avoid giving the injection into a blood vessel.
If you have any further questions on the use of this medicine, ask your doctor, healthcare professional, or pharmacist.
Side Effects What are the side effects of Tetravac
Like all vaccines and medicines, Tetravac can cause side effects, although not everyone gets them.
Severe allergic-type reactions are always a rare possibility after receiving a vaccine.
These reactions may include: difficulty in breathing, bluish discoloration of the tongue or lips, low blood pressure (causing dizziness) and fainting (collapse).
Sudden allergic manifestations such as swelling of the face, lips, tongue or other parts of the body (edema, Quincke's edema) have been reported following administration of Tetravac (their exact frequency cannot be estimated from the available data) .
When these signs or symptoms occur, they usually develop very quickly after the injection is given and while the affected person is still in the hospital or doctor's office.
If any of these symptoms occur after you leave the place where your baby was given the vaccine, you should see a doctor IMMEDIATELY.
Very common reactions (may affect more than 1 in 10 children) are:
- Loss of appetite
- Nervousness or irritability
- Abnormal crying
- Drowsiness
- Headache
- Vomiting (feeling sick)
- Myalgia (muscle pain)
- Redness at the injection site
- Pain at the injection site
- Swelling at the injection site
- Fever of 38 ° C or higher
- Malaise
Following administration of the primary series, the frequency of injection site reactions tends to increase with the booster dose.
Common reactions (may affect up to 1 in 10 children) are:
- Diarrhea
- Hardness (hardening) at the injection site
- Sleep disorders
Uncommon reactions (may affect up to 1 in 100 children) are:
- Redness and swelling of 5 cm or more at the injection site
- Fever of 39 ° C or higher
- Prolonged and inconsolable crying (inconsolable crying lasting more than 3 hours)
Rare reactions (may affect up to 1 in 1,000 children) are:
- High fever above 40 ° C
Reactions with frequency not known (frequency cannot be estimated from the available data) are:
- Fits (convulsions) with or without fever;
- Fainting
- Rash, redness and itching of the skin (erythema, hives);
- Extensive injection site reactions (> 5 cm), including extensive swelling of the limb from the injection site to beyond one or both joints. These reactions occur within 24-72 hours following vaccination and may be associated with redness , warmth, tenderness or pain at the injection site, and resolve spontaneously within 3-5 days without the need for any specific treatment.
Other reactions seen with vaccines containing the same active substances found in this vaccine include:
- Temporary loss of motility or sensation (Guillain-Barré syndrome) and loss of motility, pain and numbness (brachial neuritis) in the arm and shoulder;
- Episodes of hypotonia and hyporesponsiveness, characterized by a shock-like state or paleness, weakness and lack of response to stimuli for a certain period of time.
Other reactions that can occur when Tetravac is given at the same time as Haemophilus influenzae type b vaccine:
- Swelling of one or both of the lower limbs. This can occur at the same time as the appearance of a bluish discoloration of the skin (cyanosis), redness, small areas of bleeding under the skin (transient purpura) and loud crying. If this reaction occurs, it occurs mainly after the first (primary) injections within the first few hours of vaccination. All symptoms will disappear completely within 24 hours without the need for any specific treatment.
- Swollen glands in the neck, armpits or groin (lymphadenopathy)
In infants born very premature (at the 28th week of gestation or earlier), longer than normal intervals between one breath and the next may be observed for 2-3 days after vaccination.
If your child gets any of these side effects and they persist or worsen, talk to your child's doctor, pharmacist or healthcare professional. This also if you get any possible side effects not listed here. sheet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 / responsible. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use Tetravac after the expiry date which is stated on the carton and on the label after "EXP". The expiry date refers to the last day of the month indicated.
Store in a refrigerator (2 ° C - 8 ° C). Do not freeze. If it has been frozen, discard the vaccine.
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 Tetravac contains
One 0.5 ml dose of reconstituted vaccine contains:
The active ingredients are:
- Purified diphtheria toxoid not less than 30 I.U. *
- Purified tetanus toxoid not less than 40 I.U. *
- Purified pertussis toxoid (PTxd) 25 µg
- Purified Filamentous Haemagglutinin (FHA) 25 µg
- Inactivated poliomyelitis virus type 1 Antigen D **: 40 units
- Inactivated poliomyelitis virus type 2 Antigen D **: 8 units
- Inactivated poliomyelitis virus type 3 Antigen D **: 32 units
* U.I .: International Units
** Amount of antigen in the vaccine
The adjuvant is:
- Aluminum hydroxide (expressed as Al + 3) 0.30 milligrams
- The other ingredients are: formaldehyde, phenoxyethanol, ethanol, Medium 199 in water for injections. Medium 199 is a complex blend of amino acids (including phenylalanine), mineral salts, vitamins and other substances (such as glucose) diluted in water for injections.
Description of what Tetravac looks like and contents of the packs
Tetravac, suspension for injection, is available in single-dose pre-filled syringe (0.5 ml).
The packs are of 1 or 10, without needle, with pre-welded needle, with 1 or 2 needles supplied separately.
Not all pack sizes may be marketed.
The following information is intended for medical or healthcare professionals only
Instructions for use - Tetravac, suspension for injection.
Adsorbed diphtheria, tetanus, pertussis (acellular component) and polio (inactivated) vaccine.
Shake the pre-filled syringe so that the contents become homogeneous. Tetravac must not be mixed with other medicinal products.
For syringes without a needle, the needle must be pushed firmly into the end of the pre-filled syringe and rotated 90 degrees.
Tetravac must be administered intramuscularly. Recommended injection sites are the anterolateral aspect of the upper thigh in infants and the deltoid muscle in older children.
The intradermal or intravenous routes of administration should not be used. Do not administer intravascularly: make sure that the needle does not enter the blood vessel.
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
TETRAVAC INJECTABLE SUSPENSION
ADSORBITED ANTIDIPHTER, ANTITETAN, ANTIPERTOXIC (ACELLULAR COMPONENT) AND ANTI-OIL (INACTIVATED) VACCINE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
A 0.5 ml dose of vaccine contains:
Purified diphtheria toxoid1 ............................................... . not less than 30 IU #
Purified tetanus toxoid1 ............................................... .. not less than 40 IU *
Purified pertussis toxoid (PTxd) 1 .................................. 25 mcg
Purified Filamentous Haemagglutinin (FHA) 1 ..................... 25 mcg
Inactivated poliomyelitis virus type 12 .......................... Antigen D **: 40 units
Inactivated poliomyelitis virus type 22 .......................... Antigen D **: 8 units
Inactivated poliomyelitis virus type 32 .......................... Antigen D **: 32 units
# As an average value
* As the lower bound of the confidence interval (p = 0.95)
** Amount of antigen in the final bulk, in accordance with WHO recommendations
1 adsorbed on 0.30 mg of aluminum hydroxide (expressed as Al + 3)
2 produced on Vero cells
Excipient (s) with known effect: The vaccine contains phenylalanine and a small amount of ethanol (alcohol) (see section 4.4).
For the full list of excipients, see section 6.1.
This vaccine may contain traces of glutaraldehyde, neomycin, streptomycin and polymyxin B (see section 4.4).
03.0 PHARMACEUTICAL FORM
Suspension for injection.
Tetravac is a sterile, whitish cloudy suspension.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Active immunization against diphtheria, tetanus, pertussis and poliomyelitis:
• for primary vaccination in infants;
• for booster in children who have previously received a primary course of vaccination with a diphtheria, whole cell tetanus vaccine or acellular pertussis, polio vaccine.
04.2 Posology and method of administration
Dosage
Primary vaccination:
Primary immunization can be performed by starting vaccination at the age of two or three months, administering 3 doses with an interval of 1 or 2 months between one administration and the next; in accordance with national vaccination policies, immunization can otherwise be carried out starting from the third month of life by administering 2 doses with an interval of 2 months between one and the other, followed by a third dose at the 12th month of life .
Recall (Booster):
A fourth dose should be given within the 2nd year of life in infants who at 2 to 6 months of age have received Tetravac (either a diphtheria, tetanus, whole cell vaccine or acellular pertussis, polio vaccine, co-administered. or not with the freeze-dried conjugate vaccineHaemophilus influenzae type b), in a 3-dose primary immunization regimen.
Additional data (such as epidemiological and clinical follow-up studies) are required to establish the need for additional doses of acellular pertussis vaccine.
Tetravac can also be given to children between the ages of 5 and 12 who have previously been immunized with an acellular vaccine or with 4 doses of a whole cell vaccine.
Tetravac contains a high dosage of the diphtheria component. In some countries, in accordance with local vaccination policies, the use of vaccines containing a low dose of the diphtheria component in subjects under the age of 12 may be recommended.
Method of administration
Tetravac must be administered intramuscularly. The recommended injection sites are the anterolateral aspect of the upper thigh in infants and the deltoid muscle in older children.
The intradermal or intravenous routes should not be used.Do not administer the product intravenously: make sure that the needle does not enter a blood vessel.
04.3 Contraindications
Known systemic hypersensitivity reaction to any component of Tetravac listed in section 6.1 or to a vaccine containing the same substances or to pertussis vaccines (acellular or whole cell).
As with other vaccines, vaccination with Tetravac should be postponed in case of:
- fever or severe acute illness,
- developing encephalopathy,
- encephalopathy within 7 days of the administration of a previous dose of any vaccine containing pertussis antigens (whole cell or acellular pertussis vaccines).
04.4 Special warnings and appropriate precautions for use
Special warnings
• Since each dose may contain undetectable traces of glutaraldehyde, neomycin, streptomycin and polymyxin B, the vaccine should be administered with due precautions in subjects with hypersensitivity to these substances.
• The immunogenicity of the vaccine may be reduced in case of immunodeficiency or in the course of immunosuppressive treatments. In these cases it is recommended to postpone vaccination until the end of treatment or disease. However, vaccination is recommended in subjects with chronic immunodeficiency, such as for example in people with sustained HIV infection, although the antibody response may be reduced.
• If Guillain Barré syndrome or brachial neuritis has occurred following the first administration of a tetanus toxoid-containing vaccine, the decision to administer any tetanus toxoid-containing vaccine should be carefully considered in consideration of the potential benefits and possible risks, such as whether the primary vaccination program has been completed or not. Vaccination is generally justified in the case of infants whose primary immunization schedules are incomplete (e.g. when less than three doses of the vaccine have been administered).
• When the primary immunization program is performed in very premature infants (born at 28 weeks of gestation or earlier) and particularly in infants with a previous history of respiratory immaturity, the potential risk of apnea and the need to monitor breathing for 48-72 hours after vaccination. As the benefit of vaccination in this group of infants is high, vaccination should never be withheld or postponed.
• Tetravac contains phenylalanine which may be harmful in people with phenylketonuria (PKU).
• Tetravac contains small amounts of ethanol (alcohol), less than 10 mg per dose.
Precautions for use
• Do not administer intravascularly: make sure that the needle does not enter a blood vessel.
• As with all injectable vaccines, the vaccine should be administered with caution to individuals with thrombocytopenia or bleeding disorders as bleeding may occur following intramuscular administration of the vaccine.
• Before the administration of any dose of Tetravac, the child's parent or guardian should be asked about the child's personal medical history, family history and recent health, including information on previous immunizations. carried out, at the current state of health and any adverse event that has occurred as a result of previous immunizations.
• If any of the following events occurred temporally related to the administration of a vaccine containing the pertussis component, the decision to administer an additional "dose of vaccine containing the pertussis component should be carefully considered:
- Temperature ≥ 40 ° C within 48 hours of vaccination not related to other identifiable causes.
- Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of vaccination.
- Persistent, inconsolable crying lasting ≥ 3 hours, within 48 hours of vaccination.
- Convulsions with or without fever, within 3 days of vaccination.
• Before the injection of any biological product, the person responsible for the administration must take all known precautions to prevent allergic or any other reactions. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
04.5 Interactions with other medicinal products and other forms of interaction
Except for immunosuppressive therapy (see section 4.4), no significant clinical interactions with other treatments or biologics have been reported. A specific interaction study was performed on the co-administration of Tetravac, used for the reconstitution of the lyophilized vaccine Act-HIB (Haemophilus influenzae type b), and the MMR vaccine (measles, mumps, rubella).
04.6 Pregnancy and breastfeeding
Not relevant as the vaccine is intended for pediatric use only.
04.7 Effects on ability to drive and use machines
Not relevant.
04.8 Undesirable effects
Adverse events are listed by frequency class according to the following convention:
• Very common: ≥ 1/10
• Common: ≥ 1/100 e
• Uncommon: ≥ 1/1000 e
• Rare: ≥ 1/10000 e
• Very rare:
• Not known: frequency cannot be estimated from the available data. Based on spontaneous reports, these adverse events have been reported very rarely following commercial use of Tetravac. Since these adverse events have been reported voluntarily from a population of an ill-defined number of subjects, it is not always possible to estimate reliably frequency or establish a causal relationship to vaccine exposure.
In clinical studies in infants administered Tetravac alone or simultaneously with ACT-HIB as the primary series the most frequently reported reactions include local reactions at the injection site, abnormal crying, anorexia and irritability.
These signs and symptoms usually occur within 48 hours after vaccination and may persist for 48-72 hours; they resolve spontaneously without any specific therapy.
After the primary series, the frequency of injection site reactions tends to increase with administration of the booster dose.
The safety profile of Tetravac does not differ significantly across age groups. However, some adverse events such as myalgia, malaise and headache are specific to children two years of age and older.
Disorders of the blood and lymphatic system
You don't notice:
- Lymphadenopathy
Disorders of the immune system
Not known:
- Anaphylactic reactions such as face edema, Quincke's edema.
Metabolism and nutrition disorders
Very common:
- Anorexia (eating disorders)
Psychiatric disorders
Very common:
- Nervousness (irritability)
- Abnormal crying
Common:
- Insomnia (sleep disturbances)
Uncommon:
- Prolonged inconsolable crying
Nervous system disorders
Very common:
- Somnolence (drowsiness)
- Headache
You don't notice:
- Convulsions with or without fever
- Syncope
Gastrointestinal disorders
Very common:
- He retched
Common:
- Diarrhea
Musculoskeletal and connective tissue disorders
Very common:
- Myalgia
Skin and subcutaneous tissue disorders
You don't notice:
- Allergic-like symptoms, such as various types of rash, erythema and urticaria
General disorders and administration site conditions
Very common:
- Redness at the injection site
- Pain at the injection site
- Swelling at the injection site
- Pyrexia (fever) ≥ 38 ° C
- Malaise
Common:
- Induration at the injection site
Uncommon:
- Redness and edema ≥ 5 cm at the injection site
- Pyrexia (fever) ≥ 39 ° C
Rare:
- Pyrexia> 40 ° C (high fever)
You don't notice:
Extensive injection site reactions (> 50 mm), including extensive swelling of the limb from the injection site to beyond one or both joints, have been reported in children. These reactions occur within 24-72 hours following vaccination. , may be associated with erythema, warmth, tenderness or pain at the injection site and resolve spontaneously within 3-5 days. The risk of such reactions appears to be dependent on the number of previously taken doses of a vaccine containing the acellular component of the pertussis, with an increased risk following administration of the fourth and fifth dose.
Episodes of hypotonic-hyporesponsiveness have not been reported following the use of Tetravac in clinical studies but have been reported for other pertussis vaccines.
Oedematous reaction affecting one or both lower limbs may occur following vaccination with vaccines containing the component Haemophilus influenzae type b. If this reaction occurs, it mostly occurs after primary injections and is seen within the first few hours after vaccination.
Associated symptoms may include cyanosis, redness, transient purpura, and sharp crying. All events resolve spontaneously, without sequelae, within 24 hours.
A similar case was reported in clinical trials with diphtheria, tetanus-acellular, pertussis and polio vaccine Tetravac administered simultaneously, but at two separate injection sites, with the anti-tetanus conjugate vaccine.Haemophilus influenzae type b.
When Tetravac is indicated for administration as a last booster dose in children aged 5 to 12 years, reactions to Tetravac vaccine in children belonging to this age group are observed less than or equal to the frequency, respectively. observed following administration of DTP-IPV (whole cell pertussis) or DT-IPV, in children of the same age.
Cases of brachial neuritis and Guillain-Barré syndrome have been reported very rarely following administration of other tetanus toxoid-containing vaccines.
More information on special populations:
Apnea in very premature neonates (weeks of gestation ≤ 28) (see section 4.4)
Reporting of suspected adverse reactions
The reporting of suspected adverse reactions that occur after the authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the Italian Medicines Agency website : www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
Not relevant.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Combined bacterial and viral vaccines (diphtheria-pertussis-poliomyelitis-tetanus).
ATC code: J07CA02.
Antibody response after primary vaccination:
Immunogenicity studies conducted in infants vaccinated with 3 doses of Tetravac administered from the 2nd month of life showed that all vaccinated (100%) developed a seroprotective antibody level (≥ 0.01 IU / ml) to diphtheria antigens and tetanus.
For whooping cough, more than 87% of infants developed a 4-fold increase in initial antibody titers to PT and FHA within 1-2 months of completion of primary vaccination.
At least 99.5% of the vaccinated had, following immunization, antibody titers above the threshold value of 5 (value equal to the reciprocal of the dilution when using a seroneutralization test) against type 1, 2 and 3 and were considered protected against polio.
In a clinical efficacy study conducted in Senegal, following the primary administration of 3 doses and after 18 months without a booster dose, the protective efficacy of this acellular pertussis vaccine was lower than that of the Pasteur pertussis vaccine. Whole cell Merieux used as control However, lower reactogenicity for this acellular pertussis vaccine compared to whole cell pertussis vaccine was demonstrated in 2 controlled clinical trials.
Immune response after booster:
Immunogenicity studies conducted in infants in the second year of life who received a primary vaccination course of 3 doses of Tetravac demonstrated high antibody responses to all vaccine components following administration of the fourth (booster) dose.
Studies conducted in infants aged 12-24 months who received a 3-dose primary vaccination course with whole cell pertussis vaccine, DTP-IPV (Tetracoq) or DTP-IPV-ACT-HIB (Pentact- HIB / PENTACOQ), demonstrated that a booster dose with Tetravac is safe and immunogenic for all components of the vaccine.
Studies conducted in children aged 5 to 12 years who received 4 doses of whole cell pertussis vaccine, DTP-IPV (Tetracoq) or DTP-IPV-ACT-HIB (Pentact-HIB / PENTACOQ), have shown that a booster dose with Tetravac is immunogenic to all components of the vaccine and is well tolerated.
05.2 Pharmacokinetic properties
-
05.3 Preclinical safety data
-
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Formaldehyde
Phenoxyethanol
Ethanol
Medium 199 [complex mixture of amino acids (including phenylalanine), mineral salts, vitamins and other substances (such as glucose)]
Water for injections
06.2 Incompatibility
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Store in the refrigerator (between 2 ° C and 8 ° C).
Do not freeze.
06.5 Nature of the immediate packaging and contents of the package
0.5 ml single-dose pre-filled syringe (glass), with plunger (chlorobromobutyl elastomer or bromobutyl rubber or chlorobutyl rubber), pre-sealed needle and needle cover (elastomer).
0.5 ml single-dose pre-filled syringe (glass), with plunger (chlorobromobutyl elastomer or bromobutyl rubber or chlorobutyl rubber) and cap (elastomer), without needle.
0.5 ml single-dose pre-filled syringe (glass), with plunger (chlorobromobutyl elastomer or bromobutyl rubber or chlorobutyl rubber) and cap (elastomer), with 1 separate needle (for each syringe).
0.5 ml single-dose pre-filled syringe (glass), with plunger (chlorobromobutyl elastomer or bromobutyl rubber or chlorobutyl rubber) and cap (elastomer), with 2 separate needles (for each syringe).
Packs of 1 or 10.
Not all pack sizes and presentations may be marketed.
06.6 Instructions for use and handling
In the case of syringes without a needle, the needle must be firmly inserted into the end of the pre-filled syringe by turning it 90 °.
Shake before use until a homogeneous, cloudy white suspension is obtained.
Tetravac can be used to reconstitute lyophilized conjugate vaccine from Haemophilus influenzae type b (Act-HIB). Shake the pre-filled syringe until the contents are homogeneous. Add the suspension to the contents of the vial and shake thoroughly until the lyophilized substance is completely dissolved. After reconstitution the suspension should be a cloudy white color.
The vaccine should be administered immediately after reconstitution.
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Sanofi Pasteur Europe
2 Avenue Pont Pasteur
69007 Lyon (France)
08.0 MARKETING AUTHORIZATION NUMBER
034127011 - 0.5 ML SUSPENSION FOR INJECTION 1 SINGLE-DOSE PRE-FILLED SYRINGE WITH NEEDLE
034127023 - "0.5 ML INJECTABLE SUSPENSION" 10 PRE-FILLED SYRINGES WITH NEEDLE
034127035 - "0.5 ML INJECTABLE SUSPENSION" 1 SINGLE-DOSE PRE-FILLED SYRINGE WITHOUT NEEDLE
034127047 - "0.5 ML INJECTABLE SUSPENSION" 10 PRE-FILLED SYRINGES WITH NEEDLE
034127050 - "0.5 ML INJECTABLE SUSPENSION" 10 PRE-FILLED SYRINGES WITH NEEDLE AND NEW GOOGLE COVER
034127062 - "0.5 ML INJECTABLE SUSPENSION" 1 PRE-FILLED SYRINGE WITH NEEDLE AND NEW GOOGLE COVER
034127074 - "0.5 ML INJECTABLE SUSPENSION" 1 SINGLE-DOSE PRE-FILLED SYRINGE WITHOUT NEEDLE WITH 1 SEPARATE NEEDLE
034127086 - "0.5 ML INJECTABLE SUSPENSION" 1 SINGLE-DOSE PRE-FILLED SYRINGE WITHOUT NEEDLE WITH 2 SEPARATE NEEDLES
034127098 - "0.5 ML INJECTABLE SUSPENSION" 10 SINGLE-DOSE PRE-FILLED SYRINGES WITHOUT NEEDLE WITH 10 SEPARATE NEEDLES
034127100 - "0.5 ML INJECTABLE SUSPENSION" 10 SINGLE-DOSE PRE-FILLED SYRINGES WITHOUT NEEDLE WITH 20 SEPARATE NEEDLES
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 29/05/2000
Date of most recent renewal: 13/07/2012
10.0 DATE OF REVISION OF THE TEXT
10/2016
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