Active ingredients: Meningitis vaccine
Meningitec, suspension for injection in pre-filled syringe
Meningococcal serogroup C conjugated oligosaccharide vaccine (adsorbed)
Indications Why is Meningitec used? What is it for?
Meningitec is a serogroup C meningococcal vaccine.
Meningitec helps protect you / your baby from diseases such as: meningitis and septicemia (blood poisoning).
Meningitec is a vaccine used in children from two months of age, adolescents and adults to help prevent infections caused by a bacterium called Neisseria meningitidis serogroup C. The vaccine will not protect against other serogroups of Neisseria meningitidis or from other bacteria and viruses, which can sometimes cause meningitis and septicemia (blood poisoning).
The vaccine works by causing the body to produce its own protection (antibodies) against this bacterium. The serogroup C bacterium Neisseria meningitidis can cause serious, sometimes fatal infections such as meningitis and septicemia (blood poisoning).
This vaccine does not contain live organisms and cannot cause Meningitis C (meningococcal disease C).
It should be remembered that no vaccine can provide total, lifelong protection for all vaccinated people.
Contraindications When Meningitec should not be used
Meningitec should not be given:
- if you / your child are allergic (hypersensitive) to the active substances, or to any of the other ingredients of Meningitec;
- if you / your child have shown signs of an allergic reaction to any other vaccine containing diphtheria toxoid or CRM197 diphtheria protein;
- if you / your child have shown signs of an allergic reaction after being given a previous dose of Meningitec;
- if you / your child have had an illness with a high fever, vaccination is usually postponed but can be done if the fever and illness are mild. However, talk to your doctor or nurse first.
Precautions for use What you need to know before taking Meningitec
Talk to your doctor, pharmacist or nurse before vaccination:
- if you / your child have haemophilia or another problem that does not allow the blood to clot properly, or if you / your child is taking any medicine that does not allow the blood to clot properly.If so, your doctor may choose to take special precautions.
- if you / your child have a weak immune system, or if you / your child have recently undergone, or are currently undergoing a course of treatment with radiation, corticosteroids, or other medicines that may lower your immune defenses against infections. Meningitec can still be administered but may not protect in the same correct way as it protects other people.
- if you / your child have kidney disease characterized by the presence of a large amount of protein in the urine (called nephrotic syndrome). There have been reports of recurrence of this condition following vaccination. Your doctor will inform you if you / your child can still take Meningitec, depending on the exact type of kidney problem you have.
Although Meningitec contains a protein (called CRM197) derived from the bacterium that causes diphtheria, it does not protect against diphtheria disease, so it is important that you / your baby receive other vaccines at the right time that protect against diphtheria. Your doctor or nurse will inform you about this.
Meningitec is mainly administered to infants from two months of age, children and young adults. No information is yet available on the administration of Meningitec to people aged 65 years and over or to infants under two months of age. "age.
Interactions Which drugs or foods can modify the effect of Meningitec
Tell your doctor or pharmacist if you / your child are taking or have recently taken any other medicines, even those obtained without a prescription or have recently received any other vaccines.
Unless otherwise instructed by your doctor or nurse, you / your child should continue taking the prescribed medicines as usual, before and after vaccination.
Meningitec can be given at the same time as other vaccines used against one or more of the following diseases are given:
- Polio (including polio vaccines that are given orally or injected)
- Diphtheria
- Tetanus
- Canine cough (whooping cough)
- Haemophilus influenzae type b (known as Hib vaccine)
- Hepatitis B
- Measles, mumps and rubella (German measles)
- Pneumococcal disease (7-valent pneumococcal conjugate vaccine, and 13-valent pneumococcal conjugate vaccine).
Warnings It is important to know that:
Pregnancy and breastfeeding and fertility
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 vaccination.
Usually, Meningitec should not be given to pregnant or breastfeeding women unless the doctor deems it really necessary for the pregnant or breastfeeding woman to be vaccinated as soon as possible.
Driving and using machines
After receiving Meningitec, somnolence, dizziness and other side effects may occur which may interfere with the ability to drive and use machines (see possible side effects). Do not drive or operate machinery until you know the effect Meningitec has on you.
Meningitec contains sodium chloride
One of the ingredients of Meningitec is sodium chloride. This vaccine contains less than 1 mmol sodium (23 mg) per 0.5 ml dose, therefore it is essentially "sodium free"
Dosage and method of use How to use Meningitec: Dosage
Meningitec will be administered by a doctor or nurse.
Your doctor or nurse will make sure that the vaccine is injected correctly into a muscle (not in or near nerves or blood vessels or too deeply under the skin) and that Meningitec is not mixed with other vaccines in the same syringe. The vaccine is a 0.5 ml injection and is usually given into the thigh muscle in infants and the shoulder muscle in older children, adolescents and adults. Meningitec should not be injected into the buttock area.
For infants between 2 and 12 months of age, two doses of Meningitec should be administered, with an interval of at least 2 months between doses.
In order to maintain protection, a booster dose should be given after the two-dose course in the neonate has been completed. Your doctor will advise you when your child should receive this dose.
For adults, adolescents and children over 12 months of age who have not previously been immunized with Meningitec, a single dose (0.5 ml) is recommended.
When Meningitec will be given at the same time as other injectable vaccines, Meningitec will be given as a separate injection at a different injection site.
If you forget to go to the doctor
If you forget to go to the doctor on the scheduled date, ask your doctor or nurse for advice.
Overdose What to do if you have taken too much Meningitec
An overdose is very unlikely as the vaccine is supplied in a single dose pre-filled syringe and is administered by a doctor or nurse.
There have been few reports of administration of too many doses, too much vaccine, or doses given too close together. In the majority of cases there were no side effects, while some times there were side effects that were similar to those experienced after routine and proper use of Meningitec.
Side Effects What are the side effects of Meningitec
Like all vaccines, Meningitec can cause side effects, although not everybody gets them.
Serious allergic reactions are always a very rare possibility after the administration of a vaccine. These reactions can include:
- swelling of the face, tongue or pharynx
- difficulty swallowing
- swelling of the skin (hives) and difficulty in breathing
- low blood pressure which causes collapse and shock
When these signs or symptoms occur, they usually develop very quickly after the injection, when people with them are still in the clinic or doctor's office. If any of these symptoms occur after leaving the injection site, you should contact your doctor IMMEDIATELY.
Very rarely, severe skin redness may occur, covering a large part of the body and leading to blistering and peeling. The inside of the mouth and eyes may also be affected. Other less severe allergic reactions include skin rashes that may be red and grainy, itchy, and later a general feeling of discomfort which can cause symptoms such as fever or joint swelling.
This vaccine cannot cause meningitis C (meningococcal disease C). If you or your child experience neck pain, neck stiffness or light discomfort (photophobia), sleepiness or confusion, or develop red or purple spot-like bruises (bruises) that do not go away with pressure, you should contact your doctor or the local emergency room to rule out other causes.
If you have been previously informed by your doctor that you / your child have nephrotic syndrome (a disease of the kidney which can cause swelling, particularly around the face or eyes, protein in the urine which gives it a foamy appearance , and / or weight gain) there may be a greater chance that this condition will recur within a few months of vaccination. Tell your doctor if you notice similar symptoms after vaccination.
The frequency of side effects described in this section is as follows:
Very common: side effects which may affect more than one in ten people who are vaccinated.
Common: side effects that may occur in less than one in ten people and in more than one in a hundred people who are vaccinated.
Very rare: side effects which may occur in less than one in ten thousand vaccinated people.
Very common side effects include:
In all age groups - swelling and soreness or pain at the injection site.
In infants and toddlers - loss of appetite, irritability, drowsiness or sleep cycle disturbances, malaise, diarrhea.
In adults - headache.
In pre-school children - fever.
Common side effects include:
In all age groups - fever (very common in preschool children), but this fever is rarely severe.
In infants and toddlers - crying.
In children aged 3 to 6 years - drowsiness, headache, irritability.
In adults - muscle pain, drowsiness.
Very rare side effects include (in all age groups except those mentioned above):
Swollen glands, dizziness, weakness, numbness, tingling or pins and needles, feeling sick or unwell, bruising (bruising) or skin bleeding, relapse of certain kidney diseases in which high amounts of protein are found in the urine.
Reduced muscle tone (flaccidity) has been observed very rarely, sometimes with reduced attention or response from the child and a pale or cyanotic appearance of the skin.
Seizures (seizures) have been reported very rarely after vaccination with Meningitec including some seizures in people who have previously had seizures. In adolescents and adults some of the reported seizures may actually have been fainting. In infants and younger children, seizures were usually associated with fever and were most likely febrile seizures.
Most people recovered quickly after the seizure.
In infants born very prematurely (at the 28th week of gestation or earlier), longer than normal pauses between breaths may occur for 2-3 days after vaccination.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Expiry and Retention
Keep this vaccine out of the sight and reach of children.
Do not use Meningitec after the expiry date which is stated on the label and carton 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.
Store in the original container in order to protect it 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.
Deadline "> Other information
What Meningitec contains
The active ingredient in each 0.5ml dose is:
10 micrograms Serogroup C meningococcal oligosaccharide *
* conjugated to the carrier protein CRM197 and adsorbed on aluminum phosphate (0.125 mg).
The other ingredients used are sodium chloride and water for injections.
Description of what Meningitec looks like and contents of the pack
Meningitec is a suspension for injection and is supplied in a single-dose 0.5 ml pre-filled syringe, in packs of 1 and 10 syringes (with or without a needle).
After shaking, the vaccine appears as a homogeneous white suspension.
Not all pack sizes may be marketed.
Deadline "> Information for healthcare professionals
The following information is intended for medical or healthcare professionals only:
Instructions for use, handling and disposal
After storage, a white precipitate and a clear supernatant can be observed. Before administration, the vaccine should be shaken well to obtain a homogeneous white suspension and should be visually examined for any foreign particles and / or changes in physical appearance. Should this occur, discard the vaccine. Each product. unused or waste material must be treated in accordance with local regulations.
Meningitec MUST NOT BE ADMINISTERED UNDER ANY CASE BY INTRAVENOUS ROUTE.
Meningitec is administered by intramuscular injection; preferably in the anterolateral area of the thigh in infants, and in the deltoid muscle in older children, adolescents and adults. Meningitec should not be injected into the buttock area.
Injection into or near nerves or blood vessels should be avoided.
The vaccine should not be administered intradermally, subcutaneously or intravenously.
If multiple vaccines are administered, different injection sites should be identified. This vaccine must not be mixed with other vaccines in the same syringe.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in the event of a rare anaphylactic / anaphylactoid event following administration of the vaccine.
If petechiae and / or purpura occur following vaccination, their etiology should be carefully investigated. Both infectious and non-infectious causes must be considered.
No data are available on the applicability of the vaccine in controlling epidemics.
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 -
MENINGITEC
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
One serving (0.5 ml) contains:
Neisseria meningitidis(strain C11)
Serogroup C oligosaccharide 10 mcg
Conjugated to the CRM197 carrier protein of Corynebacterium diphteriae
approximately 15 mcg
Adsorbed on aluminum phosphate 0.125 mg Al3 +
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM -
Suspension for injection, in pre-filled syringe. After shaking, the vaccine appears as a homogeneous white suspension.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Active immunization of children from 2 months of age, adolescents and adults for the prevention of invasive disease caused by Neisseria meningitidis serogroup C.
The use of Meningitec should be defined on the basis of official recommendations.
04.2 Posology and method of administration -
Dosage
There are no data regarding the use of different serogroup C conjugated meningococcal vaccines in the primary series or for booster doses. Whenever possible, the same vaccine should be used throughout the vaccination period.
Primary immunization
Infants up to 12 months of age: 2 doses, each of 0.5 ml, the first dose given no earlier than 2 months of age and with an interval of at least 2 months between doses.
Children over 12 months of age, adolescents and adults: a single dose of 0.5 ml.
The timing of dosing should be in accordance with official recommendations.
Booster doses
It is recommended that a booster dose be given after completion of the primary immunization series in neonates. The timing of this dose should be in accordance with available official recommendations. Information on responses to booster doses and concomitant administration with other childhood vaccines can be found in sections 5.1 and 4.5, respectively.
The need for booster doses in single dose vaccinated individuals (ie, individuals 12 months of age or older at the time of the first vaccination) has not yet been established.
Method of administration
Meningitec is administered by intramuscular injection; preferably in the anterolateral area of the thigh in infants, and in the deltoid muscle in older children, adolescents and adults. Meningitec should not be injected into the buttock area.
Injection into or near nerves or blood vessels should be avoided.
The vaccine should not be administered intravenously (see section 4.4). The safety and immunogenicity of intradermal or subcutaneous administration have not been evaluated.
If multiple vaccines are administered, different injection sites should be identified (see section 4.5). This vaccine must not be mixed with other vaccines in the same syringe.
04.3 Contraindications -
Hypersensitivity to the active substance or to any of the excipients.
Hypersensitivity to any vaccine containing diphtheria toxoid or non-toxic diphtheria toxin protein.
Hypersensitivity following a previous administration of Meningitec.
As with other vaccines, administration of Meningitec should be postponed in persons with acute febrile illness.
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 anaphylactoid / anaphylactic reaction following the administration of the vaccine (see section 4.8 - Undesirable effects).
As with any intramuscular injection, the vaccine should be administered with caution to individuals with thrombocytopenia or any type of coagulation disorder or to those receiving anticoagulation therapy.
Meningitec will only protect against Neisseria meningitidis serogroup C and may not completely prevent serogroup C meningococcal disease. Will not protect against other groups of Neisseria meningitidis or other microorganisms that cause meningitis or septicemia. In the case of petechiae and / or purpura occurring following vaccination (see section 4.8), their etiology should be carefully investigated. Both infectious and non-infectious causes must be considered.
Although symptoms of meningism such as neck pain / stiffness or photophobia have been reported, there has been no evidence that the vaccine causes meningococcal group C meningitis. One should always be alert, however, to the possibility of meningitis arising at the same time.
Prior to the establishment of a large-scale immunization program, the risk of disease must be considered Neisseria meningitidis of serogroup C in a given population and the benefits obtained from an "immunization.
No data are available on the validity of the vaccine in controlling an "epidemic."
Safety and immunogenicity in infants less than 2 months of age have not been established (see section 5.1 - Pharmacodynamic properties).
There are limited data on the safety and immunogenicity of the vaccine in the adult population, and there are no data for adults 65 years of age and older (see section 5.1).
There are limited data on the use of Meningitec in immunodeficient subjects.
In individuals with impaired immune responses (whether due to immunosuppressive therapy, genetic defect, human immunodeficiency virus (HIV) infection, or other causes), the expected immune response to serogroup conjugated meningococcal vaccines may not be obtained. C. The consequences on the actual degree of protection against infection are not known, since this also depends on whether the vaccine has determined a response with immunological memory.
In individuals with complement deficiency and individuals with functional or anatomic asplenia, an immune response to serogroup C meningococcal conjugate vaccines may be triggered; therefore the degree of protection that would be obtained is unknown.
When the primary immunization series is performed in very premature infants (born at 28 weeks of gestation or earlier), the potential risk of apnea and the need to monitor respiration for 48-72 hours after vaccination should be considered. and particularly for infants with a previous history of respiratory failure. As the benefit of vaccination in this group of infants is high, vaccination should not be withheld or postponed.
Immunization with this vaccine does not replace ordinary diphtheria vaccination.
Meningitec should under no circumstances be administered intravenously.
04.5 Interactions with other medicinal products and other forms of interaction -
Meningitec must not be mixed with other vaccines in the same syringe. If more than one vaccine is being administered, separate injection sites should be used.
In clinical studies, co-administration of Meningitec (but using different injection sites for each vaccine injected) with the following vaccines did not reduce the immunological response of any of these other antigens: Oral anti-Polio (OPV) vaccine; Inactivated polio vaccine (IPV); Hepatitis B (HBV) vaccine; Tetanus and Diphtheria vaccine alone (T or D), in combination (DT or dT), or in combination with acellular or whole cell pertussis vaccine (DTwP or DTaP) ; conjugate vaccine for the "Haemophilus influenzae type B (Hib alone or in combination with other antigens) or combined rubella-measles-mumps (MMR) vaccines.
In conducting the studies, small variations in the geometric mean of antibody concentrations (GMC) or titers (GMT) were observed; however, the clinical significance of such observations, if any, has not been established.
Data supporting concomitant administration of Meningitec with acellular pertussis vaccine (i.e. DtaP) or inactivated polio vaccine (IPV) are derived from studies in which subjects received either Meningitec or the same conjugated meningococcal serogroup C as in Meningitec combined with an experimental pneumococcal conjugate vaccine, and from a concomitant administration study with a pediatric combined vaccine (DTaP-HBV-IPV / Hib).
In various studies with different vaccines, concomitant administration of serogroup C meningococcal conjugates with combinations containing acellular pertussis components (with or without inactivated poliovirus, hepatitis B surface antigens or conjugated Hib) has been shown to resolve into antibody titers ( GMT) of serum bactericidal antibodies (SBA) lower than when administered separately or when co-administered with whole cell pertussis vaccines. Proportions reaching SBA titers of at least 1: 8 or 1: 128 are not affected. Currently, they are unknown. the potential implications of these observations on the term of protection.
In a clinical study comparing separate to concomitant administration of Meningitec (two doses at 2 and 6 months of age and a booster dose at "approximately 12 months of age") and Prevenar (hepta-valent pneumococcal vaccine; three doses at 2, 3.5 and 6 months of age and a booster dose at approximately 12 months of age) no evidence of immune interference between the two conjugated vaccines was found after primary series doses or after dose recall.
04.6 Pregnancy and breastfeeding -
Pregnancy
There are no clinical data on the use of serogroup C conjugate menigococcal vaccine in pregnant women. Animal studies are insufficient with respect to effects in pregnancy, embryo / fetal development, parturition and postnatal development (see paragraph 5.3-Preclinical safety data) The potential risk in humans is unknown.
However, considering the severity of serogroup C meningococcal disease, when the risk to exposure is clearly defined, pregnancy should not preclude vaccination.
Feeding time
The risk-benefit balance should be considered before the decision to vaccinate while breastfeeding.
04.7 Effects on ability to drive and use machines -
No studies on the effects on the ability to drive and use machines have been conducted.
Some of the effects mentioned in section 4.8 (Undesirable effects), such as dizziness and somnolence, may affect the ability to drive and use machines.
04.8 Undesirable effects -
Note: The frequency descriptions below are defined as follows: Very common (≥10%); Common (≥1% e
Adverse reactions evidenced in clinical studies
Adverse reactions reported in patient groups of all ages are listed below.
Adverse reactions were collected from the day of vaccination and for the three following days. Most reactions were self-limiting and resolved within the follow-up period.
In all age groups, injection site reactions (including erythema, swelling and tenderness / pain) were very common. However, these reactions were generally not clinically significant. Where studied, erythema or swelling of at least 3 cm and soreness that interfered with movement for more than 48 hours were infrequent. During clinical trials, injection site soreness was reported in 70% of adults.
Fever of at least 38.0 ° C was common in infants and toddlers and very common in pre-school children, but did not usually exceed 39.1 ° C, especially in older age groups .
Crying was common in infants and toddlers after vaccination, while drowsiness, sleep disturbances, anorexia, diarrhea and vomiting were very common. Irritability was very common in infants and toddlers and common in children aged between 3.5 and 6. There is no evidence that these symptoms were related to Meningitec rather than concurrently administered vaccines. especially the DTP.
In clinical trials examining three-dose dosing schedules (2, 3 and 4 months or 2, 4 and 6 months) in neonates, the frequency of adverse events did not increase with subsequent doses except for fever ≥38 ° C . However, it should be considered that in these studies the infants were given other vaccines planned concurrently with Meningitec.
Myalgia was common in adults. Somnolence has been commonly reported in children between 3.5 and 6 years of age and in adults. Headache was common in children between the ages of 3.5 and 6 and very common in adults.
Adverse reactions occurring in all age groups are shown below.
General disorders and administration site conditions:
Very common: injection site reactions (e.g. erythema, swelling, pain / tenderness)
Common: fever ≥38 ° C
Other reactions seen in infants (first year of life) and toddlers (second year of life) are listed below.
Metabolism and nutrition disorders:
Very common: anorexia
Psychiatric disorders:
Very common: irritability
Common: cry
Nervous system disorders:
Very common: drowsiness, sleep disturbances
Gastrointestinal disorders:
Very common: vomiting, diarrhea.
Other reactions reported in older age groups, including adults (4 to 60 years old):
Psychiatric disorders:
Common: irritability (children aged between 3.5 and 6 years)
Nervous system disorders:
Very common: headache (adults)
Common: sleepiness, headache (children aged between 3.5 and 6 years)
Musculoskeletal, connective tissue and bone disorders:
Common: myalgia (adults)
Adverse reactions reported by pharmacovigilance post-marketing (for all age groups)
These frequencies are based on percentage data from spontaneous reports and were calculated using the number of reports and the number of doses distributed.
Disorders of the blood and lymphatic system:
Very rare: lymphadenopathy
Immune system disorders:
Very rare: anaphylactic / anaphylactoid reactions including shock, hypersensitivity reactions including bronchospasm, facial edema and angioedema.
Nervous system disorders:
Very rare: dizziness, fainting, seizures (convulsions) including febrile seizures and seizures in patients with pre-existing epileptic disorders, hypoesthesia / paraesthesia and hypotonia (including episodes of hypotonic-hyporesponsiveness [HHE])
There have been very rare episodes of seizures following Meningitec vaccination; patients usually recovered quickly. Some of the reported seizures may have been fainting. The reported seizure rate was below the rate normally observed for cases of epilepsy in children. In infants, seizures were usually associated with fever and were probably febrile seizures.
There have been very rare spontaneous reports of episodes of hypotonic-hyporesponsiveness (HHE), a condition characterized by hypotonia and reduced response, associated with pallor or cyanosis, in temporal association with administration of the group C meningococcal conjugate vaccine. cases the vaccine had been administered concomitantly with other vaccines, most of which were pertussis vaccines.
Gastrointestinal disorders:
Very rare: vomiting, nausea, abdominal pain
Skin and subcutaneous tissue disorders:
Very rare: rash, urticaria, pruritus, erythema multiforme, Stevens-Johnson syndrome
Musculoskeletal, connective tissue and bone disorders:
Very rare: arthralgia
Renal and urinary disorders:
Cases of relapse of nephrotic syndrome have been reported in association with group C conjugate meningococcal vaccines.
Petechiae and / or purpura have been reported very rarely following immunization (see also section 4.4).
Apnea in very premature infants (≤ 28 weeks of gestation) (see section 4.4).
04.9 Overdose -
Cases of overdose have been reported with Meningitec, including cases of administration of higher doses than those recommended for a single session, cases of subsequent doses administered more sooner than recommended, and cases in which the total number of doses was exceeded. recommended doses. The majority of individuals did not experience any symptoms. In general, adverse reactions reported with overdose have also been reported with the administration of a recommended single dose of Meningitec.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: Meningococcal vaccines; ATC code: J07AH07
Immunogenicity
No prospective efficacy studies have been performed.
For meningococcal type C conjugate vaccines, serological correlates for protection have not been definitively established. These are being studied.
The determination of serum bactericidal activity (SBA) cited in the text below, used rabbit serum as the source of the complement.
Primary vaccination in newborns
In infants, two doses provided antibody titer (using rabbit puppy complement) SBA ≥ 1: 8 in 98-99.5% of infants, as shown in the table below. A two-dose vaccination schedule in the newborn induced anamnestic response to the booster dose given at 12 months of age.
Percentage of subjects who achieved an SBA titer (GMT) ≥ 1: 8
* See section 4.5
# measured 2 months after the second dose
MnCC = Group C conjugated meningococcal vaccine (which is the active ingredient of Meningitec)
DTwP = whole cell pertussis vaccine with diphtheria and tetanus toxoids
OPV = Oral Polio Viral Vaccine
DTaP-IPV / Hib = acellular components pertussis, diphtheria and tetanus toxoids, inactivated polyiviruses and Hib-conjugates (tetanus toxoid transport protein)
DTaP-HBV-IPV / Hib = as above, plus recombinant hepatitis B surface antigen in the hexavalent formulation
9v-PnC-MnCC = investigational 9-valent pneumococcal conjugate vaccine (not registered) formulated with serogroup C meningococcal conjugate vaccine (which is the active ingredient of Meningitec)
23vPnPS = 23-valent pneumococcal polysaccharide vaccine.
Immunogenicity of a single primary dose in infants
91% of 75 13-month-old infants developed SBA titers ≥1 / 8 and 89% of these 75 subjects showed a four-fold increase in their pre-antibody titer after receiving a single dose of Meningitec. -vaccination.
Immunogenicity of a single primary dose in adults
All 15 adults between 18-60 years of age who received a single dose of Meningitec developed SBA titers ≥1 / 8 and a four-fold increase in antibody titer.
There are no data in adults 65 years of age and older.
Post-marketing monitoring following an immunization campaign in England
Estimates on the efficacy of the vaccine, derived from a routine immunization program carried out in England (which used different quantities of three group C conjugated meningococcal vaccines), which covered a period between the launch on the market and the end of 1999 and March 2004, demonstrate the need for a booster dose after completion of the primary series (three doses given at 2, 3, and 4 months).
Within one year of completion of the primary series, vaccine efficacy in the cohort of children was estimated to be 93% (95% CI: 67, 99).However, more than a year after the completion of the primary series, there was clear evidence of decreased protection. Estimates of efficacy based on a small number of cases indicate, to date, that there could be a decrease in protection even in infants vaccinated with a single primary dose.
The efficacy in the other age groups (up to 18 years), for subjects already vaccinated with a single dose, remained around 90% or more, within a period of one year or more after vaccination.
05.2 "Pharmacokinetic properties -
Evaluation of pharmacokinetic properties is not required for vaccines.
05.3 Preclinical safety data -
Female mice were immunized intramuscularly with serogroup C conjugated meningococcal vaccine at twice the clinical dose, both before mating and during the gestation period. Macroscopic autopsy of internal organs was performed in each mouse. All mice survived both natural birth and caesarean section No adverse clinical signs were present in any mice and none of the parameters considered were altered by vaccine administration, either in adult mice or in fetuses.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Sodium chloride, water for injections.
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 "-
2 years
06.4 Special precautions for storage -
Store in a refrigerator (2 ° C - 8 ° C).
Do not freeze. Discard the vaccine if it has been frozen.
Store in the original packaging.
06.5 Nature of the immediate packaging and contents of the package -
0.5 ml suspension in pre-filled syringe (type I glass) with a plunger stopper (latex-free gray butyl rubber) and a protective tip cap (latex-free gray butyl rubber). Packs of 1 and 10 pre-filled syringes with or without needle.
Not all packs may be marketed.
06.6 Instructions for use and handling -
After storage, a white precipitate and a clear supernatant can be observed. Before administration, the vaccine must be shaken well to obtain a homogeneous white suspension and must be visually examined for any foreign particles and / or changes in physical appearance.
If this happens, throw the vaccine away. Any unused product or waste material must be handled in accordance with local regulations.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Wyeth Lederle S.p.A. - Via Nettunense 90 - 04011 Aprilia (LT)
08.0 MARKETING AUTHORIZATION NUMBER -
Pack of 1 pre-filled syringe without needle AIC 035438047 / M
Pack of 10 pre-filled syringes without needle AIC 035438050 / M
Pack of 1 pre-filled syringe with needle AIC 035438062 / M
Pack of 10 pre-filled syringes with AIC 035438074 / M needles
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
January 15, 2008
10.0 DATE OF REVISION OF THE TEXT -
August 2009
