ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Menveo powder and solution for solution for injection
Meningococcal Group A, C, W135 and Y conjugate vaccine
2.
One dose (0.5 ml of the reconstituted vaccine) contains:
(Originally contained in the powder)
• Meningococcal group A oligosaccharide
10 micrograms
Conjugated to
Corynebacterium diphtheriae
CRM
197
protein 16.7 to 33.3 micrograms
(Originally contained in the solution)
• Meningococcal group C oligosaccharide
5 micrograms
Conjugated to
Corynebacterium diphtheriae
CRM
197
protein 7.1 to 12.5 micrograms
• Meningococcal group W135 oligosaccharide
5 micrograms
Conjugated to
Corynebacterium diphtheriae
CRM
197
protein 3.3 to 8.3 micrograms
• Meningococcal group Y oligosaccharide
5 micrograms
Conjugated to
Corynebacterium diphtheriae
CRM
197
protein 5.6 to 10.0 micrograms
For a full list of excipients, see section 6.1.
3.
Powder and solution for solution for injection (powder and solution for injection).
The powder is a white to off- white cake.
The solution is a colourless clear solution.
4.
Menveo is indicated for active immunization of adolescents (from 11 years of age) and adults at risk
of exposure to
Neisseria meningitidis
groups A, C, W135 and Y, to prevent invasive disease.
The use of this vaccine should be in accordance with official recommendations.
Posology
Adults
Menveo should be administered as a single 0.5 ml injection.
Paediatric population
Menveo is indicated from the age of 11 years and above and should be administered as a single 0.5 ml
injection.
Elderly
2
There are limited data in individuals aged 56-65 and there are no data in individuals aged >65 years.
The need for, and timing of, a booster dose of Menveo has not yet been determined.
Method of administration
Menveo is given as an intramuscular injection, preferably into the deltoid muscle.
It must not be administered intravascularly, subcutaneously or intradermally.
Separate injection sites must be used if more than one vaccine is being administered at the same time.
For instructions on preparation and reconstitution of the product, see section 6.6.
Hypersensitivity to the active substance or to any of the excipients, including diphtheria toxoid
(CRM
197
), or a life-threatening reaction after previous administration of a vaccine containing similar
components (see section 4.4).
As with other vaccines, Menveo should be postponed in individuals suffering from an acute severe
febrile illness. The presence of a minor infection is not a contraindication.
Before the injection of any vaccine, the person responsible for administration must take all
precautions known for the prevention of allergic or any other reactions including thorough medical
history and current health status. As with all injectable vaccines, appropriate medical treatment and
supervision must always be readily available in case of a rare anaphylactic event following
administration of the vaccine.
Menveo should under no circumstances be administered intravascularly.
Menveo will not protect against infections caused by any other serogroups of
N. meningitidis
not
present in the vaccine.
As with any vaccine, a protective immune response may not be elicited in all vaccinees (see section
5.1).
There are no data on the applicability of the vaccine for post-exposure prophylaxis.
In immunocompromised individuals, vaccination may not result in an appropriate protective antibody
response. While Human Immunodeficiency Virus (HIV) infection is not a contraindication, Menveo
has not been specifically evaluated in immunocompromised people. Individuals with complement
deficiencies and individuals with functional or anatomical asplenia may not mount an immune
response to meningococcal group A, C, W135 and Y conjugate vaccines.
Menveo has not been evaluated in persons with thrombocytopenia, bleeding disorders or that are
receiving anticoagulant therapy, because of the risk of haematoma. The risk-benefit ratio for persons
at risk of haematoma following intramuscular injection must be evaluated by health care
professionals.
The tip cap of the syringe contains 10% Dry Natural Rubber. Although the risk for developing allergic
latex reactions is very small, healthcare professionals are encouraged to consider the benefit risk prior
to administering this vaccine to patients with known history of hypersensitivity to latex.
3
Menveo has been evaluated in two co-administration studies with either Tetanus, Reduced Diphtheria
and Acellular Pertussis Vaccine, Adsorbed (Tdap) alone or Tdap and Human Papillomavirus
Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant (HPV), both of which support the co-
administration of the vaccines.
There was no evidence of an increased rate of reactogenicity or change in the safety profile of the
vaccines in either study. Antibody responses to Menveo and the diphtheria, tetanus or HPV vaccine
components were not negatively affected by co-administration.
The administration of Menveo one month after Tdap resulted in statistically significantly lower group
W135 seroresponses. Since there was no direct impact on the seroprotection rate, the clinical
consequences are presently unknown.
There was evidence of some suppression of antibody response to two of the three pertussis antigens.
The clinical relevance of this observation is unknown. After vaccination, over 97% of subjects had
detectable pertussis titers to all three pertussis antigens.
Concomitant administration of Menveo and other vaccines than those listed above has not been
studied. It is advised that Menveo should not be administered at the same time as other vaccines in
particular live vaccines, unless absolutely necessary. Concomitant vaccines should always be
administered at separate injection sites and preferably contralateral. It should be checked if the
adverse reactions may be intensified by any co-administration.
If a vaccine recipient is undergoing immunosuppressant treatment, the immunological response may
be diminished.
Insufficient clinical data on exposed pregnancies are available.
In non-clinical studies, Menveo had no direct or indirect harmful effects with respect to pregnancy,
embryonal/foetal development, parturition or postnatal development. Considering the severity of
invasive meningococcal disease caused by
Neisseria meningitidis
serogroups A, C, W and Y,
pregnancy should not preclude vaccination when the risk of exposure is clearly defined.
Although insufficient clinical data on the use of Menveo during breast-feeding are available, it is
unlikely that secreted antibodies in milk would be harmful when ingested by a breastfed infant.
Therefore, Menveo may be used during breast feeding.
No studies on the effects on the ability to drive and use machines have been performed.
Dizziness has
been very rarely reported following vaccination. This may temporarily affect the ability to drive or
use machines.
The safety of Menveo was evaluated in five randomized controlled clinical trials including 6,185
participants (from 11-65 years) who received Menveo. Among Menveo recipients, 61%, 17%, 22%
and 3.4% were in the 11-18 year, 19-34 year, 35-55 year and 56-65 year age groups, respectively. The
two primary safety studies were randomized, active-controlled trials that enrolled participants aged 11
to 55 years (N=2663) and 19 to 55 years (N=1606), respectively.
The incidence and severity of any, local, systemic, and other reactions were generally similar in the
Menveo groups across all studies and within the adolescent and adult age groups. The reactogenicity
4
profile and rates of adverse events among subjects aged 56-65 years who received Menveo (N=216),
were similar to that observed in Menveo recipients subjects aged 11-55.
The most common local and systemic adverse reactions observed in clinical trials were pain at the
injection site and headache.
Adverse reactions reported in three pivotal and two supportive clinical trials are listed here below per
system organ class. The most common side effects reported during clinical trials usually lasted only
one to two days and were not usually severe.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Frequencies are defined as follows:
Very common: (≥ 1/10)
Common: (≥1/100 to <1/10)
Uncommon: (≥1/1,000 to <1/100)
Rare: (≥1/10,000 to <1/1,000)
Very rare: (<1/10,000)
Not known (cannot be estimated from the available data)
Nervous system disorders
:
Very common: headache
Uncommon: dizziness
Gastrointestinal disorders
:
Very common: nausea
Skin and subcutaneous tissue disorders
:
Common: rash
General disorders and administration site conditions
:
Very common: injection site pain, injection site erythema (≤50 mm), injection site induration (≤50
mm), injection site pruritus, malaise
Common: injection site erythema (>50 mm), injection site induration (>50 mm), fever ≥38°C, chills
In the adolescent age group, the safety and tolerability of the vaccine was favourable relative to Tdap
and did not substantially change with concomitant or sequential administration of other vaccines.
No case of overdose has been reported.
5.
5.1
Pharmacodynamic properties
Pharmacotherapeutic group: Meningococcal vaccines, ATC code: Not yet assigned.
Immunogenicity
The efficacy of Menveo has been inferred by measuring the production of serogroup-specific anti-
capsular antibodies with bactericidal activity. Serum bactericidal activity (SBA) was measured using
5
human serum as the source of exogenous complement (hSBA). The hSBA was the original correlate
of protection against meningococcal disease.
Immunogenicity was evaluated in randomized, multicenter, active controlled clinical trials that
enrolled adolescents (11-18 years of age) adults (19-55 years of age) and older adults (56-65 years of
age).
In the pivotal study (V59P13), participants received either a dose of Menveo (N = 2649) or
quadrivalent, diphtheria toxoid conjugated, meningococcal vaccine as comparator (ACWY-D) (N =
875). Sera were obtained both before vaccination and 28 days after vaccination.
In another study (V59P6) conducted in 524 adolescents, the immunogenicity of Menveo was
compared to that of ACWY-PS.
Immunogenicity in adolescents
In the 11-18 year old population of the pivotal study, V59P13, the immunogenicity of a single dose of
Menveo one month post vaccination is compared with the quadrivalent, ACWY-Diphtheria toxoid
protein conjugate vaccine (ACWY-D). Immunogenicity results at one month after Menveo are
summarized below in Table 1.
In the subset of subjects aged 11-18 years who were seronegative at baseline (hSBA < 1:4), the
proportion of subjects who achieved a titer ≥ 1:8 after a dose of Menveo were as follows: serogroup
A 75% (780/1039); serogroup C 79% (771/977); serogroup W135 94% (570/609); serogroup Y 81%
(510/630).
Table 1: Serum bactericidal antibody responses following Menveo one month after vaccination
among subjects aged 11-18 years
Serogroup
N
GMT
(95% CI)
hSBA
>
1:8
(95% CI)
A
1075
29 (24 , 35)
75% (73 , 78)
C
1483
59 (48, 73)
84% (82, 86)
W135
1024
87 (74, 102)
96% (95, 97)
Y
1036
51 (42, 61)
88% (85, 90)
The persistence of immune responses for Menveo at 21 months post vaccination among subjects aged
11-18 years at the time of vaccination is shown in Table 2.
Table 2: Persistence of immune responses approximately 21 months after vaccination with
Menveo (subjects we
re aged 11-18 years at vaccination)
Serogroup
GMT
(95% CI)
hSBA ≥ 1:8
(95% CI)
A
5.29 (4.63, 6.05)
36% (30, 42)
C
10 (9.02, 12)
62% (56, 68)
W135
18 (15, 20)
84% (79, 88)
Y
12 (10, 14)
67% (61, 72)
In the non-inferiority study, V59P6, immunogenicity was assessed among adolescents aged 11-17
years who had been randomized to receive either Menveo or quadrivalent meningococcal
polysaccharide vaccine (ACWY-PS). Menveo was shown to be non-inferior to ACWY-PS vaccine
for all four serogroups (A, C, W and Y) based on seroresponse, proportions achieving hSBA titres
≥1:8, and GMTs.
6
Table 3: Immunogenicity of one dose of Menveo or ACWY-PS in adolescents, measured at one
month post vaccination
Serogroup
hSBA ≥1:8
(95% CI)
hSBA GMTs
(95% CI)
Menveo
ACWY-PS
Menveo
ACWY-PS
A
N=140
N=149
N=140
N=149
81%
(74, 87)
41%
(33, 49)
33
(25, 44)
7.31
(5.64, 9.47)
C
N=140
N=147
N=140
N=147
84%
(77, 90)
61%
(53, 69)
59
(39, 89)
28
(19, 41)
W
N=138
N=141
N=138
N=141
91%
(84, 95)
84%
(77, 89)
48
(37, 62)
28
(22, 36)
Y
N=139
N=147
N=139
N=147
95%
(90, 98)
82%
(75, 88)
92
(68, 124)
35
(27, 47)
At one year post vaccination in these same subjects, compared with ACWY-PS, a higher proportion
of subjects vaccinated with Menveo had hSBA titers ≥1:8 for serogroups C, W, and Y, with
comparable levels for serogroup A. Similar findings were observed in the comparison of hSBA
GMTs.
Immunogenicity in adults
In the pivotal immunogenicity trial, V59P13, immune responses to Menveo were assessed among
adults aged 19 to 55 years. Results are presented in Table 4.
In the subset of subjects aged 19-55 years
who were seronegative at baseline, the proportion of subjects who achieved a titer ≥ 1:8 after a dose
of Menveo were as follows: serogroup A 67% (582/875); serogroup C 71% (425/596); serogroup
W135 82% (131/160); serogroup Y 66% (173/263).
Table 4: Serum bactericidal antibody responses following Menveo one month after vaccination
among subjects aged 19-55 years
Serogroup
N
GMT
(95% CI)
hSBA ≥ 1:8
(95% CI)
A
963 31 (27, 36)
69% (66, 72)
C
961 52 (44, 60)
80% (77, 83)
W135
484 111 (93, 132)
94% (91, 96)
Y
503 44 (37, 52)
79% (76, 83)
Immunogenicity in older adults
The comparative immunogenicity of Menveo vs. ACWY-PS was evaluated in subjects aged 56-65
years, in study V59P17. The proportion of subjects with hSBA titers ≥ 1:8 was non-inferior to
ACWY-PS for all four serogroups and statistically superior for serogroups A and Y.
7
Table 5: Immunogenicity of one dose of Menveo or ACWY-PS in adults aged 56-65 years,
measured at one month post vaccination.
Serogroup
Menveo
hSBA ≥ 1:8
(95% CI)
ACWY-PS
hSBA ≥ 1:8
(95% CI)
A
N=83
N=41
87%
(78, 93)
63%
(47, 78)
C
N=84
N=41
90%
(82, 96)
83%
(68, 93)
W
N=82
N=39
94%
(86, 98)
95%
(83, 99)
Y
N=84
N=41
88%
(79, 94)
68%
(52, 82)
The European Medicines Agency has deferred the obligation to submit the results of studies with
Menveo in one or more subsets of the paediatric population in meningococcal meningitis. See 4.2 for
information on paediatric use.
5.2
Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional repeated-dose and
reproductive and developmental toxicity studies.
In laboratory animals, no adverse reactions were seen in vaccinated maternal rabbits or in their
offspring through postnatal day 29.
No effects on fertility were observed in female rabbits receiving Menveo pre-mating and during
pregnancy.
6.
6.1
List of excipients
Powder
Sucrose
Potassium dihydrogen phosphate
Solution
Sodium dihydrogen phosphate monohydrate
Disodium phosphate dihydrate
Sodium chloride
Water for injections
6.2
Incompatibilities
8
This medicinal product must not be mixed with other medicinal products except those mentioned in
section 6.6.
6.3
Shelf life
3 years.
After reconstitution, the product should be used immediately. However, chemical and physical
stability after reconstitution was demonstrated for 8 hours below 25°C.
6.4
Special precautions for storage
Store in a refrigerator (2°C - 8°C). Do not freeze.
Keep the vial and the syringe in the outer carton in order to protect from light.
For storage conditions of the reconstituted product, see section 6.3.
6.5 Nature and contents of container
Powder in vial (type I glass) with a stopper (halobutyl rubber) and solution in pre-filled syringe (type I
glass) with a tip cap (type I elastomeric closure with 10% of latex
or type II elastomeric closure
latex free
).
Each pack contains a single dose of one vial and one pre-filled syringe.
6.6 Special precautions for disposal and other handling
Menveo must be prepared for administration by reconstituting powder (in vial) with solution (in pre-
filled syringe).
The components of the vaccine should be visually inspected before and after reconstitution.
Remove the tip cap from the syringe and attach a suitable needle for the withdrawal (21G, 1 1/2’’).
Use the whole contents of the syringe (0.6 ml) to reconstitute the powder.
Gently shake the vial until the vaccine plug has dissolved. Withdraw the full contents of the vial into
the syringe. Please note that it is normal for a small amount of liquid to remain in the vial following
withdrawal of the dose.
Following reconstitution, the vaccine is a clear, colourless to light yellow solution, free from visible
foreign particles. In the event of any foreign particulate matter and/or variation of physical aspect
being observed, discard the vaccine.
Prior to injection, change the needle for one suitable for the administration (25G, 1’’). Ensure that no
air bubbles are present in the syringe before injecting the vaccine.
Any unused product or waste material should be disposed of in accordance with local requirements.
7.
Novartis Vaccines and Diagnostics S.r.l.
Via Fiorentina 1
53100 Siena, Italy
8.
EU/1/10/614/001
9
9.
15 March 2010
Detailed information on this product is available on the website of the European Medicines Agency
(EMEA) http://www.emea.europa.eu
10
ANNEX II
A.
MANUFACTURER OF THE BIOLOGICAL ACTIVE
SUBSTANCE AND MANUFACTURING AUTHORISATION
HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
B.
CONDITIONS OF THE MARKETING AUTHORISATION
11
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacture of the biological active substance
Novartis Vaccines and Diagnostics S.r.l.
Bellaria-Rosia
53018 Sovicille (SI)
Italy
Name and address of the manufacturer responsible for batch release
Novartis Vaccines and Diagnostics S.r.l.
Bellaria-Rosia
53018 Sovicille (SI)
Italy
The printed package leaflet of the medicinal product must state the name and address of the
manufacturer responsible for the release of the concerned batch.
B. CONDITIONS OF THE MARKETING AUTHORISATION
Medicinal product subject to medical prescription.
•
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT
Not applicable
•
OTHER CONDITIONS
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance, as described in version 13.1 (dated 11
June 2010) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and
functioning before and whilst the product is on the market.
Risk Management Plan
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in
the Pharmacovigilance Plan, as agreed in version 4 of 14 December 2009 of the Risk Management
Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any
subsequent updates of the RMP agreed by the CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the
updated RMP should be submitted at the same time as the next Periodic Safety Update Report
(PSUR).
In addition, an updated RMP should be submitted
12
•
When new information is received that may impact on the current Safety Specification,
Pharmacovigilance Plan or risk minimisation activities
•
Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
reached
•
At the request of the EMEA
Official batch release: in accordance with Article 114 Directive 2001/83/EC as amended, the official
batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
13
ANNEX III
LABELLING AND PACKAGE LEAFLET
14
A. LABELLING
15
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
SINGLE DOSE CARTON
1.
Menveo powder and solution for solution for injection
Meningococcal Group A, C, W135 and Y conjugate vaccine
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
After reconstitution 0.5 ml dose contains:
Meningococcal group A oligosaccharides 10 micrograms conjugated to
Corynebacterium diphtheriae
CRM
197
protein 16.7-33.3 micrograms
Meningococcal group C oligosaccharides 5 micrograms conjugated to
Corynebacterium diphtheriae
CRM
197
protein 7.1-12.5 micrograms
Meningococcal group W135 oligosaccharides 5 micrograms conjugated to
Corynebacterium
diphtheriae
CRM
197
protein 3.3-8.3 micrograms
Meningococcal group Y oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae
CRM
197
protein 5.6-10.0 micrograms.
3.
LIST OF EXCIPIENTS
Excipients: Potassium dihydrogen phosphate, sucrose, sodium chloride, sodium dihydrogen phosphate
monohydrate, disodium phosphate dihydrate, water for injection.
4.
One vial MenA lyophilised conjugate component and 1 pre-filled syringe MenCWY liquid conjugate
component.
The volume after reconstituting the powder (vial) with the solution (pre-filled syringe) is 0.5 ml (1
dose)
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Intramuscular injection.
Not for intravascular, subcutaneous or intradermal injection.
Shake well before use.
Read the package leaflet before use.
16
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP
After reconstitution, the product should be used immediately. However, chemical and physical
stability after reconstitution was demonstrated for 8 hours below 25°C.
9.
SPECIAL STORAGE CONDITIONS
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Keep the vial and the syringe in the outer carton to protect from light.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Any unused product or waste material should be disposed of in accordance with local requirement
Novartis Vaccines and Diagnostics S.r.l., Via Fiorentina 1, 53100 Siena, Italy
EU/1/10/614/001
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
17
Medicinal product subject to medical prescription
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Justification for not including Braille accepted
18
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
VIAL LABEL MenA Liophilised Conjugate Component
1.
Menveo powder for injection
MenA Conjugate
Intramuscular use
2.
METHOD OF ADMINISTRATION
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Lot
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
1 dose (0.5 ml)
6.
OTHER
19
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
PRE-FILLED SYRINGE LABEL MenCWY Liquid Conjugate Component
1.
Menveo solution for injection
MenCWY Conjugate
Intramuscular use
2.
METHOD OF ADMINISTRATION
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Lot
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
0.6 ml
6.
OTHER
20
B PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
Menveo powder and solution for solution for injection
Meningococcal Group A, C, W135 and Y conjugate vaccine
Read all of this leaflet carefully before you or your child are given this medicine
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
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.
In this leaflet:
1. What Menveo is and what it is used for
2. Before you or your child are given Menveo
3. How to use Menveo
4. Possible side effects
5. How to store Menveo
6. Further information
1.
WHAT MENVEO IS AND WHAT IT IS USED FOR
Menveo is a vaccine that is used for active immunization of adolescents (from 11 years of age) and
adults at risk of exposure to
Neisseria meningitidis
serogroups A, C, W135 and Y, to prevent invasive
disease
.
The vaccine works by causing your body to make its own protection (antibodies) against
these bacteria.
Neisseria meningitidis
group A, C, W135 and Y bacteria can cause serious and sometimes life-
threatening infections such as meningitis and sepsis (blood poisoning).
Menveo cannot cause bacterial meningitis or diphtheria.
2.
BEFORE YOU OR YOUR CHILD ARE GIVEN MENVEO
Do not use Menveo if you or your child has
:
•
ever had an allergic reaction to the active substances or any of the other ingredients of Menveo
(see Section 6
Further Information)
•
ever had an allergic reaction to diphtheria toxoid (a substance used in a number of other vaccines)
•
an illness with high fever. However, a mild fever or upper respiratory infection (for example cold)
itself is not a reason to delay vaccination.
Take special care with Menveo if you (or your child) have:
•
Haemophilia or any other problem that may stop your blood from clotting properly, such as
persons receiving blood thinners (anticoagulants).
This vaccine can only protect against meningococcal group A, C, W135, and Y bacteria. It cannot
protect against other types of meningococcal bacteria other than groups A, C, W135 and Y, or against
other causes of meningitis and sepsis (blood poisoning).
Little is known about the effectiveness of Menveo when administered to individuals with weakened
immunity due to use of immunosuppressive medications, or HIV infection, and other possible causes.
It is possible that the effectiveness of Menveo could be reduced in such individuals.
As with any vaccine, Menveo may not fully protect 100% of those who get the vaccine.
22
The tip cap of the syringe contains 10% Dry Natural Rubber. Although the risk for developing allergic
latex reactions is very small, healthcare professionals are encouraged to consider the benefit risk prior
to administering this vaccine to patients with known history of hypersensitivity to latex.
Using other medicines
Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Menveo may be given at the same time as other vaccinations. These include:
Tetanus, Reduced Diphtheria and Acellular Pertussis Vaccine (Tdap), and Human Papillomavirus
Vaccine (HPV).
Menveo’s effect could be diminished when administered to individuals who are taking medicines that
suppress the immune system.
Other injected vaccines must be given into a different arm from the site of the Menveo injection.
Pregnancy and breast-feeding
If you are pregnant, likely to become pregnant or are breast-feeding, you must tell your doctor before
Menveo is given. Your doctor or nurse may still recommend that you receive Menveo if you are at
high risk of infection with meningococcal group A, C; W-135 and Y bacteria.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
Dizziness has been very rarely reported following vaccination. This may temporarily affect the ability
to drive or use machines.
Important information about some of the ingredients of Menveo
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-
free’.
This medicinal products contains less than 1 mmol potassium (39 mg) per dose, i.e. essentially
‘potassium- free’"
3. HOW TO USE MENVEO
Menveo will be given to you or your child by a doctor or nurse.
The vaccine is usually given into the upper arm muscle (deltoid) for adolescents and adults. Your
doctor or nurse will take care to ensure the vaccine is not given into a blood vessel and will make sure
that it is injected into muscle and not into the skin.
For adolescents (from 11 years of age) and adults: a single dose (0.5 ml) of the vaccine is
recommended.
There are limited data in individuals aged 56-65 and there are no data in subjects aged older than 65
years
For information on the reconstitution of the vaccine see the section for medical or healthcare
professionals at the end of this leaflet.
23
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Menveo can cause side effects, although not everybody gets them.
The most common side effects reported during clinical trials usually lasted only one to two days and
were not usually severe. The most common side effects that were reported during clinical trials are
listed below.
Very common (affects more than 1 user in 10): headache, nausea, injection site pain, injection site
redness(≤ 50 mm), injection site firmness or swelling (≤ 50 mm), injection site itching, malaise
Common (affects 1 to 10 users in 100): rash, injection site redness (> 50 mm), injection site firmness
or swelling (> 50 mm), fever ≥ 38°C, chills
Uncommon (affects 1 to 10 users in 1,000): dizziness
5. HOW TO STORE MENVEO
Keep out of the reach and sight of children.
Do not use Menveo after the expiry date which is stated on the outer carton after EXP. The expiry
date refers to the last day of that month
Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the vial and the pre-filled syringe in the outer
carton in order to protect from light.
After reconstitution, the product should be used immediately. However, chemical and physical
stability after reconstitution was demonstrated for 8 hours below 25°C.
Medicines should not be disposed of via wastewater or household waste. Your doctor or nurse will
dispose of this medicine. These measures will help to protect the environment.
6.
FURTHER INFORMATION
What Menveo contains
One dose (0.5 ml of the reconstituted vaccine) contains:
(Originally contained in the powder)
• Meningococcal group A oligosaccharide
10 micrograms
Conjugated to
Corynebacterium diphtheriae
CRM
197
protein 16.7 to 33.3 micrograms
(Originally contained in the solution)
• Meningococcal group C oligosaccharide
5 micrograms
Conjugated to
Corynebacterium diphtheriae
CRM
197
protein 7.1 to 12.5 micrograms
• Meningococcal group W135 oligosaccharide
5 micrograms
Conjugated to
Corynebacterium diphtheriae
CRM
197
protein 3.3 to 8.3 micrograms
• Meningococcal group Y oligosaccharide
5 micrograms
Conjugated to
Corynebacterium diphtheriae
CRM
197
protein 5.6 to 10.0 micrograms
The other ingredients are
24
In the powder: potassium dihydrogen phosphate and sucrose.
In the solution: sodium chloride, sodium dihydrogen phosphate monohydrate, sodium hydrogen
phosphate dihydrate, and water for injection (See also end of Section 2).
What Menveo looks like and contents of the pack
Menveo is a powder and a solution for injection.
Each dose of Menveo is supplied as a:
•
Vial containing the MenA Lyophilised Conjugate Component as a white to off-white powder
•
Pre-filled syringe containing the MenCWY Liquid Conjugate Component as clear solution
The contents of the two components (vial and pre-filled syringe) are to be mixed prior to
vaccination providing 1 dose of 0.5 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Novartis Vaccines and Diagnostics S.r.l., Via Fiorentina 1, 53100
Siena, Italy
Manufacturer: Novartis Vaccines and Diagnostics S.r.l., Bellaria-Rosia, 53018 Sovicille (Siena), Italy
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder:
België/Belgique/Belgien
Novartis Vaccines and Diagnostics S.r.l.
Tél/Tel: +39 0577 243638
Italië/Italie/Italien
Luxembourg/Luxemburg
Novartis Vaccines and Diagnostics S.r.l.
Tél/Tel: +39 0577 243638
Italie/Italien
България
Novartis Vaccines and Diagnostics S.r.l.
Teл.: +39 0577 243638
Италия
Magyarország
Novartis Vaccines and Diagnostics
Magyarországi Kereskedelmi Képviselet
Bartók Béla út 43-47.
H-1114 Budapest
Tel.: + 36 1279 1829
Česká republika
Novartis s.r.o.
Vaccines & Diagnostics
Gemini B
Na Pankráci 1724/129
140 00 Prague 4
Czech Republic
+420 225 775 111
Malta
Novartis Vaccines and Diagnostics S.r.l.
Tel: +39 0577 243638
L-Italja
Danmark
Novartis Vaccines and Diagnostics S.r.l.
Tlf: +39 0577 243638
Italien
Nederland
Novartis Vaccines and Diagnostics S.r.l.
Tel: +39 0577 243638
Italië
Deutschland
Novartis Vaccines and Diagnostics GmbH
Tel: +49 6421 39 7798
Norge
Novartis Vaccines and Diagnostics S.r.l.
Tlf: +39 0577 243638
Italia
25
Eesti
Novartis Vaccines and Diagnostics S.r.l.
Tel: +39 0577 243638
Itaalia
Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570
Ελλάδα
Novartis Vaccines and Diagnostics S.r.l.
Τηλ: +39 0577 243638
Ιταλία
Polska
Novartis Poland Sp. z o.o.
Al. W. Witosa 31
00-710 Warszawa
Tel.: + 48
22 550-88-88
España
Novartis Vaccines and Diagnostics, S.L.
Gran Via de les Corts Catalanes 764
08013 Barcelona
tel: 93.306.42.00
Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Rua do Centro Empresarial, Edifício 8
Quinta da Beloura
2710-444 Sintra
Tel: +351 21 000 8600
France
Novartis Vaccines and Diagnostics SAS
10 rue Chevreul
92 150 Suresnes France
tél : 00 33 1 55 49 00 30
România
Novartis Vaccines and Diagnostics S.r.l.
Tel: +39 0577 243638
Italia
Ireland
Novartis Vaccines and Diagnostics S.r.l.
Tel: +39 0577 243638
Italy
Slovenija
Novartis Vaccines and Diagnostics S.r.l.
Tel: +39 0577 243638
Italija
Ísland
Novartis Vaccines and Diagnostics S.r.l.
Sími: +39 0577 243638
Ítalía
Slovenská republika
Novartis Slovakia s.r.o.
Galvaniho 15/A
821 08 Bratislava
Slovenská republika
Tel: + 421 2 5070 6111
Italia
Novartis Vaccines and Diagnostics s.r.l.
Via Fiorentina 1
53100 Siena
Tel: 800867121
Suomi/Finland
Novartis Vaccines and Diagnostics S.r.l.
Puh/Tel: +39 0577 243638
Italia/Italien
Κύπρος
Novartis Vaccines and Diagnostics S.r.l.
Τηλ: +39 0577 243638
Ιταλία
Sverige
Novartis Vaccines and Diagnostics S.r.l.
Tel: +39 0577 243638
Italien
Latvija
Novartis Vaccines and Diagnostics S.r.l.
Tel: +39 0577 243638
Itālija
United Kingdom
Novartis Vaccines and Diagnostics Ltd
Gaskill Road Speke
Liverpool L24 9GR
Tel: +44(0) 845 745 1500
Lietuva
Novartis Vaccines and Diagnostics S.r.l.
Tel: +39 0577 243638
Italija
26
This leaflet was last approved in (MM/YYYY)
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web
site: http://www.emea.europa.eu
------------------------------------------------------------------------------------------------------------------
The following information is intended for medical or healthcare professionals only:
Reconstitution of the vaccine
Menveo must be prepared for administration by reconstituting the powder in a vial with the solution.
Remove the tip cap from the syringe and attach a suitable needle for the withdrawal (21G, 1 1/2’’).
Inject the whole solution contents of the syringe into the powder vial to reconstitute the MenA
conjugate component.
Gently shake the vial until the powder plug has dissolved. Withdraw the full contents of the vial into
the syringe. Please note that it is normal for a small amount of liquid to remain in the vial following
withdrawal of the dose. Prior to injection, change the needle with one suitable for the administration
(25G, 1’’). Ensure that no air bubbles are present in the syringe before injecting the vaccine.
Following reconstitution, the vaccine is a clear, colourless solution, free from visible foreign particles.
In the event of any foreign particulate matter and/or variation of physical aspect being observed,
discard the vaccine.
Menveo is given as an intramuscular injection, preferably into the deltoid muscle.
Any unused product or waste material should be disposed of in accordance with local requirements.
27
Source: European Medicines Agency
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