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Formening

Formening

vaccine, meningococcal

Manufacturer:

Mersifarma TM
Full Prescribing Info
Contents
Meningococcal (groups A, C, Y & W-135) polysaccharide vaccine.
Description
Each vial Formening powder injection contains: Group A meningococcal polysaccharide 50 mcg, Group B meningococcal polysaccharide 50 mcg, Group Y meningococcal polysaccharide 50 mcg, Group W135 meningococcal polysaccharide 50 mcg.
Diluents: Sterile water for injection.
Indications/Uses
After vaccination, it can make the body to produce humoral immune response to prevent meningococcal disease caused by epidemic Neisseria meningitidis serogroups A, C, Y and W135.
Dosage/Direction for Use
Posology: The vaccine must be reconstituted by mixing the supplied diluents and shaken properly. Administer immediately once reconstituted.
The vaccine should be administered subcutaneously in the outer aspect of the deltoid.
Vaccinated once with dose of 0.5 mL per person. Vaccination should be completed before epidemic cerebrospinal meningitis epidemic season.
Contraindications
This vaccine should not be administered to subjects as following: Subjects with known epilepsy, convulsion, brain disorder or allergic history.
Subjects with kidney and heart disease, active tuberculosis.
Subjects with acute infectious disease and fever.
Pregnancy and animal reproduction studies have not been conducted with this vaccine. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. As a result, pregnant women are not recommended for vaccination, especially in the first three months.
Special Precautions
It should be inspected visually for container integrity, particulate matter and discoloration prior to administration. Do not use after the expiration date. If the vial is broken or any abnormal appearance of the package exists, the vaccine should not be administered.
The vaccine should be administered once opened, if it's not used immediately, placing time should not be exceeded over 30 minutes.
Pay special attention to avoid the vaccine is injected into intradermal, intramuscular and intravenous ways, since these three clinical studies have not been determined to be safe and effective.
Because of endotoxin superposition, this vaccine may not be associated with pertussis vaccine and typhoid bacteria cell vaccine injection at the same time.
It is not known whether this vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when vaccine is administered to a nursing woman.
Persons who are immunosuppressed, including persons receiving immunosuppressive therapy, may have a diminished immune response to vaccine.
It is not indicated for treatment of meningococcal infections, not be able to protect from group B meningococcal, do not provide short-term prevention for infants and children under 2 years old, but can provide short-term protection for 3 months and older children from group A meningococcal, the same as other vaccines which are not be able to provide 100% protection for susceptible populations.
Appropriate medical treatment for example epinephrine or other drugs must be available to manage possible anaphylactic reactions following administration of the vaccine, objects after injection should be observed for at least 30 minutes.
Side Effects
Through clinical research observation of this vaccine, no severe local or systemic adverse reactions are found.
Injection site reactions: Within 24 hours after vaccination, slightly pain at injection site may appear, less commonly reported adverse reactions including local, mild swelling, redness and itching, normally it can be resolved spontaneously in 1-2 days.
Systemic reactions: In general fever may be occurred after vaccination, most of which are mild fever response (below 37.5°C), normally it lasts 1-2 days can be relieved, no need for treatment. For those people who have been suffered from fever more than 48 hours, symptomatic treatment are required. Very rare adverse reactions reported as severe fever reactions which need to be treated immediately to prevent fever convulsion. In addition, fever, fatigue, drowsiness, myalgia, abdominal pain, loss of appetite, irritability and diarrhea may be occurred after vaccination, very few adverse reactions reported are vomiting and rash, it can be relieved under normal circumstances, or symptomatic treatments are required according to the specific circumstances.
The percentage of adverse events (%): See table.


Click on icon to see table/diagram/image

Storage
Store at temperature 2°C-8°C, protect from light.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07AH04 - meningococcus A,C,Y,W-135, tetravalent purified polysaccharides antigen ; Belongs to the class of meningococcal bacterial vaccines.
Presentation/Packing
Form
Formening powd for inj 200 mcg
Packing/Price
((vial) + 0.5 mL diluent (amp)) 1's
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