Powder and Solution for Solution for Injection Meningococcal Group A, C, W-135 and Conjugate Vaccine

1. WHAT ARAMEN IS AND WHAT IT IS USED FOR

Aramen is a vaccine indicated for active immunization of individuals 2 months through 55 years of age to prevent invasive meningococcal disease caused by Neisseria meningitidis groups A, C, W-135 and Y.
Aramen does not prevent N. Meningitides meningitidis serogroup B infections.
The vaccine works by causing your body to make its own protection (antibodies) against these bacteria.

Neisseria meningitidis group A, C, W-135 and Y bacteria can cause serious and sometimes life- threatening infections such as meningitis and sepsis (blood poisoning).
Aramen cannot cause bacterial meningitis or diphtheria.

2. BEFORE YOU OR YOUR CHILD ARE GIVEN ARAMEN

Do not use Aramen if you or your child has:
• ever had an allergic reaction to the active substances or any of the other ingredients of Aramen (see Section 6).
• ever had an allergic reaction to diphtheria toxoid (a substance used in a number of other vaccines).
• ever had a life-threatening reaction from previous administrations of a vaccine containing similar components.
• an illness with high fever.
Take special care with Aramen if you (or your child) have:
• A weakened immune system.
Little is known about the effectiveness of Aramen when administered to individuals with weakened immunity due to the use of immunosuppressive medications, or HIV infection, and other possible causes.
It is possible that the effectiveness of Aramen could be reduced in such individuals.

• Fainting, feeling faint or other stress-related reactions can occur as a response to any needle injection.
Tell your doctor or nurse if you have experienced this kind of reaction previously.

• This vaccine can only protect against meningococcal group A, C, W-135, and Y bacteria. It cannot protect against other types of meningococcal bacteria other than groups A, C, W-135 and Y, or against other causes of meningitis and sepsis (blood poisoning).

As with any vaccine, Aramen may not fully protect 100% of those who get the vaccine.

As with other vaccines, Aramen should be postponed in individuals suffering from an acute severe febrile illness.
The presence of a minor infection is not a contraindication.

Using other medicines
Please tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Aramen may be given at the same time as other vaccinations but any other injected vaccines should preferably be given into a different limb from the site of the Aramen injection.

In children from 2 to 23 months of age vaccinated in clinical trials,
Aramen was administered concomitantly with vaccines containing the following antigens: diphtheria toxoid, acellular pertussis, tetanus toxoid, Haemophilus influenzae type b (Hib), inactivated polio, hepatitis B (HBV), inactivated hepatitis A, 7-valent and 13-valent pneumococcal conjugate vaccine capsular antigens (PCV7 and PCV13), pentavalent rotavirus, and measles, mumps, rubella and varicella viruses (MMRV).

For children 2 to 10 years of age, no data are available for evaluating safety and immunogenicity of other childhood vaccines when administered concomitantly with Aramen.

In the adolescents (11 to 18 years of age), Aramen can be given concomitantly with tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap) and human papillomavirus quadrivalent (Types 6, 11,16 and 18) recombinant vaccine (HPV).

In adults, Aramen can be administered concomitantly with other vaccines:
monovalent and combined hepatitis A and B, yellow fever, typhoid fever (Vi polysaccharide), Japanese encephalitis and rabies.
The concomitant administration of Aramen with hepatitis A and B vaccines, or typhoid fever and yellow fever vaccines, or with Japanese encephalitis and rabies virus vaccines was evaluated in a clinical trial in adults.
Concomitant administration of Aramen and other vaccines than those listed above has not been studied Concomitant vaccines should always be administered at separate injection sites and preferably contralateral.

Aramen’s effect could be diminished when administered to individuals who are taking medicines that suppress the immune system.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before Aramen is given.
Your doctor or nurse may still recommend that you receive Aramen if you are at high risk of infection with meningococcal group A, C, W-135 and Y bacteria.

Insufficient clinical data on exposed pregnancies are available.

Although insufficient clinical data on the use of Aramen during breast-feeding are available, it is unlikely that secreted antibodies in milk would be harmful when ingested by a breastfed infant.
Therefore, Aramen may be used during breast feeding.

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 Aramen 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 ARAMEN

Aramen will be given to you or your child by a doctor or nurse.
The dosing schedule for individuals initiating vaccination is as follows:
Infants 2 months of age Aramen is to be administered as a four-dose series at 2,4, 6, and 12 months of age.

Children 7 months through 23 months of age Aramen is to be administered as a two-dose series with the second dose administered in the second year of life and at least three months after the first dose.

Children 2 years through 10 years of age Aramen is to be administered as a single dose (0.5 ml).

Adolescents and Adults 11 years through 55 years of age Aramen is to be administered as a single dose (0.5 ml).

Booster
Please tell your doctor if you have received a previous injection with Aramen or another meningococcal vaccine.
Your doctor will tell you if you need an additional injection of Aramen.
Long-term antibody persistence data following vaccination with Aramen are available up to 5 years after vaccination.

Geriatric Populations There are no data in individuals older than 65 years of age.
There are limited data in individuals aged 56-65.

Each Aramen dose is to be administered as a single 0.5 ml intramuscular injection, preferably into the anterolateral aspect of the thigh in infants or into the deltoid muscle (upper arm) in children, adolescents and adults.
It must not be administered Aramen intravascularly, subcutaneously or intradermally.

Separate injection sites must be used if more than one vaccine is being administered at the same time.

For information on the reconstitution of the vaccine see the section for medical or healthcare professionals at the end of this leaflet.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Aramen can cause side effects, although not everybody gets them.

In children from 2 to 23 months of age, the side effects that were reported during clinical trials are listed below:
Very common (may affect more than 1 in 10 people): change in eating habits, persistent crying, sleepiness, diarrhoea, vomiting, irritability, injection site tenderness, injection site redness (_50 mm) and injection site firmness (_50 mm).

Common (may affect up to 1 in 10 people):
rash, severe injection site tenderness, fever.

Uncommon (may affect up to 1 in 100 people):
injection site redness (> 50 mm), injection site firmness (>50 mm).

In children from 2 to 10 years of age, the side effects that were reported during clinical trials are listed below:
Very common: sleepiness, headache, irritability, generally feeling unwell, injection site pain, injection site redness (_50 mm), injection site firmness (_50 mm).

Common: change in eating habits, nausea, vomiting, diarrhea, rash, muscle ache, joint ache, chills, fever _38°C, injection site redness (>50 mm), injection site firmness (>50 mm).

Uncommon: injection site itching.

In adolescents (from 11 years of age) and adults, the most common side effects that were reported during clinical trials are listed below:
Very common: headache, nausea, injection site pain, injection site redness (_50 mm), injection site firmness (_50 mm), muscle ache, generally feeling unwell.

Common: rash, injection site redness (>50 mm), injection site firmness (>50 mm), joint ache, fever _38°C, chills. Uncommon: dizziness, injection site itching.

Side effects that have been reported during marketed use
include (all age groups):
Hearing impaired, ear pain, spinning sensation, dizziness, balance disorder, upper eyelid fall, injection site itching, injection site pain, injection site redness, injection site inflammation, injection site swelling, including extensive swelling of the injected limb, tiredness, generally feeling unwell, fever, allergic reaction including anaphylaxis, fall, head injury, increased liver function test result, body temperature increased, joint ache, bone pain, faint, fits (convulsions) including fits associated with fever, headache, facial nerve paralysis, sore throat, blistering of the skin called bullous conditions.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.

5. HOW TO STORE ARAMEN

Keep out of the reach and sight of children.

Do not use Aramen 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. 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 Aramen 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 CRM197 protein 16.7 to 33.3 micrograms
(Originally contained in the solution)

• Meningococcal group C oligosaccharide 5 micrograms Conjugated to Corynebacterium diphtheriae CRM197 protein 7.1 to 12.5 micrograms

• Meningococcal group W-135 oligosaccharide 5 micrograms Conjugated to Corynebacterium diphtheriae CRM197 protein 3.3 to 8.3 micrograms

• Meningococcal group Y oligosaccharide 5 micrograms Conjugated to Corynebacterium diphtheriae CRM197 protein 5.6 to 10.0 micrograms

The other ingredients are

In the powder: potassium dihydrogen phosphate and sucrose.

In the solution: sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate and water for injections.

What Aramen looks like and contents of the pack

Aramen is a powder and a solution for injection.
Each dose of Aramen is supplied as a:

• 1 Vial containing the MenA Lyophilised Conjugate Component as a white to off-white cake.

• 1 Vial containing the MenCWY Liquid Conjugate Component as colourless clear solution.

• Pack size of one dose (2 vials) or five doses (10 vials). Not all pack sizes may be marketed.

The contents of the two components in the two different containers (MenA powder and MenCWY solution) are to be mixed prior to vaccination providing 1 dose of 0.5 ml.

The vials in which the vaccine components are contained are composed of Type I glass, USP.
The container closure “synthetics rubber stoppers” do not contain latex.

This leaflet was approved in (September 2016); Version No. 4

To Report any Side Effect(s)

In Saudi Arabia, Please Contact

National Pharmacovigilance Center (NPC)