powder and suspension for injection, suspension
Herpes zoster vaccine ( recombinant, adjuvant-containing)
What Shingrix is and what it is used for
What Shingrix is used for
Shingrix is a vaccine that protects adults against shingles ( herpes zoster) and nerve pain (postherpetic neuralgia ), the long-term pain that follows shingles.
Shingrix is given to:
- adults 50 years and older
- adults 18 years and older with an increased risk of shingles.
Shingrix can not be used to prevent chickenpox (varicella).
What shingles is
- Shingles give a painful rash with blisters. The blisters often sit on an area on one side of the body and can last for several weeks.
- Shingles are caused by the same virus that causes chickenpox.
- After you have had chickenpox, the chickenpox virus stays in the body’s nerve cells.
- Sometimes, after many years, the virus can cause shingles if the immune system (the body’s natural defense system) is weakened (due to age, illness, or drug treatment).
Complications of shingles
Shingles can cause complications.
The most common complications of shingles are:
- long-term nerve pain – so-called nerve pain after shingles or postherpetic neuralgia (PHN).
- When the blisters have healed, you can get severe pain in the healed area that can persist for months or even years.
Other complications of shingles are:
- scars in places where blisters have been present.
- skin infections, weakness, muscle paralysis, and hearing or vision loss – are less common.
How Shingrix works
Shingrix reminds the body of the virus that causes shingles. This helps the immune system to be prepared to fight the virus and protect you from shingles and its complications.
What you need to know before you get Shingrix
You should not receive Shingrix if:
- you are allergic (hypersensitive) to the active substance or any of the other ingredients of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy skin rash, shortness of breath, and swelling of the face or tongue.
You should not receive Shingrix if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist.
Warnings and cautions
Talk to your doctor or pharmacist before taking Shingrix if:
- you have a severe infection with fever. In these cases, the vaccination may need to be postponed until you have recovered. A minor infection such as a cold is probably not a problem, but talk to your doctor first.
- you have a bleeding problem or a tendency to get bruises.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Shingrix.
Fainting may occur before or after a needle stick. Therefore, tell your doctor or nurse if you faint in connection with a previous injection.
Shingrix can not be used as a treatment if you already have shingles or complications of shingles.
Like all vaccines, Shingrix may not provide complete protection to all vaccinated individuals.
Talk to your doctor if you experience temporary inflammation of the nerves after vaccination with Shingrix, which causes pain, weakness, and paralysis ( Guillain-Barré syndrome, GBS ). A small increased risk of GBS (estimated to increase by 3 cases per million administered doses ) has been reported in those 65 years of age and older after vaccination with Shingrix.
Other medicines and Shingrix
Tell your pharmacist or doctor if you have recently taken, or might take any other medicines, including medicines obtained without a prescription, or if you have recently been given any other vaccine.
Shingrix can be given at the same time as other vaccines. Each vaccine is given at a new injection site.
You will likely experience fever and/or chills when a 23-valent pneumococcal polysaccharide vaccine is given at the same time as Shingrix.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this vaccine.
Driving and using machines
It is not known if Shingrix affects the ability to drive or use machines. However, do not drive or use machines if you feel sick.
Shingrix contains sodium and potassium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.
This medicine contains less than 1 mmol (39 mg) potassium per dose, ie it is essentially ‘potassium-free’.
How Shingrix is given
- Shingrix is given as an injection into a muscle (usually in the upper arm).
- You will receive 2 injections, preferably at 2-month intervals. If flexibility in the vaccination schedule is necessary, the second dose can be given between 2 and 6 months after the first dose. Depending on your medical condition, your doctor may also recommend that you receive the second injection 1 month after the first injection.
- You will be informed when you will return for the second dose of Shingrix.
Remember to complete the vaccination series. This maximizes the protection that Shingrix provides.
Shingrix can be given if you have previously been vaccinated with a live, attenuated herpes zoster vaccine. For more information, talk to your doctor.
Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Side effects reported in clinical trials with Shingrix:
Very common (may affect more than 1 in 10 vaccine doses):
- headache
- gastrointestinal disorders (including nausea, vomiting, diarrhea, and/or abdominal pain)
- muscle aches
- pain, redness, and swelling at the injection site
- fatigue, chills, fever.
Common (may affect up to 1 in 10 vaccine doses):
- itching at the injection site
- general malaise.
Uncommon (may affect up to 1 in 100 vaccine doses):
- swollen glands in the neck, armpits, or groin
- joint pain.
Most of these side effects are mild to severe and not long-lasting.
Adults aged 18‑49 with a weakened immune system may experience more side effects than adults aged 50 or older with a weakened immune system.
Adults aged 50–69 years may experience more side effects than adults aged 70 years or older.
Side effects reported after Shingrix was introduced on the market:
Rare (may affect up to 1 in 1,000 vaccine doses):
- allergic reactions including skin rash, urticaria, and swelling of the face, tongue, or throat which may cause difficulty in swallowing or breathing ( angioedema ).
How to store Shingrix
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the label and carton. The expiration date is the last day of the specified month.
- Store in a refrigerator (2 ° C -8 ° C).
- Do not freeze.
- Store in the original package. Sensitive to light.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the packaging and other information
Content declaration
- The active substances are: After reconstitution, one dose (0.5 ml) contains: Varicella zoster – virus 1 glycoprotein E antigen 2 50 micrograms
1 Varicella zoster – virus = VZV2 With AS01 B – adjuvant containing: Quillaja Saponaria Molina plant extract, fraction 21 (QS-21) 50 micrograms3-O-desacyl-4′-monophosphoryl lipid A (MPL) from Salmonella Minnesota 50 micrograms
Glycoprotein E is a protein found in the varicella-zoster virus ( the chickenpox virus). This protein is not contagious.
Adjuvant et (AS01 B ) is used to improve the body’s response to the vaccine. - Other ingredients are:
- Powder: Sucrose, polysorbate 80 (E 433), sodium dihydrogen phosphate dihydrate (E 339), dipotassium phosphate (E 340).
- Suspension: Dioleoylphosphatidylcholine, cholesterol (E 322), sodium chloride, anhydrous disodium phosphate (E 339), potassium dihydrogen phosphate (E 340), and water for injections.
What the medicine looks like and the contents of the pack
- Powder and suspension for injection, suspension.
- The powder is white.
- Suspension one is an opalescent, colorless to light brownish liquid.
A Shingrix package contains:
- Powder ( antigen ) for 1 dose in a vial.
- The suspension ( adjuvant ) for 1 dose in a vial.
Shingrix is available in a pack size of 1 vial of powder and 1 vial of suspension or a pack size of 10 vials of powder and 10 vials of suspension.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
GlaxoSmithKline Biologicals sa
Rue de l’Institut 89
B-1330 Rixensart
Belgium
Contact the representative of the marketing authorization holder to find out more about this medicine:
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