Powder and liquid for injection, suspension
vaccine against shingles ( herpes zoster), live
What ZOSTAVAX is and what it is used for
ZOSTAVAX is a vaccine used to prevent shingles ( herpes zoster) and zoster-associated postherpetic neuralgia (PHN), the long-term nerve pain that follows shingles.
ZOSTAVAX is used for the vaccination of people who are 50 years of age or older.
ZOSTAVAX cannot be used to treat existing shingles or the pain associated with existing shingles.
Information about the disease shingles:
What are shingles?
Shingles is a painful skin rashes with blisters. It usually occurs in one part of the body and can last for several weeks. It can lead to severe and long-lasting pain and scarring. Less common are bacterial skin infections, weakness, muscle paralysis, and loss of hearing or vision. Shingles are caused by the same virus as chickenpox. When you have chickenpox, the virus that caused it remains in the body in the nerve cells. Sometimes the virus becomes active again and gives rise to shingles.
What is PHN?
Once the shingles blisters have healed, the pain can continue for months and years and can be severe. This long-term nerve pain is called postherpetic neuralgia, or PHN.
What you need to know before using ZOSTAVAX
Do not use ZOSTAVAX
- if you are allergic to active substances in this vaccine (e.g. neomycin (which may be present as a residue) or any other ingredient listed in section 6)
- if you have a blood disorder or any type of cancer that weakens your immune system
- if you have been told by your doctor that you have a weakened immune system as a result of an illness, medication, or other treatment
- if you have active, untreated tuberculosis
- if you are pregnant (in addition, pregnancy should be avoided for 1 month after vaccination, see Pregnancy and breastfeeding )
Warnings and precautions
If you have experienced any of the following, talk to your doctor or pharmacist before receiving ZOSTAVAX:
- if you have or have had any medical problems and if you have any allergies
- if you have a fever
- if you have an HIV – infection
Tell your doctor if you have ever had an allergic reaction to any of the ingredients (including neomycin (which may be present as a residue) or any of the ingredients listed in section 6) before being vaccinated.
As with many vaccines, ZOSTAVAX may not fully protect everyone who is vaccinated.
If you have a coagulation disorder or low platelet levels, the vaccine should be injected under the skin as bleeding may occur after intramuscular injection.
Other medicines and ZOSTAVAX
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines or if you have recently received or might receive another vaccine.
ZOSTAVAX can be administered at the same time as inactivated influenza vaccine. The two vaccines should be given as separate injections in different places on the body.
Talk to your doctor or healthcare professional about co-the administration of ZOSTAVAX and the 23-valent polysaccharide vaccine against pneumococcal infections.
Pregnancy and breastfeeding
ZOSTAVAX should not be given to pregnant women. Women of childbearing age must use effective contraception for 1 month after vaccination.
Tell your doctor if you are breastfeeding or plan to breastfeed. The doctor decides whether you can be vaccinated with ZOSTAVAX.
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 receiving this vaccine.
Driving ability and use of machinery
There is no information to suggest that ZOSTAVAX affects the ability to drive or use machines.
ZOSTAVAX contains sodium and potassium
ZOSTAVAX contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is almost “sodium-free”.
ZOSTAVAX contains potassium
This medicine contains less than 1 mmol (39 mg) of potassium per dose, i.e. it is almost “potassium-free”.
How to use ZOSTAVAX
ZOSTAVAX should be injected under the skin or into the muscle, preferably in the upper arm.
If you have a clotting disorder or low blood platelet levels, the vaccine will be injected under the skin.
ZOSTAVAX is given as a single dose.
Preparation instructions intended for healthcare professionals can be found at the end of the package leaflet.
Possible side effects
Like all vaccines and medicines, this vaccine can cause side effects, but not all users will get them.
Rare (may affect up to 1 in 1,000 users) allergic reactions may occur. Some of these reactions can be serious and include difficulty breathing or swallowing. Contact a doctor immediately if you have an allergic reaction.
The following side effects have been observed:
- Very common (may affect more than 1 in 10 people): redness, pain, swelling, and itching at the injection site*
- Common (may affect up to 1 in 10 people): ): feeling of warmth, bruising, hard lump and rash at the injection site*, headache*, pain in arm or leg*, joint pain, muscle pain, fever, rash
- Uncommon (may affect up to 1 in 100 people): nausea, swollen glands (neck, armpit)
- Rare (may affect up to 1 in 1,000 people): hives at the injection site
- Very rare (may affect up to 1 in 10,000 users): chickenpox (varicella), shingles, damage to the retina of the eye caused by inflammation leading to changes in vision (in patients receiving immunosuppressive therapy – a treatment that suppresses the immune system).
* These side effects have been observed in clinical trials and through post-marketing surveillance. Most of those observed in clinical trials were reported to be mild.
How to store ZOSTAVAX
Keep this vaccine out of the sight and reach of children.
Use before the expiry date which is stated on the outer packaging after EXP. The expiration date is the last day of the specified month.
Store and transport cold (2 °C–8 °C). Do not freeze. Store the vial in the outer carton.
Light sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
After preparation, one dose (0.65 ml) contains :
The active substance is:
Varicella zoster virus 1, Oka/Merck strain, (live, attenuated) not less than 19,400 PFU (plaque-forming units).
1 Produced in human diploid cells (MRC-5).
Other ingredients are:
Powder
Sucrose, hydrolyzed gelatin, sodium chloride (NaCl), potassium dihydrogen phosphate, potassium chloride (KCl), sodium L- glutamate monohydrate, disodium phosphate, sodium hydroxide (NaOH) (to adjust pH ), and urea.
Liquid
ZOSTAVAX appearance and package contents
The vaccine is a powder for injection, suspension in a single-dose vial, which must be diluted with the liquid that comes with the vial of powder.
The powder is a white to off-white compact crystalline lump. The liquid is clear and colorless.
ZOSTAVAX is available in packs of 1 or 10. Not all pack sizes may be marketed.
Marketing Authorization Holder: Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN Haarlem, The Netherlands
Manufacturer: Merck Sharp and Dohme BV, Waarderweg 39, 2031 BN Haarlem, The Netherlands
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