The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 53095/0085.
Powder and solvent for suspension for injection in a pre-filled syringe
shingles (herpes zoster) vaccine (live)
1. What ZOSTAVAX is and what it is used for
2. What you need to know before you receive ZOSTAVAX
3. How to use ZOSTAVAX
4. Possible side effects
5. How to store ZOSTAVAX
6. Contents of the pack and other information
ZOSTAVAX is a vaccine used to prevent shingles (zoster) and zoster-related post-herpetic neuralgia (PHN), the long-lasting nerve pain that follows shingles.
ZOSTAVAX is used to vaccinate individuals 50 years of age or older.
ZOSTAVAX cannot be used to treat existing shingles or the pain associated with existing shingles.
What is shingles?
Shingles is a painful, blistering rash. It usually occurs in one part of the body and can last for several weeks. It may lead to severe and long-lasting pain and scarring. Less commonly, bacterial skin infections, weakness, muscle paralysis, loss of hearing or vision can occur. Shingles is caused by the same virus that causes chickenpox. After you have had chickenpox, the virus that caused it stays in your body in nerve cells. Sometimes, after many years, the virus becomes active again and causes shingles.
What is PHN?
After the shingles blisters heal, pain can last for months or years and may be severe. This long-lasting nerve pain is called post-herpetic neuralgia or PHN.
If you have experienced any of the following, talk to your doctor or pharmacist before receiving ZOSTAVAX:
Tell your doctor if you have ever had an allergic reaction to any of the ingredients (including neomycin (which may be present as trace residue) or any of the ingredients listed under section 6) before you receive this vaccine.
As with many vaccines, ZOSTAVAX may not completely protect all persons who are vaccinated.
If you have a blood clotting disorder or low levels of platelets, the vaccine should be given under the skin because bleeding may occur following administration into the muscle.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines or vaccines.
ZOSTAVAX can be administered at the same time as inactivated influenza vaccine. The two vaccines should be given as separate injections at different body sites.
For information about the administration of ZOSTAVAX and pneumococcal polysaccharide vaccine at the same time, talk to your doctor or health care provider.
ZOSTAVAX should not be given to pregnant women. Women of child-bearing potential should take the necessary precautions to avoid pregnancy for 1 month following vaccination.
Inform your doctor if you are breast-feeding or intending to breast-feed. Your doctor will decide if ZOSTAVAX should be given.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this vaccine.
There is no information to suggest that ZOSTAVAX affects the ability to drive or use machines.
This medicine contains less than 1 mmol sodium (23 milligrams) per dose, that is to say essentially ‘sodium-free'.
This medicine contains less than 1 mmol potassium (39 milligrams) per dose, that is to say essentially ‘potassium-free’.
ZOSTAVAX should be injected under the skin or into the muscle, preferably in the upper arm.
If you have a blood clotting disorder or low levels of platelets in your blood, the injection will be given under the skin.
ZOSTAVAX is given as a single dose.
Reconstitution instructions intended for healthcare professionals are included at the end of the leaflet.
Like all vaccines and medicines, this vaccine can cause side effects, although not everybody gets them.
Rarely (may affect up to 1 in 1,000 people), allergic reactions may occur. Some of these reactions may be serious and may include difficulty in breathing or swallowing. If you have an allergic reaction, call your doctor right away.
The following side effects have been observed:
*These adverse reactions have been observed in clinical trials and through post-marketing surveillance; most of those observed in clinical trials were reported as mild in intensity.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this vaccine.
Keep this vaccine out of the sight and reach of children.
Do not use this vaccine 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 and transport refrigerated (2 °C – 8 °C). Do not freeze. Keep the vial in the outer carton in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
After reconstitution, one dose (0.65 mL) contains:
The active substance is:
Varicella-zoster virus1, Oka/Merck strain, (live, attenuated) not less than 19,400 PFU (plaque-forming units).
1Produced in human diploid (MRC-5) cells
The other ingredients are:
Sucrose, hydrolysed gelatin, sodium chloride (NaCl), potassium dihydrogen phosphate, potassium chloride (KCl), monosodium L-glutamate monohydrate, disodium phosphate, sodium hydroxide (NaOH) (to adjust pH) and urea.
Water for injections
The vaccine is a powder for suspension for injection contained in a single-dose vial, which should be reconstituted with the solvent provided with the vial of powder.
The powder is a white to off-white compact crystalline plug. The solvent is a clear and colourless liquid.
One pack of ZOSTAVAX contains a vial and a pre-filled syringe without needle or with one or 2 separate needles.
ZOSTAVAX is available in packs of 1, 10 or 20 with or without needles. Not all pack sizes may be marketed.
Marketing Authorisation Holder in Great Britain:
Marketing Authorisation Holder in UK (Northern Ireland):
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in July 2022.
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
© 2022 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.