Zostavax
shingles (herpes zoster) vaccine (live)
shingles (herpes zoster) vaccine (live)
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This vaccine has been prescribed for you only. Do not pass it on to others.
If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What ZOSTAVAX is and what it is used for
What you need to know before you receive ZOSTAVAX
How to use ZOSTAVAX
Possible side effects
How to store ZOSTAVAX
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 are allergic to any of the components of this vaccine (including neomycin (which may be present as trace residue) or any of the other ingredients 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 a disease, medicines, 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
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 or any allergies
if you have a fever
if you have 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 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.
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:
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): Warmth, bruising, hard lump, and rash at the injection site*; headache*; pain in the arm or leg*; joint pain, muscle pain; fever; rash
Uncommon (may affect up to 1 in 100 people): Nausea; swollen gland (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 people): Varicella (chicken pox); shingles; damage of retina caused by inflammation resulting in changes in sight (in patients under immunosuppressive therapy).
*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 national reporting system listed in Appendix V. 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).
1 Produced in human diploid (MRC-5) cells The other ingredients are:
Powder
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.
Solvent
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.
ZOSTAVAX is available in packs of 1 or 10. Not all pack sizes may be marketed.
Marketing Authorisation Holder: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Manufacturer: Merck Sharp and Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
MSD Belgium
Tél/Tel: +32(0)27766211
UAB Merck Sharp & Dohme Tel.: +370.5.2780.247
Мерк Шарп и Доум България ЕООД, тел.: + 359 2 819 3737
MSD Belgium
Tél/Tel: +32(0)27766211
Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111
MSD Pharma Hungary Kft. Tel.: + 36.1.888.5300
MSD Danmark ApS Tlf: + 45 4482 4000
Merck Sharp & Dohme Cyprus Limited. Tel: 8007 4433 (+356 99917558)
MSD Sharp & Dohme GmbH
Tel: 0800 673 673 673 (+49 (0) 89 4561 0)
Merck Sharp & Dohme B.V.
Tel: 0800 9999000
(+31 23 5153153)
Merck Sharp & Dohme OÜ, Tel: +372.614.4200
MSD (Norge) AS Tlf: +47 32 20 73 00
MSD Α.Φ.Β.Ε.Ε.
Τηλ: +30 210 98 97 300
Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044
Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00
MSD Polska Sp. z o.o. Tel.: +48.22.549.51.00
MSD France
Tél: +33 (0)1 80 46 40 40
Merck Sharp & Dohme, Lda Tel: +351 21 4465700
Merck Sharp & Dohme d.o.o. Tel: +385 1 66 11 333
Merck Sharp & Dohme Romania S.R.L Tel: + 4021 529 29 00
Merck Sharp & Dohme Ireland (Human Health) Limited
Tel: +353 (0)1 2998700
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: +386.1.520.4201
Vistor hf.
Sími: + 354 535 7000
Merck Sharp & Dohme, s. r. o Tel: +421 2 58282010
MSD Italia S.r.l.
Tel: 800 23 99 89 (+39 06 361911)
MSD Finland Oy
Puh/Tel: +358 (0)9 804 650
Merck Sharp & Dohme Cyprus Limited
Τηλ: 800 00 673 (+357 22866700)
Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488
SIA Merck Sharp & Dohme Latvija Tel: +371.67364.224
Merck Sharp & Dohme (Human Health) Limited Tel: +353 (0)1 2998700
The following information is intended for healthcare professionals only:
Before mixing with the solvent, the powder vaccine is a white to off-white compact crystalline plug. The solvent is a clear colourless liquid. When reconstituted, ZOSTAVAX is a semi-hazy to translucent, off-white to pale yellow liquid.
Avoid contact with disinfectants as they may inactivate the vaccine virus. To reconstitute the vaccine, use the solvent provided.
It is important to use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents from one individual to another.
One needle should be used for reconstitution and a separate, new needle for injection.
Withdraw the entire content of the solvent vial into a syringe. Inject the entire content of the syringe into the vial containing the powder. Gently agitate to dissolve completely.
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration. In the event of either being observed, discard the vaccine.
Withdraw the entire content of the reconstituted vaccine from the vial into a syringe, change the needle and inject the entire volume by subcutaneous or intramuscular route.
Any unused product or waste material should be disposed of in accordance with local requirements.