ZOSTAVAX powder and solvent for suspension for injection in apre-filled syringeshingles (herpes zoster) vaccine (live)

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.

Disease information on 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.

Do not receive ZOSTAVAX

- if you are allergic (hypersensitive) to any of the components (for example, neomycin) of ZOSTAVAX (including any of the ingredients listed under ?the other ingredients are?- see section

6. Further information- what ZOSTAVAX contains) - 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 see Pregnancy and breast-feeding

Take special care with ZOSTAVAX

Talk to your doctor or pharmacist before being vaccinated with ZOSTAVAX if you have or have had any medical problems and about any allergies if you have a fever if you have HIV infection if you are pregnant or think you could be pregnant, if you are planning to become pregnant, you should consult your doctor as pregnancy must be excluded before vaccination. Women of child-bearing potential must use effective birth control to avoid pregnancy for 3 months following vaccination.

As with many vaccines, ZOSTAVAX may not completely protect all persons who are vaccinated.

ZOSTAVAX cannot be used to treat existing shingles or the pain associated with existing shingles.

Using other medicines and other vaccines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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.

ZOSTAVAX should not be given at the same time as the 23-valent pneumococcal polysaccharide vaccine. For more information about these vaccines, talk to your doctor or health care provider.

Pregnancy and breast-feeding

ZOSTAVAX should not be given to pregnant women. Women of child-bearing age should take the necessary precautions to avoid pregnancy for 3 months following vaccination.

Inform your doctor if you are breast-feeding or intending to breast-feed. Your doctor will decide if ZOSTAVAX should be given.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

There is no information to suggest that ZOSTAVAX affects the ability to drive or use machines.

Important information about the ingredients of ZOSTAVAX
Tell your doctor if you have ever had an allergic reaction to any of the ingredients (including neomycin or any of the ingredients listed under ?the other ingredients are?- see section 6. Further information- what ZOSTAVAX contains) before you receive this vaccine.

ZOSTAVAX should be injected under the skin, preferably in the upper arm.

ZOSTAVAX is given as a single dose by injection.

Reconstitution instructions intended for medical and healthcare professionals are included at the end of the leaflet.

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

In studies, the most commonly reported side effects (occurring in at least 1 in 10 individuals) were at the injection site. These side effects included redness, pain, swelling, itching, warmth, and bruising at the injection site. Headache was also commonly reported (occurring in at least 1 of 100 and less than 1 of 10 individuals).

The following additional side effects have been reported in general use with ZOSTAVAX: joint pain; muscle pain; fever; swollen gland (neck, armpit); rash; rash at the injection site; hives at the injection site; allergic reactions, which may be serious and may include difficulty in breathing or swallowing. If you have an allergic reaction, call your doctor right away.

Your doctor or pharmacist has a more complete list of side effects for ZOSTAVAX.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. If the condition persists or worsens, seek medical attention.

Keep out of the reach and sight of children.

Do not use ZOSTAVAX after the expiry date which is stated on the outer carton after EXP.

Store and transport refrigerated (2-C - 8-C). Do not freeze. Keep the vial in the outer carton in order to protect from 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 protect the environment.

What ZOSTAVAX contains

After reconstitution, 1 dose (0.65 ml) contains:
The active substance is:
Varicella-zoster virus 1, Oka/Merck strain, (live, attenuated) not less than 19400 PFU (plaque-forming units).
1Produced in human diploid (MRC-5) cells

The other ingredients are:

PowderSucrose, hydrolysed gelatin, sodium chloride, potassium dihydrogen phosphate, potassium chloride, monosodium L-glutamate, anhydrous disodium phosphate, sodium hydroxide (to adjust pH), and urea.

Solvent

Water for injections

What ZOSTAVAX looks like and contents of the pack

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 solvent is a clear and colourless liquid. Before mixing with the solvent, the powder is a white to off-white compact crystalline plug.
One pack of ZOSTAVAX contains a vial and a prefilled syringe with or without attached needles. One or 2 separate needles may be available in the secondary packaging of the presentation containing the pre-filled syringe without the attached needle
ZOSTAVAX is available in packs of 1, 10 or 20 with or without needles. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon, France

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.

België/Belgique/Belgien: Sanofi Pasteur MSD, Tél/Tel: +32.2.726.95.84
--------: ---- ---- - ---- -------- ---- ---. + 359 2 8193740
-eská republika: Merck Sharp & Dohme, IDEA, Inc., org. sl.,Tel.: +420.233.010.111 Danmark: Sanofi Pasteur MSD, Tlf: +45.23.32.69.29
Deutschland: Sanofi Pasteur MSD GmbH, Tel: +49.6224.5940
Eesti: Merck Sharp & Dohme OÜ, Tel: +372.613.9750
???-??: ?????? ?.?., ???: +30.210.8009111
España: Sanofi Pasteur MSD S.A., Tel: +34.91.371.78.00
France: Sanofi Pasteur MSD SNC, Tél: +33.4.37.28.40.00
Ireland: Sanofi Pasteur MSD Ltd, Tel: +3531.468.5600
Ísland: Sanofi Pasteur MSD, Sími: +32.2.726.95.84
Italia: Sanofi Pasteur MSD Spa, Tel: +39.06.664.092.11
K-????: Merck Sharp & Dohme Cyprus Limited, ???: +357 22866700
Latvija: SIA Merck Sharp & Dohme Latvija, Tel: +371.67364.224
Lietuva: UAB Merck Sharp & Dohme, Tel.: +370.5.2780.247
Luxembourg/Luxemburg: Sanofi Pasteur MSD, Tél: +32.2.726.95.84
Magyarország: MSD Magyarország Kft, Tel.: + 36.1.888.5300
Malta: Merck Sharp & Dohme Cyprus Limited, Tel: +357 22866700
Nederland: Sanofi Pasteur MSD, Tel: +31.23.567.96.00 Norge: Sanofi Pasteur MSD, Tlf: +47.67.50.50.20 Österreich: Sanofi Pasteur MSD GmbH, Tel: +43.1.866.70.22.202
Polska: MSD Polska Sp. z o.o., Tel.: +48.22.549.51.00
Portugal: Sanofi Pasteur MSD, SA, Tel: +351 21 470 45 50
România: Merck Sharp & Dohme Romania S.R.L. Tel: + 4021 529 29 00
Slovenija: Merck Sharp & Dohme, inovativna zdravila d.o.o., Tel: +386.1.520.4201
Slovenská republika: Merck Sharp & Dohme IDEA, Inc., Tel: +421.2.58282010
Suomi/Finland: Sanofi Pasteur MSD, Puh/Tel: +358.9.565.88.30
Sverige: Sanofi Pasteur MSD, Tel: +46.8.564.888.60
United Kingdom: Sanofi Pasteur MSD Ltd, Tel: +44.1.628.785.291

This leaflet was last approved in:

The following information is intended for medical or healthcare professionals only:

Reconstitution instructions

The solvent is a clear and colourless liquid. Before mixing with the solvent, the powder is a white to off-white compact crystalline plug. When completely reconstituted, the vaccine is a semi-hazy to translucent, off-white to pale yellow liquid.

Inject the entire content of the pre-filled syringe into the vial containing the powder. Gently agitate to dissolve completely. Withdraw the entire content of the reconstituted vaccine vial into a syringe for injection. One or 2 separate needles may be available in the secondary packaging of the presentation containing the pre-filled syringe without the attached needle. The needle should be pushed into the extremity of the syringe and rotated a quarter of a turn (90-) to secure the connection.

It is recommended that the vaccine be administered immediately after reconstitution to minimize loss of potency. Discard if reconstituted vaccine is not used within 30 minutes.

Do not use the reconstituted vaccine if you notice any particulate matter or if the appearance of the solvent or powder or of the reconstituted vaccine differs from that described above.
Any unused product or waste material should be disposed of in accordance with local requirements.

See also section 3. HOW TO USE ZOSTAVAX