Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - zostavax

Document Subject

Generated Narrative: MedicinalProductDefinition mpe635923c4f0c1291555b7edc27db8608

identifier: http://ema.europa.eu/identifier/EU/1/06/341/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: ZOSTAVAX powder and solvent for suspension for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-e635923c4f0c1291555b7edc27db8608

identifier: http://ema.europa.eu/identifier/EU/1/06/341/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - zostavax

Attesters

What is in this leaflet

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. 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 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 Pregnancy and breast-feeding). 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 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. Other medicines and ZOSTAVAX 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. Pregnancy and breast-feeding 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. Driving and using machines There is no information to suggest that ZOSTAVAX affects the ability to drive or use machines. ZOSTAVAX contains sodium This medicine contains less than 1 mmol sodium (23 milligrams) per dose, that is to say essentially sodium-free'. ZOSTAVAX contains potassium 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:

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. Reporting of side effects 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.

What ZOSTAVAX contains 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 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 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 and Manufacturer 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. Belgi /Belgique/Belgien MSD Belgium T l/Tel: +32(0)27766dpoc_belux@merck.com Lietuva UAB Merck Sharp & Dohme Tel.: +370.5.2780.msd_lietuva@merck.com

       , 

.: + 359 2 819 3info-msdbg@merck.com Luxembourg/Luxemburg MSD Belgium T l/Tel: +32(0)27766dpoc_belux@merck.com esk republika Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 dpoc_czechslovak@merck.com Magyarorsz g MSD Pharma Hungary Kft. Tel.: + 36.1.888.5hungary_msd@merck.com Danmark MSD Danmark ApS Tlf: + 45 4482 4dkmail@merck.com Malta Merck Sharp & Dohme Cyprus Limited. Tel: 8007 4433 (+356 99917558) malta_info@merck.com

Deutschland MSD Sharp & Dohme GmbH Tel: 0800 673 673 673 (+49 (0) 89 4561 0) e-mail@msd.de Nederland Merck Sharp & Dohme B.V. Tel: 0800 9999(+31 23 5153153) medicalinfo.nl@merck.com Eesti Merck Sharp & Dohme O , Tel: +372.614.4msdeesti@merck.com Norge MSD (Norge) AS Tlf: +47 32 20 73 msdnorge@msd.no

MSD . . . . . : +30 210 98 97 dpoc_greece@merck.com sterreich Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 dpoc_austria@merck.com Espa a Merck Sharp & Dohme de Espa a, S.A. Tel: +34 91 321 06 msd_info@merck.com Polska MSD Polska Sp. z o.o. Tel.: +48.22.549.51.msdpolska@merck.com France MSD France T l: +33 (0)1 80 46 40 Portugal Merck Sharp & Dohme, Lda Tel: +351 21 4465inform_pt@merck.com Hrvatska Merck Sharp & Dohme d.o.o. Tel: +385 1 66 11 croatia_info@merck.com Rom nia Merck Sharp & Dohme Romania S.R.L Tel: + 4021 529 29 msdromania@merck.com Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998medinfo_ireland@merck.com Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386.1.520.4msd.slovenia@merck.com sland Vistor hf. S mi: + 354 535 7Slovensk republika Merck Sharp & Dohme, s. r.* Tel: +421 2 58282dpoc_czechslovak@merck.com Italia MSD Italia S.r.l. Tel: 800 23 99 89 (+39 06 361911) medicalinformation.it@msd.com Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 info@msd.fi

Merck Sharp & Dohme Cyprus Limited : 800 00 673 (+357 22866700) cyprus_info@merck.com Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700medicinskinfo@merck.com Latvija SIA Merck Sharp & Dohme Latvija Tel: +371.67364.msd_lv@merck.com United Kingdom (Northern Ireland) Merck Sharp & Dohme (Human Health) Limited Tel: +353 (0)1 2998medinfoNI@msd.com

This leaflet was last revised in <{MM/YYYY}><{month YYYY}>. Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. 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. Reconstitution instructions 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. It is recommended that the vaccine be administered immediately after reconstitution to minimise loss of potency. Discard if reconstituted vaccine is not used within 30 minutes. Do not freeze the reconstituted 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. See also section