SHINGRIX 0.5 ML Порошок и раствор для инъекционной суспензии

Содержание инструкции

1. Shingrix powder and suspension for injectable suspension
   1. What is Shingrix and what is it used for
   2. What you need to know before you receive Shingrix
   3. How to administer Shingrix
   4. Possible side effects
   5. How to store Shingrix
   6. Contents of the pack and other information

Shingrix powder and suspension for injectable suspension

Vaccine for herpes zoster (recombinant, adjuvanted)

Read this leaflet carefully before you start this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Shingrix is and what it is used for
• 2. What you need to know before you receive Shingrix
• 3. How Shingrix is administered
• 4. Possible side effects
• 5. How to store Shingrix
• 6. Contents of the pack and other information

1. What is Shingrix and what is it used for

What is Shingrix used for
Shingrix is a vaccine that helps protect adults against shingles and post-herpetic neuralgia (PHN), the long-lasting nerve pain that follows shingles.
Shingrix is given to:

• adults aged 50 years and over;
• adults aged 18 years and over who are at increased risk of developing shingles.

Shingrix cannot be used to prevent chickenpox.

What is shingles (herpes zoster)

• Shingles is a painful rash with blisters. It usually occurs on one part of the body and can last for several weeks.
• Shingles is caused by the same virus that causes chickenpox.
• After having chickenpox, the virus that caused the disease remains in the body in nerve cells.
• It can happen, many years after chickenpox, when the immune system (the body's natural defense) becomes weaker (due to age, illness or a medicine you are taking), that the virus causes shingles or herpes zoster.

Complications related to shingles
Shingles can cause complications.
The most common complication of shingles is:

• persistent nerve pain - called post-herpetic neuralgia or PHN. After the blisters have healed, you may have pain that can last for months or years and can be severe. Other complications of shingles are:
• scarring where the blisters formed.
• skin infections, weakness, muscle paralysis and loss of hearing or vision - less common.

How Shingrix works
Shingrix helps remind your body about the virus that causes shingles. This helps your immune system (the body's natural defenses) build an immune response that remains ready to
fight the virus and protects you from shingles and its complications.

2. What you need to know before you receive Shingrix

You must not be given Shingrix if:

• you are allergic to the active substances or to any of the other ingredients of this vaccine (listed in section 6). The signs of an allergic reaction can include a itchy rash, shortness of breath and swelling of the face or tongue. If any of the above conditions apply to you, you must not be given Shingrix. If you are not sure, talk to your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before receiving Shingrix if:

• you have a serious infection with a high fever. In these cases, vaccination may be postponed until you have recovered. A minor infection such as a cold should not be a problem, but talk to your doctor first;
• you have bleeding problems or bruise easily. If any of the above conditions apply to you (or you are not sure), talk to your doctor or pharmacist before receiving Shingrix.

Fainting can occur before, or after, any needle injection. Therefore, tell your doctor or
nurse if you have fainted following a previous injection.
Shingrix cannot be used as treatment if you already have shingles or complications from
shingles.
As with all vaccines, Shingrix may not fully protect all vaccinated people.
Contact your doctor if after receiving Shingrix you develop a temporary inflammation of the
nerves (called Guillain-Barré syndrome), which causes pain, weakness and paralysis. In people aged
65 years or older, a slight increase in the risk of Guillain-Barré syndrome has been reported
(estimated at 3 additional cases per million doses administered) after receiving Shingrix.

Other medicines and Shingrix
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those bought without a prescription, or if you have recently
been vaccinated.
Shingrix can be given at the same time as other vaccines, such as the inactivated seasonal influenza
vaccine, the 23-valent pneumococcal polysaccharide vaccine, the 13-valent pneumococcal conjugate
vaccine, the diphtheria, tetanus and acellular pertussis vaccine with reduced
number of antigens or the mRNA COVID-19 vaccine. A different injection site should be used for
each vaccine.
You may be more likely to experience fever and/or chills when the 23-valent pneumococcal polysaccharide
vaccine is given at the same time as Shingrix.
You may be more likely to experience chills, fatigue, fever, stomach and
digestive problems (including nausea, vomiting, diarrhoea and/or stomach pain), headache, muscle aches or
joint pains when an mRNA COVID-19 vaccine is given at the same time as
Shingrix.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Some of the effects mentioned below in section 4 “Possible side effects” can
temporarily impair your ability to drive or operate machines. Do not drive or operate machines
if you do not feel well.

Shingrix contains sodium and potassium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.
This medicine contains less than 1 mmol (39 mg) of potassium per dose i.e. essentially
‘potassium-free’.

3. How to administer Shingrix

• Shingrix is administered with an injection into the muscle (usually in the upper arm).
• You will receive 2 injections spaced 2 months apart. If flexibility in the vaccination schedule is needed, the second dose can be administered between 2 and 6 months after the first dose. Based on your health conditions, your doctor may also recommend that you receive the second injection 1 month after the first injection.
• You will be informed when you need to have the second Shingrix injection.

Make sure you have completed the full course of vaccination. This will maximize the protection
offered by Shingrix.
Shingrix can also be administered even if you have already been vaccinated with a live attenuated vaccine
for herpes zoster. Talk to your doctor for further information.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Side effects reported with Shingrix during clinical studies and after marketing:

Very common(may affect more than 1 in 10 doses of vaccine):

• headache
• stomach and digestive disorders (including nausea, vomiting, diarrhoea and/or stomach pain)
• muscle pain (myalgia)
• pain, redness or swelling at the injection site
• fatigue, chills, fever

Common(may affect up to 1 in 10 doses of vaccine):

• tingling at the injection site (itching)
• feeling unwell

Uncommon(may affect up to 1 in 100 doses of vaccine)

• inflammation of the glands in the neck, armpits or groin
• joint pain

Rare(may affect up to 1 in 1,000 doses of vaccine)

• allergic reactions including skin rash, hives, swelling of the face, tongue or throat which can cause difficulty swallowing or breathing (angioedema)

Most of these side effects are mild to moderate in intensity and do not last long.
Immunocompromised adults aged 18 to 49 years may experience more side effects
than immunocompromised adults aged ≥ 50 years.
Adults aged 50-69 years may experience a greater number of side effects than
adults aged ≥ 70 years.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. * By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Shingrix

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date indicated on the label and the packaging. The expiry date refers to the last day of that month.
• Store in a refrigerator (2 °C - 8 °C)
• Do not freeze.
• Store in the original container to protect from light.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Shingrix contains

• The active substances are:

After reconstitution, one dose (0.5 mL) contains:
Varicella Zoster Virus Glycoprotein E antigen 50 micrograms
Varicella Zoster Virus = VZV
adjuvanted with AS01 containing:
Quillaja saponariaMolina plant extract, fraction 21 (QS-21) 50 micrograms
3-O-desacyl-4’-monophosphoryl lipid A (MPL) from Salmonella minnesota50 micrograms
Glycoprotein E is a protein present in the Varicella Zoster Virus. This protein is not
infectious.
The adjuvant (AS01) is used to increase the antibody response to the vaccine.

• Other ingredients are:

o Powder:sucrose, polysorbate 80 (E 433), monobasic sodium phosphate dihydrate (E 339),
dipotassium hydrogen phosphate (E 340).
o Suspension:dioleoylphosphatidylcholine (E 322), cholesterol, sodium chloride, dibasic sodium
phosphate anhydrous (E 339), monobasic potassium phosphate (E 340) and water for
injections.
See section 2 “Shingrix contains sodium and potassium”.

Description of Shingrix and contents of the pack

• Powder and suspension for injectable suspension.
• The powder is white.
• The suspension is an opalescent liquid from colorless to light brown.

A pack of Shingrix consists of:

• Powder (antigen) for 1 dose in a vial
• Suspension (adjuvant) for 1 dose in a vial.

Shingrix is available in packs of 1 vial of powder and 1 vial of suspension or in packs
of 10 vials of powder and 10 vials of suspension.
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer
GlaxoSmithKline Biologicals s.a.
Rue de l’Institut 89
B-1330 Rixensart
Belgium
For further information on Shingrix, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Tél/Tel: + 32 10 85 52 00

Lietuva
GlaxoSmithKline Biologicals SA
Tel: +370 80000334

България
GlaxoSmithKline Biologicals SA
Тел. +359 80018205

Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals s.a./n.v.

Tél/Tel: + 32 10 85 52 00
Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 2 22 00 11 11
[email protected]

Magyarország
GlaxoSmithKline Biologicals SA
Tel.: +36 80088309

Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
[email protected]

Malta
GlaxoSmithKline Biologicals SA
Tel: +356 80065004

Deutschland
GlaxoSmithKline GmbH & Co. KG
Tel: + 49 (0)89 360448701
[email protected]

Nederland
GlaxoSmithKline BV
Tel: + 31 (0)33 2081100

EestiNorge
GlaxoSmithKline Biologicals SA
Tel: +372 8002640
GlaxoSmithKline AS

Tlf: + 47 22 70 20 00
Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E
Tηλ: + 30 210 68 82 100

Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0
[email protected]

España
GlaxoSmithKline, S.A.
Tel: + 34 900 202 700
[email protected]

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (22) 576 9000

France
Laboratoire GlaxoSmithKline
Tél: + 33 (0) 1 39 17 84 44
[email protected]

Hrvatska
GlaxoSmithKline Biologicals SA
Tel.: +385 800787089

Portugal
GlaxoSmithKline - Produtos Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
[email protected]

România
GlaxoSmithKline Biologicals SA
Tel: +40 800672524

Ireland
GlaxoSmithKline (Ireland) Ltd
Tel: + 353 (0)1 495 5000

Slovenija
GlaxoSmithKline Biologicals SA
Tel: +386 80688869

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
GlaxoSmithKline Biologicals SA
Tel.: +421 800500589

Italia
GlaxoSmithKline S.p.A.
Tel: + 39 (0)45 7741 111

Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 10 30 30 30

Κύπρος
GlaxoSmithKline Biologicals SA
Τηλ: +357 80070017

Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
GlaxoSmithKline Biologicals SA
Tel: +371 80205045

United Kingdom (Northern Ireland)
GlaxoSmithKline Biologicals SA
Tel: +44(0)800 221 441
[email protected]

Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/.
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The following information is intended exclusively for healthcare professionals:
Shingrix is presented as a vial with a brown flip-off cap containing the powder (antigen) and
a vial with a blue-green flip-off cap containing the suspension (adjuvant).
The powder and suspension must be reconstituted before administration.

AntigenAdjuvant
1 dose (0.5 mL)
The powder and suspension must be visually inspected for the presence of foreign
particles and/or changes in appearance. If any of these conditions occur, do not reconstitute the vaccine.
How to prepare Shingrix:
Shingrix must be reconstituted before administration.

• 1. Withdraw the entire contents of the vial containing the suspension into the syringe.
• 2. Add the entire contents of the syringe into the vial containing the powder.
• 3. Gently shake until the powder is completely dissolved.

The reconstituted vaccine is an opalescent liquid, from colorless to light brown.
The reconstituted vaccine must be visually inspected for the presence of foreign particles and/or
changes in appearance. If any of these conditions occur, do not administer the vaccine.
After reconstitution, the vaccine must be used immediately; if this is not possible, it must
be stored in a refrigerator (2 °C – 8 °C). If not used within 6 hours, it must
be discarded.
Before administration:

• 1. Withdraw the entire contents of the vial containing the reconstituted vaccine into a syringe.
• 2. Change the needle so as to use a new needle to administer the vaccine.

Unused medicine and waste materials derived from such medicine must be disposed of in accordance
with local regulations.