Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - adjupanrix

Document Subject

Generated Narrative: MedicinalProductDefinition mp21182c5873285a39663676519ff4bbab

identifier: http://ema.europa.eu/identifier/EU/1/09/578/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Adjupanrix suspension and emulsion for emulsion for injection.

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-21182c5873285a39663676519ff4bbab

identifier: http://ema.europa.eu/identifier/EU/1/09/578/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - adjupanrix

Attesters

What is in this leaflet:

1. What Adjupanrix is and what it is used for
2. What you need to know before you receive Adjupanrix
3. How Adjupanrix is given
4. Possible side effects
5. How to store Adjupanrix
6. Contents of the pack and otherinformation

What Adjupanrix is and what it is used for Adjupanrix is a vaccine for use in prophylaxis of influenza in an officially declared pandemic situation.

Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades. It spreads rapidly around the world. The signs of pandemic flu are similar to those of ordinary flu but may be more serious.

How Adjupanrix works When a person is given the vaccine, the body s natural defence system (immune system) produces its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu.

As with all vaccines, Adjupanrix may not fully protect all persons who are vaccinated.

Adjupanrix should not be given

• If you have previously had a sudden life-threatening allergic reaction to any ingredient of this vaccine (listed in section 6) or to anything else that may be present in very small amounts, such as: egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or sodium deoxycholate.

• Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
• However, in a pandemic situation, you may still be given the vaccine. This is as long as medical treatment is available straight away, in case you have an allergic reaction.

Do not have Adjupanrix if any of the above apply to you.

If you are not sure, talk to your doctor or nurse before having this vaccine.

Warning and precautions:

Talk to your doctor or nurse before you are given Adjupanrix

• if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient of Adjupanrix (listed in section 6) or to thiomersal, to egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
• if you have a serious infection with a high temperature (over 38 C). If this applies to you then your vaccination will usually be postponed until you are feeling better. A minor infection such as a cold should not be a problem, but your doctor will advise whether you could still be vaccinated with Adjupanrix.
• if you have problems with your immune system, since your response to the vaccine may then be poor.
• if you are having a blood test to look for evidence of infection with certain viruses. In the first few weeks after vaccination with Adjupanrix the results of these tests may not be correct. Tell the doctor requesting these tests that you have recently received Adjupanrix.
• you have a bleeding problem or you bruise easily.

Fainting can occur following, or even before, any needle injection. Therefore tell the doctor or nurse if you fainted with a previous injection.

If any of the above apply to you (or you are not sure), talk to your doctor or nurse before having Adjupanrix. This is because the vaccination may not be recommended, or may need to be delayed.

Children <6 years of age If your child receives the vaccine, you should be aware that the side effects may be more intense after the second dose, especially temperature over 38 C. Therefore monitoring of temperature and measures to lower the temperature (such as giving paracetamol or other medicines that lower fever) after each dose are recommended.

Other medicines and Adjupanrix Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines or have recently received any other vaccine.

In particular, tell your doctor or nurse if you are having any treatments (such as corticosteroid treatments or chemotherapy for cancer) that affect the immune system. Adjupanrix can still be given but your response to the vaccine may be poor.

Adjupanrix is not intended to be given at the same time as some other vaccines. However, if this needs to happen, the other vaccine will be injected into the other arm. Any side effects that happen may be more serious.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this vaccine.

Driving and using machines
Some side effects listed in Section 4. Possible side effects may affect your ability to drive or use tools or machines. It is best to see how Adjupanrix affects you before you try these activities.

Adjupanrix contains thiomersal
Adjupanrix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction. Tell your doctor if you have any known allergies.

Adjupanrix contains sodium and potassium Adjupanrix contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose. It is essentially sodium- and potassium-free.

Adults aged 18 years and above

• From 18 years onwards: you will receive two doses of Adjupanrix (each 0.5 ml). The second dose should be given after an interval of at least three weeks and up to twelve months after the first dose.

• From 80 years onwards: you may receive two double injections of Adjupanrix. The first two injections should be given at the elected date and the two other injections should preferably be given 3 weeks after.

Children 6 months to <36 months of age

Your child will receive two doses (each 0.125 ml equals quarter the adult dose per injection) of Adjupanrix. The second dose will be given preferably at least three weeks after the first dose.

Children and adolescents 36 months to <18 years of age

Your child will receive two doses (each 0.25 ml equals half the adult dose per injection) of Adjupanrix. The second dose will be given preferably at least three weeks after the first dose.

Your doctor or nurse will give you Adjupanrix.

• They will give Adjupanrix as an injection into a muscle.
• This will usually be in the upper arm.
• The double injections will be given in opposite arms.

If you have any further questions on the use of this vaccine, ask your doctor or nurse.

Like all medicines, this vaccine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Allergic reactions Allergic reactions which may cause you to have dangerously low blood pressure. If this is not treated it may lead to shock. Your doctors know that this might happen and will have emergency treatment ready to use.

Other side effects:

Side effects that occurred in adults 18 years of age

Very common: may affect more than 1 in 10 people

• Headache
• Feeling tired
• Pain, redness, swelling or a hard lump where the injection was given
• Fever
• Aching muscles, joint pain

Common: may affect less than 1 in 10 people

• Warmth, itching or bruising where the injection was given
• Increased sweating, shivering, flu-like symptoms
• Swollen glands in your neck, armpit or groin

Uncommon: may affect less than 1 in 100 people

• Tingling or numbness of the hands or feet
• Sleepiness
• Feeling dizzy
• Diarrhoea, vomiting, abdominal pain, nausea
• Itching, rash
• Generally feeling unwell
• Sleeplessness

Side effects that occurred in children 6 to <36 months of age

Very common: these may occur with more than 1 in 10 doses of the vaccine

• Gastrointestinal symptoms (such as diarrhoea and vomiting)
• Decreased appetite
• Sleepiness
• Pain at the injection site
• Fever
• Irritability/Fussiness

Common: these may occur in up to 1 in 10 doses of the vaccine

• Redness and swelling at the injection site

Uncommon: these may occur in up to 1 in 100 doses of the vaccine

• (Hard) lump, scab, bruising and eczema at the injection site
• Swelling face
• Rash, including red blotches
• Hives

Side effects that occurred in children 3 to <6 years of age

Very common: these may occur with more than 1 in 10 doses of the vaccine

• Decreased appetite
• Sleepiness
• Pain at the injection site
• Irritability/Fussiness

Common: these may occur in up to 1 in 10 doses of the vaccine

• Gastrointestinal symptoms (such as nausea, diarrhoea, vomiting and abdominal pain)
• Fever
• Redness and swelling at the injection site

Uncommon: these may occur in up to 1 in 100 doses of the vaccine

• Headache
• Rash
• Aching muscles
• Feeling tired
• Chills
• Bruising and itching at the injection site

Side effects that occurred in children 6 to <18 years of age

Very common: these may occur with more than 1 in 10 doses of the vaccine

• Headache
• Aching muscles
• Joint pain
• Pain at the injection site
• Feeling tired

Common: these may occur in up to 1 in 10 doses of the vaccine

• Gastrointestinal symptoms (such as nausea, diarrhoea, vomiting and abdominal pain
• Excessive sweating
• Fever
• Redness and swelling at the injection site
• Chills

Uncommon: these may occur in up to 1 in 100 doses of the vaccine

• Decreased appetite
• Irritability/Fussiness
• Sleepiness
• Numbness
• Feeling dizzy
• Fainting
• Shaking
• Rash
• Skin Ulcer
• Musculoskeletal stiffness
• Itching at the injection site
• Armpit pain

In children aged 3 to 9 years, the following side effects were also observed: bruising, shivering and increased sweating.

The side effects listed below have happened with H1N1 AS03-containing vaccines. They may also happen with Adjupanrix. If any of the side effects below occur, please tell your doctor or nurse immediately:

• Allergic reactions leading to a dangerously low blood pressure. If this is not treated, it may lead to shock. Your doctors will know that this might happen and will have emergency treatment ready to use
• Fits
• Generalised skin reactions including urticaria (hives)

The side effects listed below have happened in the days or weeks after vaccination with vaccines given routinely every year to prevent flu. They may also happen with Adjupanrix. If any of the side effects below occur, please tell your doctor or nurse immediately:

Very rare: may affect less than 1 in 10,000 people

• Problems with your brain and nerves such as inflammation of the central nervous system (encephalomyelitis), inflammation of nerves (neuritis) or a type of paralysis known as Guillain- Barr Syndrome .
• Inflammation of your blood vessels (vasculitis). This can cause skin rashes, joint pain and kidney problems

Rare: may affectless than 1 in 1,000 people

• Serious stabbing or throbbing pain along one or more nerves
• Low blood platelet count. This can cause bleeding or bruising

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. 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 medicine.

Keep this vaccine out of the sight and reach of children.

Before the vaccine is mixed: Do not use the suspension and the emulsion after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C - 8 C).
Store in the original package in order to protect from light. Do not freeze.

After the vaccine is mixed: After mixing, use the vaccine within 24 hours and do not store above 25 C.

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 Adjupanrix contains

• Active substance:
  Split influenza virus, inactivated, containing antigen* equivalent to:

A/Vietnam/1194/2004 (H5N1) like strain used (NIBRG-14) 3.75 micrograms** per 0.5 ml dose

*propagated in eggs **expressed in microgram haemagglutinin

This vaccine complies with the WHO recommendation and EU decision for the pandemic.

• Adjuvant:
  The vaccine contains an adjuvant AS03. This adjuvant contains squalene (10.69 milligrams), DL- -tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams). Adjuvants are used to improve the body s response to the vaccine.

• Other ingredients:
  The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride, water for injections

What Adjupanrix looks like and contents of the pack

The suspension is a colourless light opalescent liquid.
The emulsion is a whitish to yellowish homogeneous milky liquid.

Before the vaccine is given, the two parts will be mixed together. The mixed vaccine is a whitish to yellowish homogeneous milky liquid emulsion.

One pack of Adjupanrix consists of:

• one pack containing 50 vials of 2.5 ml suspension (antigen)
• two packs containing 25 vials of 2.5 ml emulsion (adjuvant)

Marketing Authorisation Holder and Manufacturer

GlaxoSmithKline Biologicals s.a. Rue de l Institut B-1330 Rixensart Belgium

For any information about this medicinal vaccine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien GlaxoSmithKline Pharmaceuticals SA/NV T l/Tel: + 32 10 85 52 Lietuva GlaxoSmithKline Biologicals SA Tel: +370 80000
GlaxoSmithKline Biologicals SA . + 359 80018Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals SA/NV T l/Tel: + 32 10 85 52 esk republika GlaxoSmithKline s.r.o. Tel: + 420 2 22 00 11 cz.info@gsk.com

Magyarorsz g GlaxoSmithKline Biologicals SA Tel.: + 36 80088Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 dk-info@gsk.com

Malta GlaxoSmithKline Biologicals SA Tel: + 356 80065Deutschland GlaxoSmithKline GmbH & Co. KG Tel: + 49 (0)89 360448produkt.info@gsk.com

Nederland GlaxoSmithKline BV Tel: + 31 (0)33 2081Eesti GlaxoSmithKline Biologicals SA Tel: +372 8002Norge GlaxoSmithKline AS Tlf: + 47 22 70 20
GlaxoSmithKline A.E.B.E T : + 30 210 68 82 sterreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at.info@gsk.com

Espa a GlaxoSmithKline, S.A. Tel: + 34 900 202 es-ci@gsk.com

Polska GSK Services Sp. z o.o. Tel.: + 48 (22) 576 9France Laboratoire GlaxoSmithKline T l: + 33 (0) 1 39 17 84 diam@gsk.com Portugal GlaxoSmithKline - Produtos Farmac uticos, Lda. Tel: + 351 21 412 95 FI.PT@gsk.com Hrvatska GlaxoSmithKline Biologicals SA Tel.: + 385 800787Rom nia GlaxoSmithKline Biologicals SA Tel: +40 800672Ireland GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0)1 495 5Slovenija GlaxoSmithKline Biologicals SA Tel: + 386 80688 sland Vistor hf.
S mi: +354 535 7Slovensk republika GlaxoSmithKline Biologicals SA Tel.: + 421 800500Italia GlaxoSmithKline S.p.A. Tel: + 39 (0)45 7741 Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 10 30 30
GlaxoSmithKline Biologicals SA : + 357 80070Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 info.produkt@gsk.com

Latvija GlaxoSmithKline Biologicals SA Tel: + 371 80205United Kingdom (Northern Ireland) GlaxoSmithKline Biologicals SA Tel: +44(0)800 221customercontactuk@gsk.com

This leaflet was last revised in {MM/YYYY}..

This medicine has been authorised under exceptional circumstances . This means that for scientific reasons it has been impossible to get complete information on this medicine. The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: