Tuesday 7th November 2023.

Please check you emails and text messages for the links to the Estyn Inspection Information Letter and Parents’ Survey which was texted and emailed to you today.

Paper copies are available from the School Office.

Shwmae Sumae Day is a day marked each year in Wales to celebrate and promote the Welsh language. Shwmae and Sumae are informal greetings used in the south and the north to start a conversation. The day is celebrated on 15 October each year in order to promote community use of the language and encourage non-Welsh speakers to consider learning the language.

Shwmae Day was on a Sunday this year, so we are having our own Shwmae Day this Friday, 20th October. We’d like the children to wear something red, green or white and , of course, we’ll be using lots of Welsh on the day.

The first Shwmae Day was held in 2013, and has been held every year since.
The aim of Shwmae Day is to encourage non-Welsh speakers to start every conversation in Welsh, using Shwmae, Sumae. It is also seen as a way of increasing awareness about the language among non-Welsh speakers, encouraging new people to start learning the language.

The Welsh language belongs to all Welsh people and everyone can contribute to its future vitality.

Rho gynnig arni – Give it a go! (We may even give you one of our Welsh stickers!)

Next week, some of our Year 4 pupils will be visiting the Urdd Centre in Cardiff. We will be staying for one night, and taking part in some exciting activities.

Package leaflet: Information for the user
Fluenz® Tetra nasal spray suspension
Influenza vaccine (live attenuated, nasal)
Read all of this carefully before the vaccine is given because it contains important
information for you or your child.

• Make a note of the post. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• This vaccine has been prescribed for you or your child only. Do not pass it on to others.
• If any of the side effects gets serious, talk to your doctor, nurse or pharmacist. This includes any
  possible side effects not listed in this leaflet. See section 4.
  What is in this leaflet:

1. What Fluenz Tetra is and what it is used for
2. What you need to know before you are given Fluenz Tetra
3. How Fluenz Tetra is given
4. Possible side effects
5. How to store Fluenz Tetra
6. Contents of the pack and other information
7. What Fluenz Tetra is and what it is used for
   Fluenz Tetra is a vaccine to prevent influenza (flu). It is used in children and adolescents 24 months to
   less than 18 years of age. Fluenz Tetra will help to protect against the four virus strains contained in
   the vaccine, and other strains closely related to them.
   How Fluenz Tetra works
   When a person is given the vaccine, the immune system (the body’s natural defence system) will
   produce its own protection against the influenza virus. None of the ingredients in the vaccine can
   cause the flu.
   Fluenz Tetra vaccine viruses are grown in chicken eggs. Each year the vaccine targets four strains of
   influenza, following the annual recommendations by the World Health Organisation.
8. What you need to know before you are given Fluenz Tetra
   You will not be given Fluenz Tetra:

• if you are allergic to gentamicin, gelatin or any of the other ingredients of this vaccine (listed in
  section 6 “Contents of the pack and other information”).
• if you have ever had a severe allergic reaction to eggs or egg proteins. For signs of allergic
  reactions, see section 4 “Possible side effects”.
• if you have a blood disorder or a cancer that affects the immune system.
• if you have been told by your doctor that you have a weakened immune system as a result
  of a disease, medicine or other treatment.
• if you are already taking acetylsalicylic acid (a substance present in many medicines used
  to relieve pain and lower fever). This is because of the risk of a very rare but serious disease
  (Reye’s syndrome).
  If any of these apply, tell your doctor, nurse or pharmacist.
  Warnings and precautions
  Talk to your doctor, nurse or pharmacist before vaccination:
• if the child is less than 24 months of age. Children less than 24 months of age should not
  receive this vaccine because of the risk of side effects.
• if you have severe asthma or are currently wheezing.
• if you are in close contact with someone with a severely weakened immune system
  (for example, a bone marrow transplant patient needing isolation).
  If any of these apply, tell your doctor, nurse or pharmacist before vaccination. He or she will
  decide if Fluenz Tetra is suitable for you.
  Other medicines, other vaccines and Fluenz Tetra
  Tell your doctor, nurse or pharmacist if the person being vaccinated is taking, has recently taken or
  might take any other medicines, including medicines that do not require a prescription.
• Do not give acetylsalicylic acid (a substance present in many medicines used to relieve pain and
  lower fever) to children for 4 weeks after vaccination with Fluenz Tetra unless your doctor,
  nurse or pharmacist tells you otherwise. This is because of the risk of Reye’s syndrome, a very
  rare but serious disease that can affect the brain and liver.
• It is recommended that Fluenz Tetra is not given at the same time as influenza-specific
  antiviral medicines, such as oseltamivir and zanamivir. This is because the vaccine may work
  less effectively.
  Your doctor, nurse or pharmacist will decide if Fluenz Tetra can be given at the same time as other
  vaccines.
  Pregnancy and breast-feeding
• If you are pregnant, think you may be pregnant, plan to become pregnant soon or are
  breast-feeding, tell your doctor, nurse or pharmacist before receiving this vaccine. Fluenz
  Tetra is not recommended for women who are pregnant or are breast-feeding.
  Driving and using machines
• Fluenz Tetra has no or negligible influence on the ability to drive and use machines.

1. How Fluenz Tetra is given
   Fluenz Tetra will be administered under the supervision of a doctor, nurse or pharmacist.
   Fluenz Tetra must only be used as a nasal spray.
   Fluenz Tetra must not be injected.
   Fluenz Tetra will be given as a spray in each nostril. You can breathe normally while you are given
   Fluenz Tetra. You do not need to actively inhale or sniff.
   Dosage
   The recommended dose for children and adolescents is 0.2 ml Fluenz Tetra, administered as 0.1 ml
   in each nostril. Children who have not previously had an influenza vaccine will receive a second,
   follow-up dose after an interval of at least 4 weeks. Follow your doctor, nurse or pharmacist’s
   instructions about if and when your child should return for the second dose.
   If you have any further questions on this vaccine, ask your doctor, nurse or pharmacist.
2. Possible side effects
   Like all medicines, this vaccine can cause side effects, although not everybody gets them. In clinical
   studies with the vaccine, most side effects were mild in nature and short term.
   Ask your doctor, nurse or pharmacist if you want more information about possible side effects from
   Fluenz Tetra.
   Some side effects may be serious
   Very rare
   (may affect up to 1 in 10,000 people):

• severe allergic reaction: signs of a severe allergic reaction may include shortness of breath and
  swelling of the face or tongue.
  Tell your doctor straight away or seek urgent medical care if you experience any of the effects
  above.
  Other possible side effects of Fluenz Tetra
  Very common
  (may affect more than 1 in 10 people):
• runny or stuffy nose
• reduced appetite
• weakness
  Common
  (may affect up to 1 in 10 people):
• fever
• muscle aches
• headache
  Uncommon
  (may affect up to 1 in 100 people):
• rash
• nose bleed
• allergic reactions
  Reporting of side effects
  If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side
  effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
  at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App
  Store. By reporting side effects you can help provide more information on the safety of this medicine.

1. How to store Fluenz Tetra
   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 applicator label after the
   letters EXP.
   Store in a refrigerator (2°C to 8°C). Do not freeze.
   Keep the nasal applicator in the outer carton in order to protect from light.
   Before use, the vaccine may be taken out of the refrigerator once for a maximum period of 12 hours at
   a temperature not above 25°C. If the vaccine has not been used after this 12 hour period, it should be
   discarded.
   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.
2. Contents of the pack and other information
   What Fluenz Tetra contains
   The active substances are:
   Reassortant influenza virus* (live attenuated) of the following four strains: A/Victoria/4897/2022 (H1N1)pdm09 – like strain (A/Norway/31694/2022, MEDI 369815) 107.0±0.5 FFU*
   A/Darwin/9/2021 (H3N2) – like strain
   (A/Norway/16606/2021, MEDI 355293) 107.0±0.5 FFU* B/Austria/1359417/2021 – like strain (B/Austria/1359417/2021, MEDI 355292) 107.0±0.5 FFU*
   B/Phuket/3073/2013 – like strain
   (B/Phuket/3073/2013, MEDI 306444) 107.0±0.5 FFU***
   ……………………………………………………………………………………………………per 0.2 ml dose

• propagated in fertilised hens’ eggs from healthy chicken flocks.
  ** produced in VERO cells by reverse genetic technology. This product contains genetically
  modified organisms (GMOs).
  *** fluorescent focus units.
  This vaccine complies with the WHO (World Health Organisation) recommendations (Northern
  Hemisphere) and EU decision for the 2023/2024 season.
  The other ingredients are sucrose, dipotassium phosphate, potassium dihydrogen phosphate, gelatin
  (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate and water for
  injections.
  What Fluenz Tetra looks like and contents of the pack
  This vaccine is presented as a nasal spray suspension in a single-use nasal applicator (0.2 ml) in a pack
  size of 1 and 10. Not all pack sizes may be available.
  The suspension is colourless to pale yellow, clear to slightly cloudy. Small white particles may
  be present.
  Marketing Authorisation Holder and Manufacturer
  Marketing Authorisation Holder: AstraZeneca UK Limited, 1 Francis Crick Avenue, Cambridge, CB2
  0AA, UK.
  Manufacturer: MedImmune UK Limited, Plot 6, Renaissance Way, Boulevard Industry Park, Speke,
  Liverpool, L24 9JW, United Kingdom
  This leaflet was last revised in July 2023.
  © AstraZeneca 2023
  FLUENZ is a registered trademark of the AstraZeneca group of companies.
  INF 23 0019
  Other sources of information
  To listen to or request a copy of this leaflet in Braille, large print or
  audio please call, free of charge:
  0800 198 5000 (UK only)
  Please be ready to give the following information:
  Product name Reference number
  Fluenz Tetra nasal spray suspension 17901/0324
  This is a service provided by the Royal National Institute of the Blind.