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Generated Narrative: Composition

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Profile: Composition (ePI)

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type: Package Leaflet (#100000155538)

category: Focused (Category of EPI#F)

date: 2023-04-22 15:15:46+0000

author: See above (Organization/mah-45fe50eae508b5755dd140ab2093eb5e)

title: TEST PURPOSES ONLY - Flucelvax

Attesters

-ModeTime
*Official (Composition Attestation Mode#official)2023-04-22 15:15:46+0000
" }, "extension" : [{ "extension" : [{ "url" : "elementClass", "valueString" : "pregnancyCategory" }, { "url" : "concept", "valueCodeableReference" : { "concept" : { "coding" : [{ "system" : "http://snomed.info/sct", "code" : "77386006", "display" : "Pregnancy" }] } } }], "url" : "http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink" }], "identifier" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "value" : "asdasd" }], "status" : "final", "type" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "code" : "100000155538" }], "text" : "Package Leaflet" }, "category" : [{ "coding" : [{ "system" : "http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs", "code" : "F", "display" : "Focused" }] }], "subject" : [{ "reference" : "MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1" }], "date" : "2023-04-22T15:15:46Z", "author" : [{ "reference" : "Organization/mah-45fe50eae508b5755dd140ab2093eb5e" }], "title" : "TEST PURPOSES ONLY - Flucelvax", "attester" : [{ "mode" : { "coding" : [{ "system" : "http://hl7.org/fhir/composition-attestation-mode", "code" : "official" }] }, "time" : "2023-04-22T15:15:46Z" }], "section" : [{ "title" : "B. Package Leaflet", "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "code" : "100000155538" }], "text" : "B. PACKAGE LEAFLET" }, "text" : { "status" : "additional", "div" : "
<p class=\"MsoNormal\" style=\"text-align: center;\" align=\"center\"><strong style=\"mso-bidi-font-weight: normal;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\">Package leaflet: Information for the user</span></strong></p> <p class=\"MsoNormal\" style=\"text-align: center; line-height: normal; mso-list: skip; tab-stops: 36.0pt; background: white;\" align=\"center\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\"> </span></p> <p class=\"SmPC-PLtext\" style=\"text-align: center;\" align=\"center\"><strong style=\"mso-bidi-font-weight: normal;\"><span style=\"mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;\">Flucelvax Tetra</span></strong><strong style=\"mso-bidi-font-weight: normal;\"><span lang=\"EN-GB\" style=\"color: windowtext;\"> - suspension for injection in pre-filled syringe</span></strong></p> <p class=\"SmPC-PLtext\" style=\"text-align: center;\" align=\"center\"><span lang=\"EN-GB\" style=\"color: windowtext;\">Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)</span></p> <p class=\"MsoNormal\" style=\"line-height: normal; tab-stops: 36.0pt;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\"> </span></p> <p class=\"MsoNormal\" style=\"line-height: normal; tab-stops: 36.0pt;\"><span lang=\"EN-GB\" style=\"mso-no-proof: yes;\"><img src=\"data:image/png;base64,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\" annotationsrc=\"~/_entity/annotation/76a10366-26e0-ed11-a7c6-000d3aaa0403\" />This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.</span></p> <p class=\"MsoNormal\" style=\"line-height: normal; mso-hyphenate: none; tab-stops: 36.0pt;\"><strong style=\"mso-bidi-font-weight: normal;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\"> </span></strong></p> <p class=\"MsoNormal\" style=\"line-height: normal; mso-hyphenate: none; tab-stops: 36.0pt;\"><strong style=\"mso-bidi-font-weight: normal;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\">Read all of this leaflet carefully before you receive this medicine because it contains important information for you.</span></strong></p> <p class=\"MsoNormal\" style=\"text-indent: -1.0cm; line-height: normal; mso-list: l0 level1 lfo1; tab-stops: 36.0pt; margin: 0cm -.1pt .0001pt 1.0cm;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\"><span style=\"mso-list: Ignore;\">-<span style=\"font: 7.0pt 'Times New Roman';\">              </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\">Keep this leaflet. You may need to read it again. </span></p> <p class=\"MsoNormal\" style=\"text-indent: -1.0cm; line-height: normal; mso-list: l0 level1 lfo1; tab-stops: 36.0pt; margin: 0cm -.1pt .0001pt 1.0cm;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\"><span style=\"mso-list: Ignore;\">-<span style=\"font: 7.0pt 'Times New Roman';\">              </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\">If you have any further questions, ask your doctor, pharmacist or nurse.</span></p> <p class=\"MsoNormal\" style=\"margin-left: 1.0cm; text-indent: -1.0cm; line-height: normal; mso-list: l0 level1 lfo1;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt;\"><span style=\"mso-list: Ignore;\">-<span style=\"font: 7.0pt 'Times New Roman';\">              </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\">If you get any side effects, talk to your doctor, pharmacist or nurse.</span><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; color: red;\"> </span><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt;\">This includes any possible side effects not listed in this leaflet. See section 4.</span></p> <p class=\"MsoNormal\" style=\"margin-right: -.1pt; line-height: normal; tab-stops: 36.0pt;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\"> </span></p> <p class=\"MsoNormal\" style=\"margin-right: -.1pt; line-height: normal; tab-stops: 36.0pt;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\"> </span></p> <p class=\"MsoNormal\" style=\"margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;\"><strong style=\"mso-bidi-font-weight: normal;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\">What is in this leaflet</span></strong></p> <p class=\"MsoNormal\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\"> </span></p> <p class=\"MsoNormal\" style=\"margin-right: -1.45pt; line-height: normal; mso-list: skip; tab-stops: 21.3pt;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\">1.<span style=\"mso-tab-count: 1;\">    </span>What </span><span style=\"mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;\">Flucelvax Tetra </span><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\">is and what it is used for </span></p> <p class=\"MsoNormal\" style=\"margin-right: -1.45pt; line-height: normal; mso-list: skip; tab-stops: 21.3pt;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\">2.<span style=\"mso-tab-count: 1;\">    </span>What you need to know before you <span class=\"SmPC-PLtextChar\">receive </span></span><span style=\"mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;\">Flucelvax Tetra</span><span style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\"> </span></p> <p class=\"MsoNormal\" style=\"margin-right: -1.45pt; line-height: normal; mso-list: skip; tab-stops: 21.3pt;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\">3.<span style=\"mso-tab-count: 1;\">    </span>How </span><span style=\"mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;\">Flucelvax Tetra </span><span class=\"SmPC-PLtextChar\"><span lang=\"EN-GB\">is given</span></span><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\"> </span></p> <p class=\"MsoNormal\" style=\"margin-right: -1.45pt; line-height: normal; mso-list: skip; tab-stops: 21.3pt;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\">4.<span style=\"mso-tab-count: 1;\">    </span>Possible side effects </span></p> <p class=\"MsoNormal\" style=\"margin-right: -1.45pt; line-height: normal; tab-stops: 21.3pt;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\">5.<span style=\"mso-tab-count: 1;\">    </span>How to store </span><span style=\"mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;\">Flucelvax Tetra </span><span style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\"><span style=\"mso-spacerun: yes;\"> </span></span></p> <p class=\"MsoNormal\" style=\"margin-right: -1.45pt; line-height: normal; tab-stops: 21.3pt;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\">6.<span style=\"mso-tab-count: 1;\">    </span>Contents of the pack and other information</span></p>
" }, "section" : [{ "title" : "Package leaflet: Information for the user", "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "code" : "100000155538" }], "text" : "Package leaflet: Information for the user" }, "text" : { "status" : "additional", "div" : "
unavailable
" }, "emptyReason" : { "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason", "code" : "unavailable" }] } }, { "title" : "What is in this leaflet", "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "code" : "100000155538" }], "text" : "What is in this leaflet" }, "text" : { "status" : "additional", "div" : "
unavailable
" }, "emptyReason" : { "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason", "code" : "unavailable" }] } }, { "title" : "1. What asdad is and what it is used for", "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "code" : "100000155538" }], "text" : "1. What asdad is and what it is used for" }, "text" : { "status" : "additional", "div" : "
<p class=\"SmPC-PLtext\"><span style=\"mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;\">Flucelvax Tetra</span><span style=\"mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;\"> </span><span lang=\"EN-GB\" style=\"color: windowtext;\">is a vaccine against flu (influenza). </span><span style=\"mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;\">Flucelvax Tetra</span><span style=\"mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;\"> </span><span class=\"SmPC-PLtextChar\"><span lang=\"EN-GB\" style=\"color: windowtext;\">is prepared in cell cultures, and, therefore, is egg-free.</span></span></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\">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 flu.</span></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\"> </span></p> <p class=\"SmPC-PLtext\"><span style=\"mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;\">Flucelvax Tetra</span><span style=\"mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;\"> </span><span lang=\"EN-GB\" style=\"color: windowtext;\">is used to prevent flu in adults and children from 2 years of age.</span></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\"> </span></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\">The vaccine targets four strains of influenza virus following the recommendations by the World Health Organisation for the 2022/2023 SEASON.</span></p>
" } }, { "title" : "2. What you need to know before you take asdad", "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "code" : "100000155538" }], "text" : "2. What you need to know before you take asdad" }, "text" : { "status" : "additional", "div" : "
<p class=\"SmPC-PLtext\" style=\"margin-left: 14.2pt; text-indent: -14.2pt;\"><span lang=\"EN-GB\" style=\"color: windowtext;\">If you are allergic to:</span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 36.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 42.55pt;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext;\"><span style=\"mso-list: Ignore;\">·<span style=\"font: 7.0pt 'Times New Roman';\">        </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"color: windowtext;\">the active ingredients or any of the other ingredients of this medicine (listed in section 6)</span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 36.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 42.55pt;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext;\"><span style=\"mso-list: Ignore;\">·<span style=\"font: 7.0pt 'Times New Roman';\">        </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"color: windowtext;\">beta-propiolactone, cetyltrimethylammonium bromide, or polysorbate 80, which are trace residues from the manufacturing process.</span></p>
" } }, { "title" : "3. How to take asdad", "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "code" : "100000155538" }], "text" : "3. How to take asdad" }, "text" : { "status" : "additional", "div" : "
<p class=\"MsoNormal\" style=\"line-height: normal; mso-list: skip; tab-stops: 36.0pt;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\">Talk to your doctor, pharmacist or nurse before <span class=\"SmPC-PLtextChar\">receiving</span> </span><span style=\"mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;\">Flucelvax Tetra</span><span class=\"SmPC-PLtextChar\"><span lang=\"EN-GB\">.</span></span></p> <p class=\"MsoNormal\" style=\"margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\"> </span><u><span style=\"color: windowtext; mso-ansi-language: EN-US;\">BEFORE receiving the vaccine</span></u></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 18.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext; mso-ansi-language: EN-US;\"><span style=\"mso-list: Ignore;\">·<span style=\"font: 7.0pt 'Times New Roman';\">        </span></span></span><!--[endif]--><span style=\"color: windowtext; mso-ansi-language: EN-US;\">Your <span style=\"mso-bidi-font-weight: bold;\">doctor or nurse</span> will make sure that appropriate medical treatment and supervision is readily available in case of a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty in breathing, dizziness, a weak and rapid pulse and skin rash) following the administration. This reaction may occur with </span><span style=\"mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;\">Flucelvax Tetra</span><span class=\"SmPC-PLtextChar\"><span style=\"color: windowtext;\"> </span></span><span style=\"color: windowtext; mso-ansi-language: EN-US;\">as with all vaccines that are injected.</span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 18.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext; mso-ansi-language: EN-US;\"><span style=\"mso-list: Ignore;\">·<span style=\"font: 7.0pt 'Times New Roman';\">        </span></span></span><!--[endif]--><span style=\"color: windowtext; mso-ansi-language: EN-US;\">You should tell your doctor if you have an acute illness associated with fever. Your doctor may decide to delay your vaccination until your fever is gone.</span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 18.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext; mso-ansi-language: EN-US;\"><span style=\"mso-list: Ignore;\">·<span style=\"font: 7.0pt 'Times New Roman';\">        </span></span></span><!--[endif]--><span style=\"color: windowtext; mso-ansi-language: EN-US; mso-bidi-font-weight: bold;\">You</span><span style=\"color: windowtext; mso-ansi-language: EN-US;\"> should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e.g. with medicine against cancer (chemotherapy) or corticosteroid medicines (see section “Other medicines and Flucelvax Tetra”).</span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 18.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext; mso-ansi-language: EN-US;\"><span style=\"mso-list: Ignore;\">·<span style=\"font: 7.0pt 'Times New Roman';\">        </span></span></span><!--[endif]--><span style=\"color: windowtext; mso-ansi-language: EN-US;\">You should tell your doctor if you have a bleeding problem or bruise easily.</span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 18.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext; mso-ansi-language: EN-US;\"><span style=\"mso-list: Ignore;\">·<span style=\"font: 7.0pt 'Times New Roman';\">        </span></span></span><!--[endif]--><span style=\"color: windowtext; mso-ansi-language: EN-US;\">Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if you fainted with a previous injection.</span></p> <p class=\"SmPC-PLtext\" style=\"tab-stops: 36.0pt;\"><span style=\"color: windowtext; mso-ansi-language: EN-US;\"> </span><span style=\"color: windowtext; mso-ansi-language: EN-US;\">As with all vaccines, Flucelvax Tetra may not fully protect all persons who are vaccinated.</span></p>
" } }, { "title" : "4. Possible side effects", "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "code" : "100000155538" }], "text" : "4. Possible side effects" }, "text" : { "status" : "additional", "div" : "
<p class=\"MsoNormal\" style=\"margin-right: -1.45pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\">Like all medicines, this medicine can cause side effects, although not everybody gets them.</span></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\">The following side effects have been reported during clinical trials and during general use:</span></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\"> </span></p> <p class=\"SmPC-PLtext\" style=\"page-break-after: avoid;\"><strong style=\"mso-bidi-font-weight: normal;\"><span lang=\"EN-GB\" style=\"color: windowtext;\">Very serious side effects</span></strong></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\">Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following side effect – you may need urgent medical attention or hospitalisation:</span></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\"> </span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"color: windowtext;\"><span style=\"mso-list: Ignore;\">•<span style=\"font: 7.0pt 'Times New Roman';\">      </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"color: windowtext;\">Difficulty in breathing, dizziness, a weak and rapid pulse and skin rash which are symptoms of an anaphylactic reaction (a very severe allergic reaction)</span></p> <p class=\"SmPC-PLtext\" style=\"tab-stops: 36.0pt;\"><span lang=\"EN-GB\" style=\"color: windowtext;\"> </span></p> <p class=\"SmPC-PLtext\" style=\"page-break-after: avoid;\"><strong style=\"mso-bidi-font-weight: normal;\"><span lang=\"EN-GB\" style=\"color: windowtext;\">Serious side effects</span></strong></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\">Tell your doctor immediately if you experience any of the following side effects – you may need medical attention:</span></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\"> </span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"color: windowtext;\"><span style=\"mso-list: Ignore;\">•<span style=\"font: 7.0pt 'Times New Roman';\">      </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"color: windowtext;\">You feel weak, you have difficulty moving around or you experience numbness or tingling in your limbs. These can be symptoms of <span style=\"mso-spacerun: yes;\"> </span>Guillain-Barré syndrome (GBS), an autoimmune disease caused by your body’s own immune system.</span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"color: windowtext;\"><span style=\"mso-list: Ignore;\">•<span style=\"font: 7.0pt 'Times New Roman';\">      </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"color: windowtext;\">Extensive swelling of injected limb</span></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\"> </span></p> <p class=\"SmPC-PLtext\"><strong style=\"mso-bidi-font-weight: normal;\"><span lang=\"EN-GB\" style=\"color: windowtext;\">Mild side effects</span></strong></p> <p class=\"SmPC-PLtext\"><u><span lang=\"EN-GB\" style=\"color: windowtext;\">Very common</span></u><span lang=\"EN-GB\" style=\"color: windowtext;\"> (may affect more than 1 in 10 people):</span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"color: windowtext;\"><span style=\"mso-list: Ignore;\">•<span style=\"font: 7.0pt 'Times New Roman';\">      </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"color: windowtext;\">Injection site pain, bruising, reddening and hardening or swelling at the site of the injection</span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"color: windowtext;\"><span style=\"mso-list: Ignore;\">•<span style=\"font: 7.0pt 'Times New Roman';\">      </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"color: windowtext;\">Headache</span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"color: windowtext;\"><span style=\"mso-list: Ignore;\">•<span style=\"font: 7.0pt 'Times New Roman';\">      </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"color: windowtext;\">Muscle pain <span style=\"mso-spacerun: yes;\"> </span></span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"color: windowtext;\"><span style=\"mso-list: Ignore;\">•<span style=\"font: 7.0pt 'Times New Roman';\">      </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"color: windowtext;\">Tiredness </span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"color: windowtext;\"><span style=\"mso-list: Ignore;\">•<span style=\"font: 7.0pt 'Times New Roman';\">      </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"color: windowtext;\">Loss of appetite</span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"color: windowtext;\"><span style=\"mso-list: Ignore;\">•<span style=\"font: 7.0pt 'Times New Roman';\">      </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"color: windowtext;\">Irritability (only reported in children from 2 to < 6 years)</span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"color: windowtext;\"><span style=\"mso-list: Ignore;\">•<span style=\"font: 7.0pt 'Times New Roman';\">      </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"color: windowtext;\">Sleepiness (only reported in children 2 to < 6 years)</span></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\">Hardening or swelling at the site of the injection, headache, muscle pain, and tiredness were common in the elderly.</span></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\">Bruising at the site of the injection was common in adults, eldery and children 9 to < 18 years.</span></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\">Headache was common in the elderly.</span></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\">Loss of appetite was common in adults, eldery and children 9 to < 18 years.</span></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\"> </span></p> <p class=\"SmPC-PLtext\" style=\"page-break-after: avoid;\"><u><span lang=\"EN-GB\" style=\"color: windowtext;\">Common</span></u><span lang=\"EN-GB\" style=\"color: windowtext;\"> (may affect up to 1 in 10 people):</span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"color: windowtext;\"><span style=\"mso-list: Ignore;\">•<span style=\"font: 7.0pt 'Times New Roman';\">      </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"color: windowtext;\">Nausea, vomiting, diarrhoea </span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"color: windowtext;\"><span style=\"mso-list: Ignore;\">•<span style=\"font: 7.0pt 'Times New Roman';\">      </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"color: windowtext;\">Joint pain</span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"color: windowtext;\"><span style=\"mso-list: Ignore;\">•<span style=\"font: 7.0pt 'Times New Roman';\">      </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"color: windowtext;\">Shivering</span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"color: windowtext;\"><span style=\"mso-list: Ignore;\">•<span style=\"font: 7.0pt 'Times New Roman';\">      </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"color: windowtext;\">Change in eating habits (only reported in children from 2 to < 6 years)</span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"color: windowtext;\"><span style=\"mso-list: Ignore;\">•<span style=\"font: 7.0pt 'Times New Roman';\">      </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"color: windowtext;\">Fever (<u>></u> 38°C)</span></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\">Vomiting was uncommon in the elderly.</span></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\">Fever was uncommon in adults and the elderly.</span></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\"> </span></p> <p class=\"SmPC-PLtext\"><u><span lang=\"EN-GB\" style=\"color: windowtext;\">Not known</span></u><span lang=\"EN-GB\" style=\"color: windowtext;\"> (frequency cannot be estimated from the available data):</span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"color: windowtext;\"><span style=\"mso-list: Ignore;\">•<span style=\"font: 7.0pt 'Times New Roman';\">      </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"color: windowtext;\">Numbness and tingling sensation (paraesthesia)</span></p> <p class=\"SmPC-PLtext\" style=\"margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;\"><!-- [if !supportLists]--><span lang=\"EN-GB\" style=\"color: windowtext;\"><span style=\"mso-list: Ignore;\">•<span style=\"font: 7.0pt 'Times New Roman';\">      </span></span></span><!--[endif]--><span lang=\"EN-GB\" style=\"color: windowtext;\">Generalised skin reactions including itching, bumps on the skin (pruritis, urticaria) or non-specific rash </span></p>
" } }, { "title" : "5. How to store asdad", "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "code" : "100000155538" }], "text" : "5. How to store asdad" }, "text" : { "status" : "additional", "div" : "
<p class=\"MsoNormal\" style=\"margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\">Keep this <span class=\"SmPC-PLtextChar\">vaccine</span> out of the sight and reach of children.</span></p> <p class=\"MsoNormal\" style=\"margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\"> </span></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\">Store in a refrigerator (2 °C to 8 °C). Do not freeze.</span></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\">Keep the pre-filled syringe in the outer carton in order to protect from light.</span></p> <p class=\"MsoNormal\" style=\"margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\"> </span></p> <p class=\"MsoNormal\" style=\"margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\">Do not use this <span class=\"SmPC-PLtextChar\">vaccine</span> after the expiry date which is stated on the label and carton after <span class=\"SmPC-PLtextChar\">EXP</span>. The expiry date refers to the last day of that month.</span></p> <p class=\"MsoNormal\" style=\"margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\"> </span></p> <p class=\"MsoNormal\" style=\"margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;\"><span lang=\"EN-GB\" style=\"mso-bidi-font-size: 11.0pt; mso-no-proof: yes;\">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.</span></p>
" } }, { "title" : "6. Contents of the pack and other information", "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "code" : "100000155538" }], "text" : "6. Contents of the pack and other information" }, "text" : { "status" : "additional", "div" : "
<p class=\"SmPC-PLtext\"><span style=\"mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;\">Flucelvax Tetra</span><span style=\"mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;\"> </span><span lang=\"EN-GB\" style=\"color: windowtext;\">is a suspension for injection in a pre-filled syringe (ready to use syringe). <br /></span><span style=\"mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;\">Flucelvax Tetra</span><span style=\"mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;\"> </span><span lang=\"EN-GB\" style=\"color: windowtext;\">is a clear to slightly opalescent suspension.</span></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\">A single syringe contains 0.5 ml of suspension for injection.</span></p> <p class=\"SmPC-PLtext\"><span style=\"mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;\">Flucelvax Tetra</span><span style=\"mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;\"> </span><span lang=\"EN-GB\" style=\"color: windowtext;\">is available in packs containing 1 pre-filled syringe with or without needle or 10 pre-filled syringes with or without needles.</span></p> <p class=\"SmPC-PLtext\"><span lang=\"EN-GB\" style=\"color: windowtext;\">Not all pack sizes may be marketed.</span></p>
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*INFLUENZA A VIRUS A/Darwin/11/2021 (H3N2) WHOLE (beta#JS7E5ZZ3AC)

Strengths

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name

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part

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part

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Usages

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