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node role: treeRoot
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type:
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timestamp:
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entry:
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entry:
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entry:
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language:
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text:
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extension:
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extension:
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extension:
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extension:
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extension:
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extension:
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identifier:
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    code:
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    display:
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subject:
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date:
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title:
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attester:
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      code:
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  time:
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section:
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      code:
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    code:
      text:
        v: Package leaflet: Information for the user
    text:
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        v: additional
      div:
        v: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. If Biktarvy has been prescribed for your child, please note that all the information in this leaflet is addressed to your child (in this case please read “your child” instead of “you”).
  section:
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      v: What is in this leaflet
    code:
      text:
        v: What is in this leaflet
    text:
      status:
        v: additional
      div:
        v: What is in this leaflet What Biktarvy is and what it is used for What you need to know before you take Biktarvy How to take Biktarvy Possible side effects How to store Biktarvy Contents of the pack and other information

http://hl7.eu/fhir/ig/gravitate-health/ClinicalUseDefinition/cud-d79af6e660f456c6c7091803d6bd1a92
type: ClinicalUseDefinition
meta:
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text:
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identifier:
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type:
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subject:
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ingredient-for-biktarvy-bictegravirsodium
type: Ingredient
id:
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meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-biktarvy-bictegravirsodium Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/4L5MP1Y7W7 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1289/001 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1289/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E827gy; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1289/001; status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet role: Active substance Codes - Concept * BICTEGRAVIR SODIUM Strengths - Presentation[x] Basis * 50 mg (Details: UCUM codemg = 'mg') active ingredient - basis of strength
identifier:
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  system:
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status:
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for:
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role:
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    display:
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substance:
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      value:
        v: 50
      system:
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        l: unitsofmeasure.org
      code:
        v: mg

ingredient-for-biktarvy-emtricitabine
type: Ingredient
id:
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meta:
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text:
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identifier:
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  value:
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status:
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for:
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role:
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    display:
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substance:
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      value:
        v: 200
      system:
        v: http://unitsofmeasure.org
        l: unitsofmeasure.org
      code:
        v: mg

ingredient-for-biktarvy-tenofoviralafenamide
type: Ingredient
id:
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meta:
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    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
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identifier:
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status:
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for:
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role:
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substance:
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        v: 25
      system:
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        l: unitsofmeasure.org
      code:
        v: mg

ingredient-for-biktarvy-microcrystallinecellulose
type: Ingredient
id:
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meta:
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text:
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    code:
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    display:
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ingredient-for-biktarvy-croscarmellosesodium
type: Ingredient
id:
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meta:
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text:
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identifier:
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    l: beta
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status:
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role:
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      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-biktarvy-magnesiumstearate
type: Ingredient
id:
  v: ingredient-for-biktarvy-magnesiumstearate
meta:
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    l: Ingredient-uv-epi
text:
  status:
    v: generated
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identifier:
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    v: official
  system:
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v: 100000155538

v: 100000155538

title:
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      v: https://spor.ema.europa.eu/rmswi/
      l: rmswi
    code:
      v: 100000155538
  text:
    v: 1. What Biktarvy 50 mg/200 mg/25 mg film-coated tablets is and what it is used for
text:
  status:
    v: additional
  div:
    v: Biktarvy contains three active substances: bictegravir, an antiretroviral medicine known as an integrase strand transfer inhibitor (INSTI) emtricitabine, an antiretroviral medicine of a type known as a nucleoside reverse transcriptase inhibitor (NRTI) tenofovir alafenamide, an antiretroviral medicine of a type known as a nucleotide reverse transcriptase inhibitor (NtRTI) Biktarvy is a single tablet for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults, adolescents and children 2 years of age and older, who weigh at least 14 kg. Biktarvy reduces the amount of HIV in your body. This will improve your immune system and reduce the risk of developing illnesses linked to HIV infection.

title:
  v: 2. What you need to know before you take Biktarvy 50 mg/200 mg/25 mg film-coated tablets
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      v: https://spor.ema.europa.eu/rmswi/
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      v: 100000155538
  text:
    v: 2. What you need to know before you take Biktarvy 50 mg/200 mg/25 mg film-coated tablets
text:
  status:
    v: additional
  div:
    v: Do not take Biktarvy If you are allergic to bictegravir, emtricitabine, tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6). If you are currently taking any of the following medicines: rifampicin used to treat some bacterial infections such as tuberculosis St. John’s wort (Hypericum perforatum), a herbal remedy used for depression and anxiety, or products that contain it. If any of these apply to you, do not take Biktarvy and tell your doctor immediately. Warnings and precautions Talk to your doctor before taking Biktarvy: If you have liver problems or a history of liver disease, including hepatitis. Patients with liver disease including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications. If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you. If you have hepatitis B infection. Liver problems may become worse after you stop taking Biktarvy Do not stop taking Biktarvy if you have hepatitis B. Talk to your doctor first. For more details, see section 3, Do not stop taking Biktarvy. If you have had kidney disease or if tests have shown problems with your kidneys. Your doctor may order blood tests to monitor how your kidneys work when starting and during treatment with Biktarvy. While you are taking Biktarvy Once you start taking Biktarvy, look out for: Signs of inflammation or infection Joint pain, stiffness or bone problems If you notice any of these symptoms, tell your doctor immediately. For more information see section 4, Possible side effects. There is a possibility that you may experience kidney problems when taking Biktarvy over a long period of time (see Warnings and precautions). This medicine is not a cure for HIV infection. While taking Biktarvy you may still develop infections or other illnesses associated with HIV infection. Children and adolescents Do not give this medicine to childr…

title:
  v: 3. How to take Biktarvy 50 mg/200 mg/25 mg film-coated tablets
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      v: https://spor.ema.europa.eu/rmswi/
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  text:
    v: 3. How to take Biktarvy 50 mg/200 mg/25 mg film-coated tablets
text:
  status:
    v: additional
  div:
    v: Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. There are two strengths of Biktarvy tablets. Your doctor will prescribe the appropriate tablet for your age and weight. The recommended dose is: Children 2 years of age and older, who weigh at least 14 kg but less than 25 kg: one tablet each day with or without food (one 30 mg/120 mg/15 mg tablet). Due to the bitter taste, it is recommended not to chew or crush the tablet. If you have difficulty swallowing the tablet whole, you can split it in half. Take both halves of the tablet one after the other to get the full dose. Do not store the split tablet. The score line on the tablet is only there to help you break the tablet if your child has difficulty swallowing it whole. The 90-day multipack contains three 30-day packs together. Get advice from a doctor or pharmacist if you are taking: antacids to treat stomach ulcers, heartburn, or acid reflux, containing aluminium and/or magnesium hydroxide mineral supplements or vitamins containing magnesium or iron See section 2 for more information on taking these medicines with Biktarvy. If you are on dialysis, take your daily dose of Biktarvy following completion of dialysis. If you take more Biktarvy than you should If you take more than the recommended dose of Biktarvy you may be at higher risk of side effects of this medicine (see section 4, Possible side effects). Contact your doctor or nearest emergency department immediately for advice. Keep or take the tablet bottle or carton with you so that you can easily describe what you have taken. If you forget to take Biktarvy It is important not to miss a dose of Biktarvy. If you miss a dose: If you notice within 18 hours of the time you usually take Biktarvy, you must take the tablet as soon as possible. Then take the next dose as usual. If you notice 18 hours or more after the time you usually take Biktarvy, then do not take the missed dose. Wait and take t…

title:
  v: 4. Possible side effects
code:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi/
      l: rmswi
    code:
      v: 100000155538
  text:
    v: 4. Possible side effects
text:
  status:
    v: additional
  div:
    v: Like all medicines, this medicine can cause side effects, although not everybody gets them. Possible side effects: tell a doctor immediately Any signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started. It is thought that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. Autoimmune disorders, when the immune system attacks healthy body tissue, may also occur after you start taking medicines for HIV infection. Autoimmune disorders may occur many months after the start of treatment. Look out for any symptoms of infection or other symptoms such as: muscle weakness weakness beginning in the hands and feet and moving up towards the trunk of the body palpitations, tremor or hyperactivity If you notice these or any symptoms of inflammation or infection, tell your doctor immediately. Common side effects (may affect up to 1 in 10 people) depression abnormal dreams headache dizziness diarrhoea feeling sick (nausea) tiredness (fatigue) Uncommon side effects (may affect up to 1 in 100 people) anaemia vomiting stomach pain problems with digestion resulting in discomfort after meals (dyspepsia) wind (flatulence) swelling of the face, lips, tongue or throat (angioedema) itching (pruritus) rash hives (urticaria) joint pain (arthralgia) suicidal thoughts and suicide attempt (particularly in patients who have had depression or mental health problems before) anxiety sleep disorders Blood tests may also show: higher levels of substances called bilirubin and/or serum creatinine in the blood Rare side effects (may affect up to 1 in 1000 people) Stevens-Johnson syndrome (SJS) is a serious life-threatening condition which usually starts with f…

title:
  v: 5. How to store Biktarvy 50 mg/200 mg/25 mg film-coated tablets
code:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi/
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    code:
      v: 100000155538
  text:
    v: 5. How to store Biktarvy 50 mg/200 mg/25 mg film-coated tablets
text:
  status:
    v: additional
  div:
    v: Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and bottle or blister strips after {EXP}. The expiry date refers to the last day of that month. Store in the original package in order to protect from moisture. Keep the bottle tightly closed. Do not use if the seal over the bottle opening is broken or missing. 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.

title:
  v: 6. Contents of the pack and other information
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    system:
      v: https://spor.ema.europa.eu/rmswi/
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      v: 100000155538
  text:
    v: 6. Contents of the pack and other information
text:
  status:
    v: additional
  div:
    v: What Biktarvy contains The active substances are bictegravir, emtricitabine and tenofovir alafenamide. Each Biktarvy tablet contains bictegravir sodium equivalent to 30 mg of bictegravir, 120 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 15 mg of tenofovir alafenamide. The other ingredients areTablet coreMicrocrystalline cellulose (E460), croscarmellose sodium (E468), magnesium stearate (E470b). Film-coatingPolyvinyl alcohol (E203), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide red (E172), iron oxide black (E172). What Biktarvy looks like and contents of the pack Biktarvy 30 mg/120 mg/15 mg film-coated tablets are pink, capsule-shaped, film-coated tablets, debossed with “BVY” on one side and a score line on the other side of the tablet. The tablets are supplied in a bottle. Not all pack sizes may be marketed. Biktarvy comes in bottles of 30 tablets and in packs made up of 3 bottles, each containing 30 tablets. Each bottle contains a silica gel desiccant that must be kept in the bottle to help protect your tablets. The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.

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