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http://hl7.eu/fhir/ig/gravitate-health/Composition/composition-en-16598f252d07b4784b82ba43cf9e847e
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title:
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      v: Package leaflet: Information for the patient Dovato 50 mg/300 mg film-coated tablets dolutegravir/lamivudine 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.
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        v: Dovato 50 mg/300 mg film-coated tablets dolutegravir/lamivudine 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.
  section:
    title:
      v: What is in this leaflet
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        v: What is in this leaflet
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        v: additional
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        v: What in this leaflet What Dovato is and what it is used for What you need to know before you take Dovato How to take Dovato Possible side effects How to store Dovato Contents of the pack and other information
  section:
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      v: 1. What Dovato is and what it is used for
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        v: 1. What Dovato is and what it is used for
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        v: Dovato is a medicine that contains two active ingredients used to treat human immunodeficiency virus (HIV) infection: dolutegravir and lamivudine. Dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs), and lamivudine belongs to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs). Dovato is used to treat HIV in adults and adolescents over 12 years old who weigh at least 40 kg. Dovato does not cure HIV infection; it keeps the amount of virus in your body at a low level. This helps maintain the number of CD4 cells in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection. Not everyone responds to treatment with Dovato in the same way. Your doctor will monitor the effectiveness of your treatment.
  section:
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      v: 2. What you need to know before you take Dovato
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        v: 2. What you need to know before you take Dovato
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        v: Do not take Dovato if you are allergic (hypersensitive) to dolutegravir or lamivudine or any of the other ingredients of this medicine (listed in section 6). If you are taking a medicine called fampridine (also known as dalfampridine; used in multiple sclerosis). If you think any of these apply to you, tell your doctor. Warnings and precautions Some people taking Dovato or other combination treatments for HIV are more at risk of serious side effects than others. You need to be aware of the extra risks: if you have moderate or severe liver disease if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, don’t stop Dovato without your doctor’s advice, as your hepatitis may come back) • if you have a kidney problem. → Talk to your doctor before using Dovato if any of these apply to you. You may need extra checkups, including blood tests, while you’re taking your medicine. See section 4 for more information. Allergic reactions Dovato contains dolutegravir. Dolutegravir can cause a serious allergic reaction known as a hypersensitivity reaction. You need to know about important signs and symptoms to look out for while you’re taking Dovato. → Read the information ‘Allergic reactions’ in section 4 of this leaflet. Look out for important symptoms Some people taking medicines for HIV infection develop other conditions, which can be serious. These include: • symptoms of infections and inflammation • joint pain, stiffness and bone problems. You need to know about important signs and symptoms to look out for while you’re taking Dovato. → Read the information ‘Other possible side effects’ in section 4 of this leaflet. Children This medicine is not for use in children under 12 years of age, because it has not been studied in these patients. Other medicines and Dovato Tell your doctor if you are taking, have recently taken or might take any other medicines. Don't take Dovato with the following medicine: fampridine (also known as dalfampridi…
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      v: 3. How to take Dovato
    code:
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        v: 3. How to take Dovato
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        v: Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose of Dovato is one tablet once a day. Swallow the tablet with some liquid. Dovato can be taken with or without food. Use in adolescents Adolescents aged between 12 and 17 years and weighing at least 40 kg can take the adult dose of one tablet once a day. Antacid medicines Antacids, to treat indigestion and heartburn, can stop Dovato being absorbed into your body and make it less effective. Do not take an antacid during the 6 hours before you take Dovato, or for at least 2 hours after you take it. You can take other acid-lowering medicines like ranitidine and omeprazole at the same time as Dovato. Talk to your doctor for further advice on taking acid-lowering medicines with Dovato. Supplements or multivitamins containing calcium, iron or magnesium Supplements or multivitamins containing calcium, iron or magnesium can stop Dovato being absorbed into your body and make it less effective. If you take Dovato with food, you can take supplements or multivitamins containing calcium, iron or magnesium at the same time as Dovato. If you do not take Dovato with food, do not take a supplement or multivitamin containing calcium, iron or magnesium during the 6 hours before you take Dovato, or for at least 2 hours after you take it. Talk to your doctor for further advice on taking supplements or multivitamins containing calcium, iron or magnesium with Dovato. If you take more Dovato than you should If you take too many tablets of Dovato contact your doctor or pharmacist for advice. If possible, show them the Dovato pack. If you forget to take Dovato If you miss a dose, take it as soon as you remember. But if your next dose is due within 4 hours, skip the dose you missed and take the next one at the usual time. Then continue your treatment as before. Do not take a double dose to make up for a forgotten dose. Don’t stop taking Dovato without adv…
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      v: 4. Possible side effects
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        v: 4. Possible side effects
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        v: additional
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        v: Like all medicines, this medicine can cause side effects, although not everybody gets them, so it is very important to talk to your doctor about any changes in your health. Allergic reactions Dovato contains dolutegravir. Dolutegravir can cause a serious allergic reaction known as a hypersensitivity reaction. This is an uncommon reaction (may affect up to 1 in 100 people) in people taking dolutegravir. If you get any of the following symptoms: skin rash a high temperature (fever) lack of energy (fatigue) swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing muscle or joint aches. See a doctor straight away. Your doctor may decide to carry out tests to check your liver, kidneys or blood, and may tell you to stop taking Dovato. Very common side effects These may affect more than 1 in 10 people: headache diarrhoea feeling sick (nausea). Common side effects These may affect up to 1 in 10 people: depression (feelings of deep sadness and unworthiness) rash itching (pruritus) being sick (vomiting) stomach (abdominal) pain or discomfort weight gain wind (flatulence) dizziness feeling drowsy difficulty sleeping (insomnia) abnormal dreams lack of energy (fatigue) hair loss anxiety joint pain muscle pain. Common side effects that may show up in blood tests are: increase in the level of liver enzymes (aminotransferases) increase in the level of enzymes produced in the muscles (creatine phosphokinase). Uncommon side effects These may affect up to 1 in 100 people: inflammation of the liver (hepatitis) suicidal attempt (particularly in patients who have had depression or mental health problems before) suicidal thoughts (particularly in patients who have had depression or mental health problems before). panic attack Uncommon side effects that may show up in blood tests are: a decreased number of cells involved in blood clotting (thrombocytopenia) a low red blood cell count (anaemia) or low white blood cell count (neutropenia). Rare side effects Thes…
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    title:
      v: 5. How to store Dovato
    code:
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        v: 5. How to store Dovato
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        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 after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. 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.
  section:
    title:
      v: 6. Contents of the pack and other information
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        v: 6. Contents of the pack and other information
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        v: Contents of the pack and other information What Dovato contains The active substances are dolutegravir and lamivudine. Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine. The other ingredients are microcrystalline cellulose, sodium starch glycolate, magnesium stearate, mannitol (E421), povidone (K29/32), sodium stearyl fumarate, hypromellose (E464), macrogol, titanium dioxide (E171). This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree’. What Dovato looks like and contents of the pack Dovato film-coated tablets are oval, biconvex, white tablets debossed with 'SV 137' on one face. The film-coated tablets are provided in bottles closed with child-resistant closures. Each bottle contains 30 film-coated tablets. Multipacks containing 90 film-coated tablets (3 packs of 30 film-coated tablets) are also available. Not all pack sizes may be available in your c ountry

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    l: Ingredient-uv-epi
text:
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identifier:
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    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 3OWL53L36A
status:
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for:
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role:
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      l: rmswi
    code:
      v: 100000072082
    display:
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substance-dolutegravirsodium
type: SubstanceDefinition
id:
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meta:
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text:
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identifier:
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    v: official
  system:
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    l: beta
  value:
    v: 1Q1V9V5WYQ
version:
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status:
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      l: publication-status
    code:
      v: active
molecular weight:
  type:
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      v: exact
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      v: 441.36
structure:
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    v: C20H18F2N305.Na
name:
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        l: beta
      code:
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substance-lamivudine
type: SubstanceDefinition
id:
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meta:
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    l: SubstanceDefinition-uv-epi
text:
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identifier:
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    v: official
  system:
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    l: beta
  value:
    v: 2T8Q726O95
version:
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status:
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      l: publication-status
    code:
      v: active
molecular weight:
  type:
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      v: exact
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    value:
      v: 229.26
structure:
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name:
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        l: beta
      code:
        v: x
      display:
        v: Chemical Name

http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f
type: AdministrableProductDefinition
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text:
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identifier:
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  value:
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status:
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form of:
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administrable dose form:
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    code:
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    display:
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unit of presentation:
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      l: rmswi
    code:
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    display:
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route of administration:
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        l: rmswi
      code:
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      display:
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http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorization49178f16170ee8a6bc2a4361c1748d5f0
type: RegulatedAuthorization
meta:
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    l: RegulatedAuthorization-uv-epi
text:
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identifier:
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  system:
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    l: pmswi
  value:
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subject:
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type:
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      l: rmswi
    code:
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    display:
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status:
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      l: publication-status
    code:
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    display:
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status date:
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http://hl7.eu/fhir/ig/gravitate-health/Organization/man-173fde4cb6b1018cb7ec8ab708d3961c
type: Organization
meta:
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    l: Organization-uv-epi
text:
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identifier:
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  system:
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    l: omswi
  value:
    v: ORG-100004538
active:
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type:
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      l: rmswi
    code:
      v: 220000000033
    display:
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name:
  v: GLAXO WELLCOME, S.A.
contact:
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      v: work
    type:
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    text:
      v: Avda. Extremadura 3, 09400 Aranda De Duero Aranda De Duero ES
    line:
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    city:
      v: Aranda De Duero
    country:
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http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-31ff1af739c7dcf77386a86f8dd83d29
type: Organization
meta:
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    l: Organization-uv-epi
text:
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identifier:
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  system:
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  value:
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active:
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type:
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    code:
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    display:
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name:
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contact:
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    use:
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    type:
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    text:
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    line:
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    city:
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    country:
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http://hl7.eu/fhir/ig/gravitate-health/Organization/mra-7c9b97127f73ff3605a10eb1c2cc24d1
type: Organization
meta:
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    l: Organization-uv-epi
text:
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identifier:
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active:
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type:
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    code:
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    display:
      v: Medicines Regulatory Authority
name:
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contact:
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    use:
      v: work
    type:
      v: physical
    text:
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    line:
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    city:
      v: Amsterdam
    postal code:
      v: 1083 HS
    country:
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http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-2977a2afce16a0bd914b8d242dd126b5
type: PackagedProductDefinition
meta:
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    l: PackagedProductDefinition-uv-epi
text:
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identifier:
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name:
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type:
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    code:
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package for:
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status:
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    code:
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    display:
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status date:
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packaging:
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    quantity:
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mp16598f252d07b4784b82ba43cf9e847e
type: MedicinalProductDefinition
id:
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meta:
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text:
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identifier:
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type:
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    code:
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    display:
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domain:
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      l: medicinal-product-domain
    code:
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status:
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    code:
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    display:
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legal status of supply:
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name:
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http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f
type: ManufacturedItemDefinition
meta:
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text:
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identifier:
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status:
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manufactured dose form:
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    code:
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unit of presentation:
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v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 1Q1V9V5WYQ

v: DOLUTEGRAVIR SODIUM

v: ACTIB

v: active ingredient - basis of strength

v: 2T8Q726O95

v: lamivudine

v: ACTIB

v: active ingredient - basis of strength

v: OP1R32D61U

v: microcrystalline cellulose

v: H8AV0SQX4D

v: sodium starch glycolate

v: 70097M6I30

v: magnesium stearate

v: 3OWL53L36A

v: mannitol

v: 100000109093

v: Human

v: 100000073504

v: Child-resistant closure

v: 200000003203

v: Glass

v: 220000000002

v: Invented name part

v: 220000000003

v: Scientific name part

v: 220000000004

v: Strength part

v: 220000000005

v: Pharmaceutical dose form part

v: urn:iso:std:iso:3166
l: 3166

v: GBR

v: United Kingdom

v: urn:iso:std:iso:3166
l: 3166

v: GBR

v: United Kingdom

v: urn:ietf:bcp:47
l: 47

v: en

v: English