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http://hl7.eu/fhir/ig/gravitate-health/Composition/composition-en-b62cc095c7be2116a8a65157286376a3
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title:
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  section:
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      v: Package leaflet: Information for the user
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        v: Package leaflet: Information for the user
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        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 sign 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: What is in this leaflet What Amoxicillin capsules is and what it is used for What you need to know before you take Amoxicillin capsules How to take Amoxicillin capsules Possible side effects How to store Amoxicillin capsules Contents of the pack and other information
  section:
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      v: 1. What amoxicillin is and what it is used for
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        v: 1. What amoxicillin is and what it is used for
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        v: What Amoxicillin capsules is and what it is used for What Amoxicillin Capsule is Amoxicillin 250 mg and 500 mg Capsules is an antibiotic. The active ingredient is amoxicillin. This belongs to a group of medicines called ‘penicillins’. What Amoxicillin Capsule is used for Amoxicillin Capsule is used to treat infections caused by bacteria in different parts of the body. Amoxicillin Capsule may also be used in combination with other medicines to treat stomach ulcers.
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        v: 2. What you need to know before you take amoxicillin
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        v: Do not take Amoxicillin capsule: if you are allergic to amoxicillin, penicillin or any of the other ingredients of this medicine (listed in section 6) if you have ever had an allergic reaction to any antibiotic. This can include a skin rash or swelling of the face or throat. Do not take Amoxicillin Capsules if any of the above apply. If you are not sure, talk to your doctor or pharmacist before taking Amoxicillin Capsules. Warnings and Precautions Talk to your doctor or pharmacist before taking Amoxicillin Capsule if you: have glandular fever (fever, sore throat, swollen glands and extreme tiredness) have kidney problems are not urinating regularly. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Amoxicillin Capsules. Blood and urine tests If you are having: Urine tests (glucose) or blood tests for liver function Oestriol tests (used during pregnancy to check the baby is developing normally) Tell your doctor or pharmacist that you are taking Amoxicillin Capsule. This is because Amoxicillin Capsule can affect the results of these tests. Other medicines and Amoxicillin Capsules Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you are taking allopurinol (used for gout) with Amoxicillin Capsules, it may be more likely that you will have an allergic skin reaction. If you are taking probenecid, (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended. Your doctor may decide to adjust your dose of Amoxicillin Capsules. If you are taking medicines to help stop blood clots (such as warfarin), you may need extra blood tests. If you are taking other antibiotics (such as tetracycline) Amoxicillin Capsules may be less effective. If you are taking methotrexate (used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate causing a potential increase in side effects. Pregnancy …
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      v: 3. How to take amoxicillin
    code:
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        v: 3. How to take amoxicillin
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        v: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Swallow with water without opening capsule. Space the doses evenly during the day, at least 4 hours apart. The recommended dose is: Children weighing less than 40 kg All doses are worked out depending on the child’s body weight in kilograms. Your doctor will advise you how much Amoxicillin Capsules you should give to your baby or child. The usual dose is 40 mg to 90 mg for each kilogram of body weight a day, given in two or three divided doses. The maximum recommended dose is 100 mg for each kilogram of body weight a day. Adults, elderly patients and children weighing 40 kg or more The usual dose of Amoxicillin Capsules is 250 mg to 500 mg three times a day or 750 mg to 1 g every 12 hours, depending on the severity and type of infection. Severe infections: 750 mg to 1 g three times a day. Urinary tract infection: 3 g twice daily for one day. Lyme disease (an infection spread by parasites called ticks): Isolated erythema migrans (early stage – red or pink circular rash): 4 g a day, Systemic manifestations (late stage – for more serious symptoms or when the disease spreads around your body): up to 6 g a day. Stomach ulcers: one 750 mg or one 1 g dose twice a day for 7 days with other antibiotics and medicines to treat stomach ulcers. To prevent heart infection during surgery: the dose will vary according to the type of surgery. Other medicines may also be given at the same time. Your doctor, pharmacist or nurse can give you more details. The maximum recommended dose is 6 g per day. Kidney problems If you have kidney problems the dose might be lower than the usual dose. If you take more Amoxicillin Capsules than you should If you have taken too much Amoxicillin Capsules, signs might be an upset stomach (feeling sick, being sick or diarrhoea) or crystals in the urine, which may be seen as cloudy urine, or problems urinating. Talk to your…
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      v: 4. Possible side effects
    code:
      text:
        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. Stop taking Amoxicillin Capsules and see a doctor straight away, if you notice any of the following serious side effects – you may need urgent medical treatment: The following are very rare (may affect up to 1 in 10,000 people) allergic reactions, the signs may include: skin itching or rash, swelling of the face, lips, tongue, body or breathing difficulties. These can be serious and occasionally deaths have occurred rash or pinpoint flat red round spots under the skin surface or bruising of the skin. This is due to inflammation of blood vessel walls due to an allergic reaction. It can be associated with joint pain (arthritis) and kidney problems a delayed allergic reaction can occur usually 7 to 12 days after having Amoxicillin Capsules, some signs include: rashes, fever, joint pains and enlargement of the lymph nodes especially under the arms a skin reaction known as ‘erythema multiforme’ where you may develop: itchy reddish purple patches on the skin especially on the palms of the hands or soles of the feet, ‘hive-like’raised swollen areas on the skin, tender areas on the surfaces of the mouth, eyes and genitals. You may have a fever and be very tired other severe skin reactions can include: changes in skin colour, bumps under the skin, blistering, pustules, peeling, redness, pain, itching, scaling. These may be associated with fever, headaches and body aches flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)). high temperature (fever), chills, a sore throat or other signs of an infection, or if you bruise easily. These may be signs of a problem with your blood cells the Jarisch-Herxheimer reaction which occur during treatment with Amoxicillin Capsules for Lyme disease and causes fever, chills, headache, m…
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    title:
      v: 5. How to store amoxicillin
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        v: 5. How to store amoxicillin
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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 after EXP. The expiry date refers to the last day of that month. Store in the original pack below 30°C. Do not use this medicine if you notice visible signs of deterioration. Do not throw away any medicines via waste water 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
    code:
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        v: 6. Contents of the pack and other information
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    v: Generated Narrative: Ingredient ingredient-for-amox-silicondioxide Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/ETJ7Z6XBU4 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#106036 (use: official, ); status = active; manufacturedDoseForm = Capsule; unitOfPresentation = Capsule MedicinalProductDefinition: identifier = http://fakesys.com/ids#hack-1; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#10637; status = active; administrableDoseForm = Capsule; unitOfPresentation = Capsule role: Excipient substance Codes - Concept * Silicon dioxide
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: ETJ7Z6XBU4
status:
  v: active
for:
  l: mpb62cc095c7be2116a8a65157286376a3
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-amox-titaniumdioxide
type: Ingredient
id:
  v: ingredient-for-amox-titaniumdioxide
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-amox-titaniumdioxide Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/15FIX9V2JP (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#106036 (use: official, ); status = active; manufacturedDoseForm = Capsule; unitOfPresentation = Capsule MedicinalProductDefinition: identifier = http://fakesys.com/ids#hack-1; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#10637; status = active; administrableDoseForm = Capsule; unitOfPresentation = Capsule role: Excipient substance Codes - Concept * Titanium Dioxide
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 15FIX9V2JP
status:
  v: active
for:
  l: mpb62cc095c7be2116a8a65157286376a3
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-amox-magnesiumstearate
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:
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    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-amox-magnesiumstearate Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/70097M6I30 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#106036 (use: official, ); status = active; manufacturedDoseForm = Capsule; unitOfPresentation = Capsule MedicinalProductDefinition: identifier = http://fakesys.com/ids#hack-1; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#10637; status = active; administrableDoseForm = Capsule; unitOfPresentation = Capsule role: Excipient substance Codes - Concept * Magnesium stearate
identifier:
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    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
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status:
  v: active
for:
  l: mpb62cc095c7be2116a8a65157286376a3
role:
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      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-amox-carnaubawax
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-amox-carnaubawax Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/R12CBM0EIZ (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#106036 (use: official, ); status = active; manufacturedDoseForm = Capsule; unitOfPresentation = Capsule MedicinalProductDefinition: identifier = http://fakesys.com/ids#hack-1; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#10637; status = active; administrableDoseForm = Capsule; unitOfPresentation = Capsule role: Excipient substance Codes - Concept * Carnauba wax
identifier:
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    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: R12CBM0EIZ
status:
  v: active
for:
  l: mpb62cc095c7be2116a8a65157286376a3
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

substance-amoxicillin
type: SubstanceDefinition
id:
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meta:
  profile:
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    l: SubstanceDefinition-uv-epi
text:
  status:
    v: generated
  div:
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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: 804826J2HU
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active

http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-b62cc095c7be2116a8a65157286376a3
type: AdministrableProductDefinition
meta:
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    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi
    l: AdministrableProductDefinition-uv-epi
text:
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  div:
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identifier:
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    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: 10637
status:
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form of:
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administrable dose form:
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    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 200000016452
    display:
      v: Capsule
unit of presentation:
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    system:
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      l: rmswi
    code:
      v: 200000002113
    display:
      v: Capsule
route of administration:
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        l: rmswi
      code:
        v: 100000073619
      display:
        v: Oral use

http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorizationb62cc095c7be2116a8a65157286376a30
type: RegulatedAuthorization
meta:
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    l: RegulatedAuthorization-uv-epi
text:
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  div:
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identifier:
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    v: official
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: hack-1
subject:
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type:
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    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 220000000061
    display:
      v: Marketing Authorisation
status:
  coding:
    system:
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      l: publication-status
    code:
      v: active
    display:
      v: Active
status date:
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http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-0880223fada9f23e0f3760dee80fc7a3
type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi
    l: Organization-uv-epi
text:
  status:
    v: generated
  div:
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identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/omswi
    l: omswi
  value:
    v: ORG-100000789
active:
  v: true
type:
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    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 220000000034
    display:
      v: Marketing authorisation holder
name:
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contact:
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    use:
      v: work
    type:
      v: physical
    text:
      v: street x and y Paris FR
    line:
      v: street x and y
    city:
      v: Paris
    country:
      v: FR

http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-eac9778d48eb0b894852b7d0d82c3aa8
type: PackagedProductDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi
    l: PackagedProductDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: PackagedProductDefinition ppd-eac9778d48eb0b894852b7d0d82c3aa8 Profile: PackagedProductDefinition (ePI) identifier: https://spor.ema.europa.eu/pmswi/10637 (use: official, ) name: amoxicillin 250 mg tablets 15 type: Chemical Medicinal Product packageFor: MedicinalProductDefinition: identifier = http://fakesys.com/ids#hack-1; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription status: Active statusDate: 2015-02-07 13:28:17+0000 containedItemQuantity: 250 mg (Details: UCUM codemg = 'mg') packaging type: Box quantity: 1 material: Cardboard packaging identifier: https://spor.ema.europa.eu/pmswi/123456 type: Blister quantity: 15 material: PolyVinyl Chloride containedItem Items - Reference * ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#106036 (use: official, ); status = active; manufacturedDoseForm = Capsule; unitOfPresentation = Capsule
identifier:
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    v: official
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: 10637
name:
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type:
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    system:
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      l: rmswi
    code:
      v: 100000155527
    display:
      v: Chemical Medicinal Product
package for:
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status:
  coding:
    system:
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      l: publication-status
    code:
      v: active
    display:
      v: Active
status date:
  v: 2015-02-07T13:28:17Z
contained item quantity:
  value:
    v: 250
  system:
    v: http://unitsofmeasure.org
    l: unitsofmeasure.org
  code:
    v: mg
packaging:
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    coding:
      system:
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        l: rmswi
      code:
        v: 100000073498
      display:
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  quantity:
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  material:
    coding:
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        l: rmswi
      code:
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      display:
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        l: pmswi
      value:
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    quantity:
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mpb62cc095c7be2116a8a65157286376a3
type: MedicinalProductDefinition
id:
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meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi
    l: MedicinalProductDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: MedicinalProductDefinition mpb62cc095c7be2116a8a65157286376a3 Profile: MedicinalProductDefinition (ePI) identifier: http://fakesys.com/ids/hack-1 type: Medicinal Product domain: Human use status: active legalStatusOfSupply: Medicinal product subject to medical prescription name productName: amoxicillin 250 mg tablets type: Full name part part: Amoxicillin type: Invented name part part part: AMOXY type: Scientific name part part part: 250 mg type: Strength part part part: tablet type: Pharmaceutical dose form part Usages - Country Jurisdiction Language * United kingdom United kingdom English
identifier:
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    v: http://fakesys.com/ids
    l: ids
  value:
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type:
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    system:
      v: http://hl7.org/fhir/medicinal-product-type
      l: medicinal-product-type
    code:
      v: MedicinalProduct
    display:
      v: Medicinal Product
domain:
  coding:
    system:
      v: http://hl7.org/fhir/medicinal-product-domain
      l: medicinal-product-domain
    code:
      v: Human
    display:
      v: Human use
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active
    display:
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legal status of supply:
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      l: rmswi
    code:
      v: 100000072084
    display:
      v: Medicinal product subject to medical prescription
name:
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  type:
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        l: https://spor.ema.europa.eu/lists/220000000000
      code:
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      display:
        v: Full name
  part:
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      v: Amoxicillin
  part:
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      v: AMOXY
  part:
    part:
      v: 250 mg
  part:
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http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-b62cc095c7be2116a8a65157286376a3
type: ManufacturedItemDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi
    l: ManufacturedItemDefinition-uv-epi
text:
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  div:
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identifier:
  use:
    v: official
  system:
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    l: pmswi
  value:
    v: 106036
status:
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manufactured dose form:
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    system:
      v: https://spor.ema.europa.eu/rmswi/
      l: rmswi
    code:
      v: 200000016452
    display:
      v: Capsule
unit of presentation:
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    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 200000002113
    display:
      v: Capsule

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: unavailable

v: M28OL1HH48

v: Croscarmellose sodium

v: OP1R32D61U

v: Microcrystalline cellulose

v: 804826J2HU

v: AMOXICILLIN

v: ACTIB

v: active ingredient - basis of strength

v: 3NXW29V3WO

v: Hypromellose

v: SA1B764746

v: Macrogol 3000

v: EWQ57Q8I5X

v: Lactose Monohydrate

v: ETJ7Z6XBU4

v: Silicon dioxide

v: 15FIX9V2JP

v: Titanium Dioxide

v: 70097M6I30

v: Magnesium stearate

v: R12CBM0EIZ

v: Carnauba wax

v: 100000109093

v: Human

v: 100000073496

v: Blister

v: 200000003222

v: PolyVinyl Chloride

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: UK

v: United kingdom

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

v: UK

v: United kingdom

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

v: en

v: English