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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 using this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. Your doctor will also give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with Remsima. When starting a new card, keep this card as a reference for 4 months after your last dose of Remsima. If you have any further questions, ask your doctor, pharmacist or nurse. 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, pharmacist or nurse. This includes any possible side efects not listed in this leaflet. See section 4.
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      v: What is in this leaflet
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        v: What is in this leaflet
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        v: What is in this leaflet What Remsima is and what it is used for What you need to know before you use Remsima How to use Remsima Possible side effects How to store Remsima Contents of the pack and other information Instructions for use
  section:
    title:
      v: 1. What Remsima 100 mg powder for concentrate for solution for infusion is and what it is used for
    code:
      text:
        v: 1. What Remsima 100 mg powder for concentrate for solution for infusion is and what it is used for
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        v: Remsima contains the active substance infliximab. Infliximab is a monoclonal antibody - a type of protein that attaches to a specific target in the body called TNF (tumour necrosis factor) alpha. Remsima belongs to a group of medicines called ‘TNF blockers’. It is used in adults for the following inflammatory diseases: Rheumatoid arthritis Psoriatic arthritis Ankylosing spondylitis (Bechterew’s disease) Psoriasis Crohn’s disease Ulcerative colitis. Remsima works by selectively attaching to TNF alpha and blocking its action. TNF alpha is involved in inflammatory processes of the body so blocking it can reduce the inflammation in your body. Rheumatoid arthritisRheumatoid arthritis is an inflammatory disease of the joints. If you have active rheumatoid arthritis you will first be given other medicines. If these medicines do not work well enough, you will be given Remsima which you will take with another medicine called methotrexate to: reduce the signs and symptoms of your disease, slow down the damage in your joints, improve your physical function. Psoriatic arthritisPsoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. If you have active psoriatic arthritis you will first be given other medicines. If these medicines do not work well enough, you will be given Remsima to: reduce the signs and symptoms of your disease, slow down the damage in your joints, improve your physical function. Ankylosing spondylitis (Bechterew’s disease)Ankylosing spondylitis is an inflammatory disease of the spine. If you have ankylosing spondylitis you will first be given other medicines. If these medicines do not work well enough, you will be given Remsima to: reduce the signs and symptoms of your disease, improve your physical function. PsoriasisPsoriasis is an inflammatory disease of the skin. If you have moderate to severe plaque psoriasis, you will first be given other medicines or treatments, such as phototherapy. If these medicines or treatmen…
  section:
    title:
      v: 2. What you need to know before you take Remsima 100 mg powder for concentrate for solution for infusion
    code:
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        v: 2. What you need to know before you take Remsima 100 mg powder for concentrate for solution for infusion
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        v: You must not use Remsima if you are allergic to infliximab or any of the other ingredients of this medicine (listed in section 6), you are allergic to proteins that come from mice, you have tuberculosis (TB) or another serious infection such as pneumonia or sepsis (serious bacterial infection of the blood), you have heart failure that is moderate or severe. Do not use Remsima if any of the above applies to you. If you are not sure, talk to your doctor before you are given Remsima. Warnings and precautions Talk to your doctor before or during treatment with Remsima if you have: Had treatment with any medicine containing infliximab before Tell your doctor if you have had treatment with medicines containing infliximab in the past and are now starting Remsima treatment again. If you have had a break in your treatment with infliximab of more than 16 weeks, there is a higher risk for allergic reactions when you start the treatment again. Local injection site reactions Some patients receiving infliximab via injection under the skin have experienced local injection site reactions. Signs of a local injection site reaction can include redness, pain, itching, swelling, hardness, bruising, bleeding, cold sensation, tingling sensation, irritation, rash, ulcer, hives, blisters and scab on the skin of the injection site. Most of these reactions are mild to moderate and mostly resolve on their own within a day. Infections Tell your doctor before you are given Remsima if you have an infection even if it is a very minor one. Tell your doctor before you are given Remsima if you have ever lived in or travelled to an area where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common. These infections are caused by specific types of fungi that can affect the lungs or other parts of your body. You may get infections more easily when you are being treated with Remsima. If you are 65 years of age or older, you have a greater risk. These infections may be serious an…
  section:
    title:
      v: 3. How to take Remsima 100 mg powder for concentrate for solution for infusion
    code:
      text:
        v: 3. How to take Remsima 100 mg powder for concentrate for solution for infusion
    text:
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        v: additional
      div:
        v: Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Rheumatoid arthritis Your doctor will start your treatment with or without two Remsima intravenous infusion doses of 3 mg for every kg of body weight (given to you into a vein, usually in your arm, over a period of 2 hours). If Remsima intravenous infusion doses are given to start the treatment, they are administered 2 weeks apart via intravenous infusion. After 4 weeks from the last intravenous infusion, you will be given Remsima via injection under the skin (subcutaneous injection). The usual recommended dose of Remsima subcutaneous injection is 120 mg once every 2 weeks regardless of weight. Psoriatic arthritis, ankylosing spondylitis (Bechterew’s disease) and psoriasis Your doctor will start your treatment with two Remsima intravenous infusion doses of 5 mg for every kg of body weight (given to you into a vein, usually in your arm, over a period of 2 hours). They are administered 2 weeks apart via intravenous infusion. After 4 weeks from the last intravenous infusion, you will be given Remsima via injection under the skin (subcutaneous injection). The usual recommended dose of Remsima subcutaneous injection is 120 mg once every 2 weeks regardless of weight. Crohn’s disease and ulcerative colitis Your doctor will start your treatment with two Remsima intravenous infusion doses of 5 mg for every kg of body weight (given to you into a vein, usually in your arm, over a period of 2 hours). They are administered 2 weeks apart via intravenous infusion. After 4 weeks from the last intravenous infusion, you will be given Remsima via injection under the skin (subcutaneous injection). The usual recommended dose of Remsima subcutaneous injection is 120 mg once every 2 weeks regardless of weight. How Remsima is given Remsima 120 mg solution for injection is administered by injection under the skin (subcutaneous use) only. It is important to check the product labels to en…
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      v: 4. Possible side effects
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        v: 4. Possible side effects
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        v: Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However some patients may experience serious side effects and may require treatment. Side effects may also occur after your treatment with Remsima has stopped. Tell your doctor straight away if you notice any of the following: Signs of an allergic reaction such as swelling of your face, lips, mouth or throat which may cause difficulty in swallowing or breathing, skin rash, hives, swelling of the hands, feet or ankles. Some of these reactions may be serious or life-threatening. An allergic reaction could happen within 2 hours of your injection or later. More signs of allergic side effects that may happen up to 12 days after your injection include pain in the muscles, fever, joint or jaw pain, sore throat or headache. Signs of a local injection site reaction such as redness, pain, itching, swelling, hardness, bruising, bleeding, cold sensation, tingling sensation, irritation, rash, ulcer, hives, blisters and scab. Signs of a heart problem such as chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea (feeling sick), vomiting, fluttering or pounding in your chest, a fast or a slow heartbeat, and swelling of your feet. Signs of infection (including TB) such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, collection of pus in the gut or around the anus (abscess), dental problems or burning sensation when urinating. Possible signs of cancer including but not limited to swelling of lymph nodes, weight loss, fever, unusual skin nodules, changes in moles or skin colouring, or unusual vaginal bleeding. Signs of a lung problem such as coughing, breathing difficulties or tightness in the chest. Signs of a nervous system problem (including eye problems) such as signs of a stroke…
  section:
    title:
      v: 5. How to store Remsima 100 mg powder for concentrate for solution for infusion
    code:
      text:
        v: 5. How to store Remsima 100 mg powder for concentrate for solution for infusion
    text:
      status:
        v: additional
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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 label and the carton after “EXP”. The expiry date refers to the last day of that month. Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the medicinal product in its outer carton to protect from light. This medicine can also be stored in the original carton outside of refrigerated storage up to a maximum of 25°C for a single period of up to 28 days, but not beyond the original expiry date. In this situation, do not return to refrigerated storage again. Write the new expiry date on the carton including day/month/year. Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier. 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: What Remsima contains The active substance is infliximab. Each 1 ml single dose pre-filled syringe contains 120 mg of infliximab. The other ingredients are acetic acid, sodium acetate trihydrate, sorbitol, polysorbate 80 and water for injections. What Remsima looks like and contents of the pack Remsima is a clear to opalescent, colourless to pale brown solution which is supplied as a single use pre-filled syringe. Each pack contains 1 pre-filled syringe with 2 alcohol pads, 2 pre-filled syringes with 2 alcohol pads, 4 pre-filled syringes with 4 alcohol pads or 6 pre-filled syringes with 6 alcohol pads. Each pack contains 1 pre-filled syringe with automatic needle guard with 2 alcohol pads, 2 pre-filled syringes with automatic needle guard with 2 alcohol pads, 4 pre-filled syringes with automatic needle guard with 4 alcohol pads or 6 pre-filled syringes with automatic needle guard with 6 alcohol pads. Not all pack sizes may be marketed

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      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

substance-infliximab
type: SubstanceDefinition
id:
  v: substance-infliximab
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi
    l: SubstanceDefinition-uv-epi
text:
  status:
    v: generated
  div:
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identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: B72HH48FLU
version:
  v: 1
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active
structure:
  molecular formula:
    v: C6458H9934N1728O2040S44
name:
  name:
    v: IMMUNOGLOBULIN G (HUMAN-MOUSE MONOCLONAL CA2 HEAVY CHAIN ANTI-HUMAN TUMOR NECROSIS FACTOR), DISULFIDE WITH HUMAN-MOUSE MONOCLONAL CA2 LIGHT CHAIN, DIMER
  type:
    coding:
      system:
        v: https://gsrs.ncats.nih.gov/ginas/app/beta/
        l: beta
      code:
        v: x
      display:
        v: Chemical Name

http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-e3e5e78d4e002ed9e15b925cd546e20b
type: AdministrableProductDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi
    l: AdministrableProductDefinition-uv-epi
text:
  status:
    v: generated
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identifier:
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
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status:
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form of:
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administrable dose form:
  coding:
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      l: rmswi
    code:
      v: 100000074029
    display:
      v: Powder for concentrate for solution for infusion
unit of presentation:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 200000002158
    display:
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route of administration:
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    coding:
      system:
        v: https://spor.ema.europa.eu/rmswi
        l: rmswi
      code:
        v: 100000073611
      display:
        v: Intravenous use

http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorizatione3e5e78d4e002ed9e15b925cd546e20b0
type: RegulatedAuthorization
meta:
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    l: RegulatedAuthorization-uv-epi
text:
  status:
    v: generated
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identifier:
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    v: official
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: EU/1/13/853/001
subject:
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type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072062
    display:
      v: Marketing Authorisation
status:
  coding:
    system:
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      l: publication-status
    code:
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    display:
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status date:
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type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi
    l: Organization-uv-epi
text:
  status:
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  div:
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identifier:
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    v: official
  system:
    v: https://spor.ema.europa.eu/omswi
    l: omswi
  value:
    v: ORG-100000826
active:
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type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 220000000034.0
    display:
      v: Marketing authorisation holder
name:
  v: Celltrion Healthcare Hungary Kft.
contact:
  address:
    use:
      v: work
    type:
      v: physical
    text:
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    line:
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    city:
      v: Budapest
    postal code:
      v: 1062
    country:
      v: HU

http://hl7.eu/fhir/ig/gravitate-health/Organization/mra-e3da03c458d6c0f3c5f1c39a2c6a1084
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-100013412
active:
  v: true
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: nan
    display:
      v: Medicines Regulatory Authority
name:
  v: European Medicines Agency
contact:
  address:
    use:
      v: work
    type:
      v: physical
    text:
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    line:
      v: Carretera De Martorell 41 61, Poligono Industrial Nord-Est
    city:
      v: Amsterdam
    postal code:
      v: 1083 HS
    country:
      v: NL

http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-515e8ffbb9f74e0d03d7ec46f9b79d8f
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:
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identifier:
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    v: official
  system:
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    l: pmswi
  value:
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name:
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type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000155527
    display:
      v: Chemical Medicinal Prodcut
package for:
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status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active
    display:
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status date:
  v: 2012-02-07T13:28:17Z
contained item quantity:
  value:
    v: 1
  system:
    v: http://unitsofmeasure.org
    l: unitsofmeasure.org
  code:
    v: {vial}
packaging:
  type:
    coding:
      system:
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        l: rmswi
      code:
        v: 100000073498
      display:
        v: Box
  quantity:
    v: 1
  material:
    coding:
      system:
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        l: rmswi
      code:
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      display:
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  packaging:
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        l: pmswi
      value:
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    quantity:
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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:
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identifier:
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  value:
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identifier:
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    l: phpid
  value:
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type:
  coding:
    system:
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      l: medicinal-product-type
    code:
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    display:
      v: Medicinal Product
domain:
  coding:
    system:
      v: http://hl7.org/fhir/medicinal-product-domain
      l: medicinal-product-domain
    code:
      v: Human
    display:
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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:
  coding:
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      l: rmswi
    code:
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    display:
      v: Medicinal product subject to medical prescription
name:
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    v: Remsima 100 mg powder for concentrate for solution for infusion
  type:
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        l: https://spor.ema.europa.eu/lists/220000000000
      code:
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      display:
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  part:
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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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identifier:
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    v: official
  system:
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    l: pmswi
  value:
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status:
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manufactured dose form:
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    code:
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    display:
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unit of presentation:
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    code:
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v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: B72HH48FLU

v: INFLIXIMAB

v: ACTIB

v: active ingredient - basis of strength

v: 94255I6E2T

v: Disodium phosphate dihydrate

v: 593YOG76RN

v: Sodium dihydrogen phosphate monohydrate

v: 6OZP39ZG8H

v: POLYSORBATE 80

v: C151H8M554

v: Sucrose

v: 100000109093

v: Human

v: 100000073504

v: Child-resistant closure

v: 200000003529

v: Cardboard

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