bundlepackageleafletxyntha
type: Bundle
node role: treeRoot
id:
  v: bundlepackageleafletxyntha
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi
    l: Bundle-uv-epi
language:
  v: en
identifier:
  system:
    v: https://www.jordan.gov.jo/
    l: www.jordan.gov.jo
  value:
    v: xyntha
type:
  v: document
timestamp:
  v: 2020-09-01T00:00:00Z
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Composition/compositionpmixyntha
    l: compositionpmixyntha
  resource: compositionpmixyntha
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Organization/organizationwyeth
    l: organizationwyeth
  resource: organizationwyeth
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Organization/organizationpfizercanada
    l: organizationpfizercanada
  resource: organizationpfizercanada
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Binary/binarypfizerlogo
    l: binarypfizerlogo
  resource: binarypfizerlogo
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Binary/binaryimage003
    l: binaryimage003
  resource: binaryimage003
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Binary/binaryimage004
    l: binaryimage004
  resource: binaryimage004
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Binary/binaryimage006
    l: binaryimage006
  resource: binaryimage006
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Binary/binaryimage007
    l: binaryimage007
  resource: binaryimage007
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Binary/binaryimage008
    l: binaryimage008
  resource: binaryimage008
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Binary/binaryimage010
    l: binaryimage010
  resource: binaryimage010
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Binary/binaryimage012a
    l: binaryimage012a
  resource: binaryimage012a
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Binary/binaryimage012b
    l: binaryimage012b
  resource: binaryimage012b
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Binary/binaryimage013
    l: binaryimage013
  resource: binaryimage013
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Binary/binaryimage0014
    l: binaryimage0014
  resource: binaryimage0014

compositionpmixyntha
type: Composition
id:
  v: compositionpmixyntha
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi
    l: Composition-uv-epi
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Composition compositionpmixyntha Language: en Profile: Composition (ePI) identifier: https://www.jordan.gov.jo//0d69fdcb-33cf-407f-8209-a6529856ab4f status: Final type: Package Leaflet date: 2020-09-01 00:00:00+0000 author: Organization Pfizer Canada ULC. Organization Manufactured, Packaged and Released By Wyeth Farma S.A title: Patient Medicination Information Xyntha® Lyophilized Powder for Reconstitution in a Vial
identifier:
  system:
    v: https://www.jordan.gov.jo/
    l: www.jordan.gov.jo
status:
  v: final
type:
  coding:
    system:
      v: https://www.jordan.gov.jo/
      l: www.jordan.gov.jo
    code:
      v: 100000155538
  text:
    v: Package Leaflet
date:
  v: 2020-09-01T00:00:00Z
author:
  l: organizationpfizercanada
  reference:
    v: Organization/organizationpfizercanada
author:
  l: organizationwyeth
  reference:
    v: Organization/organizationwyeth
title:
  v: Patient Medicination Information Xyntha® Lyophilized Powder for Reconstitution in a Vial
section:
  title:
    v: TITLE PAGE
  code:
    coding:
      system:
        v: https://www.jordan.gov.jo/
        l: www.jordan.gov.jo
      code:
        v: 100000155538
    text:
      v: Title Page
  text:
    status:
      v: additional
    div:
      v: Xyntha® Lyophilized Powder for Reconstitution in a Vial 250, 500, 1000, or 2000 IU in single-use vials and one pre-filled diluent syringe containing 4 mL 0.9% Sodium Chloride for reconstitution* Antihemophilic Factor (Recombinant) [BDDrFVIII] For Intravenous Injection Antihemorrhagic Blood Coagulation Factor VIII Reference Market: Canada
section:
  title:
    v: PACKAGE LEAFLET
  code:
    coding:
      system:
        v: https://www.jordan.gov.jo/
        l: www.jordan.gov.jo
      code:
        v: 100000155538
    text:
      v: Package leaflet
  text:
    status:
      v: additional
    div:
      v: Xyntha® Moroctocog alfa, Antihemophilic Factor (Recombinant) Xyntha 250, 500, 1000, & 2000 IU Powder and Solvent for Solution for Injection This leaflet is a summary and will not tell you everything about Xyntha. Contact your doctor or hemophilia treatment center if you have any questions about the drug.
section:
  title:
    v: ABOUT THIS MEDICATION
  code:
    coding:
      system:
        v: https://www.jordan.gov.jo/
        l: www.jordan.gov.jo
      code:
        v: 100000155538
    text:
      v: ABOUT THIS MEDICATION
  text:
    status:
      v: additional
    div:
      v: What the medication is used for: Coagulation Factor VIII is a protein that is necessary for blood to clot. People who have the hereditary bleeding disease factor VIII deficiency (hemophilia A) lack this clotting factor, causing their blood to take longer to form a clot. Xyntha is a form of coagulation factor VIII. Xyntha is used for the control and treatment of bleeding and the routine and surgical prevention of bleeding in people with hemophilia A. What is does: Administering Xyntha increases blood levels of factor VIII and helps prevent and control bleeding episodes in patients with hemophilia A. Xyntha has the same clot-promoting effects as factor VIII protein made from human plasma. When it should not be used: You should not take Xyntha unless your doctor confirms you have hemophilia A. Xyntha should not be used for the treatment of other clotting factor deficiencies such as von Willebrand’s disease or hemophilia B. Xyntha is produced in hamster cells and may contain trace amounts of hamster proteins. Patients who have a known history of allergic reactions to hamster proteins should not take Xyntha. Your doctor will advise you if you have had allergic reactions to hamster proteins. Do not use Xyntha after the expiry date printed on the pack. Do not use Xyntha if the packaging is torn or shows signs of tampering. What the medicinal ingredient is: Xyntha is a coagulation factor VIII product that is produced by recombinant technology. Xyntha does not contain any human blood or plasma, albumin, preservatives, or added animal or human components in the final product, making it naturally free from the risk of transmission of blood-borne pathogens such as human immunodeficiency virus (HIV), hepatitis viruses, and parvovirus. What the important nonmedicinal ingredients are: Polysorbate 80 (0.4 mg/vial), Sucrose (12 mg/vial), L-Histidine (6 mg/vial), Calcium Chloride Dihydrate (1 mg/vial), Sodium Chloride (72 mg/vial) [after reconstitution with diluent]. What dosage form…
section:
  title:
    v: WARNINGS AND PRECAUTIONS
  code:
    coding:
      system:
        v: https://www.jordan.gov.jo/
        l: www.jordan.gov.jo
      code:
        v: 100000155538
    text:
      v: WARNINGS AND PRECAUTIONS
  text:
    status:
      v: additional
    div:
      v: Serious Warnings and Precautions Xyntha may cause allergic reactions. Signs of allergy include hives (rash with itching), swelling, chest tightness, difficulty breathing, wheezing, faintness, and rapid heart rate. If any of these symptoms occur, stop using Xyntha immediately and contact your hemophilia doctor or seek emergency medical care. The initial infusions of Xyntha should be administered under proper medical supervision, where proper medical care for allergic reactions could be provided. Notify your hemophilia doctor if you are unable to prevent or control episodes of bleeding with your normal dose of Xyntha. Your body may produce inhibitors against Xyntha. Inhibitors are antibodies produced by your immune system that can prevent Xyntha from working properly. Check with your hemophilia doctor to make sure you are closely monitored with blood tests for the presence of inhibitors. BEFORE you use Xyntha talk to your hemophilia doctor if: You are pregnant or planning to become pregnant. It is not known whether Xyntha can affect your ability to have children or harm your developing baby. You are breastfeeding or planning to breast feed. It is not known whether Xyntha passes into breast milk. You are taking other medicines. Tell your hemophilia doctor if you are taking any other medicines or naturopathic products, including any that you buy without a prescription from your pharmacy, supermarket, or health food shop. Your hemophilia doctor will advise you whether or not to take Xyntha or if you need to adjust the dose, or adapt your treatment.
  section:
    title:
      v: INTERACTIONS WITH THIS MEDICATION
    code:
      text:
        v: INTERACTIONS WITH THIS MEDICATION
    text:
      status:
        v: additional
      div:
        v: No interactions of Xyntha with other medicinal products are known.
section:
  title:
    v: PROPER USE OF THIS MEDICATION
  code:
    coding:
      system:
        v: https://www.jordan.gov.jo/
        l: www.jordan.gov.jo
      code:
        v: 100000155538
    text:
      v: PROPER USE OF THIS MEDICATION
  text:
    status:
      v: additional
    div:
      v: You should always follow the specific instructions given by your hemophilia doctor. The steps listed below are general guidelines for using Xyntha. If you are unsure of the procedures, please call your hemophilia doctor or nurse before using. Your hemophilia doctor will decide the dose of Xyntha you will receive. The dose and duration of Xyntha treatment will depend on your individual need for replacement factor VIII therapy. Your hemophilia doctor may decide to change your dose of Xyntha. In the presence of an inhibitor, you may need higher doses or specific treatment. Contact your hemophilia doctor or nurse immediately if bleeding is not controlled after using Xyntha. Do not stop taking Xyntha or lower your dose, without checking with your hemophilia doctor, unless you think you are having an allergic reaction. Your doctor may occasionally need to take blood tests to make sure that the level of factor VIII in your blood is high enough to allow normal blood clotting. Each Xyntha vial kit contains: 1 vial of Xyntha powder 1 syringe pre-filled with 4 mL of sodium chloride diluent 1 plunger rod for the syringe 1 vial adapter 1 sterile infusion set 2 alcohol swabs 1 bandage 1 gauze 1 package insert Xyntha Hospital pack contains: 3 vial of Xyntha powder 3 syringe pre-filled with 4 mL of sodium chloride diluent 3 plunger rods for the syringe 3 vial adapters 1 package insert Xyntha Hospital pack does not contain: sterile infusion set (tubing and butterfly needle) alcohol swabs bandage gauze Not all strengths/pack sizes may be marketed. Xyntha is supplied in a sterile, freeze-dried powder form, and it is intended for injection directly into your vein, usually either by yourself, your doctor, your hemophilia nurse, or other trained person. Before it can be injected, the powder must be dissolved with the liquid diluent supplied (0.9% sodium chloride) to make it an injectable liquid. An infusion set (tubing and butterfly needle), sterile alcohol swabs, gauze pads and bandages…
section:
  title:
    v: SIDE EFFECTS AND WHAT TO DO ABOUT THEM
  code:
    coding:
      system:
        v: https://www.jordan.gov.jo/
        l: www.jordan.gov.jo
      code:
        v: 100000155538
    text:
      v: SIDE EFFECTS AND WHAT TO DO ABOUT THEM
  text:
    status:
      v: additional
    div:
      v: Xyntha may cause allergic reactions. Some side effects of Xyntha include cold sensation, chest pain, rapid heart beat, sweating, drowsiness, muscle weakness, loss of appetite, muscle pain, pain, coughing, shortness of breath, diarrhea, stomach cramps, altered taste, injection site pain or inflammation and weakness. Contact your hemophilia doctor immediately if your bleeding does not stop as expected. Your body can also produce inhibitors, or antibodies, against Xyntha, which may prevent Xyntha from working properly. If your bleeding is not controlled with the usual dose of Xyntha, call your hemophilia doctor or nurse. You should be monitored in order to find out whether a factor VIII inhibitor is present. These are not all the possible side effects of Xyntha. Call your hemophilia doctor or nurse right away if any side effect becomes serious, if you notice any side effects not listed in this leaflet, or if there is any other side effect that concerns you. Tell all your doctors, dentists, and pharmacists who are treating you that you are taking Xyntha. If you are about to start taking any new medication, tell your doctor and pharmacist that you are taking Xyntha. If you become pregnant while taking Xyntha, tell your hemophilia doctor and your doctor who will look after you during your pregnancy. SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM Symptom / effect Talk with your doctor Stop the infusion and call your doctor Only if severe In all cases Uncommon Headache x Rare Fever x Nausea x Vomiting x Very Rare Bleeding does not stop as expected after infusing Xyntha x Using an increasing amount of Xyntha to control your bleed x Chills x Flushing x Allergic reactions (such as skin rash, itching, chest tightness, wheezing, dizziness, hives, faintness, rapid heartbeat, shortness of breath, and/or a swollen face) x This is not a complete list of side effects. For any unexpected effects while taking Xyntha, contact your doctor or hemophilia treatment ce…
section:
  title:
    v: HOW TO STORE IT
  code:
    coding:
      system:
        v: https://www.jordan.gov.jo/
        l: www.jordan.gov.jo
      code:
        v: 100000155538
    text:
      v: HOW TO STORE IT
  text:
    status:
      v: additional
    div:
      v: Keep the freeze-dried Xyntha vial and the diluent syringe in the refrigerator at a temperature of 2° to 8°C. Xyntha may be stored at room temperature not above 25°C for up to 3 months and not to exceed the expiration date. You should write the date in the space provided on the outer carton when you first store Xyntha at room temperature. After room temperature storage, the product can be returned to refrigerated storage until the expiration date. Do not store Xyntha at room temperature and return it to refrigerated storage more than once. DO NOT freeze. DO NOT use after the expiration date (month and year) on the label, even if it has been stored properly. Avoid exposure of the Xyntha vials to light. Xyntha does not contain a preservative. Use the dissolved solution as soon as possible after mixing. If the solution is not used right away, it can be stored at room temperature and must be used within 3 hours. DO NOT use Xyntha if the dissolved solution is not clear to slightly pearly and colorless. Keep Xyntha (and needles) where young children cannot reach it.
section:
  title:
    v: MORE INFORMATION
  code:
    coding:
      system:
        v: https://www.jordan.gov.jo/
        l: www.jordan.gov.jo
      code:
        v: 100000155538
    text:
      v: MORE INFORMATION
  text:
    status:
      v: additional
    div:
      v: Last revised: April 2016 Marketing Authorisation Holder: Pfizer Canada ULC. 17300 Trans-Canada Highway Kirkland, Quebec Canada, H9J 2M5 Manufactured, Packaged and Released By: Wyeth Farma S.A, Autovia Del Norte A-1, KM 23 Desvio Algete, KM 1, 28700 San Sebastian De Los Reyes Madrid, Spain THIS IS A MEDICAMENT Medicament is a product which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor's prescription, the method of use and the instructions of the Pharmacist who sold the medicament. The doctor and the Pharmacist are experts in medicines, their benefits and risks. Do not by yourself interrupt the period of treatment prescribed. Do not repeat the same prescription without consulting your doctor. Keep all medicaments out of reach and sight of children Council of Arab Health Ministers Union of Arabic Pharmacists

organizationwyeth
type: Organization
id:
  v: organizationwyeth
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi
    l: Organization-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Organization organizationwyeth Profile: Organization (ePI) identifier: https://spor.ema.europa.eu/omswi/placeholder (use: official, ) active: true type: Marketing authorisation holder name: Manufactured, Packaged and Released By Wyeth Farma S.A Contacts - Address * Wyeth Farma S.A, Autovia Del Norte A-1, KM 23, Desvio Algete, KM 1, 28700 San Sebastian De Los Reyes, Madrid, Spain (work)
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/omswi
    l: omswi
  value:
    v: placeholder
active:
  v: true
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 220000000034
    display:
      v: Marketing authorisation holder
  text:
    v: Marketing authorisation holder
name:
  v: Manufactured, Packaged and Released By Wyeth Farma S.A
contact:
  address:
    use:
      v: work
    type:
      v: physical
    text:
      v: Wyeth Farma S.A, Autovia Del Norte A-1, KM 23, Desvio Algete, KM 1, 28700 San Sebastian De Los Reyes, Madrid, Spain
    line:
      v: Autovia Del Norte A-1
    city:
      v: Madrid
    country:
      v: ES

organizationpfizercanada
type: Organization
id:
  v: organizationpfizercanada
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi
    l: Organization-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Organization organizationpfizercanada Profile: Organization (ePI) identifier: https://spor.ema.europa.eu/omswi/placeholder (use: official, ) active: true type: Marketing authorisation holder name: Pfizer Canada ULC. Contacts - Address * Pfizer Canada ULC., 17300 Trans-Canada Highway, Kirkland, Quebec, Canada, H9J 2M5(work)
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/omswi
    l: omswi
  value:
    v: placeholder
active:
  v: true
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 220000000034
    display:
      v: Marketing authorisation holder
  text:
    v: Marketing authorisation holder
name:
  v: Pfizer Canada ULC.
contact:
  address:
    use:
      v: work
    type:
      v: physical
    text:
      v: Pfizer Canada ULC., 17300 Trans-Canada Highway, Kirkland, Quebec, Canada, H9J 2M5
    line:
      v: Trans-Canada Highway
    city:
      v: Kirkland
    country:
      v: CA

binarypfizerlogo
type: Binary
id:
  v: binarypfizerlogo
content type:
  v: image/jpeg

binaryimage003
type: Binary
id:
  v: binaryimage003
content type:
  v: image/jpeg

binaryimage004
type: Binary
id:
  v: binaryimage004
content type:
  v: image/jpeg

binaryimage006
type: Binary
id:
  v: binaryimage006
content type:
  v: image/jpeg

binaryimage007
type: Binary
id:
  v: binaryimage007
content type:
  v: image/jpeg

binaryimage008
type: Binary
id:
  v: binaryimage008
content type:
  v: image/jpeg

binaryimage010
type: Binary
id:
  v: binaryimage010
content type:
  v: image/jpeg

binaryimage012a
type: Binary
id:
  v: binaryimage012a
content type:
  v: image/jpeg

binaryimage012b
type: Binary
id:
  v: binaryimage012b
content type:
  v: image/jpeg

binaryimage013
type: Binary
id:
  v: binaryimage013
content type:
  v: image/jpeg

binaryimage0014
type: Binary
id:
  v: binaryimage0014
content type:
  v: image/jpeg

v: 100000155538