Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/joofio/test-epi-composition/ and changes regularly. See the Directory of published versions
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:Bundle ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "bundlepackageleaflet-en-8d0c124d18ae7d118dd0c09ef060535b"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi> ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:identifier [ fhir:system [ fhir:v "http://ema.europa.eu/identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "None" ] ] ; # fhir:type [ fhir:v "document"] ; # fhir:timestamp [ fhir:v "2023-06-27T10:09:22Z"^^xsd:dateTime] ; # fhir:entry ( [ fhir:fullUrl [ fhir:v "Composition/composition-en-8d0c124d18ae7d118dd0c09ef060535b"^^xsd:anyURI ] ; ( fhir:resource <Composition/composition-en-8d0c124d18ae7d118dd0c09ef060535b> ) ] [ fhir:fullUrl [ fhir:v "MedicinalProductDefinition/mp8d0c124d18ae7d118dd0c09ef060535b"^^xsd:anyURI ] ; ( fhir:resource <MedicinalProductDefinition/mp8d0c124d18ae7d118dd0c09ef060535b> ) ] ) . # <Composition/composition-en-8d0c124d18ae7d118dd0c09ef060535b> a fhir:Composition ; fhir:id [ fhir:v "composition-en-8d0c124d18ae7d118dd0c09ef060535b"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi> ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><a name=\"Composition_composition-en-8d0c124d18ae7d118dd0c09ef060535b\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-en-8d0c124d18ae7d118dd0c09ef060535b</b></p><a name=\"composition-en-8d0c124d18ae7d118dd0c09ef060535b\"> </a><a name=\"hccomposition-en-8d0c124d18ae7d118dd0c09ef060535b\"> </a><a name=\"composition-en-8d0c124d18ae7d118dd0c09ef060535b-en-US\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Language: en</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Composition-uv-epi.html\">Composition (ePI)</a></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/18/1270/001</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi/ 100000155538}\">Package Leaflet</span></p><p><b>category</b>: <span title=\"Codes:{http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs R}\">Raw</span></p><p><b>date</b>: 2022-02-16 13:28:17+0000</p><p><b>author</b>: <a href=\"Organization-mah-ema.html\">Organization ACME industry</a></p><p><b>title</b>: TEST PURPOSES ONLY - semglee</p><h3>Attesters</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/composition-attestation-mode official}\">Official</span></td><td>2022-02-16 13:28:17+0000</td></tr></table></div>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://ema.europa.eu/identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "EU/1/18/1270/001" ] ] ) ; # fhir:status [ fhir:v "final"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "Package Leaflet" ] ] ; # fhir:category ( [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs"^^xsd:anyURI ] ; fhir:code [ fhir:v "R" ] ; fhir:display [ fhir:v "Raw" ] ] ) ] ) ; # fhir:subject ( [ fhir:reference [ fhir:v "MedicinalProductDefinition/mp8d0c124d18ae7d118dd0c09ef060535b" ] ] ) ; # fhir:date [ fhir:v "2022-02-16T13:28:17Z"^^xsd:dateTime] ; # fhir:author ( [ fhir:reference [ fhir:v "Organization/mah-ema" ] ] ) ; # fhir:title [ fhir:v "TEST PURPOSES ONLY - semglee"] ; # fhir:attester ( [ fhir:mode [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/composition-attestation-mode"^^xsd:anyURI ] ; fhir:code [ fhir:v "official" ] ] ) ] ; fhir:time [ fhir:v "2022-02-16T13:28:17Z"^^xsd:dateTime ] ] ) ; # fhir:section ( [ fhir:title [ fhir:v "B. Package Leaflet" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "B. Package Leaflet" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>" ] ; fhir:emptyReason [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ; fhir:code [ fhir:v "unavailable" ] ] ) ] ; ( fhir:section [ fhir:title [ fhir:v "Package leaflet: Information for the user" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "Package leaflet: Information for the user" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "What is in this leaflet" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "What is in this leaflet" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What is in this leaflet</p><ol type=\"1\"><li>What Semglee is and what it is used for</li><li>What you need to know before you use Semglee</li><li>How to use Semglee</li><li>Possible side effects</li><li>How to store Semglee</li><li>Contents of the pack and other information</li></ol></div>" ] ] [ fhir:title [ fhir:v "1. What semglee is and what it is used for" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "1. What semglee is and what it is used for" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Semglee contains insulin glargine. This is a modified insulin, very similar to human insulin.</p><p>Semglee is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and above. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar. Insulin glargine has a long and steady blood-sugar-lowering action.</p></div>" ] ] [ fhir:title [ fhir:v "2. What you need to know before you take semglee" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "2. What you need to know before you take semglee" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not use Semglee</p><ul><li>if you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in section 6).</li></ul><p>Warnings and precautions</p><p>Semglee in pre-filled pen is only suitable for injecting just under the skin (see also section 3). Speak to your doctor if you need to inject your insulin by another method.</p><p>Talk to your doctor, pharmacist or nurse before using Semglee. Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical activity (physical work and exercise), injection technique as discussed with your doctor.</p><p>Skin changes at the injection site:<br/>The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work very well if you inject into a lumpy area (see How to use Semglee). Contact your doctor if you are currently injecting into a lumpy area before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medicines dose.</p><p>If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the end of this leaflet).</p><p>Travel</p><p>Before travelling consult your doctor. You may need to talk about</p><ul><li>the availability of your insulin in the country you are visiting,</li><li>supplies of insulin, needles etc.,</li><li>correct storage of your insulin while travelling,</li><li>timing of meals and insulin administration while travelling,</li><li>the possible effects of changing to different time zones,</li><li>possible new health risks in the countries to be visited,</li><li>what you should do in emergency situations when you feel unwell or become ill.</li></ul><p>Illnesses and injuries</p><p>In the following situations, the management of your diabetes may require a lot of care (for example, adjustment to insulin dose, blood and urine tests):</p><ul><li>If you are ill or have a major injury then your blood sugar level may increase (hyperglycaemia).</li><li>If you are not eating enough your blood sugar level may become too low (hypoglycaemia).</li></ul><p>In most cases you will need a doctor. Make sure that you contact a doctor early.</p><p>If you have type 1 diabetes (insulin dependent diabetes mellitus), do not stop your insulin and continue to get enough carbohydrates. Always tell people who are caring for you or treating you that you require insulin.</p><p>Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin). However, only very rarely, this will require a change to your insulin dose.</p><p>Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone (oral anti-diabetic medicine used to treat type 2 diabetes mellitus) and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).</p><p>Children</p><p>There is no experience with the use of Semglee in children below the age of 2 years.</p><p>Other medicines and Semglee</p><p>Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation). In each case, it may be necessary to adjust your insulin dose to avoid blood sugar levels that are either too low or too high. Be careful when you start or stop taking another medicine.</p><p>Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Before taking a medicine ask your doctor if it can affect your blood sugar level and what action, if any, you need to take.</p><p>Medicines that may cause your blood sugar level to fall (hypoglycaemia) include:</p><ul><li>all other medicines to treat diabetes,</li><li>angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure),</li><li>disopyramide (used to treat certain heart conditions),</li><li>fluoxetine (used to treat depression),</li><li>fibrates (used to lower high levels of blood lipids),</li><li>monoamine oxidase (MAO) inhibitors (used to treat depression),</li><li>pentoxifylline, propoxyphene, salicylates (such as acetylsalicylic acid, used to relieve pain and lower fever),</li><li>sulfonamide antibiotics.</li></ul><p>Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:</p><ul><li>corticosteroids (such as \"cortisone\" used to treat inflammation),</li><li>danazol (medicine acting on ovulation),</li><li>diazoxide (used to treat high blood pressure),</li><li>diuretics (used to treat high blood pressure or excessive fluid retention),</li><li>glucagon (pancreas hormone used to treat severe hypoglycaemia),</li><li>isoniazid (used to treat tuberculosis),</li><li>oestrogens and progestogens (such as in the contraceptive pill used for birth control),</li><li>phenothiazine derivatives (used to treat psychiatric disorders),</li><li>somatropin (growth hormone),</li><li>sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma),</li><li>thyroid hormones (used to treat thyroid gland disorders),</li><li>atypical antipsychotic medicines (such as clozapine, olanzapine),</li><li>protease inhibitors (used to treat HIV).</li></ul><p>Your blood sugar level may either rise or fall if you take:</p><ul><li>beta-blockers (used to treat high blood pressure),</li><li>clonidine (used to treat high blood pressure),</li><li>lithium salts (used to treat psychiatric disorders).</li></ul><p>Pentamidine (used to treat some infections caused by parasites) may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.</p><p>Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia.</p><p>If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist.</p><p>Semglee with alcohol</p><p>Your blood sugar levels may either rise or fall if you drink alcohol.</p><p>Pregnancy and breast-feeding</p><p>Ask your doctor or pharmacist for advice before taking any medicine.</p><p>Inform your doctor if you are planning to become pregnant, or if you are already pregnant. Your insulin dose may need to be changed during pregnancy and after giving birth. Particularly careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.</p><p>If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.</p><p>Driving and using machines</p><p>Your ability to concentrate or react may be reduced if:</p><ul><li>you have hypoglycaemia (low blood sugar levels),</li><li>you have hyperglycaemia (high blood sugar levels),</li><li>you have problems with your sight.</li></ul><p>Keep this possible problem in mind in all situations where you might put yourself and others at risk (such as driving a car or using machines). You should contact your doctor for advice on driving if:</p><ul><li>you have frequent episodes of hypoglycaemia,</li><li>the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent.</li></ul><p>Semglee contains sodium</p><p>This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially sodium-free .</p></div>" ] ] [ fhir:title [ fhir:v "3. How to take semglee" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "3. How to take semglee" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.</p><p>Although Semglee contains the same active substance as insulin glargine 300 units/ml, these medicines are not interchangeable. The switch from one insulin therapy to another requires medical prescription, medical supervision and blood glucose monitoring. Please, consult your doctor for further information.</p><p>Dose</p><p>Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will</p><ul><li>determine how much Semglee per day you will need and at what time,</li><li>tell you when to check your blood sugar level, and whether you need to carry out urine tests,</li><li>tell you when you may need to inject a higher or lower dose of Semglee.</li></ul><p>Semglee is a long-acting insulin. Your doctor may tell you to use it in combination with a short-acting insulin or with tablets used to treat high blood sugar levels.</p><p>Many factors may influence your blood sugar level. You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low. See the box at the end of this leaflet for further information.</p><p>Use in children and adolescents</p><p>Semglee can be used in adolescents and children aged 2 years and above. Use this medicine exactly as your doctor has told you.</p><p>Frequency of administration</p><p>You need one injection of Semglee every day, at the same time of the day. Semglee pen delivers insulin in increments of 1 unit up to a maximum single dose of 80 units.</p><p>Method of administration</p><p>Semglee is injected under the skin. Do NOT inject Semglee in a vein, since this will change its action and may cause hypoglycaemia.</p><p>Your doctor will show you in which area of the skin you should inject Semglee. With each injection, change the puncture site within the particular area of skin that you are using.</p><p>How to handle Semglee pen</p><p>Semglee in pre-filled pen is only suitable for injecting just under the skin. Speak to your doctor if you need to inject your insulin by another method.</p><p>Read carefully the \"Instructions for Use\" included in this package leaflet. You must use the pen as described in these Instructions for Use.</p><p>A new needle must be attached before each use. Only use needles that are compatible with Semglee pen (see Instructions for Use ). A safety test must be performed before each injection.</p><p>Look at the cartridge before you use the pen. Do not use Semglee if you notice particles in the solution. Only use Semglee if the solution is clear and colourless. Do not shake or mix it before use.</p><p>To prevent the possible transmission of disease, never share your pen with anyone else. This pen is only for your use.</p><p>Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse. If you think you may have a problem with Semglee pen, consult your doctor, pharmacist or nurse.</p><p>Empty pens must not be re-filled and must be properly discarded.</p><p>Do not use Semglee pen if it is damaged or not working properly (due to mechanical defects), it has to be discarded and a new Semglee pen has to be used.</p><p>Insulin mix-ups</p><p>You must always check the insulin label before each injection to avoid mix-ups between Semglee and other insulins.</p><p>If you use more Semglee than you should</p><p>If you have injected too much Semglee, your blood sugar level may become too low (hypoglycaemia). Check your blood sugar frequently. In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar. For information on the treatment of hypoglycaemia, see box at the end of this leaflet.</p><p>If you forget to use Semglee</p><p>If you have missed a dose of Semglee or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia). Check your blood sugar frequently. For information on the treatment of hyperglycaemia, see box at the end of this leaflet.</p><p>Do not take a double dose to make up for a forgotten dose.</p><p>If you stop using Semglee</p><p>This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar). Do not stop Semglee without speaking to a doctor, who will tell you what needs to be done.</p><p>If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.</p></div>" ] ] [ fhir:title [ fhir:v "4. Possible side effects" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "4. Possible side effects" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Like all medicines, this medicine can cause side effects, although not everybody gets them.</p><p>If you notice signs of your blood sugar being too low (hypoglycaemia), take action to increase your blood sugar level straight away (see the box at the end of this leaflet). Hypoglycaemia (low blood sugar) can be very serious and is very common with insulin treatment (may affect more than 1 in 10 people). Low blood sugar means that there is not enough sugar in your blood. If your blood sugar level falls too low you may pass out (become unconscious). Serious hypoglycaemia may cause brain damage and may be life-threatening. For more information, see the box at the end of this leaflet.</p><p>Severe allergic reactions (rare, may affect up to 1 in 1,000 people) the signs may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating. Severe allergic reactions to insulins may become life-threatening. Tell a doctor straight away if you notice signs of severe allergic reaction.</p><p>Skin changes at the injection site If you inject insulin too often at the same place, the fatty tissue may either shrink (lipoatrophy; may affect up to 1 in 100 people) or thicken (lipohypertrophy; may affect up to 1 in 10 people). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy area. Change the injection site with each injection to help prevent these skin changes.</p><p>Common reported side effects (may affect up to 1 in 10 people)</p><p>Skin and allergic reactions at the injection site The signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation. This can spread around the injection site. Most minor reactions to insulins usually disappear in a few days to a few weeks.</p><p>Rare reported side effect (may affect up to 1 in 1,000 people)</p><p>Eye reactions A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily. If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.</p><p>General disorders In rare cases, insulin treatment may also cause temporary build-up of water in the body, with swelling in the calves and ankles.</p><p>Very rare reported side effects (may affect up to 1 in 10,000 people) In very rare cases, dysgeusia (taste disorders) and myalgia (muscular pain) can occur.</p><p>Use in children and adolescents In general, the side effects in children and adolescents of 18 years of age or less are similar to those seen in adults. Complaints of injection site reactions (injection site reaction, injection site pain) and skin reactions (rash, urticaria) are reported relatively more frequently in children and adolescents of 18 years of age or less than in adults. There is no experience in children under 2 years.</p><p>Reporting of side effects</p><p>If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.</p></div>" ] ] [ fhir:title [ fhir:v "5. How to store semglee" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "5. How to store semglee" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Keep this medicine out of the sight and reach of children.</p><p>Do not use this medicine after the expiry date which is stated on the carton and on the label of the pen after EXP . The expiry date refers to the last day of that month.</p><p>Not in-use pens Store in a refrigerator (2 C-8 C). Do not freeze or place next to the freezer compartment of your refrigerator or a freezer pack. Keep the pre-filled pen in the outer carton in order to protect from light.</p><p>In-use pens Pre-filled pens in use or carried as a spare may be stored for a maximum of 4 weeks not above 25 C and away from direct heat or direct light. Do not use it after this time period. The pen in use must not be stored in a refrigerator. It is recommended that the date of the first use be noted. The pen cap must be put back on the pen after each injection in order to protect from light.</p><p>Remove the needle after the injection and store the pen without the needle. Also, be sure to remove the needle before disposing of the pen. Needles must not be re-used.</p><p>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.</p></div>" ] ] [ fhir:title [ fhir:v "6. Contents of the pack and other information" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "6. Contents of the pack and other information" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What Semglee contains</p><ul><li>The active substance is insulin glargine. Each ml of the solution contains 100 units of insulin glargine (equivalent to 3.64 mg).</li><li>The other ingredients are: zinc chloride, metacresol, glycerol, sodium hydroxide (for pH adjustment) (see section 2 Semglee contains sodium ), hydrochloric acid (for pH adjustment) and water for injections.</li></ul><p>What Semglee looks like and contents of the pack</p><p>Semglee 100 units/ml solution for injection in a pre-filled pen is a clear colourless solution. Each pen contains 3 ml of solution for injection (equivalent to 300 units). Semglee is available in pack sizes of 1, 3, 5, 10 pens and in a multipack compromising of 2 cartons, each containing 5 pens. Not all pack sizes may be marketed.</p><p>Marketing Authorisation Holder</p><p>Biosimilar Collaborations Ireland Limited Unit 35/Grange Parade, Baldoyle Industrial Estate, Dublin DUBLIN Ireland<br/>D13 R20R</p><p>Manufacturer</p><p>Biosimilar Collaborations Ireland Limited Block B, The Crescent Building, Santry Demesne Dublin D09 C6X8 Ireland</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien Biocon Biologics Belgium BV T l/Tel: 0080008250Lietuva Biosimilar Collaborations Ireland Limited Tel: 0080008250<br/>Biosimilar Collaborations Ireland Limited : 0080008250Luxembourg/Luxemburg Biocon Biologics France S.A.S T l/Tel: 0080008250 esk republika Biocon Biologics Germany GmbH<br/>Tel: 0080008250Magyarorsz g Biosimilar Collaborations Ireland Limited<br/>Tel.: 0080008250Danmark Biocon Biologics Finland OY<br/>Tlf: 0080008250Malta Biosimilar Collaborations Ireland Limited<br/>Tel.: 0080008250Deutschland Biocon Biologics Germany GmbH<br/>Tel: 0080008250Nederland Biocon Biologics France S.A.S Tel: 0080008250Eesti Biosimilar Collaborations Ireland Limited Tel: 0080008250Norge Biocon Biologics Finland OY<br/>Tlf: +47 800 62<br/>Biocon Biologics Greece<br/>. .<br/>.: 0080008250 sterreich Biocon Biologics Germany GmbH Tel: 0080008250Espa a Biocon Biologics Spain S.L. Tel: 0080008250Polska Biosimilar Collaborations Ireland Limited<br/>Tel: 0080008250France Biocon Biologics France S.A.S<br/>Tel: 0080008250Portugal Biocon Biologics Spain S.L. Tel: 0080008250Hrvatska Biocon Biologics Germany GmbH<br/>Tel: 0080008250Rom nia Biosimilar Collaborations Ireland Limited<br/>Tel: 0080008250Ireland Biosimilar Collaborations Ireland Limited<br/>Tel: 1800 777 Slovenija Biosimilar Collaborations Ireland Limited<br/>Tel: 0080008250 sland Biocon Biologics Finland OY<br/>S mi: +345 8004Slovensk republika Biocon Biologics Germany GmbH<br/>Tel: 0080008250Italia Biocon Biologics Spain S.L. Tel: 0080008250Suomi/Finland Biocon Biologics Finland OY<br/>Puh/Tel: 99980008250<br/>Biosimilar Collaborations Ireland Limited<br/>: 0080008250Sverige Biocon Biologics Finland OY<br/>Tel: 0080008250Latvija Biosimilar Collaborations Ireland Limited<br/>Tel: 0080008250This leaflet was last revised in {month YYYY}.</p><p>Other sources of information</p><p>Detailed information on this medicine is available on the European Medicines Agency web site:</p></div>" ] ] ) ] ) . # <MedicinalProductDefinition/mp8d0c124d18ae7d118dd0c09ef060535b> a fhir:MedicinalProductDefinition ; fhir:id [ fhir:v "mp8d0c124d18ae7d118dd0c09ef060535b"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_mp8d0c124d18ae7d118dd0c09ef060535b\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mp8d0c124d18ae7d118dd0c09ef060535b</b></p><a name=\"mp8d0c124d18ae7d118dd0c09ef060535b\"> </a><a name=\"hcmp8d0c124d18ae7d118dd0c09ef060535b\"> </a><a name=\"mp8d0c124d18ae7d118dd0c09ef060535b-en-US\"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/18/1270/001</p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-type MedicinalProduct}\">Medicinal Product</span></p><p><b>domain</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-domain Human}\">Human use</span></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">active</span></p><p><b>legalStatusOfSupply</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072084}\">Medicinal product subject to medical prescription</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Semglee 100 units/ml solution for injection in pre-filled pen</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000001}\">Full name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000002}\">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000003}\">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000004}\">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000005}\">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{urn:iso:std:iso:3166 EU}\">EU</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 EU}\">EU</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 en}\">en</span></td></tr></table></blockquote></div>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://ema.europa.eu/identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "EU/1/18/1270/001" ] ] ) ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "MedicinalProduct" ] ; fhir:display [ fhir:v "Medicinal Product" ] ] ) ] ; # fhir:domain [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-domain"^^xsd:anyURI ] ; fhir:code [ fhir:v "Human" ] ; fhir:display [ fhir:v "Human use" ] ] ) ] ; # fhir:status [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/publication-status"^^xsd:anyURI ] ; fhir:code [ fhir:v "active" ] ; fhir:display [ fhir:v "active" ] ] ) ] ; # fhir:legalStatusOfSupply [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000072084" ] ; fhir:display [ fhir:v "Medicinal product subject to medical prescription" ] ] ) ] ; # fhir:name ( [ fhir:productName [ fhir:v "Semglee 100 units/ml solution for injection in pre-filled pen" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000001" ] ; fhir:display [ fhir:v "Full name" ] ] ) ] ; ( fhir:part [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000002" ] ; fhir:display [ fhir:v "Invented name part" ] ] ) ] ] [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000003" ] ; fhir:display [ fhir:v "Scientific name part" ] ] ) ] ] [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000004" ] ; fhir:display [ fhir:v "Strength part" ] ] ) ] ] [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000005" ] ; fhir:display [ fhir:v "Pharmaceutical dose form part" ] ] ) ] ] ) ; ( fhir:usage [ fhir:country [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; fhir:code [ fhir:v "EU" ] ; fhir:display [ fhir:v "EU" ] ] ) ] ; fhir:jurisdiction [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; fhir:code [ fhir:v "EU" ] ; fhir:display [ fhir:v "EU" ] ] ) ] ; fhir:language [ ( fhir:coding [ fhir:system [ fhir:v "urn:ietf:bcp:47"^^xsd:anyURI ] ; fhir:code [ fhir:v "en" ] ; fhir:display [ fhir:v "en" ] ] ) ] ] ) ] ) . #
IG © 2021+ Gravitate Health Project. Package hl7.eu.fhir.ghepi#0.1.0 based on FHIR 5.0.0. Generated 2024-10-14
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The Gravitate Health project has received funding from the IMI 2 Joint Undertaking under grant agreement No 945334.
This joint undertaking receives support from the EU H2020 research and innovation programme and EFPIA.
