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-001a1e1abfef180b40eba1bcc5ecf9fa"] ; # 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-001a1e1abfef180b40eba1bcc5ecf9fa"^^xsd:anyURI ] ; ( fhir:resource <Composition/composition-en-001a1e1abfef180b40eba1bcc5ecf9fa> ) ] [ fhir:fullUrl [ fhir:v "MedicinalProductDefinition/mp001a1e1abfef180b40eba1bcc5ecf9fa"^^xsd:anyURI ] ; ( fhir:resource <MedicinalProductDefinition/mp001a1e1abfef180b40eba1bcc5ecf9fa> ) ] ) . # <Composition/composition-en-001a1e1abfef180b40eba1bcc5ecf9fa> a fhir:Composition ; fhir:id [ fhir:v "composition-en-001a1e1abfef180b40eba1bcc5ecf9fa"] ; # 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-001a1e1abfef180b40eba1bcc5ecf9fa\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-en-001a1e1abfef180b40eba1bcc5ecf9fa</b></p><a name=\"composition-en-001a1e1abfef180b40eba1bcc5ecf9fa\"> </a><a name=\"hccomposition-en-001a1e1abfef180b40eba1bcc5ecf9fa\"> </a><a name=\"composition-en-001a1e1abfef180b40eba1bcc5ecf9fa-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/1/18/1266/001</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 - steglujan</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/1/18/1266/001" ] ] ) ; # 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/mp001a1e1abfef180b40eba1bcc5ecf9fa" ] ] ) ; # 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 - steglujan"] ; # 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 Steglujan is and what it is used for</li><li>What you need to know before you take Steglujan</li><li>How to take Steglujan</li><li>Possible side effects</li><li>How to store Steglujan</li><li>Contents of the pack and other information</li></ol></div>" ] ] [ fhir:title [ fhir:v "1. What steglujan 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 steglujan 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>What Steglujan is Steglujan contains two active substances, ertugliflozin and sitagliptin. Each belongs to a group of medicines called oral anti-diabetics . These are medicines taken by mouth to treat diabetes.</p><ul><li>Ertugliflozin belongs to a group of medicines called sodium glucose co-transporter-2 (SGLT2) inhibitors.</li><li>Sitagliptin belongs to a group of medicines called DPP-4 (dipeptidyl peptidase-4) inhibitors. What Steglujan is used for</li><li>Steglujan lowers blood sugar levels in adult patients (aged 18 years and older) with type 2 diabetes.</li><li>Steglujan can be used instead of taking both ertugliflozin and sitagliptin as separate tablets.</li><li>Steglujan can be used alone or with some other medicines that lower blood sugar.</li><li>You need to keep following your food and exercise plan while taking Steglujan. How Steglujan works</li><li>Ertugliflozin works by blocking the SGLT2 protein in your kidneys. This causes blood sugar to be removed in your urine.</li><li>Sitagliptin helps to increase the levels of insulin produced after a meal. It also lowers the amount of sugar made by your body. What is type 2 diabetes? Type 2 diabetes is a condition in which your body does not make enough insulin or the insulin that your body produces does not work as well as it should. This leads to a high level of sugar in your blood. When this happens, this can lead to serious medical problems like heart disease, kidney disease, blindness and poor circulation.</li></ul></div>" ] ] [ fhir:title [ fhir:v "2. What you need to know before you take steglujan" ] ; 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 steglujan" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not take Steglujan</p><ul><li>if you are allergic to ertugliflozin or sitagliptin or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor, pharmacist, or nurse before and while taking Steglujan if you:</li><li>have kidney problems. Your doctor may do blood tests to check how well your kidneys are working.</li><li>have or have had urinary tract infections</li><li>have or have had yeast infections of the vagina or penis.</li><li>have or have had a disease of the pancreas (such as pancreatitis).</li><li>have or have had gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood. These medical conditions can increase your chance of getting pancreatitis (see section 4).</li><li>have type 1 diabetes. Steglujan should not be used to treat this condition as it may increase the risk of diabetic ketoacidosis in these patients.</li><li>take other diabetes medicines: you are more likely to get low blood sugar with certain medicines.</li><li>might be at risk of dehydration (for example, if you are taking medicines that increase urine production [diuretics] or lower blood pressure or if you are over 65 years old). Ask about ways to prevent dehydration.</li><li>experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat contact a doctor or the nearest hospital straight away. These symptoms could be a sign of diabetic ketoacidosis a problem you can get with diabetes because of increased levels of ketone bodies in your urine or blood, seen in tests. The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness. If you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop Steglujan. It is important to check your feet regularly and adhere to any other advice regarding foot care given by your healthcare professional. Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving sitagliptin (see section 4). Talk to your doctor immediately if you develop a combination of symptoms of pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus with fever or feeling generally unwell. These symptoms could be a sign of a rare but serious or even life-threatening infection, called necrotising fasciitis of the perineum or Fournier s gangrene which destroys the tissue under the skin. Fournier s gangrene has to be treated immediately. When this medicine is used in combination with insulin or medicines that increase insulin release from the pancreas, low blood sugar (hypoglycaemia) can occur. Your doctor may reduce the dose of your insulin or other medicine. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Urine glucose Because of how Steglujan works, your urine will test positive for sugar (glucose) while you are on this medicine. Children and adolescents Children and adolescents below 18 years should not take this medicine. It is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age. Other medicines and Steglujan Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor:</li><li>if you are taking medicines which increase urine production (diuretics).</li><li>if you are taking other medicines that lower the amount of sugar in your blood, such as insulin or medicines that increase insulin release from the pancreas.</li><li>if you are taking digoxin (a medicine used to treat irregular heartbeat and other heart problems). The level of digoxin in your blood may need to be checked if you are taking it with Steglujan. If any of the above apply to you (or you are not sure), tell your doctor. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is not known if Steglujan can harm your unborn baby. You should not take this medicine during pregnancy. It is not known if this medicine passes into breast milk. Talk with your doctor about the best way to feed your baby if you take Steglujan. You should not use this medicine if you are breast-feeding or plan to breast-feed. Driving and using machines This medicine has no or negligible influence on the ability to drive and use machines. However, dizziness and drowsiness have been reported with sitagliptin, which may affect your ability to drive or use machines. Do not drive or use any tools or machines if you feel dizzy while taking Steglujan. Taking this medicine in combination with insulin or medicines that increase insulin release from the pancreas can cause blood sugar levels to drop too low (hypoglycaemia), which may cause symptoms such as shaking, sweating or changes in vision and may affect your ability to drive and use machines. Steglujan contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free .</li></ul></div>" ] ] [ fhir:title [ fhir:v "3. How to take steglujan" ] ; 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 steglujan" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. How much to take</p><ul><li>The recommended dose of Steglujan is one tablet once a day.</li><li>The dose of Steglujan that you take will depend on your condition and the amount of ertugliflozin and sitagliptin needed to control your blood sugar.</li><li>Your doctor will prescribe the right dose for you. Do not change your dose unless your doctor has told you to. Taking this medicine</li><li>Swallow the tablet; if you have difficulties with swallowing the tablet can be broken or crushed.</li><li>Take one tablet every morning. Try to take it at the same time; this will help you remember to take it.</li><li>You can take your tablet with or without food.</li><li>You need to keep following your food and exercise plan while taking Steglujan. If you take more Steglujan than you should If you take too much Steglujan, talk to a doctor or pharmacist straight away. If you forget to take Steglujan What to do if you forget to take a tablet depends on how long it is until your next dose.</li><li>If it is 12 hours or more until your next dose, take a dose of Steglujan as soon as you remember. Then take your next dose at the usual time.</li><li>If it is less than 12 hours until your next dose, skip the missed dose. Then take your next dose at the usual time. Do not take a double dose (two doses on the same day) to make up for a forgotten dose. If you stop taking Steglujan Do not stop taking this medicine without talking to your doctor. Your blood sugar levels may increase if you stop the medicine. If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.</li></ul></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. Stop taking Steglujan and contact a doctor straight away if you notice any of the following serious side effects:</p><ul><li>Severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be signs of an inflamed pancreas (pancreatitis, frequency not known).</li><li>A serious allergic reaction (frequency not known), including rash, hives, blisters on the skin/peeling skin and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes. If you notice any of the serious side effects above, stop taking this medicine and contact a doctor straight away. Contact a doctor or the nearest hospital straight away if you have any of the following serious side effects: Diabetic ketoacidosis (rare, may affect up to 1 in 1 000 people) These are the signs of diabetic ketoacidosis (see also section Warnings and precautions ):</li><li>increased levels of ketone bodies in your urine or blood</li><li>rapid weight loss</li><li>feeling sick or being sick</li><li>stomach pain</li><li>excessive thirst</li><li>fast and deep breathing</li><li>confusion</li><li>unusual sleepiness or tiredness</li><li>a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat This may occur regardless of blood glucose level. Your doctor may decide to temporarily or permanently stop your treatment with Steglujan. Necrotising fasciitis of the perineum or Fournier s gangrene (not known, cannot be estimated from the available data) A serious soft tissue infection of the genitals or the area between the genitals and the anus (see section Warnings and precautions for symptoms). If you notice any of the side effects above, contact a doctor or the nearest hospital straight away. Contact your doctor as soon as possible if you notice the following side effects: Urinary tract infection (very common, may affect more than 1 in 10 people) The signs of urinary tract infection are:</li><li>burning sensation when passing urine</li><li>urine that appears cloudy</li><li>pain in the pelvis or mid-back (when kidneys are infected) Although uncommon, if you have fever or see blood in your urine, tell your doctor immediately. Dehydration (losing too much water from your body; common, may affect up to 1 in 10 people) Symptoms of dehydration include:</li><li>dry mouth</li><li>feeling dizzy, light-headed, or weak, especially when you stand up</li><li>fainting You may be more likely to get dehydrated if you:</li><li>have kidney problems</li><li>take medicines that increase your urine production (diuretics) or lower blood pressure</li><li>are 65 years or older Low blood sugar (hypoglycaemia) Hypoglycaemia may occur commonly when Steglujan is used alone or with other diabetes medicines that do not cause hypoglycaemia. Hypoglycaemia may be very common when Steglujan is used with other diabetes medicines that can cause hypoglycaemia (like insulin or sulphonylurea). Your doctor will tell you how to treat low blood sugar and what to do if you have any of the symptoms or signs below. The doctor may lower the dose of your insulin or other diabetes medicine. Signs and symptoms of low blood sugar may include:</li><li>headache</li><li>drowsiness</li><li>irritability</li><li>hunger</li><li>dizziness</li><li>confusion</li><li>sweating</li><li>feeling jittery</li><li>weakness</li><li>fast heartbeat If you notice any of the side effects above, contact your doctor as soon as possible. Other side effects include: Very common</li><li>vaginal yeast infection (thrush) Common</li><li>yeast infections of the penis</li><li>changes in urination, including urgent need to urinate more often, in larger amounts, or at night</li><li>thirst</li><li>vaginal itching</li><li>blood tests may show changes in the amount of urea in your blood</li><li>blood tests may show changes in the amount of total and bad cholesterol (called low density lipoprotein (LDL)-cholesterol - a type of fat in your blood)</li><li>blood tests may show changes in the amount of red blood cells in your blood (called haemoglobin)</li><li>flatulence</li><li>swelling of the hands or legs</li><li>flu (when used with insulin (with or without metformin))</li><li>headache</li><li>upper respiratory infection</li><li>stuffy or runny nose and sore throat</li><li>osteoarthritis</li><li>arm or leg pain</li><li>nausea/vomiting Uncommon (may affect up to 1 in 100 people)</li><li>blood tests may show changes related to kidney function (such as creatinine )</li><li>stomach ache</li><li>diarrhoea</li><li>constipation (common in combination with other medicines)</li><li>drowsiness</li><li>dry mouth</li><li>dizziness</li><li>itching Rare</li><li>reduced number of platelets Not known (frequency cannot be estimated from the available data)</li><li>kidney problems (sometimes requiring dialysis)</li><li>joint pain</li><li>joint disease</li><li>muscle pain</li><li>back pain</li><li>interstitial lung disease</li><li>bullous pemphigoid (a type of skin blister)</li><li>rash</li><li>hives</li><li>swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing</li><li>inflammation of blood vessels in the skin</li><li>blisters on the skin/peeling skin Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. 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.</li></ul></div>" ] ] [ fhir:title [ fhir:v "5. How to store steglujan" ] ; 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 steglujan" ] ] ; 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. Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not use this medicine if the packaging is damaged or shows signs of tampering. Do not throw away 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 Steglujan contains</p><ul><li>The active substances are ertugliflozin and sitagliptin.* Each Steglujan 5 mg/100 mg film-coated tablet contains ertugliflozin L-pyroglutamic acid, equivalent to 5 mg of ertugliflozin, and sitagliptin phosphate monohydrate, equivalent to 100 mg of sitagliptin.* Each Steglujan 15 mg/100 mg film-coated tablet contains ertugliflozin L-pyroglutamic acid, equivalent to 15 mg of ertugliflozin, and sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.</li><li>The other ingredients are:* Tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate (anhydrous), croscarmellose sodium, sodium stearyl fumarate (E487), magnesium stearate (E470b), propyl gallate.* Tablet coat: hypromellose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172), carnauba wax (E903). What Steglujan looks like and contents of the pack</li><li>Steglujan 5 mg/100 mg film-coated tablets (tablets) are beige, 12.0 x 7.4 mm, almond-shaped, film-coated tablets debossed with 554 on one side and plain on the other side.</li><li>Steglujan 15 mg/100 mg film-coated tablets (tablets) are brown, 12.0 x 7.4 mm, almond-shaped, film-coated tablets debossed with 555 on one side and plain on the other side. Steglujan is available in Alu/PVC/PA/Alu blisters. The pack sizes are 14, 28, 30, 84, 90 and 98 film- coated tablets in non-perforated blisters and 30x1 film-coated tablets in perforated unit dose blisters. Not all pack sizes may be marketed. Marketing Authorisation Holder Manufacturer Merck Sharp & Dohme B.V. Organon Heist bv Waarderweg Industriepark 2031 BN Haarlem 2220 Heist-op-den-Berg The Netherlands Belgium Merck Sharp & Dohme B.V. Waarderweg 2031 BN Haarlem The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien MSD Belgium T l/Tel: +32(0)<a href=\"mailto:27766dpoc_belux@merck.com\">27766dpoc_belux@merck.com</a></li></ul><p>Lietuva UAB Merck Sharp & Dohme Tel: + 370 5 <a href=\"mailto:2780msd_lietuva@merck.com\">2780msd_lietuva@merck.com</a></p><p>Te .: + 359 2 819 <a href=\"mailto:3info-msdbg@merck.com\">3info-msdbg@merck.com</a></p><p>Luxembourg/Luxemburg MSD Belgium T l/Tel: +32(0)<a href=\"mailto:27766dpoc_belux@merck.com\">27766dpoc_belux@merck.com</a> esk republika Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 <a href=\"mailto:dpoc_czechslovak@merck.com\">dpoc_czechslovak@merck.com</a></p><p>Magyarorsz g MSD Pharma Hungary Kft. Tel.: + 36 1 <a href=\"mailto:888-5hungary_msd@merck.com\">888-5hungary_msd@merck.com</a> Danmark MSD Danmark ApS Tlf: +45 4482 <a href=\"mailto:4dkmail@merck.com\">4dkmail@merck.com</a></p><p>Malta Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) <a href=\"mailto:malta_info@merck.com\">malta_info@merck.com</a> Deutschland MSD Sharp & Dohme GmbH Tel: 0800 673 673 673 (+49 (0) 89 4561 0) <a href=\"mailto:e-mail@msd.de\">e-mail@msd.de</a></p><p>Nederland Merck Sharp & Dohme B.V. Tel: 0800 9999000 (+31 23 5153153) <a href=\"mailto:medicalinfo.nl@merck.com\">medicalinfo.nl@merck.com</a> Eesti Merck Sharp & Dohme O Tel: + 372 6144 <a href=\"mailto:msdeesti@merck.com\">msdeesti@merck.com</a></p><p>Norge MSD (Norge) AS Tlf: + 47 32 20 73 <a href=\"mailto:msdnorge@msd.no\">msdnorge@msd.no</a></p><p>MSD . . . . . : + 30 210 98 97 <a href=\"mailto:dpoc_greece@merck.com\">dpoc_greece@merck.com</a></p><p>sterreich Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 <a href=\"mailto:dpoc_austria@merck.com\">dpoc_austria@merck.com</a> Espa a Merck Sharp & Dohme de Espa a, S.A. Tel: +34 91 321 06 <a href=\"mailto:msd_info@merck.com\">msd_info@merck.com</a></p><p>Polska MSD Polska Sp. z o.o. Tel.: +48 22 549 51 <a href=\"mailto:msdpolska@merck.com\">msdpolska@merck.com</a> France MSD France T l: + 33 (0) 1 80 46 40 Portugal Merck Sharp & Dohme, Lda Tel: + 351 21 <a href=\"mailto:4465inform_pt@merck.com\">4465inform_pt@merck.com</a> Hrvatska Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 <a href=\"mailto:croatia_info@merck.com\">croatia_info@merck.com</a></p><p>Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Rom nia Merck Sharp & Dohme Romania S.R.L. Tel: +40 21 529 29 <a href=\"mailto:msdromania@merck.com\">msdromania@merck.com</a> Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 5204Tel: +353 (0)1 <a href=\"mailto:2998medinfo_ireland@merck.com\">2998medinfo_ireland@merck.com</a></p><p><a href=\"mailto:msd_slovenia@merck.com\">msd_slovenia@merck.com</a> sland Vistor hf. S mi: + 354 535 7Slovensk republika Merck Sharp & Dohme, s.r.o. Tel: + 421 (2) <a href=\"mailto:58282dpoc_czechslovak@merck.com\">58282dpoc_czechslovak@merck.com</a> Italia MSD Italia S.r.l. Tel: 800 23 99 89 (+39 06 361911) <a href=\"mailto:medicalinformation.it@msd.com\">medicalinformation.it@msd.com</a> Suomi/Finland MSD Finland Oy Puh/Tel: + 358 (0)9 <a href=\"mailto:804info@msd.fi\">804info@msd.fi</a></p><p>Merck Sharp & Dohme Cyprus Limited : 800 00 +357 <a href=\"mailto:22866cyprus_info@merck.com\">22866cyprus_info@merck.com</a> Sverige Merck Sharp & Dohme (Sweden) AB Tfn: + 46 (0)77 570 04 <a href=\"mailto:medicinskinfo@merck.com\">medicinskinfo@merck.com</a> Latvija SIA Merck Sharp & Dohme Latvija Tel: + 371 67 <a href=\"mailto:364msd_lv@merck.com\">364msd_lv@merck.com</a> United Kingdom (Northern Ireland) Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 <a href=\"mailto:2998medinfoNI@msd.com\">2998medinfoNI@msd.com</a> This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency web site: <a href=\"http://www.ema.europa.eu\">http://www.ema.europa.eu</a>.</p></div>" ] ] ) ] ) . # <MedicinalProductDefinition/mp001a1e1abfef180b40eba1bcc5ecf9fa> a fhir:MedicinalProductDefinition ; fhir:id [ fhir:v "mp001a1e1abfef180b40eba1bcc5ecf9fa"] ; # 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_mp001a1e1abfef180b40eba1bcc5ecf9fa\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mp001a1e1abfef180b40eba1bcc5ecf9fa</b></p><a name=\"mp001a1e1abfef180b40eba1bcc5ecf9fa\"> </a><a name=\"hcmp001a1e1abfef180b40eba1bcc5ecf9fa\"> </a><a name=\"mp001a1e1abfef180b40eba1bcc5ecf9fa-en-US\"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/18/1266/001</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>: Steglujan 5 mg/100 mg film-coated tablets</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/1/18/1266/001" ] ] ) ; # 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 "Steglujan 5 mg/100 mg film-coated tablets" ] ; 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
Links: Table of Contents |
QA Report
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.
