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Document Details
Generated Narrative: Bundle TEST PURPOSES ONLY - harvoni
Language: en
Profile: Bundle - ePI
Final Document at 2022-02-16 13:28:17+0000 by Organization ACME industry for Bundle: identifier = http://ema.europa.eu/identifier#None; type = document; timestamp = 2023-06-27 10:09:22+0000
Document Subject
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identifier: http://ema.europa.eu/identifier
/EU/1/14/958/001
type: Medicinal Product
domain: Human use
status: active
legalStatusOfSupply: Medicinal product subject to medical prescription
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Country Jurisdiction Language EU EU en
Document Content
Generated Narrative: Composition composition-en-52f798a2a01bd37d07b0ffeba290b5e0
Language: en
Profile: Composition (ePI)
identifier: http://ema.europa.eu/identifier
/EU/1/14/958/001
status: Final
type: Package Leaflet
category: Raw
date: 2022-02-16 13:28:17+0000
author: Organization ACME industry
title: TEST PURPOSES ONLY - harvoni
Mode | Time |
Official | 2022-02-16 13:28:17+0000 |
If Harvoni has been prescribed for your child, please note that all the information in this leaflet is applicable to your child (in this case please read your child instead of you ).
What is in this leaflet
Harvoni is a medicine that contains the active substances ledipasvir and sofosbuvir. Harvoni is given to treat chronic (long-term) hepatitis C virus infection in adults and children 3 years of age and older.
Hepatitis C is a virus that infects the liver. The active substances in the medicine work together by blocking two different proteins that the virus needs to grow and reproduce itself, allowing the infection to be permanently eliminated from the body.
Harvoni is sometimes taken with another medicine, ribavirin.
It is very important that you also read the leaflets for the other medicines that you will be taking with Harvoni. If you have any questions about your medicines, please ask your doctor or pharmacist.
Do not take Harvoni
If you are allergic to ledipasvir, sofosbuvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
If you are currently taking any of the following medicines:
rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis);
St. John s wort (herbal medicine used to treat depression);
carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures);
rosuvastatin (a medicine used to treat high cholesterol).
If any of these conditions apply to you, do not take Harvoni and tell your doctor immediately.
Warnings and precautions
Your doctor will know if any of the following conditions apply to you. These will be considered before treatment with Harvoni is started.
Talk to your doctor or pharmacist before taking Harvoni if:
Tell your doctor immediately if you currently take, or have taken in the last months, any medicines for heart problems and during treatment you experience:
Blood tests
Your doctor will test your blood before, during and after your treatment with Harvoni. This is so that:
Children and adolescents
Do not give this medicine to children under 3 years of age. The use of Harvoni in children under 3 years of age has not yet been studied.
Other medicines and Harvoni
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Warfarin and other similar medicines called vitamin K antagonists used to thin the blood. Your doctor may need to increase the frequency of your blood tests to check how well your blood can clot.
Your liver function may change with treatment of hepatitis C and therefore may affect other medications (e.g. medicines used to suppress your immune system, etc.). Your doctor may need to closely monitor these other medicines you are taking and make adjustments after starting Harvoni.
If you are not sure about taking any other medicines, talk to your doctor or pharmacist.
Some medicines should not be taken with Harvoni.
Do not take any other medicine that contains sofosbuvir, one of the active substances in Harvoni.
Tell your doctor or pharmacist if you are taking any of the medicines below:
amiodarone used to treat irregular heartbeats
tenofovir disoproxil fumarate or any medicine containing tenofovir disoproxil fumarate, used to treat HIV infection
digoxin used to treat heart conditions
dabigatran used to thin the blood
statins used to treat high cholesterol
rifapentine (antibiotic used to treat infections, including tuberculosis)
oxcarbazepine (a medicine used to treat epilepsy and prevent seizures)
tipranavir (used to treat HIV infection).
Taking Harvoni with any of these may stop your medicines from working properly, or make any side effects worse. Your doctor may need to give you a different medicine or adjust the dose of medicine you are taking.
Pregnancy and contraception
The effects of Harvoni during pregnancy are not known. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy must be avoided if Harvoni is taken together with ribavirin. It is very important that you read the "Pregnancy" section in the ribavirin package leaflet very carefully. Ribavirin can be very damaging to an unborn baby. Therefore, special precautions in sexual activity must be taken if there is any chance for pregnancy to occur.
Breast-feeding
Do not breast-feed during treatment with Harvoni. It is not known whether ledipasvir or sofosbuvir, the two active substances of Harvoni, pass into human breast milk.
Driving and using machines
If you feel tired after taking Harvoni you should not take part in activities that require concentration, for example, do not drive, ride a bike or operate machines.
Harvoni 90 mg/400 mg and 45 mg/200 mg film-coated tablets contain lactose
Harvoni 90 mg/400 mg film-coated tablets contains sunset yellow FCF (E110) which can cause allergic reactions
Harvoni contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free .
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Recommended dose
Harvoni is to be taken as advised by your doctor. The recommended dose of Harvoni in adults is one 90 mg/400 mg film-coated tablet once a day. Your doctor will tell you for how many weeks you should take Harvoni.
The recommended dose of Harvoni in children aged 3 years and above is based on weight. Take Harvoni as advised by your doctor.
Swallow the tablet(s) whole with or without food. Do not chew, crush or split the tablet as it has a very bitter taste. Tell your doctor or pharmacist if you have problems swallowing tablets.
If you are taking an antacid, take it at least 4 hours before or at least 4 hours after Harvoni.
If you are taking a proton pump inhibitor, take the proton pump inhibitor at the same time as Harvoni. Do not take it before Harvoni.
If you are sick (vomit) after taking Harvoni it may affect the amount of Harvoni in your blood. This may make Harvoni work less well.
If you take more Harvoni than you should
If you accidentally take more than the recommended dose you should contact your doctor or nearest emergency department immediately for advice. Keep the tablet bottle with you so that you can easily describe what you have taken.
If you forget to take Harvoni
It is important not to miss a dose of this medicine.
If you do miss a dose, work out how long it is since you last took your Harvoni:
Do not stop taking Harvoni
Do not stop taking this medicine unless your doctor tells you to. It is very important that you complete the full course of treatment to give the medicine the best chance to treat your hepatitis C virus infection.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine may cause side effects. If you take Harvoni you may get one or more of the side effects below:
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Other effects that may be seen during treatment with Harvoni
The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
Other effects that may be seen during treatment with sofosbuvir:
The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
Reporting of side effects
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.
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 bottle and 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 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.
What Harvoni contains
The active substances are ledipasvir and sofosbuvir. Each film-coated tablet contains 90 mg ledipasvir and 400 mg sofosbuvir or 45 mg ledipasvir and 200 mg sofosbuvir.
The other ingredients are Tablet core: Copovidone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate
Film-coating: Polyvinyl alcohol, titanium dioxide, macrogol, talc, and for the 90 mg/400 mg tablet only; sunset yellow FCF (E110)
What Harvoni looks like and contents of the pack
Harvoni 90 mg/400 mg film-coated tablets are orange, diamond-shaped tablets debossed with GSI
on one side and 7985 on the other side. The tablet is approximately 19 mm long and 10 mm wide.
Harvoni 45 mg/200 mg film-coated tablets are white, capsule-shaped, debossed with GSI on one side and HRV on the other side. The tablet is approximately 14 mm long and 7 mm wide.
Each bottle contains a silica gel desiccant (drying agent) that must be kept in the bottle to help protect your tablets. The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed. The following pack sizes are available:
Marketing Authorisation Holder Gilead Sciences Ireland UC Carrigtohill County Cork, T45 DPIreland
Manufacturer Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill County Cork Ireland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Belgi /Belgique/Belgien Gilead Sciences Belgium SRL-BV T l/Tel: + 32 (0) 24 01 35 Lietuva Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1
Gilead Sciences Ireland UC .: + 353 (0) 1 686 1Luxembourg/Luxemburg Gilead Sciences Belgium SRL-BV T l/Tel: + 32 (0) 24 01 35 esk republika Gilead Sciences s.r.o. Tel: + 420 910 871 Magyarorsz g Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1Danmark Gilead Sciences Sweden AB Tlf: + 46 (0) 8 5057 1Malta Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1Deutschland Gilead Sciences GmbH Tel: + 49 (0) 89 899890-0
Nederland Gilead Sciences Netherlands B.V. Tel: + 31 (0) 20 718 36 Eesti Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1Norge Gilead Sciences Sweden AB Tlf: + 46 (0) 8 5057 1
Gilead Sciences . . : + 30 210 8930 sterreich Gilead Sciences GesmbH Tel: + 43 1 260 Espa a Gilead Sciences, S.L. Tel: + 34 91 378 98 Polska Gilead Sciences Poland Sp. z o.o. Tel: + 48 22 262 8France Gilead Sciences T l: + 33 (0) 1 46 09 41 Portugal Gilead Sciences, Lda. Tel: + 351 21 7928Hrvatska Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1Rom nia Gilead Sciences (GSR) S.R.L. Tel: + 40 31 631 18 Ireland Gilead Sciences Ireland UC Tel: + 353 (0) 214 825 Slovenija Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1 sland Gilead Sciences Sweden AB S mi: + 46 (0) 8 5057 1Slovensk republika Gilead Sciences Slovakia s.r.o. Tel: + 421 232 121 Italia Gilead Sciences S.r.l. Tel: + 39 02 439Suomi/Finland Gilead Sciences Sweden AB Puh/Tel: + 46 (0) 8 5057 1
Gilead Sciences . . : + 30 210 8930 Sverige Gilead Sciences Sweden AB Tel: + 46 (0) 8 5057 1Latvija Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1United Kingdom (Northern Ireland) Gilead Sciences Ireland UC Tel: + 44 (0) 8000 113This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site:
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type: Package Leaflet
category: Raw
date: 2022-02-16 13:28:17+0000
author: Organization ACME industry
title: TEST PURPOSES ONLY - harvoni
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