KAYFANDA 200 ?g Hard capsule
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Инструкция по применению KAYFANDA
Содержание инструкции
KAYFANDA 200 micrograms hard capsules, 400 micrograms hard capsules, 600 micrograms hard capsules, 1 200 micrograms hard capsules
odevixibat
Medicinal product subject to additional monitoring. This will allow the rapid identification of new safety information. You can contribute by reporting any adverse effects you experience during the use of this medicine (see section 4 for information on how to report adverse effects).
Read this leaflet carefully before taking this medicine as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist (see section 4).
Contents of this leaflet
- 1. What KAYFANDA is and what it is used for
- 2. What you need to know before you take KAYFANDA
- 3. How to take KAYFANDA
- 4. Possible side effects
- 5. How to store KAYFANDA
- 6. Contents of the pack and other information
1. What is KAYFANDA and what is it used for
KAYFANDA contains the active ingredient odevixibat. This medicine helps the removal of bile acids
that are found in the digestive fluid called bile, a fluid produced by the liver that helps to
digest fats in the intestine. After helping with digestion, bile acids are reabsorbed
by the intestine and return to the liver.
What KAYFANDA is used for
KAYFANDA is used to treat itching caused by the accumulation of bile acids in patients aged
6 months or older with Alagille syndrome (ALGS).
Alagille syndrome is a rare genetic disease that can affect several parts of the body, including
liver, heart, eyes, face, skeleton, blood vessels and kidneys. Patients with this syndrome have
reduced bile flow, which leads to an accumulation of bile acids in the blood and liver (cholestasis) which
worsens over time and is often accompanied by severe itching.
How KAYFANDA (odevixibat) works
The active ingredient of Kayfanda, odevixibat, reduces the absorption of bile acids by
the intestine. This allows bile acids to be eliminated from the body with the stool and avoid their
accumulation in the liver. In this way, odevixibat reduces the amount of bile acids present in
the blood.
2. What you need to know before you take KAYFANDA
Do not take KAYFANDA
- if you are allergic to odevixibat or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking KAYFANDA if:
- you have severely reduced liver function;
- you have reduced stomach or intestinal function, or a reduced flow of bile acids between the liver, gallbladder and small intestine due to taking medicines, surgery or diseases other than ALGS. These may reduce the effect of odevixibat.
Contact your doctor if you experience diarrhoea while taking KAYFANDA. If you experience diarrhoea,
drink plenty of fluids to prevent dehydration.
During treatment with KAYFANDA, an increase in liver enzyme levels may occur in liver function tests. Your doctor will check your liver function before and during treatment with KAYFANDA. Your doctor should recommend more frequent monitoring if high values are recorded in liver function tests.
Before and during treatment with KAYFANDA, your doctor should also check the levels of
vitamins A, D and E in your blood and your INR (international normalised ratio, which measures the
risk of bleeding).
Children
KAYFANDA is not recommended for children under 6 months of age, as it is not known whether the
medicine is safe and effective in this age group.
Other medicines and KAYFANDA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Treatment with odevixibat may affect the absorption of fat-soluble vitamins, such as
vitamins A, D and E.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding,
ask your doctor for advice before taking this medicine.
The use of KAYFANDA is not recommended during pregnancy and in women of childbearing potential who are not
using contraceptive measures.
It is not known whether odevixibat can pass into breast milk and have effects on the baby. Your doctor
will help you decide whether to stop breastfeeding or avoid treatment with odevixibat,
considering the benefit of breastfeeding for the baby and taking odevixibat for the
mother.
Driving and using machines
KAYFANDA does not or negligibly alters the ability to drive and operate
machinery.
3. How to take KAYFANDA
Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Treatment must be initiated and supervised by a doctor experienced in the management of progressive liver disease with reduced bile flow.
The dose of KAYFANDA to be taken
- The dose of odevixibat depends on weight. Your doctor will determine the correct amount and the dosage of capsules to take.
- The recommended dose is 120 micrograms of odevixibat per kilogram of body weight once a day (up to a maximum of 7,200 micrograms once a day). Your doctor may recommend a dose reduction to 40 micrograms of odevixibat per kilogram of body weight once a day if you experience diarrhea lasting ≥ 3 days, the diarrhea is considered severe or requires intravenous hydration.
If the medicine does not improve your condition after 6 months of continuous daily treatment, your
doctor will advise you on alternative treatment.
How to take KAYFANDA
Take the capsules once a day in the morning with or without food.
All capsules can be swallowed whole with a glass of water or opened and sprinkled on
food or dispersed in a suitable liquid for age (breast milk, infant formula or water).
The larger 200 and 600 microgram capsules are intended to be opened and sprinkled on food or
dispersed in a suitable liquid for age, but they can also be swallowed whole.
The smaller 400 and 1,200 microgram capsules are intended to be swallowed whole, but they can
also be opened and sprinkled on food or dispersed in a suitable liquid for age.
Instructions for opening the capsules and sprinkling the contents on food or in a liquid are provided at the end
of this leaflet.
If you take more KAYFANDA than you should
Inform your doctor if you think you have taken an excessive amount of KAYFANDA.
Possible symptoms of overdose are diarrhea, stomach problems and intestinal problems.
If you forget to take KAYFANDA
If you miss taking KAYFANDA, take the missed dose as soon as possible, but do not
take more than one dose a day.
If you stop taking KAYFANDA
Treatment with KAYFANDA should not be stopped without first consulting your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can occur with the following frequency:
very common(may affect more than 1 in 10 people)
- diarrhoea
common(may affect up to 1 in 10 people)
- abdominal pain (stomach ache)
- vomiting
- increased levels of liver enzymes, measured with blood tests
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help to provide more information on the safety of this medicine.
5. How to store KAYFANDA
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 pack and bottle after
Exp. The expiry date refers to the last day of that month.
Keep the medicine in its original packaging to protect it from light. Do not store at
a temperature above 25 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What KAYFANDA contains
- The active substance is odevixibat. Each KAYFANDA 200 microgram hard capsule contains 200 micrograms of odevixibat (as sesquihydrate). Each KAYFANDA 400 microgram hard capsule contains 400 micrograms of odevixibat (as sesquihydrate). Each KAYFANDA 600 microgram hard capsule contains 600 micrograms of odevixibat (as sesquihydrate). Each KAYFANDA 1 200 microgram hard capsule contains 1 200 micrograms of odevixibat (as sesquihydrate).
- The other ingredients are:
Capsule contents
Microcrystalline cellulose, hypromellose
Capsule shell
KAYFANDA 200 micrograms and 600 micrograms hard capsules
Hypromellose, titanium dioxide (E171), iron oxide yellow (E172)
KAYFANDA 400 micrograms and 1 200 micrograms hard capsules
Hypromellose, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172)
Printing ink
Shellac, propylene glycol, iron oxide black (E172)
Description of KAYFANDA and package contents
KAYFANDA 200 microgram hard capsules:
Size 0 (21.7 mm × 7.64 mm) capsules with an opaque ivory cap and an opaque white body, with the inscription
“A200” in black ink.
KAYFANDA 400 microgram hard capsules:
Size 3 (15.9 mm × 5.82 mm) capsules with an opaque orange cap and an opaque white body, with the
inscription “A400” in black ink.
KAYFANDA 600 microgram hard capsules:
Size 0 (21.7 mm × 7.64 mm) capsules with an opaque ivory cap and body, with the inscription “A600” in
black ink.
KAYFANDA 1 200 microgram hard capsules:
Size 3 (15.9 mm × 5.82 mm) capsules with an opaque orange cap and body, with the inscription “A1200”
in black ink.
KAYFANDA hard capsules are packaged in a plastic bottle (High-density polyethylene (HDPE) bottle)
with a child-resistant and tamper-evident polypropylene closure.
Pack size: 30 hard capsules
Marketing Authorisation Holder
Ipsen Pharma
65 quai Georges Gorse
92100 Boulogne-Billancourt
France
Manufacturer
Almac Pharma Services Limited
Seagoe Industrial Estate
Portadown, Craigavon
County Armagh
BT63 5UA
United Kingdom (Northern Ireland)
An authorisation has been granted for this medicinal product in “exceptional circumstances”. This means that
due to the rarity of the disease, complete information on this medicinal product could not be obtained.
The European Medicines Agency will annually review any new information on this
Other sources of information
Detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu. Additionally, links to other websites on rare diseases and
related therapeutic treatments are provided.
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Instructions
Instructions for opening the capsules and sprinkling the contents on food:
Step 1. Place a small amount of soft food in a bowl (2 tablespoons/30 mL of yogurt,
applesauce, banana puree or carrot puree, chocolate pudding, rice pudding or oatmeal). The
food should be at room temperature or cooler.
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Instructions for opening the capsules and pouring the contents into a liquid suitable for the age:
Contact your pharmacy if you do not have a suitable oral administration syringe for
administration at home.
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ANNEX IV
CONCLUSIONS RELATING TO THE GRANT OF THE MARKETING AUTHORISATION
IN EXCEPTIONAL CIRCUMSTANCES PRESENTED BY THE
EUROPEAN MEDICINES AGENCY
Conclusions presented by the European Medicines Agency on:
- Grant of marketing authorisation in exceptional circumstancesFollowing the evaluation of the marketing authorisation application, the Committee for Medicinal Products for Human Use (Committee for human medicinal products, CHMP) considers that the benefit/risk balance is favourable in order to recommend the grant of the marketing authorisation in exceptional circumstances, as further described in the European Public Assessment Report (European Public Assessment Report, EPAR).
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- Страна регистрации
- Форма выпускаHard capsule, 200 ?g
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги KAYFANDAФорма выпуска: Hard capsule, 200 MCGДействующее вещество: odevixibatПроизводитель: IPSEN PHARMAОтпускается по рецептуФорма выпуска: Film-coated tablet, 80 mgДействующее вещество: elafibranorПроизводитель: IPSEN PHARMAОтпускается по рецептуФорма выпуска: Oral solution, 9.5 mg / mLДействующее вещество: Мараликсибат хлоридПроизводитель: Mirum Pharmaceuticals International B.V.Отпускается по рецепту
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KAYFANDA производится компанией IPSEN PHARMA. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
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