Kalydeco 75mg granules sachets

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Ivacaftor

Доступна с:

Vertex Pharmaceuticals (UK

код АТС:

R07AX02

ИНН (Международная Имя):

Ivacaftor

дозировка:

75mg

Фармацевтическая форма:

Granules

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF:

тонкая брошюра

65
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KALYDECO 50 MG GRANULES IN SACHET
KALYDECO 75 MG GRANULES IN SACHET
Ivacaftor
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of
section 4 for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS TAKING
THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOUR CHILD.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your child’s doctor or
pharmacist.

This medicine has been prescribed for your child only. Do not pass it
on to others. It may harm
them, even if their signs of illness are the same as your child’s.

If your child gets any side effects, talk to your child’s doctor or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Kalydeco is and what it is used for
2.
What you need to know before your child takes Kalydeco
3.
How to take Kalydeco
4.
Possible side effects
5.
How to store Kalydeco
6.
Contents of the pack and other information
1.
WHAT KALYDECO IS AND WHAT IT IS USED FOR
Kalydeco contains the active ingredient ivacaftor. Ivacaftor acts at
the level of the cystic fibrosis
transmembrane conductance regulator (CFTR), a protein that forms a
channel at the cell surface that
allows the movement of particles such as chloride in and out of the
cell. Due to mutations in the
_CFTR _
gene (see below), chloride movement is reduced in those with cystic
fibrosis (CF). Ivacaftor helps
certain abnormal CFTR proteins open more often to improve chloride
movement in and out of the cell.
Kalydeco granules are indicated for the treatment of children with
cystic fibrosis (CF) aged 2 years
and older and weighing less than 25 kg who have one of the following
gating mutations in the
_CFTR_
gene:
_G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N _
or
_ S549R_
.
2.

Характеристики продукта

OBJECT 1
KALYDECO 50MG AND 75MG GRANULES SACHETS
Summary of Product Characteristics Updated 02-Oct-2017 | Vertex
Pharmaceuticals (Europe) Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Kalydeco 50 mg granules in sachet
Kalydeco 75 mg granules in sachet
2. Qualitative and quantitative composition
Kalydeco 50 mg granules in sachet
Each sachet contains 50 mg of ivacaftor.
Excipient with known effect
Each sachet contains 73.2 mg of lactose (as monohydrate)
Kalydeco 75 mg granules in sachet
Each sachet contains 75 mg of ivacaftor.
Excipient with known effect
Each sachet contains 109.8 mg of lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Granules in sachet.
White to off-white granules approximately 2 mm in diameter.
4. Clinical particulars
4.1 Therapeutic indications
Kalydeco granules are indicated for the treatment of children with
cystic fibrosis (CF) aged 2 years and
older and weighing less than 25 kg who have one of the following
gating (class III) mutations in the
_CFTR_ gene: _G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P,
S549N _or _S549R_ (see sections
4.4 and 5.1).
4.2 Posology and method of administration
Kalydeco should only be prescribed by physicians with experience in
the treatment of cystic fibrosis. If
the patient's genotype is unknown, an accurate and validated
genotyping method should be performed
before starting treatment to confirm the presence of one of the
above-listed gating (class III) mutations in
at least one allele of the _CFTR_ gene.
Posology
_Children aged 2 years and older, adolescents and adults should be
dosed according to Table 1._
TABLE 1. DOSING RECOMMENDATIONS FOR PATIENTS AGED 2 YEARS AND OLDER
WEIGHT
DOSE
TOTAL DAILY DOSE
<14 kg
50 mg granules taken orally every 12 hours with
fat-c