VYNDAQEL

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

TAFAMIDIS AS MEGLUMINE

Dostupné z:

PFIZER PHARMACEUTICALS ISRAEL LTD

ATC kód:

N07XX08

Forma lieku:

CAPSULES SOFT GELATIN

Zloženie:

TAFAMIDIS AS MEGLUMINE 12.2 MG

Spôsob podávania:

PER OS

Typ predpisu:

Required

Výrobca:

MILLMOUNT HEALTHCARE LTD., IRELAND

Terapeutické oblasti:

TAFAMIDIS

Terapeutické indikácie:

For the treatment of transthyretin amyloidosis in adult patients with stage 1 symptomatic polyneuropathy to delay peripheral neurologic impairment.

Dátum Autorizácia:

2020-06-30

Príbalový leták

Vyndaqel PIL TC CC 08 Mar 2022
2022-0076691
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
VYNDAQEL
®
SOFT CAPSULES 12.2 MG
EACH SOFT CAPSULE CONTAINS: TAFAMIDIS (AS MEGLUMINE) 12.2 MG
Inactive and allergenic ingredients: see section 2 under ‘Important
information about
some of this medicine’s ingredients’ and the section 6 ‘Further
information’.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet
contains concise information about the medicine. If you have further
questions, refer
to the doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar to yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
This medicine is intended to treat a disease called transthyretin
amyloidosis. The
disease is caused by impaired function of the transthyretin (TTR)
protein, which is
essential for carrying various substances in the body, such as
hormones.
In patients with this disease, the protein breaks up and may form
amyloid fibers. This
amyloid can build up around nerve cells (known as transthyretin
amyloid
polyneuropathy ATTR-PN) and in other places in the body. The amyloid
causes the
symptoms of this disease. Amyloid buildup prevents nerve cells from
working
normally. Vyndaqel
®
can prevent breakdown of the protein and formation of amyloid.
This medicine is used to treat transthyretin amyloidosis in adult
patients with nerve
damage (symptomatic polyneuropathy), to delay disease progression.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
you are sensitive (allergic) to the active ingredient or to any of the
other
ingredients contained in the medicine (see section 6).
Consult with your doctor, pharmacist or nurse before starting
treatment with this
medicine.
CHILDREN AND ADOLESCENTS
The symptoms of transthyretin amyloidosis are not manifested in
child

Súhrn charakteristických

Vyndaqel LPD Israel CC 29 May 2023 WC 11 Dec 2023
2023-0085598 2023-0083319
1
NAME OF THE MEDICINAL PRODUCT
Vyndaqel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 20 mg of micronized tafamidis meglumine
equivalent to 12.2 mg tafamidis.
Excipient with known effect
Each soft capsule contains no more than 44 mg of sorbitol (E 420).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Soft capsule.
Oblong, opaque yellow soft gelatin capsule filled with a white to pink
suspension and printed with
“VYN 20” in red
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Vyndaqel is indicated for the treatment of transthyretin amyloidosis
in adult patients with stage 1
symptomatic polyneuropathy to delay peripheral neurologic impairment.
4.2
Posology and method of administration
Treatment should be initiated under the supervision of a physician
knowledgeable in the management
of patients with transthyretin amyloid polyneuropathy (ATTR-PN).
Posology
The recommended dose of tafamidis meglumine is 20 mg orally once
daily.
Tafamidis and tafamidis meglumine are not interchangeable on a per mg
basis.
If vomiting occurs after dosing, and the intact Vyndaqel capsule is
identified, then an additional dose
of Vyndaqel should be administered if possible. If no capsule is
identified, then no additional dose is
necessary, with resumption of dosing the next day as usual.
Special populations
_ _
_Elderly _
No dosage adjustment is required for elderly patients (≥ 65 years)
(see section 5.2).
_ _
_hepatic and renal impairment _
No dosage adjustment is required for patients with renal or mild and
moderate hepatic impairment.
Limited data are available in patients with severe renal impairment
(creatinine clearance less than or
equal to 30 mL/min). Tafamidis meglumine has not been studied in
patients with severe hepatic
impairment and caution is recommended (see section 5.2).
_Paediatric population _
Vyndaqel LPD Israel WC 07 Mar 2022
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There is no relevant use of tafamidis i