Amversio

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

betaine

MAH:

SERB SA

ATC_code:

A16AA06

INN:

betaine anhydrous

therapeutic_group:

Other alimentary tract and metabolism products,

therapeutic_area:

Homocystinuria

therapeutic_indication:

Amversio is indicated as adjunctive treatment of homocystinuria, involving deficiencies or defects in:•         cystathionine beta-synthase (CBS),•         5,10 methylene tetrahydrofolate reductase (MTHFR),•         cobalamin cofactor metabolism (cbl).

authorization_status:

Authorised

authorization_date:

2022-05-05

PIL

16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMVERSIO 1 G ORAL POWDER
betaine anhydrous
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Amversio is and what it is used for
2.
What you need to know before you take Amversio
3.
How to take Amversio
4.
Possible side effects
5.
How to store Amversio
6.
Contents of the pack and other information
1.
WHAT AMVERSIO IS AND WHAT IT IS USED FOR
Amversio contains betaine anhydrous which is intended to be an
adjunctive treatment of
homocystinuria, an inherited (genetic) disease where the amino acid
methionine cannot be broken
down completely by the body.
Methionine is present in regular food protein (such as meat, fish,
milk, cheese, eggs). It is converted
into homocysteine which is then normally converted into cysteine
during digestion. Homocystinuria is
a disease caused by the accumulation of homocysteine which is not
converted to cysteine and is
characterised by formation of clots in the veins, bone weakness, and
skeletal and crystalline lens
abnormalities. The use of Amversio together with other treatments such
as vitamin B6, vitamin B12,
folate and a specific diet aims to reduce the elevated homocysteine
levels in your body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMVERSIO
_ _
DO NOT TAKE AMVERSIO
-
if you are allergic to betaine anhydrous.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Amversio.
-
If you notice side effects like headaches, vomiting or a change in
your vision and you are of the
homocyst

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Amversio 1 g oral powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of powder contains 1 g of betaine anhydrous.
3.
PHARMACEUTICAL FORM
Oral powder.
White crystalline free flowing powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amversio is indicated as adjunctive treatment of homocystinuria,
involving deficiencies or defects in:
•
cystathionine beta-synthase (CBS),
•
5,10-methylene-tetrahydrofolate reductase (MTHFR),
•
cobalamin cofactor metabolism (cbl).
Amversio should be used as supplement to other therapies such as
vitamin B6 (pyridoxine), vitamin
B12 (cobalamin), folate and a specific diet.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Amversio treatment should be supervised by a physician experienced in
the treatment of patients with
homocystinuria.
Posology
_ _
_Children and adults _
The recommended total daily dose is 100 mg/kg/day given in 2 doses
daily. However, the dose should
be individually titrated according to plasma levels of homocysteine
and methionine. In some patients
doses above 200 mg/kg/day were needed to reach therapeutic goals.
Caution should be exercised with
up-titrating doses for patients with CBS deficiency due to the risk
for hypermethioninaemia.
Methionine levels should be closely monitored in these patients.
_ _
_Special populations _
_Hepatic or renal impairment _
Experience with betaine anhydrous therapy in patients with renal
insufficiency or non-alcoholic
hepatic steatosis has demonstrated no need to adapt the dose regimen
of Amversio.
_Therapeutic monitoring _
The aim of treatment is to keep plasma levels of total homocysteine
below 15 μmol/L or as low as
possible. The steady-state response usually occurs within a month.
Method of administration
Oral use
3
The bottle should be lightly shaken before opening. Three measuring
spoons are provided which
dispense either 100 mg, 150 mg or 1 g of betaine anhydrous. It is
recommended that a heaped
measuring spoon is removed from the bottl