CYSTADANE- betaine powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BETAINE (UNII: 3SCV180C9W) (BETAINE - UNII:3SCV180C9W)

Available from:

Orphan Europe SARL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Unapproved drug for use in drug shortage

Summary of Product characteristics

CYSTADANE- BETAINE POWDER, FOR SOLUTION
ORPHAN EUROPE SARL
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 your 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 Cystadane is and what it is used for
2. What do you need to know before you take Cystadane
3. How to take Cystadane
4. Possible side effects
5. How to store Cystadane
6. Contents of the pack and other information
1. WHAT CYSTADANE IS AND WHAT IT IS USED FOR
Cystadane 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 (e.g. 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 Cystadane 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 CYSTADANE
DO NOT TAKE CYSTADANE
If you are allergic to betaine anhydrous.
WAR