Teatrois 0.35mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tiratricol

Available from:

Imported (France)

INN (International Name):

Tiratricol

Dosage:

350microgram

Pharmaceutical form:

Oral tablet

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF:

Summary of Product characteristics

Medical information – Emcitate® (tiratricol)
Medical Department, Rare Thyroid Therapeutics International AB
Medical Information Emcitate® – MCT8 Deficiency Ver 005
INSTRUCTION ON HOW TO REPORT AN ADVERSE DRUG REACTION AND PRODUCT
INFORMATION
EMCITATE® (TIRATRICOL)
_EMCITATE IS NOT APPROVED FOR THE TREATMENT OF MCT8 DEFICIENCY ( ALSO
KNOWN AS ALLAN-HERNDON- _
_DUDLEY SYNDROME) OR ANY OTHER INDICATION IN ANY COUNTRY. _
_TREATMENT WITH EMCITATE FOR A SPECIFIC PATIENT REQUIRES SPECIAL
PERMISSION FROM THE NATIONAL _
_HEALTH/REGULATORY AUTHORITIES, WHICH IS APPLIED FOR BY THE
PRESCRIBING PHYSICIAN. _
_ADVERSE EVENTS/ADVERSE DRUG REACTIONS SHOULD BE REPORTED TO
[e-mail] BY USING THE _
_ATTACHED FORM _
_THE PRODUCT IS UNDER CONTINUED CLINICAL DEVELOPMENT. THIS PRODUCT
INFORMATION ONLY REPRESENTS A _
_CONDENSED SUMMARY OF DATA CURRENTLY KNOWN AND IS ONLY PROVIDED BY THE
MEDICAL DEPARTMENT ON _
_REQUEST FROM A HEALTH CARE PROFESSIONAL. _
_A GLOBAL REFERENCE CENTER FOR THE DIAGNOSIS AND MANAGEMENT OF MCT8
DEFICIENCY IS AVAILABLE AT THE _
_ERASMUS MEDICAL CENTER IN ROTTERDAM, THE NETHERLANDS. _
ACTIVE PHARMACEUTICAL INGREDIENT
Tiratricol (3,3',5-triiodothyroacetic acid)
PHARMACEUTICAL INFORMATION
Emcitate 350 mcg (white, round)
Other ingredients: calcium hydrogen phosphate, corn starch, lactose
monohydrate, magnesium stearate.
THERAPEUTIC EFFECTS
Treatment of MCT8 deficiency, also known as the Allan-Herndon-Dudley
Syndrome (AHDS)
DOSAGE / POSOLOGY
The tablets should be suspended in water before administration. The
tablets do not need to be crushed or ground before
suspension. The volume of water used to suspend the tablets should be
adjusted to each individual dose (see Table

1).
The suspension should be thoroughly mixed and immediately given to the
participant either orally (if needed it can be
mixed with mashed food or by PEG tube.
If the participant can swallow food/liquid and is normally fed orally,
the medication should be given either as a suspension,
or by mixing the suspension with mashed food if