Synthroid

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Levothyroxine sodium 175ug (plus a 9% manufacturing overage); Levothyroxine sodium 175ug (plus a 2% manufacturing overage)

Tillgänglig från:

Viatris Limited

INN (International namn):

Levothyroxine sodium 175 µg (plus a 9% manufacturing overage)

Dos:

175 mcg

Läkemedelsform:

Tablet

Sammansättning:

Active: Levothyroxine sodium 175ug (plus a 9% manufacturing overage) Excipient: Acacia Brilliant blue FCF D&C Red Lake Blend #9570 Lactose monohydrate Magnesium stearate Povidone Purified talc Sucrose Active: Levothyroxine sodium 175ug (plus a 2% manufacturing overage) Excipient: Acacia Brilliant blue FCF D&C Red Lake Blend #9570 Lactose monohydrate Magnesium stearate Povidone Purified talc Sucrose

Enheter i paketet:

Bottle, plastic, white HDPE with PP CRC and StabilOX canister 90 tablets, 90 tablets

Klass:

Prescription

Receptbelagda typ:

Prescription

Tillverkad av:

AbbVie Inc

Terapeutiska indikationer:

SYNTHROID (levothyroxine sodium, USP) is indicated as replacement or supplemental therapy in patients of any age or state (including pregnancy) with hypothyroidism of any etiology except transient hypothyroidism during the recovery phase of subacute thyroiditis; Specific indication include: primary hypothyroidism resulting from thyroid dysfunction, primary atrophy, or partial or total absence of thyroid gland, or from the effects of surgery, radiation or drugs, with or without the presence of goiter, including subclinical hypothyroidism; secondary (pituitary) hypothyroidism; and tertiary (hypothalamic) hypothyroidism.

Produktsammanfattning:

Package - Contents - Shelf Life: Bottle, plastic, white 40 cc HDPE or HDPE/EVOH/HDPE with PP CRC and StabilOX canister or dessicant - 90 tablets - 15 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, plastic, white 175 cc HDPE or HDPE/EVOH/HDPE with PP CRC and StabilOX canister or dessicant - 1000 tablets - 15 months from date of manufacture stored at or below 25°C protect from light and moisture

Tillstånd datum:

2008-09-02

Bipacksedel

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
SYNTHROID
®
_LEVOTHYROXINE SODIUM, 25 MCG, 50 MCG AND 100 MCG _
_TABLETS_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking
SYNTHROID.
This leaflet answers some common
questions about SYNTHROID.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking SYNTHROID
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING SYNTHROID, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. YOU MAY NEED TO READ
IT AGAIN.
WHAT SYNTHROID IS
TAKEN FOR
SYNTHROID is used to replace a
hormone that is normally produced
by your thyroid gland. It is also used
to help decrease the size of
enlarged thyroid glands (known as
goiter) and to treat thyroid cancer.
The thyroid gland produces and
releases two hormones: thyroxine
and liothyronine. These hormones
are responsible for maintaining a
normal rate of metabolism in the
body.
When the thyroid gland is unable to
produce normal amounts of
thyroxine, the level of thyroid
hormones in the blood decreases
(hypothyroidism). This results in a
reduced rate of metabolism and
interferes with the proper function of
many body organs.
SYNTHROID contains levothyroxine
sodium, the same as the thyroxine
hormone, produced by the normally
functioning thyroid gland.
Generally, replacement therapy is to
be taken for life, except in cases of
transient (temporary)
hypothyroidism, which is usually
associated with inflammation of the
thyroid gland (thyroiditis).
ASK YOUR DOCTOR IF YOU HAVE
QUESTIONS ABOUT WHY
SYNTHROID HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed
SYNTHROID for another reason.
BEFORE YOU TAKE
SYNTHROID
_WHEN YOU MUST NOT TAKE IT_
SYNTHROID SHOULD NOT BE USED
IN PATIENTS WITH:
•
Overactive thyroid gland
(thyrotoxicosis) of any
cause
•
Uncorrected/untreated
adrenal gland under-activity
•
A h

Produktens egenskaper

Page 1 of 21
NEW ZEALAND DATA SHEET
SYNTHROID
®
1. PRODUCT NAME
Synthroid, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg,
137 mcg, 150 mcg, 175
mcg, 200 mcg, 300 mcg tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Synthroid tablet contains 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100
mcg, 112 mcg, 125 mcg, 137
mcg, 150 mcg, 175 mcg, 200 mcg or 300 mcg of levothyroxine sodium.
Excipients with known effect: Synthroid tablets contain lactose and
sucrose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Synthroid tablets are round, colour coded, contain a score line and
are debossed with “SYNTHROID”
and potency.
The score line is not intended for breaking the tablet.
The colour code is as follows in table 1:
TABLE 1: SYNTHROID TABLET VISUAL CHARACTERISTICS
STRENGTH (MCG)
TABLET COLOUR
25
Orange
50
White
75*
Violet
88*
Olive
100
Yellow
112*
Rose
125*
Brown
137*
Dark blue
150*
Blue
175*
Lilac
200*
Pink
300*
Green
*not currently marketed.
Page 2 of 21
4. CLINICAL PARTICULARS
_4.1_
_THERAPEUTIC INDICATIONS_
Synthroid is indicated as replacement or supplemental therapy in
patients of any age or state
(including pregnancy) with hypothyroidism of any etiology except
transient hypothyroidism during
the recovery phase of subacute thyroiditis. Specific indications
include: primary hypothyroidism
resulting from thyroid dysfunction, primary atrophy, or partial or
total absence of thyroid gland, or
from the effects of surgery, radiation or drugs, with or without the
presence of goiter, including
subclinical
hypothyroidism;
secondary
(pituitary)
hypothyroidism;
and
tertiary
(hypothalamic)
hypothyroidism.
Synthroid is also indicated as a pituitary TSH suppressant in the
treatment or prevention of various
types of euthyroid goiters, including thyroid nodules, subacute or
chronic lymphocytic thyroiditis
(Hashimoto’s), multinodular goiter, and in conjunction with surgery
and radioactive iodine therapy in
the management of thyrotropin-dependent well-differentiated papillary
or follicular carc