LEVOTHOX levothyroxine sodium 150 microgram tablet bottle

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

levothyroxine sodium, Quantity: 150 microgram

Fáanlegur frá:

Accord Healthcare Pty Ltd

Lyfjaform:

Tablet, uncoated

Samsetning:

Excipient Ingredients: sodium stearylfumarate; light magnesium oxide; sodium starch glycollate; microcrystalline cellulose; indigo carmine aluminium lake

Stjórnsýsluleið:

Oral

Einingar í pakka:

200, 90

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

LEVOTHOX is indicated for the management of demonstrated thyroid hormone deficiency.,LEVOTHOX is also used to suppress thyrotropin (TSH) for the management of TSH-responsive tumours of the thyroid.

Vörulýsing:

Visual Identification: Round, blue coloured, uncoated tablets, with a break line on both sides. Debossed with "P" and "9" on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Leyfisstaða:

Registered

Leyfisdagur:

2022-07-25

Vara einkenni

LEVOTHOX - Product Information v 1 June 22
Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION – LEVOTHOX (LEVOTHYROXINE
SODIUM) TABLETS
LEVOTHOX is bioequivalent to ELTROXIN.
LEVOTHOX is not bioequivalent on a same-dose basis with
EUTROXSIG/OROXINE. If a decision is
made to switch a patient from EUTROXSIG/OROXINE to LEVOTHOX, then
prescribers should have a
plan for monitoring TSH. Prescribers should be aware that dose
adjustment may be required.
Prescribers should tell their patients not to interchange LEVOTHOX and
EUTROXSIG/OROXINE unless
a decision has been made to switch products, and there is a plan for
monitoring TSH levels and
review of dose.
1
NAME OF THE MEDICINE
Levothyroxine sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each LEVOTHOX tablet contains levothyroxine sodium.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Oral Tablets
LEVOTHOX 25 microgram: Round, orange coloured, uncoated tablets, with
a break line on both
sides. Debossed with "P" and "1" on one side and plain on the other
side.
LEVOTHOX 50 microgram: Round, white coloured, uncoated tablets, with a
break line on both sides.
Debossed with "P" and "2" on one side and plain on the other side.
LEVOTHOX 75 microgram: Round, violet coloured, uncoated tablets, with
a break line on both sides.
Debossed with "P" and "3" on one side and plain on the other side.
LEVOTHOX 88 microgram: Round, olive coloured, uncoated tablets, with a
break line on both sides.
Debossed with "P" and "4" on one side and plain on the other side.
LEVOTHOX 100 microgram: Round shaped, yellow coloured, uncoated
tablets, with a break line on
both sides. Debossed with "P" and "14" on one side and plain on the
other side.
LEVOTHOX 112 microgram: Round, rose coloured, uncoated tablets, with a
break line on both sides.
Debossed with "P" and "6" on one side and plain on the other side.
LEVOTHOX 125 microgram: Round, brown coloured, uncoated tablets, with
a break line on both
sides. Debossed with "P" and "7" on one side and plain on the othe