APEX THYROXINE ORAL SOLUTION

Nazione: Australia

Lingua: inglese

Fonte: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Principio attivo:

LEVOTHYROXINE SODIUM (97%-102%)

Commercializzato da:

DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.

INN (Nome Internazionale):

thyroxine sodium(1mg/mL)

Forma farmaceutica:

ORAL SOLUTION/SUSPENSION

Composizione:

LEVOTHYROXINE SODIUM (97%-102%) Active 1.0 mg/ml

Confezione:

100mL; 50mL

Classe:

VM - Veterinary Medicine

Prodotto da:

APEX LABORATORIES

Area terapeutica:

ENDOCRINE SYSTEM

Dettagli prodotto:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [HYPOTHYROIDISM]; Thyroid replacement therapy for conditions where production of thyroid hormone is inadequate.See contraindications and precautions on label.

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2023-07-01

Foglio illustrativo

APEX THYROXINE ORAL SOLUTION
67226/130469
Product Name:
APVMA Approval
No:
Label Name:
APEX THYROXINE ORAL SOLUTION
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
READ SAFETY DIRECTIONS
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
1 mg/ml LEVOTHYROXINE SODIUM
Claims:
Thyroid replacement therapy for conditions where production of thyroid
hormone is
inadequate.
Net Contents:
100mL
50mL
Directions for Use:
Restraints:
Contraindications:
Do not use in animals with hyperthyroidism or uncorrected
hypoadrenocorticism.
This product is contraindicated for use in cases of acute myocardial
infarction.
This product is contraindicated in dogs with hypersensitivity to
Levothyroxine sodium.
Precautions:
Use with caution in dogs with heart disease, hypertension, diabetes
mellitus, treated
hypoadrenocorticism or any disease causing an increase in metabolic
rate. In these
patients it is advisable to gradually introduce levothyroxine therapy,
beginning with 25%
of the recommended label dose and increasing in 25% increments every
two weeks until
stabilisation in the therapeutic range is achieved.
Use of Apex Thyroxine Oral Solution in pregnant, lactating or breeding
dogs has not been
evaluated, however, thyroxine is essential for normal foetal
development. Hypothyroidism
in pregnancy may result in impaired cognitive development and
increased foetal mortality.
Maternal thyroid requirements may increase during pregnancy. Therefore
regular
monitoring of breeding bitches throughout pregnancy and lactation
should be undertaken
as dose requirements may be altered during this time. RLP APPROVED
Drug interactions:
The absorption of Levothyroxine sodium may be impaired by the presence
of antacids such
as aluminium or magnesium salts, calcium carbonate, ferrous sulphate
and sucralfate.
Administration of Apex Thyroxine Oral Solution should therefore not
occur within two hours
of administration of one of these substances.
Any compound that influences the metabolism and disposition of thyroid
hormones may
also inf

Scheda tecnica

1. IDENTIFICATION OF THE MATERIAL AND SUPPLIER
THYROXINE SOLUTION
SYNONYMS
VETERINARY USE
USES
1.2 USES AND USES ADVISED AGAINST
1.3 DETAILS OF THE SUPPLIER OF THE PRODUCT
APEX LABORATORIES PTY LTD
SUPPLIER NAME
2 Cal Close, Somersby, NSW, 2250, AUSTRALIA
ADDRESS
1300 015 825
TELEPHONE
[phone]
FAX
[e-mail]
EMAIL
13 11 26 (Poisons Information Centre)
EMERGENCY
1.4 EMERGENCY TELEPHONE NUMBERS
http://www.apexlabs.com.au
WEBSITE
1.1 PRODUCT IDENTIFIER
APEX THYROXINE ORAL SOLUTION
PRODUCT NAME
2. HAZARDS IDENTIFICATION
NOT CLASSIFIED AS HAZARDOUS ACCORDING TO SAFE WORK AUSTRALIA CRITERIA
2.2 GHS LABEL ELEMENTS
No signal word, pictograms, hazard or precautionary statements have
been allocated.
No information provided.
2.3 OTHER HAZARDS
2.1 CLASSIFICATION OF THE SUBSTANCE OR MIXTURE
3. COMPOSITION/ INFORMATION ON INGREDIENTS
INGREDIENT
CAS NUMBER
EC NUMBER
CONTENT
<1%
111-42-2
203-868-0
DIETHANOLAMINE
<1%
25416-65-3
685-634-1
LEVOTHYROXINE SODIUM
<1%
1310-73-2
215-185-5
SODIUM HYDROXIDE
Remainder
Not Available
Not Available
NON HAZARDOUS INGREDIENTS
30 to 60%
57-55-6
200-338-0
PROPYLENE GLYCOL (PROPANE-1,2-DIOL)
3.1 SUBSTANCES / MIXTURES
4. FIRST AID MEASURES
If
in eyes,
hold eyelids apart
and flush continuously with running water.
Continue flushing until
advised to
stop by a Poisons Information Centre, a doctor, or for at least 15
minutes.
4.1 DESCRIPTION OF FIRST AID MEASURES
EYE
If inhaled, remove from contaminated area. Apply artificial
respiration if not breathing.
INHALATION
If
skin or
hair
contact
occurs,
remove contaminated clothing and flush skin and hair
with running water.
Continue flushing with water until advised to stop by a Poisons
Information Centre or a doctor.
SKIN
SDS Date:
27 Jun 2018
Version No:
1
of
Page 1
6
APEX THYROXINE ORAL SOLUTION
PRODUCT NAME
For advice, contact a Poisons Information Centre on 13 11 26
(Australia Wide) or a doctor (at once).
INGESTION
None allocated.
FIRST AID FACILITIES
See Section 11 for more detailed information on health effects and
symptoms.
4.2 MOS