Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
L Thyroxine Sodium
MSD Animal Health UK Limited
QH03AA01
L Thyroxine Sodium
Oral solution
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Hormone
Authorized
2007-04-23
Revised: August 2020 AN: 00299/2020 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Leventa 1 mg/ml Oral Solution for Dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance: Levothyroxine sodium (as multihydrate) 1 milligram (equivalent to 0.97 milligram levothyroxine) Excipients: Ethanol 96 % 0.15 ml For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution. Clear, slight reddish coloured solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of hypothyroidism in dogs. 4.3 CONTRAINDICATIONS Do not use in dogs with hyperthyroidism or uncorrected adrenal insufficiency (hypoadrenocorticism). Do not use in case of hypersensitivity to levothyroxine sodium or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS The product should be used with caution in dogs with cardiac disease, diabetes mellitus or treated adrenal insufficiency (hypoadrenocorticism). For these dogs, gradual introduction of levothyroxine therapy, starting with 25 % of the normal Revised: August 2020 AN: 00299/2020 Page 2 of 6 dose and increasing by 25 % increments every two weeks until optimal stabilisation is achieved is recommended. The clinical diagnosis of hypothyroidism should be confirmed by laboratory tests. II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS In the case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Note: this product contains a high concentration of L-thyroxine sodium and may present a risk to humans if ingested. Wash hands after use. In case of eye contact, flush immediately with water. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Adverse reactions associated with treatment with L-thyroxine sodium are primarily those of hyperthyroidis Read the complete document