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Leventa 1mg/ml Oral Solution For Dogs 30ml

Item Number: LEVENTA

Leventa 1mg/ml Oral Solution For Dogs 30ml
  • 30ml

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    £ 18.75

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Description

Target Species
Dogs.
Indications for use
Treatment of hypothyroidism in dogs.
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.


Data Sheets

Leventa® 1 mg/ml Oral Solution for Dogs Species:Dogs

Therapeutic indication:Pharmaceuticals: Hormones and therapeutically related products: Others

Active ingredient:Levothyroxine Sodium

Product:Leventa® 1 mg/ml Oral Solution for Dogs

Product index:Leventa®

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 the full list of excipients, see section “Pharmaceutical particulars”.

Pharmaceutical form

Oral solution.

Clear, slight reddish coloured solution.

Clinical particulars

Target Species

Dogs.

Indications for use

Treatment of hypothyroidism in dogs.

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.

Special warnings for each target species

None.

Special precautions for use

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 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.

Operator warnings

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.

Adverse Reactions

Adverse reactions associated with treatment with L-thyroxine sodium are primarily

those of hyperthyroidism due to therapeutic overdose. They include body weight loss, hyperactivity, tachycardia, polydipsia, polyuria, polyphagia, vomiting and diarrhoea. Transient, self-resolving skin reactions such as mild to moderate scale formation may occur.

Use during pregnancy or lactation

The safety of use in pregnant bitches has not been evaluated. However, thyroxine is essential for normal foetal development. Hypothyroidism during pregnancy may be associated with impaired cognitive development and increased foetal mortality. During pregnancy, maternal thyroid hormone requirements may increase. Pregnant bitches receiving treatment should therefore be monitored on a regular basis from conception until several weeks after delivery, as dose requirements may change during pregnancy and lactation.

Use in lactating bitches or animals intended for future breeding has not been evaluated

Interactions

L-thyroxine absorption may be impaired by the concomitant administration of antacids, e.g. aluminium or magnesium salts or calcium carbonate, or ferrous sulphate, and sucralfate. Therefore, concomitant administration of Leventa with the above mentioned compounds should be avoided. At least 2 hours should elapse between administration of Leventa and such products.

The therapeutic response to Leventa may be altered by any compound that influences thyroid hormone metabolism and disposition (e.g. drugs displacing protein-binding site, modifying serum thyroxine-binding globulin concentration, or altering hepatic degradation of thyroxine or peripheral conversion of thyroxine to triiodothyronine). Thus, in case of concomitant administration of Leventa with a compound exhibiting one of these properties, it is recommended to recheck that thyroid hormone concentrations are appropriate and to adjust the dose of Leventa accordingly if needed.

Conversely, L-thyroxine supplementation may affect the pharmacokinetics and activity of concurrent therapies. In diabetic dogs treated with insulin, L-thyroxine supplementation may alter insulin requirements. In dogs with cardiac insufficiency, therapeutic response to cardiac glycosides may be decreased by L-thyroxine supplementation. Therefore, if treated with any of these compounds, dogs should be monitored carefully during initiation of treatment with Leventa.

Amounts to be administered and administration route

For oral use only.

In thyroid hormone replacement therapy with L-thyroxine, the dose rate and regime have to be tailored individually to each dog. A starting dose rate of 20 microgram L-thyroxine sodium/kg once daily is recommended; this corresponds to 0.2 ml of the product per 10 kg bodyweight.

At re-examination four weeks later, dose adjustments should be performed based on the clinical response to treatment and thyroid hormone concentration evaluated 4-6 hours after administration of the product. Further assessment of hormonal responses and dose adjustment may be repeated at 4 week intervals if required.

A maintenance dose rate between 10 and 40 microgram/kg body weight once daily is generally sufficient to control the clinical signs of hypothyroidism and to restore thyroid hormone concentrations to within the reference range. Depending on the dose rate determined as suitable for the dog and on its body weight, the volume (in ml) of the product to be administered once daily can be estimated using the following table:

Dosage (microgram/kg)

10 20 30 40
Body weight (kg) Volume of the product (ml)
5 0.05 0.10 0.15 0.20
10 0.10 0.20 0.30 0.40
15 0.15 0.30 0.45 0.60
20 0.20 0.40 0.60 0.80
25 0.25 0.50 0.75 1.00
30 0.30 0.60 0.90 1.20
35 0.35 0.70 1.05 1.40
40 0.40 0.80 1.20 1.60
45 0.45 0.90 1.35 1.80
50 0.50 1.00 1.50 2.00
Once a suitable dose rate and regime have been established, it is recommended to recheck every 6 months that thyroid hormone concentrations are appropriate.

The improvement in clinical signs occurs differentially following the onset of treatment with L-thyroxine: whilst metabolic signs improve within two weeks after the onset of treatment, dermatological signs may require 6 weeks or more of treatment before improvement is seen.

The product should be administered at the same time every day. The absorption of L-thyroxine is influenced by food.

In order to achieve consistent absorption of L-thyroxine, it is recommended to administer L-thyroxine 2 – 3 hours prior to feeding, which will maximise the degree of absorption and minimize variation in absorption.

If L-thyroxine is administered less than 2 hours before feeding, at or after feeding, the feed given (type and amount) should be standardized.

Instruction for use of the oral syringe:

Open the bottle. Attach the dosing syringe to the bottle by gently pushing the end of the syringe onto the insert in the bottle. Turn the bottle/syringe upside down and draw the solution into the syringe by pulling the plunger out until the edge of the ring on the end of the plunger coincides with the expected volume or body weight in kilograms. Turn the bottle/syringe right way up and remove the syringe from the insert. After administering the product, clean the syringe by flushing with clean water and allow to dry naturally.

Overdose

Clinical signs of overdose with L-thyroxine are identical to those of hyperthyroidism and include body weight loss, hyperactivity, tachycardia, polydipsia, polyuria, polyphagia and diarrhoea. These signs are generally mild and fully reversible.

Overdose may be accompanied by reversible changes in blood biochemistry, e.g. elevated glucose, inorganic phosphorus and albumin:globulin ratio, and reduced total protein and cholesterol.

In a tolerance study, healthy dogs treated with the product at 40 μg/kg body weight once daily during 91 consecutive days did not present any relevant clinical sign. At dose rates of 120 and 200 μg/kg body weight, dogs did not exhibit signs other than those of hyperthyroidism, mainly body weight loss. These signs were mild and reversible, with recovery occurring within 5 weeks after cessation of treatment.

Standard measures should be taken to remove non-absorbed drug from the gastro-intestinal tract.

If chronic overdosage is suspected, the dose should be re-evaluated.

Withdrawal period

Not applicable.

Pharmacological particulars

ATC Vet Code: QH03AA01.

Pharmacotherapeutic group

Thyroid hormones

Pharmacodynamic properties

L-thyroxine is identical in structure and mode of action to the thyroxine (T4) secreted physiologically and present in mammals with a normally functioning thyroid gland. Thyroxine is metabolised mainly to tri-iodothyronine (T3). T4 and T3 have a large variety of biological effects throughout the body. They are essential for the regulation of basal metabolism, cardiac function and blood flow, lipid and carbohydrate metabolism. They are also essential for the normal growth and development of the neurological and skeletal systems.

Pharmacokinetic properties

There is considerable variation in the pharmacokinetics between individual dogs. After oral administration of the product to euthyroid, fasted dogs, tmax occurred at approximately 2.5 – 3 hours. The serum half-life of L-thyroxine was approximately 7 hours. Bioavailability was 22 %.

After repeated oral administration over 14 consecutive days at a dose rate of 40 μg/kg/day, there was no accumulation of L-thyroxine in serum. Concomitant administration of food with the product delays absorption and reduces the extent of absorption of L-thyroxine from the gastrointestinal tract by approximately 50 %. L-thyroxine is highly protein bound.

The major site of thyroxine (T4) metabolism is the liver. The main pathway for the metabolism of T4 is its conversion, by deiodination, to the active metabolite triiodothyronine (T3). Further deiodination of T4 and T3 leads to production of inactive compounds.

Excretion is mainly observed via biliary and, to a lesser extent, urinary routes.

Pharmaceutical particulars

Excipients

Ethanol 96 %

Hydroxypropylbetadex

Sodium hydrogen carbonate

Sodium hydroxide

Hydrochloric acid

Purified Water

Major incompatibilities

None known.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: 6 months.

Special precautions for storage

Store in a refrigerator (2 °C – 8 °C).

Store in the original container.

Immediate packaging

30 ml amber glass bottle with a transparent LDPE insert and with a white HDPE child-resistant cap with tamper-proof closure in a printed carton.

A 1 ml oral syringe graduated in 0.05 ml increments is supplied with the product.

Pack sizes: 1 x 30 ml, 6 x 30 ml and 12 x 30 ml.

Not all pack sizes may be marketed.

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Marketing Authorisation Holder (if different from distributor)

Marketing Authorisation Number

UK: Vm 01708/4527

Significant changes

Date of the first authorisation or date of renewal

23 April 2007.

Date of revision of the text

August 2020.

Any other information

For animal treatment only. Keep out of the sight and reach of children.

Legal category

Legal category:POM-V

GTIN

GTIN description:Leventa® 1x30ml:

GTIN:8713184082121

Delivery

Shipping charges mainland UK zone1

ValueWeightDelivery Charge
Over £49.00Any WeightFREE
Under £49.00No weight limit£4.50
Under £49.00Under 250g£2.99

Most orders are despatched the same day and standard delivery is 3 to 5 working days from despatch. FAST Expedited options are available.

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Overseas orders

Postage outside of the UK is from £4.50

Prescription Items

Prescription items will be sent on receipt of a valid signed and dated prescription.

Pick up

We offer a pickup service for orders placed over the phone.

Please ring us on 01833 641112 for more information.

Refrigerated Items

Refrigerated items will be sent by carrier or Royal Mail with coolpacks unless you pay for a premium for a refrigerated delivery. We will contact you prior to despatch for your instructions.

Returns

We want you to be completely satisfied with any purchase. If not any item* can be returned to us within 14 days of receipt for exchange or refund Please give us a ring for a returns number on 01833 641112 or alternatively email [email protected] to obtain a returns number.

*Due to legal requirements medicines may not be returned except to correct an error in despatch or in response to an "official recall". If an item is believed to be faulty it should be returned for inspection and it may be necessary to forward it to the manufacturers for testing before replacements or refunds can be authorised. This does not infringe legal rights. Please contact our customer services for a "Returns Number" which must appear on the outside of the package or it will not be accepted. We advise customers to use an insured method of shipping and to retain proof of despatch. We may refuse returns on products specially obtained or manufactured to order. Items must be returned unsoiled and unused and sent adequately packed and carriage paid.

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