A small number of
Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. Introduction  Company name: Dechra Veterinary Products Limited Address: (A business unit of Dechra Pharmaceuticals PLC)
Sansaw Business Park
Hadnall, Shrewsbury
Shropshire SY4 4AS Telephone: 01939 211200 Fax: 01939 211201 Email: info@dechra-uk.com Website: www.dechra.com Presentation
Each ml contains:
Active substance:
Phenylpropanolamine 40.29 mg (equivalent to 50 mg phenylpropanolamine hydrochloride)
Excipients: Sodium methyl parahydroxybenzoate
(E219) 1.5 mg
Sodium propyl parahydroxybenzoate
(E217) 0.15 mg
Clear, viscous solution. Uses
Phenylpropanolamine is a sympathomimetic agent, which acts by direct stimulation of the smooth muscle of the urethral sphincter. It is indicated in the treatment of urinary incontinence associated with acquired urethral sphincter incompetence in the bitch only.
The efficacy of phenylpropanolamine has only been demonstrated in ovariohysterectomised bitches. Dosage and administration
For oral administration. The recommended dose is 0.8 mg/kg body weight phenylpropanolamine (equivalent to 1 mg/kg phenylpropanolamine HCl) three times daily in the feed, corresponding to 0.1 ml Urilin® syrup/5 kg body weight three times daily.
1 drop for every 2.34 kg body weight three times daily in feed. Advice on correct administration: Do not shake the bottle, simply invert it over the food and count the required number of drops. Contraindications, warnings, etc
Do not use in animals treated with non-selective monoamine oxidase inhibitors.
Do not use in cases of known hypersensitivity to the active substance or to any of the excipients. Adverse reactions: In some dogs, loose stools, liquid diarrhoea, a decrease in appetite, arrhythmia and collapse have been reported following treatment with phenylpropanolamine. Treatment was continued depending on the severity of the undesirable effect observed. Occasional nausea and vomiting have also been reported.
As phenylpropanolamine is a sympathomimetic agent it is possible to produce a wide range of effects, most of which mimic the results of excess stimulation of the sympathetic nervous system (e.g. effects on the heart rate and blood pressure).
Dizziness and restlessness have been reported in some dogs following treatment.
Hypersensitivity may occur in very rare cases.
If you notice any serious effects or other effects not mentioned in the data sheet, please inform your veterinary surgeon. Target species: Dogs (bitches). Special warnings: For animal treatment only.
Keep out of the reach and sight of children.
Because phenylpropanolamine is a sympathomimetic agent, it may affect the cardiovascular system, especially blood pressure and heart rate, and therefore should be used with caution in animals with cardiovascular diseases.
Care should be exercised in treating animals with severe renal or hepatic insufficiency, diabetes mellitus, hyperadrenocorticism, glaucoma or other metabolic disorders.
In bitches less than 1 year old the possibility of anatomical disorders contributing to incontinence should be considered prior to treatment.
It is not appropriate to use the product for the behavioural cause of inappropriate urination. Special precautions for the person administering the veterinary medicinal product to animals: Phenylpropanolamine hydrochloride is toxic when overdoses are ingested. Adverse effects may include dizziness, headache, nausea, insomnia or restlessness, and increased blood pressure. High overdose may be fatal, especially in children.
In the event of accidental skin contact, wash the contaminated area with soap and water. Wash hands after use of the product.
In the event of accidental eye contact, rinse the eye with clean water for about 15 minutes and seek medical advice.
To avoid accidental ingestion, the product must be used and kept out of the reach and sight of children.
Always replace the cap firmly after use to ensure the child resistant closure operates correctly.
In the event of accidental ingestion, seek immediate medical attention showing the doctor the data sheet. Use during pregnancy, lactation or lay: Do not use in pregnant or lactating bitches. Interaction with other medicinal products and other forms of interaction: Care should be exercised in administering the product with other sympathomimetic drugs, anticholinergic drugs, tricyclic antidepressants or specific type B monoamine oxidase. Overdose: In healthy dogs, no side effects were observed at up to 5 times the recommended dose. However, an overdose could produce signs of excessive stimulation of the sympathetic nervous system. Treatment should be symptomatic. Alpha-adrenergic blockers may be appropriate in the case of severe overdose. However, no specific recommendation on drugs or dosages can be given. Pharmaceutical precautions
Do not store above 25°C. Keep the container in the outer carton.
Shelf life after first opening the immediate packaging: 3 months.
Do not use after the expiry date stated on the label after EXP. Special precautions for the disposal of unused product or waste materials: Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority. Legal category
POM-V Packaging quantities
50 ml or 100 ml amber type III glass bottles containing 45 ml or 100 ml of syrup, with a low density polyethylene dropper and a polypropylene child resistant screw cap.
Not all pack sizes may be marketed. Further information
Urinary incontinence in the dog may be due to several underlying mechanisms.
Urilin® is most effective in the control of urinary incontinence due to urethral sphincter incompetence in the bitch, particularly that associated with ovariohysterectomy.
Urilin® is not effective in all cases and may be of limited effectiveness in other forms of urinary incontinence.
To be supplied only on veterinary prescription.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder. Manufacturer for the batch release: Dales Pharmaceuticals, Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW. Marketing authorisation holder (if different from distributor)
Dechra Limited, Dechra House, Jamage Industrial Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW. Marketing authorisation number
Vm 10434/4003. |