Propalin Syrup 100 ml

1. NAME OF THE VETERINARY MEDICINAL PRODUCT:

Propalin Syrup

2. QUALITATIVE AND QUANTITATIVE COMPOSITION:

Phenylpropanolamine hydrochloride 50 mg (5% w/v)
Excipients per 1 ml (per 100 ml)

3. PHARMACEUTICAL FORM:

Syrup. Colorless solution for oral use.

4. PHARMACOLOGICAL PROPERTIES:

Summary of the presentation of the active substance:
Phenylpropanolamine hydrochloride is a sympathomimetic agent. It is an analogue of endogenous sympathomimetic amines.
ATC veterinary code: QG04BX91

4.1 PHARMACODYNAMIC PROPERTIES:

The clinical effect of phenylpropanolamine in urinary incontinence is based on its stimulating effect on α-adrenergic receptors. This leads to an increase and stabilization of the closing pressure in the urethra, which is innervated mainly by adrenergic nerves.
Phenylpropanolamine is a racemic mixture of D and L enantiomers.

4.2 PHARMACOKINETICS:

In dogs, the average duration of action of Phenylpropanolamine is approximately 3 hours, and maximum plasma concentrations can be recorded after approximately 1 hour. No accumulation of phenylpropanolamine was observed following administration of a dose of 1 mg/kg 3 times daily for 15 days.
When administered to dogs before feeding, bioavailability increases significantly.

5. CLINICAL PARTICULARS:

5.1 TARGET SPECIES:

Dogs

5.2 INDICATIONS FOR USE IN TARGET SPECIES:

Treatment of urinary incontinence associated with urethral sphincter incompetence in bitches. The efficacy of the treatment has only been demonstrated in ovariohysterectomized bitches.

5.3 CONTRAINDICATIONS:

The use of Propalin is not indicated in the treatment of behavioral causes of inappropriate urination. Do not administer to patients treated with non-selective monoamine oxidase inhibitors.

5.4 ADVERSE EFFECTS, FREQUENCY AND SEVERITY:

During clinical trials, loose stools, watery diarrhea, loss of appetite, arrhythmia, and collapse were reported in some dogs. Treatment was continued depending on the severity of the adverse effect observed.
Sympathomimetics can produce a wide range of effects, most of which mimic the results of excessive stimulation of the sympathetic nervous system (e.g. effects on heart rate and blood pressure).

5.5 SPECIAL PRECAUTIONS FOR USE:

Phenylpropanolamine, a sympathomimetic drug, can affect the cardiovascular system, especially blood pressure and heart rate, and should be used with caution in animals with cardiovascular disease.
Special attention should also be paid to the treatment of animals with severe renal or hepatic insufficiency, diabetes, hyperadrenocorticism, glaucoma, hyperthyroidism or other metabolic dysfunctions.
In bitches younger than 1 year of age, the possibility of anatomical dysfunctions that may contribute to incontinence should be considered before treatment.

5.6 ADMINISTRATION DURING PREGNANCY AND LACTATION:

Do not administer to pregnant or lactating bitches.

5.7 INTERACTIONS WITH OTHER MEDICINAL PRODUCTS OR OTHER FORMS OF INTERACTION:

Increased attention should be paid when administering Propalin Syrup in combination with other sympathomimetic or anticholinergic drugs, antidepressants or monoamine oxidase type B inhibitors. It should not be administered to patients treated with non-selective monoamine oxidase inhibitors.

5.8 DOSAGE AND ADMINISTRATION:

The recommended dose of Propalin is 1 mg/kg body weight 3 times a day in food, equivalent to 0.1 ml Propalin Syrup/5 kg body weight 3 times a day.
The absorption rate is higher in dogs administered before feeding.

5.9 OVERDOSE:

No adverse effects have been observed in healthy dogs when administered up to 5 times the recommended dose. However, an overdose of phenylpropanolamine may produce symptoms of excessive stimulation of the sympathetic nervous system. Symptomatic treatment should be applied. Alpha-adrenergic blockers are recommended in severe overdoses. However, there are no specific recommendations for specific drugs or doses.

5.10 SPECIAL WARNINGS FOR EACH TARGET SPECIES:

It doesn't exist.

5.11 WAITING TIME:

It doesn't exist.

5.12 SPECIAL PRECAUTIONS FOR THE PERSON ADMINISTRATING THE PRODUCT TO ANIMALS

Phenylpropanolamine hydrochloride is toxic when ingested in large doses. Adverse effects may include dizziness, headache, nausea, insomnia or agitation, and
high blood pressure. Large overdoses can be fatal, especially in children. To avoid accidental ingestion, the product should not be used or stored within the reach of children. Always close the cap tightly after use. In case of accidental ingestion, seek medical advice immediately and show the contents of the package. In case of accidental skin contact, wash the contaminated area with soap and water. Wash hands after using the product. In case of accidental eye contact, rinse with water for approximately 15 minutes and seek medical advice.

Use the product within 3 months after opening the first dose.
Discard unused material.

6. PHARMACEUTICAL PARTICULARS:

6.1 INCOMPATIBILITY (major):

It doesn't exist.

6.2 VALIDITY:

2 years.

After opening the package: 3 months.

6.3 SPECIAL STORAGE PRECAUTIONS:

Do not store above 25 °C.

Protect from frost.

6.4 NATURE AND CONTENTS OF PACKAGING:

30 ml and 100 ml: HDPE bottle with LDPE syringe adapter and polypropylene safety cap;
The pack also contains a marked 1.5 ml syringe made of LDPE/polystyrene.

Currently, product safety information is not available.

Currently, manufacturer information is not available.

Currently, information about the person responsible is not available.

Presentation type: Liquid

Brand Name: Vetoquinol

Weight: 100ml

Action: Urinary incontinence

Quantity: 100 ml