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Date: Friday, May 7, 2021 16:39

Description: Dechra
Release 5.106
Pardale-V™ Oral Tablets
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Neurological preparations: Analgesics
Active ingredient: Codeine Phosphate, Paracetamol
Product:Pardale-V™ Oral Tablets
Product index: Pardale-V Oral Tablets
Qualitative and quantitative composition
Each tablet contains: Active substances:
Paracetamol 400 mg
Codeine phosphate hemihydrate 9 mg
Pharmaceutical form
Tablet. White, flat tablets with a bevelled edge and a break-line.
Clinical particulars
Target species
Dogs.
Indications for use
For analgesic therapy in dogs only. The product is indicated for acute pain of traumatic origin, as a complementary treatment in pain associated with other conditions and post operative analgesia.
Contraindications
Do not exceed stated dose or duration of treatment.
Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, where there is a possibility of gastrointestinal ulceration or bleeding, or where there is evidence of a blood dyscrasia or hypersensitivity to the product.
Do not use this product for cats.
Do not use in cases of hypersensitivity to the active substances or any of the excipients.
Special warnings for each target species
Seek veterinary advice if the treated condition does not improve or worsens during treatment, or if any side-effects or adverse reactions are experienced.
Special precautions for use in animals
Use in animals less than 6 weeks of age or in aged animals may involve additional risk. If such use cannot be avoided, animals may require a reduced dosage and careful clinical management.
Avoid use in dehydrated, hypovolaemic or hypotensive animals, as there is a potential risk of increased renal toxicity.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after use.
Adverse reactions
Occasional constipation may occur due to codeine content.
During the post-marketing surveillance, transient gastrointestinal signs such as vomiting and diarrhoea and systemic signs such as lethargy and anorexia have been observed very rarely.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy and lactation
There are no known contraindications for use during pregnancy.
Interactions
Concurrent administration of potentially nephrotoxic drugs should be avoided.
Amounts to be administered and administration route
For oral administration. 1 tablet/12 kg body weight every 8 hours.
Small dogs (up to 6 kg body weight): ½ tablet every 8 hours.
Medium dogs (6-18 kg body weight): ½-1½ tablets every 8 hours.
Large dogs (18-42 kg body weight): 1½-3½ tablets every 8 hours.
Treat for a maximum of 5 days.
Overdose
Immediately seek the advice of a veterinary surgeon, and show him/her the product literature.
Carry out lavage and treat with intravenous injection of acetylcysteine (200 mg/ml) at a rate of 140 mg/kg every 6 hours for 7 treatments. Ascorbic acid (30 mg/kg) should also be given orally with each dose of acetylcysteine.
If necessary instigate fluid therapy using Ringers or bicarbonate solution.
Treat for codeine overdose with injection of naloxone (1.0 mg/kg) repeated as necessary.
Provide oxygen support.
Pharmacological particulars
Pharmacotherapeutic group: Analgesics, other analgesics and antipyretics, anilides.
ATCvet code: QN02BE71
Pharmacodynamic properties
Paracetamol is a para aminophenyl derivative with analgesic properties.
Codeine is an opioid analgesic.
Pharmacokinetic properties
Both paracetamol and codeine are readily absorbed from the gastrointestinal tract. They are metabolised in the liver (codeine to morphine and narcodeine). Codeine and its metabolites are excreted almost entirely by the kidney, whilst less than 5% of paracetamol is excreted unchanged.
Pharmaceutical particulars
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Special precautions for storage
Do not store above 25°C.
Immediate packaging
Polypropylene container with a low density polyethylene tamper evident lid, containing 100 or 500 plain white, flat tablets with bevelled edges and a break line on one side and DPL on the other.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Dechra Limited, Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW, United Kingdom.
Marketing Authorisation Number
Vm 10434/4034
Significant changes
Date of the first authorisation or date of renewal
10 October 2007
Date of revision of the text
December 2019
Any other information
For animal treatment only. To be supplied only on veterinary prescription. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
Legal category description:CD(Sch 5)
GTIN
GTIN description:Pardale-V Oral Tablets 100 tablets:
GTIN:05701170427479
GTIN description:Pardale-V Oral Tablets 500 tablets:
GTIN:05701170427486