Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.
Introduction
Company name: Pfizer Limited
Address: Ramsgate Road
Sandwich
Kent CT13 9NJ
Telephone: 0845 300 8034 (Out of hours: 01304 616161)
Fax: 01737 332521
Email: UKVetLine@pfizer.com
Website: www.pfizerah.co.uk
Presentation
Dopram-V Drops is a clear colourless, aqueous, oral drops, solution. Each 1 ml contains Doxapram Hydrochloride 20 mg. The product also contains chlorobutanol 5 mg/ml as an antimicrobial preservative.
Uses
To initiate or stimulate respiration in neonatal dogs, cats, calves and lambs, following dystocia or caesarean section.
Dosage and administration
ENSURE AIRWAY IS NOT OBSTRUCTED BEFORE USE.
FOR SUBLINGUAL USE ONLY
Administer on the ventral (underside) surface of the tongue at the following doses:.
Puppies:
| 2-10 drops
| 1-5 mg
|
Kittens:
| 2-4 drops
| 1-2 mg
|
Lambs:
| 10-20 drops
| 5-10 mg
|
Calves:
| 80-200 drops (2-5 ml)
| 40-100 mg
|
The dosage should be adjusted to meet the requirements of the situation, in particular the size of the neonate and degree of respiratory depression. Repeated doses should not be given until the effects of the first dose have passed and the condition of the animal requires it. Do not exceed the recommended dosage. The action of the drops is rapid, usually beginning in a few seconds. The duration and intensity of response depends on the dose and the condition of the animal at the time it is administered.
Contra-indications, warnings, etc
FOR ANIMAL TREATMENT ONLY
Dopram-V Drops are contra-indicated for use in food producing animals with the exception of neonatal calves and lambs. For neonatal calves and lambs the meat withdrawal period is 28 days from last administration. Not intended for use in animals producing milk for human consumption.
Excessive doses may produce hyperventilation which may be followed by reduced carbon dioxide tension in the blood, cerebral vasoconstriction, hypoxia and possible brain damage.
In trials carried out on conscious cats to determine the total dose required to initiate hyperventilation compared to the total dose required to produce convulsions, the convulsive to respirogenic dose was calculated to be 38:1.
Avoid contact with skin and eyes. In the event of contact, wash with plenty of water. If irritation or other symptoms persist, seek medical advice. Do not smoke, eat or drink when using the product. Wash hands after use.
Pharmaceutical precautions
Following withdrawal of the first dose, use the product within 28 days. Discard unused material. The cap should be replaced on the bottle immediately after use. Store at +2°C - +8°C. Do not freeze. Protect from light.
Keep out of reach and sight of children.
Legal category
POM-VPS
Packaging Quantities
5 ml and 25 ml plastic dropper bottles.
Not all pack sizes may be marketed.
Further information
Dopram-V is also available in 20 ml vials for injection.
Disposal:
Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste under national waste disposal regulations.
Marketing authorisation number
Vm 00057/4332.
Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.
Introduction
Company name: Pfizer Limited
Address: Ramsgate Road
Sandwich
Kent CT13 9NJ
Telephone: 0845 300 8034 (Out of hours: 01304 616161)
Fax: 01737 332521
Email: UKVetLine@pfizer.com
Website: www.pfizerah.co.uk
Presentation
Dopram-V Solution for Injection is a clear colourless solution for injection or sublingual use. Each ml contains Doxapram Hydrochloride 20 mg. It also contains Chlorbutanol 5 mg/ml as an antimicrobial preservative. Dopram-V (doxapram hydrochloride) is a potent respiratory stimulant. It differs from the analeptic agents in having greater specificity of action on the respiratory centre.
Metabolism:
The metabolism of doxapram has been studied in the rat, dog and man. Doxapram is extensively metabolised; the metabolites and unchanged doxapram are excreted in the bile and urine. The pharmacokinetic properties of doxapram can be described by a multi-compartmental model. Due to rapid redistribution the pharmacological effects of an intravenous injection of doxapram are terminated within 15-20 minutes following administration.
Uses
Respiratory stimulant
For dogs, cats and horses:
1.To stimulate respiration during and after general anaesthesia.
2.To speed awakening and return of reflexes after anaesthesia, when this is considered beneficial.
For neonatal dogs, cats, calves and lambs:
1.To initiate respiration following dystocia or Caesarean section.
2.To stimulate respiration following dystocia or Caesarean section.
Dosage and administration
To ensure adequate dosing an insulin-type syringe must be used for administration to low bodyweight animals.
Post-anaesthetic use
For intravenous use only.
Dogs and cats: Following intravenous anaesthesia 2–5 mg/kg (0.1–0.25 ml/kg) depending on response.
Following inhalation anaesthesia 1–2 mg/kg (0.05–0.1 ml/kg) depending on response.
Dosage should be adjusted for depth of anaesthesia and degree of respiratory depression. Dosage can be repeated in 15 to 20 minutes if necessary.
Horses: Following intravenous or inhalation anaesthesia 0.5–1.0 mg/kg (2.5–5.0 ml/100 kg) depending on response. Dosage should be adjusted for depth of anaesthesia and degree of respiratory depression.
Neonatal use
For intravenous or subcutaneous injection and for topical sublingual use.
Puppies: 1–5 mg (0.05–0.25 ml) depending on size of neonate and degree of respiratory depression.
Kittens: 1–2 mg (0.05–0.1 ml) depending on size of neonate and degree of respiratory depression.
Calves: For intravenous, intramuscular, subcutaneous or sublingual use.
40–100 mg (2.0–5.0 ml) depending on size of neonate and degree of respiratory depression.
Lambs: For intravenous, subcutaneous or sublingual use.
5–10 mg (0.25–0.5 ml) depending on size of neonate and degree of respiratory depression.
The action is rapid, usually beginning in a few seconds. The duration and intensity of response depends upon the dose, the condition of the animal at the time the drug is administered, and depth of anaesthesia. Repeated doses should not be given until the effects of the first dose have passed, and the condition of the patient requires it.
However, the therapeutic ratio (convulsive dose: respirogenic dose) is very high. In trials carried out on conscious cats to determine the total dose required to initiate hyperventilation compared to the total dose required to produce convulsions, the convulsive dose to respirogenic dose was calculated to be 38:1.
Contra-indications, warnings, etc
Dopram-V Injection is contra-indicated for use in food producing animals with the exception of neonatal calves and lambs, and horses.
Withdrawal period
Not for use in animals producing milk for human consumption. For neonatal calves lambs and horses, the meat withdrawal period is 28 days from last administration.
Warnings
Dosage should be adjusted to meet the requirements of the situation. Adequate, but not excessive, doses should be used. A patent airway is essential. Reflexes should be checked periodically.
Excessive doses may produce hyperventilation which may be followed by reduced carbon dioxide tension in the blood, cerebral vasoconstriction, hypoxia, and possible brain damage.
Excessive doses administered to animals during, or following anaesthesia with cyclopropane or halogenated hydrocarbon anaesthetics may precipitate cardiac arrhythmias.
The product should be used with extreme caution in dogs which have been sedated with morphine. Administration of Dopram-V Injection at a dose of 10 mg/kg to such animals may be followed by convulsions.
Foetal toxicity studies with doxapram in the rat and rabbit have not revealed any teratogenic effects, nor evidence of any effect on male or female fertility.
Operator warning
Avoid self injection with the product. Avoid direct contact with skin and eyes. In the event of contact, wash with plenty of water. If irritation or other symptoms persist, seek medical advice. Do not smoke, eat or drink when using the product. Wash hands after use.
For animal treatment only. Keep out of the reach and sight of children.
Disposal
Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.
Pharmaceutical precautions
Keep container in outer carton.
Following withdrawal of the first dose, the product should be used within 28 days.
When the container is broached for the first time, using the in-use shelf-life which is specified on this datasheet, the date on which any product remaining in the container should be discarded should be worked out. The discard date should be written in the space provided on the label. Discard any unused material. Should any apparent growth or discolouration occur the product should be discarded.
Dopram-V Injection is incompatible with alkaline solutions such as aminophylline, frusemide, and thiopentone. Do not store above 25°C. Protect from freezing. Protect from light.
Legal category
POM-V
Packaging Quantities
20 ml multi-dose vials.
Further information
Dopram-V Injection has been used extensively in the treatment of exotic species. Doses of 1 mg/kg have been used; the dose being adjusted according to response and the overall condition of the animal. It has been found to be of particular use in the treatment of respiratory failure associated with lungworm infestation in pinnipeds, respiratory depression produced by barbiturate poisoning in felines and in the anaesthetic management of the giraffe.
Dopram-V is also available in 5 ml dropper bottles for topical sublingual use.
Marketing authorisation number
Vm 00057/4331.
