Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Dopram-V Drops are presented in dropper bottles containing 5 ml. Each 1 ml contains Doxapram Hydrochloride 20 mg. The product also contains chlorobutanol 5 mg/ml as an antimicrobial preservative.

Uses

Respiratory stimulant.

For neonate (new born) puppies, kittens, calves and lambs:

To initiate or stimulate respiration following dystocia (difficult birth) or Caesarean section.

Dosage and administration

ENSURE AIRWAY IS NOT OBSTRUCTED BEFORE USE.

FOR SUBLINGUAL (TOPICAL) USE ONLY

Administer on the ventral (underside) surface of the tongue. The dose should be adjusted to meet the requirements of the situation, in particular the size of the neonate and the 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.

Recommended doses are indicated in the table below:

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 action of Dopram-V 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. In 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.

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. Protect from freezing. 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 01596/4239.