DOPRAM-V 20MG/ML SOLUTION FOR INJECTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DOXAPRAM HYDROCHLORIDE

Available from:

Zoetis Ireland Limited

ATC code:

QR07AB01

INN (International Name):

DOXAPRAM HYDROCHLORIDE

Dosage:

20 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

POM

Therapeutic group:

Bovine, Canine, Equine - Food, Feline, Ovine

Therapeutic area:

Doxapram

Therapeutic indications:

Respiratory Tract Preparations

Authorization status:

Authorised

Authorization date:

2014-01-24

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Dopram-V 20 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or sublingual use.
A clear colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs, cats, horses, calves and lambs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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.
_Neonate dogs, cats, calves and lambs:_
1.
To initiate respiration following dystocia or Caesarean section.
2.
To stimulate respiration following dystocia or Caesarean section.
4.3 CONTRAINDICATIONS
Do not use in food producing animals with the exception of neonatal calves, lambs and horses.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special warnings apart from use in dogs which have been sedated with morphine (see 4.5 ).
Each ml contains:
ACTIVE SUBSTANCE
Doxapram Hydrochloride
20 mg
(equivalent to 17.5mg/ml doxapram)
EXCIPIENTS
Chlorobutanol hemihydrate (preservative) 5 mg
IRISH MEDICINES BOARD
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_Date Printed 24/01/2014_
_CRN 7016897_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Dosage of Dopram-V 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 vasocons