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: Prescription Only Medicine as defined in relevant national legislation

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
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4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Dosage of Dopram-V should be adjus