Caninsulin 40 IU/ml Suspension for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Insulin

Available from:

Intervet Ireland Limited

ATC code:

QA10AC03

INN (International Name):

Insulin

Dosage:

40 international unit(s)/millilitre

Pharmaceutical form:

Suspension for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Dogs

Therapeutic area:

insulin (pork)

Therapeutic indications:

Hormone

Authorization status:

Authorised

Authorization date:

1997-01-10

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Caninsulin 40 IU/ml suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
:
Insulin* 40 IU.
*Porcine insulin present as 35% amorphous Zinc insulin and 65%
crystalline Zinc insulin.
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION
IS ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Zinc chloride
Methyl parahydroxybenzoate (E218)
1.00 mg
Sodium acetate trihydrate
Sodium chloride
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injection
A white to almost white suspension for injection.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs and cats.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For use in cases of diabetes mellitus (insulin deficiency) in dogs and
cats, where the required blood
glucose levels are achieved by using an individually adjusted dose of
the veterinary medicinal product.
3.3
CONTRAINDICATIONS
Do not administer intravenously.
Do not use in case of hypersensitivity to porcine insulin or to any of
the excipients.
3.4
SPECIAL WARNINGS
In cats, diabetic remission may be possible.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
It is important to establish a strict feeding schedule in consultation
with the owner which will include a
minimum of fluctuations and changes. See also information relating to
owner precautions under
“Maintenance” in section 3.9.
The use of progestogens (oestrus inhibitors) in patients suffering
from diabetes mellitus should be
avoided. Ovariohysterectomy may have to be considered.
Stress and irregular extra exercise must be avoided.
Care must be taken with the use of corticosteroids.
The veterinary medicinal product is a medium duration insulin and is
not intended for the treatment of
animals with severe acute diabetes presenting in a ketoacidotic state.
Special precautions to be taken by the person administe