Analeptol 50 mg/ml + 50 mg/ml solution for injection for cattle, horses, pigs, dogs and cats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Heptaminol hydrochloride; Diprophylline

Available from:

CP-Pharma Handelsgesellschaft mbH

ATC code:

QR03DA51

INN (International Name):

Heptaminol hydrochloride; Diprophylline

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

diprophylline, combinations

Authorization date:

2023-07-07

Summary of Product characteristics

_[Version 9,07/2021] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Analeptol 50 mg/ml + 50 mg/ml
_ _
solution for injection for cattle, horses, pigs, dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
ACTIVE SUBSTANCES:
Heptaminol
50 mg
(equivalent to 62.6 mg heptaminol hydrochloride)
Diprophylline
50 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION IS
ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Benzyl alcohol (E1519)
20 mg
Sodium hydroxide (E524), for pH adjustment
Hydrochloric acid, diluted (E507), for pH
adjustment
Water for injections
Clear, colourless to slightly yellow solution for injection.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle, horses, pigs, dogs and cats
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Supportive (analeptic) treatment of acute cardiovascular and / or
respiratory failures
3.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to benzyl alcohol.
Do not use in hypertensive animals.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals:
The veterinary medicinal product may cause hypersensitivity reactions
due to the presence of benzyl
alcohol. People with known hypersensitivity to benzyl alcohol should
avoid contact with the
veterinary medicinal product. In case of skin contact, rinse
immediately with water. If you develop
symptoms such as a skin rash following exposure, seek medical advice
and show the package leaflet to
the physician.
The veterinary medicinal product may cause irritation to the skin
and/or eyes. Avoid contact with skin
and eyes. If the veterinary medicinal product comes into contact with
the skin or eyes, rinse
immediately with water. If irritation persists, seek medical advice.
Wash hands after us