NEOSKILAB 1.5 mg/ml solution for injection for cattle, sheep, goats and horses

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Neostigmine Metilsulfate

Available from:

Labiana Life Sciences, S.A.

ATC code:

QN07AA01

INN (International Name):

Neostigmine Metilsulfate

Dosage:

1.5 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

neostigmine

Authorization status:

Authorised

Authorization date:

2021-06-11

Summary of Product characteristics

Health Products Regulatory Authority
11 June 2021
CRN009MWF
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
NEOSKILAB 1.5 mg/ml solution for injection for cattle, sheep, goats
and horses
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
​
Neostigmine metilsulfate
​1.5 mg
Equivalent to 1.0 mg of Neostigmine
EXCIPIENTS:
​
Methyl Parahydroxybenzoate (E 218)
​1.0 mg
​
Propyl Parahydroxybenzoate
​0.2 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear and colourless solution free from particles.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, sheep, goats and horses.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle, sheep and goats:
- Ruminal atony
- Intestinal atony
Horses:
- Intestinal atony
- Bladder atony
4.3 CONTRAINDICATIONS
Do not use in cases of mechanical obstruction of the gastrointestinal
or the urinary tract, peritonitis and doubtful viability of
the intestinal wall.
Do not use in animals with known cases of hypersensitivity to the
active substance or to any of the excipients.
Do not use in case of proximal disorders of the enteral tract in
horses.
Do not use in pregnant or lactating animals (see section 4.7)
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The animal must be monitored for the appearance of cholinergic effects
(see section 4.6) as adverse effects are dose-related.
The product should be used with caution in the following conditions
Health Products Regulatory Authority
11 June 2021
CRN009MWF
Page 2 of 4

Bronchial asthma (mainly in horses)

Cardiac arrhythmia (risk of bradycardia)

Peptic ulcer disease (because of increase of gastric secretions)
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Neostigmine is an acetylcholinesterase enzyme inhibitor. Do not use
this medicinal product if your doctor has advised