Ultrapen LA 300 mg/ml Suspension for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Procaine benzylpenicillin

Available from:

Norbrook Laboratories Limited

ATC code:

QJ01CE09

INN (International Name):

Procaine benzylpenicillin

Dosage:

300 milligram(s)/millilitre

Pharmaceutical form:

Suspension for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Pigs

Therapeutic area:

procaine benzylpenicillin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1997-12-12

Summary of Product characteristics

Health Products Regulatory Authority
08 November 2018
CRN000YNL
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ultrapen LA 300 mg/ml Suspension for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Procaine Benzylpenicillin
300
mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
0.1
mg
Butylhydroxytoluene (E321)
0.1
mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection. A white to off-white suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Ultrapen LA is specifically formulated to provide sustained
antibacterial activity
following a single administration.
Ultrapen LA is indicated for use in cattle and pigs in the treatment
and control of a
wide range of common systemic, respiratory, urinary and local
infections caused by
or associated with organisms sensitive to penicillin, including
_Corynebacterium _
_pyogenes_, _Erysipelothrix rhusiopathiae_, _Pasteurella haemolytica_,
_Pasteurella multocida_,
_Staphylococcus _spp. (non-penicillinase producing) and _Streptococcus
_spp.
Ultrapen LA will therefore be effective in the treatment of
infections, caused by
susceptible organisms including:
Erysipelas; navel/joint-ill; respiratory tract infections, including
pneumonia and
atrophic rhinitis; meningitis; septicaemia; toxaemia associated with
mastitis;
urogenital tract infections and the control of secondary bacterial
invaders in diseases
primarily of viral origin.
Health Products Regulatory Authority
08 November 2018
CRN000YNL
Page 2 of 5
4.3 CONTRAINDICATIONS
Do not administer by the intravenous route.
Do not use on very small herbivores such as guinea pigs, gerbils and
hamsters.
Do not use in animals with known hypersensitivity to the active
ingredient.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINI