Ultrapen LA 30% Suspension for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Procaine Benzylpenicillin

Available from:

Norbrook Laboratories Limited

ATC code:

QJ01CE09

INN (International Name):

Procaine Benzylpenicillin

Pharmaceutical form:

Suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

1997-01-21

Summary of Product characteristics

An: 00652/2013
Revised: October 2013
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ultrapen LA 30% Suspension for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Procaine Benzylpenicillin
30%w/v [300 mg/ml]
EXCIPIENTS:
Butylhydroxyanisole (E320) as an antioxidant:
0.007% w/v
Butylhydroxytoluene (E321) as an antioxidant:
0.007% w/v
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for Injection
An oily white/off-white suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Procaine penicillin G 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
_Arcanobacterium _
_pyogenes_,
_Erysipelothrix _
_rhusiopathiae_,
_Mannheimia _
_haemolytica_,
_Pasteurella _
_multocida_ 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; urogenital tract
infections and the control of
secondary bacterial invaders in diseases primarily of viral origin.
An: 00652/2013
Revised: October 2013
Page 2 of 5
4.3
CONTRAINDICATIONS
Ultrapen LA is contraindicated in known cases of hypersensitivity to
penicillins.
Do not inject intravenously or by the intrathecal route.
Not to be used on very small herbivores such as guinea pigs, gerbils
and hamsters.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i) Special precautions for use in animals
Shake
the
vial
before
use.
This
product
does
not
contain
an
antimicrobial
preservative. Swab the septum before removing ea