Unicillin 300 mg/ml Suspension for Injection

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Benzylpenicillin procaine

Fáanlegur frá:

Univet Limited

ATC númer:

QJ01CE09

INN (Alþjóðlegt nafn):

Benzylpenicillin procaine

Skammtar:

300 milligram(s)/millilitre

Lyfjaform:

Suspension for injection

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Meðferðarhópur:

Bovine, Ovine, Porcine

Lækningarsvæði:

procaine benzylpenicillin

Ábendingar:

Antibacterial

Leyfisstaða:

Authorised

Leyfisdagur:

1987-10-01

Vara einkenni

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Unicillin 300mg/ml Suspension for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Benzylpenicillin Procaine 300 mg
EXCIPIENTS (PRESERVATIVE):
Methyl Parahydroxybenzoate (E218) 1 mg
For the 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, sheep and pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections caused by bacteria sensitive to
penicillins in cattle,
sheep and pigs.
4.3
CONTRAINDICATIONS
Do not administer to animals known to be sensitive to penicillin.
Do not use when it is known that penicillinase-producing
staphylococcus organisms
are present.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Occasionally in sucking and fattening pigs administration of products
containing
procaine penicillin may cause a transient pyrexia, vomiting,
shivering, listlessness
and incordination.
Procaine penicillin G can, under certain circumstances, be toxic and
even lethal to
pigs and this is thought to be due to a sudden release of toxic
amounts of free
procaine.
The
symptoms
include
shivering,
lassitude,
inappetence,
vomiting,
cyanosis of the extremities and pronounced pyrexia (40°C and over). A
vulval
discharge may appear and some animals may abort. Alarming side-effects
are most
likely to occur when pigs with erysipelas are injected with an older
and, or, heat-
affected procaine penicillin formulation. Treatment with 5 mg
dexamethasone will
result in rapid recovery.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use of this product should be based on susceptibility testing of the
bacteria isolated
from the animal. If this is not possible, therapy should be based on
local (regional,
farm level) epidemiological information about susceptibility of the
target bacteria.
Whenever possible the product should only be used on the basis of
susceptibility
testing.
Spe