Ultrapen LA 300 mg/ml Suspension for Injection

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Procaine benzylpenicillin

Tersedia dari:

Norbrook Laboratories (Ireland) Limited

Kode ATC:

QJ01CE09

INN (Nama Internasional):

Procaine benzylpenicillin

Dosis:

300 milligram(s)/millilitre

Bentuk farmasi:

Suspension for injection

Jenis Resep:

POM: Prescription Only Medicine as defined in relevant national legislation

Area terapi:

procaine benzylpenicillin

Status otorisasi:

Authorised

Tanggal Otorisasi:

1997-12-12

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ultrapen LA 300 mg/ml Suspension for Injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Procaine Benzylpenicillin
300 mg/ml
EXCIPIENTS:
Butylhydroxyanisole (E320)
0.1 mg/ml
Butylhydroxytoluene (E321)
0.1 mg/ml
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.
4.3
CONTRAINDICATIONS
Do not administer by the intravenous route. Do not use on very small
herbivores such
as
guinea
pigs,
gerbils
or
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 ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Penicillins
and
cephalosporins
may
cause
hypersensitivity
(allergy)
following
injection, inhal