Neopen Suspension for Injection

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: VMD (Veterinary Medicines Directorate)

מרכיב פעיל:

Neomycin, Procaine Benzylpenicillin

זמין מ:

MSD Animal Health UK Limited

קוד ATC:

QJ01RA01

INN (שם בינלאומי):

Neomycin, Procaine Benzylpenicillin

טופס פרצבטיות:

Suspension for injection

סוג מרשם:

POM-V - Prescription Only Medicine – Veterinarian

קבוצה תרפויטית:

Cats, Dogs, Horses, Pigs, Sheep

איזור תרפויטי:

Antimicrobial

מצב אישור:

Authorized

תאריך אישור:

1992-12-16

מאפייני מוצר

Revised: June 2021
AN: 00308/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Neopen suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Neomycin (as neomycin sulphate)
100 mg
Procaine benzylpenicillin
200 mg
Excipients:
Methyl parahydroxybenzoate
1.1 mg
Sodium formaldehyde sulphoxylate
1.0 mg
anhydrous
See section 6.1 for list of excipients
3.
PHARMACEUTICAL FORM
Suspension for injection
White to cream coloured suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses, sheep, pigs, dogs and cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infectious diseases in horses, sheep, pigs, dogs
and cats
caused by bacteria sensitive to the combination.
Penicillin
is
active
against
some
Gram-negative
and
most
Gram-positive
bacteria. Neomycin is a broad spectrum antibiotic active against a
number of
Gram-positive and Gram-negative bacteria. The combination shows a
broad
spectrum of activity. _In vitro _activity has been demonstrated
against all tested
isolates of _ E. rhusiopathiae_, Streptococcus spp. and _ A. pyogenes_
and the
majority
of
tested
isolates
of
Pasteurella,
Salmonella,
Klebsiella
and
Staphylococcus species.
4.3
CONTRA-INDICATIONS
Not to be used in animals known to be hypersensitive to Beta-lactam
antibiotics.
Revised: June 2021
AN: 00308/2021
Page 2 of 5
4.4
SPECIAL WARNING FOR EACH TARGET SPECIES
None known
4.5
SPECIAL PRECAUTIONS FOR USE
(i)
Special precautions for use in animals
See 4.3 above. Shake container before use.
(ii)
Special precautions to be taken by the person administering the
medicinal
product to the animals
Care should be taken to avoid accidental self-injection.
Penicillin and cephalosporins may cause hypersensitivity (allergy)
following
injection, inhalation, ingestion or skin contact. Hypersensitivity to
penicillin may
lead to cross sensitivity to cephalosporins and _vice versa_. Allergic
reactions to
these substances may occasionally be serious.
1.
Do no