AMPICILLIN SODIUM FOR INJECTION BP POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

AMPICILLIN (AMPICILLIN SODIUM)

Διαθέσιμο από:

AURO PHARMA INC

Φαρμακολογική κατηγορία (ATC):

J01CA01

INN (Διεθνής Όνομα):

AMPICILLIN

Δοσολογία:

250MG

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

AMPICILLIN (AMPICILLIN SODIUM) 250MG

Οδός χορήγησης:

INTRAMUSCULAR

Μονάδες σε πακέτο:

10ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

AMINOPENICILLINS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0105872002; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2017-03-09

Αρχείο Π.Χ.Π.

Page 1 of 12
PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
PR
AMPICILLIN SODIUM FOR INJECTION BP
Powder for solution
250 mg, 500 mg, 1 g and 2 g ampicillin (as ampicillin sodium) per vial
For intramuscular or Intravenous Use
STERILE
ANTIBIOTIC
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8
CANADA
Date of Revision:
December 22, 2021
Submission Control No: 254972
Page 2 of 12
PRESCRIBING INFORMATION
PR AMPICILLIN SODIUM FOR INJECTION BP
Powder for solution
Sterile
ANTIBIOTIC
ACTIONS AND CLINICAL PHARMACOLOGY
Ampicillin has a broad spectrum of bactericidal activity against many
gram-positive and gram-
negative aerobic and anaerobic bacteria. It acts through the
inhibition of cell wall mucopeptide
biosynthesis during the stage of active multiplication.
INDICATIONS AND CLINICAL USE
The treatment of infections due to susceptible gram negative organisms
(including strains of
shigellae, _S. typhosa_ and other salmonellae, _E. coli, H.
influenzae_, and _P. mirabilis_) and
susceptible gram positive organisms (including streptococci,
pneumococci, and non-beta-
lactamase (penicillinase) producing staphylococci).
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Ampicillin Sodium for Injection BP and other antibacterial drugs,
Ampicillin Sodium for
Injection BP should be used only to treat infections that are proven
or strongly suspected to be
caused by susceptible bacteria. When culture and susceptibility
information are available, they
should be considered in selecting or modifying antibacterial therapy.
In the absence of such data,
local epidemiology and susceptibility patterns may contribute to the
empiric selection of therapy.
CONTRAINDICATIONS
A history of allergic reactions to penicillin or cephalosporins.
WARNINGS
Before therapy, inquiry as to past penicillin or other allergies is
essential as reactions occur more
frequently in hypersensitive persons. During therapy, if allergic or
anaphylactic reactions occur,
discontinue
tre