DBL™ Gentamicin Injection BP

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Gentamicin sulfate 16mg (Gentamicin sulfate 16mg/mL (BP) equivalent to 10mg/mL (10,000IU) Gentamicin)

Disponibil de la:

Pfizer New Zealand Limited

INN (nume internaţional):

Gentamicin sulfate 16 mg (Gentamicin sulfate 16mg/mL (BP) equivalent to 10mg/mL (10,000IU) Gentamicin)

Dozare:

10 mg/mL

Forma farmaceutică:

Solution for injection

Compoziție:

Active: Gentamicin sulfate 16mg (Gentamicin sulfate 16mg/mL (BP) equivalent to 10mg/mL (10,000IU) Gentamicin) Excipient: Disodium edetate dihydrate Sodium methyl hydroxybenzoate Sodium propyl hydroxybenzoate Water for injection

Unități în pachet:

Vial, glass, 2mL, 5 dose units

Clasă:

Prescription

Tip de prescriptie medicala:

Prescription

Produs de:

Lek Pharmaceuticals d.d.

Indicații terapeutice:

DBL™ Gentamicin Injection BP is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa Proteus species (indole positive and indole negative) Escherichia coli Klebsiella - Enterobacter - Serratia species Staphylococcus species (coagulase positive and coagulase negative) DBL™ Gentamicin Injection BP should be considered for the treatment of the following conditions when caused by susceptible organisms: Septicaemia Respiratory tract infections Infected wounds, bone and soft tissue infections including peritonitis, septic abortion and burns complicated by sepsis Urinary tract infections (recurrent, complicated) DBL™ Gentamicin Injection BP is not routinely indicated in the initial treatment of uncomplicated urinary tract infections unless the organism is resistant to other less toxic antibacterials. DBL™ Gentamicin Injection BP may be considered as initial therapy in suspected or confirmed gram negative infections and therapy may be instituted before obtained results of susceptibility testing. If anaerobic organisms are suspected, additional antimicrobial therapy should be added to the gentamicin regime.

Rezumat produs:

Package - Contents - Shelf Life: Vial, glass, 2mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C - Vial, glass, 2mL - 50 dose units - 24 months from date of manufacture stored at or below 25°C

Data de autorizare:

1984-11-01

Caracteristicilor produsului

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NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
DBL
™
Gentamicin Injection BP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Gentamicin Injection BP contains Gentamicin sulfate BP equivalent
to gentamicin base
10 mg or 40 mg per mL.
EXCIPIENT(S) WITH KNOWN EFFECT
Each
vial
of
DBL
Gentamicin
Injection
BP
contains
sodium
methyl
hydroxybenzoate
(2.06 mg/mL) and sodium propyl hydroxybenzoate (0.225 mg/mL) as
preservative.
Each vial of DBL Gentamicin Injection BP contains less than 1 mmol
sodium (23 mg), that is
to say essentially 'sodium-free’.
Also refer to Section 4.4, Excipients Information.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
DBL Gentamicin Injection BP is a sterile solution for injection.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL Gentamicin Injection BP is indicated in the treatment of serious
infections caused by
susceptible strains of the following microorganisms:
_Pseudomonas aeruginosa_
_Proteus_ species (indole positive and indole negative)
_Escherichia coli_
_Klebsiella_ -_ Enterobacter - Serratia _species
_Staphylococcu_s species (coagulase positive and coagulase negative)
DBL Gentamicin Injection BP should be considered for the treatment of
the following
conditions when caused by susceptible organisms:
Septicaemia
Respiratory tract infections
Infected wounds, bone and soft tissue infections including
peritonitis, septic abortion and burns
complicated by sepsis
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Urinary tract infections (recurrent, complicated)
DBL
Gentamicin
Injection
BP
is
not
routinely
indicated
in
the
initial
treatment
of
uncomplicated urinary tract infections unless the organism is
resistant to other less toxic
antibacterials.
DBL Gentamicin Injection BP may be considered as initial therapy in
suspected or confirmed
gram negative infections and therapy may be instituted before obtained
results of susceptibility
testing. If anaerobic organisms are suspected, additional
antimicrobial therapy should be added
to