Tobramycin Viatris

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Tobramycin 80mg

Available from:

Viatris Limited

INN (International Name):

Tobramycin 80 mg

Dosage:

80 mg/2mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Tobramycin 80mg Excipient: Disodium edetate Sodium bisulfate Sodium hydroxide Sulfuric acid Water for injection

Prescription type:

Prescription

Manufactured by:

Chongqing Daxin Pharmaceuticals Co Ltd

Therapeutic indications:

Tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: - Septicaemia in the neonate, child, and adult caused by P aeruginosa, E coli, and Klebsiella sp - Lower respiratory tract infections caused by P aeruginosa, Klebsiella sp, Enterobacter sp, Serratia sp, E coli, and S aureus (penicillinase and non-penicillinase-producing strains) - Serious central-nervous-system infections (meningitis) caused by susceptible organisms - Intra-abdominal infections, including peritonitis, caused by E coli, Klebsiella sp, and Enterobacter sp - Skin, bone, and skin-structure infections (including burns) caused by P aeruginosa, Proteus sp, E coli, Klebsiella sp, Enterobacter sp, and S aureus - Complicated and recurrent urinary tract infections caused by P aeruginosa, Proteus sp (indole-positive and indole-negative), E coli, Klebsiella sp, Enterobacter sp, Serratia sp, S aureus, Providencia sp, and Citrobacter sp.

Product summary:

Package - Contents - Shelf Life: Vial, glass, 2 mL Type 1 flint tubular with rubber closure and flip-off Al seal - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2014-12-09

Patient Information leaflet

Page 1 of 3
NEW ZEALAND CONSUMER MEDICINE INFORMATION
TOBRAMYCIN VIATRIS
_TOBRAMYCIN, SOLUTION FOR INJECTION, 80 MG/2 ML_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using Tobramycin
Viatris.
This leaflet answers some common
questions about Tobramycin Viatris.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Tobramycin
Viatris against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT TOBRAMYCIN
VIATRIS IS USED FOR
Tobramycin Viatris is used to treat

meningitis (infection of the
brain)

septicaemia (infection of the
blood)

respiratory tract infections

gastrointestinal tract
infections

skin, bone and skin
structure infections,
including burns

urinary tract infections.
Tobramycin Viatris contains the
active ingredient tobramycin. It
belongs to a group of medicines
called aminoglycoside antibiotics.
It works by preventing bacteria from
growing and thereby killing them.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU ARE GIVEN
TOBRAMYCIN VIATRIS
_WHEN YOU MUST NOT BE _
_GIVEN IT_
DO NOT USE TOBRAMYCIN VIATRIS IF
YOU HAVE AN ALLERGY TO:

any medicine containing
tobramycin

any of the ingredients listed
at the end of this leaflet

any other similar
aminoglycoside antibiotics
such as amikacin,
streptomycin, neomycin,
kanamycin, gentamicin and
paromomycin.
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing or
difficulty breathing; swelling of the
face, lips, tongue or other parts of
the body; rash, itching or hives on
the skin.
Tobramy

Summary of Product characteristics

Page 1 of 13
NEW ZEALAND DATA SHEET
TOBRAMYCIN VIATRIS
1. PRODUCT NAME
Tobramycin Viatris, 80 mg/ 2 mL, solution for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution for injection contains 40 mg of tobramycin.
Each 2 mL vial contains 80 mg of tobramycin.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tobramycin Viatris is a clear colourless liquid
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Tobramycin is indicated for the treatment of serious bacterial
infections caused by susceptible strains
of the designated microorganisms in the diseases listed below:
-
Septicaemia in the neonate, child, and adult caused by _P aeruginosa,
E coli, _and _Klebsiella sp _
-
Lower respiratory tract infections caused by _ P aeruginosa,
Klebsiella sp, Enterobacter sp, _
_Serratia sp, E coli, _and _S aureus _(penicillinase and
non-penicillinase-producing strains)
-
Serious central-nervous-system infections (meningitis) caused by
susceptible organisms
-
Intra-abdominal
infections,
including
peritonitis,
caused
by
_E _
_coli, _
_Klebsiella _
_sp, _
_and _
_Enterobacter sp _
-
Skin, bone, and skin-structure infections (including burns) caused by
_P aeruginosa, Proteus sp, _
_E coli, Klebsiella sp, Enterobacter sp, _and _S aureus _
-
Complicated and recurrent urinary tract infections caused by _P
aeruginosa, Proteus sp _(indole-
positive
and
indole-negative),
_E _
_coli, _
_Klebsiella _
_sp, _
_Enterobacter _
_sp, _
_Serratia _
_sp, _
_S aureus, Providencia sp, _and _Citrobacter sp. _
Aminoglycosides, including tobramycin, are not indicated in
uncomplicated initial episodes of urinary
tract infections unless the causative organisms are not susceptible to
antibiotics having less potential
toxicity. Tobramycin may be considered in serious staphylococcal
infections when penicillin or other
potentially less toxic medicines are contraindicated and when
bacterial susceptibility testing and
clinical judgment indicate its use.
Bacterial cultures should be obtained prior to and durin