DBL™ Gentamicin Injection BP

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Gentamicin sulfate 16 mg (Gentamicin sulfate 16mg/mL (BP) equivalent to 10mg/mL (10,000IU) Gentamicin)
Available from:
Pfizer New Zealand Limited
INN (International Name):
Gentamicin sulfate 16 mg (Gentamicin sulfate 16mg/mL (BP) equivalent to 10mg/mL (10,000IU) Gentamicin)
Dosage:
10 mg/mL
Pharmaceutical form:
Solution for injection
Composition:
Active: Gentamicin sulfate 16 mg (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
Units in package:
Vial, glass, 2mL, 5 dose units
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Lek Pharmaceuticals d.d.
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 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 an
Product summary:
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
Authorization number:
TT50-3048a
Authorization date:
1984-11-01

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NEW ZEALAND DATA SHEET

1.

PRODUCT NAME

Gentamicin Injection BP

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Gentamicin Injection BP contains Gentamicin sulphate BP equivalent to gentamicin

base 10mg or 40mg per ml

Excipient(s) with known effect

Sodium methyl hydroxybenzoate (vial product)

Sodium propyl hydroxybenzoate (vial product)

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Gentamicin Injection BP is a sterile solution for injection.

4.

CLINICAL PARTICULARS

4.1 Therapeutic indications

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)

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)

Gentamicin

Injection

routinely

indicated

initial

treatment

uncomplicated urinary tract infections unless the organism is resistant to other less toxic

antibacterials.

Gentamicin

Injection

considered

initial

therapy

suspected

confirmed gram negative infections and therapy may be instituted before obtained results of

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susceptibility testing. If anaerobic organisms are suspected, additional antimicrobial therapy

should be added to the gentamicin regime.

decision

continue

therapy

with

gentamicin

should

based

results

susceptibility tests, the severity of the infection, and the important additional considerations

outlined in section 4.4. If the causative organisms are resistant to gentamicin and the patient is

not responding favourably, other appropriate therapy should be instituted.

4.2 Dose and method of administration

Gentamicin Injection BP is given by the intramuscular route or intravenously when

intramuscular administration is not feasible, e.g. in shocked or severely burned patients. The

dosage is the same for either route of administration (see below).

Whenever possible, and especially in patients with impaired renal function, peak and trough

gentamicin serum concentrations should be determined and dosage adjusted where necessary,

to maintain desired serum concentrations.

In general, desired peak concentrations are

between 4 and 10 micrograms/mL, and trough concentrations are below 2 micrograms/mL.

Prolonged concentrations greater than these values may be associated with an increased risk

of toxicity.

Blood specimens for the determination of peak gentamicin concentrations should be obtained

approximately one hour following I.M. administration and 30 minutes after completion of a

30 minute infusion. Blood specimens for the trough gentamicin concentration should be

obtained immediately prior to the next I.M. or I.V. dose.

Dosage in patients with normal renal function

Adults

Type of Infection

Dosage

Dosage Interval

Duration of Therapy

Systemic &

3 mg/kg/day

8 hours

7-10 days

Severe urinary

(bodyweight > 60 kg:

Tract infections*

Usual individual dose

Such as

80 mg

pyelonephritis

Bodyweight < 60 kg:

Usual individual dose

60 mg)

Life threatening

5 mg/kg/day initially

6-8 hours

7-10 days Longer

infections

Then 3 mg/kg/day as

Therapy may be

Soon as clinically

Required. If so,

indicated

Auditory renal and

Vestibular functions

Should be

Monitored.

*Note:

Gentamicin activity is increased at pH 7.5. It may therefore be advantageous to

alkalinise the patient’s urine before therapy

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Paediatric

Type of Infection

Dosage #

Dosage Interval

Systemic

0 - 7 days

5 mg/kg/day initially

12 hours

1 week - 1 year

6 mg/kg/day initially

12 hours

1 year - 12 years

4.5 mg/kg/day initially

8 hours

Uncomplicated

3 mg/kg/day

8 – 12 hours

Urinary tract

infections

Life threatening

0 - 7 days

5 mg/kg/day initially

12 hours

infections

1 week - 1 year

7.5 mg/kg/day initially

8 hours

1 year - 12 years

6 mg/kg/day initially

8 hours

#Note:

In neonates, infants and children, where possible, serum levels should be

determined and the dose adjusted to provide the desired serum level.

Dosage in patients with impaired renal function

In the presence of renal failure it is particularly important to monitor renal, auditory and

vestibular functions during gentamicin therapy. Dosage should be adjusted for patients with

renal impairment to minimise the risk of toxicity. The first dose should be as normal;

subsequent

doses

should

given

less

frequently,

depending

degree

renal

impairment. The following table provides guidelines for adjustment of the dosage interval

based on renal function tests.

Creatinine

Serum creatinine

Dosage interval

Clearance

(mmol/litre)

(mmol/litre)

(mL/minute)

over 70

less than 0.12

less than 6.5

8 hours

35 – 70

0.12 - 0.17

6.5 - 10

12 hours

24 – 34

0.18 - 0.25

11 - 14

18 hours

16 – 23

0.26 - 0.33

15 - 18

24 hours

10 – 15

0.34 - 0.47

19 - 26

36 hours

5 – 9

0.48 - 0.64

27 - 36

48 hours

In adults with renal failure undergoing haemodialysis, the amount of gentamicin removed

from the blood may vary depending upon several factors including the dialysis method used.

eight-hour

haemodialysis

reduce

serum

concentrations

gentamicin

approximately 50%. The recommended dosage at the end of each dialysis period is 1 to

1.7 mg/kg depending upon the severity of infection.

The above dosage schedules are provided as guidelines only, and are not intended as a rigid

dosage recommendations. The measurement of gentamicin serum levels is highly desirable in

patients with renal impairment to ensure optimal serum gentamicin concentrations.

Intravenous administration:

For IV administration, the prescribed dose of gentamicin may be diluted in 100 to 200 mL of

sterile normal saline or 5% glucose in water. The concentration of gentamicin in the solution

should not exceed 1 mg/mL. Infusion periods of 30 minutes to 2 hours have been advocated.

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Administration of the dose by bolus injection produces serum levels which are initially in

excess of what is regarded as being safe from toxic side effects. The high serum level does

however rapidly fall and the potential danger or safety of this method of administration is yet

to be established.

Gentamicin Injection BP must not be physically mixed with other drugs, but should be

administered by separate infusion (see section 4.5).

Gentamicin Injection BP is available in ampoules. Ampoules of the injection do not

contain any bacteriostat and should be discarded following a single use.

Bodyweight

Prior

administration,

patient’s

bodyweight

should

measured

correct

calculation of dosage. In obese patients, the appropriate dose can be calculated by assuming

the bodyweight is the patient’s estimated lean bodyweight plus 40% of the excess.

4.3 Contraindications

Gentamicin is contraindicated in patients with a history of hypersensitivity to gentamicin,

other aminoglycoside or any constituents of the injection (see section 6.1), as well as in

patients who have experienced serious toxic reactions (ototoxicity or nephrotoxicity) to

gentamicin or to other aminoglycoside therapy.

4.4 Special warnings and precautions for use

Cross allergenicity among aminoglycosides has been known to occur.

Patients

treated

with

aminoglycoside

antibiotics,

including

gentamicin,

injection,

irrigation or local application, should be under close clinical observation because these

drugs have the inherent potential for causing neurotoxicity and nephrotoxicity, particularly

if patients have preexisting renal damage or if the drug is administered for longer periods

or at higher doses than those recommended.

Neurotoxicity, manifested by both vestibular and auditory ototoxicity can occur. The

auditory changes are generally irreversible, usually bilateral and may be partial or total.

Other

manifestations

neurotoxicity

include

numbness,

skin

tingling,

muscle

twitching and convulsions.

Renal and eighth cranial nerve function should be closely monitored, especially in patients

with known or suspected reduced renal function at onset of therapy and also in those

whose renal function is initially normal but who develop signs of renal dysfunction during

therapy. Urine should be examined for decreased specific gravity, increased excretion of

protein, and the presence of cells or casts. Blood urea nitrogen, serum creatinine, or

creatinine clearance should be determined periodically. When feasible, it is recommended

that serial audiograms be obtained in patients old enough to be tested, particularly high-

risk patients. Evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears or

hearing loss) or nephrotoxicity requires dosage adjustment or discontinuance of the drug.

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As with the other aminoglycosides, on rare occasions changes in renal and eighth cranial

nerve function may not become manifest until soon after completion of therapy.

Serum concentrations of aminoglycosides should be monitored to assure adequate levels

and to avoid potentially toxic levels. When monitoring gentamicin peak concentrations,

dosage should be adjusted so that prolonged levels above 12 micrograms/mL are avoided.

When monitoring gentamicin trough concentrations, dosage should be adjusted so that

levels

above

2 micrograms/mL

avoided.

Excessive

peak

and/or

trough

serum

concentrations of aminoglycosides may increase the risk of renal and eighth cranial nerve

toxicity. In the event of overdose or toxic reactions, haemodialysis may aid in the removal

of gentamicin from the blood, especially if renal function is or becomes compromised.

The rate of removal of gentamicin is considerably less by peritoneal dialysis than by

haemodialysis.

Concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or

nephrotoxic drugs, (see section 4.5) should be avoided. This includes concurrent use with

potent diuretics, cephalosporins or other aminoglycosides. Other factors which may

increase the risk of toxicity are dehydration and advancing age.

Patients should be well hydrated during therapy

Because of its toxicity, gentamicin should be used with caution in elderly patients only

after less toxic alternatives have been considered and/or found ineffective. Elderly

patients are more likely to have an age-related decrease in renal function. This may not be

evident in the results of routine screening test such as BUN or serum creatinine. A

creatinine clearance determination may be more useful. Recommended doses should not

be exceeded, and the patient’s renal function should be carefully monitored during

therapy. Geriatric patients may require smaller daily doses of gentamicin in accordance

with their increased age, decreased renal function, and possibly, decreased weight. In

addition, loss of hearing may result even in patients with normal renal function.

Gentamicin should be used with caution in premature and neonatal infants because their

renal immaturity may result in the prolongation of the serum half life of the drug and

subsequent gentamicin induced toxicity.

Neuromuscular blockade and respiratory paralysis have been reported in cats receiving

very high doses of gentamicin (40 mg/kg). The possibility that prolonged or secondary

apnoea may occur should be considered if the drug is administered to anaesthetised

patients who are also receiving neuromuscular blocking agents such as succinylcholine,

tubocurarine or decamethonium or in patients receiving massive transfusions of citrated

blood. If neuromuscular blockade occurs it may be reversed by the administration of

calcium salts.

Aminoglycosides, including gentamicin, should be used with caution in patients with

muscular disorders, such as myasthenia gravis or parkinsonism, since these drugs may

aggravate muscle weakness because of their potential curare-like effect on neuromuscular

junction.

If overgrowth of nonsusceptible organisms occurs, appropriate therapy should be initiated.

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4.5 Interaction with other medicines and other forms of interaction

Potent diuretics: If possible, do not give gentamicin in conjunction with ethacrynic acid,

frusemide or other potent diuretics which may themselves cause ototoxicity or enhance

aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue.

Other neurotoxic and/or nephrotoxic agents: If possible, avoid concurrent or sequential use of

other neurotoxic and/or nephrotoxic antibiotics, including other aminoglycosides, polymyxin

B, colistin, cisplatin, vancomycin, amphotericin B, clindamycin and cephalosporins.

Neuromuscular

blocking

agents

medications

with

neuromuscular

blocking

activity:

Concurrent

gentamicin

with

agents

with

neuromuscular

blocking

activity

e.g.

succinylcholine,

tubocurarine,

decamethonium,

halogenated

hydrocarbon

inhalation

anaesthetics, opioid analgesics and massive transfusions with citrated anticoagulated blood,

should

carefully

monitored;

neuromuscular

blockade

enhanced,

resulting

skeletal

muscle

weakness

respiratory

depression

paralysis

(apnea);

caution

recommended when these medications and gentamicin are used concurrently during surgery

or in the postoperative period, especially if there is a possibility of incomplete reversal of

neuromuscular blockade postoperatively; treatment with anticholinesterase agents or calcium

salts may help reverse the blockade.

Penicillins: Gentamicin is inactivated by solutions containing penicillins. This inactivation is

brought about by the opening of the beta-lactam ring and combination of the penicillin with

an amino group of gentamicin to form a biologically inactive amide. For this reason,

gentamicin and penicillins should not be combined in intravenous injections/infusions. The

inactivation of gentamicin by penicillins may occur in vivo, especially in patients with renal

failure who maintain a higher level of the penicillin for a longer period of time compared to

patients with normal renal function. Therefore, when gentamicin and penicillins are used

together in patients with renal failure, the time of administration of each drug should be

staggered so that several hours separate each infusion.

Although the inactivation of gentamicin and penicillin proceeds on an equimolar basis, in

practice the penicillin is present in such an excess that only the decline in activity of

gentamicin is of concern. A combination of penicillin and gentamicin is often used in the

treatment of enterococcal endocarditis.

4.6 Fertility, pregnancy and lactation

Fertility

No data available.

Pregnancy

Category D

Gentamicin and other aminoglycosides are known to cross the placenta. There is evidence of

selective uptake of gentamicin by the foetal kidney resulting in cellular damage (probably

Category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of

human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects.

Version 5.0

reversible) to immature nephrons. Eighth cranial nerve damage has also been reported

following in-utero exposure to some of the aminoglycosides. Because of their chemical

similarity, aminoglycosides must be considered potentially nephrotoxic and ototoxic to the

foetus. It should also be noted that therapeutic blood levels in the mother do not equate with

safety for the foetus.

Use in lactation

Aminoglycosides are excreted in breast milk in small but variable amounts. Although

aminoglycosides are poorly absorbed from the gastrointestinal tract and problems in nursing

infants have not been documented, it is not know whether they are harmful to the newborn.

Therefore gentamicin should not be administered to lactating women unless the benefit clearly

justifies the potential risks, including possible ototoxic and nephrotoxic effects on the baby.

4.7 Effects on ability to drive and use machines

The effects of this medicine on a person’s ability to drive and use machines were not assessed

as part of its registration.

4.8 Undesirable effects

Nephrotoxicity: (see section 4.4) Adverse renal effects, as demonstrated by the presence of

casts, cells or protein in the urine or by rising BUN, NPN, serum creatinine or oliguria, have

been reported. They occur more frequently in patients with a history of renal impairment and

in patients treated for longer periods or with larger dosage than recommended.

Neurotoxicity: (see section 4.4) Serious adverse effects on both vestibular and auditory

branches of the eighth cranial nerves have been reported, primarily in patients with renal

impairment (especially if dialysis is required), and in patients on high doses and/or prolonged

therapy. Symptoms include dizziness, vertigo, tinnitus, roaring in the ears and hearing loss,

which, as with the other aminoglycosides, may be irreversible. Hearing loss is usually

manifested initially by diminution of high-tone acuity. Other factors which may increase the

risk of toxicity include excessive dosage, dehydration and previous exposure to other ototoxic

drugs.

Peripheral

neuropathy

encephalopathy,

including

numbness,

skin

tingling,

muscle

twitching, convulsions and a myasthenia gravis-like syndrome, have been reported.

Note: The risk of toxic reactions is low in patients with normal renal function who do not

receive DBL

Gentamicin Injection BP at higher doses or for longer periods of time than

recommended.

Other

reported

adverse

reactions

possibly

related

gentamicin

include:

respiratory

depression, lethargy, confusion, depression, visual disturbances, decreased appetite, weight

loss, and hypotension

and hypertension; rash, itching, urticaria, generalized burning, laryngeal edema, anaphylactoid

reactions, fever, and headache, nausea, vomiting, increased salivation, and stomatitis; purpura,

pseudotumor cerebri, acute organic brain syndrome, pulmonary fibrosis, alopecia, joint pain,

transient hepatomegaly, and splenomegaly.

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While local tolerance of DBL

Gentamicin Injection BP is generally excellent, there has been

an occasional report of pain at the injection site. Subcutaneous atrophy or fat necrosis

suggesting local irritation has been reported rarely.

Laboratory abnormalities possibly related to gentamicin include: increased levels of serum

transaminase (ALT, AST) serum LDH and bilirubin; decreased serum calcium, magnesium,

sodium

potassium;

anemia,

leukopenia,

granulocytopenia,

transient

agranulocytosis,

eosinophilia, increased and decreased reticulocyte counts, and thrombocytopenia. While

clinical laboratory test abnormalities may be isolated findings, they may also be associated

with clinically related signs and symptoms. For example, tetany and muscle weakness may be

associated with hypomagnesemia, hypocalcemia and hypokalemia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It

allows

continued

monitoring

benefit/risk

balance

medicine.

Healthcare

professionals

asked

report

suspected

adverse

reactions

https://nzphvc.otago.ac.nz/reporting/.

4.9 Overdose

Peritoneal dialysis or haemodialysis will aid in the removal of gentamicin from the blood.

This is particularly important in patients with renal malfunction.

For advice on the management of overdose please contact the National Poisons Centre on

0800 POISON (0800 764766).

5.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Mechanism of action

Gentamicin is a bactericidal aminoglycoside antibiotic which acts by inhibiting protein

synthesis of susceptible bacteria. It is effective against a wide variety of pathogenic aerobic

gram negative bacilli and some gram positive organisms (see section 4.1). It is not active

against anaerobic organisms.

5.2 Pharmacokinetic properties

Absorption

When gentamicin is administered intramuscularly, peak serum concentrations occur between

30 and 90 minutes after injection; effective concentrations persist for 6 to 8 hours.

Gentamicin is poorly absorbed by the oral route, and only minimal amounts have been found

in the blood following oral administration.

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In patients with normal renal function, peak serum concentrations of gentamicin, expressed in

microgram/mL, are usually about four times the single dose expressed in mg/kg; for example,

an injection of gentamicin 1 mg/kg may be expected to result in peak serum concentration of

approximately 4 microgram/mL. Gentamicin administered every 8 hours does not accumulate

in the serum except in patients with impaired renal function in whom the serum concentration

of gentamicin is usually higher, and measurable for longer periods. When gentamicin is

administered by intravenous infusion, over 1 to 2 hours, the serum concentrations are similar

to those obtained with intramuscular administration. About 25 to 30% of the administered

dose of gentamicin is bound by serum protein; it is released as the drug is excreted.

Gentamicin is excreted principally in the urine by glomerular filtration.

After initial administration to patients with normal renal function, 30 to 100% of the

gentamicin is recoverable in the urine in 24 hours. High urine concentrations (above 100

microgram/mL) may be achieved. After several days treatment, the amount of gentamicin

excreted in the urine approaches the daily dose administered. Renal clearance of gentamicin is

similar to that of endogenous creatinine.

In patients with impaired renal function, the clearance of gentamicin is decreased; the more

severe the impairment, the slower the clearance. Therefore, the interval between doses should

be adjusted according to the degree of renal impairment. Endogenous creatinine clearance

rate and serum creatinine, which have high correlation with serum half-life of gentamicin,

may be used as a guide for this purpose (see section 4.2).

Distribution

Following parenteral administration, gentamicin can be detected in tissues and body fluids.

Concentrations in bile in general have been low and have suggested minimal biliary excretion.

Gentamicin

administered

intramuscularly

been

found

concentrations

cerebrospinal fluid. Gentamicin has also been found in the sputum, pleural fluid, and

peritoneal fluid. Gentamicin crosses the peritoneal as well as the placental membranes.

5.3 Preclinical safety data

No data available

6.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

(Ampoule product)

-Disodium edetate dihydrate

-Water for injection

Ampoules of DBL™ Gentamicin Injection BP do not contain any antimicrobial preservative

or antioxidant.

(Vial product)

-Disodium edetate dihydrate

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-Sodium methyl hydroxybenzoate

-Sodium propyl hydroxybenzoate

-Water for injection

Vials of DBL

Gentamicin Injection BP contain sodium methyl hydroxybenzoate (2.06

mg/mL) and sodium propyl hydroxybenzoate (0.225 mg/mL) as preservative.

6.2 Incompatibilities

When gentamicin is used in combination with any other medicine mixing the medicines

before administration should be avoided at all costs.

6.3 Shelf life

Gentamicin 10mg/ml Injection BP (1ml ampoule): 36 months

DBL™Gentamicin 10mg/ml Injection BP (2ml glass vial): 24 months

DBL™Gentamicin 40mg/ml Injection BP (2ml glass ampoule): 36 months

DBL™Gentamicin 40mg/ml Injection BP (2ml plastic ampoule): 24 months

DBL™Gentamicin 40mg/ml Injection BP (2ml glass vial): 24 months

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

Gentamicin Injection BP is available in ampoules and vials. Ampoules of the injection

do not contain any antimicrobial preservative.

Presentation

Packs

10 mg/mL

10 mg/mL

5 x 2 mL glass vials

50 x 2 mL glass vials

10 mg/mL

5 x 1 mL ampoules

40 mg/mL

5 x 1 mL ampoules

60 mg/1.5 mL

5 x 1.5 mL ampoules

80 mg/2 mL

5 x 2 mL glass ampoules

80 mg/2 mL

80 mg/2 mL

5 x 2 mL glass vials

50 x 2 mL glass vials

80 mg/2 mL

5 x 2 mL plastic ampoules

80 mg/2 mL

50 x 2 mL plastic ampoules

Version 5.0

6.6 Special precautions for disposal

Any unused medicine or waste material should be disposed of in accordance with local

requirements.

7.

MEDICINE SCHEDULE

Prescription Medicine.

8.

SPONSOR

Toll Free Number: 0800 736 363

9.

DATE OF FIRST APPROVAL

Gentamicin 10mg/ml Injection BP- Vials (TT50-3048a): 10

December 1984

Gentamicin 10mg/ml Injection BP (TT50-3048b): 25

September 2008

Gentamicin 40mg/ml Injection BP (TT50-3048): 14

January 1982

10. DATE OF REVISION OF THE TEXT

26 October 2018

Summary table of changes

Section changed

Summary of new information

Reformatted to MedSafe Data Sheet guidance

Statement added: Bodyweight: Prior to administration, the patient’s

bodyweight should be measured for the correct calculation of dosage. In obese

patients, the appropriate dose can be calculated by assuming the bodyweight

is the patient’s estimated lean bodyweight plus 40% of the excess.

Addition of the material of construction of the immediate container.

Pfizer New Zealand Limited,

PO Box 3998

Auckland, New Zealand, 1140

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