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NEBCIN INJECTION 40MG/1ML

Active substance(s): TOBRAMYCIN

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Package leaflet: Information for the user

Nebcin injection
40mg/ml

Tobramycin
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
 Keep this leaflet. You may need to read
it again.
 If you have any further questions, ask your
doctor or pharmacist.
 If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. What Nebcin injection is and
what it is used for
2. What you need to know before you are
given Nebcin injection
3. How you are given Nebcin injection
4. Possible side effects
5. How to store Nebcin injection
6. Contents of the pack and other information

1 What Nebcin injection is and
what it is used for

Nebcin is a vial containing a solution for
injection of the active ingredient tobramycin,
which is an antibiotic.

Nebcin is used to treat the following infections
caused by micro-organisms that can be killed
by tobramycin:
 blood poisoning
 infection of the lining of the brain and other
infections of the nervous system
 infection of the wall of the abdomen and
other infections of the digestive system
 infection of the kidneys, bladder, and other
infections of the urinary tract which have
been difficult to treat with other antibiotics
 infection of lung tissue, the airways and
other infections of the lower respiratory tract
 skin, bone and soft tissue infections,
including burns.

2 What you need to know before you
are given Nebcin injection

You should not be given Nebcin injection if:
 you are allergic to Nebcin (tobramycin),
any aminoglycoside (similar antibiotic)
or any of the other ingredients of this
medicine (listed in section 6). An allergic
reaction may include rash, itching, difficulty
breathing or swelling of the face, lips, throat
or tongue.
Nebcin injection must only be injected into
a muscle or vein.
Warnings and precautions
Tell your doctor if you:
 have ever had an allergic reaction to a
sulfate or bisulfite (preservatives)

have a kidney disorder or need dialysis
(you may need a reduced dose, especially if
you are elderly)
 have a muscle disorder, such as myasthenia
gravis, or Parkinson’s disease
 are elderly or dehydrated (needing fluids).
Nebcin injection should be used with caution
in premature and neonatal infants, and also in
patients with extensive burns.
Tell your doctor if any of the above applies to
you before this medicine is given to you.
Other medicines and Nebcin injection
Tell your doctor if you are taking, have recently
taken or might take any other medicines.
In particular, the following medicines may
interact with this medicine:
 other aminoglycosides (similar antibiotics
such as amikacin, streptomycin, neomycin,
kanamycin, gentamicin or paromomcyin)
 other antibiotics such as amphotericin
B, cephaloridine, viomycin, polymyxin B,
colistin, vancomycin, and cephalosporin
antibiotics (such as cephalothin)
 cisplatin (a drug used for chemotherapy)
 diuretics (water tablets)
 medicines used as muscle relaxants during
general anaesthesia.
 ciclosporin (used to reduce the activity of
the immune system)
 neostigmine and pyridostigmine (for the
treatment of muscle weakness)
 warfarin and phenindione (used to thin
the blood).


It may still be alright for you to be given
Nebcin injection and your doctor will be able to
decide what is suitable for you.
Pregnancy, breast-feeding and fertility
You should not have Nebcin injection if you
are pregnant unless your doctor tells you to.
Nebcin may harm the unborn baby.
You should not have Nebcin injection if you are
breast-feeding.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
Following rapid injection, Nebcin may cause
muscle weakness or certain muscles not to
work, and so may affect your ability to drive or
use machines. If you are affected, you should
not drive or operate heavy machinery until
you feel it is safe to do so.
Nebcin injection contains Sodium
metabisulfite (E223)
May rarely cause severe hypersensitivity
reactions and bronchospasm (difficulty in
breathing).

3 How you are given Nebcin injection

Dosage
A doctor or nurse will give you Nebcin injection.
The recommended dose is:
Adults: 3mg per kg of body weight every
24 hours, given as 3 doses of 1mg per kg
of body weight every 8 hours. If you have a
serious bacterial infection, your doctor may
use larger doses.

INFORMATION FOR THE HEALTH CARE PROFESSIONAL

Table 1: DOSAGE SCHEDULE GUIDE FOR ADULTS WITH NORMAL
RENAL FUNCTION (Dosage at 8 Hour Intervals)

1. NAME OF THE MEDICINAL PRODUCT

Patient Usual dose for serious Maximum dose for life threatening
Weight infections 1mg/kg q 8 h infections (reduce as soon as possible)
kg
(total 3mg/kg/day)
1.66mg/kg q 8 h (total 5mg/kg/day

unless monitored)

mg/dose
ml/dose* mg/dose
ml/dose*
120
120
3.0
200
5.0
100
100
2.5
166
4.0
80
80
2.0
133
3.0
60
60
1.5
100
2.5
40
40
1.0
66
1.6

Nebcin injection 40mg/1ml
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
Nebcin is indicated for the treatment of the following infections
caused by susceptible micro organisms:
Central nervous system infections, including meningitis, septicaemia
and neonatal sepsis
Gastro-intestinal infections, including peritonitis, and other significant
infections such as complicated and recurrent urinary tract infections,
including pyelonephritis and cystitis
Lower respiratory tract infections, including pneumonia,
bronchopneumonia and acute bronchitis
Skin, bone and soft tissue infections, including burns
Nebcin may be considered in serious staphylococcal infections for
which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical
judgement indicate its use.
See section 5.1. for species clinical breakpoints and prevalence of
resistance of commonly susceptible bacterial species.
4.2 Posology and method of administration
Posology
The intramuscular dose is the same as the intravenous dose.
It is recommended that both peak and trough serum levels should be
determined whenever possible to ensure the correct dosage is given.
Blood levels should always be determined in patients with chronic
infections such as cystic fibrosis, or where longer duration of
treatment may be necessary, or in patients with decreased renal
function.
Patients with normal renal function
Adults: The usual recommended dosage for adults with serious
infections is 3mg/kg/day, administered in three equal doses every
eight hours (Table 1). For life threatening infections, dosages up to
5mg/kg/day may be administered in three or four equal doses. The
dosage should be reduced to 3mg/kg/day as soon as clinically
indicated. To prevent increased toxicity due to excessive blood levels,
dosage should not exceed 5mg/kg/day unless serum levels are
monitored
(see section 4.4).
To achieve therapeutic serum levels in patients with cystic fibrosis, it
may be necessary to administer up to 8 to 10mg/kg/day in equally
divided doses. Because serum concentrations of tobramycin vary from
one patient to another, serum levels should be monitored.

*Applicable to 40mg/ml product forms.
In adults with normal renal function, mild to moderate infections of
the urinary tract have responded to a dosage of 2-3mg/kg/day
administered as a single intramuscular injection.
The elderly: As for adults, but see recommendations for patients with
impaired renal function.
Obese patients: The appropriate dose may be calculated using the
patient’s estimated lean body weight, plus 40% of the excess, as the
weight on which to determine mg/kg.
Paediatric population
Children: The recommended dosage is 6-7.5mg/kg/day,
administered in three or four equally divided doses. In some patients
it may be necessary to administer higher doses.
Premature or full term neonates: Dosages of up to 4mg/kg/day
may be administered in two equal doses every 12 hours, for those
between 1.5 and 2.5kg body weight.
The usual duration of treatment is 7 to 10 days. A longer course of
therapy may be necessary in difficult and complicated infections. In
such cases, monitoring of renal, auditory and vestibular functions is
advised, because neurotoxicity is more likely to occur when treatment
is extended for longer than 10 days.
Patients with impaired renal function
Following a loading dose of 1mg/kg, subsequent dosage in these
patients must be adjusted, either with lower doses administered at
eight hour intervals or with normal doses at prolonged intervals
(Table 2). Both of these regimens are suggested as guides to be used
when serum levels of tobramycin cannot be measured directly. They
are based on either the creatinine clearance or the serum creatinine of
the patient, because these values correlate with the half life of
tobramycin. Neither regimen should be used when dialysis is being
performed.
Reduced dosage at eight hour intervals (Regimen I):
An appropriately reduced dosage range can be found in the
accompanying table (Table 2) for any patient for whom the blood
urea, creatinine clearance or serum creatinine values are known. The
choice of dose within the indicated range should be based on the
severity of the infection, the sensitivity of the pathogen, and
individual patient considerations, especially renal function. An

Method of administration
Nebcin may be given intramuscularly or intravenously. The patient’s
pre-treatment body weight should be obtained for calculation of
correct dosage.
For instructions on dilution of the medicinal product before
administration, see section 6.6.
4.3 Contraindications
Intrathecal administration.
Hypersensitivity to any aminoglycoside is a contra-indication to the
use of tobramycin because of the known cross-allergenicity of drugs
in this class.
4.4 Special warnings and precautions for use
Table 2: TWO MAINTENANCE REGIMENS BASED ON RENAL FUNCTION
Warnings
AND BODY WEIGHT FOLLOWING AN INITIAL DOSE OF 1mg/kg*
Nebcin contains sodium metabisulfite which may cause allergic-type

reactions, including anaphylactic symptoms and
Renal function†
Regimen I
or Regimen II

life-threatening or less severe asthmatic episodes,

Adjusted doses at
Normal dosage
in certain susceptible people. The overall

8 hour intervals
at prolonged
prevalence of sulfite sensitivity in the general
intervals

population is unknown and probably low, but it
Blood urea
Serum creatinine
Creatinine Weight
Weight/Dose

occurs more frequently in asthmatic patients.
clearance

Patients treated with tobramycin should be
mg/100ml mmol/l
mg/100ml mcmol/l
ml/min
50-60kg 60-80kg
50-60kg: 60mg
under close observation because tobramycin and
60-80kg:
80mg

other aminoglycoside antibiotics have an

inherent potential for causing nephrotoxicity
Normal:
and ototoxicity.

<42 <7.0 <1.3 <114.9 >70
60mg
80mg
q8h
42-74
7.0-12.3 1.4-1.9
123.8-168 69-40
30-60mg 50-80mg
q 12 h

Both vestibular and auditory ototoxicity can
75-105 12.5-17.5 2.0-3.3
176.8-291.7 39-20
20-25mg 30-45mg
q 18 h

occur. The auditory changes are irreversible, are

usually bilateral, and may be partial or total.
106-140 17.7-23.3 3.4-5.3
300.6-468.5 19-10
10-18mg 15-24mg
q 24 h
Eighth cranial nerve impairment may develop in
141-160 23.5-26.7 5.4-7.5
477.4-663 9-5
5-9mg
7-12mg
q 36 h
patients with pre-existing renal damage and if
>160
>26.7
>7.6
>671.8
<4
2.5-4.5mg 3.5-6mg
q 48 h§

tobramycin is administered for longer periods or
in higher doses than those recommended. Other manifestations of
* For life threatening infections, dosages 50% above those
neurotoxicity may include numbness, skin tingling, muscle twitching
normally recommended may be used. The dosages should be
and convulsions. The risk of aminoglycoside-induced hearing loss
reduced as soon as possible when improvement is noted.
increases with the degree of exposure to either high peak or high
† If used to estimate degree of renal impairment, blood urea and
trough serum concentrations. Patients who develop cochlear damage
serum creatinine concentrations should reflect a steady state of
may not have symptoms during therapy to warn them of eighth nerve
renal uraemia.
toxicity, and partial or total irreversible bilateral deafness may continue
§ When dialysis is not being performed.
to develop after the drug has been discontinued. Rarely, nephrotoxicity
Following IM administration of a single dose of tobramycin of l mg/kg
may not become manifest until the first few days after cessation of
in adults with normal renal function, peak plasma tobramycin
therapy. Aminoglycoside-induced nephrotoxicity is usually reversible.
concentrations averaging 4-6 micrograms/ml are attained within
Therefore, renal and eighth cranial nerve function should be closely
30-90 minutes; plasma concentrations of the drug are 1 microgram/
monitored in patients with known or suspected renal impairment and
ml or less at 8 hours. Following intravenous infusion of the same dose
also in those whose renal function is initially normal but who develop
over 30-60 minutes, similar plasma concentrations of the drug are
signs of renal dysfunction during therapy. Evidence of impairment in
obtained.
renal, vestibular and/or auditory function requires discontinuation of
In neonates, average peak plasma tobramycin concentrations of
the drug or dosage adjustment.
about 5 micrograms/ml are attained 30-60 minutes after a single IM
Monitoring of renal function is particularly important in elderly patients
dose of 2mg/kg; plasma concentrations average 1-2 micrograms/ml
who may have reduced renal function that may not be evident in the
at 12 hours.
results of routine screening tests, such as blood urea or serum
creatinine. A creatinine clearance determination may be more useful.
alternative rough guide for determining reduced dosage at eight hour
intervals (for patients whose steady state serum creatinine values are
known) is to divide the normally recommended dose by the patient’s
serum creatinine value (mg/100ml).
Normal dosage at prolonged intervals (Regimen II):
Recommended intervals between doses are given in the
accompanying table (Table 2). As a general rule, the dosage
frequency in hours can be determined by multiplying the patient’s
serum creatinine level (mg/100ml) by six.
The dosage schedules derived from either method should be used in
conjunction with careful clinical and laboratory observations of the
patient and should be modified as necessary (see section 4.4).

Serum concentrations should be monitored when feasible, and
prolonged concentrations above 12mg/l should be avoided. Rising
trough levels (above 2mg/l) may indicate tissue accumulation.
A useful guideline would be to perform serum level assays after two
or three doses, so that the dosage could be adjusted if necessary, and
also at three to four day intervals during therapy. In the event of
changing renal function, more frequent serum levels should be
obtained and the dosage or dosage intervals adjusted according to
the guidelines provided in the ‘Posology and Method of
Administration’ section. In order to measure the peak level, a serum
sample should be drawn about 30 minutes following intravenous
infusion or at one hour after intramuscular injection. Trough levels are
measured by obtaining serum samples at eight hours or just prior to
the next dose of tobramycin.
Urine should be examined for increased excretion of protein, cells and
casts. Serum creatinine or creatinine clearance (preferred over blood
urea) should be measured periodically. When feasible, it is
recommended that serial audiograms be obtained in patients old
enough to be tested, particularly high-risk patients.
The risk of toxic reactions is low in patients with normal renal function
who do not receive tobramycin in higher doses or for longer periods
of time than those recommended.
Patients with reduced renal function, however, are particularly prone
to the potential ototoxic and nephrotoxic effects of this drug, so
dosage should be adjusted carefully on the basis of regular
monitoring of serum drug concentrations and of renal function.
Precautions
General: Serum calcium, magnesium, and sodium should be
monitored. It is particularly important to monitor serum levels closely
in patients with known renal impairment.
In patients with extensive burns, altered pharmacokinetics may
result in reduced serum concentrations of aminoglycosides. In such
patients treated with tobramycin, measurement of serum
concentration is especially recommended as a basis for determination
of appropriate dosage.
Aminoglycosides may be absorbed in significant quantities from body
surfaces after local irrigation or application and may cause
neurotoxicity and nephrotoxicity.
Although not indicated for intraocular and/or subconjunctival use,
there have been reports of macular necrosis following this type of
injection.
Aminoglycosides 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 function.
Neuromuscular blockade or respiratory paralysis may occur following
rapid intravenous administration of many aminoglycosides and have
been reported in cats receiving very high doses of tobramycin
(40mg/kg). The possibility of prolonged secondary apnoea should be
considered if tobramycin is administered to anaesthetised patients
who are also receiving neuromuscular blocking agents such as
succinylcholine, tubocurarine or decamethonium, or to patients

receiving massive transfusions of citrated blood. If neuromuscular
blockade occurs, it may be reversed by the administration of
calcium salts.
The inactivation of tobramycin by beta lactam antibiotics (penicillins
or cephalosporins) has been demonstrated in vitro and in patients
with severe renal impairment. Such inactivation has not been found in
patients with normal renal function if the drugs are administered by
separate routes.
If overgrowth of non susceptible organisms occurs, appropriate
therapy should be initiated.
Paediatric population
Use in neonates: Tobramycin should be used with caution in
premature and neonatal infants because of their renal immaturity
and the resulting prolongation of serum half-life of the drug.
4.5 Interaction with other medicinal products and
other forms of interaction
Concurrent and/or sequential use of other potentially neurotoxic and/
or nephrotoxic drugs, particularly other aminoglycosides (eg,
amikacin, streptomycin, neomycin, kanamycin, gentamicin and
paromomycin), amphotericin B, cephaloridine, viomycin, polymyxin B,
colistin, cisplatin and vancomycin, requires careful monitoring.
Other factors that may increase patient risk are advanced age and
dehydration.
Tobramycin should not be given concurrently with potent diuretics.
Some diuretics themselves cause ototoxicity, and intravenously
administered diuretics enhance aminoglycoside toxicity by altering
antibiotic concentrations in serum and tissue.
Antibacterials: Tobramycin used in conjunction with other
antibacterials such as cephalosporins notably cephalothin, there is an
increased risk of nephrotoxicity.
Muscle Relaxants: Enhanced blockade of respiratory paralysis can
occur with skeletal muscle relaxants.
Cytotoxics and Cyclosporins: There is increased risk of nephrotoxicity
and possibly ototoxicity with Cisplatin as well as increased risk of
nephrotoxicity with cyclosporins.
Tobramycin has been known to potentiate warfarin and phenindione.
Cholinergics: Antagonism of effect of neostigmine and pyridostigmine.
4.6 Fertility, pregnancy and lactation
Pregnancy
Aminoglycosides can cause foetal harm when administered to a
pregnant woman. Aminoglycoside antibiotics
cross the placenta, and there have been several reports of total
irreversible bilateral congenital deafness in children whose mothers
received streptomycin during pregnancy. Serious side-effects to
mother, foetus, or newborn have not been reported in the treatment
of pregnant women with other aminoglycosides, but tobramycin
should not be administered to the pregnant patient unless the
potential benefits clearly outweigh any potential risk. If tobramycin is
used during pregnancy or if the patient becomes pregnant whilst
taking tobramycin, she should be informed of the potential hazard
to the foetus.

Breast-feeding
Tobramycin is excreted in the breast milk and should be avoided in
nursing women.
4.7 Effects on ability to drive and use machines
Not relevant
4.8 Undesirable effects
Renal function changes, as shown by rising blood urea and serum
creatinine and by oliguria, cylindruria and increased proteinuria, have
been reported, especially in patients with a history of renal
impairment who are treated for longer periods or with higher doses
than those recommended. These changes can occur in patients with
initially normal renal function.
Side-effects on both vestibular and auditory branches of the eighth
cranial nerve have been reported, especially in patients receiving high
doses or prolonged therapy, in those given previous courses of
therapy with an ototoxin, and in cases of dehydration. Symptoms
include dizziness, vertigo, tinnitus, roaring in the ears and hearing
loss. Hearing loss is usually irreversible and is manifested initially by
diminution of high tone acuity.
Other reported side effects, possibly related to tobramycin, include
increased AST, ALT and serum bilirubin; decreased serum calcium,
magnesium, sodium and potassium; anaemia, granulocytopenia,
thrombocytopenia, leucopenia, leucocytosis and eosinophilia; and
fever, rash, exfoliative dermatitis, itching, urticaria, nausea, vomiting,
diarrhoea, headache, lethargy, pain at the injection site, mental
confusion and disorientation.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continues monitoring of the
benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via
the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Signs and Symptoms: Severity of the manifestations of a tobramycin
overdose depend on the dose, the patient’s renal function, state of
hydration, age and whether concurrent medication with similar
toxicities is being given. Toxicity may occur in patients treated for
more than 10 days, given more than 5mg/kg/day, children given
more than 7.5mg/kg/day, or patients with reduced renal function
whose dose has not been appropriately adjusted.
Nephrotoxicity following the parenteral administration of an
aminoglycoside is most closely related to the AUC of serum
concentration versus time. Nephrotoxicity is more likely if trough levels
fail to fall below 2mg/l and is also proportional to the average blood
concentration. Patients who are elderly, have renal impairment, are
receiving other nephrotoxic or ototoxic drugs, or are volume depleted,
are at greater risk for developing acute tubular necrosis. Auditory and
vestibular toxicities have been associated with aminoglycoside
overdose. These toxicities occur in patients treated longer than 10
days, in patients with abnormal renal function, in dehydrated patients,
or in patients on other ototoxic drugs. These patients may not have

signs or symptoms, or may experience dizziness, tinnitus, vertigo and
a loss of high tone acuity. Signs and symptoms may not occur until
long after the drug has been discontinued.
Neuromuscular blockade or respiratory failure may occur following
rapid intravenous administration of many aminoglycosides. These
reactions and prolonged respiratory paralysis may occur more
commonly in patients with myasthenia gravis or Parkinson’s disease,
or those receiving decamethonium, tubocurarine or succinylcholine.
Neuromuscular blockade may be reversed by the administration of
calcium salts, but mechanical assistance may be necessary.
Toxicity from ingested tobramycin is unlikely because aminoglycosides
are poorly absorbed from an intact gastro-intestinal tract.
Treatment: Resuscitative measures should be initiated promptly if
respiratory paralysis occurs. Neuromuscular blockade may be reversed
by giving calcium salts. Fluid balance, creatinine clearance and
tobramycin plasma levels should be carefully monitored until the
tobramycin level falls below 2mg/l. Haemodialysis or peritoneal
dialysis will help remove tobramycin from the blood. Between 25%
and 70% of the administered dose may be removed, depending on
the duration and type of dialysis employed; haemodialysis is the more
effective method.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Aminoglycoside antibacterials,
ATC code: JO1GB01
Mode of Action: in vitro tests demonstrate that tobramycin is
bactericidal and that it acts by inhibiting the synthesis of protein in
bacterial cells.
EUCAST Clinical MIC Breakpoints
The non-species related breakpoints for susceptible (S) and resistant
(R) species are: S< 2mg/L and R > 4mg/L
For Enterobacteriacaea S< 2mg/L and R > 4mg/L
For Pseudomonas
S< 4mg/L and R > 4mg/L
For Acinetobacter
S< 4mg/L and R > 4mg/L
For Staphylococcus
S< 1mg/L and R > 1mg/L
The prevalence of acquired resistance may vary geographically and
with time for selected species and local information on resistance is
desirable, particularly when treating severe infections. As necessary,
expert advice should be sought when the local prevalence of
resistance is such that the utility of the agent in at least some types
of infections is questionable.

Commonly Susceptible Species
5.2 Pharmacokinetic properties
The serum half-life in normal individuals is two hours. An inverse
Gram-positive aerobes
Gram-negative aerobes
relationship exists between serum half-life and creatinine clearance,
Staphylococcus aureus
Citrobacter freundii
and the dosage schedule should be adjusted according to the degree
Staphylococcus coagulase negative Citrobacter koseri
of renal impairment (see ‘Posology and Method of Administration’).

Enterobacter aerogenes
In patients undergoing dialysis, 25% to 70% of the administered dose
Staphylococcus saprophyticus
Enterobacter cloacae
may be removed, depending on the duration and type of dialysis.

Enterobacter sakazakii
Tobramycin can be detected in tissues and body fluids after

Enterobacter spp
parenteral administration. Concentrations in bile and stools ordinarily
have been low, which suggests minimum biliary excretion.


Escherihia coli
Tobramycin has appeared in low concentration in the cerebrospinal

Klebsiella oxytoca
fluid following parenteral administration and concentrations are

Klebsiella pneumoniae

dependent on dose, rate of penetration and degree of meningeal

Klebsiella spp
inflammation. It has also been found in sputum, peritoneal fluid,

Morganella morganii
synovial fluid and abscess fluids, and it crosses the placental

Proteus mirabilis
membranes. Concentrations in the renal cortex are several times

Proteus spp higher than the usual serum levels.

Proteus vulgaris
Tobramycin levels may be somewhat lower than expected in adults
with a large volume of extracellular fluid. Also, it has been reported

Pseudomonas aeruginosa
that the serum half-life of tobramycin in severely burned patients
Species for which acquired resistance may be a problem
may be decreased and this may result in lower serum levels.
Gram-positive aerobes
Gram-negative aerobes
Probenecid does not affect the renal tubular transport of tobramycin.
Staphylococcus capitis
Citrobacter spp - other
5.3 Preclinical safety data
Staphylococcus epidermidis
Klebsiella ozaenae
There are no preclinical data of relevance to the prescriber.
Staphylococcus haemolyticus
Serratia liquefaciens
6. PHARMACEUTICAL PARTICULARS
Staphylococcus hominis
Serratia marcescens
6.6 Special precautions for disposal and other handling
Staphylococcus lugdunensis
Serratia spp
Prior to administration, parenteral drug products should be inspected
Staphylococcus warnerii
visually for particulate matter and discolouration whenever solution
Inherently resistant organisms
and container permit.
Aminoglycosides have a low order of activity against most
Intramuscular administration: Nebcin may be administered by
gram-positive organisms, including Streptococcus pyogenes,
withdrawing the appropriate dose directly from the vial.
Streptococcus pneumoniae and enterococci.
Intravenous administration: For intravenous administration, the
Although most strains of enterococci demonstrate in vitro resistance,
usual volume of diluent (0.9% Sodium Chloride Intravenous Infusion
some strains are susceptible. In vitro studies have shown that an
BP or 5% Dextrose Intravenous Infusion BP) for adult doses is
aminoglycoside combined with an antibiotic that interferes with
50-100ml. For children, the volume of diluent should be
cell-wall synthesis affects some enterococcal strains synergistically.
proportionately less than for adults. The diluted solution should be
The combination of penicillin G and tobramycin results in a synergistic
infused over a period of 20-60 minutes avoiding admixture with any
bactericidal effect in vitro against certain strains of Enterococcus
other drug. Nebcin may be administered slowly by direct intravenous
faecalis (formerly Streptococcus faecalis).
injection or into the tubing of a drip set. When given in this way,
However, this combination is not synergistic against other closely
serum levels may exceed 12mg/l for a short time (see ‘Contra
related organisms, e.g. Enterococcus faecium (formerly Streptococcus
indications, Warnings, etc.’).
faecium). Speciation of enterococci alone cannot be used to predict
No special requirements for disposal.
susceptibility. Susceptibility testing and tests for antibiotic synergism
Any unused medicinal product or waste material should be disposed
are emphasised.
of in accordance with local requirements
Cross resistance between aminoglycosides occurs and depends largely
10. DATE OF REVISION OF THE TEXT
on inactivation by bacterial enzymes.
To be completed on approval
The combination of tobramycin and carbenicillin is synergistic in vitro
against most strains of Ps. aeruginosa. Other Gram-negative
organisms may be affected synergistically by the combination of
tobramycin and a cephalosporin.
‘Nebcin’ is a Flynn trade mark

Use in children and adolescents
Children: 6 to 7.5mg per kg of body weight
every 24 hours, given as 3 or 4 equal doses.
Premature or new-born babies: Up to 4mg
per kg of body weight every 24 hours, given
as 2 equal doses every 12 hours.
Kidney disorder: If you have a kidney
disorder, your doctor will reduce your dose.
This may happen during your treatment.
The usual length of treatment is 7 to 10 days.
If you are treated for longer than this, your
doctor will need to test your kidneys and
ears because they may be damaged by the
treatment.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4 Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Very serious side effects
All medicines can cause allergic reactions,
although serious allergic reactions are very
rare. Tell your doctor straight away if you get
any sudden wheeziness, difficulty in breathing,
swelling of the eyelids, face or lips, rash or
itching (especially affecting your whole body),
or any of the following:
 severe peeling skin (exfoliative dermatitis)
 ringing or roaring in one or both ears
(tinnitus)
 hearing loss in one or both ears
 dizziness

sensation of spinning (vertigo)
muscle twitching
 numbness or pins and needles
 fits
 changes in the number of different
types of blood cells. You may notice
unexplained bleeding or bruising (caused
by low platelets) or are unable to fight off
infections (reduced levels of white blood
cells), feel tired all the time (reduced blood
cells, anaemia) or have sudden fever or
sore throat.*
*(these conditions would be detected in a
blood test carried out by a doctor).
These are serious side effects, and you may
only notice them after you stop treatment.
You should see your doctor immediately.
The following side effects have also been
reported:
 effects on the kidneys causing an increase
in waste products in the blood which are
normally eliminated by them or the kidneys
not to work properly
 reduced or no urine production
 cloudy urine (caused by protein or granules).
If you notice changes in your urine or the
number of times you need to urinate, tell your
doctor straight away.
Other side effects reported are:
 headache
 tiredness
 confusion and disorientation
 fever

rash (with no other symptoms)
itching
 feeling sick
 being sick
 diarrhoea
 pain at the injection site
 raised liver enzymes*
 the amount of calcium, magnesium, sodium
and potassium in your blood may decrease
(symptoms are muscle weakness, muscle
cramps, feeling thirsty all the time, drinking
all the time, urinating frequently, vomiting
and, possibly, having a fit)*
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme Website:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the safety of
this medicine.









5 How to store Nebcin injection

Your doctor or pharmacist knows how to store
Nebcin injection.
Keep this medicine out of the sight and reach
of children.
Store below 25°C.
Do not use this medicine after the expiry date
which is stated on the carton. The expiry date
refers to the last day of that month.

Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use.These measures will help protect
the environment.

6 Contents of the pack and
other information

What Nebcin injection contains
Each 1ml solution contains 40mg of the active
substance tobramycin.
The other ingredients are: phenol, sodium
metabisulfite, disodium edetate, water for
injection, sulfuric acid.
What Nebcin injection looks like and
contents of the pack
Nebcin injection is a clear, colourless solution
provided in rubber stoppered glass vials in
individual cartons.
Marketing Authorisation Holder
Flynn Pharma Ltd
Alton House, 4 Herbert Street
Dublin 2, Ireland
Manufacturer
Vianex SA
12th km National Road
Athens-Lamia, 14451
Metamorphossis Attiki
Athens, Greece.
This leaflet was last revised in
October 2015.

Artwork for:
Flynn Pharma Limited
Product name:
Nebcin Injection
PL/PA no:
PL 13621/0059
Type: Leaflet
Artwork dimensions: 115mm x 530mm
Profile supplied:
No. Estimated
Date of first artwork: 26 April 2012
Reason for request:
Text edits
Version no: 10DB
Date of revision:
23 October 2015
Colours:
As swatch(es)
Font(s):
8pt FF Zwo
Artwork software:
InDesign CS6
Proof software: PDF
BAC ref: S803

Black

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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