Gentamicin Injection USP 80mg/2ml Taj Pharma

Name of the medicinal product

Gentamicin Injection USP 20mg/2ml Taj Pharma
Gentamicin Injection USP 80mg/2ml Taj Pharma
Gentamicin Injection USP 800mg/20ml Taj Pharma

Qualitative and quantitative composition

a) Gentamicin Injection USP 20mg/2ml
Each ml contains:
Gentamicin sulfate equivalent
to Gentamicin 10mg
Water for injection q.s
Sodium hydroxide/Sulphuric acid may have added for pH adjustment.

b) Gentamicin Injection USP 80mg/2ml
Each ml contains:
Gentamicin sulfate equivalent
to Gentamicin 40mg
Water for injection q.s
Sodium hydroxide/Sulphuric acid may have added for pH adjustment.

c) Gentamicin Injection USP 800mg/20ml
Each ml contains:
Gentamicin sulfate equivalent
to Gentamicin 40mg
Water for injection q.s
Sodium hydroxide/Sulphuric acid may have added for pH adjustment.

Excipients with known effect:

Sodium chloride: 12.84 mg/2 ml ampoule or vial.

For the full list of excipients, see section 6.1.

Pharmaceutical form

Solution for Injection.

Clear, colourless solution.

Clinical particulars

4.1 Therapeutic indications

Gentamicin is an aminoglycoside antibiotic with broad-spectrum bactericidal activity. It is indicated to treat severe infections caused by bacteria susceptible to Gentamicin such as, but not limited to:

Urinary tract infections
Respiratory tract infections
Intra-abdominal infections
CNS infections
Severe neonatal infections

It is usually active against most strains of the following organisms: Escherichia coli, Klebsiella spp., Proteus spp. (indole positive and indole negative), Pseudomonas aeruginosa, Staphylococci, Enterobacter spp., Citrobacter spp. and Providencia spp.

Consideration should be given to official local guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration

Posology

Adults

The recommended dose in adults with normal renal function is 3 – 5 mg/kg/day, depending on the severity of infection, administered as one single dose (preferred) or in two divided doses. The dose should be adjusted according to clinical response and serum concentration levels (see below). Dose calculations should be based on ideal body weight. A dosing frequency of more than twice daily may be adopted for some specific pathogens or some sites of infection as recommended in national and local guidance.

Once daily dosing is not recommended in cases of endocarditis, depending on the responsible pathogens. National and local guidance on treatment with Gentamicin and serum level monitoring in endocarditis should be followed.

In patients with normal renal function, 160 mg once daily may be used for the treatment of urinary tract infections.

Paediatric population

The daily dose recommended in children aged 1 year and above and adolescents with normal renal function, is 3 – 6 mg/kg/day as one single dose (preferred) or two divided doses.

The daily dose in infants after the first month of life is 4.5 – 7.5 mg/kg/day as one single dose (preferred) or two divided doses.

The daily dose in neonates and pre-term infants (aged 0 – 4 weeks old) is 4 – 7 mg/kg/day. Due to the longer half-life, newborns are given the required daily dose in one single dose.

Elderly

There is some evidence that elderly patients may be more susceptible to aminoglycoside toxicity whether secondary to previous auditory/vestibular impairment or borderline renal dysfunction. Accordingly, therapy should be closely monitored by frequent determination of Gentamicin serum levels, assessment of renal function and signs of ototoxicity.

Renal impairment

In impaired renal function, the recommended daily dose has to be decreased and adjusted to the renal function. This can be achieved by reducing the dose and/or increasing the dose interval.

In all patients with renal impairment, serum Gentamicin peak and trough concentration and renal function must be monitored frequently (see below).

Nomograms are available for the calculation of dose, which depends on the patient’s age, weight and renal function. Local guidance should be followed where available.

No clear recommendation can be made for once daily dosing; dosing should be guided by plasma concentration levels. In patients with moderate renal impairment, in whom once daily dosing would be considered appropriate if their renal function were normal, the dose interval should be at least 24 hours and extended according to the degree of renal impairment and the results of serum Gentamicin monitoring. Limited data are available in patients with severe renal impairment (creatinine clearance < 30 ml/min) after once daily dose administration.

The following table may be useful for adults on multiple daily dose regimens:

Blood Urea		Creatinine clearance (GFR) (ml/min)	Dose & frequency of administration
(mg/100 ml)	(mmol/L)	Creatinine clearance (GFR) (ml/min)	Dose & frequency of administration
< 40	6 – 7	> 70	80 mg* 8 hourly
40 – 100	6 – 17	30 – 70	80 mg* 12 hourly
100 – 200	17 – 34	10 – 30	80 mg* daily
> 200	> 34	5 – 10	80 mg* every 48 hours
Twice weekly intermittent haemodialysis		< 5	80 mg* after dialysis

*60 mg if body weight < 60 kg.

Monitoring advice

Regular serum concentration monitoring of Gentamicin is recommended for all patients, and especially in the elderly, newborns, obesity and in patients with impaired renal function, as well as patients with cystic fibrosis. Gentamicin should not be prescribed if serum concentrations cannot be monitored.

There are no universally accepted guidelines for therapeutic drug monitoring of Gentamicin. Local monitoring and dose adjustment guidelines should be followed where available.

Pre-dose (“trough level”) monitoring is recommended to ensure that the interval between doses is correct. Trough levels are measured at the end of a dosing interval and should not exceed 1 mg/L for once daily dosing or 2 mg/L for multiple daily dosing. Levels in excess of these indicate the need to extend the interval between doses, not reduction of the dose.

Post-dose (“peak level”) monitoring is recommended to check the adequacy of a dose or to ensure that it is not excessive and likely to cause toxicity. Peak levels should be measured one hour after an intravenous bolus or intramuscular bolus dose, or 30 minutes after the end of an infusion. A plasma concentration < 4 mg/L indicates that the dose is likely to be inadequate and a dose increase should be considered; plasma concentrations > 10 mg/L indicate an increased risk for toxicity, particularly ototoxicity, and a dose reduction should be considered.

Any change in dose should be re-assessed with pre- and post-dose levels to confirm the adequacy of the new dose and the appropriateness of the dose interval.

Method of administration

The recommended dose and precautions for intramuscular and intravenous administration are identical. Gentamicin when given intravenously should be injected directly into a vein or into the drip set tubing over no less than three minutes. If administered by infusion, this should be over 20 – 30 minutes and in no greater volume of fluid than 100 ml. Longer infusion times of up to 60 minutes may be used, in particular for a once daily dosing regimen. Once daily dosing should only be administered through the intravenous route.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Myasthenia gravis.

4.4 Special warnings and precautions for use

Ototoxicity and nephrotoxicity

Ototoxicity has been reported following the use of aminoglycosides, including Gentamicin. Symptoms include loss of balance and hearing loss, which may be irreversible (see section 4.8). Important risk factors include renal impairment, high doses, prolonged duration of treatment and age (neonates/infants and possibly the elderly). Due to the potential for ototoxicity and nephrotoxicity, monitoring of vestibule, cochlea and renal function is recommended before, during and shortly after treatment (see section 4.8). Serum levels are determined so as to avoid peak concentrations above 10 mg/L and troughs above 1 mg/L when administering Gentamicin once daily and 2 mg/L when administering Gentamicin twice daily.

As there is some evidence that risk of both ototoxicity and nephrotoxicity is related to the level of total exposure, duration of therapy should be the shortest possible compatible with clinical recovery. In some patients with impaired renal function there has been a transient rise in blood-urea-nitrogen which has usually reverted to normal during or following cessation of therapy. It is important to adjust the frequency of dosage according to the degree of renal function.

To avoid adverse events, continuous monitoring (before, during and after treatment) of hepatic and laboratory parameters is also recommended.

Gentamicin should only be used in pregnancy if considered essential by the physician (see section 4.6).

Gentamicin should be used with care in conditions characterised by muscular weakness.

In cases of significant obesity Gentamicin serum concentrations should be closely monitored and a reduction in dose should be considered.

4.5 Interaction with other medicinal products and other forms of interaction

Concurrent administration of Gentamicin and other potentially ototoxic or nephrotoxic drugs should be avoided. Potent diuretics such as etacrynic acid and furosemide are believed to enhance the risk of ototoxicity whilst amphotericin B, cisplatin and ciclosporin are potential enhancers of nephrotoxicity.

Any potential nephrotoxicity of cephalosporins, and in particular cephaloridine, may also be increased in the presence of Gentamicin. Consequently, if this combination is used monitoring of kidney function is advised.

Neuromuscular blockade and respiratory paralysis have been reported from administration of aminoglycosides to patients who have received curare-type muscle relaxants during anaesthesia.

Indometacin possibly increases plasma concentrations of Gentamicin in neonates.

Concurrent use with oral anticoagulants may increase the hypothrombinanaemic effect.

Concurrent use of bisphosphonates may increase the risk of hypocalcaemia.

Concurrent use of the Botulinum Toxin and Gentamicin may increase the risk of toxicity due to enhanced neuromuscular block.

Antagonism of effect may occur with concomitant administration of Gentamicin with either neostigmine or pyridostigmine.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no proven cases of intrauterine damage caused by Gentamicin. However, in common with most drugs known to cross the placenta, usage in pregnancy should only be considered in life threatening situations where expected benefits outweigh possible risks.

Breast-feeding

In the absence of gastro-intestinal inflammation, the amount of Gentamicin ingested from the milk is unlikely to result in significant blood levels in breast-fed infants.

4.7 Effects on ability to drive and use machines

Not known.

4.8 Undesirable effects

The following CIOMS frequency rating is used, when applicable: Very common (≥ 1/10); common (≥ 1/100 to ≤ 1/10); uncommon (≥ 1/1,000 to ≤ 1/100); rare (≥ 1/10,000 to ≤ 1/1,000); very rare (≤ 1/10,000); not known (cannot be estimated from the available data).

Infections and infestations:

Not known: antibiotic-associated colitis

Blood and lymphatic system disorders:

Not known: anaemia, blood dyscrasias

Immune system disorders:

Not known: hypersensitivity, anaphylaxis/anaphylactic reaction (including anaphylactic shock)

Metabolism and nutrition disorders:

Not known: hypomagnesaemia on prolonged therapy

Psychiatric disorders:

Not known: depression, hallucinations, confusion

Nervous system disorders:

Not known: central neuropathy (including convulsions, lethargy, encephalopathy), peripheral neuropathy

Ear and labyrinth disorders:

Not known: vestibular damage, transitory hearing loss, irreversible hearing loss, deafness, particularly after exposure to ototoxic drugs or in the presence of renal dysfunction (see section 4.4).

Gastrointestinal disorders:

Very common: vomiting

Not known: stomatitis, nausea

Hepatobiliary disorders:

Not known: abnormal liver function, transaminases increased

Skin and subcutaneous tissue disorders:

Not known: rash, purpura, urticaria, pruritus

Renal and urinary disorders:

Very rare: acute renal failure, Fanconi-like syndrome in patients treated with a prolonged course of high-dose

Not known: nephrotoxicity (usually reversible) has been reported.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

4.9 Overdose

Haemodialysis and peritoneal dialysis will aid the removal from blood but the former is probably more efficient. Calcium salts given intravenously have been used to counter the neuromuscular blockade caused by Gentamicin.

Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use.

Gentamicin is a mixture of antibiotic substances produced by the growth of micromonospora purpurea. It is bactericidal with greater antibacterial activity than streptomycin, neomycin or kanamycin.

Gentamicin exerts a number of effects on cells of susceptible bacteria. It affects the integrity of the plasma membrane and the metabolism of RNA, but its most important effects is inhibition of protein synthesis at the level of the 30s ribosomal subunit.

5.2 Pharmacokinetic properties

Gentamicin is not readily absorbed from the gastro-intestinal tract. Gentamicin is 70 – 85% bound to plasma albumin following administration and is excreted 90% unchanged in urine. The half-life for its elimination in normal patients is 2 – 3 hours.

Effective plasma concentration is 4 – 8 µg/ml.
The volume of distribution (vd) is 0.3 l/kg.
The elimination rate constant is:

0.02 hr^-1for anuric patients*
0.30 hr^-1normal

* Therefore in those with anuria care must be exercised following the usual initial dose, any subsequent administration being reduced in-line with plasma concentrations of Gentamicin.

Paediatric population (premature infants and neonates)

Distribution

The distribution volume of Gentamicin is about equivalent to the volume of extracellular water. In the newborn water makes up 70 – 75% of bodyweight, compared with 50 – 55% in adults. The extracellular water compartment is larger (40% of body weight compared with 25% of body weight in adults). Therefore, the volume of distribution of Gentamicin per kg bodyweight is affected and decreases with increasing age from 0.5 – 0.7 l/kg for a premature newborn to 0.25 l/kg for an adolescent. The larger volume of distribution per kg bodyweight means that for adequate peak blood concentration a higher dose per kg bodyweight needs to be administered.

Elimination

Gentamicin is not metabolized in the body but is excreted unchanged in microbiologically active form predominantly via the kidneys. In patients with normal renal function the elimination half-life is about 2 – 3 hours. In neonates elimination rate is reduced due to immature renal function.

Elimination half-life averages approximately 8 hours in neonates at a gestational age of 26 – 34 weeks compared with about 6.7 hours in neonates at a gestational age of 35 – 37 weeks.

Correspondingly, clearance values increase from about 0.05 l/h in neonates at a gestational age of 27 – 0.2 l/h in neonates at a gestational age of 40 weeks.

5.3 Preclinical safety data

Not applicable.

Pharmaceutical particulars

6.1 List of excipients

Sodium chloride

Water for Injections

2N Sodium Hydroxide (for pH adjustment)

2N Sulphuric Acid (for pH adjustment)

6.2 Incompatibilities

In general, Gentamicin injection should not be mixed.

In particular the following are incompatible in mixed solution with Gentamicin injection:

– penicillins

– cephalosporins

– erythromycin

– heparins

– sodium bicarbonate

*Dilution in the body will obviate the danger of physical and chemical incompatibility and enable Gentamicin to be given concurrently with the drugs listed above either as a bolus injection into the drip tubing, with adequate flushing, or at separate sites. In the case of carbenicillin, administration should only be at a separate site.

*Carbon dioxide may be liberated on addition of the two solutions. Normally this will dissolve in the solution but under some circumstances small bubbles may form.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25°C. Do not refrigerate or freeze.

6.5 Nature and contents of container

Gentamicin is supplied in in packs of 5 x 2 ml colourless glass ampoules (Type I) with an OPC (one point cut) break system and red and green rings or in packs of 5 x 2 ml colourless glass vials (Type I) closed with a chlorobutyl rubber stopper sealed with an aluminium capsule type flip-off.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7.Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Gentamicin Injection USP 20mg/2ml Taj Pharma
Gentamicin Injection USP 80mg/2ml Taj Pharma
Gentamicin Injection USP 800mg/20ml Taj Pharma

PACKAGE LEAFLET : INFORMATION FOR THE PATIENT

Gentamicin Sulphate

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 further questions, ask your doctor or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Gentamicin is and what it is used for
2. What you need to know before you have Gentamicin
3. How to have Gentamicin
4. Possible side effects
5. How to store Gentamicin
6. Contents of the pack and other information

What Gentamicin is and what it is used for

The name of this medicine is Gentamicin 80mg/2ml Solution for Injection (called Gentamicin throughout this leaflet). It contains a medicine called gentamicin. This belongs to a group of antibiotics called ‘aminoglycosides’.

Gentamicin is used to treat infections caused by bacteria. This includes infections in:

Your urinary tract (including your kidneys or bladder)
Your chest (including your lungs)
Your abdomen (including your gut)
Your brain and spinal cord
Your blood – this is sometimes called ‘bacteraemia’ or ‘septicaemia’
Newborn babies

What you need to know before you have Gentamicin

Do not have Gentamicin if:

You are allergic (hypersensitive) to gentamicin, any other antibiotics or to any of the other ingredients of this medicine (see section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat and tongue.
You have myasthenia gravis. This is a disease that causes muscle weakness.

Do not have this medicine if any of the above applies to you. If you are not sure, talk to your doctor or nurse before having Gentamicin .

Warnings and precautions

Talk to your doctor or nurse before having Gentamicin if:

You are pregnant, think you may be pregnant or are planning to have a baby.
You are breast-feeding or are planning to breast-feed.
You have any muscle weakness problems.
You are extremely overweight (obese).
You have kidney problems.
You have cystic fibrosis.
You are elderly (over 65 years of age) or the patient is less than 1 year old.

Your doctor will need to monitor you before, during and shortly after your treatment. Your doctor may check your hearing, balance, how your kidneys are working and the amount of gentamicin in your blood. This is to prevent damage to your ears and/or kidneys and is particularly important if you have kidney problems, are obese, suffer from cystic fibrosis or are over 65 years of age, or the patient is less than 1 year old.

If you are not sure if any of the above applies to you, talk to your doctor or nurse before having Gentamicin .

Other medicines and Gentamicin

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.

This includes medicines you buy without a prescription, including herbal medicines. This is because Gentamicin can affect the way some other medicines work. Also, some medicines can affect the way Gentamicin works.

In particular tell your doctor if you are taking any of the following:

Medicines used to thin the blood such as warfarin.
Water tablets or injections (diuretics) such as furosemide or etacrynic acid.
Amphotericin B (used to treat fungal infections).
Cephalosporin antibiotics such as cephaloridine.
Ciclosporin (used in organ transplants or for severe skin problems).
Neostigmine or pyridostigmine (used to treat myasthenia gravis).
Muscle relaxants – sometimes used during operations which need an anaesthetic.
Indometacin (used to treat pain or swelling).
Bisphosphonates (used to treat osteoporosis).
Cisplatin (used to treat some cancers).
Botulinum toxin – used to lower the activity of overactive muscles. This is also sometimes used in cosmetic procedures.

These medicines may increase the chances of getting certain side effects. If you are unsure about any of the above, consult your doctor or nurse.

Pregnancy and breast-feeding

Ask your doctor or nurse for advice before having this medicine if:

You are pregnant, think you may be pregnant or are planning to have a baby. Gentamicin should not normally be used during pregnancy.
You are breast-feeding or are planning to breast-feed.

Gentamicin contains very little sodium

It contains less than 1mmol sodium (23mg) per ampoule or vial.

How to have Gentamicin

Gentamicin is always given to you by a doctor or nurse. This is because it needs to be given as an injection.

Having this medicine

Your doctor will decide how much to give you, depending on your weight. The correct dose also depends on the type of infection and any other illnesses you may have, in particular diseases of the kidney.

Tests

Blood samples will be taken by your doctor or nurse to check the dose is right for you. You should not receive Gentamicin if these blood tests cannot be performed. You may also need tests to check your hearing and balance.

Elderly or obese people, newborns, people with impaired kidney function and those with cystic fibrosis should be particularly closely monitored when having this medicine.

How much Gentamicin is given

Adults

The usual daily dose in adults is 3-5mg for each kg of body weight.
This is is given either as one single dose (preferred) or split into two or three daily doses.
This dose may be increased or decreased by your doctor depending on your illness and the results of your blood tests.
If you have kidney problems your doctor may give you a lower dose or may prolong the interval between doses.

Use in children and adolescents

Children (aged 1 year and above)

The usual daily dose is 3-6mg for each kg of body weight.
This is given either as one single dose (preferred) or split into two separate doses.

Babies (aged 4 weeks to 1 year)

The usual daily dose is 4.5-7.5mg for each kg of body weight.
This is given either as one single dose (preferred) or split into two separate doses.

Premature babies or new born babies (up to 4 weeks)

The usual daily dose is 4-7mg for each kg of body weight.
This is given in one single dose.

If you have more Gentamicin than prescribed

It is most unlikely that you will be given too much medicine by the doctor or nurse. Your doctor or nurse will be checking your progress and checking the medicine that you are given. Ask if you are not sure why you are getting a dose of medicine.

If you miss a dose of Gentamicin

Your doctor or nurse have instructions about when to give you your medicine. It is most unlikely that you will not be given the medicine as it has been prescribed. If you think that you may have missed a dose then talk to your nurse or doctor.

If you stop having Gentamicin

It is important that the course of treatment your doctor has prescribed is finished. You may start to feel better but it is important to continue your treatment until the doctor advises. If you stop, your infection may get worse again.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

Not known (frequency cannot be estimated from available data)

Allergic reactions (including serious allergic reactions such as anaphylaxis), which may include:

An itchy, lumpy rash (hives) or nettle rash (urticaria)
Swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing
Fainting, dizziness, feeling lightheaded (low blood pressure)

Tell your doctor or nurse as soon as possible if any of the following side effects happen:

Very rare side effects (may affect less than 1 in 10,000 people)

Acute kidney failure, which may cause you to pass less urine than is normal for you, fluid retention, breathlessness or fatigue/tiredness

Not known (frequency cannot be estimated from available data)

Temporary or irreversible hearing loss or deafness
Unusual difficulty in moving which has not happened before
Numbness, weakness and pain in the arms and legs (peripheral neuropathy)
Blood in the urine
Diarrhoea, with or without blood and/or stomach cramps

Tell your doctor or nurse if any of the following side effects gets serious or last longer than a few days. Also tell them if you notice any side effects not listed in this leaflet

Very common side effects (may affect more than 1 in 10 people)

Feeling sick (vomiting)

Not known (frequency cannot be estimated from available data)

Feeling sick (nausea)
Mouth ulcers
Rash, itching or a purplish or reddish-brown skin colouring
Depression
Seeing or hearing things that are not real (hallucinations)
Feeling confused, tired or weak
Fits

Other possible side effects:

Very rare side effects (may affect less than 1 in 10,000 people)

High levels of phosphate and amino acids (so-called Fanconi-like syndrome, associated with high doses given over a long time)

Not known (frequency cannot be estimated from available data)

Changes in the number of blood cells (including anaemia) – shown up in the results of blood tests
Changes in the amount of liver enzymes – shown up in the results of blood tests
A decrease in the level of magnesium in the blood, associated with prolonged therapy

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Gentamicin

This medicine will be kept by your doctor or nurse in a safe place out of the sight and reach of children.
You will not be asked to store your medicine. It will be brought to you ready to be given straight away.
Do not store this medicine above 25^° It should not be kept in a fridge or freezer.
Do not have this medicine after the expiry date. This is stated in month and year on the carton and on the label after “EXP”. The expiry date refers to the last day of that month. If you are not sure when this is, check with your doctor or nurse.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Gentamicin contains

The active substance is gentamicin sulphate equivalent to 80mg of gentamicin.
The other ingredients are sulphuric acid and sodium hydroxide (for pH adjustment), sodium chloride and water for injections.

What Gentamicin looks like and contents of the pack

The medicine is a clear, colourless solution for injection in 2ml ampoules or vials. Gentamicin is available in packs of 5 glass ampoules with an OPC (one point cut) break system and red and green rings or in packs of 5 glass vials closed with a chlorobutyl rubber stopper sealed with an aluminium capsule type flip-off.

Not all pack sizes may be marketed.