Gentamicin 40mg/ml Solution for Injection / Infusion

Patient Leaflet Updated 22-Nov-2021 | Noridem Enterprises Ltd / Kent Pharma UK Ltd

Gentamicin 40mg/ml Solution for Injection / Infusion

Package leaflet: Information for the user

Gentamicin 20 mg / mL Solution for injection / infusion

Gentamicin 40 mg / mL Solution for injection / infusion

Gentamicin 80 mg / mL Solution for injection / infusion

Gentamicin

Read all of this leaflet carefully before you are given 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, pharmacist or nurse.
  • If you get any side effects, talk to your doctor, pharmacist 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 are given Gentamicin
3. How Gentamicin is given
4. Possible side effects
5. How to store Gentamicin
6. Contents of the pack and other information

1. What Gentamicin is and what it is used for

Gentamicin contains the active substance gentamicin. It belongs to a group of antibiotics called aminoglycosides.

This medicine is used to treat severe infections caused by bacteria. This includes:

  • infections of the urinary tract (including kidneys or bladder)
  • infections in the chest (including lungs), such as hospital-acquired and ventilator-associated pneumonia (HAP and VAP)
  • bacterial inflammation of the heart lining (endocarditis)
  • infections of the abdomen
  • infections of the brain and spinal cord (meningitis caused by bacterial)
  • infections of the bones and joints (osteomyelitis and bacterial arthritis)
  • management of neutropenic patients with fever that is suspected to be due to a bacterial infection
  • infections of the whole body due to the presence of Listeria monocytogenes in the blood
  • severe infection in newborn babies
  • infections of the blood (bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above)

Note:

Combination treatment is mainly indicated together with a beta lactam antibiotic (such as penicillin) or with an antibiotic effective against anaerobic bacteria (bacteria that do not live or grow when oxygen is present) in the following cases: life threatening infections with an unknown bacteria, mixed anaerobic/aerobic infections, bacterial inflammation of the heart’s inner lining (endocarditis), generalised Pseudomonas infections, patients with a reduced immune system who lack of certain white blood cells (neutropenia).

2. What you need to know before you are given Gentamicin

You must not be given Gentamicin

  • if you are allergic to gentamicin or any of the other ingredients of this medicine (listed in section 6).
  • subcutaneously (beneath the skin), as it is not effective via this route and necrosis (death of body tissue) may occur at the injection site.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Gentamicin:

  • if you have problems with your kidneys
  • if you have liver problems
  • if you have diabetes
  • if you suffer from deafness or have an ear hearing or balance disorder, a history of ear infections or if you have been treated with medicines that affect hearing in the past

In these cases, you will be given gentamicin only if your doctor regards this treatment as absolutely essential to treat your illness. Your doctor will take special care to adjust your gentamicin dose exactly.

Your doctor will be particularly vigilant if you have a disease affecting your nerve and muscle functions, such as Parkinson’s disease or myasthenia gravis, or if you are given a muscle relaxant during surgery, because gentamicin may have a blocking effect on your nerve and muscle functions.

Children and adolescents

According to the data available, renal and auditory toxicities remain rare in newborn infants and children.

Monitoring during treatment

To reduce the risk of damage to your kidneys and the nerves in your ears, your doctor will closely follow the recommendations:

  • Monitoring of hearing, balance and kidney function before, during and after treatment.
  • Selection of a dosage adjusted to your kidney capacity.
  • Monitoring of blood gentamicin levels during treatment, if necessary in your case.
  • At the same time as gentamicin, avoid administration of other substances that may cause damage to the nerves in the ear or kidneys. If this cannot be avoided, close monitoring of your kidney function is necessary.
  • You must tell your doctor immediately if you have severe diarrhoea.
  • Additionally, you must ensure adequate hydration and urine production.

Other medicines and Gentamicin

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

Medicines that may damage the kidneys and hearing

Tell your doctor if you are receiving or about to receive treatment with medicines that may potentially damage the kidneys or hearing, as there is an increased risk of side effects. These medicines include:

  • Amphotericin B (used to treat fungal infections)
  • Polymyxin B (antibiotic)
  • Ciclosporin (used in organ transplants or for severe skin problems)
  • Cisplatin and other organoplatinum compounds (used to treat cancer)
  • Other antibiotics of aminoglycoside group, such as tobramycin, streptomycin
  • Water tablets or injections (diuretics), such as furosemide
  • Tacrolimus (used after organ transplants)
  • Cephalothin (antibiotic of cephalosporins group)
  • Methoxyflurane (an anaesthetic gas)
  • Indomethacin (one of a group of medicines called nonsteroidal anti-inflammatory agents, used to treat pain and inflammations)
  • Anticoagulants (used to thin the blood), such as warfarin and phenindione
  • Biphosphonates (used to treat osteoporosis)
  • Iodinated contrast media (agent used to facilitate radiographic imaging), antiviral agents (such as the ciclovir group, foscarnet), methotrexate, pentamidine
  • Antibiotics of the glycopeptide group, such as vancomycin and teicoplanin
  • Neostigmine or pyridostigmine (used to treat muscle weakness)
  • Digoxin (used to treat various heart conditions)

Medicines whose effect may be increased by gentamicin

Also tell your doctor if you are taking the following medicines, as their effect may be increased when used together with gentamicin:

  • Botulinum toxin (used to lower the activity of overactive muscles)
  • Curare medicines (muscle relaxants)

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.

Pregnancy

Gentamicin should only be used during pregnancy for life-threatening indications and when no safer treatment alternatives are available due to the potential danger for the unborn baby. This medicine is not recommended for use in pregnancy unless considered appropriate by your doctor.

Breast-feeding

Do not breast-feed during your treatment with gentamicin.

Small amounts of gentamicin are excreted in human milk and low concentrations have been found in the serum of breastfed infants. A decision must be made whether to stop breastfeeding or whether to discontinue or not to give gentamicin.

The breast-fed infant may suffer from diarrhoea and thrush in the mouth (fungal infection) whilst the mother is being treated with this medicine.

Fertility

It is advised for men to not have children while receiving treatment with this medicine and to use effective contraception during and up to 3 months after this treatment is finished. Talk to your doctor before starting treatment for advice on sperm storage.

Gentamicin contains sodium and sodium metabisulfite

This medicine contains less than 1 mmol sodium (23 mg) per ampoule, that is to say essentially ‘sodium-free’.

This medicine contains sodium metabisulfite, which may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How Gentamicin is given

Gentamicin is always given to you by a doctor or nurse.

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. Blood samples will be taken by your doctor or nurse to check the dose is right for you.

The amount of gentamicin in your blood will be measured regularly to check that the correct blood levels have been achieved. Treatment with gentamicin may cause damage to hearing and also to kidney function. Your doctor will decide, depending on your condition, how long you should receive gentamicin. In some cases, your doctor may carry out blood tests to check your kidney function before and during treatment with gentamicin. Occasionally you may also be asked to take a hearing test to check the medicine is not affecting your hearing.

Dosage

The recommended daily dose for children, adolescents and adults with normal kidney function is 3 to 6 mg / kg body weight per day and should preferably be given as a single dose, or else divided into 2 separate doses.

Use in infants

The daily dose recommended in children aged 1 year and above with normal renal function, is 3 – 6 mg / kg / day as one single dose (preferred) or two divided doses.The recommended daily dose for infants after the first month of life is 4.5 – 7.5 mg / kg body weight per day and should be preferably given as a single dose, or else divided into 2 separate doses. The recommended daily dose for newborn infants is 4 – 7 mg / kg body weight per day. Due to the longer half-life, newborn infants are given the required dose as a single dose.

Use in patients with kidney problems

If you have kidney problems your daily recommended dose should be reduced and adjusted to kidney function.

Method of administration

This medicine is injected into a muscle (intramuscularly) or into a vein (intravenously) after dilution.

Duration of use

The duration of use is decided by your doctor.

For common bacterial infectious diseases, the duration of treatment depends on the progression of the disease.

Normally, a treatment period of 7 to 14 days is sufficient.

The duration of therapy should preferably not exceed 10 to 14 days.

A course of treatment with Gentamicin immediately after a previous course of aminoglycoside treatment should be avoided. You should wait 7 to 14 days before starting treatment with gentamicin.

Please talk to your doctor or nurse if you have the impression that the effect of Gentamicin is too strong or too weak.

If you are given more Gentamicin than you should

It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will monitor your progress and check the medicine you are given. Always ask your doctor or nurse 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 doctor or nurse.

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.

If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

4. 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 signs of an allergic reaction, including anaphylactic shock (life-threatening allergic reaction), such as:

  • itching or skin rashes
  • swelling of the face, lips or throat
  • difficulty in breathing or wheeziness

Other possible side effects:

Common: may affect up to 1 in 10 people

  • problems with kidney function

Uncommon: may affect up to 1 in 100 people

  • problems with blood clotting
  • more or less intense skin redness without papules or blisters

Rare: may affect up to 1 in 1,000 people

  • low blood levels of potassium, calcium and magnesium
  • increased levels of aldosterone in the blood
  • loss of appetite
  • weight loss
  • damage of peripheral nerves
  • loss of feeling
  • feeling or being sick
  • increased liver enzymes and urea in the blood (all reversible)
  • increased production of saliva
  • inflammation of the mouth lining
  • skin reddening
  • muscle pain
  • increased body temperature
  • increased serum bilirubin level in the blood

Very rare: may affect up to 1 in 10,000 people

  • superinfection (with gentamicin-resistant germs)
  • very severe inflammation of the colon
  • blood disorders affecting certain blood components and generally detected by blood tests
  • decrease in the amount of phosphates in the blood
  • confusion, hallucinations, depression
  • a collection of brain problems
  • seizures (fits)
  • neuromuscular block
  • dizziness, vertigo, balance disorders, headache
  • visual disturbances
  • loss of hearing
  • inner ear problems, tinnitus
  • low blood pressure
  • high blood pressure
  • serious allergic reaction of the skin and mucous membranes with blistering and redness of the skin (erythema multiforme) which can, in very severe cases, affect the internal organs and become life-threatening (stevens-johnson syndrome, toxic epidermal necrolysis), skin detachment (toxic epidermal necrolysis, or lyell’s syndrome)
  • hair loss
  • muscle wasting (decrease in the mass of the muscle)
  • acute kidney failure, raised phosphate levels in the urine and amino acids (known as fanconi syndrome, associated with high doses administered over a long period of time)
  • pain at the injection site

Not known: frequency cannot be estimated from the available data

  • irreversible loss of hearing, deafness
  • lethargy (lack of energy and enthusiasm)
  • urticarial (a rash of round, red welts on the skin that itches)
  • symptoms of bruising, discolouration of skin, small red spots. These could be a sign of purpura

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

For UK:

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store.

For IE:

HPRA Pharmacovigilance
Website: www.hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Gentamicin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the outer package and ampoules after EXP. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions. Do not refrigerate or freeze.

Your doctor or nurse will ensure that your medicine is properly stored.

Gentamicin should be used immediately after opening the ampoule.

Gentamicin is chemically and physically stable for 24 hours at 25°C after dilution in Sodium chloride 0.9 % (9 mg / mL) solution for injection or Glucose 5 % (50 mg / mL) solution for injection. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

After opening, unused portions must not be stored and should be discarded immediately.

This medicine should be visually inspected prior to use.

Only clear solutions, practically free from particles, should be used.

Do not throw away any medicines via wastewater or household waste. Ask your nurse or 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 Gentamicin contains

  • The active substance is gentamicin.

Gentamicin 20 mg / mL:

Each mL solution contains 20 mg gentamicin (as gentamicin sulfate).

Each ampoule of 2 mL solution contains 40 mg gentamicin.

Gentamicin 40 mg / mL:

Each mL solution contains 40 mg gentamicin (as gentamicin sulfate).

Each ampoule of 2 mL solution contains 80 mg gentamicin.

Gentamicin 80 mg / mL:

Each mL solution contains 80 mg gentamicin (as gentamicin sulfate).

Each ampoule of 2 mL solution contains 160 mg gentamicin.

  • The other ingredients are disodium edetate, sodium metabisulfite (E 223), sodium hydroxide 1 N (for pH-adjustment), sulfuric acid 0.5 M (for pH-adjustment), water for injections.

What Gentamicin looks like and contents of the pack

Gentamicin Solution for injection / infusion is a clear and colourless solution for injection / infusion.

Each glass ampoule contains 2 mL solution. Pack sizes of 5, 10, 20, 25, 50 or 100 ampoules and pack sizes of 10 (2 x 5), 20 (4 x 5), 25 (5 x 5) or 50 (5 x 10) ampoules are available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorization Holder:

Noridem Enterprises Limited
Evagorou & Makariou
Mitsi Building 3
Office 115
1065 Nicosia
Cyprus

Manufacturer:

DEMO S.A. PHARMACEUTICAL INDUSTRY
21st Km National Road Athens–Lamia
14568 Krioneri
Attiki
Greece
T: +30 210 8161802
F: +30 2108161587

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany:

Gentamicin Noridem 20 mg / ml Injektions- /Infusionslösung

Gentamicin Noridem 40 mg / ml Injektions- /Infusionslösung

Gentamicin Noridem 80 mg / ml Injektions- /Infusionslösung

Cyprus:

OCTORET 20 mg / mL Διάλυμα για ένεση/έγχυση

OCTORET 40 mg / mL Διάλυμα για ένεση/έγχυση

OCTORET 80 mg / mL Διάλυμα για ένεση/έγχυση

Greece:

OCTORET 20 mg / mL Διάλυμα για ένεση/έγχυση

OCTORET 40 mg / mL Διάλυμα για ένεση/έγχυση

OCTORET 80 mg / mL Διάλυμα για ένεση/έγχυση

Ireland:

Gentamicin 20 mg / mL Solution for injection / infusion

Gentamicin 40 mg / mL Solution for injection / infusion

Gentamicin 80 mg / mL Solution for injection / infusion

Netherlands:

Gentamicine Noridem 20 mg / mL oplossing voor injectie / infusie

Gentamicine Noridem 40 mg / mL oplossing voor injectie / infusie

Gentamicine Noridem 80 mg / mL oplossing voor injectie / infusie

Poland:

Gentamicin Noridem

Gentamicin Noridem

Gentamicin Noridem

United Kingdom:

Gentamicin 20 mg / mL Solution for injection / infusion

Gentamicin 40 mg / mL Solution for injection / infusion

Gentamicin 80 mg / mL Solution for injection / infusion

Hungary:

Gentamicin Noridem 20 mg / ml oldatos injekció / infúzió

Gentamicin Noridem 40 mg / ml oldatos injekció / infúzió

Gentamicin Noridem 80 mg / ml oldatos injekció / infúzió

This leaflet was last revised in 10/2020.

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Company Contact Details
Noridem Enterprises Ltd / Kent Pharma UK Ltd
Address

The Bower, 4 Roundwood Avenue, Stockley Park, Heathrow, UB11 1AF, UK

Telephone

0845 437 5565

Medical Information Direct Line

+44 (0)1233 506 574

Customer Care direct line

0800 220 280

WWW

http://www.kentpharm.co.uk

Fax

0845 437 5567

Medical Information e-mail