Genta Gobens 80 mg/ml solution for injection and for infusion
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
Package Leaflet: Information for the Patient
Genta Gobens 80 mg/ml solution for injection and infusion
gentamicin (sulfate)
Read the entire leaflet carefully before you start using this medicine because it contains important information for you.
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Keep this leaflet as you may need to read it again.
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If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
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If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. See section 4.
Leaflet Contents:
- What Genta Gobens is and what it is used for
- What you need to know before using Genta Gobens
- How to use Genta Gobens
- Possible adverse effects
- Storage of Genta Gobens
- Contents of the pack and other information
1. What Genta Gobens is and what it is used for
Genta Gobens belongs to a group of medicines called antibiotics, which are used to treat serious bacterial infections that can be eliminated by the active substance gentamicin.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.
It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.
Do not store or reuse this medicine. If you have any antibiotic left after completing your treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.
Genta Gobens should only be used in combination with other antibiotics for the treatment of the conditions listed below, except for complicated infections of the kidney, urinary tract, and bladder.
Genta Gobens may be prescribed for the treatment of the following conditions:
- Complicated and recurrent infections of the kidney, urinary tract, and bladder.
- Lung and respiratory tract infections occurring during hospital treatment.
- Abdominal infections, such as peritonitis.
- Skin and soft tissue infections, such as severe burns.
- Sepsis (systemic infection), bacteria in the blood.
- Inflammation of the inner lining of the heart (to treat infections).
- Post-surgical infections.
2. What you need to know before using Genta Gobens
Do not use Genta Gobens
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If you are allergic to gentamicin or to any of the other ingredients of this medicine (listed in section 6).
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If you have myasthenia gravis.
Warnings and precautions
Talk to your doctor or pharmacist before using Genta Gobens if:
- You are pregnant or breastfeeding.
- You have impaired kidney function or inner ear deafness.
- If you have, or have a maternal family history of mitochondrial mutation disease (a genetic disorder), or hearing loss due to antibiotic medications, you are advised to inform your doctor or pharmacist before taking an aminoglycoside; certain mitochondrial mutations may increase the risk of hearing loss with this medicine. Your doctor may recommend a genetic test before administering Genta Gobens.
In such cases, you will receive gentamicin only if your doctor considers it essential for treating your condition. Your doctor will be especially careful in correctly adjusting your gentamicin dose.
Your doctor will be particularly cautious if you have any condition affecting nerve and muscle function, such as Parkinson's disease, or if you are receiving a muscle relaxant during surgery, because gentamicin may produce a blocking effect on neuromuscular function.
You should inform your doctor immediately if you experience severe diarrhoea.
Your infection may not respond to gentamicin if it did not respond to other aminoglycosides, and you may have an allergic reaction to gentamicin if you are already allergic to another aminoglycoside.
Experience with once-daily administration of gentamicin in elderly patients is limited.
To reduce the risk of ototoxicity (nerve damage to the ear) and nephrotoxicity (kidney damage), your doctor will be especially careful in evaluating the following:
- Monitoring of hearing, balance, and kidney function before, during, and after treatment.
- Dosing strictly according to kidney function.
- If you have impaired kidney function, additional antibiotics administered directly at the site of infection will be taken into account when determining the total antibiotic dose.
- Monitoring of serum gentamicin concentrations during treatment, if required by your individual case.
- Additional monitoring of balance and hearing function is required if you already have inner ear nerve damage (hearing impairment or balance disturbance), or if treatment is prolonged.
- Whenever possible, gentamicin treatment should not exceed 10–14 days (usually 7–10 days).
- A sufficient interval of 7–14 days should elapse between individual courses of gentamicin and other closely related antibiotics.
- Avoid administering other substances with potential harmful effects on the auditory nerve or kidneys together with gentamicin. If this is unavoidable, especially careful monitoring of kidney function is required.
- Body fluid levels and urine output must remain within normal ranges.
Other medicines and Genta Gobens
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Special attention is required with the following medicines:
Ether, muscle relaxants
The neuromuscular blocking effect of aminoglycosides is enhanced by ether and muscle relaxants. Therefore, you will be closely monitored while receiving these substances.
Anaesthesia with methoxyflurane
The anaesthetist must be aware if you have received or are receiving aminoglycosides before administering methoxyflurane (an anaesthetic gas), and should avoid using this agent if possible, due to an increased risk of kidney damage.
Other medicines with potential harmful effects on the auditory nerve and kidneys
You will be monitored very closely if you receive gentamicin before, during, or after treatment with medicines containing the following substances:
- amphotericin B (for fungal infections),
- colistin (for intestinal decontamination),
- cyclosporine (to suppress undesirable immune reactions),
- cisplatin (anticancer agent),
- vancomycin, streptomycin, viomycin, carbenicillin, other aminoglycosides, cephalosporins (antibiotics).
Close monitoring is also required if you receive diuretics (medicines to increase urine flow) containing, for example, ethacrynic acid or furosemide.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine. This medicine should not be used during pregnancy unless absolutely necessary.
Breastfeeding
Inform your doctor if you are breastfeeding. Your doctor will carefully assess whether you should discontinue breastfeeding or stop treatment with gentamicin.
Driving and using machines
Caution is advised when driving or operating machinery due to possible adverse effects such as dizziness and vertigo.
Genta Gobens may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden sensation of suffocation) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).
This medicine may cause severe allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains sodium metabisulfite (E-223).
This medicine contains less than 23 mg of sodium (1 mmol) per vial, i.e., essentially “sodium-free”.
3. How to use Genta Gobens
Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Genta Gobens is supplied as a solution ready for intramuscular administration, or for intravenous use after dilution.
Dosage for patients with normal renal function
The recommended daily dose in adolescents and adults with normal renal function is 3 to 6 mg/kg body weight per day, given as 1 dose (preferably) or up to 2 divided doses.
You will usually receive gentamicin treatment for no more than 7 to 10 days; treatment may exceed 10 days only in cases of severe and complicated infections.
Your blood levels of gentamicin will be closely monitored by examining blood samples taken at the end of a dosing interval and immediately after completion of infusion, primarily to monitor renal function. Your dose will be carefully adjusted to avoid kidney damage.
Use in children
The daily dose in newborns is 4 to 7 mg/kg body weight per day. Newborns receive the required daily dose as a single dose.
The recommended daily dose in infants after the first month of life is 4.5 to 7.5 mg/kg body weight per day, given as 1 dose (preferably) or up to 2 divided doses.
The recommended daily dose in older children (2 to 12 years) with normal renal function is 3 to 6 mg/kg body weight per day, given as 1 dose (preferably) or up to 2 divided doses.
Dosage in patients with renal impairment
If you have renal impairment, your gentamicin blood concentrations will be monitored and the dose will be appropriately adjusted either by reducing the dose or by extending the time between individual doses. Your doctor knows how to adjust the dosing regimen in such cases.
Dosage in patients undergoing renal dialysis
In this case, the dose will be carefully adjusted according to your blood gentamicin level.
Elderly patients may require lower maintenance doses than younger adults to achieve adequate gentamicin blood levels.
In obese patients, the initial dose should be based on ideal body weight plus 40% of excess body weight.
No dose adjustment is required in patients with hepatic impairment.
If you receive more Genta Gobens than you should
In case of accumulation (e.g., due to renal impairment), additional kidney damage and damage to the auditory nerve may occur.
Treatment in case of overdose
Treatment will initially be discontinued. There is no specific antidote. Gentamicin can be removed from the blood by renal dialysis. For treatment of neuromuscular blockade, calcium chloride and artificial respiration may be administered if necessary.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
If you forget to use Genta Gobens:
Do not take a double dose to make up for forgotten doses.
If you stop treatment with Genta Gobens:
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Under certain conditions, gentamicin may produce toxic effects on the auditory nerve and the kidneys. Renal impairment is commonly observed in patients treated with gentamicin and usually resolves after discontinuation of the drug. In most cases, renal toxicity is associated with an excessively high dose or prolonged treatment, pre-existing renal abnormalities, or concomitant use of other substances that also have a nephrotoxic effect. Additional risk factors for renal toxicity include advanced age, low blood pressure, reduced blood volume, shock, or pre-existing liver disease. Risk factors for toxic effects on the auditory nerve include pre-existing liver or hearing impairment, bacteria in the blood (bacteraemia), and fever.
The following side effects, which may very rarely occur (i.e. in less than 1 in 10,000 treated patients), can be serious and may require immediate treatment:
- Severe acute hypersensitivity (allergic) reactions.
- Acute renal failure.
Skin rash, itching, and breathing difficulties may be signs of acute hypersensitivity.
Reduced urine output or complete cessation of urination (oliguria, anuria), excessive urination at night, and generalized swelling (fluid retention) are signs of acute renal failure.
Infections and infestations: | |
Very rare (may affect up to 1 in 10,000 people) | Infection by other microorganisms resistant to gentamicin, inflammation of the large intestine (usually due to other antibiotics) |
Blood and lymphatic system disorders: | |
Uncommon (may affect up to 1 in 100 people) | Abnormal blood composition |
Very rare (may affect up to 1 in 10,000 people) | Abnormally low counts of different types of blood cells, increased eosinophil count (a specific group of white blood cells) |
Immune system disorders - allergic reactions: | |
Very rare (may affect up to 1 in 10,000 people) | Drug fever, acute and severe hypersensitivity reactions |
Metabolism and nutrition disorders: | |
Uncommon (may affect up to 1 in 1,000 people) | Low levels of potassium, calcium, and magnesium in the blood (associated with high doses administered over a prolonged period), loss of appetite, weight loss |
Very rare (may affect up to 1 in 10,000 people) | Low levels of phosphate in the blood (associated with high doses administered over a prolonged period) |
Psychiatric disorders: | |
Very rare (may affect up to 1 in 10,000 people) | Confusion, hallucinations, mental depression |
Nervous system disorders: | |
Uncommon (may affect up to 1 in 1,000 people) | Peripheral nerve damage, impaired or loss of sensation |
Very rare (may affect up to 1 in 10,000 people) | Organic brain disease, seizures, blockade of nerve and muscle function, dizziness, balance disorders, headache |
Eye disorders: | |
Very rare (may affect up to 1 in 10,000 people) | Visual impairment |
Ear and labyrinth disorders: | |
Very rare (may affect up to 1 in 10,000 people) | Damage to the auditory nerve, hearing loss, Ménière's disease, tinnitus (ringing or noises in the ears), vertigo |
Vascular disorders: | |
Very rare (may affect up to 1 in 10,000 people) | Decreased blood pressure, increased blood pressure |
Gastrointestinal disorders: | |
Uncommon (may affect up to 1 in 1,000 people) | Vomiting, nausea, increased salivation, mouth inflammation |
Liver and biliary disorders: | |
Uncommon (may affect up to 1 in 1,000 people) | Elevated liver enzymes and blood bilirubin levels (all reversible) |
Skin and subcutaneous tissue disorders: | |
Uncommon (may affect up to 1 in 100 people) | Allergic skin rash, itching |
Uncommon (may affect up to 1 in 1,000 people) | Redness of the skin |
Very rare (may affect up to 1 in 10,000 people) | Hair loss, severe allergic reaction of the skin and mucous membranes accompanied by blisters and skin redness (erythema multiforme), which in very severe cases may affect internal organs and may be potentially fatal (Stevens-Johnson syndrome, toxic epidermal necrolysis) |
Muscle, skeletal and connective tissue disorders: | |
Uncommon (may affect up to 1 in 1,000 people) | Muscle pain (myalgia) |
Very rare (may affect up to 1 in 10,000 people) | Muscle tremor (causing difficulty standing up) |
Renal and urinary disorders: | |
Common (may affect up to 1 in 10 people) | Impaired kidney function (which usually resolves after stopping treatment) |
Uncommon (may affect up to 1 in 1,000 people) | Elevated blood urea levels (reversible) |
Very rare (may affect up to 1 in 10,000 people) | Acute kidney failure and increased levels of phosphate and amino acids in urine (known as acquired Fanconi syndrome, associated with high doses administered over a long period of time) |
General disorders and administration site conditions: | |
Uncommon (may affect up to 1 in 1,000 people) | Increased body temperature |
Very rare (may affect up to 1 in 10,000 people) | Pain at injection site |
The following adverse reactions have also been reported, although their frequency is unknown: Frequencies cannot be estimated from the available data:
- Irreversible hearing loss, deafness.
Reporting of adverse reactions
If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. Storage of Genta Gobens
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 bottle and on the outer packaging after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the container and additional information
Composition of Genta Gobens 80 mg/ml injectable solution:
- The active substance is gentamicin (sulfate). Each vial contains 240 mg of gentamicin (sulfate).
- The other components (excipients) are sodium metabisulfite (E-223), methylparaben (E-218), propylparaben (E-216), EDTA (ethylenediaminetetraacetic acid), sodium hydroxide (E-524), and water for injections.
Appearance of the product and contents of the container
The solution contained in the vials of Genta Gobens 80 mg/ml injectable solution is transparent, colourless or slightly yellow. Each pack contains 1 vial. Each 3 ml vial contains 240 mg of gentamicin (as sulfate).
Marketing Authorization Holder and Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)
Other presentations:
Genta Gobens 20 mg/ml solution for injection and infusion.
Genta Gobens 40 mg/ml solution for injection and infusion.
Date of latest revision of this summary: March 2024.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.