Gentamicin Braun 3 mg/ml solution for infusion
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Gentamicin Braun 3 mg/ml is and what it is used for
- 2. What you need to know before using Gentamicina Braun 3 mg/ml
- **Driving and use of machines:**
- 3. How to use Gentamicin Braun 3 mg/ml
- **If you use more Gentamicina Braun 3 mg/ml than you should:**
- 4. Possible adverse effects
- 5. Storage of Gentamicin Braun 3 mg/ml.
- 6. Package contents and other information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Gentamicin Braun 3 mg/ml solution for infusion
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
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Package leaflet contents:
- What Gentamicin Braun 3 mg/ml is and what it is used for
- What you need to know before using Gentamicin Braun 3 mg/ml
- How to use Gentamicin Braun 3 mg/ml
- Possible side effects
- How to store Gentamicin Braun 3 mg/ml
- Contents of the pack and other information
1. What Gentamicin Braun 3 mg/ml is and what it is used for
Gentamicin Braun 3 mg/ml is an aqueous solution of gentamicin, a bactericidal antibiotic belonging to the aminoglycoside group.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza 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 over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.
Gentamicin Braun is indicated for short-term treatment, in combination with other antibiotics, for the following conditions, except for complicated kidney, urinary tract, and bladder infections.
Main indications are:
- Blood infection, known as septicemia
- Skin and soft tissue infections (including burns)
- Lower respiratory tract infections occurring during hospitalization, including severe pneumonia
- Complicated and recurrent urinary tract infections
- Gastrointestinal tract infections, including peritonitis
- Heart valve infections (bacterial endocarditis)
- Post-surgical infections
2. What you need to know before using Gentamicina Braun 3 mg/ml
Do not use Gentamicina Braun 3 mg/ml:
- If you are allergic to gentamicin or to any of the other components of this medicine (see section 6), or to other aminoglycoside antibiotics.
- If you have myasthenia gravis.
- It must not be administered together with other products that are toxic to the ear or kidney, or with potent diuretics.
Warnings and precautions
Talk to your doctor or nurse before starting to use Gentamicina Braun 3 mg/ml.
Inform your doctor of any allergies or medical conditions you currently have or have had in the past, especially:
- if you are allergic to gentamicin or to other aminoglycoside antibiotics.
- if your kidneys do not function properly, as this may increase the risk of toxicity.
- if you have muscle disorders such as myasthenia gravis or Parkinson’s disease, as muscle weakness may worsen.
- if you are taking diuretics that may be ototoxic (toxic to the ear).
- if you develop symptoms of ototoxicity such as dizziness, vertigo, tinnitus (ringing sensation), buzzing in the ears, or hearing loss, or symptoms of nephrotoxicity (kidney toxicity).
- 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 Gentamicina Braun 3 mg/ml.
- if you develop severe diarrhea.
- it is possible that your infection will not respond to gentamicin if it did not respond to other aminoglycosides, and you may have an allergic reaction if you are already allergic to another aminoglycoside.
- if you are pregnant or breastfeeding.
To reduce the risk of nerve damage to the ear and kidneys, 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 for total dosing.
- Monitoring of serum gentamicin concentrations during treatment if the specifics of your case require it.
- If you already have nerve damage in the ear (impaired hearing or balance), or if treatment is long-term, additional monitoring of balance and hearing function is required.
- Whenever possible, gentamicin treatment should not exceed 10–14 days (typically 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 in combination with gentamicin. If this is unavoidable, especially careful monitoring of kidney function is required.
- Body fluid levels and urine output should remain within normal ranges.
Other medicines and Gentamicina Braun 3 mg/ml
Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.
The administration of Gentamicina Braun 3 mg/ml together with the following medicines may require dose adjustments or discontinuation of treatment.
Ether, muscle relaxants
The nerve and muscle blocking effect of aminoglycosides is enhanced by ether and muscle relaxants. Therefore, you will be monitored especially closely while receiving these substances.
Anesthesia with methoxyflurane
The anesthesiologist must know whether you have received or are receiving aminoglycosides before administering methoxyflurane (an anesthetic gas), and should avoid using this agent if possible, due to an increased risk of kidney damage.
Other medicines with potential ototoxic and nephrotoxic effects
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 unwanted immune responses),
- cisplatin (anticancer agent),
- vancomycin, streptomycin, viomycin, carbenicillin, other aminoglycosides, cephalosporins (antibiotics).
You will also be monitored very closely if you receive medications to increase urine flow that contain, for example, ethacrynic acid or furosemide.
Gentamicin may alter laboratory test values for certain substances such as: blood urea nitrogen, transaminases, alkaline phosphatase, bilirubin, creatinine, lactate dehydrogenase, sodium, potassium, magnesium, and calcium.
Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Treatment during pregnancy is not recommended, although your doctor will assess whether its use is justified. If the medicine is used during pregnancy, or if the patient becomes pregnant during treatment, she must be informed of the potential risks.
As a general rule, breastfeeding should not be performed while the mother is undergoing treatment. Your doctor will assess whether use is appropriate in each individual case.
Driving and use of machines:
The use of this medicine may affect your ability to drive vehicles or operate machinery, even after treatment has ended, particularly if you have received prolonged treatment or high doses, in cases of uncontrolled renal insufficiency, or in elderly patients. Therefore, you should exercise extreme caution when driving vehicles or operating machinery.
Gentamicin Braun 3 mg/ml contains sodium:
80 ml vials:
This medicine contains 283.47 mg of sodium (the main component of table/cooking salt) per 80 ml vial. This corresponds to 14.17% of the maximum daily recommended sodium intake for an adult.
100 ml vials:
This medicine contains 354.33 mg of sodium (the main component of table/cooking salt) per 100 ml vial. This corresponds to 17.72% of the maximum daily recommended sodium intake for an adult.
3. How to use Gentamicin Braun 3 mg/ml
Follow exactly the instructions for administration provided in this leaflet or as directed by your doctor or nurse. If in doubt, consult your doctor or nurse.
Your doctor will determine the duration of your treatment. Do not stop the treatment prematurely.
Gentamicin Braun 3 mg/ml will be administered by healthcare personnel only via intravenous infusion over 30–60 minutes.
Your doctor will determine the most appropriate dose for you based on your age, body weight, general condition, severity of infection, and kidney function. Renal function should be monitored throughout treatment.
Adults and Adolescents (12 to 17 years of age)
As a general rule, the recommended dose in adults and adolescents with normal renal function is 3–6 mg/kg/day of gentamicin base, given as a single daily dose or divided into two daily infusions.
Typically, gentamicin treatment will not last longer than 7–10 days; only in cases of severe or complicated infections may treatment exceed 10 days.
Gentamicin blood levels will be carefully monitored by analyzing blood samples taken at the end of a dosing interval and immediately after the end of the 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 daily dose in infants after the first month of life is 4.5–7.5 mg/kg body weight per day, given as one (preferred) to two single doses.
The recommended daily dose in older children with normal renal function is 3–6 mg/kg body weight per day, given as one (preferred) to two single doses.
Dosing in patients with impaired renal function
If you have impaired kidney function, you will be closely monitored to appropriately adjust gentamicin blood concentrations, either by reducing the dose or by prolonging the interval between individual doses. Your doctor knows how to adjust the dosing regimen in such cases.
Dosing in patients undergoing renal dialysis
In such cases, your dose will be carefully adjusted based on serum gentamicin levels.
In patients with impaired liver function, dose adjustment is not necessary.
Use in elderly patients:
Elderly patients may require lower maintenance doses than younger adults to achieve adequate gentamicin blood levels.
Dosing in obese patients
The initial dose should be based on ideal body weight plus 40 percent of excess body weight.
If you use more Gentamicina Braun 3 mg/ml than you should:
In case of overdose or accidental ingestion, contact the Toxicology Information Service (telephone: 91 562 04 20) or consult your doctor or pharmacist. Take this leaflet with you.
If a toxic reaction occurs due to high dosing or accumulation—particularly to be considered in patients with severe renal insufficiency—peritoneal dialysis or hemodialysis may enhance elimination of the antibiotic.
If a hypersensitivity reaction occurs, administration will be discontinued and the patient will be given appropriate specific treatment according to the nature and severity of the reaction (antihistamines, corticosteroids, adrenaline...).
If you have any further questions about the use of this product, ask your doctor or pharmacist.
If you forget to use Gentamicina Braun 3 mg/ml:
Do not take a double dose to make up for forgotten doses.
If you stop treatment with Gentamicina Braun 3 mg/ml:
If you have any further questions about the use of this medicine, ask your doctor or nurse.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The following is a list of adverse reactions categorized by affected systems and listed in decreasing order of frequency according to the following criteria:
Very common (1 in 10 patients), common (1 in 100 patients), uncommon (1 in 1,000 patients), rare (1 in 10,000 patients), and very rare (less than 1 in 100,000 patients)
Organ system affected | Frequency | Adverse reactions |
Renal and urinary disorders: | very common: rare: very rare: | nephrotoxicity: increased blood urea nitrogen and creatinine levels, albuminuria, presence of red and white blood cells in urine increased blood urea levels (reversible) acute kidney injury, 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) |
Ear and labyrinth disorders: | very common: frequency not known | neurotoxicity-ototoxicity: toxicity of the eighth cranial nerve: hearing loss, vertigo, cochlear damage including high-frequency hearing loss. Dizziness, ataxia (a disorder affecting voluntary movements), vertigo, tinnitus, ringing in the ears, and hearing loss may occur. irreversible hearing loss, deafness |
Nervous system disorders: | rare: very rare: | peripheral nerve damage, impaired or loss of sensation organic brain disease, seizures, blockade of nerve and muscle function, dizziness, balance disorder, headache |
Eye disorders | very rare: | visual disturbances |
Skin and subcutaneous tissue disorders: | uncommon: rare: very rare: | allergic skin rash, itching skin redness hair loss, severe allergic reaction of the skin and mucous membranes accompanied by blisters and skin redness (erythema multiforme), which in very severe cases can affect internal organs and be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis) |
Gastrointestinal disorders: | uncommon: | nausea, vomiting, antibiotic-associated diarrhea |
Hepatobiliary disorders | rare: | increased levels of liver enzymes and bilirubin in blood (reversible) |
Musculoskeletal and connective tissue disorders: | rare: very rare: | muscle pain (myalgia) muscle tremors (causing difficulty standing) |
General disorders and administration site conditions: | rare: very rare: | increased body temperature pain at injection site |
Blood and lymphatic system disorders: | uncommon: very rare: | abnormal blood composition abnormally low counts of different types of blood cells, increased eosinophil count (a specific type of white blood cells) |
Immune system disorders | very rare: | drug fever, acute severe hypersensitivity reactions |
Metabolism and nutrition disorders | very rare: rare: | low phosphate levels in blood (associated with high doses administered over a long period of time) low potassium, calcium, and magnesium levels in blood (associated with high doses administered over a long period of time), loss of appetite, weight loss |
Psychiatric disorders | very rare: | confusion, hallucinations, depression |
Vascular disorders: | very rare: | hypotension (low blood pressure); hypertension (high blood pressure) |
Infections and infestations | very rare: | infection by other germs resistant to gentamicin, inflammation of the large intestine (usually due to other antibiotics) |
Reporting of adverse reactions
If you experience any type of adverse reaction, consult your doctor or nurse, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. Storage of Gentamicin Braun 3 mg/ml.
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use Gentamicin Braun 3 mg/ml after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.
The contents of the vials must be used immediately after opening. After opening, discard any unused portion of the solution.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Package contents and other information
Composition of Gentamicin Braun 3 mg/ml
The active substance in Gentamicin Braun 3 mg/ml is gentamicin sulfate.
Each vial contains 3 mg/ml of gentamicin base.
The active substance is gentamicin (in the form of sulfate).
Each ml of solution contains gentamicin (as sulfate) equivalent to 3 mg of gentamicin.
Each 80 ml bottle contains 240 mg of gentamicin.
Each 100 ml bottle contains 300 mg of gentamicin.
The other components are: sodium chloride, sodium edetate, and water for injections in sufficient quantity.
Appearance of the product and contents of the container
It is presented in packs of 1 and 20 polyethylene bottles containing 80 ml and 100 ml of solution.
Marketing Authorization Holder and Manufacturer
- Braun Medical, S.A.
Ctra. de Terrassa, 121
08191-Rubí (Barcelona)
Spain
This leaflet was approved in October 2024.
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).
This information is intended exclusively for physicians or healthcare professionals:
Renal function and auditory nerve function must be carefully monitored in patients with renal impairment when the drug is used for prolonged periods or administered at doses exceeding those recommended. The appearance of signs of nephrotoxicity or ototoxicity will determine dosage adjustment or discontinuation of treatment, as appropriate.
Patients should remain well hydrated during treatment.
Gentamicin Braun 3 mg/ml solution for intravenous infusion is a ready-to-use solution and therefore must not be diluted prior to administration. However, it may be administered simultaneously through the same intravenous line with 0.9% sodium chloride or 5% glucose solutions.
Aminoglycosides must not be mixed with any other medication, but administered separately.
Handle under normal aseptic conditions used for intravenous infusion solutions.
After opening the container, any unused portion of the solution must be discarded.
Due to the potential toxicity of aminoglycosides, fixed-dose regimens not based on body weight must not be followed. Instead, dosage calculation is essential to meet the individual needs of each patient.
MEDICINAL PRODUCT SUBJECT TO MEDICAL PRESCRIPTION
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