Garamicin

Package Leaflet: Information for the Patient

Garamycin, 2 mg/cm², Sponge

Gentamicin

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• Ask your doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed for you only. Do not pass it on to others.
• It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, or if any side effects get worse, tell your doctor, pharmacist, or nurse.

Table of Contents of the Leaflet:

• 1. What is Garamycin and what is it used for
• 2. Important information before using Garamycin
• 3. How to use Garamycin
• 4. Possible side effects
• 5. How to store Garamycin
• 6. Contents of the pack and other information

1. What is Garamycin and what is it used for

Garamycin sponge is a sterile implant containing gentamicin sulfate - an aminoglycoside antibiotic with a broad spectrum of antibacterial activity. It is used to provide a high local concentration of gentamicin, resulting in the elimination of local inflammation or prevention of its occurrence. The collagen contained in the medicine has a hemostatic effect. The medicine is intended for the treatment of bacterial infections of bones and soft tissues. It can be used during surgical procedures on infected or potentially infected tissues to prevent local soft tissue and bone infections (e.g., in bone grafts and during artificial joint replacement surgery without the use of cement). The patient will also receive a suitable antibiotic administered systemically.

2. Important information before using Garamycin

When not to use Garamycin:

• if you are allergic to gentamicin or other aminoglycoside antibiotics, or any of the other ingredients of this medicine (listed in section 6);
• in patients who have had immunological diseases or diseases of the connective tissue.

Warnings and precautions

Before starting treatment with Garamycin, consult your doctor, pharmacist, or nurse.

Special caution is required when using Garamycin:

• if you have kidney function disorders,
• if you have neuromuscular disorders (muscle weakness, Parkinson's disease, or botulism in children), as it may worsen muscle weakness,
• if you are taking other aminoglycoside antibiotics; sometimes it may be necessary to assess the concentration of these antibiotics in the serum or monitor kidney function (based on creatinine level measurement),
• if you have or suspect an infection; in this case, you will receive a systemically acting antibiotic, selected according to microbiological test results.

Other medicines and Garamycin

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Avoid concurrent use of gentamicin with potent diuretics, such as ethacrynic acid or furosemide, as these diuretics may damage hearing. Intravenously administered diuretics may enhance the toxic effects of aminoglycosides. Avoid using medicines that may harm the nervous system, such as cisplatin, streptomycin, kanamycin, cephaloridine, viomycin, polymyxin B, or polymyxin E, either concurrently or alternately, either locally or systemically.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. In pregnant women, the medicine should only be used if absolutely necessary. Due to the potential for the medicine to be excreted into breast milk and cause severe side effects in the child, a decision must be made whether to discontinue breastfeeding or not to use the medicine.

Driving and using machines

Garamycin sponge has no influence on the ability to drive and use machines.

3. How to use Garamycin

Garamycin is administered only by a doctor during a surgical procedure. The dosage and administration method are described at the end of the leaflet, in the section "Information intended for healthcare professionals only".

4. Possible side effects

Like all medicines, Garamycin can cause side effects, although not everybody gets them. The active substance of the medicine (gentamicin) may harm kidney function. The adverse effect of gentamicin on the kidneys is manifested by the presence of casts, red blood cells, and protein in the urine, or an increase in creatinine and urea levels in the blood, as well as oliguria. These changes are usually mild. Such effects are more common in patients who have had kidney function disorders in the past. During treatment with the medicine, local redness, itching, and increased discharge from the wound may occur due to collagen resorption. In sensitive individuals, allergic reactions to the Garamycin sponge may occur.

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Garamycin

Keep the medicine out of the sight and reach of children. Store in a temperature not exceeding 25°C. Do not use Garamycin after the expiry date stated on the packaging. The expiry date refers to the last day of the month. Do not use Garamycin if the blister containing the sponge is damaged. Use Garamycin immediately after opening the outer packaging; otherwise, discard it. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Garamycin contains

• The active substance is gentamicin in the form of gentamicin sulfate. A sponge measuring 5 × 20 × 0.5 cm or 10 × 10 × 0.5 cm contains 130 mg of gentamicin in the form of gentamicin sulfate (200 mg). A sponge measuring 5 × 5 × 0.5 cm contains 32.5 mg of gentamicin in the form of gentamicin sulfate (50 mg).
• The other excipients are purified collagen from bovine tendons.

What Garamycin looks like and contents of the pack

A gelatin sponge in a blister pack made of polyethylene terephthalate glycol (PETG)/Tyvek 1073B in a PET/PE/Tyvek 1073B bag, placed in a cardboard box. The box contains: 1 sponge, 5 or 10 sponges measuring 5 × 20 × 0.5 cm, 10 × 10 × 0.5 cm, or 5 × 5 × 0.5 cm.

Marketing authorization holder and manufacturer

SERB SA, Avenue Louise, 480, 1050 Brussels, Belgium. For more detailed information, please contact the representative of the marketing authorization holder: tel. +48 (0)22 307 03 61.

Date of last revision of the leaflet: 09/2020

Information intended for healthcare professionals only

Method of administration: Remove the blister from the outer packaging while maintaining sterility. Then, under aseptic conditions, remove the implant from the blister. The implant should only be used dry. Moistening the Garamycin sponge before use may cause loss of efficacy due to premature leaching of the water-soluble gentamicin sulfate. The implant should be used immediately after opening the outer packaging; otherwise, it should be discarded. The product cannot be resterilized. Application to soft tissues (treatment and prevention): usually, one sponge is used (a maximum of three sponges measuring 10 × 10 × 0.5 cm or 5 × 20 × 0.5 cm). For smaller defects, the sponge can be cut into smaller pieces in the operating field. Bone inflammation and other indications for use in bone tissues (treatment of infections and prevention): usually, one sponge is used (a maximum of five sponges measuring 10 × 10 × 0.5 cm or 5 × 20 × 0.5 cm). The dose size (number of sponges) depends on the extent of the surgical site and the size of the treated defect. In patients weighing less than 50 kg, it is recommended to limit the concurrent dose (number of sponges) to three, and above 50 kg to a maximum of five sponges measuring 10 × 10 × 0.5 cm or 5 × 20 × 0.5 cm. General method of applying the sponge: it is administered locally or on the skin. After surgical cleaning of the wound, the sponge is introduced into it. The Garamycin sponge is soft and can be adapted to the desired size using standard surgical scissors. Dry gloves and instruments should be used, as the sponge may stick in a moist environment. The product has been used in various ways (using the whole sponge, shaping it, and cutting it into pieces); it has been applied flat, rolled into a cylinder, or folded and placed loosely in the wound (soft tissues) or tightly pressed against the bone. It has also been placed around the wound, cut into small pieces, and mixed with macerated spongy bone and placed together in the bone defect. In supportive treatment and prevention of infections, the Garamycin sponge has been applied in situ to cover the entire surgical site or part of it requiring local antibiotic therapy. In all bone surgeries, attention should be paid to the stability of the bone union, as even minor instabilities may not be clinically apparent but can lead to infection (especially with Staphylococcus aureus bacteria). Concurrent use of flow drainage and application of the Garamycin product, sponge, should be avoided. Consider administering the product after completion of this drainage. It is possible to use the Garamycin product, sponge, and concurrent gravity drainage. In this case, the product should be applied so as not to cover the drain lumen. The product should not be removed from the site of application.