SERASEPT 2 Solution, Antiseptic treatment of wounds

Serasept 1/Serasept 2, antiseptic solution. Active ingredient: Polihexanide 0.02% (Serasept 1) and 0.04% (Serasept 2). Indications: Adjuvant antiseptic treatment of wounds, e.g., after surgical debridement. Serasept 1/Serasept 2 is a medicine that will be administered to you by a doctor or medical staff.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Serasept 1/Serasept 2, antiseptic solution Active
ingredient: Polihexanide 0.02% (Serasept 1) and 0.04% (Serasept 2)

This medicine is available without a prescription. However, to achieve the best possible treatment results, Serasept 1 and Serasept 2 must be used as directed.

• Keep this leaflet. You may want to read it again later.
• Ask your pharmacist if you need further information or advice.
• If your symptoms worsen, you should definitely see a doctor.
• If any of the side effects listed affect you seriously or if you notice side effects not listed in this leaflet, please inform your doctor or pharmacist.

This package leaflet contains:

1. WHAT IS SERASEPT 1 AND SERASEPT 2 AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING SERASEPT 1 AND SERASEPT 2?
3. HOW SHOULD SERASEPT 1 AND SERASEPT 2 BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD SERASEPT 1 AND SERASEPT 2 BE STORED?
6. MORE INFORMATION

1. WHAT ARE SERASEPT 1 AND SERASEPT 2 AND WHAT ARE THEY USED FOR?

Substance or indication group/mode of action:
Serasept 1/Serasept 2 is a sterile antiseptic solution. Its composition corresponds to a Ringer's solution DAB 7 with 0.02% polihexanide (Serasept 1) or 0.04% polihexanide (Serasept 2).

Indication:
Adjuvant antiseptic treatment of wounds, e.g., after surgical debridement. Serasept 1/Serasept 2 is a medicine that will be administered to you by a doctor or medical professional.

2. WHAT MUST YOU CONSIDER BEFORE USING SERASEPT 1 AND SERASEPT 2?

Serasept 1 and Serasept 2 must not be used:

• in the area of cartilage and joints,
• intraperitoneally,
• if you are hypersensitive to any of the ingredients.

Special precautions are required when using Serasept 1 and Serasept 2:
During pregnancy: since the safety of using Serasept 1/Serasept 2 during pregnancy has not been proven, Serasept 1/Serasept 2 should not be used. During breastfeeding: it is not known whether the active ingredient passes into breast milk and causes adverse effects in the breastfed child. Serasept 1/Serasept 2 should therefore not be used during breastfeeding. During pregnancy and breastfeeding, consult your doctor or pharmacist before taking/using any medication.

In children and infants: there is insufficient experience with the use of Serasept 1/Serasept 2 in children and infants, so its use should only be considered if absolutely necessary.

Do not use for injection or infusion. Do not mix with additives. Do not resterilize!

When using Serasept 1 and Serasept 2 with other medicines:
No interactions with other medicines are known (information on incompatibility: see additional information for healthcare professionals).

3. HOW SHOULD SERASEPT 1 AND SERASEPT 2 BE USED?

This medicine will be administered to you by a doctor or medical staff. The dosage depends on the type and severity of the condition. Your doctor will inform you about the frequency and duration of use of Serasept 1 and Serasept 2. Compresses moistened with Serasept are applied directly to the wound surface. The wound dressing is completely replaced once a day after moistening and is moistened again once a day with the solution. Initially, Serasept 2 (0.04% polihexanide) should be used, especially for dirty and festering wounds. For repeated application to wounds, Serasept 1 (0.02% polihexanide) is used.

Method of administration:
Solution for application to the skin. Moist wound treatment is carried out using Serasept-soaked compresses (approx. 10 ml of solution per 10 x 10 cm² compress area).

Duration of use:
The duration of use is determined by the treating physician depending on the condition of the wound. Treatment is generally continued until the wound is completely closed. Clinical studies have provided application data for polihexanide up to a period of 6 months. Please speak to your doctor or pharmacist if you feel that the effect of Serasept 1/Serasept 2 is too strong or too weak.

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

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, Serasept 1/Serasept 2 can cause side effects, although not everybody gets them.

Hypersensitivity reactions (urticaria and rash). Very rare: systemic anaphylactic reactions.

Reporting of side effects:
If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: By reporting side effects, you can help provide more information on the safety of this medicine.

Additional information for healthcare professionals:
Reporting suspected side effects:
Reporting suspected side effects after authorization is very important. It allows continuous monitoring of the benefit-risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, 

5. HOW SHOULD SERASEPT 1 AND SERASEPT 2 BE STORED?

Keep out of the sight and reach of children! Do not use this medicine after the expiry date printed on the container and outer packaging. The expiry date refers to the last day of that month. Use only clear solutions in undamaged containers! Any refilling must only be done under aseptic conditions (sterile bench). Shelf life after opening: From a microbiological point of view, Serasept 1/Serasept 2 should be used immediately unless the method of opening excludes the risk of contamination. From a microbiological point of view, the product can be stored for a maximum of 8 weeks after initial opening.

6. FURTHER INFORMATION

What Serasept 1 and Serasept 2 contains:
Active ingredient: 1000 ml of solution contains:

Other ingredients: Sodium chloride, potassium chloride, calcium chloride dihydrate, Macrogol 4000, water for injections, sodium hydroxide.

Dosage form and contents
: Solution in a plastic bottle. Pack sizes: 1 x 125 ml, 20 x 125 ml, 1 x 250 ml, 10 x 250 ml, 1 x 1000 ml, 6 x 1000 ml.

Pharmaceutical entrepreneur and manufacturer:
Serag-Wiessner GmbH & Co. KG
Zum Kugelfang 8 - 12
95119 Naila, Germany


This package leaflet was last revised in October 2024.

Source: Information from the package leaflet
, as of: 03/2025

Active ingredient: Polihexanide 0.02% (Serasept 1) and 0.04% (Serasept 2). Indications: Adjuvant antiseptic treatment of wounds, e.g., after surgical debridement. Serasept 1/Serasept 2 is a medicine that will be administered to you by a doctor or medical professional.

Antiseptic treatment of wounds, SERASEPT 2 Solution