Oxovasin®

Oxovasin® is a therapeutic agent for the local treatment of wounds and wound healing disorders. The effectiveness of Oxovasin® solution is based on the influence on the wound repair mechanism. This is demonstrated by an improved wound cleansing. Oxovasin® also improves the formation of granulation tissue and leads to a wound closure by means of influencing wound contraction as well as faster epithelization.

Use

Oxovasin® is a colourless, aqueous solution. It is usually applied to the wound twice daily. Alternatively, a cotton compress soaked in Oxovasin® can be placed on the wound. For a wound the size of 10 x 10cm which can be covered by a folded sterile cotton compress of equal size, 5ml of Oxovasin® should be sufficient. For more information, please consult the package leaflet and the information about the application .

Pack sizes and recommended retail prices (Germany) for pharmacies

Oxovasin® is sold through pharmacies as follows:

Package sizeRecommended retail price including sales tax
50 ml24,97 EUR
100 ml39,97 EUR
Packaged goods for hospitals
10 x 50 ml
10 x 100 ml

Larger packages are available for hospitals (details and price list available on request). Please note that we exclusively deliver to pharmaceutical wholesalers, hospitals, and pharmacies.

Details

Name

Oxovasin® solution

Composition

Composition
Active ingredient:
Reaction product 6.9 x 106 U.*)
Produced from: 10.28mg sodium chlorite, 1.38mg sodium hypochlorite,
0.75mg sulfuric acid 69%, 0.6µg potassium chlorate,
0.37mg sodium carbonate – hydrogen peroxide (2:3),
1.09mg sodium peroxide
*) 1U. = 1 pmol ethylene, released by aminocyclopropanoic acid in the presence of hemin as the activator during quantitative determination

Other ingredients:
Glycerol, Purified water

Therapeutic group/Mode of Operation

Wound healing agent

Therapeutic indications

Treatment of wounds and wound healing disorders by improvement of wound cleansing, of granulation, of epithelization, and of would closure, including:

  • posttraumatic wound healing disorders, also with osteitis
  • postoperative wound healing disorders, also with accompanying fistulae and wound cavities
  • leg ulcers caused by venous insufficiency
  • wounds caused by arterial circulatory disturbance

Contraindications

Oxovasin® solution should not be applied in case of hypersensitivity against Oxovasin® or one of the other ingredients contained in Oxovasin®. In pregnant women and infants, Oxovasin® should only be used in life-threatening cases, as observations on humans are not available. Experimental studies did not give any hints of teratogenic effects.

Precautions and warnings for use

Due to its mode of action, Oxovasin® should be used as a monotherapeutic agent. The application of additional topical drugs to the wound should be avoided under all circumstances, since besides the possibility of a chemical interaction most disinfectants or dye solutions counteract the effect of granulation promoted by Oxovasin®.

Interaction

Oxovasin® should not be applied to the wound in combination with other externally used medications or colorants such as brilliant green, gentian violet, fuchsine, and malachite green as this may lead to the loss in the activity of the major ingredient.

Side effects

In rare cases (e 1/10,000, < 1/1,000) the application of Oxovasin® solution resulted in hypersensitivity reactions (allergic contact dermatitis) caused by the active ingredient. In uncommon cases (e 1/1,000, < 1/100) reddening of the skin, itching or burning sensations and in rare cases mild pain may appear in the wound region at the beginning of the treatment.

As assessory symptoms and signs of wound healing were noted: Reddening of the wound margin, Itching, burning sensation, mild pain, wound secretion with Ulcus cruris and Decubitus, Spontaneous bleeding, Wound expansion.
These accompanying appearances as noted above may be due to the exudation preceding the restorative phase of wound healing. These appearances are predominantly seen in the treatment of venous ulcers in the lower leg and will normalize themselves in course of treatment.

Warning

If hypersensitivity reactions are observed in the area surrounding the wound, the treating physician has to be informed.

Instructions and Declaration of the Shelf Life of the Drug

The expiration date is printed on the outer box and the label on the bottle. Do not use this product after this expiration date! Oxovasin® bottles for multiple uses must be securely fastened after use and stored in a dark place; otherwise the effectiveness may be lessened. Contact between the bottle opening and the skin or wound should be avoided. The solution must not be used more than 14 days after opening of the bottle. Oxovasin® solution is to be stored in the packaging carton, protected from sunlight. Oxovasin® solution should not be stored at a temperature higher than 25 °C.

Drug approval no. and date

19052.00.00 | 2 June 1994 | Oxovasin is available as OTC in pharmacies

Handling

Opening the bottle

The screw cap is equipped with an inner pin. By twisting the cap to the right, the inner pin is piercing, and thereby opening the bottle.

Storage

Oxovasin® solution can be stored at ambient temperature. Once open, the bottles for multiple uses must be securely fastened and stored in a dark place (in the outer carton), otherwise the effectiveness may be lessened.

Stability

Contact between the bottle opening and the skin or wound should be avoided. The sterile solution must not be used more than 14 days after opening of the bottle.

Application

How to apply Oxovasin?

Oxovasin® solution should be applied directly to the wound, either by applying cotton compresses dampened with Oxovasin®, or by instillation into fistulas and wound cavities.

How much Oxovasin® should be applied – and how often?

Oxovasin® is a colorless, aqueous solution. It should be applied twice daily to the wound or wound cavern.
On visually progressive wound healing, the dosage may be reduced to once daily.
The amount to be used depends on the size of the wound. For a wound size of 10cm x 10cm which can be covered by a sterile cotton compress of the same size, 5ml Oxovasin® should be sufficient. The overall quantity of the necessary solution depends on the wound size which can be covered by an appropriate number of cotton compresses.
With large wound pockets and caverns, the amount of Oxovasin® solution is determined by the number of loosely packed cotton compresses being used.
Between 5–10ml of Oxovasin® can be used when instilling fistula systems or deep wound cavities.

How and when should you apply Oxovasin®?

The recommended method of treatment consists of applying cotton compresses dampened with Oxovasin®. Oxovasin® solution is compatible with all dressing materials not containing pharmaceutical active ingredients.
If the dressing only needs to be changed once daily, the wound can be moistened by applying Oxovasin® to the overlying bandage. With deep wound pockets a cotton compress dampened with Oxovasin solution should be loosely packed into the pocket. This ensures that Oxovasin® solution reaches deeper wound regions. All pressure should be avoided as not to damage the new tissue formation (granulation). Should the application of Oxovasin® solution not be possible via an overlying bandage, then the solution can be applied into wound pockets and caverns through existing drainages. Also, the application into fistula systems is possible. Mechanical flushing with saline solution prior to the application of Oxovasin® is recommended. In this mode of application, 5-10ml of Oxovasin® solution is also sufficient.

How long you should apply Oxovasin®?

The duration of treatment corresponds with the pre-determined treatment goal. Based on the treatment goal, this can take 3 weeks (e.g., wound healing disturbances) to possibly several months (e.g., lower leg ulcerations).

Special observations during Oxovasin® treatment

Side-effects of treatment with Oxovasin® solution may be caused by the formation of wound secretion (exudation) preceding the reparative phase of the wound healing. These appearances are predominantly seen in the treatment of venous ulcers in the lower leg and will normalize themselves in due course with treatment.

Reddening the wound edges

The reddening of the surrounding tissue near to the wound at the beginning of the treatment is a sign of improved circulation (hyperemic reaction).

Itching, burning, mild pain

Occasionally at the beginning of treatment, these sensations indicate the start of the wound-healing process. If this occurs, the wound can be remoistened using saline solution. Swelling in the near surroundings of the wound may lead to mild pain. These are also signs of healing (exudative pressure on nerve end fibers).

Wound secretion with venous leg ulcers or decubitus ulcers

In the starting phase of wound healing, an increase in wound secretion may be seen. This can lead to the necessity of repeated bandage changing per day. If after initial wound cleansing, an increased wound smear as well as increased secretion and discoloration of the granulation tissue appear during further treatment, a case of overdosing must be assumed. On reducing the amount of Oxovasin® solution being used, a healthy appearance should return. The principal of moistened wound therapy should be maintained in any event (possibly alternating use of Oxovasin®/saline solution).

Spontaneous bleeding

If spontaneous bleeding occurs following the contact with the newly formed granulation tissue, this is a positive sign indicating the development of new capillaries and does not require additional therapeutic measures.

Enlargement of the wound

An apparent increase in wound size at the beginning of treatment may be caused by the disintegration of unviable tissue unable to participate in the regeneration process. Upon Oxovasin® therapy, a quick demarcation between healthy and dead tissue is seen.

Use Oxovasin® solution only following the instructions described in the package leaflet. If you have any questions, please consult your doctor or pharmacist.