Granulox Haemoglobin Spray 12ml- CALL US TO ORDER (for collection only)

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Granulox is a topical haemoglobin-based wound spray designed to improve oxygen availability in chronic hypoxic wounds.

When applied to a cleaned wound, the haemoglobin in Granulox binds oxygen from the surrounding air and transports it through the wound exudate towards the wound bed. This helps improve topical oxygen supply and supports the normal wound-healing process.

Granulox is used as an adjunct to appropriate standard wound care and treatment of the underlying condition.

Key features:

• Topical haemoglobin wound spray
• Designed to oxygenate chronic hypoxic wounds
• Contains 10% carbonylated haemoglobin
• Supports oxygen transport through wound exudate
• Suitable for a range of chronic wounds
• Can be used on appropriately treated:
  • Sloughy wounds
  • Infected wounds
• Simple spray application
• No need to shake before use
• Applied at dressing changes or at least every 3 days
• Approximately 1–2 seconds of spraying covers a 2cm × 3cm wound area
• One 12ml can provides up to approximately 30 applications, depending on wound size
• Medical device
• NHS prescribable

Suitable wound types include:

Granulox is indicated for the treatment of chronic wounds including:

• Diabetic foot ulcers
• Venous leg ulcers
• Arterial leg ulcers
• Mixed leg ulcers
• Pressure ulcers / pressure injuries
• Secondary healing of surgical wounds

Granulox may also be used on:

• Sloughy wounds
• Infected wounds

provided that the wound has received appropriate clinical treatment.

How Granulox works:

Chronic wounds may have insufficient oxygen available at the wound bed.

Granulox contains highly purified haemoglobin which acts as a carrier for oxygen.

After application:

1. Haemoglobin enters the moist wound environment.
2. It binds oxygen available from the surrounding air.
3. The oxygenated haemoglobin diffuses through the wound exudate.
4. Oxygen is released in areas where oxygen concentration is lower.
5. This improves topical oxygen availability at the wound bed.

Granulox should be considered an adjunct to good wound management, rather than a substitute for treatment of the underlying cause of the wound.

Composition:

Granulox contains:

• 10% carbonylated haemoglobin
• 0.7% phenoxyethanol
• 0.9% sodium chloride
• 0.05% N-acetylcysteine
• Water

The product is a red aqueous solution.

How to use:

Granulox may be applied by a healthcare professional or by a patient or carer who has been appropriately instructed and is under healthcare-professional supervision.

Before treatment:

1. Ensure the underlying cause of the wound is being appropriately treated.
2. Carry out appropriate wound assessment.
3. Debride the wound where clinically necessary.
4. Clean the wound appropriately.
5. If an antiseptic or proteolytic/enzymatic debridement product has been used, rinse the wound thoroughly with an appropriate physiological solution before applying Granulox.

Application:

1. Remove the protective cap.
2. Hold the spray nozzle approximately 5–10cm from the wound.
3. Spray Granulox evenly over the entire wound bed.
4. Apply only enough to form a thin, even coating.
5. Approximately 1–2 seconds of spraying is normally sufficient for a wound measuring around 2cm × 3cm.
6. Replace the protective cap after use.
7. Cover the wound with an appropriate breathable, permeable wound dressing.

Granulox should be applied:

• At every dressing change, or
• At least once every 3 days

unless otherwise directed by the treating healthcare professional.

Do not shake the can.

Granulox maintains a constant consistency, so shaking is unnecessary.

Choice of secondary dressing:

After application, cover the wound with a suitable permeable, non-occlusive dressing.

Granulox should not be used with:

• Occlusive plastic films
• Hydrocolloid dressings

because these may interfere with the oxygenation mechanism.

Use with antiseptics:

Some wound antiseptics can impair the effectiveness of Granulox.

If an antiseptic has been used:

• Thoroughly rinse the wound with a physiological solution before applying Granulox.

The same precaution applies following proteolytic / enzymatic debridement.

Use with topical medicines:

Granulox should not be used simultaneously with locally acting medicines such as topical antibiotics, because potential interactions with haemoglobin have not been adequately evaluated.

If topical medication is required, seek advice from the treating healthcare professional regarding compatibility and treatment sequencing.

Arterial wounds:

Granulox is indicated for arterial wounds, but the underlying arterial insufficiency must be appropriately assessed and managed.

For chronic arterial wounds, appropriate standard-of-care options for improving blood flow should have been considered or exhausted before Granulox is used.

Granulox does not replace:

• Vascular assessment
• Revascularisation where appropriate
• Pressure off-loading
• Compression therapy where indicated
• Infection management
• Debridement
• Other treatment of the underlying cause

Infected wounds:

Granulox may be used on infected wounds after appropriate treatment.

It does not replace appropriate management of wound infection.

Seek clinical review if there is:

• Increasing redness
• Swelling
• Increasing pain
• Purulent discharge
• Offensive odour
• Fever
• Spreading infection
• Rapid deterioration of the wound

Contraindications and precautions:

Do not use Granulox:

• In patients with known hypersensitivity to any of the product components
• During pregnancy, because use in pregnancy has not been adequately assessed
• Simultaneously with locally acting medicines such as topical antibiotics
• With occlusive plastic films
• With hydrocolloid dressings

Stop using Granulox and seek medical advice if:

• The wound deteriorates
• Symptoms worsen
• A suspected hypersensitivity reaction occurs
• Any unexpected adverse effect develops

Nozzle care:

Because the spray valve is very fine, the nozzle may occasionally become blocked.

If this occurs:

• Replace it with one of the spare spray heads supplied with the product, or
• Clean the spray head using an appropriate sterile or preserved cleaning solution.

After cleaning a nozzle, discard the first spray before applying Granulox to the wound.

On first use, continuous spraying can occasionally occur because of the tight nozzle mechanism. If this happens, gently move the nozzle backwards and forwards and slightly upwards until spraying stops.

Storage:

Granulox should normally be stored in a refrigerator at:

2°C to 8°C

On days when the product is being used, it can be kept at room temperature up to:

25°C

If Granulox is being used daily, the container may be kept continuously at room temperature until empty, but total storage at room temperature must not exceed:

6 weeks

After opening, Granulox can be used until the stated expiry date, provided it has been stored correctly.

Keep out of the reach of children.

Pressurised container:

• May burst if heated
• Do not pierce the container
• Do not burn or incinerate, even when empty
• Protect from excessive heat

Product type: Topical Oxygen Therapy / Haemoglobin Wound Spray

Form: Aqueous spray

Haemoglobin content: 10% carbonylated haemoglobin

Application frequency: At every dressing change or at least every 3 days

Approximate coverage: 1–2 seconds for approximately 2cm × 3cm

Approximate applications per can: Up to 30, depending on wound size

Bottle size: 12ml

Pack size: 1 × 12ml spray

Manufacturer reference: 360001

PIP code: 402-8973

NHS / NPC code: ELZ969

BNF / dm+d code: 20032900001

Manufacturer: Hälsa Pharma GmbH

Distributed by: Mölnlycke Health Care

Granulox should be used as part of an appropriate wound-management programme. Chronic, diabetic, arterial, infected or otherwise complex wounds should be assessed and monitored by an appropriately trained healthcare professional.

Product Information Leaflet