Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - nexobrid

Document Subject

Generated Narrative: MedicinalProductDefinition mp9af2a44fa579cd6ab6e3934e61bad8e0

identifier: http://ema.europa.eu/identifier/EU/1/12/803/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: NexoBrid 2 g powder and gel for gel

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-9af2a44fa579cd6ab6e3934e61bad8e0

identifier: http://ema.europa.eu/identifier/EU/1/12/803/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - nexobrid

Attesters

What is in this leaflet

1. What NexoBrid is and what it is used for
2. What you need to know before NexoBrid is used
3. How NexoBrid is used
4. Possible side effects
5. How NexoBrid is stored
6. Contents of the pack and other information

What NexoBrid is NexoBrid contains a mixture of enzymes called concentrate of proteolytic enzymes enriched in bromelain , which is produced from an extract from the stem of the pineapple plant.

What NexoBrid is used for NexoBrid is used in adults, adolescents and children of all ages to remove burnt tissue from deep or partially deep burn wounds of the skin.
Using NexoBrid may reduce the need for, or the extent of, surgical removal of burnt tissue and/or skin transplantation.

NexoBrid must not be used:

• if you or your child are allergic to bromelain
• if you or your child are allergic to pineapples
• if you or your child are allergic to papaya/papain
• if you or your child are allergic to any of the other ingredients of the powder or gel (listed in section 6).

Warnings and precautions Talk to your doctor or nurse before NexoBrid is used if:

• you or your child have a heart disease;
• you or your child have diabetes;
• you or your child have an active peptic ulcer in the stomach,
• you or your child have a vascular disease (with vascular occlusion);
• you or your child have enlarged veins in the area close to the burn;
• you or your child have implants or a pacemaker or a vascular shunt;
• you or your child have problems with bleeding or if you or your child take blood-thinners;
• your or your child's wound(s) came into contact with chemicals or other hazardous substances;
• you or your child have a lung disease;
• your or your child's lung has been, or may have been damaged by inhalation of smoke;
• you or your child are allergic to latex, bee stings, or olive tree pollen. If so, you or your child may also experience allergic reactions to NexoBrid. Allergic reactions can cause, for example, breathing difficulties, swelling of the skin, hives, other skin reactions, redness of the skin, low blood pressure, fast heart rate and abdominal discomfort, or a combination of such effects. If you or your child notice any of these signs or symptoms, inform your doctor or caregiver immediately. Allergic reactions can be severe and require medical treatment. In case of skin contact, rinse NexoBrid off with water. This is to make an allergic reaction to NexoBrid
  less likely.

The use of NexoBrid to remove burnt tissue may lead to fever, to wound inflammation or wound infection, and possibly to general infection. You or your child may be checked regularly for these conditions and
may receive medicines to prevent or treat infections.

NexoBrid may reduce the ability of the blood to form clots, which increases the risk of bleeding. NexoBrid should be used with caution if you or your child are treated with medicines that reduce the blood s ability to form clots (so-called blood-thinners) or if you or your child have a general tendency to bleed, a stomach ulcer, blood poisoning, or another condition that could cause you or your child to bleed. After treatment with NexoBrid your doctor may check blood coagulation levels.

Direct contact of NexoBrid with the eyes should be avoided. If NexoBrid goes into the eyes, wash them with lots of water for at least 15 minutes.

To prevent wound-healing problems, the treated burn wound will be covered as soon as possible by temporary or permanent skin substitutes or dressings.

NexoBrid should not be used in chemical burn wounds, electrical burns, foot burns in diabetic patients and patients with occlusive vascular disease, in contaminated wounds and wounds where NexoBrid could come in contact with foreign materials (for example, implants, pacemakers, and shunts) or large blood vessels, the eyes or other important body parts. NexoBrid should be used with caution in areas of varicose veins (enlarged twisted veins), to prevent risk of bleeding from them.

Other medicines and NexoBrid Tell your doctor if you or your child are taking, have recently taken or might take any other medicines.

Your doctor will be cautious and watch for signs of reduced blood coagulation or bleeding when prescribing other medicines that affect blood coagulation, because NexoBrid may reduce blood coagulation.

NexoBrid may:

• increase the effects of certain medicines that are inactivated by a liver enzyme called CYP2C8 and CYP2C9. This is because NexoBrid can be absorbed from the burn wound into the blood stream.

Examples of such medicines are:

• amiodarone (used to treat certain forms of irregular heartbeat),

• amodiaquine and chloroquine (used to treat malaria and some forms of inflammation),

• fluvastatin (used to treat high cholesterol),

• pioglitazone, repaglinide, tolbutamide and glipizide (used to treat diabetes),

• paclitaxel (used to treat cancer),

• torasemide (used to increase urine flow),

• ibuprofen (used to treat fever, pain and some forms of inflammation),

• losartan (used to treat high blood pressure),

• celecoxib (used to treat some forms of inflammation),

• warfarin (used to reduce blood coagulation), and

• phenytoin (used to treat epilepsy).

• intensify your or your child s reaction to the cancer medicines fluorouracil and vincristine.

• cause an unwanted drop in blood pressure when you or your child are treated with medicines called ACE inhibitors, which are used to treat high blood pressure and other conditions.

• increase drowsiness when used at the same time with medicines that can cause drowsiness. These medicines include, for example, sleep medications, so-called tranquilizers, some pain medications and antidepressants.

• Silver sulfadiazine or povidone-iodine at the wound site may decrease the efficacy of the medicinalproduct.

If you are not sure whether you or your child are taking any of the medicines mentioned above, ask your doctor before NexoBrid is used.

Pregnancy and breast-feeding The use of NexoBrid during pregnancy is not recommended. As a precautionary measure, you should not breast-feed for at least 4 days after NexoBrid application. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, talk to your doctor or pharmacist before this medicine is used.

NexoBrid is for use by specialists in burn clinics only. It will be prepared directly before use and applied by a doctor or another healthcare professional.

2 g NexoBrid powder mixed in 20 g gel is applied 1.5 to 3 millimetres thick to a burn wound area of 1 percent of an adult patient s body surface.

It should be left for 4 hours, and then be removed. A second and subsequent application is not recommended.

NexoBrid should not be applied to more than 15% of the total body surface in adults and children/adolescents from 4 18 years.

In children aged 0-3 years this medicine should not be applied to more than 10% of the total body

surface.

Instructions for the preparation of the NexoBrid gel are given at the end of this leaflet in the section intended for medical or healthcare professionals.

Before it is applied to a burn wound, NexoBrid powder is mixed into a gel. It should be used within 15 minutes after mixing.

NexoBrid will be applied to a wound area that is clean, blister free, and moist.

Other medicines (such as silver sulfadiazine or povidone-iodine) will be removed from the wound area before NexoBrid is applied.

Before NexoBrid application, a dressing soaked with an antibacterial solution will be applied for 2 hours.

You or your child will be given appropriate medicine to prevent and treat pain at least 15 minutes before NexoBrid is applied and before removal.

After NexoBrid and the dead tissue have been removed from the wound, a dressing soaked with an antibacterial solution will be applied for an additional 2 hours.

The vial containing powder, gel bottle, and the prepared mixed gel are for single use only.

If too much NexoBrid is used
If too much NexoBrid gel is applied on a burn wound, excess gel may be wiped off.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions to NexoBrid can occur and can cause, for example, breathing difficulties, swelling of the skin, hives, redness of the skin, low blood pressure, fast heart rate and sickness/vomiting/stomach cramp, or a combination of such effects. If you or your child notice any of these symptoms or signs, inform your doctor or caregiver immediately.

Very common (may affect more than 1 in 10 people)

• Fever

Common (may affect up to 1 in 10 people)

• Pain in the treated area of the burn wound (even if medicines are used to prevent or lessen pain caused by the removal of burnt tissue)
• Infection of the burn wound, including infection of the skin around the wound (cellulitis)
• Complications of the wound including wound deepening, wound opening, wounds drying out and breaking down, failure of skin grafts to heal properly.
• Rash or redness in the area around the burn wound
• Non serious allergic reactions such as rash.
• Rapid heartbeat
• Itching in the burn wound area. Itching of the burn wound area, is very frequent as part of the normal burn healing process.

Uncommon

• Bruising in the wound area

Not known frequency (frequency cannot be estimated from the available data)

• Serious allergic reactions including anaphylaxis

Reporting of side effects If you or your child get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use NexoBrid after the expiry date which is stated on the label of the vial, bottle, and box after EXP . The expiry date refers to the last day of that month.

Store and transport refrigerated (2 C-8 C).

NexoBrid must be stored upright to keep the gel at the bottom of the bottle and in the original package to protect from light. Do not freeze.

NexoBrid should be used within 15 minutes after mixing the powder with the gel. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Nexobrid contains

• The active substance (in the powder in the vial) is a concentrate of proteolytic enzymes enriched in bromelain: one vial contains 2 g, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing.
• The other ingredients are: * for the powder: ammonium sulphate and acetic acid * and for the gel carbomer 980, disodium phosphate anhydrous, sodium hydroxide, and water for injections.

What NexoBrid looks like and contents of the pack This medicinal product is provided as a powder and gel for gel (powder in a vial (2 g) and gel in a bottle (20 g)), pack size of 1 (a pack contains one vial of powder and one bottle of gel)

The powder is off-white to light tan and the gel is clear and colourless.

For any information about this medicine, please contact the Marketing Authorisation holder.

Marketing Authorisation Holder

MediWound Germany GmbH Hans-Sachs-Strasse 65428 R sselsheim Germany e-mail: info@mediwound.com

Manufacturer Diapharm GmbH & Co. KG
Am Mittelhafen 56 48155 M nster
Germany

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: