solutions for tissue adhesives. Active substances: human fibrinogen, human thrombin, aprotinin, calcium chloride dihydrate
1. What Artiss is and what it is used for
What Artiss is
Artiss is a two-component tissue adhesive that contains two of the proteins that make the blood coagulate. These proteins are called fibrinogen and thrombin. When these proteins are mixed during application, they form a clot where a surgeonapplies them.
Artiss is prepared as two solutions (protein solution for tissue adhesives and thrombin solution) which are mixed upon application.
What Artiss is used for
Artiss is a tissue adhesive.
Artiss is applied to tissues to glue them together in plastic, reconstructive, and burn surgery. Artiss can be used, for example, when fixing skin grafts or skin flaps on burns or to attach the skin to the underlying tissue during plastic surgery. Artificial skin can also be fixed on wounds with Artiss.
The clot created with Artiss is very similar to a natural blood clot, which means that it dissolves naturally and leaves no residue. However, aprotinin (a protein that delays the dissolution of the clot) is added to increase the shelf life of the clot and to prevent it from dissolving prematurely.
2. What you need to know before using Artiss
Do not use Artiss
- If you are allergic to any of the active substances or any of the other ingredients of this medicine (listed in section 6).
- Artiss should not be used in case of heavy or heavy bleeding.
- Artiss is not indicated for replacement of skin sutures to end a surgical wound.
- Artiss is not indicated for use in neurosurgery or as suture support in gastrointestinal anastomoses or vascular anastomoses as there are no data to support these indications.
- Artiss MUST NOT be injected into blood vessels (veins or arteries ) or into tissues . Because Artiss forms a clot when applied, injection of Artiss can cause severe reactions (eg clogging of vessels ). Artiss should only be applied as a thin layer on the tissue surface where it is needed.
- You must not use Artiss if you are allergic (hypersensitive) to the active substances, bovine protein, or any other ingredient (see section 6) of Artiss. It can cause severe allergic reactions.
Tell your doctor or surgeon if you know you are allergic to aprotinin or any bovine protein .
Warnings and cautions
- Talk to your doctor, pharmacist or nurse before using Artiss.
- Artiss may not be used in laparoscopic surgery (peephole surgery).
- Life-threatening / fatal air or gas embolism (air enters the bloodstream, which can be serious or life-threatening) has occurred when the pressure regulator spray is used to administer fibrin tissue adhesives. This seems to be related to the use of the spray set at higher pressures than recommended and/or close to the tissue surface. The risk appears to be greater when fibrin tissue adhesive is sprayed with air compared to CO 2 and can therefore not be ruled out for Artiss.
- When Artiss is applied using a spray set, the pressure and spray distance must be within the range recommended by the manufacturer of the spray set. Artiss should only be administered in strict accordance with the instructions and only with the devices recommended for this product.
- When Artiss is sprayed on, changes in blood pressure , heart rate , oxygen saturation and final CO2 must be monitored for possible gas embolism.
- Artiss must not be used together with EasySpray / Spray set systems in closed cavities on the body.
- Use only CE-marked applicators intended for the administration of Artiss.
- If you have received Artiss or aprotinin before, your body may have become hypersensitive to it. It is possible that you are allergic to the material, even if you did not react at the first application. If you think you have been treated with any of the products in a previous operation, you must inform your doctor.
- If there are any signs of an allergic reaction, your doctor will immediately stop using Artiss and give you appropriate treatment.
- Before applying Artiss, the parts of the body that are not to be treated must be protected/covered to prevent tissue gluing in unwanted areas.
- Artiss is applied in a thin layer. Too thick a layer can adversely affect the efficiency of the product and the wound healing process.
When medicines are made from human blood or human plasma, special measures are taken to prevent the transmission of infection to patients. These include:
- careful selection of blood and plasma donors to ensure that people at risk of becoming carriers are excluded;
- testing of individual donations and plasma pools for signs of virus / infection,
- inclusion of steps in the processing of blood and plasma that can inactivate and secrete viruses .
Nevertheless, the risk of transmission of infection can not be completely ruled out when drugs made from human blood or human plasma are given. This also applies to new, hitherto unknown viruses and other types of infections . The measures taken are considered effective for enveloped viruses, such as human immunodeficiency virus ( HIV ), hepatitis B virus, and hepatitis C virus, and for the non-enveloped hepatitis A virus.
The measures may be of limited value against non-enveloped viruses such as parvovirus B19. A parvovirus B19 infection can be serious in pregnant women ( fetal infection ) and in individuals with a weakened immune system or who have certain types of anemia (eg sickle cell anemia or hemolytic anemia ).
It is strongly recommended that the product name and batch number be noted each time you receive a dose of Artiss to enable traceability of the product used.
Other drugs and Artiss
Artiss can be used at the same time as other medicines. There are no known interactions between Artiss and other medical products. Your doctor will not use products containing oxycellulose as an aid in the application as these may reduce the effectiveness of Artiss.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Artist with food and drink
Consult a doctor. Your doctor will decide if you are allowed to eat or drink before applying Artiss.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice. Your doctor will decide if you can use Artiss during pregnancy or breast-feeding.
Driving and using machines
Artiss does not affect your ability to drive or use any other type of machine.
3. How to use Artiss
- Artiss is only applied during a surgical procedure. The use of Artiss is limited to experienced surgeons who have been trained in the use of Artiss.
- The amount of Artiss used depends on a number of factors, including the type of surgery, the surface area of the tissue to be treated during the operation and the way Artiss is applied. A surgeon decides how much is appropriate.
- During the operation, the surgeon applies an Artis on the relevant tissue surface with the special device that comes with it. This unit ensures that an equal amount of both tissue adhesive components is applied at the same time, which is important to get the optimal effect of Artiss.
- Before Artiss, the surface area of the wound must be wiped with standard techniques (eg repeated application of compresses or cotton swabs, or with the help of suction devices.
- Artiss may only be sprayed on visible application areas.
- It is recommended that the initial application covers the entire intended application area.
When applying Artiss using a spray set, be sure to use a pressure and a distance from tissue one that is within the range recommended by the manufacturer as follows:
| Recommended pressure, distance and device for spraying Artiss | |||||
|---|---|---|---|---|---|
| The spray set to be used | Applicator tips to be used | Pressure regulator to be used | Recommended distance from the target tissue | Recommended spray pressure | |
| Open surgery on the subcutaneoustissue | Tisseel / Artiss sprayset | not applicable | EasySpray | 10 – 15 cm | 1.5–2.0 bar(21.5-28.5 psi) |
| Tisseel / Artiss sprayset 10 pack | not applicable | EasySpray |
When Artiss is sprayed on, changes in blood pressure , heart rate , oxygen saturation and final tidal CO2 should be monitored for the risk of air or gas embolism (see section 2) .
If you use too much Artiss
Artiss is only applied during a surgical procedure. It is applied by surgeon one and the amount of Artis is determined by surgeon one.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following table shows what is meant by a certain frequency.
| very common: may affect more than 1 user in 10 |
| common: may affect up to 1 in 10 users |
| uncommon: may affect up to 1 in 100 people |
| rare: may affect up to 1 in 1000 users |
| very rare: may affect up to 1 in 10,000 users |
| no known frequency (cannot be calculated from the available data) |
- There is a small possibility that you may have an allergic reaction to any of the components in Artiss (see section 6). It is more likely if you have been treated with Artiss or aprotinin in a previous operation. Allergic reactions can be serious and it is very important that you discuss this risk in detail with your doctor.
- Anaphylactic / anaphylactoid allergic reactions may occur, the frequency of such reactions is unknown. Early symptoms of allergic reactions may include: flushing, drop in blood pressure, increased or decreased heart rate, nausea, rash, itching, difficulty breathing.
- The treating surgeon team is aware of the risk of such a type of reaction. If they see any symptoms, the application of Artiss is stopped immediately. Severe symptoms may require emergency care. The frequency of allergic reactions is unknown.
- If Artiss is injected into soft tissues, it can cause local tissue damage. The frequency is not known.
- If Artiss is injected into blood vessels (veins or arteries ), it can lead to blood clots ( thrombosis ). The frequency is not known.
- Because Artiss is made from plasma from blood donors, the risk of infection can not be completely ruled out, but the manufacturer takes several measures to reduce the risk (see section 2).
Adverse reactions have been reported from clinical trials with Artiss and proven experience with the use of Baxter tissue adhesive after the product launch is summarized below. Known frequencies of these side effects are based on a controlled clinical study of 138 patients where Artiss has been used to attach skin grafts to surgically removed burns. None of the cases observed in the clinical study were classified as serious.
| Table 1Side effect ar | |
|---|---|
| Side effect | Frequency |
| Skin cyst | Less common |
| Itching | Usual |
| Failed skin graft | Usual |
| Gas bubbles in the bloodstream (air embolism) * | None known |
* The appearance of air or gas bubbles in the bloodstream (air embolism) has been noted when fibrin tissue adhesive is applied using the spray in combination with pressurized air or gas; this is thought to be caused by improper use of the spray set (eg at higher pressures than recommended and too close to the tissue surface).
The following side effects have been reported for other tissue adhesives. Frequencies of these side effects can not be calculated: Allergy , severe allergic reaction , slow heartbeat, fast heartbeat, low blood pressure , bloodshed, shortness of breath, nausea, hives , swelling, impaired healing, swelling, fever and accumulation of lymphor other clear body fluids at the surgical site.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How Artiss should be stored
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the label after “EXP”.
- Store and transport frozen (≤ -20 ° C). The free chain must not be broken before use.
- Store the syringe in the original package. Sensitive to light.
Storage after thawing:
Unopened bags, thawed at room temperature, can be stored for up to 14 days at controlled room temperature (not above + 25 ° C).
After thawing, the solutions must not be frozen again or stored in the refrigerator!
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
Artiss contains two components:
Component 1 = Protein solution for tissue adhesives
The active substance in 1 ml of protein solution for tissue adhesives is:
Human fibrinogen, 91 mg / ml, synthetic aprotinin 3000 KIU / ml.
Excipients are human albumin, L-histidine, niacinamide, polysorbate 80, sodium citrate dihydrate and water for injections .
Component 2 = Thrombin solution
The active substance in 1 ml of thrombin solution is:
Human thrombin 4 IU / ml, calcium chloride dihydrate 40 µmol / ml
Excipients are human albumin, sodium chloride and water for injections .
| After mixing | 1 ml | 2 ml | 4 ml | 10 ml |
|---|---|---|---|---|
| Component 1: Protein solution for tissue adhesivesHuman fibrinogen(as coagulable protein )Aprotinin (synthetic) | 45.5 mg 1500 KIU | 91 mg 3000 KIU | 182 mg 6000 KIU | 455 mg 15000 KIU |
| Component 2: Thrombin solutionHuman Thrombin Calcium Chloride | 2 IU20 µmol | 4 IU40 .mol | 8 IU80 .mol | 20 IU200 µmol |
Artiss contains human factor XIII, co-purified with human fibrinogen, at a level of 0.6 – 5 IU / ml.
What the medicine looks like and contents of the pack
1 ml, 2 ml or 5 ml protein solution for tissue glue and 1, 2 or 5 ml thrombin solution in a single dose two-chamber syringe (polypropylene) with a protective cap in a bag, and an accessory set with a double syringe plunger, 2 nozzles and 4 application needles.
The solution is colorless or pale yellow.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Baxter Medical AB
Box 63
164 94 Kista
Manufacturer
Baxter AG
Industriestraße 67
A-1221 Vienna
Austria
This medicinal product is authorized under the European Economic Area under the names:
ARTISS in the following countries: Austria, Belgium, the Czech Republic, Germany, Greece, Spain, Finland, France, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, the United Kingdom.
Artist in Denmark, Iceland,