Instruction for use: Collatamp IG material implantable

Dosage form: Collagen plate

Pharmacological group

Coagulants (including coagulation factors), hemostatics

The nosological classification (ICD-10)

I78.8 Other capillary diseases: Capillary bleeding; Capillary bleeding in dentistry; Capillary bleeding from superficial wounds; Capillary bleeding in general surgery; Bleeding capillary; Increased brittleness of blood vessels; Teleangiectasia

R58 Bleeding, not elsewhere classified: Abdominal apoplexy; Hemorrhagia; Haemorrhage of the esophagus; Hemorrhage; Generalized bleeding; Diffuse bleeding; Diffuse bleeding; Prolonged bleeding; Blood loss; Blood loss during surgical interventions; Bleeding during surgery and in the postoperative period; Bleeding during labor; Bleeding and haemorrhage in hemophilia B; Bleeding from the gums; Bleeding intraoperative abdominal; Bleeding against a background of coumarin anticoagulants; Hepatic hepatitis; Bleeding in hemophilia A; Bleeding at hemophilia A; Bleeding with inhibitory forms of hemophilia A and B; Bleeding due to leukemia; Bleeding in patients with leukemia; Bleeding; Bleeding due to portal hypertension; Bleeding due to hyperfibrinolysis; Drug bleeding; Local bleeding; Local bleeding due to activation of fibrinolysis; Massive blood loss; Acute blood loss; Parenchymal hemorrhage; Hepatic bleeding; Postoperative hemorrhage; Kidney bleeding; Vascular-platelet hemostasis; Traumatic bleeding; Threatening bleeding; Chronic blood loss

Z100 * CLASS XXII Surgical practice: Abdominal surgery; adenomectomy; Amputation; Coronary angioplasty; Angioplasty of the carotid arteries; Antiseptic skin treatment for wounds; Antiseptic Hand; Appendectomy; atherectomy; Balloon coronary angioplasty; Vaginal hysterectomy; The coronary bypass; Interventions in the vagina and cervix; Interventions on the bladder; Intervention in the mouth; Restoration and reconstructive surgery; Hand hygiene of medical personnel; Gynecologic surgery; Gynecological intervention; Gynecological surgery; Hypovolemic shock during operations; Disinfection of purulent wounds; Disinfection of wounds edges; Diagnostic intervention; Diagnostic procedures; Cervical Diathermocoagulation; Long-surgery; Replacing the fistula catheters; Infection in orthopedic surgery; Artificial heart valve; cystectomy; Short-term outpatient surgery; Short-term operation; Short surgical procedures; Krikotireotomiya; Blood loss during surgery; Bleeding during surgery and in the postoperative period; Kuldotsentez; laser photocoagulation; laser coagulation; retinal laser coagulation; Laparoscopy; Laparoscopy in Gynecology; CSF fistula; Small gynecological operations; Small surgical procedures; Mastectomy and subsequent plastic; mediastinotomy; Microsurgical operations on the ear; Mukogingivalnye operation; suturing; Minor surgery; neurosurgical operation; Immobilization of the eyeball in ophthalmic surgery; testectomy; pancreatectomy; Perikardektomiya; The period of rehabilitation after surgery; The period of convalescence after surgery; Percutaneous transluminal coronary angioplasty; Pleural thoracentesis; Pneumonia postoperative and posttraumatic; Preparation for surgical procedures; Preparation for surgery; Preparation of the surgeon's hands before surgery; Preparation of the colon for surgical procedures; Postoperative aspiration pneumonia in neurosurgical and thoracic surgery; Postoperative nausea; Postoperative bleeding; postoperative granuloma; postoperative shock; The early postoperative period; myocardial revascularization; Radiectomy; gastric Resection; bowel resection; uterine Resection; liver Resection; enterectomy; Resection of part of the stomach; Reocclusion of the operated vessel; Bonding tissues during surgical procedures; Removal of sutures; Condition after eye surgery; Condition after surgery; Condition after surgery in the nasal cavity; Condition after gastrectomy; Status after resection of the small intestine; Condition after tonsillectomy; Condition after removal of the duodenum; Condition after phlebectomy; Vascular surgery; Splenectomy; Sterilization of surgical instruments; Sterilization of surgical instruments; sternotomy; Dental surgery; Dental intervention in periodontal tissues; strumectomy; Tonsillectomy; Thoracic surgery; Thoracic surgery; total gastrectomy; Transdermal intravascular coronary angioplasty; Transurethral resection; Turbinektomiya; Removal of a tooth; cataract surgery; Removal of cysts; tonsillectomy; Removal of fibroids; Removing the mobile primary teeth; Removing polyps; Removing broken tooth; Removal of the uterus body; Removal of sutures; Fistula likvoroprovodyaschih ways; Frontoetmoidogaymorotomiya; Surgical infection; Surgical treatment of chronic limb ulcers; Surgery; The surgery in the anal area; The surgery on the colon; Surgical practice; The surgical procedure; Surgical interventions; Surgery on the gastrointestinal tract; Surgical procedures on the urinary tract; Surgical procedures on the urinary system; Surgical intervention of the genitourinary system; Surgical procedures on the heart; Surgical manipulation; surgery; Surgery on the veins; Surgical intervention; Vascular surgery; Surgical treatment of thrombosis; Surgery; cholecystectomy; Partial gastric resection; hysterectomy; Percutaneous transluminal coronary angioplasty; Percutaneous transluminal angioplasty; Coronary artery bypass; tooth Extirpation; Extirpation of milk teeth; pulpectomy; pulsative cardiopulmonary bypass; tooth Extraction; teeth Extraction; cataract extraction; Electrocoagulation; endourological intervention; episiotomy; Etmoidotomiya; Complications after tooth extraction

Composition

Implantable material (collagen plate) 1 cm2

Active substances: Renatured collagen tendon horse 2,8 mg

Gentamicin sulfate 2 mg

Pharmachologic effect

Mode of action - Hemostatic, antibacterial local.

Action on the body

Renature fibrils of collagen forming the basis of Collatamp® IG, in contact with blood, cause (along with endogenous tissue factors isolated in the wound) enhanced adhesion and aggregation of platelets. This provides stability and acceleration of the process of blood coagulation, which is mechanically promoted by the spongy structure of the material Collatamp® IG.

Gentamicin has a local antibacterial (bactericidal) effect.

Component properties

Collagen has a hemostatic effect, plays an active role in subsequent granulation and epithelialization. The presence of gentamicin in Collatamp® IG reduces the risk of developing a local infection.

Recommended

Implantable material Collatamp® IG is used for local hemostasis in parenchymal and capillary diffuse bleeding localized in areas with a high risk of infection. Fast and complete absorption of Collatamp® IG eliminates the need for its removal during surgery after achieving stable hemostasis.

Contraindications

An allergy to protein;

Intolerance to gentamicin.

With caution: patients with renal insufficiency (under strict medical supervision).

Application of pregnancy and breastfeeding

Due to insufficiently studied tolerability of Collatamp® IG in pregnant or lactating women, they should only use this material if prescribed by a physician.

Side effects

To date, no side effects have been observed.

Interaction

There is no information on the interaction with other drugs. If the use requires the treatment of aminoglycoside antibiotics, as well as other oto- or nephrotoxic drugs, the possible cumulative effect should be considered.

Dosing and Administration

For application to the area of parenchymal / capillary bleeding to provide local hemostasis and reduce the risk of local infection.

In the absence of other indications, the material implanted with Collatamp® IG is applied whole or cut into parts corresponding to the area of the planned application (the area of hemostasis). In each individual case, it is possible to use no more than 3 Kollatamp® IG plates (calculation by size 10 × 10 cm). It should also take into account the patient's body weight and the total amount of absorbed gentamicin-the total dose should not be above 9 mg / kg of gentamycin sulfate (for reference: 1 cm2 of Collatamp® IG contains 2 mg of gentamycin sulfate). Such control of the use of this material avoids the occurrence of therapeutically effective concentrations of gentamicin in plasma.

Before applying Kollatamp® IG, the application area should be dried as much as possible. To ensure a firm fixation, a dry plate of Collatamp® IG should be pressed firmly against the wound surface for 3 minutes. To avoid undesirable adherence of Collatamp® IG to gloves and medical instruments, they should be pre-wetted.

Special instructions

The material is intended for single use only.

Do not use the material if the sterile packaging is damaged.

Repeated sterilization of Collatamp® IG is prohibited.

Release Form

The implantable material is "Collatamp® IG" 5 × 5 × 0.5 cm; 10 × 10 × 0.5 cm; 5 × 20 × 0.5 cm (packages contain 1 plate).

Manufacturer

"Cintacoll GmbH", Germany.

Syntacoll GmbH. Donaustrafie 2

Distributor: "UZA Farma (Europe) Ltd.", Great Britain.

EUSAPharma (Europe) Ltd.

The Magdalen Center, Oxford Science Park, Oxford OX4 4GA, United Kingdom.

Representative in the Russian Federation: LLC "Robertc Helskear (RUS)"

119361, Moscow.

Storage conditions of the drug Collatamp IG material implantable

In a dark, cool place, at a temperature of 4-25 ° C. In the original packaging.

Keep out of the reach of children.

The shelf life of the drug Collatamp IG material implantable

4 years.

Do not use beyond the expiration date printed on the package.