의사와 환자가 환자의 상태에 대해 논의합니다

ITB 요법에 대한 정보

중증 경직

알약이나 주사제와 같은 치료법이 중증 경직에 대한 충분한 완화 효과를 제공하지 못하거나 견딜 수 없는 부작용을 유발하는 경우, 바클로펜 펌프 또는 ITB 요법SM이라고 하는 FDA 승인 치료법에 대해 전문가와 상담하십시오. 바클로펜 펌프를 고려해야 하는 이유는 무엇일까요?

무엇인가요?

바클로펜 펌프를 사용한 치료법의 작동 방식에 대해 알아보십시오.

자세히


펌프

메드트로닉 싱크로메드(SynchroMed)® 펌프는 리오레살® 경막내(Lioresal® Intrathecal)(바클로펜 주사)라는 전문의약품을 저장 및 전달하는 프로그래밍 가능, 배터리 구동식 의료기기입니다. 이 펌프는 수술을 통해 복부에 삽입됩니다. 카테터라고 하는 가늘고 유연한 관이 척추 가까이에 삽입되어 펌프에 연결됩니다.

자세히 보기: SynchroMed II 펌프


이익 및 위험

바클로펜 펌프를 사용한 치료법의 이익과 위험에 대해 알아보십시오.

자세히


질문과 답변

바클로펜 펌프를 사용한 치료법에 대해 자주 묻는 몇 가지 질문에 대해 답변을 제공해 드렸습니다.

자세히



The Medtronic baclofen pump is part of the Synchromed® Infusion System, which delivers the drug called Lioresal® Intrathecal (baclofen injection) for ITB TherapySM, a treatment for severe spasticity. Please read the following important safety information about ITB Therapy.

IMPORTANT SAFETY INFORMATION FOR ITB THERAPY (Intrathecal Baclofen Therapy)

Please follow your doctor's instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious baclofen withdrawal symptoms such as high fever, changed mental status, muscle stiffness, and in rare cases may result in loss of function of many vital organs and death. It is very important that your doctor be called right away if you experience any of the above symptoms.

It is important for you to keep your scheduled refill visits so you don't run out of medication (baclofen) and to know the early symptoms of baclofen withdrawal. Some patients are at more risk than others for baclofen withdrawal; speak with your doctor about this.

People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, brain injury, or spinal cord injury may be candidates for ITB Therapy. If you have spasticity due to spinal cord injury or multiple sclerosis, you may be considered for ITB Therapy if oral baclofen has not controlled your spasticity or has resulted in serious side effects that you cannot accept. If you suffered a brain injury due to trauma you must wait until one year after the injury to be considered for ITB Therapy. A trial of ITB Therapy will help to show if ITB Therapy can help you. You should not receive ITB Therapy if you have an infection, are allergic to baclofen, or your body size is too small for the implantable pump.

The implanted pump and catheter (tube that delivers the drug from the pump to the fluid around the spinal cord) are placed under the skin during a surgery. Some complications that you may experience with the surgery include infection, meningitis (infection of the lining of the brain and central nervous system), spinal fluid leak, paralysis, headache, swelling, bleeding, and bruising.

The most common and/or serious drug-related side effects of ITB Therapy include loose muscles, sleepiness, upset stomach, vomiting, headaches, and dizziness. Failure of the pump placed under your skin may cause symptoms due to overdose (receiving too much) or underdose (receiving too little) of intrathecal baclofen. The signs and symptoms of overdose include drowsiness, lightheadedness, dizziness, respiratory depression (difficulty breathing), hypothermia (lower than normal body temperature), seizures, loss of consciousness, and coma. Once the infusion system (the pump and the catheter) is implanted, possible complications include unintended movement of the catheter or pump within the body or breakdown of the skin over the pump. The catheter could leak, tear, kink, or become disconnected from the pump, resulting in underdose or no baclofen infusion. Symptoms of underdose include an increase or return in spasticity, itching, low blood pressure, lightheadedness, and tingling sensation. These symptoms are often early signs of baclofen withdrawal. The pump could stop because the battery has run out or because of a problem with one or more of its inner parts. The pump will sound an alarm when the pump needs to be filled with baclofen, replaced, or if there is a problem with the pump. You or your caregiver should always inform any healthcare personnel that you have an implanted infusion system before any medical or diagnostic procedure such as MRI or diathermy.

For more information, please read the Lioresal® Intrathecal (baclofen injection) Full Prescribing Information and the SynchroMed Infusion System Information.

This therapy is not for everyone. Please contact your doctor. A prescription is required.

Lioresal® is a registered trademark of Medtronic, Inc.

USA Rx Only Rev 0913

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.


Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.