의사와 환자가 환자의 상태에 대해 논의합니다

SynchroMed II
약물 펌프

중증 경직

synch2-th

SynchroMed® II 약물 펌프는 몸 안에 약물을 저장하고 분배하는 소형의 배터리 구동 장치입니다. 펌프는 카테터라는 얇고 유연한 관을 통해 척추 주변 체액에 약을 전달합니다.

의사가 특정 양의 약물을 방출하도록 펌프를 프로그래밍합니다. 양과 타이밍 모두 필요에 따라 조정할 수 있습니다. 중증 경직 치료를 위해 펌프가 Lioresal® Intrathecal(바클로펜 주입)이라는 액체 형태의 바클로펜을 지속적으로 전달합니다.

특징

  • 환자의 필요에 맞게 프로그래밍 가능 – 담당 의사가 전달해야 하는 약물의 양을 지정하도록 장치를 프로그래밍합니다. 나중에 경직이 심해지거나 새로운 치료 목표가 생기는 경우 의사가 용량을 조정할 수 있습니다.
  • 유연한 투여 – 펌프는 하루에 13번까지 약물의 양을 변화시키도록 프로그래밍할 수 있으므로 필요할 때 바클로펜의 양을 늘리거나 줄일 수 있습니다. 프로그래밍은 계획한 활동에 맞게 날마다 달라질 수도 있습니다.
  • 장치 정보 저장 – 펌프에 장치 및 설정에 관한 중요한 데이터가 저장되므로 여행을 가거나 병원을 변경할 때 기록을 가져갈 필요가 없습니다. 의사는 임상의 프로그래밍 장치를 사용해 해당 정보에 액세스할 수 있습니다.
  • 교체 시기 예측 가능 – 배터리가 소진되기 전에 경보가 울리므로 교체를 계획할 시간이 충분합니다.
  • MR 조건부 안전 – 이 펌프는 특정 조건하에서 3-Tesla MRI 장비에서 사용할 수 있도록 승인되었습니다.

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.