RYANODX®를 선택하는 이유
1분 투여
1분 미만의 재구성 및 투여
대부분의 환자에게 1개 바이알
바이알당 250mg 댄트롤렌 나트륨 함유
1명의 제공자 재구성
한 명의 의료 제공자에 의한 간단한 재구성
Understanding Malignant Hyperthermia (MH)
What is Malignant Hyperthermia?
Malignant hyperthermia (MH) is a pharmacogenetic disease that causes hypermetabolism, a fast rise in body temperature and severe muscle contractions when an affected person receives general anesthesia using volatile anesthetics or the paralytic succinylcholine.
The disorder is due to an acceleration of the metabolism in skeletal muscle. The underlying defect is abnormally increased levels of cellular calcium in the skeletal muscle.
How Prevalent is MH?
Incidences of MH during anesthesia procedures
Time to Treatment is Critical
Every minute counts in MH crisis management
⚠️ An initial 20-minute delay in administration of dantrolene sodium raises the risk of complications to 30%
Every delay in treatment increases the risk of further complications during an MH crisis
Dantrolene Administration Time vs. Complications
Based on clinical study data (2014)
Complication Rate (%)
Early Signs of MH
Multiple signs may prompt a diagnosis of MH by anesthesia practitioners
🚨 Hypercarbia is often the first clinical sign of MH
Other early signs include sinus tachycardia and masseter spasm
Signs and Symptoms Include:
High Fluid Volumes Complications
With low-concentration, high-volume MH treatment, the MHAUS recommendation of 2.5 mg/kg loading dose requires considerable volumes of sterile water (e.g., 750 mL for a 100 kg patient)
Potential complications from high fluid volumes:
How Response Time Affects MH Treatment Outcomes
Stopping the triggering agents and administering dantrolene sodium as quickly as possible are the greatest priorities in an MH crisis
The time and human resources needed to prepare and administer low-concentration formulations of dantrolene sodium may cause treatment delays
RYANODX®는 나노현탁 기술을 사용합니다
RYANODX®의 나노크리스탈 현탁액 농도는 표준 댄트롤렌의 150배입니다.
10초 재구성
독특한 나노현탁 기술 제제는 10초 안에 신속한 재구성을 가능하게 하며, 투여 전에 용해할 필요가 없어 대용량, 저농도 댄트롤렌 나트륨 제제에 비해 더 적은 멸균수를 사용합니다.
1명의 제공자가 1개의 바이알을 사용하여 1분 이내에 신속한 반응을 가능하게 하는 RYANODX®에 대해 알아보세요.
고급 나노현탁 기술과 동결건조 제제의 결합으로 RYANODX®는 다른 댄트롤렌 나트륨 제제와 비교하여 현저히 짧은 투여 시간으로 주사용 멸균수로 재구성할 수 있습니다.
적응증
주사용 현탁액 RYANODX® (댄트롤렌 나트륨)은 적절한 지지 요법과 함께 악성 고열증의 치료와 고위험 환자에서 악성 고열증의 예방에 적응됩니다.
RYANODX® vs. Other Dantrolene Formulations
See the dramatic difference in preparation time and efficiency
Out with the Old, In with the New
The future of MH treatment is here
Traditional 20mg Dantrolene
Multiple vials required
RYANODX® 250mg
Single vial solution
ℹ️ Note: Traditional formulations will still be stocked in pharmacy for post-emergent treatment after initial stabilization
Preparation and Administration of 250 mg of Dantrolene
| Dantrolene Sodium Nanosuspension | Dantrolene Sodium | |
|---|---|---|
| Dantrolene per vial | 250 mg | 20 mg |
| Volume of sterile water for injection to reconstitute | 5 mL | 60 mL |
| Vials to be reconstituted | 1 | 13 |
| Reconstitution and administration time | <1 minute | >22 minutes |
| Sterile water for injection | 5 mL | 750 mL |
| Staff needed | 1 | >2 |
| Final concentration of dantrolene | 50 mg/mL | 0.33 mg/mL |
Patient Weight-Based Dosing Comparison
| Patient weight | Required dose of dantrolene | RYANODX® | Other Formulations | ||
|---|---|---|---|---|---|
| Required number of vials | Volume of sterile water needed for reconstitution | Required number of vials | Volume of sterile water needed for reconstitution | ||
| 10 kg | 25.0 mg | 1 | 5 mL | 2 | 120 mL |
| 50 kg | 125.0 mg | 1 | 5 mL | 7 | 420 mL |
| 80 kg | 200.0 mg | 1 | 5 mL | 10 | 600 mL |
| 110 kg | 275.0 mg | 2 | 10 mL | 14 | 840 mL |
⚡ Pediatric administration for RYANODX® requires significantly fewer vials than other formulations
💧 Volume of sterile water is a consideration
RYANODX® Product Gallery
Real product packaging and detailed specifications
Package back with Eagle Pharmaceuticals branding
Product labeling and key information
Detailed composition and storage instructions
Modern package design with QR code
Key Specifications
RYANODX® (dantrolene sodium) for injectable suspension
Composition per vial
pH approximately 10.3 when reconstituted with 5 mL Sterile Water for Injection
Storage & Handling
📦 Store unreconstituted product at 20°C to 25°C (68°F to 77°F)
⏰ Use within 6 hours after reconstitution
🛡️ Protect from light
Manufacturer
🦅 Eagle Pharmaceuticals, Inc.
📍 Woodcliff Lake, NJ 07677
🇹🇼 Product of Taiwan
Revolutionary Features
High-concentration nanosuspension technology
Single-dose vial convenience
Rapid reconstitution (< 1 minute)
Minimal fluid volume requirements
4가지 간단한 단계 - 1분 이내 투여
재구성
박테리오스타틱 제제 없는 주사용 멸균수 5mL 추가
흔들기
균일한 오렌지색 현탁액이 되도록 바이알을 흔들어주세요
약 10초 필요
주사기 채우기
투여 전 바이알을 육안으로 검사하여 입자 및 변색 확인
재구성된 현탁액의 적정 용량을 주사기에 뽑아냅니다
투여
RYANODX®는 정맥내 푸시로 투여해야 합니다
성인 및 소아 용량
치료 용량
RYANODX®를 정맥내 푸시로 최소 용량 1 mg/kg로 투여
MH의 생리적 및 대사적 이상이 지속되면 최대 누적 용량 10 mg/kg까지 정맥내 푸시 계속
MHAUS는 초기 및 반복 치료 용량으로 2.5 mg/kg를 권장
예방 용량
권장 예방 용량: 2.5 mg/kg를 최소 1분에 걸쳐 정맥내 투여, 수술 약 75분 전 시작
MH 유발 약물 피하기
장시간 수술의 경우 마취 및 수술 중 추가 개별화된 RYANODX® 용량 투여
중요: 바이알의 내용물은 재구성 후 6시간 이내에 사용해야 합니다. 재구성된 현탁액은 제어된 실온(68°F~77°F 또는 20°C~25°C)에서 보관하십시오.
MH Crisis Dosing and Administration
Required Supportive Measures
In addition to RYANODX® treatment, the following supportive measures should be taken:
- Discontinue MH triggering anesthetic agents (such as volatile anesthetic gases and succinylcholine)
- Manage metabolic acidosis
- Cooling when necessary
- Maintain adequate diuresis as needed
Dosing And Administration of RYANODX® During An MH Crisis
Administer RYANODX® by intravenous push at a minimum dose of 1 mg/kg. If the physiologic and metabolic abnormalities of MH continue, administer additional intravenous boluses up to the maximum cumulative dosage of 10 mg/kg. If the physiologic and metabolic abnormalities reappear, repeat RYANODX® dosing by intravenous push starting with 1 mg/kg.
Dosing for MH Recurrence
If physiological and metabolic abnormalities reappear, repeat RYANODX® administration by intravenous push starting at 1 mg/kg.
Dosing for Prevention of Malignant Hyperthermia
The recommended prophylactic dose of RYANODX® is 2.5 mg/kg administered intravenously over at least 1 minute, starting approximately 75 minutes before surgery. Avoid MH triggering agents.
When administering RYANODX® preoperatively to prevent malignant hyperthermia, precautions should be taken including monitoring vital signs, avoiding known triggers, and monitoring for early clinical and metabolic signs of malignant hyperthermia that may indicate the need for additional treatment.
For prolonged surgery, give additional individualized RYANODX® doses during anesthesia and surgery.
Dosing in Pediatric Patients
For these indications, the recommended dose of RYANODX® in pediatric patients for treatment and prevention of MH is the same as in adults.
*The Malignant Hyperthermia Association of the United States (MHAUS) recommends initial and repeat treatment doses of 2.5 mg/kg.
Learn how RYANODX® enables speed and efficiency in MH crisis.
This is an MH case simulation. It shows real medical professionals following real MH protocols. This is a unique opportunity to observe the same MH crisis occurring with different formulations.
Important Safety Information
RYANODX® is not a substitute for appropriate supportive measures in the treatment of malignant hyperthermia (MH), including discontinuation of MH triggering anesthetic agents, attention to increased oxygen consumption, management of metabolic acidosis, cooling when necessary, and administration of diuretics to prevent late kidney injury due to myoglobinuria (the amount of mannitol in RYANODX® is not adequate to maintain diuresis).
RYANODX® is associated with skeletal muscle weakness such as loss of grip strength and leg weakness, as well as drowsiness, dizziness, difficulty swallowing, difficulty breathing, and decreased inspiratory capacity. Patients should not be allowed to ambulate without assistance until they have recovered normal strength and balance.
Due to the high pH of reconstituted RYANODX® suspension and the potential for tissue necrosis, care must be taken to prevent extravasation of RYANODX® into surrounding tissues.
See complete prescribing information: Prescribing Information
연락처 정보
Singapore BIOPHARMA PTE. LTD.
동아시아 및 동남아시아 독점 총대리
9 Tampines Grande, Asia Green, #02-00, Singapore 528735
제조업체: Alcami Carolinas Corporation, USA
RYANODX® 상표권자: Eagle Pharmaceuticals, Inc.