RYANODX®を選ぶ理由
1分間投与
1分以内での再構成と投与
ほとんどの患者に1バイアル
バイアル当たり250mgのダントロレンナトリウムを含有
1人の提供者による再構成
単一の医療提供者による簡単な再構成
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®はナノサスペンション技術を使用
RYANODX®のナノクリスタル懸濁液の濃度は、標準的なダントロレンの150倍です。
10秒再構成
独特のナノサスペンション技術製剤は、投与前に溶解する必要がないため、大容量・低濃度のダントロレンナトリウム製剤と比較してより少ない滅菌水を使用して、10秒での迅速な再構成を可能にします。
1人の提供者が1バイアルを使用して1分以内で迅速な対応を可能にするRYANODX®について学びましょう。
高度なナノサスペンション技術と凍結乾燥製剤の組み合わせにより、RYANODX®は他のダントロレンナトリウム製剤と比較して著しく短い投与時間で注射用滅菌水で再構成することができます。
適応症
注射用懸濁液RYANODX®（ダントロレンナトリウム）は、適切な支持療法と併用して悪性高熱症の治療、および高リスク患者における悪性高熱症の予防に適応されます.
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
4つの簡単なステップ - 1分以内での投与
再構成
注射用滅菌水5mL（細菌静止剤なし）を追加
振る
均一なオレンジ色の懸濁液になるようにバイアルを振る
約10秒必要
シリンジに充填
投与前にバイアルの微粒子や変色を目視で検査
再構成した懸濁液の適切な用量をシリンジに吸引
投与
RYANODX®は静脈内プッシュで投与する必要があります
成人および小児の用量
治療用量
RYANODX®を静脈内プッシュで最小用量1 mg/kgで投与
MHの生理学的および代謝異常が持続する場合は、最大累積用量10 mg/kgまで静脈内プッシュを継続
MHAUSは初回および反復治療用量として2.5 mg/kgを推奨
予防用量
推奨予防用量：2.5 mg/kgを最低1分間かけて静脈内投与、手術の約75分前から開始
MH誘発薬剤を避ける
長時間手術の場合は、麻酔および手術中に追加の個別化RYANODX®用量を投与
重要: バイアルの内容物は再構成後6時間以内に使用する必要があります。再構成した懸濁液は制御された室温（68°F～77°Fまたは20°C～25°C）で保管してください。
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
連絡先情報
Singapore BIOPHARMA PTE. LTD.
東アジアおよび東南アジア独占総代理店
9 Tampines Grande, Asia Green, #02-00, Singapore 528735
製造元：Alcami Carolinas Corporation, USA
RYANODX®商標権者：Eagle Pharmaceuticals, Inc.