RYANODX®
Suspensi Injeksi Dantrolene Sodium
Satu-satunya Formulasi Dantrolene Yang Memungkinkan Respons Cepat
Dalam pengobatan malignant hyperthermia (MH), hanya formulasi RYANODX® dantrolene sodium yang memungkinkan respons cepat dalam waktu kurang dari 1 menit oleh 1 penyedia menggunakan 1 vial.
Mengapa Pilih RYANODX®
Administrasi 1 Menit
Reconstitution dan administrasi dalam waktu kurang dari 1 menit
1 Vial untuk Sebagian Besar Pasien
Mengandung 250mg dantrolene sodium per vial
Reconstitution oleh 1 Penyedia
Reconstitution sederhana oleh satu penyedia layanan kesehatan
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® Menggunakan Teknologi Nanosuspensi
Konsentrasi suspensi nanokristal RYANODX® adalah 150 kali lipat dari dantrolene standar.
Rekonstitusi 10 Detik
Formulasi teknologi nanosuspensi yang unik memungkinkan rekonstitusi cepat dalam 10 detik, menggunakan lebih sedikit air steril dibandingkan formulasi dantrolene sodium volume besar, konsentrasi rendah, karena tidak perlu larut sebelum pemberian.
Pelajari bagaimana RYANODX® memungkinkan respons cepat dalam waktu kurang dari 1 menit oleh 1 penyedia menggunakan 1 vial.
Teknologi nanosuspensi canggih yang dikombinasikan dengan formulasi liofilisasi memungkinkan RYANODX® untuk direkonstitusi dengan air steril untuk injeksi dengan waktu administrasi yang jauh lebih singkat dibandingkan formulasi dantrolene sodium lainnya.
Indikasi
RYANODX® untuk suspensi injeksi (dantrolene sodium) diindikasikan untuk pengobatan malignant hyperthermia bersama dengan tindakan suportif yang tepat, dan untuk pencegahan malignant hyperthermia pada pasien berisiko tinggi.
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 Langkah Sederhana - Administrasi dalam Waktu Kurang dari 1 Menit
Rekonstitusi
Tambahkan 5mL air steril untuk injeksi (tanpa agen bakteriostatik)
Kocok
Kocok vial untuk memastikan suspensi oranye yang merata
~10 detik diperlukan
Isi Semprit
Periksa secara visual vial untuk partikel dan perubahan warna sebelum pemberian
Tarik dosis yang tepat dari suspensi yang telah direkonstitusi ke dalam semprit
Berikan
RYANODX® harus diberikan melalui push intravena
Dosis untuk Dewasa dan Anak-anak
Dosis Pengobatan
Berikan RYANODX® melalui push intravena dengan dosis minimum 1 mg/kg
Jika kelainan fisiologis dan metabolik MH berlanjut, lanjutkan push intravena hingga dosis kumulatif maksimum 10 mg/kg
MHAUS merekomendasikan dosis pengobatan awal dan berulang 2.5 mg/kg
Dosis Pencegahan
Dosis profilaksis yang direkomendasikan: 2.5 mg/kg diberikan intravena selama minimal 1 menit, dimulai sekitar 75 menit sebelum operasi
Hindari agen pemicu MH
Untuk operasi yang berkepanjangan, berikan dosis RYANODX® individual tambahan selama anestesi dan operasi
Penting: Isi vial harus digunakan dalam waktu 6 jam setelah rekonstitusi. Simpan suspensi yang telah direkonstitusi pada suhu ruang terkontrol (68°F hingga 77°F 또는 20°C hingga 25°C).
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
Informasi Kontak
Singapore BIOPHARMA PTE. LTD.
Distributor Eksklusif untuk Asia Timur & Asia Tenggara
9 Tampines Grande, Asia Green, #02-00, Singapore 528735
Diproduksi oleh: Alcami Carolinas Corporation, USA
Pemegang merek dagang RYANODX®: Eagle Pharmaceuticals, Inc.