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Products
Byfavo (remimazolam) - procedural sedation
Indication and use
Remimazolam 20 mg is indicated in adults for sedation during a procedure.
Mechanism of action
Remimazolam is an ultra-short-acting benzodiazepine sedative. The effect of remimazolam on the CNS depends on the dose administered intravenously and the presence or absence of other drugs. Remimazolam binds with high affinity to the benzodiazepine sites of gamma-aminobutyric acid receptors type A [GABAA], whereas its carboxylic acid metabolite (CNS7054) has an affinity to these receptors that is about 300 times lower. Remimazolam has no clear selectivity between the subtypes of the GABAA receptor.
Dosage and administration
The dosage of remimazolam should be individually adjusted to an effective dose that produces the desired level of sedation and minimizes side effects. Additional doses may be administered as needed to induce or maintain the desired level of sedation. At least 2 minutes should elapse before administering an additional dose to fully assess the sedative effect. If 5 doses of remimazolam do not produce the desired level of sedation within 15 minutes, an additional or different sedative should be considered. Remimazolam is associated with a rapid onset and resolution of sedation. In clinical studies, the peak of sedation was reached 3 to 3.5 minutes after the first bolus, and patients were fully awake 12 to 14 minutes after the last dose of remimazolam.
Dosage guidelines:
Induction:
Injection: 5 mg (2 mL) over 1 minute (with an opioid); 7 mg (2.8 mL) over 1 minute (without opioid).
Wait 2 minutes.
Maintenance/titration:
Injection: 2.5 mg (1 ml) over 15 seconds, if necessary.
The maximum total dose administered in the clinical studies was 33 mg.
Data from clinical studies
The efficacy of remimazolam was based on two pivotal studies CNS7056-006 and CNS7056-008 in adult patients (aged 18 to 95 years) with ASA-PS I-III who were scheduled for colonoscopy and bronchoscopy, respectively.
Statistically significantly higher success rates were observed for the difference between remimazolam and placebo (p< 0.0001).
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The most common adverse effects in patients with intravenous remimazolam are hypotension (37.2 %), respiratory depression (13.1 %) and bradycardia (6.8 %).
Adverse effects of intravenous remimazolam observed in controlled clinical trials for procedural sedation and post-marketing include headache, dizziness and drowsiness.
Byfavo (remimazolam) - general anesthesia
Indication and use
Remimazolam 50 mg is indicated for the intravenous induction and maintenance of general anesthesia in adults.
Mechanism of action
Remimazolam is an ultra-short-acting benzodiazepine sedative/hypnotic. The effect of remimazolam on the CNS depends on the dose administered intravenously and the presence or absence of other drugs.
Remimazolam binds with high affinity to the benzodiazepine sites of the gamma-aminobutyric acid receptors type A [GABAA], whereas its carboxylic acid metabolite (CNS7054) has an affinity to these receptors that is about 300 times lower. Remimazolam has no clear selectivity between the subtypes of the GABAA receptor.
Dosage and administration
The dose of Byfavo should be individually adjusted based on the patient’s response and the premedication used.
Induction of anesthesia:
The infusion rate of remimazolam should be set at 6 mg/min and measured by the patient’s response until clinical signs indicate the onset of anesthesia, and can be increased to a maximum of 12 mg/min if necessary.
Most adult patients are likely to require 10-40 mg of Byfavo.
Maintenance of anesthesia:
The recommended starting dose for maintenance of anesthesia is 1 mg/min. Remimazolam with a range of 0.1 to 2.5 mg/min at clinical discretion to maintain satisfactory anesthesia. To maintain anesthesia, additional boluses of 6 mg over one minute may be given during the current infusion as clinically required. A maximum of three (3) boluses not less than 5 minutes apart may be administered within 60 minutes.
Data from clinical studies
The efficacy of remimazolam was based on two pivotal studies (CNS7056-022 and ONO-2745-05) in adult patients (aged 20 to 91 years) with ASA-PS I-IV undergoing mixed elective surgery.
All doses of remimazolam were non-inferior to propofol. Hemodynamic stability with remimazolam was superior to that with propofol in study CNS7056-022.
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The most common adverse effects in patients administered remimazolam intravenously for general anesthesia are hypotension (51%), nausea (22.1%), vomiting (15.2%) and bradycardia (12.8%). Particular caution is required when remimazolam is administered to a patient with myasthenia gravis.
Xerava (eravacycline) - overview for 100 mg indication
Indication and use
Xerava is used for the treatment of complicated intra-abdominal infections (cIAI) in adults. It should be used in accordance with the official guidelines for the appropriate use of antibacterial agents.
Mechanism of action
Eravacyclin disrupts bacterial protein synthesis by binding to the ribosomal subunit 30S, preventing the incorporation of amino acids into elongating peptide chains. Its unique substitutions at the C-7 and C-9 positions maintain efficacy against Gram-positive and Gram-negative bacteria, including strains with tetracycline-specific resistance mechanisms.
Dosage and administration
The standard dosing regimen is 1 mg/kg every 12 hours intravenously for 4 to 14 days. In patients taking concomitant strong CYP3A4 inducers, the recommended dose is 1.5 mg/kg every 12 hours for 4 to 14 days. No dose adjustments are required in elderly patients, patients with impaired renal function or patients with impaired hepatic function. Xerava is only administered via a one-hour intravenous infusion.
Data from clinical studies
Xerava has demonstrated efficacy against several pathogens associated with complicated intra-abdominal infections, including Escherichia coli, Klebsiella pneumoniae, Staphylococcus aureus, Enterococcus faecalis, Enterococcus faecium and viridans Streptococcus spp. Clinical studies have shown it to be non-inferior to ertapenem and meropenem in the treatment of these infections.
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Xerava should not be used in people with hypersensitivity to eravacycline, its excipients or other tetracycline antibiotics. The most common adverse effects are nausea, vomiting and phlebitis at the infusion site. Serious hypersensitivity reactions are possible, as are superinfections with prolonged use due to the overgrowth of non-susceptible organisms, including fungi. Eravacycline can prolong both the prothrombin time (PT) and the activated partial thromboplastin time (aPTT). In addition, hypofibrinogenemia has been reported with the use of eravacycline. Therefore, blood coagulation parameters such as PT or other appropriate anticoagulation tests, including blood fibrinogen, should be monitored before starting treatment with eravacycline and regularly during treatment.
Giapreza (angiotensin II) - Overview of the indications
Indication and use
Indication:
Giapreza is indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and the use of catecholamines and other available vasopressor therapies.
Mechanism of action
Mechanism:
Angiotensin II increases blood pressure by vasoconstriction; increased aldosterone release by direct action of angiotensin II on the vascular wall is mediated by binding to the G-protein-coupled angiotensin II receptor type 1 on vascular smooth muscle cells, which stimulates Ca2+/calmodulin-dependent phosphorylation of myosin and causes smooth muscle contraction.
The effect on blood pressure lasts for at least the first three hours of continuous intravenous infusion. Due to the short half-life of angiotensin II (less than one minute), abrupt discontinuation of angiotensin II can lead to rebound hypotension.
Dosage and administration
Dosing guidelines:
The recommended starting dose of Giapreza is 20 nanograms (ng)/kg per minute via continuous intravenous infusion. Once the infusion is established, the dose can be titrated in 5-minute increments of up to 15 ng/kg per minute depending on the patient’s condition and the target mean arterial pressure. During the first 3 hours of treatment, 80 ng/kg per minute should not be exceeded. Maintenance doses should not exceed 40 ng/kg per minute. Doses lower than 1.25 ng/kg per minute can also be used.
Route of administration:
Giapreza should only be administered by continuous intravenous infusion under close monitoring of hemodynamics and end organ perfusion. For intravenous use only after dilution. It is recommended that Giapreza be administered via a central venous line.
Data from clinical studies
Efficacy and safety:
The Angiotensin II Treatment of Hypertensive Shock Study (ATHOS-3) was a Phase 3, randomized, placebo-controlled, double-blind, international, multicenter safety and efficacy study in which 321 adults with septic or other distributive shock who remained hypotensive despite fluid and vasopressor therapy were randomized 1:1 to Giapreza or placebo. The primary endpoint was the percentage of subjects who achieved either a MAP ≥ 75 mmHg or an increase in MAP of ≥ 10 mmHg at 3 hours without increasing baseline vasopressor therapy. The primary endpoint was met by 70% of patients treated with Giapreza compared to 23% of placebo patients (a treatment effect of 47%).
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Contraindications:
Hypersensitivity to the active substance or one of the excipients listed in section 6.1. of the product information
Warnings and precautions:
Clinical experience with Giapreza is limited to septic or other distributive shock. The use of Giapreza is not recommended for other types of shock (e.g. cardiogenic shock).
In clinical studies, thromboembolic events have been reported with the use of angiotensin II.
Peripheral ischemia has been reported with the use of angiotensin II.
Adverse effects:
The most common adverse effects in the Giapreza group were thromboembolic events (12.9%) and transient hypertension (22.7%).
Report undesirable side effects
Adverse events and complaints about product quality should be reported to PAION Pharma by e-mail to: pharmacovigilance@paionpharma.com .
Please provide detailed information, such as the product name, dosage and type of event, to ensure an appropriate assessment.