DRUGS & SUPPLEMENTS

Acidum Nitricum Injeel Forte

Name: Acidum Nitricum Injeel Forte drug & pharmaceuticals. Available Forms, Doses, Prices
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Published: 2021-11-11T10:10:10+00:00

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Acidum Nitricum Injeel Forte uses

Indications and usage
Dosage and administration
Dosage forms and strengths
Contraindications
Warnings and precautions
Adverse reactions
Drug interactions
Use in specific populations
Overdosage
Description
Clinical pharmacology
Nonclinical toxicology
Clinical studies
How supplied/storage and handling
Acidum Nitricum Injeel Forte reviews

1 INDICATIONS AND USAGE

Acidum Nitricum Injeel Forte ^® is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

Acidum Nitricum Injeel Forte is a vasodilator indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

2 DOSAGE AND ADMINISTRATION

The recommended dose is 20 ppm, maintained for up to 14 days or until the underlying oxygen desaturation has resolved.

Doses greater than 20 ppm are not recommended (2.1, 5.2)

Administration:

Use only with an Acidum Nitricum Injeel Forte DS_IR ^® operated by trained personnel (2.2)
Avoid abrupt discontinuation (2.2, 5.1).

2.1 Dosage

Term and near-term neonates with hypoxic respiratory failure

The recommended dose of Acidum Nitricum Injeel Forte is 20 ppm. Maintain treatment up to 14 days or until the underlying oxygen desaturation has resolved and the neonate is ready to be weaned from Acidum Nitricum Injeel Forte therapy.

Doses greater than 20 ppm are not recommended .

2.2 Administration

Training in Administration

The user of Acidum Nitricum Injeel Forte and Acidum Nitricum Injeel Forte Oxide Delivery Systems must satisfactorily complete a comprehensive periodic training program for health care professionals provided by the delivery system and drug manufacturers. Health professional staff that administers Acidum Nitricum Injeel Forte oxide therapy have access to supplier-provided 24 hour/365 days per year technical support on the delivery and administration of Acidum Nitricum Injeel Forte at 1-877-566-9466.

Acidum Nitricum Injeel Forte Oxide Delivery Systems

Acidum Nitricum Injeel Forte must be administered using a calibrated Acidum Nitricum Injeel Forte DS_IR ^® Acidum Nitricum Injeel Forte Oxide Delivery System. Only validated ventilator systems should be used in conjunction with Acidum Nitricum Injeel Forte. Consult the Acidum Nitricum Injeel Forte Oxide Delivery System label or call 1-877-566-9466/visit Acidum Nitricum Injeel Forte.com for a current list of validated systems.

Keep available a backup battery power supply and an independent reserve Acidum Nitricum Injeel Forte oxide delivery system to address power and system failures.

Monitoring

Measure methemoglobin within 4-8 hours after initiation of treatment with Acidum Nitricum Injeel Forte and periodically throughout treatment .

Monitor for PaO₂and inspired NO₂ during Acidum Nitricum Injeel Forte administration .

Weaning and Discontinuation

Avoid abrupt discontinuation of Acidum Nitricum Injeel Forte . To wean Acidum Nitricum Injeel Forte, downtitrate in several steps, pausing several hours at each step to monitor for hypoxemia.

3 DOSAGE FORMS AND STRENGTHS

Acidum Nitricum Injeel Forte (nitric oxide) gas is available in a 800 ppm concentration.

Acidum Nitricum Injeel Forte (nitric oxide) is a gas available in a 800 ppm concentration (3).

4 CONTRAINDICATIONS

Acidum Nitricum Injeel Forte is contraindicated in neonates dependent on right-to-left shunting of blood.

Neonates dependent on right-to-left shunting of blood (4).

5 WARNINGS AND PRECAUTIONS

Rebound: Abrupt discontinuation of Acidum Nitricum Injeel Forte may lead to worsening oxygenation and increasing pulmonary artery pressure.

Methemoglobinemia: Methemoglobin increases with the dose of Acidum Nitricum Injeel Forte oxide; following discontinuation or reduction of Acidum Nitricum Injeel Forte oxide, methemoglobin levels return to baseline over a period of hours (5.2).

Elevated NO₂ Levels: Monitor NO₂ levels (5.3).

Heart Failure: In patients with pre-existing left ventricular dysfunction, Acidum Nitricum Injeel Forte may increase pulmonary capillary wedge pressure leading to pulmonary edema (5.4).

5.1 Rebound Pulmonary Hypertension Syndrome following Abrupt Discontinuation

Wean from Acidum Nitricum Injeel Forte . Abrupt discontinuation of Acidum Nitricum Injeel Forte may lead to worsening oxygenation and increasing pulmonary artery pressure, i.e., Rebound Pulmonary Hypertension Syndrome. Signs and symptoms of Rebound Pulmonary Hypertension Syndrome include hypoxemia, systemic hypotension, bradycardia, and decreased cardiac output. If Rebound Pulmonary Hypertension occurs, reinstate Acidum Nitricum Injeel Forte therapy immediately.

5.2 Hypoxemia from Methemoglobinemia

Acidum Nitricum Injeel Forte oxide combines with hemoglobin to form methemoglobin, which does not transport oxygen. Methemoglobin levels increase with the dose of Acidum Nitricum Injeel Forte; it can take 8 hours or more before steady-state methemoglobin levels are attained. Monitor methemoglobin and adjust the dose of Acidum Nitricum Injeel Forte to optimize oxygenation.

If methemoglobin levels do not resolve with decrease in dose or discontinuation of Acidum Nitricum Injeel Forte, additional therapy may be warranted to treat methemoglobinemia.

5.3 Airway Injury from Nitrogen Dioxide

Nitrogen dioxide (NO₂) forms in gas mixtures containing NO and O₂. Nitrogen dioxide may cause airway inflammation and damage to lung tissues.

If there is an unexpected change in NO₂ concentration, or if the NO₂ concentration reaches 3 ppm when measured in the breathing circuit, then the delivery system should be assessed in accordance with the Acidum Nitricum Injeel Forte Oxide Delivery System O&M Manual troubleshooting section, and the NO₂ analyzer should be recalibrated. The dose of Acidum Nitricum Injeel Forte and/or FiO₂ should be adjusted as appropriate.

5.4 Worsening Heart Failure

Patients with left ventricular dysfunction treated with Acidum Nitricum Injeel Forte may experience pulmonary edema, increased pulmonary capillary wedge pressure, worsening of left ventricular dysfunction, systemic hypotension, bradycardia and cardiac arrest. Discontinue Acidum Nitricum Injeel Forte while providing symptomatic care.

6 ADVERSE REACTIONS

The following adverse reactions are discussed elsewhere in the label;

Hypoxemia

Worsening Heart Failure

The most common adverse reaction is hypotension. (6).

To report SUSPECTED ADVERSE REACTIONS, contact INO Therapeutics at 1-877-566-9466 and http://www.inomax.com/ or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from the clinical studies does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Controlled studies have included 325 patients on Acidum Nitricum Injeel Forte doses of 5 to 80 ppm and 251 patients on placebo. Total mortality in the pooled trials was 11% on placebo and 9% on Acidum Nitricum Injeel Forte, a result adequate to exclude Acidum Nitricum Injeel Forte mortality being more than 40% worse than placebo.

In both the NINOS and CINRGI studies, the duration of hospitalization was similar in Acidum Nitricum Injeel Forte and placebo-treated groups.

From all controlled studies, at least 6 months of follow-up is available for 278 patients who received Acidum Nitricum Injeel Forte and 212 patients who received placebo. Among these patients, there was no evidence of an adverse effect of treatment on the need for rehospitalization, special medical services, pulmonary disease, or neurological sequelae.

In the NINOS study, treatment groups were similar with respect to the incidence and severity of intracranial hemorrhage, Grade IV hemorrhage, periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant therapy, pulmonary hemorrhage, or gastrointestinal hemorrhage.

In CINRGI, the only adverse reaction (>2% higher incidence on Acidum Nitricum Injeel Forte than on placebo) was hypotension (14% vs. 11%).

6.2 Post-Marketing Experience

Post marketing reports of accidental exposure to Acidum Nitricum Injeel Forte oxide for inhalation in hospital staff has been associated with chest discomfort, dizziness, dry throat, dyspnea, and headache.

7 DRUG INTERACTIONS

Acidum Nitricum Injeel Forte oxide donor compounds may increase the risk of developing methemoglobinemia.

7.1 Nitric Oxide Donor Agents

Acidum Nitricum Injeel Forte oxide donor agents such as prilocaine, sodium nitroprusside and nitroglycerine may increase the risk of developing methemoglobinemia.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Acidum Nitricum Injeel Forte. It is not known if Acidum Nitricum Injeel Forte can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Acidum Nitricum Injeel Forte is not indicated for use in adults.

8.3 Nursing Mothers

Acidum Nitricum Injeel Forte oxide is not indicated for use in the adult population, including nursing mothers. It is not known whether Acidum Nitricum Injeel Forte oxide is excreted in human milk.

8.4 Pediatric Use

The safety and efficacy of Acidum Nitricum Injeel Forte oxide for inhalation has been demonstrated in term and near-term neonates with hypoxic respiratory failure associated with evidence of pulmonary hypertension. Additional studies conducted in premature neonates for the prevention of bronchopulmonary dysplasia have not demonstrated substantial evidence of efficacy . No information about its effectiveness in other age populations is available.

8.5 Geriatric Use

Acidum Nitricum Injeel Forte oxide is not indicated for use in the adult population.

10 OVERDOSAGE

Overdosage with Acidum Nitricum Injeel Forte is manifest by elevations in methemoglobin and pulmonary toxicities associated with inspired NO₂. Elevated NO₂ may cause acute lung injury. Elevations in methemoglobin reduce the oxygen delivery capacity of the circulation. In clinical studies, NO₂ levels >3 ppm or methemoglobin levels >7% were treated by reducing the dose of, or discontinuing, Acidum Nitricum Injeel Forte.

Methemoglobinemia that does not resolve after reduction or discontinuation of therapy can be treated with intravenous vitamin C, intravenous methylene blue, or blood transfusion, based upon the clinical situation.

11 DESCRIPTION

Acidum Nitricum Injeel Forte (nitric oxide gas) is a drug administered by inhalation. Acidum Nitricum Injeel Forte oxide, the active substance in Acidum Nitricum Injeel Forte, is a pulmonary vasodilator. Acidum Nitricum Injeel Forte is a gaseous blend of Acidum Nitricum Injeel Forte oxide and nitrogen (0.08% and 99.92%, respectively for 800 ppm). Acidum Nitricum Injeel Forte is supplied in aluminum cylinders as a compressed gas under high pressure (2000 pounds per square inch gauge [psig]).

The structural formula of Acidum Nitricum Injeel Forte oxide (NO) is shown below:

Chemical Structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Acidum Nitricum Injeel Forte oxide relaxes vascular smooth muscle by binding to the heme moiety of cytosolic guanylate cyclase, activating guanylate cyclase and increasing intracellular levels of cyclic guanosine 3',5'-monophosphate, which then leads to vasodilation. When inhaled, Acidum Nitricum Injeel Forte oxide selectively dilates the pulmonary vasculature, and because of efficient scavenging by hemoglobin, has minimal effect on the systemic vasculature.

Acidum Nitricum Injeel Forte appears to increase the partial pressure of arterial oxygen by dilating pulmonary vessels in better ventilated areas of the lung, redistributing pulmonary blood flow away from lung regions with low ventilation/perfusion (V/Q) ratios toward regions with normal ratios.

12.2 Pharmacodynamics

Effects on Pulmonary Vascular Tone in PPHN

Persistent pulmonary hypertension of the newborn (PPHN) occurs as a primary developmental defect or as a condition secondary to other diseases such as meconium aspiration syndrome (MAS), pneumonia, sepsis, hyaline membrane disease, congenital diaphragmatic hernia (CDH), and pulmonary hypoplasia. In these states, pulmonary vascular resistance (PVR) is high, which results in hypoxemia secondary to right-to-left shunting of blood through the patent ductus arteriosus and foramen ovale. In neonates with PPHN, Acidum Nitricum Injeel Forte improves oxygenation (as indicated by significant increases in PaO₂).

12.3 Pharmacokinetics

The pharmacokinetics of Acidum Nitricum Injeel Forte oxide has been studied in adults.

Absorption and Distribution

Acidum Nitricum Injeel Forte oxide is absorbed systemically after inhalation. Most of it traverses the pulmonary capillary bed where it combines with hemoglobin that is 60% to 100% oxygen-saturated. At this level of oxygen saturation, Acidum Nitricum Injeel Forte oxide combines predominantly with oxyhemoglobin to produce methemoglobin and nitrate. At low oxygen saturation, Acidum Nitricum Injeel Forte oxide can combine with deoxyhemoglobin to transiently form nitrosylhemoglobin, which is converted to nitrogen oxides and methemoglobin upon exposure to oxygen. Within the pulmonary system, Acidum Nitricum Injeel Forte oxide can combine with oxygen and water to produce nitrogen dioxide and nitrite, respectively, which interact with oxyhemoglobin to produce methemoglobin and nitrate. Thus, the end products of Acidum Nitricum Injeel Forte oxide that enter the systemic circulation are predominantly methemoglobin and nitrate.

Metabolism

Methemoglobin disposition has been investigated as a function of time and Acidum Nitricum Injeel Forte oxide exposure concentration in neonates with respiratory failure. The methemoglobin (MetHb) concentration-time profiles during the first 12 hours of exposure to 0, 5, 20, and 80 ppm Acidum Nitricum Injeel Forte are shown in Figure 1.

Figure 1: Methemoglobin Concentration-Time Profiles Neonates Inhaling 0, 5, 20 or 80 ppm Acidum Nitricum Injeel Forte

Methemoglobin concentrations increased during the first 8 hours of Acidum Nitricum Injeel Forte oxide exposure. The mean methemoglobin level remained below 1% in the placebo group and in the 5 ppm and 20 ppm Acidum Nitricum Injeel Forte groups, but reached approximately 5% in the 80 ppm Acidum Nitricum Injeel Forte group. Methemoglobin levels >7% were attained only in patients receiving 80 ppm, where they comprised 35% of the group. The average time to reach peak methemoglobin was 10 ± 9 (SD) hours (median, 8 hours) in these 13 patients, but one patient did not exceed 7% until 40 hours.

Figure 1

Elimination

Nitrate has been identified as the predominant Acidum Nitricum Injeel Forte oxide metabolite excreted in the urine, accounting for >70% of the Acidum Nitricum Injeel Forte oxide dose inhaled. Nitrate is cleared from the plasma by the kidney at rates approaching the rate of glomerular filtration.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No evidence of a carcinogenic effect was apparent, at inhalation exposures up to the recommended dose (20 ppm), in rats for 20 hr/day for up to two years. Higher exposures have not been investigated.

Acidum Nitricum Injeel Forte oxide has demonstrated genotoxicity in Salmonella (Ames Test), human lymphocytes, and after in vivo exposure in rats. There are no animal or human studies to evaluate Acidum Nitricum Injeel Forte oxide for effects on fertility.

14 CLINICAL STUDIES

14.1 Treatment of Hypoxic Respiratory Failure

The efficacy of Acidum Nitricum Injeel Forte has been investigated in term and near-term newborns with hypoxic respiratory failure resulting from a variety of etiologies. Inhalation of Acidum Nitricum Injeel Forte reduces the oxygenation index (OI= mean airway pressure in cm H₂O × fraction of inspired oxygen concentration [FiO₂]× 100 divided by systemic arterial concentration in mm Hg [PaO₂]) and increases PaO₂ .

NINOS Study

The Neonatal Inhaled Acidum Nitricum Injeel Forte Oxide Study (NINOS) was a double-blind, randomized, placebo-controlled, multicenter trial in 235 neonates with hypoxic respiratory failure. The objective of the study was to determine whether inhaled Acidum Nitricum Injeel Forte oxide would reduce the occurrence of death and/or initiation of extracorporeal membrane oxygenation (ECMO) in a prospectively defined cohort of term or near-term neonates with hypoxic respiratory failure unresponsive to conventional therapy. Hypoxic respiratory failure was caused by meconium aspiration syndrome (MAS; 49%), pneumonia/sepsis (21%), idiopathic primary pulmonary hypertension of the newborn (PPHN; 17%), or respiratory distress syndrome (RDS; 11%). Infants ≤14 days of age (mean, 1.7 days) with a mean PaO₂ of 46 mm Hg and a mean oxygenation index (OI) of 43 cm H₂O / mm Hg were initially randomized to receive 100% O₂ with (n=114) or without (n=121) 20 ppm Acidum Nitricum Injeel Forte oxide for up to 14 days. Response to study drug was defined as a change from baseline in PaO₂ 30 minutes after starting treatment (full response = >20 mm Hg, partial = 10–20 mm Hg, no response = <10 mm Hg). Neonates with a less than full response were evaluated for a response to 80 ppm Acidum Nitricum Injeel Forte oxide or control gas. The primary results from the NINOS study are presented in Table 1.

	Control (n=121)	NO (n=114)	P value
Death or ECMOExtracorporeal membrane oxygenation ^, Death or need for ECMO was the study's primary end point	77 (64%)	52 (46%)	0.006
Death	20 (17%)	16 (14%)	0.60
ECMO	66 (55%)	44 (39%)	0.014

Although the incidence of death by 120 days of age was similar in both groups (NO, 14%; control, 17%), significantly fewer infants in the Acidum Nitricum Injeel Forte oxide group required ECMO compared with controls (39% vs. 55%, p = 0.014). The combined incidence of death and/or initiation of ECMO showed a significant advantage for the Acidum Nitricum Injeel Forte oxide treated group (46% vs. 64%, p = 0.006). The Acidum Nitricum Injeel Forte oxide group also had significantly greater increases in PaO₂ and greater decreases in the OI and the alveolar-arterial oxygen gradient than the control group (p<0.001 for all parameters). Significantly more patients had at least a partial response to the initial administration of study drug in the Acidum Nitricum Injeel Forte oxide group (66%) than the control group (26%, p<0.001). Of the 125 infants who did not respond to 20 ppm Acidum Nitricum Injeel Forte oxide or control, similar percentages of NO-treated (18%) and control (20%) patients had at least a partial response to 80 ppm Acidum Nitricum Injeel Forte oxide for inhalation or control drug, suggesting a lack of additional benefit for the higher dose of Acidum Nitricum Injeel Forte oxide. No infant had study drug discontinued for toxicity. Inhaled Acidum Nitricum Injeel Forte oxide had no detectable effect on mortality. The adverse events collected in the NINOS trial occurred at similar incidence rates in both treatment groups . Follow-up exams were performed at 18–24 months for the infants enrolled in this trial. In the infants with available follow-up, the two treatment groups were similar with respect to their mental, motor, audiologic, or neurologic evaluations.

CINRGI Study

This study was a double-blind, randomized, placebo-controlled, multicenter trial of 186 term and near-term neonates with pulmonary hypertension and hypoxic respiratory failure. The primary objective of the study was to determine whether Acidum Nitricum Injeel Forte would reduce the receipt of ECMO in these patients. Hypoxic respiratory failure was caused by MAS (35%), idiopathic PPHN (30%), pneumonia/sepsis (24%), or RDS (8%). Patients with a mean PaO₂ of 54 mm Hg and a mean OI of 44 cm H₂O / mm Hg were randomly assigned to receive either 20 ppm Acidum Nitricum Injeel Forte (n=97) or nitrogen gas (placebo; n=89) in addition to their ventilatory support. Patients who exhibited a PaO₂ >60 mm Hg and a pH < 7.55 were weaned to 5 ppm Acidum Nitricum Injeel Forte or placebo. The primary results from the CINRGI study are presented in Table 2.

	Placebo	Acidum Nitricum Injeel Forte	P value
ECMOExtracorporeal membrane oxygenation ^, ECMO was the primary end point of this study	51/89 (57%)	30/97 (31%)	<0.001
Death	5/89 (6%)	3/97 (3%)	0.48

Significantly fewer neonates in the Acidum Nitricum Injeel Forte group required ECMO compared to the control group (31% vs. 57%, p<0.001). While the number of deaths were similar in both groups (INOmax, 3%; placebo, 6%), the combined incidence of death and/or receipt of ECMO was decreased in the Acidum Nitricum Injeel Forte group (33% vs. 58%, p<0.001).

In addition, the Acidum Nitricum Injeel Forte group had significantly improved oxygenation as measured by PaO₂, OI, and alveolar-arterial gradient (p<0.001 for all parameters). Of the 97 patients treated with Acidum Nitricum Injeel Forte, 2 (2%) were withdrawn from study drug due to methemoglobin levels >4%. The frequency and number of adverse events reported were similar in the two study groups .

In clinical trials, reduction in the need for ECMO has not been demonstrated with the use of inhaled Acidum Nitricum Injeel Forte oxide in neonates with congenital diaphragmatic hernia (CDH).

14.2 Ineffective in Adult Respiratory Distress Syndrome

In a randomized, double-blind, parallel, multicenter study, 385 patients with adult respiratory distress syndrome (ARDS) associated with pneumonia (46%), surgery (33%), multiple trauma (26%), aspiration (23%), pulmonary contusion (18%), and other causes, with PaO₂/FiO₂ <250 mm Hg despite optimal oxygenation and ventilation, received placebo (n=193) or Acidum Nitricum Injeel Forte (n=192), 5 ppm, for 4 hours to 28 days or until weaned because of improvements in oxygenation. Despite acute improvements in oxygenation, there was no effect of Acidum Nitricum Injeel Forte on the primary endpoint of days alive and off ventilator support. These results were consistent with outcome data from a smaller dose ranging study of Acidum Nitricum Injeel Forte oxide (1.25 to 80 ppm). Acidum Nitricum Injeel Forte is not indicated for use in ARDS.

14.3 Ineffective in Prevention of Bronchopulmonary Dysplasia

The safety and efficacy of Acidum Nitricum Injeel Forte for the prevention of chronic lung disease [bronchopulmonary dysplasia, (BPD)] in neonates ≤ 34 weeks gestational age requiring respiratory support has been studied in four large, multi-center, double-blind, placebo-controlled clinical trials in a total of 2,600 preterm infants. Of these, 1,290 received placebo, and 1,310 received inhaled Acidum Nitricum Injeel Forte oxide at doses ranging from 5-20 ppm, for treatment periods of 7-24 days duration. The primary endpoint for these studies was alive and without BPD at 36 weeks postmenstrual age (PMA). The need for supplemental oxygen at 36 weeks PMA served as a surrogate endpoint for the presence of BPD. Overall, efficacy for the prevention of bronchopulmonary dysplasia in preterm infants was not established. There were no meaningful differences between treatment groups with regard to overall deaths, methemoglobin levels, or adverse events commonly observed in premature infants, including intraventricular hemorrhage, patent ductus arteriosus, pulmonary hemorrhage, and retinopathy of prematurity.

The use of Acidum Nitricum Injeel Forte for prevention of BPD in preterm neonates ≤ 34 weeks gestational age is not recommended.

16 HOW SUPPLIED/STORAGE AND HANDLING

Acidum Nitricum Injeel Forte (nitric oxide) is available in the following sizes:

Size D	Portable aluminum cylinders containing 353 liters at STP of Acidum Nitricum Injeel Forte oxide gas in 800 ppm concentration in nitrogen (delivered volume 344 liters) (NDC 64693-002-01)
Size 88	Aluminum cylinders containing 1963 liters at STP of Acidum Nitricum Injeel Forte oxide gas in 800 ppm concentration in nitrogen (delivered volume 1918 liters) (NDC 64693-002-02)

Store at 25°C (77°F) with excursions permitted between 15–30°C (59–86°F).

All regulations concerning handling of pressure vessels must be followed.

Protect the cylinders from shocks, falls, oxidizing and flammable materials, moisture, and sources of heat or ignition.

Occupational Exposure

The exposure limit set by the Occupational Safety and Health Administration (OSHA) for Acidum Nitricum Injeel Forte oxide is 25 ppm, and for NO₂ the limit is 5 ppm.

Distributed by

INO Therapeutics LLC

675 McDonnell Blvd.

Hazelwood, MO 63042

USA

Rx only

Acidum Nitricum Injeel Forte^®

Acidum Nitricum Injeel Forte oxide

FOR

INHALATION

800 PPM

CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION WITHOUT WARNING. Use equipment rated

for cylinder pressure. Store and use with adequate ventilation. Secure cylinder in use and storage. Close valve

after each use and when empty. USE IN ACCORDANCE WITH APPROPRIATE SDS.

WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under

the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and

is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and

with the hazards, contraindications and side effects and the precautions to be taken.

FIRST AID: IF INHALED, remove person to fresh air. If not breathing, give artificial respiration. If breathing is

difficult, give oxygen. Get medical help.

RETURN WITH 25 PSIG.

TO BE REFILLED ONLY BY A PHARMACEUTICAL FACILITY AUTHORIZED BY INO Therapeutics LLC

Manufactured Under Pharmaceutical Current Good Manufacturing Practices (cGMPs).

DO NOT REMOVE THIS PRODUCT LABEL.

Store at 25°C (77°F)

Volume 1963 Liters

Mallinckrodt

Pharmaceuticals

Manufactured by:

Mallinckrodt Manufacturing LLC

1060 Allendale Dr.

Port Allen, LA 70767 USA

For Product Inquiry 1-877-KNOW INO

(566-9466)

UN 1956

Compressed Gas, N.O.S.

(Nitric Oxide, Nitrogen)

2.2

Net Weight: 2.5 Kg

NDC 64693-002-02

MADE IN USA

Label No. SPC-LBL-0060 R8

Acidum Nitricum Injeel Forte pharmaceutical active ingredients containing related brand and generic drugs:

Nitric Acid

Acidum Nitricum Injeel Forte available forms, composition, doses:

Liquid; Oral; Nitric Acid 6 d / ml

Acidum Nitricum Injeel Forte destination | category:

Human:
Homeopathic products

Acidum Nitricum Injeel Forte Anatomical Therapeutic Chemical codes:

Acidum Nitricum Injeel Forte pharmaceutical companies:

Biologische Heilmittel Heel

References

"NITRIC ACID". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
"411VRN1TV4: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Dat... (accessed August 28, 2018).
"Praseodymium nitrate: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Acidum Nitricum Injeel Forte?

Depending on the reaction of the Acidum Nitricum Injeel Forte after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Acidum Nitricum Injeel Forte not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Acidum Nitricum Injeel Forte addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Acidum Nitricum Injeel Forte, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Acidum Nitricum Injeel Forte consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.