Ofirmev (acetaminophen)
Product Images NDC 51662-1424

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Ofirmev (acetaminophen) (NDC 51662-1424). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hf Acquisition Co Llc, Dba Healthfirst, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Adverse (Adverse)

The given text displays a table showing Treatment-Emergent Adverse Reactions in adult patients treated with OFIRMEV which occurred at a frequency greater than placebo in repeated-dose studies. The table lists the frequency of reactions within different system organ classes including Gastrointestinal Disorders, General Disorders & Administration Site Conditions, Nervous System Disorders, and Psychiatric Disorders. It also warns healthcare practitioners that the antipyretic effects of OFIRMEV may mask fever as shown by the frequency data of Pyrexia adverse reaction.*

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Boxed Warning (Boxed Warning)

OFIRMEV Injection is a medication that contains acetaminophen and requires caution in prescribing, preparing and administering it to avoid medication errors and hepatotoxicity. There is a risk of accidental overdose and death if not done correctly. Dosing needs to be based on weight for patients under 50 kg and infusion pumps need to be correctly programmed. It is important to not exceed the maximum daily limits of acetaminophen from all sources to avoid acute liver failure, which can result in liver transplant or even death.*

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Clinical Studies (Clinical Studies)

This appears to be a graph showing the mean temperature (in degrees Celsius) over time post-dose (in hours) for a medication (IV acetaminophen) compared to a placebo. The temperatures are listed on the left-hand side of the graph, with time points numbered below. However, there seems to be an error with the temperature listed at the bottom of the graph. Therefore, the description is incomplete and limited.*

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Clinical P (Clinical)

Table 5 shows the pharmacokinetic parameters of OFIRMEV for different subpopulations such as Children, Adolescents, and Adults. The parameters include the mean values for AUCg-6n, Crmax, Ty, and Hgx in (hg/mL), (L), (<3), and (h/mL) respectively, along with their corresponding standard deviation values denoted by SD in parentheses.*

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Dosage 1 (Dosage 1)

This is a table showing the dosing of medication for adults and adolescents. It includes dosages for a single dose and dosages given every four or six hours. There are different dosages based on weight in kilograms.*

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Dosage 2 (Dosage 2)

This text provides a table of dosing for children outlining the maximum daily dose of acetaminophen that can be given every 6 hours based on age. The dosage is given in milligrams per kilogram of body weight and provides a maximum single dose and a maximum total daily dose. The age group specified is from birth up to 12 years old.*

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Dosage 3 (Dosage 3)

This is a dosage chart that provides guidelines for the treatment of fever in neonates and infants. The chart outlines the recommended dose for acetaminophen to be given every 6 hours based on the age group of the patient. It also indicates the maximum total daily dose of acetaminophen that should be given, based on all routes of administration. The dosing guidelines vary based on the age group, with neonates (birth to 28 days) receiving a lower dose of 12.5 mg/kg and a maximum total daily dose of 50 mg/kg, while infants (29 days to 2 years) receive a higher dose of 15 mg/kg and a maximum total daily dose of 60 mg/kg.*

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Highlights (Highlights 1)

OFIRMEV Injection is a medication containing acetaminophen, which can lead to acute liver failure and even death if not prescribed or administered properly. The prescribing information warns against dosing errors and exceeding the recommended daily limits. Recent changes to the dosage and administration guidelines are also noted. OFIRMEV Injection should only be used as directed by a healthcare professional.*

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Serialized Labeling (Serialized Vial)

This appears to be a description of a prescription medication called OFIRMEV, which is an injection containing 1000mg/100mL of acetaminophen. The medication is only for use through intravenous infusion and is contained in a single-use vial. Doses less than 1000mg require aseptic transfer to a separate container prior to dispensing. The manufacturer's package insert should be consulted before use. The medication is distributed by HF Acquisition Co., LLC in Mukilteo, WA 98275. The text contains some special characters that appear to be errors, so it is unclear what they represent.*

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Structure (Structure)

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Vial Label (Vial Label)

This is a description of a medication called "ST". The medication is in the form of an injection containing acetaminophen (a pain reliever), mannitol, cysteine hydrochloride monohydrate, and sodium phosphates. The recommended dosage and other important information can be found in the package insert. The medication is manufactured by Malinchoct Hospital Products and is intended for intravenous use only. The medication comes in a single use vial and unused portions should be discarded. Patents have been issued for this medication.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.