CYANOKIT- hydroxocobalamin injection, powder, lyophilized, for solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Hydroxocobalamin (UNII: Q40X8H422O) (Hydroxocobalamin - UNII:Q40X8H422O)

Mevcut itibaren:

Meridian Medical Technologies, Inc.

INN (International Adı):

Hydroxocobalamin

Kompozisyon:

Hydroxocobalamin 5 g in 250 mL

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

CYANOKIT is indicated for the treatment of known or suspected cyanide poisoning. None Risk Summary Available data from cases reported in the published literature and postmarketing surveillance with CYANOKIT use in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal and fetal outcomes. There are risks to the pregnant woman and fetus associated with untreated cyanide poisoning (see Clinical Considerations) . In animal studies, hydroxocobalamin administered to pregnant rats and rabbits during the period of organogenesis caused skeletal and soft tissue abnormalities, including alterations in the central nervous system, at exposures similar to human exposures at the therapeutic dose (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated backgr

Ürün özeti:

Each CYANOKIT carton (NDC 11704-370-01) consists of the following: Diluent is not included. Storage Lyophilized form Store at 25°C (77°F); excursions permitted to 15-30°C (59 to 86°F) [see USP Controlled Room Temperature]. CYANOKIT may be exposed during short periods to the temperature variations of usual transport (15 days submitted to temperatures ranging from 5 to 40°C (41 to 104°F), transport in the desert (4 days submitted to temperatures ranging from 5 to 60°C (41 to 140°F)) and freezing/defrosting cycles (15 days submitted to temperatures ranging from -20 to 40°C (-4 to 104°F)). Reconstituted solution Store up to 6 hours at a temperature not exceeding 40ºC (104°F). Do not freeze. Discard any unused portion after 6 hours.

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

CYANOKIT- HYDROXOCOBALAMIN INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
MERIDIAN MEDICAL TECHNOLOGIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CYANOKIT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CYANOKIT.
CYANOKIT (HYDROXOCOBALAMIN FOR INJECTION) FOR INTRAVENOUS INFUSION
INITIAL U.S. APPROVAL: 1975
RECENT MAJOR CHANGES
Warnings and Precautions, Risk of Renal Injury (5.3)
12/2018
Warnings and Precautions, Use of Blood Cyanide Assay (5.7)
12/2018
INDICATIONS AND USAGE
CYANOKIT is indicated for the treatment of known or suspected cyanide
poisoning. (1)
DOSAGE AND ADMINISTRATION
If clinical suspicion of cyanide poisoning is high, administer
CYANOKIT without delay and in conjunction
with appropriate airway, ventilatory, and circulatory support, oxygen
administration as well as
management of seizures. (2.1)
The expert advice of a regional poison control center may be obtained
by calling 1-800-222-1222. (2.1)
Dosing:
The starting dose of CYANOKIT for adults is 5 g, administered by
intravenous infusion over 15 minutes.
One 5 g vial is a complete starting dose. (2.2)
Depending upon the severity of the poisoning and the clinical
response, a second dose of 5 g may be
administered by intravenous infusion for a total dose of 10 g. (2.2)
The rate of infusion for the second 5 g dose may range from 15 minutes
(for patients in extremis) to
2 hours based on patient condition. (2.2)
The recommended diluent is 0.9% Sodium Chloride injection. (2.3)
CYANOKIT requires a separate intravenous line for administration.
(2.4)
DOSAGE FORMS AND STRENGTHS
CYANOKIT (hydroxocobalamin for injection) for intravenous infusion
consists of 1 vial, containing 5 g
lyophilized hydroxocobalamin dark red crystalline powder for
injection. After reconstitution, the vial
contains hydroxocobalamin for injection, 25 mg/mL. (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Risk of Anaphylaxis and Other Hypersensitivity Reactions: Consider
alternative therapie