SEACALPHYX SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

SODIUM THIOSULFATE

זמין מ:

SEAFORD PHARMACEUTICALS INC

קוד ATC:

V03AB06

INN (שם בינלאומי):

THIOSULPHATE

כמות:

250MG

טופס פרצבטיות:

SOLUTION

הרכב:

SODIUM THIOSULFATE 250MG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

100ML

סוג מרשם:

Ethical

איזור תרפויטי:

ANTIDOTES

leaflet_short:

Active ingredient group (AIG) number: 0109248001; AHFS:

מצב אישור:

MARKETED

תאריך אישור:

2013-01-08

מאפייני מוצר

PRESCRIBING INFORMATION
Pr
SEACALPHYX®
(SODIUM THIOSULFATE PENTAHYDRATE INJECTION BP)
Solution for Injection: 250 mg/mL
Antidote for acute cyanide poisoning
Seaford Pharmaceuticals Inc.
Date of Revision: July 16, 2014
28-1530 Drew Road
Mississauga, Ontario, Canada L5S 1W8
Tel. #:[phone]
Control Number: 173993
SUMMARY PRODUCT INFORMATION
ROUTE OF ADMINISTRATION
DOSAGE FORM/STRENGTH
CLINICALLY RELEVANT NONMEDICINAL INGREDIENTS
Intravenous
Solution/25%
Sodium metabisulfite
_For a complete listing see Dosage Forms, _
_Composition and Packaging section. _
INDICATIONS AND CLINICAL USE
Seacalphyx (Sodium thiosulfate pentahydrate injection BP), is
indicated for sequential use with sodium
nitrite for the treatment of acute cyanide poisoning that is judged to
be life-threatening. When the
diagnosis of cyanide poisoning is uncertain, the potential risks
associated with Seacalphyx, should be
carefully weighed against the potential benefits, especially if the
patient is not in extremis.
IDENTIFYING PATIENTS WITH CYANIDE POISONING
Cyanide poisoning may result from inhalation, ingestion, or dermal
exposure to various cyanide-
containing compounds, including smoke from closed-space fires. Sources
of cyanide poisoning include
hydrogen cyanide and its salts, cyanogenic plants, aliphatic nitriles,
and prolonged exposure to sodium
nitroprusside.
The presence and extent of cyanide poisoning are often initially
unknown. There is no widely available,
rapid, confirmatory cyanide blood test. Treatment decisions must be
made on the basis of clinical history
and signs and symptoms of cyanide intoxication. If clinical suspicion
of cyanide poisoning is high,
sodium thiosulfate pentahydrate injection and Sodium Nitrite Injection
should be administered without
delay.
TABLE 1. COMMON SIGNS AND SYMPTOMS OF CYANIDE POISONING
Symptoms
Headache
Confusion
Dyspnea
Chest Tightness
Nausea
Signs
Altered Mental Status
(e.g., confusion, disorientation)
Seizures or Coma
Mydriasis
Tachypnea/Hyperpnea (early)
Bradypnea/Apnea (late)
Hypertension (early)