IMMITICIDE- melarsomine dihydrochloride and water kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

melarsomine dihydrochloride (UNII: 9CVA716Q71) (melarsomine - UNII:374GJ0S41A)

Available from:

Merial, Inc.

INN (International Name):

melarsomine dihydrochloride

Composition:

melarsomine dihydrochloride 50 mg in 2 mL

Prescription type:

PRESCRIPTION

Therapeutic indications:

IMMITICIDE Sterile Power is indicated for the treatment of stabilized Class 11, 22, and 33 heartworm disease caused by immature (4 month-old, stage L5 ) to mature adult infections of Dirofilaria immitis in dogs. Heartworm Disease Classification : The following parameters were used to classify the dogs in the clinical field trials for IMMITICIDE. Other parameters may be considered. As a general rule, conservative treatment should be employed since heartworm disease is serious and potentially fatal. If there is evidence of a high worm burden, patients should be categorized as Class 3. IMMITICIDE is contraindicated in dogs with very severe (Class 4) heartworm disease. Patients in this category have Caval Syndrome (D. immitis present in the venae cavae and right atrium).

Product summary:

IMMITICIDE is provided as: 5 - 50 mg vials of lyophilized melarsomine dihydrochloride with accompanying 5 - 2 mL vials of sterile water for injection.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

IMMITICIDE- MELARSOMINE DIHYDROCHLORIDE AND WATER
MERIAL, INC.
----------
IMMITICIDE STERILE POWDER (MELARSOMINE DIHYDROCHLORIDE)
NADA 141-042, Approved by FDA
CAUTION
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
WARNING
IMMITICIDE® SHOULD BE ADMINISTERED BY DEEP INTRAMUSCULAR INJECTION IN
THE LUMBAR
(EPAXIAL) MUSCLES (L3 - L5) ONLY.
DO NOT USE IN ANY OTHER MUSCLE GROUP. DO NOT USE INTRAVENOUSLY.
CARE SHOULD BE TAKEN TO AVOID SUPERFICIAL INJECTION OR LEAKAGE. (SEE
SAFETY).
ACTIVE INGREDIENT
IMMITICIDE Sterile Powder contains 50.0 mg melarsomine dihydrochloride
and 33.75 mg glycine
USP.
1 vial: when reconstituted with the provided 2 mL of STERILE DILUENT
(sterile water for injection)
contains 25 mg/mL of active ingredient.
PHARMACOLOGY
Melarsomine dihydrochloride is an organic arsenical chemotherapeutic
agent. Melarsomine has a
molecular weight of 501.34 and is chemically designated as 4 – [(4,
6-diamino-1, 3, 5-triazon-2-yl)
amino] phenyl-dithioarsenite of di (2-aminoethyl), dihydrochloride. It
is freely soluble in water. When
injected intramuscularly, it is rapidly absorbed. The exact mode of
action on _D. immitis_ is unknown.
INDICATIONS
IMMITICIDE Sterile Power is indicated for the treatment of stabilized
Class 1 , 2 , and 3 heartworm
disease caused by immature (4 month-old, stage L ) to mature adult
infections of _Dirofilaria immitis_ in
dogs.
_HEARTWORM DISEASE CLASSIFICATION_: The following parameters were used
to classify the dogs in the
clinical field trials for IMMITICIDE. Other parameters may be
considered. As a general rule,
conservative treatment should be employed since heartworm disease is
serious and potentially fatal. If
there is evidence of a high worm burden, patients should be
categorized as Class 3.
1
2
®
1
2
3
5
Class 1: Patients in this category are characterized as having
asymptomatic to mild heartworm disease. No
radiographic signs or signs of anemia are evident. Patients with mild
disease may have subjective signs such as a
general loss of cond