IMMITICIDE POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MELARSOMINE DIHYDROCHLORIDE

Available from:

BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC.

Dosage:

50MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

MELARSOMINE DIHYDROCHLORIDE 50MG

Administration route:

INTRAMUSCULAR

Units in package:

5ML

Prescription type:

Prescription

Therapeutic group:

DOGS

Product summary:

Active ingredient group (AIG) number: 0140464001

Authorization status:

APPROVED

Authorization date:

2018-04-10

Patient Information leaflet

Lot.:
Exp.:
921923
abcd
CODE: 0 036 921923
Version : A 240616
PTG : 0130
DIMENSIONS PLIÉ(E)S:
DIMENSIONS À PLAT (MM):
NOIR/BLACK
P RUBINE RED
P XXX
MAGENTA
YELLOW
P XXX
P XXX
P XXX
P XXX
ETU IMMITICIDE 5X50MG
AJ - COMPOSER RH
A 17/07/19 15h00
B 22/08/19 16h30
C 13/09/19 11h00
Canada (CA)
NA
74 x 53 x 154
0 036 919942
NA
H 020316
Boehringer Ingelheim Animal Health Canada Inc./
Boehringer Ingelheim Santé Animale Canada Inc.
5180 South Service Road
Burlington ON L7L 5H4
Immiticide
®
is a registered trademark of the Boehringer Ingelheim Group.
Immiticide
®
est une marque déposée du Groupe Boehringer Ingelheim.
ACTIVE INGREDIENT
50.0 mg melarsomine dihydrochloride per vial
5 x 50 mg vials
Diluent for reconstitution: Sterile water for injection USP
5 x 2 mL vials
STORAGE
Store at room temperature (15-30°C).
Protect from light.
After reconstitution, store in the refrigerator (4°C) for up to 24
hours.
Do not freeze reconstituted solution.
INGRÉDIENT ACTIF
50,0 mg dichlorhydrate de mélarsomine par flacon
5 flacons de 50 mg
Diluant pour reconstitution : Eau stérile pour injection USP
5 flacons de 2 mL
ENTREPOSAGE
Conserver à la température ambiante (entre 15 et 30 °C), à l'abri
de la
lumière.
Une fois reconstituée, la solution doit être réfrigérée (à 4
°C). Se conserve
pendant 24 heures.
La solution reconstituée ne doit pas être congelée.
READ PACKAGE INSERT CAREFULLY PRIOR TO ADMINISTERING IMMITICIDE
®
. CONSIDER ALL WARNINGS, CONTRAINDICATIONS, AND
PRECAUTIONS AND FOLLOW DIRECTIONS REGARDING DOSAGE AND ADMINISTRATION
CAREFULLY.
Dosage and Administration: Refer to the package insert for information
on heartworm disease classification. Administer 2.5 mg/kg (0.1 mL/kg)
twice,
24 hours apart to dogs with asymptomatic (Class 1) to stabilized,
moderate (Class 2) heartworm disease. Alternate Dosing Regime: Dogs
with severe
(Class 3) heartworm disease should be stabilized prior to treatment
and then dosed with a single injection at 2.5 mg/kg (0.1 mL/kg) then
approximately 1 month later with 2.5 mg/kg