PROZINC- protamine zinc recombinant human insulin injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INSULIN HUMAN (UNII: 1Y17CTI5SR) (INSULIN HUMAN - UNII:1Y17CTI5SR)

Available from:

Boehringer Ingelheim Animal Health USA Inc.

INN (International Name):

INSULIN HUMAN

Composition:

INSULIN HUMAN 40 [iU] in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

PROZINC is contraindicated in cats sensitive to protamine zinc recombinant human insulin or any other ingredients in PROZINC. PROZINC is contraindicated during episodes of hypoglycemia. PROZINC is contraindicated in dogs sensitive to protamine zinc recombinant human insulin or any other ingredients in PROZINC. PROZINC is contraindicated during episodes of hypoglycemia.

Product summary:

PROZINC is supplied as a sterile injectable suspension in 10 mL and 20 mL multi-dose vials. Each mL of PROZINC contains 40 IU recombinant human insulin. PROZINC is supplied as a sterile injectable suspension in 10 mL and 20 mL multi-dose vials. Each mL of PROZINC contains 40 IU recombinant human insulin.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

PROZINC- PROTAMINE ZINC RECOMBINANT HUMAN INSULIN INJECTION
BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
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PROZINC®
(PROTAMINE ZINC RECOMBINANT HUMAN INSULIN) 40 IU/ML
PACKAGE INSERT FOR CATS
PROZINC®
(PROTAMINE ZINC RECOMBINANT HUMAN INSULIN)
40 IU/ML
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION:
PROZINC is a sterile aqueous protamine zinc suspension of recombinant
human insulin.
EACH ML CONTAINS:
recombinant human insulin............................40 International
Units (IU)
protamine sulfate............................................0.466 mg
zinc
oxide........................................................0.088 mg
glycerin...........................................................16.00
mg
dibasic sodium phosphate, heptahydrate........ 3.78 mg
phenol (added as preservative)....................... 2.50 mg
hydrochloric acid............................................ 1.63 mg
water for injection (maximum)....................... 1005 mg
pH is adjusted with hydrochloric acid and/or sodium hydroxide.
INDICATION:
PROZINC (protamine zinc recombinant human insulin) is indicated for
the reduction of
hyperglycemia and hyperglycemia-associated clinical signs in cats with
diabetes mellitus.
DOSAGE AND ADMINISTRATION:
USE OF A SYRINGE OTHER THAN A U-40 SYRINGE WILL RESULT IN INCORRECT
DOSING.
FOR SUBCUTANEOUS INJECTION ONLY.
DO NOT SHAKE OR AGITATE THE VIAL.
PROZINC SHOULD BE MIXED BY GENTLY ROLLING THE VIAL PRIOR TO
WITHDRAWING EACH
DOSE FROM THE VIAL. Once mixed, PROZINC suspension has a white, cloudy
appearance. Clumps or visible white particles can form in insulin
suspensions: do not
use the product if clumps or visible white particles persist after
gently rolling the vial.
Using a U-40 insulin syringe, the injection should be administered
subcutaneously on the
back of the neck or on the side of the cat.
Always provide the Client Information Sheet with each prescription.
The initial recommended PROZINC dose is 0.1 - 0.3 IU insulin/pound of
body we