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Protamine Zinc Recombinant Human Insulin

Detailed information about Protamine Zinc Recombinant Human Insulin

Official label facts Owner quick guide first Marketing clearly labeled

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Reviewed / Updated / Sources

Reviewed: Not available

Updated: February 12, 2026, 10:44 PM UTC

Sources:

Pet Owner Quick Guide

Start here first for the simple next-step summary.

Used for:

Your vet decides this. Here's what owners typically ask/watch for.

What to watch for:

  • Underdose (1 reports)
  • Low serum alkaline phosphatase (1 reports)
  • Lack of efficacy - NOS (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

What to ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?
Safety & side effects

What to watch:

  • Underdose
  • Low serum alkaline phosphatase
  • Lack of efficacy - NOS

Most reported reactions:

  • Underdose (1 reports)
  • Low serum alkaline phosphatase (1 reports)
  • Lack of efficacy (bacteria) - NOS (1 reports)

When to call your vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.

Data freshness: source data appears current.

Latest refresh: Mar 21, 2026, 10:01 a.m.

Data freshness
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 8, 2026, 10:03 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:21 AM UTC
Image coming soon
Protamine Zinc Recombinant Human Insulin

Protamine Zinc Recombinant Human Insulin

Drug type: Generic ingredient • Generic profile No FDA branded products linked

Species: Both

Manufacturer: Not available (source)

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Not available
Identifiers:
NDC Package: 0010-4499-01 NDC Package: 0010-4499-02 NDC Product: 0010

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Tap or hover a reaction to see what it means in plain language.

Tracked signals
25
Reported cases
21
Serious reports
15
Species represented
2
Grouped by Body System
Digestive (4) · Vomiting, Partial anorexia, Loss of appetite Neurologic (1) · Tiredness (lethargy) Effectiveness (3) · Lack of efficacy - NOS, Lack of efficacy (bacteria) - NOS, Lack of efficacy (bacteria) - Leptospira Other (17) · Vocalisation, Urinary tract disorder NOS, Underdose
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Cat 1
Other 1 Cat 1
Effectiveness 1 Dog 1
Effectiveness 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1

Species coverage: Cat (18) Dog (7)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Digestive Cat Non-serious - 1
Other Cat Non-serious - 1
Other Cat Non-serious - 1
Other Cat Serious - 1
Neurologic Cat Non-serious - 1
Digestive Cat Non-serious - 1
Other Cat Serious - 1
Effectiveness Dog Non-serious - 1
Effectiveness Dog Serious - 1
Effectiveness Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Digestive Dog Unknown - -
Other Cat Unknown - -
Other Cat Unknown - -
Digestive Cat Unknown - -
Source metadata:
Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 8, 2026, 10:03 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:21 AM UTC
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Case-reported brands (openFDA): MSK
Catalog species: Both
Safety (openFDA)
Top reactions: Dog 11 Cat 17 View
Case summaries: 10 (showing 8) View
openFDA reports are unverified and do not prove causation.

Diagnosis Codes

Diagnosis-code mappings are not available for this medication yet.

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Top reaction signals
Underdose (1) Low serum alkaline phosphatase (1) Lack of efficacy (bacteria) - NOS (1) Lack of efficacy (bacteria) - Leptospira (1) Hypophosphataemia (1) Hyponatremia (1) Hypokalaemia (1) Hypoglycaemia (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
NDC Package: 0010-4499-01 NDC Package: 0010-4499-02 NDC Product: 0010
Package NDC Product NDC Form / Route Status
0010-4499-01 0010 -
0010-4499-02 0010 -

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 1 Clinical 0 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, INEFFECTIVE, GLYCEMIC CONTROL, Hypoglycaemia, Vomiting, Death, Lethargy (see also Central nervous sys… (Official, 2026-02-12)
Recent Revisions
  • side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Vomiting (1) • Cat Partial anorexia (1) • Cat Loss of appetite • Dog Diarrhea • Cat

Showing top 5 for Digestive.

Neurologic
Tiredness (1) • Cat

Showing top 5 for Neurologic.

Effectiveness
Lack of efficacy - NOS (1) • Dog Lack of efficacy (bacteria) - NOS (1) • Dog Lack of efficacy (bacteria) - Leptospira (1) • Dog

Showing top 5 for Effectiveness.

Other
Vocalisation (1) • Cat Urinary tract disorder NOS (1) • Cat Underdose (1) • Cat Low serum alkaline phosphatase (1) • Cat Hypophosphataemia (1) • Cat
Show more (10)
Hyponatremia (1) • Cat Hypokalaemia (1) • Cat Hypoglycaemia (1) • Dog Hypochloraemia (1) • Cat Haemangiosarcoma (1) • Cat Granuloma (1) • Dog Elevated total bilirubin (1) • Cat Elevated alanine aminotransferase (1) • Cat Death by euthanasia (1) • Cat Death (1) • Dog

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Cat, Domestic Shorthair, Male, 15 year, 6.622 kilogram • Drug: MSK, Suspension, Subcutaneous, Dose: 2 [iU] per animal, Frequency: 12 per hour • Reactions: Vocalisation, Vomiting, Tiredness (lethargy), Urinary tract disorder NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-054382
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 15.00 Year
  • Weight: 6.622 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Suspension
  • Dose: 2 [iU] per animal
  • Frequency: 12 per hour
Reactions Reported:
Vocalisation Vomiting Tiredness (lethargy) Urinary tract disorder NOS
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Female, 12 year, 8.074 kilogram • Drug: MSK, Injection, solution, Subcutaneous • Reactions: Underdose, Haemangiosarcoma, Urinary tract disorder NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-053444
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 12.00 Year
  • Weight: 8.074 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Injection, solution
Reactions Reported:
Underdose Haemangiosarcoma Urinary tract disorder NOS
Outcomes: Ongoing

Dog, Pinscher - Miniature, Female, 13 year, 4.037 kilogram • Drug: MSK, Suspension, Unknown • Reactions: Lack of efficacy (bacteria) - Leptospira, Death, Granuloma, Lack of efficacy (bacteria) - NOS • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-052644
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 13.00 Year
  • Weight: 4.037 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Suspension
Reactions Reported:
Lack of efficacy (bacteria) - Leptospira Death Granuloma Lack of efficacy (bacteria) - NOS
Outcomes: Died

Cat, Maine Coon, Male, 10 year, 4.944 kilogram • Drug: MSK, Suspension, Unknown, Dose: 0.61 [iU] per kilogram • Reactions: Elevated total bilirubin, Low serum alkaline phosphatase, Elevated alanine aminotransferase, Hyponatremia, Hypokalaemia… • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2025-US-052205
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 4.944 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Suspension
  • Dose: 0.61 [iU] per kilogram
Reactions Reported:
Elevated total bilirubin Low serum alkaline phosphatase Elevated alanine aminotransferase Hyponatremia Hypokalaemia Hypochloraemia Hypophosphataemia Death by euthanasia
Outcomes: Euthanized

Cat, Domestic Shorthair, Male, 10 year, 5.67 kilogram • Drug: MSK, Suspension, Subcutaneous, Dose: 0.88 [iU] per kilogram, Frequency: 12 per hour • Reactions: Lack of efficacy - NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-049903
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 5.670 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Suspension
  • Dose: 0.88 [iU] per kilogram
  • Frequency: 12 per hour
Reactions Reported:
Lack of efficacy - NOS
Outcomes: Outcome Unknown

Cat, Cat (unknown), Male, 11 year, 4.536 kilogram • Drug: MSK, Suspension, Unknown, Dose: 0.60 [iU] per kilogram, Frequency: 12 per hour • Reactions: Vomiting, Partial anorexia, Lack of efficacy - NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-049447
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 11.00 Year
  • Weight: 4.536 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Suspension
  • Dose: 0.60 [iU] per kilogram
  • Frequency: 12 per hour
Reactions Reported:
Vomiting Partial anorexia Lack of efficacy - NOS
Outcomes: Outcome Unknown

Dog, Schnauzer (unspecified), Unknown • Drug: MSK, Suspension, Unknown, Dose: 0.40 [iU] per kilogram • Reactions: Lack of efficacy - NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-049309
  • Serious AE: No
  • Treated For AE: No
  • Sex: Unknown
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Suspension
  • Dose: 0.40 [iU] per kilogram
Reactions Reported:
Lack of efficacy - NOS
Outcomes: Outcome Unknown

Dog, Dog (unknown), Unknown • Drug: MSK, Suspension, Unknown • Reactions: Lack of efficacy - NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-039089
  • Serious AE: No
  • Treated For AE: No
  • Sex: Unknown
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Suspension
Reactions Reported:
Lack of efficacy - NOS
Outcomes: Outcome Unknown

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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