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Roxee Meds Catalog

Protamine Zinc Recombinant Human Insulin

Medication catalog facts with explicit FDA-approval, off-label, source-limited, and safety context.

Both Source review pending Biologic/vaccine record Owner quick guide first

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Showing simplified owner view. Switch to Vet View for full technical detail.

Data freshness

Storefront facts
Source review pending
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Roxee is still reviewing source support for this medication profile.

FDA applications
Regulatory match pending
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Roxee has safety or ingredient evidence for this medication, but a regulatory product/application match is still pending.

Safety reports
Safety data refreshed
May 5, 2026, 10:01 a.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:05 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: April 22, 2026

Updated: April 22, 2026, 10:07 AM UTC

Sources:
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Protamine Zinc Recombinant Human Insulin

Protamine Zinc Recombinant Human Insulin

Drug type: Biologic/vaccine record • Generic profile Biologic/vaccine record

Both 58% storefront ready

Species: Both

Approval status: Vaccine or biologic source record. This record is tracked as vaccine, biologic, strain, recombinant, or lot-level source data. It is not labeled here as an FDA-approved animal drug; use the source documents and veterinarian guidance.

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Protamine Zinc Recombinant Human Insulin

Generic name
Protamine Zinc Recombinant Human Insulin
Species
Both
Completeness
58%
Validation
Incomplete

Side Effects

Top reported reactions (openFDA): Lack of efficacy - NOS, INEFFECTIVE, GLYCEMIC CONTROL, Hypoglycaemia, Vomiting, Death, Lethargy (see also Central nervous system depression in 'Neurological').

FAQ

Both

Source Transparency

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Roxee still has limited plain-language guidance for this medication. Use the official documents and your veterinarian's instructions for product-specific details.

Used for:

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

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

  • Walking difficulty (1 reports)
  • wobbly/unsteady walking (1 reports)
  • Underdose (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 tell or 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?
Major cautions & emergency warning signs

Side effects to monitor:

  • Walking difficulty
  • wobbly/unsteady walking
  • Underdose

Most reported reactions:

  • Walking difficulty (1 reports)
  • Unsteady walking (ataxia) (1 reports)
  • Underdose (1 reports)

Emergency warning signs:

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

Quick Facts

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

Species: Both
Manufacturer: Manufacturer not confirmed
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
31
Reported cases
28
Serious reports
21
Species represented
2
Grouped by Body System
Digestive (4) · Vomiting, Partial anorexia, Loss of appetite Skin & allergy (1) · Twitching Neurologic (3) · Unsteady walking (ataxia), Tiredness (lethargy), Seizure NOS Effectiveness (3) · Lack of efficacy - NOS, Lack of efficacy (bacteria) - NOS, Lack of efficacy (bacteria) - Leptospira Other (20) · Walking slowly, Walking difficulty, Vocalisation
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Dog 1
Neurologic 1 Cat 1
Other 1 Cat 1
Skin & allergy 1 Cat 1
Neurologic 1 Dog 1
Other 1 Dog 1
Neurologic 1 Cat 1
Other 1 Cat 1

Species coverage: Cat (23) Dog (8)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Other Cat Non-serious - 1
Other Dog Serious - 1
Digestive Cat Non-serious - 1
Other Cat Non-serious - 1
Other Cat Non-serious - 1
Neurologic Cat Serious - 1
Other Cat Serious - 1
Skin & allergy Cat Serious - 1
Neurologic Dog Serious - 1
Other Dog Serious - 1
Neurologic Cat 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 Non-serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat 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 Cat Serious - 1
Other Dog Serious - 1
Digestive Cat Unknown - -
Digestive Cat Unknown - -
Other 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
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:05 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 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 5 Cat 9 View
Case summaries: 9 (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
Walking difficulty (1) Unsteady walking (ataxia) (1) Underdose (1) Twitching (1) Tiredness (lethargy) (1) Shivering (1) Seizure NOS (1) Low serum alkaline phosphatase (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 10 Clinical 1 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… (Clinical, 2026-04-11)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, INEFFECTIVE, GLYCEMIC CONTROL, Hypoglycaemia, Vomiting, Death, Lethargy (see also Central nervous sys… (Official, 2026-05-05)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, INEFFECTIVE, GLYCEMIC CONTROL, Hypoglycaemia, Vomiting, Death, Lethargy (see also Central nervous sys… (Official, 2026-05-03)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, INEFFECTIVE, GLYCEMIC CONTROL, Hypoglycaemia, Vomiting, Death, Lethargy (see also Central nervous sys… (Official, 2026-04-30)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, INEFFECTIVE, GLYCEMIC CONTROL, Hypoglycaemia, Vomiting, Death, Lethargy (see also Central nervous sys… (Official, 2026-04-29)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, INEFFECTIVE, GLYCEMIC CONTROL, Hypoglycaemia, Vomiting, Death, Lethargy (see also Central nervous sys… (Official, 2026-04-28)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, INEFFECTIVE, GLYCEMIC CONTROL, Hypoglycaemia, Vomiting, Death, Lethargy (see also Central nervous sys… (Official, 2026-04-27)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, INEFFECTIVE, GLYCEMIC CONTROL, Hypoglycaemia, Vomiting, Death, Lethargy (see also Central nervous sys… (Official, 2026-04-26)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, INEFFECTIVE, GLYCEMIC CONTROL, Hypoglycaemia, Vomiting, Death, Lethargy (see also Central nervous sys… (Official, 2026-04-25)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, INEFFECTIVE, GLYCEMIC CONTROL, Hypoglycaemia, Vomiting, Death, Lethargy (see also Central nervous sys… (Official, 2026-04-22)
  • 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 2026-05-05 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-05-03 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-29 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-28 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-27 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-26 10:06 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-25 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • 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 • Cat Diarrhea • Cat

Showing top 5 for Digestive.

Skin & allergy
Twitching (1) • Cat

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Cat Tiredness (1) • Dog Seizure NOS (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
Walking slowly (1) • Cat Walking difficulty (1) • Dog Vocalisation (1) • Cat Urinary tract disorder NOS (1) • Cat Underdose (1) • Cat
Show more (15)
Shivering (1) • Dog Low serum alkaline phosphatase (1) • Cat INEFFECTIVE, GLYCEMIC CONTROL (1) • Cat Hypophosphataemia (1) • Cat Hyponatremia (1) • Cat Hypokalaemia (1) • Cat Hypoglycaemia (1) • Cat 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 Abdominal pain • Cat

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, Cat (unknown), Male, 4.536 kilogram • Drug: MSK, Suspension, Unknown, Dose: 3 [iU] per animal, Frequency: 12 per hour • Reactions: INEFFECTIVE, GLYCEMIC CONTROL • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-075105
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Weight: 4.536 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Suspension
  • Dose: 3 [iU] per animal
  • Frequency: 12 per hour
Reactions Reported:
INEFFECTIVE, GLYCEMIC CONTROL
Outcomes: Outcome Unknown

Cat, Cat (unknown), Male, 9 year, 6.804 kilogram • Drug: MSK, Suspension, Unknown, Frequency: 12 per hour • Reactions: Lack of efficacy - NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-075084
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 9.00 Year
  • Weight: 6.804 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Suspension
  • Frequency: 12 per hour
Reactions Reported:
Lack of efficacy - NOS
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Female, 15 year, 6.804 kilogram • Drug: MSK, Suspension, Subcutaneous, Dose: 4 [iU] per animal, Frequency: 2 per day • Reactions: Unsteady walking (ataxia), Twitching, Seizure NOS, Hypoglycaemia, Hypokalaemia • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075490
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 15.00 Year
  • Weight: 6.804 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Suspension
  • Dose: 4 [iU] per animal
  • Frequency: 2 per day
Reactions Reported:
Unsteady walking (ataxia) Twitching Seizure NOS Hypoglycaemia Hypokalaemia
Outcomes: Ongoing

Cat, Domestic Shorthair, Male, 12 year, 5.443 kilogram • Drug: MSK, Suspension, Subcutaneous, Dose: 0.60 [iU] per kilogram, Frequency: 12 per hour • Reactions: Death • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-075108
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 12.00 Year
  • Weight: 5.443 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Suspension
  • Dose: 0.60 [iU] per kilogram
  • Frequency: 12 per hour
Reactions Reported:
Death
Outcomes: Died

Cat, Domestic Shorthair, Male, 11 year, 5.942 kilogram • Drug: MSK, Suspension, Subcutaneous, Frequency: 12 per hour • Reactions: Walking slowly, Lack of efficacy - NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-074752
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 11.00 Year
  • Weight: 5.942 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Suspension
  • Frequency: 12 per hour
Reactions Reported:
Walking slowly Lack of efficacy - NOS
Outcomes: Outcome Unknown

Dog, Terrier - Yorkshire, Male, 9 year, 3.992 kilogram • Drug: MSK, Suspension, Subcutaneous, Dose: 0.60 [iU] per kilogram, Frequency: 1 per day • Reactions: Lack of efficacy - NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-074642
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 9.00 Year
  • Weight: 3.992 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Suspension
  • Dose: 0.60 [iU] per kilogram
  • Frequency: 1 per day
Reactions Reported:
Lack of efficacy - NOS
Outcomes: Outcome Unknown

Dog, Terrier - West Highland White, Female, 11 year, 6.94 kilogram • Drug: MSK, Suspension, Subcutaneous, Dose: 1.28 [iU] per kilogram, Frequency: 1 per day • Reactions: Walking difficulty, Shivering, Tiredness (lethargy), Hypoglycaemia, Lack of efficacy - NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-074658
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 11.00 Year
  • Weight: 6.940 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Suspension
  • Dose: 1.28 [iU] per kilogram
  • Frequency: 1 per day
Reactions Reported:
Walking difficulty Shivering Tiredness (lethargy) Hypoglycaemia Lack of efficacy - NOS
Outcomes: Outcome Unknown

Dog, Shepherd Dog - Australian, Male, 11 year, 12.791 kilogram • Drug: MSK, Suspension, Subcutaneous, Dose: 0.48 [iU] per kilogram, Frequency: 24 per hour • Reactions: Lack of efficacy - NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-071993
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 11.00 Year
  • Weight: 12.791 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Suspension
  • Dose: 0.48 [iU] per kilogram
  • Frequency: 24 per hour
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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