Berinert Powder For Solution For Injection 500U Drug Medication Dosage Information
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Berinert: Powder for solution for injection (500U)

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What is this Medicine?

C1 INHIBITOR, HUMAN (C1 in HIB i ter, HYOO muhn) helps to treat angioedema attacks.

In-Depth Information

Berinert 500units Powder for Injection

NDC: 638330825
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Hereditary Angioedema

Storage Information
Store in original package until time of use
Protect from light
Do not freeze reconstituted product
Discard unused portion. Do not store for later use.
Do not freeze
Diluted product must be used within 8 hours
Store between 36 to 77 degrees F
Berinert 500units Powder for Injection

Reported Side Effects for Berinert 500units Powder for Injection

Infection Incidence:
1.8-3.5%*
Severity: MILD
Onset: DELAYED
Itching Incidence:
2.0%*
Severity: MILD
Onset: RAPID
Lightheadedness Incidence:
2.0%*
Severity: MILD
Onset: EARLY
Skin Redness Incidence:
2.0%*
Severity: MODERATE
Onset: EARLY
Injection Site Reaction Incidence:
3.0%*
Severity: MILD
Onset: RAPID
Flu Incidence:
3.5%*
Severity: MILD
Onset: DELAYED
Sore Throat Incidence:
3.5%*
Severity: MILD
Onset: DELAYED
Skin Rash Incidence:
3.5-10.0%*
Severity: MILD
Onset: EARLY
Metallic Taste Incidence:
4.7%*
Severity: MILD
Onset: EARLY
Fever Incidence:
5.0%*
Severity: MILD
Onset: EARLY
Stomach Pain Incidence:
7.0%*
Severity: MILD
Onset: EARLY
Headache Incidence:
7.0-19.0%*
Severity: MILD
Onset: EARLY
Vomiting Incidence:
10.0%*
Severity: MILD
Onset: EARLY
Upset Stomach Incidence:
18.0%*
Severity: MILD
Onset: EARLY
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
FIRST Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

SECOND Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

THIRD Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Lactation

Compatible - This drug is generally safe to take by nursing mothers.


Learning More About
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