Novoseven Lyophilisate For Solution For Injection 1200Mcg Drug Medication Dosage Information
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NovoSeven: Lyophilisate for solution for injection (1200mcg)

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What is this Medicine?

FACTOR VIIa, RECOMBINANT (fak tir VIIa, ree kom bi nant) helps to prevent or control bleeding in patients with hemophilia A or hemophilia B who have clotting factor inhibitors. This medicine may also be used to treat bleeding in patients with factor VII deficiency or in select patients who have other types of bleeding problems.

In-Depth Information

Novoseven 1.2mg Powder for Injection

NDC: 001697060
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Factor VII Deficiency, Glanzmann’s Thrombasthenia, Acquired Hemophilia

Sometimes used for but not FDA approved for the following conditions:
Coumarin Toxicity, Thrombocytopenia, Hemophilia A, Von Willebrand's Disease, Hemophilia B

Storage Information
Store unreconstituted product in refrigerator (36 to 46 degrees F)
Protect from light
Protect from freezing
Reconstituted product should be used within 3 hours
Novoseven 1.2mg Powder for Injection

Reported Side Effects for Novoseven 1.2mg Powder for Injection

Blood Clot Incidence:
0.2-4.0%*
Severity: SEVERE
Onset: DELAYED
Blood Clot Incidence:
0.2-4.0%*
Severity: SEVERE
Onset: DELAYED
Skin Rash Incidence:
1.0%*
Severity: MILD
Onset: EARLY
Bruises Incidence:
1.0%*
Severity: MILD
Onset: DELAYED
Injection Site Reaction Incidence:
1.0%*
Severity: MILD
Onset: RAPID
Slow Heart Beat Incidence:
1.0%*
Severity: SEVERE
Onset: RAPID
Disseminated Intravascular Coagulation (DIC) Incidence:
1.0%*
Severity: SEVERE
Onset: DELAYED
Swelling Incidence:
1.0%*
Severity: MODERATE
Onset: DELAYED
Vomiting Incidence:
1.0%*
Severity: MILD
Onset: EARLY
Headache Incidence:
1.0%*
Severity: MILD
Onset: EARLY
Low Prothrombin Level Incidence:
1.0%*
Severity: MODERATE
Onset: DELAYED
Low Blood Pressure Incidence:
1.0%*
Severity: MODERATE
Onset: RAPID
Itching Incidence:
1.0%*
Severity: MILD
Onset: RAPID
Bleeding Incidence:
15.0%*
Severity: MODERATE
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

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


Learning More About
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