Medication info

Green Cross - Fibrinogen Injection (Lyophilized Human Fibrinogen)

Prescription medicationInjections정맥
Ingredient · strength
Human Fibrinogen›1g / 1 vial
Manufacturer / importer
(주)녹십자
Appearance
A white to light yellow powder in a colorless and transparent vial, which becomes nearly colorless and slightly turbid when dissolved with the diluent.
Packaging
1 set/box [1 lyophilized vial (1 gram) + 1 diluent vial (50 milliliters)]
Approval status
Active

MFDS item code 200403354 · Approved 2004.11.15 · Insurance code 643600821

Summary

Main use
Treatment of congenital and acquired hypofibrinogenemia
Who receives it
Adults
Adult administration
Dissolve 3 g in injectable water and administer by intravenous injection. Repeat until the plasma fibrinogen level is achieved, based on symptoms. Adjust dosage appropriately according to weight, age, and symptoms.

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

Treatment of congenital and acquired hypofibrinogenemia

  • Congenital hypo- and afibrinogenemia
  • acquired hypofibrinogenemia
View approved original text

This medication is used for congenital hypofibrinogenemia and acquired hypofibrinogenemia.

How it is given

Adult administration

Dissolve 3 g in injectable water and administer by intravenous injection. Repeat until the plasma fibrinogen level is achieved, based on symptoms. Adjust dosage appropriately according to weight, age, and symptoms.

Precautions

This medicine is made from human plasma and cannot completely eliminate the risk of infections from viruses and other infectious agents that can be transmitted through blood. It is particularly recommended for hemophilia patients or patients with severely weakened immune systems to receive appropriate vaccinations, such as the Hepatitis A vaccine, and that doctors regularly check for infections when using this medication. It is important to explain the infection risks to patients when using this medication and to use it minimally only when necessary for treatment. Individuals allergic to this medication or its components should not use it, and careful use is necessary for patients with hemolytic anemia or severe anemia, as well as those with impaired immune function. Allergic reactions such as chills or fever may occur when using this medication, and in severe cases, anaphylactic shock may happen, so symptoms should be closely monitored. Also, due to the risk of thrombosis, the condition should be monitored carefully through blood tests, etc. There have been reports of liver dysfunction or viral infections such as Non-A, Non-B hepatitis, so appropriate actions should be taken if any liver issues arise. This medication cannot completely eliminate viruses, so careful monitoring of the patient's condition after administration is necessary due to infection possibilities. It is necessary to explain the infection risks to the patient before treatment and obtain their understanding. Remember that this medication is for patients with a very low fibrinogen level by nature. The safety of this medication during pregnancy has not been established, and there is a possibility of Parvovirus B19 infection, which may pose risks to the fetus, so it should only be used in pregnant or potentially pregnant women when the benefits outweigh the risks. Elderly patients may have decreased bodily functions, so they should be observed closely and administered with caution. When administering, it is recommended to use a transfusion set with a micropore filter and to inject slowly, as a rapid injection may lead to side effects such as intravascular coagulation or cyanosis. Should not be used if sediment is present when dissolving, and should not be mixed with other medications. Care should be taken when used together with dextran preparations as sediment may form. In cases of fluid abnormalities, it is advisable to improve the condition first with fluid injections before usage. Use within 1 hour after dissolution, and it is safe not to use any remaining medication due to the risk of bacterial contamination.

Side effects and when to seek care immediately

Serious side effects

  • Respiratory distress, wheezing, chest discomfort → Severe allergic reaction related to anaphylactic shock
  • Symptoms of liver damage → Viral infections and liver issues such as Non-A, Non-B hepatitis
  • Thrombosis (deep vein thrombosis, mesenteric thrombosis, pulmonary embolism) → Severe thrombosis issues
  • Acute and severe anemia and emergency systemic symptoms due to Human Parvovirus B19 infection
  • Fetal disorders (miscarriage, fetal edema, fetal death) when administered to pregnant women

Mild side effects

  • Symptoms of hypersensitivity, such as chills and fever
  • Symptoms related to thrombosis (deep vein thrombosis, mesenteric thrombosis, pulmonary embolism, etc.)
  • Cyanosis, palpitations
  • Hypotension, weak pulse
  • Sediment upon dissolution

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a sealed container to prevent air from entering, in a cool place at a temperature below 10 degrees Celsius to maintain its effectiveness and safety.

Appearance and packaging

Appearance

A white to light yellow powder in a colorless and transparent vial, which becomes nearly colorless and slightly turbid when dissolved with the diluent.

Package unit

1 set/box [1 lyophilized vial (1 gram) + 1 diluent vial (50 milliliters)]

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.