Data from FDA - Curated by Toby Galbraith - Last updated 17 April 2017
FDA (Food and Drug Administration, USA)
(2.1, 5.1, 6.1)
(6.2) To report SUSPECTED
6.1 Clinical Studies Experience The most serious and
Because clinical studies are conducted under widely
Duration of exposure ranged from 1 day to 8 years.
6.2 Post-marketing Experience The following
Because these reactions are reported voluntarily from
2 DOSAGE AND ADMINISTRATION Initiate treatment under the supervision of a physician experienced in using coagulation factors/inhibitors where
(2.1) NA = Not applicable; Q = every.
CEPROTIN Dosing Schedule for
100-120 IU/kg 60 - 80 IU/kg Q 6 hours 45 - 60 IU/kg Q 6 or 12 hours Long-term Prophylaxis NA NA 45 - 60 IU/kg Q 12 hours Store at 2°C - 8°C (36°F-46°F) and
Administer via intravenous injection within 3 hours of reconstitution.
(16) 2.1 General Treatment with CEPROTIN should be initiated under the supervision of a physician experienced in replacement therapy with coagulation factors/inhibitors where
CEPROTIN is administered by intravenous injection after reconstitution of the powder for solution for injection with Sterile Water for Injection.
See WARNINGS/PRECAUTIONS: Hypersensitivity/
The dose, administration frequency and duration of treatment with CEPROTIN depends on the
See DOSAGE AND ADMINISTRATION: Protein C Activity Monitoring (2.2).
Table 1 provides the CEPROTIN dosing schedule for
Table 1: CEPROTIN Dosing Schedule for
Prophylaxis and Long-term ProphylaxisDosing is based upon a pivotal clinical trial of 15 patients.
NA = Not applicable; Q = every.
100-120 IU/kg 60 - 80 IU/kg Q 6 hours 45 - 60 IU/kg Q 6 or 12 hours Long-term Prophylaxis NA NA 45 - 60 IU/kg Q 12 hours An initial dose of 100-120 IU/kg for determination of recovery and
In patients receiving prophylactic administration of CEPROTIN, higher peak protein
C activity levels may be warranted in situations of an
See USE IN SPECIFIC POPULATIONS: Pediatric Use (8.4) and CLINICAL PHARMACOLOGY: Pharmacokinetics (12.3).
2.2 Protein C Activity Monitoring The measurement of protein C activity using
The half-life of CEPROTIN may be shortened in certain clinical conditions such as
See CLINICAL PHARMACOLOGY: Pharmacokinetics (12.3).
In the case of an
After the patient is stabilized, continue monitoring the protein C levels to maintain the trough protein C level above 25 %.
Patients treated during the
Coagulation parameters should also be checked; however, in
2.3 Initiation of Vitamin K
This transient effect may be explained by the fact that protein C, itself a vitamin K-dependent plasma protein, has a
In the initial phase of treatment, the activity of protein C is more rapidly
For this reason, if the patient is switched to oral anticoagulants, protein C replacement must be continued until
Although warfarin-induced skin necrosis can occur in any patient during the initiation of treatment with oral anticoagulant therapy, individuals with
During the initiation of oral anticoagulant therapy, it is advisable to start with a
2.4 Preparation of CEPROTIN [Protein C Concentrate (Human)] Reconstitution:
Remove caps from the CEPROTIN and diluent vials.
Invert diluent vial over the upright CEPROTIN vial; then rapidly insert the
The vacuum in the vial will draw in the diluent.
If there is
Disconnect the two vials by removing the needle from the diluent vial stopper.
Then, remove the transfer needle from the CEPROTIN vial.
Be sure that CEPROTIN is completely dissolved; otherwise,
2.5 Administration of CEPROTIN [Protein C Concentrate (Human)] Administration: Use Aseptic Technique Parenteral drug products should be inspected visually for particulate matter and
CEPROTIN should be administered at room temperature not more than 3 hours after reconstitution.
Insert the filter needle into the vial of reconstituted CEPROTIN. Inject air into the vial and then withdraw the reconstituted CEPROTIN into the syringe.
Filter needles are intended to filter the contents of a single vial of CEPROTIN only.
Administration by Infusion CEPROTIN should be administered at a maximum injection rate of 2 mL per minute except for children with a body weight of < 10 kg, where
8 USE IN SPECIFIC POPULATIONS Pregnancy: Not studied.
(8.1) Labor and Delivery: Not studied.
(8.2) Nursing Mothers: Not studied.
(8.3) Pediatric Use:
(2.1, 8.4, 12.3) Renal/Hepatic
(8.6) 8.1 Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with CEPROTIN.
It is also not known whether CEPROTIN can cause fetal
CEPROTIN has not been studied for use in pregnancy.
8.2 Labor and Delivery There has been one report of
CEPROTIN has not been studied for use during labor and delivery.
8.3 Nursing Mothers It is not known whether CEPROTIN is excreted in human milk.
CEPROTIN has not been studied for use in nursing mothers.
8.4 Pediatric Use Neonatal and
8.5 Geriatric Use Clinical studies of CEPROTIN did not include
|Date Last Revised||12-08-2010|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||Baxter Healthcare Corporation|