Csl Behring Gmbh

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Csl Behring Gmbh Drugs

Laxative

Laxative

For intravenous use only.

2.1 Treatment of Congenital Fibrinogen Deficiency

RiaSTAP dosing, duration of dosing and frequency of administration should be individualized based on the extent of bleeding, laboratory values, and the clinical condition of the patient.

RiaSTAP dose when baseline fibrinogen level is known

Dose should be individually calculated for each patient based on the target plasma fibrinogen level based on the type of bleeding, actual measured plasma fibrinogen level and body weight, using the following formula (see Pharmacokinetics [12.3]):
[Target level (mg/dL) - measured level (mg/dL)] 1.7 (mg/dL per mg/kg body weight)
RiaSTAP dose when baseline fibrinogen level is not known

If the patient's fibrinogen level is not known, the recommended dose is 70 mg per kg of body weight administered intravenously.

Monitoring of patient's fibrinogen level is recommended during treatment with RiaSTAP. A target fibrinogen level of 100 mg/dL should be maintained until hemostasis is obtained.

2.2 Preparation and Reconstitution

The procedures below are provided as general guidelines for preparation and reconstitution of RiaSTAP.

Use aseptic technique when preparing and reconstituting RiaSTAP.

Reconstitute RiaSTAP at room temperature as follows:
Remove the cap from the product vial to expose the central portion of the rubber stopper. Clean the surface of the rubber stopper with an antiseptic solution and allow it to dry. Using an appropriate transfer device or syringe, transfer 50 mL of Sterile Water for Injection into the product vial. Gently swirl the product vial to ensure the product is fully dissolved. Do not shake the vial.
After reconstitution, the RiaSTAP solution should be colorless and clear to slightly opalescent. Inspect visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates. Discard partially used vials.

RiaSTAP is stable for 8 hours after reconstitution when stored at 20-25ºC and should be administered within this time period.

2.3 Administration

Do not mix RiaSTAP with other medicinal products or intravenous solutions, and should be administered through a separate injection site.

Use aseptic technique when administering RiaSTAP.

Administer RiaSTAP at room temperature by slow intravenous injection at a rate not exceeding 5 mL per minute.
Xenical

Xenical

For Intravenous Use Only.

Administer Berinert at a dose of 20 International Units (IU) per kg body weight by intravenous injection. Doses lower than 20 IU/kg body weight should not be administered.

Berinert is provided as a freeze-dried powder for reconstitution with the Sterile Water for Injection, USP provided. Store the vial in the original carton in order to protect from light. Do not freeze.

2.1 Preparation and Handling
Check the expiration date on the product vial label. Do not use beyond the expiration date. Prepare and administer using aseptic techniques [see Dosage and Administration (2.2)]. Use a silicone-free syringe for reconstitution and administration of Berinert. After reconstitution and prior to administration, inspect Berinert visually for particulate matter and discoloration. The reconstituted solution should be colorless, clear, and free from visible particles. Do not use if the solution is cloudy, discolored, or contains particulates. The Berinert vial is for single use only. Berinert contains no preservative. Any product that has been reconstituted should be used promptly. The reconstituted solution must be used within 8 hours. Discard partially used vials. Do not freeze the reconstituted solution.
2.2 Reconstitution and Administration

Each Berinert vial containing 500 IU of C1 esterase inhibitor as a lyophilized concentrate for reconstitution with 10 mL of Sterile Water for Injection, USP provided.

Use either the Mix2Vial® transfer set provided with Berinert [see How Supplied/Storage and Handling (16.1)] or a commercially available double-ended needle and vented filter spike.

Reconstitution

The procedures below are provided as general guidelines for the reconstitution and administration of Berinert.
1. Ensure that the Berinert vial and diluent vial are at room temperature. 2. Place the Berinert vial, diluent vial and Mix2Vial transfer set on a flat surface. 3. Remove the flip caps from the Berinert and diluent vials. Wipe the vial stoppers with the alcohol swab provided. Allow to dry prior to opening the Mix2Vial transfer set package. 4. Open the Mix2Vial transfer set package by peeling away the lid (Figure 1). Leave the Mix2Vial transfer set in the clear package. Figure 1 5. Place the diluent vial on a flat surface and hold the vial tightly. Grip the Mix2Vial transfer set together with the clear package and push the plastic spike at the blue end of the Mix2Vial transfer set firmly through the center of the stopper of the diluent vial (Figure 2). Figure 2 6. Carefully remove the clear package from the Mix2Vial transfer set. Make sure that you pull up only the clear package, and not the Mix2Vial transfer set (Figure 3). Figure 3 7. With the Berinert vial placed firmly on a flat surface, invert the diluent vial with the Mix2Vial transfer set attached and push the plastic spike of the transparent adapter firmly through the center of the stopper of the Berinert vial (Figure 4). The diluent will automatically transfer into the Berinert vial. Figure 4 8. With the diluent and Berinert vial still attached to the Mix2Vial transfer set, gently swirl the Berinert vial to ensure that the Berinert is fully dissolved (Figure 5). Do not shake the vial. Figure 5 9. With one hand, grasp the Berinert-side of the Mix2Vial transfer set and with the other hand grasp the blue diluent-side of the Mix2Vial transfer set and unscrew the set into two pieces (Figure 6). Figure 6 10. Carefully look at reconstituted solution in each vial of Berinert. It should be colorless, clear, and free from visible particles. Do not use the vial if the liquid looks cloudy, contains particles, or has changed color. Do not use if the expiration date on the label has expired. 11. Draw air into an empty, sterile syringe. Use a silicone-free syringe. While the Berinert vial is upright, screw the syringe to the Mix2Vial transfer set. Inject air into the Berinert vial. While keeping the syringe plunger pressed, invert the system upside down and draw the concentrate into the syringe by pulling the plunger back slowly (Figure 7). Figure 7 12. Now that the concentrate has been transferred into the syringe, firmly grasp the barrel of the syringe (keeping the plunger facing down) and unscrew the syringe from the Mix2Vial transfer set (Figure 8). Attach the syringe to a suitable intravenous administration set. Figure 8 13. If patient requires more than one vial, pool the contents of multiple vials into one syringe. A new unused Mix2Vial transfer set should be used for each Berinert vial. 14. Do not refrigerate after reconstitution. When reconstitution is carried out using aseptic technique, administration may begin within 8 hours, provided the solution has been stored at up to 25°C (77°F). Do not refrigerate or freeze the reconstituted solution. Only store the reconstituted product in the vial.
Administration
Do not mix Berinert with other medicinal products. Administer Berinert by a separate infusion line. Use aseptic technique when administering Berinert. Use a silicone-free syringe. Follow recommended venipuncture guidelines for initiating intravenous therapy. Administer Berinert by slow intravenous injection at a rate of approximately 4 mL per minute. Please refer to the illustration in step 6 of the self-administration section in the Patient Product Information (PPI) section. For self-administration, provide the patient with instructions and training for intravenous injection outside of a clinic setting so patients may self-administer Berinert upon recognition of symptoms of an HAE attack [see Patient Counseling Information (17)]. After administration, immediately discard any unused product and all used disposable supplies in accordance with local requirements.
Humate-p

Humate-p

2.1 Therapy for Hemophilia A

One International Unit (IU) of Factor VIII (FVIII) activity per kg body weight will increase the circulating FVIII level by approximately 2.0 International Units (IU)/dL. Dosage must be individualized based on the patient's weight, type and severity of hemorrhage, FVIII level, and presence of inhibitors. Judge the adequacy of treatment by clinical effects and, in all cases, adjust doses as needed based on clinical judgment and on frequent monitoring of the patient's FVIII level. Table 1 provides dosing recommendations for the treatment of hemophilia A in adults.
Table 1: Dosing Recommendations for the Treatment of Hemophilia A in Adults1 Hemorrhagic Event Dosage (IU FVIII:C/kg Body Weight) IU = International Units. Minor hemorrhage: Early joint or muscle bleed Severe epistaxis Loading dose 15 IU FVIII:C/kg to achieve a FVIII:C plasma level of approximately 30% of normal; one infusion may be sufficient. If needed, half of the loading dose may be given once or twice daily for 1-2 days. Moderate hemorrhage: Advanced joint or muscle bleed Neck, tongue, or pharyngeal hematoma (without airway compromise) Tooth extraction Severe abdominal pain Loading dose 25 IU FVIII:C/kg to achieve a FVIII:C plasma level of approximately 50% of normal, followed by 15 IU FVIII:C/kg every 8-12 hours for the first 1-2 days to maintain the FVIII:C plasma level at 30% of normal. Continue the same dose once or twice daily for up to 7 days or until adequate wound healing is achieved. Life-threatening hemorrhage: Major surgery Gastrointestinal bleeding Neck, tongue, or pharyngeal hematoma (with potential for airway compromise) Intracranial, intraabdominal, or intrathoracic bleeding Fractures Initially 40-50 IU FVIII:C/kg, followed by 20-25 IU FVIII:C/kg every 8 hours to maintain the FVIII:C plasma level at 80-100% of normal for 7 days. Continue the same dose once or twice daily for another 7 days to maintain the FVIII:C level at 30-50% of normal.
2.2 Treatment of Bleeding Episodes in VWD

Administer 40 to 80 International Units (IU) VWF:RCo (corresponding to 17 to 33 International Units (IU) FVIII in Humate-P) per kg body weight every 8 to 12 hours. Adjust the dosage based on the extent and location of bleeding. Administer repeat doses as long as needed based on monitoring of appropriate clinical and laboratory measures [see Warnings and Precautions (5.2, 5.3)]. Expected levels of VWF:RCo are based on an expected in vivo recovery (IVR) of 2.0 International Units (IU)/dL rise per International Unit (IU)/kg VWF:RCo administered. The administration of 1 International Unit (IU) of FVIII per kg body weight can be expected to lead to a rise in circulating VWF:RCo of approximately 5 International Units (IU)/dL. Table 2 provides dosing recommendations for adult and pediatric patients [see Use in Specific Populations (8.4)].2
Table 2: VWF:RCo Dosing Recommendations for the Treatment of Bleeding Episodes by VWD Type VWD Type Severity of Hemorrhage Dosage (IU* VWF:RCo/kg Body Weight) * IU = International Units. † For major bleeds in all types of VWD where repeated dosing is required, monitor and maintain the patient's FVIII level according to the guidelines for hemophilia A therapy. Type 1 VWD – Mild(baseline VWF:RCo activity typically >30%) Minor(e.g., epistaxis, oral bleeding, menorrhagia) Typically treatable with desmopressin. Minor(when desmopressin is known or suspected to be inadequate)Major† (e.g., severe or refractory epistaxis, GI bleeding, CNS trauma, traumatic hemorrhage) Loading dose 40-60 IU/kg.Then 40-50 IU/kg every 8-12 hours for 3 days to keep the trough level of VWF:RCo >50%.Then 40-50 IU/kg daily for up to 7 days. Type 1 VWD – Moderate or severe (baseline VWF:RCo typically <30%) Minor(e.g., epistaxis, oral bleeding, menorrhagia) 40-50 IU/kg (1 or 2 doses). Major(e.g., severe or refractory epistaxis, GI bleeding, CNS trauma, hemarthrosis, traumatic hemorrhage) Loading dose 50-75 IU/kg.Then 40-60 IU/kg every 8-12 hours for 3 days to keep the trough level of VWF:RCo >50%.Then 40-60 IU/kg daily for up to 7 days. Type 2 VWD (all variants) and Type 3 VWD Minor(clinical indications above) 40-50 IU/kg (1 or 2 doses). Major(clinical indications above) Loading dose 60-80 IU/kg.Then 40-60 IU/kg every 8-12 hours for 3 days to keep the trough level of VWF:RCo >50%.Then 40-60 IU/kg daily for up to 7 days.
2.3 Prevention of Excessive Bleeding During and After Surgery in VWD

The following information provides guidelines for calculating loading and maintenance doses of Humate-P for patients undergoing surgery. However in the case of emergency surgery, administer a loading dose of 50 to 60 International Units (IU) VWF:RCo/kg body weight and, subsequently, closely monitor the patient's trough coagulation factor levels.

Measure incremental IVR and assess plasma VWF:RCo and FVIII:C levels in all patients prior to surgery when possible.

To determine IVR:
Measure the baseline plasma VWF:RCo level. Infuse a calculated dose [International Units (IU)/kg] of VWF:RCo product intravenously at "time 0". At "time+30 minutes", measure the plasma VWF:RCo level.
Use the following formula to calculate IVR:
IVR = (Plasma VWF:RCotime+30 min – Plasma VWF:RCobaseline International Units (IU)/dL) Calculated dose (International Units (IU)/kg)
For example, assuming a baseline VWF:RCo of 30 International Units (IU)/dL at "time 0", a calculated dose of 60 International Units (IU)/kg, and a VWF:RCo of 120 International Units (IU)/dL at "time+30 minutes", the IVR would be 1.5 International Units (IU)/dL per International Units (IU)/kg of VWF:RCo administered.

Loading Dose

Table 3 provides guidelines for calculating the loading dose for adult and pediatric patients based on the target peak plasma VWF:RCo level, the baseline VWF:RCo level, body weight in kilograms, and IVR. When individual recovery values are not available, a standardized loading dose can be used based on an assumed VWF:RCo IVR of 2.0 International Units (IU)/dL per International Unit (IU)/kg of VWF:RCo administered.
Table 3: VWF:RCo and FVIII:C Loading Dose Calculations for the Prevention of Excessive Bleeding During and After Surgery for All Types of VWD Type of Surgery VWF:RCo Target Peak Plasma Level FVIII:C Target Peak Plasma Level Calculation of Loading Dose(to be administered 1 to 2 hours before surgery) IU = International Units.BW = body weight. * Δ = Target peak plasma VWF:RCo level – baseline plasma VWF:RCo level. † IVR = in vivo recovery as measured in the patient. ‡ Oral surgery is defined as extraction of fewer than three teeth, if the teeth are non-molars and have no bony involvement. Extraction of more than one impacted wisdom tooth is considered major surgery due to the expected difficulty of the surgery and the expected blood loss, particularly in subjects with type 2A or type 3 VWD. Extraction of more than two teeth is considered major surgery in all patients. Major 100 IU/dL 80-100 IU/dL Δ* VWF:RCo × BW (kg) IVR† = IU VWF:RCo required If the IVR is not available, assume an IVR of 2.0 IU/dL per IU/kg and calculate the loading dose as follows:(100 – baseline plasma VWF:RCo) × BW (kg)/2.0 Minor/Oral‡ 50-60 IU/dL 40-50 IU/dL Δ* VWF:RCo × BW (kg) IVR = IU VWF:RCo required Emergency 100 IU/dL 80-100 IU/dL Administer a dose of 50-60 IU VWF:RCo/kg body weight.
For example, the loading dose of Humate-P required assuming a target VWF:RCo level of 100 International Units (IU)/dL, a baseline VWF:RCo level of 20 International Units (IU)/dL, an IVR of 2.0 International Units (IU)/dL per International Units (IU)/kg, and a body weight of 70 kg would be 2,800 International Units (IU) VWF:RCo, calculated as follows:
IU = International Units. (100 IU/dL – 20 IU/dL) × 70 kg = 2,800 IU VWF:RCo required 2.0 (IU/dL)/(IU/kg)
Attaining a target peak FVIII:C plasma level of 80 to 100 International Units (IU) FVIII:C/dL for major surgery and 40 to 50 International Units (IU) FVIII:C/dL for minor surgery or oral surgery might require additional dosing with Humate-P. Because the ratio of VWF:RCo to FVIII:C activity in Humate-P is 2.4:1, any additional dosing will increase VWF:RCo proportionally more than FVIII:C. Assuming an incremental IVR of 2.0 International Units (IU) VWF:RCo/dL per International Units (IU)/kg infused, additional dosing to increase FVIII:C in plasma will also increase plasma VWF:RCo by approximately 5 International Units (IU)/dL for each International Unit (IU)/kg of FVIII administered.

Maintenance Doses

The initial maintenance dose of Humate-P for the prevention of excessive bleeding during and after surgery should be half of the loading dose, irrespective of additional dosing required to meet FVIII:C targets. Subsequent maintenance doses should be based on the patient's VWF:RCo and FVIII levels. Table 4 provides recommendations for target trough plasma levels (based on type of surgery and number of days following surgery) and minimum duration of treatment for subsequent maintenance doses. These recommendations apply to both adult and pediatric patients.
Table 4: VWF:RCo and FVIII:C Target Trough Plasma Level and Minimum Duration of Treatment Recommendations for Subsequent Maintenance Doses for the Prevention of Excessive Bleeding During and After Surgery Type of Surgery VWF:RCoTarget Trough Plasma Level* FVIII:CTarget Trough Plasma Level* Minimum Duration of Treatment Up to 3 days following surgery After Day 3 Up to 3 days following surgery After Day 3 IU = International Units. * Trough levels for either coagulation factor should not exceed 100 IU/dL. † Oral surgery is defined as extraction of fewer than three teeth, if the teeth are non-molars and have no bony involvement. Extraction of more than one impacted wisdom tooth is considered major surgery due to the expected difficulty of the surgery and the expected blood loss, particularly in subjects with type 2A or type 3 VWD. Extraction of more than two teeth is considered major surgery in all patients. ‡ Administer at least one maintenance dose following oral surgery based on individual pharmacokinetic values. Subsequent therapy with an antifibrinolytic agent is usually administered until adequate healing is achieved. Major >50 IU/dL >30 IU/dL >50 IU/dL >30 IU/dL 72 hours Minor ≥30 IU/dL – – >30 IU/dL 48 hours Oral† ≥30 IU/dL – – >30 IU/dL 8-12 hours‡
Based on individual pharmacokinetic-derived half-lives, the frequency of maintenance doses is generally every 8 or 12 hours; patients with shorter half-lives may require dosing every 6 hours. In the absence of pharmacokinetic data, it is recommended that Humate-P be administered initially every 8 hours with further adjustments determined by monitoring trough coagulation factor levels. When hemostatic levels are judged insufficient or trough levels are outside the recommended range, consider modifying the administration interval and/or the dose.

It is advisable to monitor trough VWF:RCo and FVIII:C levels at least once a day in order to adjust Humate-P dosing as needed to avoid excessive accumulation of coagulation factors. The duration of treatment generally depends on the type of surgery performed, but must be assessed for individual patients based on their hemostatic response [see Clinical Studies (14.2)].

2.4 Reconstitution and Administration

Humate-P is for intravenous use only.
Prepare and administer using aseptic techniques. Use either the Mix2Vial® filter transfer set provided with Humate-P [see How Supplied/Storage and Handling (16)] or a commercially available double-ended needle and vented filter spike. Use plastic disposable syringes with Humate-P. Protein solutions of this type tend to adhere to the ground glass surface of all-glass syringes. Reconstitute Humate-P at room temperature as follows: 1. Ensure that the Humate-P vial and diluent vial are at room temperature. 2. Place the Humate-P vial, diluent vial and Mix2Vial transfer set on a flat surface. 3. Remove the Humate-P and diluent vial flip caps and wipe the stoppers with the alcohol swab provided. Allow to dry prior to opening the Mix2Vial transfer set package. 4. Open the Mix2Vial transfer set package by peeling away the lid (Figure 1). Leave the Mix2Vial transfer set in the clear package. Figure 1 5. Place the diluent vial on a flat surface and hold the vial tightly. Grip the Mix2Vial transfer set together with the clear package and push the plastic spike at the blue end of the Mix2Vial transfer set firmly through the center of the stopper of the diluent vial (Figure 2). Figure 2 6. Carefully remove the clear package from the Mix2Vial transfer set. Make sure that you pull up only the package and not the Mix2Vial transfer set (Figure 3). Figure 3 7. With the Humate-P vial placed firmly on a flat surface, invert the diluent vial with the Mix2Vial transfer set attached and push the plastic spike of the transparent adapter firmly through the center of the stopper of the Humate-P vial (Figure 4). The diluent will automatically transfer into the Humate-P vial. Figure 4 8. With the diluent and Humate-P vial still attached to the Mix2Vial transfer set, gently swirl the Humate-P vial to ensure the Humate-P is fully dissolved (Figure 5). Do not shake the vial. Figure 5 9. With one hand grasp the Humate-P side of the Mix2Vial transfer set and with the other hand grasp the blue diluent-side of the Mix2Vial transfer set, and unscrew the set into two pieces (Figure 6). Figure 6 10. Draw air into an empty, sterile syringe. While the Humate-P vial is upright, screw the syringe to the Mix2Vial transfer set. Inject air into the Humate-P vial. While keeping the syringe plunger pressed, invert the system upside down and draw the concentrate into the syringe by pulling the plunger back slowly (Figure 7). Figure 7 11. Now that the concentrate has been transferred into the syringe, firmly grasp the barrel of the syringe (keeping the syringe plunger facing down) and unscrew the syringe from the Mix2Vial transfer set (Figure 8). Attach the syringe to a suitable intravenous administration set. Figure 8 12. If patient requires more than one vial, pool the contents of multiple vials into one syringe. Use a separate unused Mix2Vial for each product vial. The solution should be clear or slightly opalescent. After filtering/withdrawal the reconstituted product should be inspected visually for particulate matter and discoloration prior to administration. Even if the directions for use for the reconstitution procedure are precisely followed, it is not uncommon for a few flakes or particles to remain. The filter included in the Mix2Vial device removes those particles completely. Filtration does not influence dosage calculations. Do not use visibly cloudy solutions or solutions still containing flakes or particles after filtration. Do not refrigerate Humate-P after reconstitution. Administer within 3 hours after reconstitution. Slowly infuse the solution (maximally 4 mL/minute) with a suitable intravenous administration set. Discard the administration equipment and any unused Humate-P after use.
Kcentra

Kcentra

For intravenous use only.

2.1 Dosage
Measurement of INR prior to treatment and close to the time of dosing is important because coagulation factors may be unstable in patients with acute major bleeding or an urgent need for surgery and other invasive procedures. Individualize Kcentra dosing based on the patient's current pre-dose International Normalized Ratio (INR) value, and body weight (see Table 1). The actual potency per vial of Factors II, VII, IX and X, Proteins C and S is stated on the carton. Administer Vitamin K concurrently to patients receiving Kcentra. Vitamin K is administered to maintain Vitamin K-dependent clotting factor levels once the effects of Kcentra have diminished. The safety and effectiveness of repeat dosing have not been established and it is not recommended. Dose ranging within pre-treatment INR groups has not been studied in randomized clinical trials of Kcentra. Table 1: Dosage Required for Reversal of VKA Anticoagulation in Patients with acute major bleeding or need for an urgent surgery/invasive procedure Pre-treatment INR 2–< 4 4–6 > 6 * Dosing is based on body weight. Dose based on actual potency as stated on the carton, which will vary from 20–31 Factor IX units/mL after reconstitution. Nominal potency is 500 or 1000 units per vial, approximately 25 units per mL after reconstitution. † Units refer to International Units. ‡ Dose is based on body weight up to but not exceeding 100 kg. For patients weighing more than 100 kg, maximum dose should not be exceeded. Dose* of Kcentra (units† of Factor IX) / kg body weight 25 35 50 Maximum dose‡ (units of Factor IX) Not to exceed 2500 Not to exceed 3500 Not to exceed 5000
Example dosing calculation for 80 kg patient

For example, an 80 kg patient with a baseline of INR of 5.0, the dose would be 2,800 Factor IX units of Kcentra, calculated as follows based on INR range of 4–6, see Table 1:
* For a vial with an actual potency of 30 units/mL Factor IX, 93 mL would be given (2,800 U/30 U per mL = 93 mL). 35 units of Factor IX/kg × 80 kg = 2,800 units of Factor IX required*
Monitor INR and clinical response during and after treatment. In clinical trials, Kcentra decreased the INR to ≤ 1.3 within 30 minutes in most subjects. The relationship between this or other INR values and clinical hemostasis in patients has not been established [see Clinical Studies (14)].

2.2 Preparation and Reconstitution
Reconstitute using aseptic technique with 20 mL (500 U kit) or 40 mL (1000 U kit) of diluent provided with the kit. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration whenever solution and container permit. Reconstituted Kcentra solution should be colorless, clear to slightly opalescent, and free from visible particles. Do not use solutions that are cloudy or have deposits. Kcentra is for single use only. Contains no preservatives. Discard partially used vials.
The procedures provided in Table 2 are general guidelines for the preparation and reconstitution of Kcentra.

Reconstitute at room temperature as follows:
Table 2: Kcentra Reconstitution Instructions 1. Ensure that the Kcentra vial and diluent vial are at room temperature. Prepare and administer using aseptic technique. 2. Place the Kcentra vial, diluent vial, and Mix2Vial ® transfer set on a flat surface. 3. Remove Kcentra and diluent vial flip caps. Wipe the stoppers with the alcohol swab provided and allow to dry prior to opening the Mix2Vial transfer set package. 4. Open the Mix2Vial transfer set package by peeling away the lid. [ Fig. 1] Leave the Mix2Vial transfer set in the clear package. Fig. 1 5. Place the diluent vial on a flat surface and hold the vial tightly. Grip the Mix2Vial transfer set together with the clear package and push the plastic spike at the blue end of the Mix2Vial transfer set firmly through the center of the stopper of the diluent vial. [ Fig. 2] Fig. 2 6. Carefully remove the clear package from the Mix2Vial transfer set. Make sure that you pull up only the clear package, not the Mix2Vial transfer set. [ Fig. 3] Fig. 3 7. With the Kcentra vial placed firmly on a flat surface, invert the diluent vial with the Mix2Vial transfer set attached and push the plastic spike of the transparent adapter firmly through the center of the stopper of the Kcentra vial. [ Fig. 4] The diluent will automatically transfer into the Kcentra vial. Fig. 4 8. With the diluent and Kcentra vial still attached to the Mix2Vial transfer set, gently swirl the Kcentra vial to ensure that the Kcentra is fully dissolved. [ Fig. 5] Do not shake the vial. Fig. 5 9. With one hand, grasp the Kcentra side of the Mix2Vial transfer set and with the other hand grasp the blue diluent-side of the Mix2Vial transfer set, and unscrew the set into two pieces. [ Fig. 6] Fig. 6 10. Draw air into an empty, sterile syringe. While the Kcentra vial is upright, screw the syringe to the Mix2Vial transfer set. Inject air into the Kcentra vial. While keeping the syringe plunger pressed, invert the system upside down and draw the concentrate into the syringe by pulling the plunger back slowly. [ Fig. 7] Fig. 7 11. Now that the concentrate has been transferred into the syringe, firmly grasp the barrel of the syringe (keeping the plunger facing down) and unscrew the syringe from the Mix2Vial transfer set. [ Fig. 8] Attach the syringe to a suitable intravenous administration set. Fig. 8 12. After reconstitution, administration should begin promptly or within 4 hours. 13. If the same patient is to receive more than one vial, you may pool the contents of multiple vials. Use a separate unused Mix2Vial transfer set for each product vial.
2.3 Administration
Do not mix Kcentra with other medicinal products; administer through a separate infusion line. Use aseptic technique when administering Kcentra. Administer at room temperature. Administer by intravenous infusion at a rate of 0.12 mL/kg/min (~3 units/kg/min), up to a maximum rate of 8.4 mL/min (~210 units/min). No blood should enter the syringe, as there is a possibility of fibrin clot formation.
Doxycycline

Doxycycline

2.1 Dose
40 International Units (IU) per kg body weight at a rate not to exceed 4 mL per minute Adjust dose ±5 IU per kg to maintain 5% to 20% trough level of FXIII activity as provided in the example below
Dose Adjustment Using the Berichrom Activity Assay
Factor XIII Activity Trough Level (%) Dosage Change One trough level of <5% Increase by 5 IU per kg Trough level of 5% to 20% No change Two trough levels of >20% Decrease by 5 IU per kg One trough level of >25% Decrease by 5 IU per kg
2.2 Administration
Administer at a rate not exceeding 4 mL per minute For routine prophylaxis, administer every 28 days For peri-operative management of surgical bleeding: Dosing should be individualized based on the patient's FXIII activity level, type of surgery, and clinical response Monitor patient's FXIII activity levels during and after surgery Following are dose adjustment examples for peri-operative management in reference to the patient's last prophylactic dose:
Dose Adjustment for Peri-operative Management
Time Since Last Dose Dose Within 7 days Additional dose may not be needed 8 – 21 days Additional partial or full dose may be needed based on FXIII activity level 21 – 28 days Full prophylactic dose
The potency expressed in International Units is determined using the Berichrom activity assay, referenced to the current International Standard for Blood Coagulation Factor XIII, Plasma.

2.3 Reconstitution

Perform a visual inspection of the reconstituted solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

The procedures below are provided as general guidelines for the preparation and reconstitution of Corifact.

Reconstitute Corifact at room temperature as follows:
1. Ensure that the Corifact vial and diluent vial are at room temperature. 2. Place the Corifact vial, diluent vial, and Mix2Vial ® transfer set on a flat surface. 3. Remove Corifact and diluent vial flip caps and wipe the stoppers with the alcohol swab provided. Allow to dry prior to opening the Mix2Vial transfer set package. 4. Open the Mix2Vial transfer set package by peeling away the lid ( Fig. 1). Leave the Mix2Vial transfer set in the clear package. Fig. 1 5. Place the diluent vial on a flat surface and hold the vial tightly. Grip the Mix2Vial transfer set together with the clear package and push the plastic spike at the blue end of the Mix2Vial transfer set firmly through the center of the stopper of the diluent vial ( Fig. 2). Fig. 2 6. Carefully remove the clear package from the Mix2Vial transfer set. Make sure that you pull up only the clear package, not the Mix2Vial transfer set ( Fig. 3). Fig. 3 7. With the Corifact vial placed firmly on a flat surface, invert the diluent vial with the Mix2Vial transfer set attached and push the plastic spike of the transparent adapter firmly through the center of the stopper of the Corifact vial ( Fig. 4). The diluent will automatically transfer into the Corifact vial. Fig. 4 8. With the diluent and Corifact vial still attached to the Mix2Vial transfer set, gently swirl the Corifact vial to ensure that the Corifact is fully dissolved ( Fig. 5). Do not shake the vial. Fig. 5 9. With one hand, grasp the Corifact side of the Mix2Vial transfer set and with the other hand grasp the blue diluent-side of the Mix2Vial transfer set, and unscrew the set into two pieces. ( Fig. 6). Fig. 6 10. Draw air into an empty, sterile syringe. While the Corifact vial is upright, screw the syringe to the Mix2Vial transfer set. Inject air into the Corifact vial. While keeping the syringe plunger pressed, invert the system upside down and draw the concentrate into the syringe by pulling the plunger back slowly. ( Fig. 7). Fig. 7 11. Now that the concentrate has been transferred into the syringe, firmly grasp the barrel of the syringe (keeping the plunger facing down) and unscrew the syringe from the Mix2Vial transfer set ( Fig. 8). Attach the syringe to a suitable intravenous administration set. Fig. 8 12. If patient requires more than one vial, pool the contents of multiple vials into one syringe. Use a separate unused Mix2Vial transfer set for each product vial. 13. Corifact is for single use only. Contains no preservatives. The product must be used within 4 hours after reconstitution. Do not refrigerate or freeze the reconstituted solution. Discard partially used vials.

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