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Components:
Octocog Alfa
Method of action:
Antihemorrhagics, Hemostatic
Medically reviewed by Oliinyk Elizabeth Ivanovna, Pharmacy. Last updated on 2019.12.11

Name of the medicinal product

Kovaltry

Qualitative and quantitative composition

Octocog Alfa

Pharmaceutical form

Powder and solvent for solution for injection

Therapeutic indications

The information provided in Therapeutic indications of Kovaltry is based on data of another medicine with exactly the same composition as the Kovaltry of the medicine (Octocog Alfa). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Kovaltry directly from the package or from the pharmacist at the pharmacy.
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Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Kovaltry is indicated in all age groups.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Kovaltry is based on data of another medicine with exactly the same composition as the Kovaltry of the medicine (Octocog Alfa). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Kovaltry directly from the package or from the pharmacist at the pharmacy.
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Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and with resuscitation support immediately available in case of anaphylaxis.

Posology

The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition.

The number of units of factor VIII is expressed in International Units (IU), which are related to the WHO standard for factor VIII products. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IUs (relative to the international standard for factor VIII in plasma).

One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml of normal human plasma.

On demand treatment

The calculation of the required dose of factor VIII is based on the empirical finding that 1 IU factor VIII per kg body weight raises the plasma factor VIII activity by 2 IU/dl. The required dose is determined using the following formula:

Required units (IU) = body weight (kg) x desired factor VIII rise (%) x 0.5

In case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma activity level (in % of normal or IU/dl) in the corresponding period. The following table 1 can be used to guide dosing in bleeding episodes and surgery:

Table 1 Guide for dosing in bleeding episodes and surgery

Degree of haemorrhage/type of surgical procedure

Factor VIII level required (% or IU/dl)

Frequency of doses (hours)/duration of therapy (days)

Haemorrhage

Early haemarthrosis, muscle bleeding or oral bleeding.

 

 

More extensive haemarthrosis, muscle bleeding or haematoma.

 

Life-threatening haemorrhages.

 

20 - 40

 

 

30 - 60

 

60 - 100

 

Repeat injections every 12 to 24 hours (8 to 24 hours for patients under the age of 6) for at least 1 day, until the bleeding episode, as indicated by pain, is resolved or healing is achieved.

Repeat injections every 12 to 24 hours (8 to 24 hours for patients under the age of 6) for 3 - 4 days or more until pain and acute disability are resolved.

Repeat injections every 8 to 24 hours (6 to 12 hours for patients under the age of 6) until threat is resolved.

Surgery

Minor

Including tooth extraction.

Major

 

30 - 60

 

80 - 100

(pre- and postoperative)

 

Every 24 hours (12 to 24 hours for patients under the age of 6), at least 1 day, until healing is achieved.

Repeat injections every 8 to 24 hours (6 to 24 hours for patients under the age of 6) until adequate wound healing, then continue therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).

The dose and frequency of administration should be adapted to the clinical response in the individual case. Under certain circumstances (e.g. presence of a low-titre inhibitor), doses larger than those calculated using the formula may be necessary.

During the course of treatment, appropriate determination of plasma factor VIII levels is advised to guide the dose to be administered and the frequency of repeated injections. In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of plasma factor VIII activity assay is indispensable. Individual patients may vary in their response to factor VIII, achieving different levels of in vivo recovery and demonstrating different half-lives.

Prophylaxis

For long-term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of factor VIII per kg body weight at intervals of 2 to 3 days.

Paediatric population

For on demand treatment dosing in paediatric patients (0 to 18 years of age) does not differ from adult patients. In patients under the age of 6, doses of 20 to 50 IU of factor VIII per kg body weight 3 to 4 times weekly are recommended for prophylactic therapy.

Use of 2 ml presentations has not been documented for paediatric subjects < 2 years of age.

Method of administration

Kovaltry should be administered via the intravenous route. In case of administration by a non health care professional appropriate training is needed.

The rate of administration should be determined to ensure the comfort of the patient up to a maximum of 10 ml/min.

After reconstitution, the solution is clear, colourless, free from foreign particles and has a pH of 6.7 to 7.3.

Contraindications

The information provided in Contraindications of Kovaltry is based on data of another medicine with exactly the same composition as the Kovaltry of the medicine (Octocog Alfa). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Kovaltry directly from the package or from the pharmacist at the pharmacy.
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Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Kovaltry is based on data of another medicine with exactly the same composition as the Kovaltry of the medicine (Octocog Alfa). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Kovaltry directly from the package or from the pharmacist at the pharmacy.
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Hypersensitivity

Allergic type hypersensitivity reactions, including anaphylaxis, have been reported with Kovaltry. The product contains traces of mouse and hamster proteins. If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the product immediately and contact their physician. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.

In case of shock, standard medical treatment for shock should be implemented.

Due to the decrease in injection volume for Kovaltry reconstituted in 2 ml sterilised water for injections, if hypersensitivity reactions occur there is less time to react by stopping the injection. Therefore, caution is advised during injection of Kovaltry reconstituted in 2 ml sterilised water for injections, especially in children.

Inhibitors

The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified assay. The risk of developing inhibitors is correlated to the severity of the disease as well as the exposure to factor VIII, this risk being highest within the first 20 exposure days. Rarely, inhibitors may develop after the first 100 exposure days.

Cases of recurrent inhibitor (low titre) have been observed after switching from one factor VIII product to another in previously treated patients with more than 100 exposure days who have a previous history of inhibitor development. Therefore, it is recommended to monitor all patients carefully for inhibitor occurrence following any product switch.

The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre inhibitors which are transiently present or remain consistently low titre posing less of a risk of insufficient clinical response than high titre inhibitors.

In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed. In patients with high levels of inhibitor, factor VIII therapy may not be effective and other therapeutic options should be considered. Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors.

Misapplication of Kovaltry

For Kovaltry reconstituted with 2 ml sterilised water for injections, misapplication (intra-arterially or paravenously) may lead to mild, short term injection site reactions, such as bruising and erythema.

Catheter-related complications in treatment

If central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteremia and catheter site thrombosis should be considered.

Excipient related considerations

After reconstitution this medicinal product contains 0.45 mmol sodium (10 mg) per vial. To be taken into consideration by patients on a controlled sodium diet.

It is strongly recommended that every time Kovaltry is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.

Paediatric population:

The listed warnings and precautions apply to both adults and children.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Kovaltry is based on data of another medicine with exactly the same composition as the Kovaltry of the medicine (Octocog Alfa). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Kovaltry directly from the package or from the pharmacist at the pharmacy.
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Kovaltry has no influence on the ability to drive and use machines.

Undesirable effects

The information provided in Undesirable effects of Kovaltry is based on data of another medicine with exactly the same composition as the Kovaltry of the medicine (Octocog Alfa). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Kovaltry directly from the package or from the pharmacist at the pharmacy.
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Summary of the safety profile

Clinical studies with Kovaltry included 418 subjects with at least one exposure to Kovaltry reporting in total 93 adverse drug reactions (ADRs). The ADRs that occurred in the highest frequency were development of neutralising antibodies to factor VIII (inhibitors), headache and fever.

Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).

Development of antibodies to mouse and/or hamster protein with related hypersensitivity reactions may be observed.

Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Kovaltry. If such inhibitors occur, the condition will manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be contacted.

Tabulated summary of adverse reactions

The following table 2 provides the frequency of adverse drug reactions in clinical trials and from spontaneous reporting. The table is according to the MedDRA system organ classification (SOC and Preferred Term Level).

Frequency categories are defined according to the following convention: very common (> 1/10), common (> 1/100 to < 1/10), uncommon (> 1/1,000 to < 1/100), rare (> 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Table 2 Frequency of adverse drug reactions (ADRs) in clinical trials and from spontaneous reports

MedDRA Standard System Organ Class

Adverse reaction

Frequencya

Infections and infestations

Influenza

Uncommon

Laryngitis

Uncommon

Blood and lymphatic system disorders

Factor VIII inhibition

Uncommon (PTPs)d

Very common (PUPs)d

Lymphangitis

Uncommon

Immune system disorders

Anaphylactic reaction

Not known

Hypersensitivityc

Not known

Nervous system disorders

Headache

Common

Dizziness

Uncommon

Memory impairment

Uncommon

Syncope

Uncommon

Tremor

Uncommon

Migraine

Uncommon

Dysgeusia

Uncommon

Eye disorders

Eye inflammation

Uncommon

Cardiac disorders

Palpitations

Uncommon

Vascular disorders

Haematoma

Uncommon

Hot flush

Uncommon

Pallor

Uncommon

Respiratory, thoracic and mediastinal disorders

Dyspnoea

Uncommon

Gastrointestinal disorders

Diarrhoea

Uncommon

Abdominal pain upper

Uncommon

Nausea

Uncommon

Vomiting

Uncommon

Skin and subcutaneous tissue disorders

Pruritus

Uncommon

Rash

Uncommon

Hyperhidrosis

Uncommon

Urticaria

Uncommon

General disorders and administration site conditions

Pyrexia

Common

Peripheral oedema

Uncommon

Chest pain

Uncommon

Chest discomfort

Uncommon

Chills

Uncommon

Feeling abnormal

Uncommon

Vessel puncture site haematoma

Uncommon

Fatigue

Not known

Injection site reaction

Not known

Malaise

Not known

Investigations

Monocyte Count increased

Uncommon

Coagulation factor VIII level decreasedb

Uncommon

Haematocrit decreased

Uncommon

Laboratory test abnormal

Uncommon

Injury, poisoning and procedural complications

Post procedural complication

Uncommon

Post procedural haemorrhage

Uncommon

Procedural site reaction

Uncommon

a) Calculated based on total number of patients who received Kovaltry (418).

b) The unexpected decrease in coagulation factor VIII levels occurred in one patient during continuous infusion of Kovaltry following surgery (postoperative days 10-14). Haemostasis was maintained at all times during this period and both plasma factor VIII levels and clearance rates returned to appropriate levels by postoperative day 15. Factor VIII inhibitor assays performed after completion of continuous infusion and at study termination were negative.

c) ADR explained in the section below.

d) Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients

Description of selected adverse reactions

ADRs specific to residues from the manufacturing process

Of the 229 treated patients who were assessed for antibodies to Chinese hamster ovary (CHO) cell protein, 3 showed a statistically significant upward trend in titres, 4 displayed sustained peaks or transient spikes and one patient had both but no clinical symptoms. Of the 229 treated patients who were assessed for antibodies to murine IgG, 10 showed a statistically significant upward trend, 2 displayed a sustained peak or transient spike and one patient had both. Four of these patients reported isolated events of urticaria, pruritus, rash, and slightly elevated eosinophil counts amongst repeated exposures to the study product.

Hypersensitivity

Allergic type reactions include anaphylaxis and have been manifested by dizziness, paresthesias, rash, flushing, face swelling, urticaria, and pruritus.

Paediatric population

Other than the development of inhibitors in previously untreated paediatric patients (PUPs), and catheter-related complications, no age-specific differences in ADRs were noted in the clinical studies.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Overdose

The information provided in Overdose of Kovaltry is based on data of another medicine with exactly the same composition as the Kovaltry of the medicine (Octocog Alfa). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Kovaltry directly from the package or from the pharmacist at the pharmacy.
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No symptoms of overdose with recombinant coagulation factor VIII have been reported.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Kovaltry is based on data of another medicine with exactly the same composition as the Kovaltry of the medicine (Octocog Alfa). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Kovaltry directly from the package or from the pharmacist at the pharmacy.
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Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor VIII. ATC code: B02BD02.

The factor VIII/von Willebrand Factor complex consists of two molecules (factor VIII and von Willebrand Factor) with different physiological functions. Kovaltry contains recombinant coagulation factor VIII (octocog alfa), a glycoprotein that is biologically equivalent to the factor VIII glycoprotein found in human plasma.

Octocog alfa is a glycoprotein consisting of 2332 amino acids with an approximate molecular mass of 280 kD. When infused into a haemophilia patient, octocog alfa binds to endogenous von Willebrand Factor in the patient's circulation. Activated factor VIII acts as a Cofactor for activated Factor IX, accelerating the conversion of Factor X to activated Factor X. Activated Factor X converts prothrombin to thrombin. Thrombin then converts fibrinogen into fibrin and a clot can be formed. Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII activity and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. The plasma levels of factor VIII are increased by replacement therapy, thereby enabling a temporary correction of the factor VIII deficiency and correction of the bleeding tendency.

Data on Immune Tolerance Induction (ITI) in patients with inhibitors have been collected. Within a sub-study of PUP-study 060103, ITI-treatments in 11 PUPs were documented. Retrospective chart review was done for 30 subjects on ITI (study 060703) and collection of Registry data is on-going.

In study 060201 two long-term prophylaxis treatment schemes have been compared in 53 PTPs: an individualized pharmacokinetic guided dosing regimen (within a range of 20 to 80 IU of factor VIII per kg body weight at intervals of 72 ± 6 hours, n=23) with a standard prophylactic dosing regimen (20 to 40 IU/kg every 48 ±6 hours, n=30). The pharmacokinetic guided dosing regimen (according to a specific formula) was targeted to maintain factor VIII trough levels > 1% at the inter-dosing interval of 72 hours. The data from this study demonstrate that the two prophylactic dosing regimens are comparable in terms of reduction of bleeding rate.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Kovaltry is based on data of another medicine with exactly the same composition as the Kovaltry of the medicine (Octocog Alfa). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Kovaltry directly from the package or from the pharmacist at the pharmacy.
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All pharmacokinetic studies with Kovaltry were conducted in previously treated patients with severe to moderately severe haemophilia A (baseline factor VIII ≤ 2%). The analysis of plasma samples was conducted in a central laboratory using a one-stage clotting assay.

A total of 195 subjects with severe haemophilia A (baseline factor VIII < 1%) provided PK parameters that were included in the Per-Protocol PK analysis set. Categories of these analyses for infants (1 month to <2 years of age), children (2 to <5 years of age), older children (5 to <12 years of age), adolescents (12 to <18 years of age), and adults (18 years of age and older) were used to summarize PK parameters, where age was defined as age at time of PK infusion.

Table 3 Summary of Pharmacokinetic Parameters of Kovaltry per Age Group with severe haemophilia A (baseline factor VIII < 1%)

Parameter (mean ± standard deviation)

Infants

(n=5)

Children

(n=30)

Older Children

(n=18)

Adolescents

(n=33)

Adults

(n=109)

Total AUC (IU*·h/dl)

1362.1 ± 311.8

1180.0 ± 432.7

1506.6 ± 530.0

1317.1 ± 438.6

1538.5 ± 519.1

Adjusted Incremental Recovery at Cmax (IU/dL per IU/kg)a

2.2 ± 0.6

1.8 ± 0.4

2.0 ± 0.5

2.1 ± 0.6

2.2 ± 0.6

Half-life (h)

9.0 ± 1.5

9.6 ± 1.7

11.8 ± 3.8

12.1 ± 3.2

12.9 ± 4.3

Maximum Plasma Concentration Post Infusion (IU/dl)

110.5 ± 30.2

90.8 ± 19.1

100.5 ± 25.6

107.6 ± 27.6

111.3 ± 27.1

Mean Residence Time (h)

11.0 ± 2.8

12.0 ± 2.7

15.1 ± 4.7

15.0 ± 5.0

16.2 ± 6.1

Volume of Distribution at Steady State (dl/kg)

0.4 ± 0.1

0.5 ± 0.1

0.5 ± 0.2

0.6 ± 0.2

0.5 ± 0.2

Clearance (ml/kg*h)

3.9 ± 0.9

4.8 ± 1.5

3.8 ± 1.5

4.1 ± 1.0

3.6 ± 1.2

a Calculated as (Cmax - baseline Factor VIII) divided by the dose in IU/kg, where Cmax is the maximal post-infusion Factor VIII measurement.

The safety and haemostatic efficacy of Kovaltry in the paediatric population are similar to that of adult patients. Adjusted recovery and terminal half-life (t½) was approximately 20% lower in young children (less than 6 years of age) than in adults, which may be due in part to the known higher plasma volume per kilogram body weight in younger patients.

Pharmacokinetic data with Kovaltry on previously untreated patients are currently not available.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Kovaltry is based on data of another medicine with exactly the same composition as the Kovaltry of the medicine (Octocog Alfa). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Kovaltry directly from the package or from the pharmacist at the pharmacy.
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antihaemorrhagics, blood coagulation factor VIII. ATC code: B02BD02.

Preclinical safety data

The information provided in Preclinical safety data of Kovaltry is based on data of another medicine with exactly the same composition as the Kovaltry of the medicine (Octocog Alfa). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Kovaltry directly from the package or from the pharmacist at the pharmacy.
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Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, acute toxicology, repeated dose toxicity, local toxicity and genotoxicity.

A local tolerance study in rabbits showed that Kovaltry reconstituted with 2 ml of sterilised water for injections is well tolerated after intravenous administration. Slight transient reddening at the administration site was observed after intraarterial application and after paravenous administration. However, no correlating adverse histopathological changes could be observed indicating a transient nature of this finding.

Incompatibilities

The information provided in Incompatibilities of Kovaltry is based on data of another medicine with exactly the same composition as the Kovaltry of the medicine (Octocog Alfa). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Kovaltry directly from the package or from the pharmacist at the pharmacy.
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In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or solvents.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Kovaltry is based on data of another medicine with exactly the same composition as the Kovaltry of the medicine (Octocog Alfa). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Kovaltry directly from the package or from the pharmacist at the pharmacy.
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Kovaltry is to be administered intravenously after reconstitution of the product.

The reconstituted solution should be inspected visually for any foreign particulate matter and/or discoloration.

After reconstitution the solution should be clear, colourless and free from foreign particles.

Do not use solutions that are cloudy or have deposits.

- For administration the use of a luer-lock syringe is required.

- Use within three hours after reconstitution.

- Do not refrigerate the preparation after reconstitution.

- Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Reconstitution with the BAXJECT II device

- For reconstitution use only the sterilised water for injections and the reconstitution device provided in the pack.

- Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration.

- Aseptic Technique should be used

1. If the product is still stored in a refrigerator, take both the Kovaltry powder and solvent vials from the refrigerator and let them reach room temperature (between 15 °C and 25 °C).

2. Wash your hands thoroughly using soap and warm water.

3. Remove caps from powder and solvent vials.

4. Cleanse stoppers with alcohol swabs. Place the vials on a flat clean surface.

5. Open the package of BAXJECT II device by peeling away the paper lid without touching the inside (Fig. a). Do not remove the device from the package. Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration.

6. Turn the package over and insert the clear plastic spike through the solvent stopper. Grip the package at its edge and pull the package off BAXJECT II (Fig. b). Do not remove the blue cap from the BAXJECT II device.

7. For reconstitution only the sterilised water for injections and the reconstitution device provided in the pack should be used. With BAXJECT II attached to the solvent vial, invert the system so that the solvent vial is on top of the device. Insert the white plastic spike through the Kovaltry powder stopper. The vacuum will draw the solvent into the Kovaltry powder vial (Fig. c).

8. Swirl gently until all material is dissolved. Be sure that the Kovaltry powder is completely dissolved, otherwise not all reconstituted solution will pass through the device filter. The product dissolves rapidly (usually in less than 1 minute). After reconstitution the solution should be clear, colourless and free from foreign particles.

Reconstitution with the BAXJECT III system

- Do not use if the lid is not completely sealed on the blister

1. If the product is still stored in a refrigerator, take the sealed blister (contains powder and solvent vials preassembled with the system for reconstitution) from the refrigerator and let it reach room temperature (between 15 °C and 25 °C).

2. Wash your hands thoroughly using soap and warm water.

3. Open the Kovaltry package by peeling away the lid. Remove the BAXJECT III system from the blister.

4. Place the Kovaltry on a flat surface with the solvent vial on top (Fig. 1). The solvent vial has a blue stripe. Do not remove the blue cap until instructed in a later step.

5. With one hand holding the Kovaltry in the BAXJECT III system, press down firmly on the solvent vial with the other hand until the system is fully collapsed and the solvent flows down into the Kovaltry vial (Fig. 2). Do not tilt the system until the transfer is complete.

6. Verify that the solvent transfer is complete. Swirl gently until all material is dissolved. Be sure that the Kovaltry powder is completely dissolved, otherwise not all reconstituted solution will pass through the device filter. The product dissolves rapidly (usually in less than 1 minute). After reconstitution the solution should be clear, colourless and free from foreign particles.

Administration

Use Aseptic Technique

Parenteral medicinal products should be inspected for particulate matter prior to administration, whenever solution and container permit. Only a clear and colourless solution should be used.

1. Remove the blue cap from BAXJECT II / BAXJECT III. Do not draw air into the syringe. Connect the syringe to BAXJECT II / BAXJECT III.

2. Invert the system (the vial with the reconstituted solution has to be on top). Draw the reconstituted solution into the syringe by pulling the plunger back slowly.

3. Disconnect the syringe.

4. Attach a butterfly needle to the syringe. Inject intravenously. The solution should be administered slowly, at a rate as determined by the patient's comfort level, not to exceed 10 ml per minute. The pulse rate should be determined before and during administration of Kovaltry. Should a significant increase occur, reducing the rate of administration or temporarily interrupting the injection usually allows the symptoms to disappear promptly.

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