Advait - instructions for use, doses, side effects, contraindications

Active substanceOktokog alfaOktokog alfa

Similar drugsTo uncover

Adv

lyophilizate in / in

Baxter AG Austria

Kogenate FS

lyophilizate in / in

Bayer Helscher LLS USA

Recombinant

lyophilizate in / in

Baxter, C.A. Belgium

Dosage form: & nbsplyophilizate for the preparation of a solution for intravenous administration

Composition:

1 bottle with lyophilizate contains:

active substance: octochologia alfa 250 ME, 500 ME, 1000 ME or 1500 ME;

Excipients (per 1 ml of reconstituted solution): trehalose dihydrate 8.0 mg / ml, histidine 1.6 mg / ml, trometamol 1.2 mg / ml, sodium chloride 5.3 mg / ml, calcium chloride dihydrate 0.2 mg / ml, glutathione (reduced) 0.08 mg / ml, polysorbate-80 0.1 mg / ml, mannitol 32 mg / ml.

1 vial with solvent contains:

water for injection 5 ml.

The specific activity of ADVATE is between 4,000 and 10,000 ME per milligram of protein.

ADVATE is produced by the method of recombinant technology in the culture of ovarian cells of Chinese hamster, without the addition of proteins of human or animal origin in the manufacturing process.

The drug ADVATE approximately contains (after reconstitution with 5 ml of water for injection):

- 50 IU / mL octocoal for dosage 250 ME;

- 100 IU / ml octocoal for dosage 500 ME;

- 200 IU / ml octocoal for dosage 1000 ME;

- 300 IU / mL octocoal for dosage 1500 ME;

The drug does not contain preservatives.

Description:

Lyophilizate: powder or brittle mass of white or white and yellowish tinge.

Solvent: clear, colorless liquid.

The reconstituted solution: transparent clear solution without mechanical impurities.

Pharmacotherapeutic group:Hemostatic agent

ATX: & nbsp

B.02.B.D.02 Coagulation factor VIII

Pharmacodynamics:

Complex factor VIII/ Willebrand factor consists of two molecules (factor VIII and von Willebrand factor) having different physiological functions.

The drug ADVATE contains recombinant coagulation factor VIII (octobic alpha), which is a glycoprotein with an amino acid sequence similar to human factor VIII.

Octokog alpha is a glycoprotein consisting of 2332 amino acids with an approximate molecular weight of 280 kDa. When administered to patients, octobic alpha is associated with the endogenous factor of von Willebrand. Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X promotes the prothrombin transition to thrombin. Thrombin, in turn, promotes the transition of fibrinogen into fibrin, which leads to the formation of a clot (blood clot).

Hemophilia A is hereditary, associated with sex, a violation of the coagulation system of crocs with a decrease in the level of activity of factor VIII. Clinically manifested profuse bleeding in the joints, muscles or internal organs, both spontaneous, and resulting from injuries or surgical interventions. When carrying out substitution treatment, the level of factor VIII in the plasma increases, resulting in a temporary correction of the deficiency of the factor in the blood plasma and a decrease in the tendency to increased bleeding.

Pharmacokinetics:

All pharmacokinetic studies of the ADVATE drug were conducted with the participation of patients previously treated for severe or moderately severe haemophilia A (baseline level of factor VIII ≤ 2). In summary, summary pharmacokinetic data were obtained and analyzed in 195 previously treated patients with severe haemophilia A (baseline level of factor VIII ≤ 1%).

Table 1. Pharmacokinetic parameters of ADVATE preparation in patients of different age groups with severe haemophilia A (initial level of factor VIII <1%).

Parameter	Infants 1 month-2 years (n=5)	Children 2-5 years (n=30)	Children 5-12 years old (n=18)	Teens 12-18 years (n=33)	Adults (n=109)
AUC_0-∞ (MEXh / dL)	1362,1±311,8	1180,0±432,7	1506,6±530,0	1317,1±438,6	1538,5±529,1
Adjusted recovery growth by FROM_max (IU / dl per IU / kg) *	2,2±0,6	1,8±0,4	2,0±0,5	2,1 ±0,6	2,2±0,6
Period half-life (h)	9,0±1,5	9,6± 1,7	11,8±3.8	12,1±3,2	12,9±4,3
The maximum plasma concentration after infusion (IU / dL)	110,5 ±30,2	90,8 ±19,1	100,5 ±25,6	107,6 ±27,6	111,3 ±27,1
Mean time of circulation in plasma (h)	11,0±2,8	12,0±2,7	15,1 ±4,7	15,0±5,0	16,2±6,1
Scope distribution in the equilibrium state (dl / kg)	0,4±0,1	0,5±0,1	0,5±0,2	0,6±0,2	0,5±0,2
Clearance (dl / (kghh))	3,9±0.9	4,8±1,5	3,8± 1,5	4,1±1,0	3,6±1,2

* Calculated as (C_mOhminus the base level of factor VIII) divided into a vine (ME / kg), where C_mOh- the maximum level of factor VIII, determined after administration.

Safety and hemostatic efficacy of ADVATE in children are similar to safety and hemostatic efficacy in adult patients.

The corrected reduction index and half-life in the final phase (T_1/2) in patients younger than 6 years were 20% less than in adults, which in part can be explained by the large volume of plasma per kg of body weight in children.

Currently there are no data on the pharmacokinetics parameters of the ADVATE drug in patients who have not previously received treatment.

Indications:

Treatment and prevention of bleeding in adults and children with hemophilia A (hereditary deficiency of factor VIII).

The drug ADVATE does not contain von Willebrand factor in an amount necessary to achieve a pharmacological effect, and therefore is not indicated for the treatment of von Willebrand disease.

Contraindications:

Known hypersensitivity to the active substance or to any of the excipients, as well as to the mouse / hamster proteins.

Pregnancy and lactation:

The effect of ADVATE on the reproductive function of animals has not been studied. In connection with the fact that hemophilia A women suffer extremely rarely, the safety of ADVATE in pregnant women and women during lactation is not established. Before prescribing ADVATE during pregnancy and lactation, the doctor should carefully weigh the potential risks and expected benefits for each individual patient.

Dosing and Administration:

Treatment with the drug should be started under the supervision of a doctor who has experience in the treatment of hemophilia, and if there is the possibility of immediate resuscitation in the event of anaphylaxis.

Doses and duration of treatment depend on the degree of factor VIII deficiency, localization and intensity of bleeding, as well as on the clinical condition of the patient.Careful laboratory monitoring of replacement therapy is especially important in cases of large surgical interventions and life-threatening bleeding.

One International Unit (ME) of factor VIII activity is equivalent to the amount of factor VIII that is contained in 1 ml of normal human plasma.

Treatment "on demand"

The calculation of the required dose of factor VIII is based on empirical data, according to which the preparation of factor VIII, administered at a dose of 1 ME per 1 kg of body weight, increases the activity of factor VIII in plasma by 2 IU / dl.

The required dose of ADVATE is determined by the formula:

Required dose (ME) = body weight (kg) x required% increase in factor VIII x 0.5

In case of bleeding and the clinical situations indicated in Tables 2 and 3, the activity of factor VIII should not fall below a predetermined level (expressed as a percentage of normal activity or in IU / dL) in the relevant period. When choosing the dose and frequency of administration for episodes of bleeding and surgical interventions can be guided by Tables 2 and 3.

Table 2. Application of ADVATE drug for various types of bleeding

Degree of bleeding	The required activity of factor VIII after administration (in% of the norm or IU / dl)	Frequency of administration (interval between administrations in hours) / Duration of treatment (in days)
Initial signs of hemarthrosis, hemorrhage and muscle or bleeding and oral cavity	20-40	Injections are repeated every 12-24 hours (every 8-24 hours for patients under the age of 6) for at least 1 day before the relief of bleeding, as indicated by the absence of pain, or until complete recovery
More pronounced hemarthrosis, bleeding in the muscle or bruising	30-60	Injections are repeated every 12-24 hours (every 8-24 hours for patients under the age of 6 years) for 3-4 days or more until pain relief and recovery of motor activity
Life-threatening bleeding	60-100	Injections are repeated every 8-24 hours (every 6-12 hours for patients younger than 6 years) until complete relief of bleeding and eliminating the threat of life

Table 3. Use of ADVATE drug in surgical interventions

Type of surgical intervention

The required activity of factor VIII after administration (in% of the norm or IU / dl)

Frequency of management (interval between administrations in hours) / duration of treatment (in days)

Small surgical

interventions, including

removal of a tooth

30-60

Enter every 24 hours (every 12-24 hours for patients under the age of 6 lay down) for at least 1 day until recovery is achieved.

Large surgical

interventions

80-100

(before and after surgery)

Injections are repeated every 8-24 hours (every 6-24 hours for patients under 6 years of age) to adequate wound healing, then continue treatment for at least 7 more days, maintaining factor VIII activity ranging from 30% to 60% (IU / dl).

The dose and frequency of administration should be adapted individually, taking into account the clinical response. Under certain circumstances (for example, in the presence of inhibitors in low titre), doses of the drug exceeding the calculated ones may be required.

During the course of treatment, the level of coagulation factor VIII in the plasma should be determined so that if necessary adjust the dose or frequency of administration.

When performing large surgical interventions, it is mandatory to monitor substitution therapy by determining the activity of factor VIII in plasma.

Different patients may differ in the clinical response to treatment with a factor VIII drug, achieving different pharmacokinetic parameters, in particular half-life and recovery rates in vivo.

Aboutbleeding syndrome

For long-term prophylaxis of bleeding in patients with severe haemophilia A, doses usually range from 20 to 40 ME factor VIII per kg body weight with an interval between administrations from 2 to 3 days.

Use of the drug in children

When using the drug in the "on-demand" mode, the recommended doses and frequency of ADVATE drug administration in children aged 0-18 are the same as in adult patients. For long-term prophylaxis of bleeding in patients younger than 6 years, the use of the drug in a dose of 20 to 50 is recommended ME factor VIII per kg of body weight 3-4 times a week.

Mode of application

If the drug is administered by a person who does not have a specialized medical education, then this person must undergo appropriate training on the introduction of ADVATE,

The speed of administration of the drug should be selected in such a way as to provide the patient with maximum comfort. The rate of administration should not exceed 10 ml / min. It is recommended, in the interests of the patient, to write down the name of the drug and the serial number each time the drug is administered.

The drug ADVATE should be administered intravenously after reconstitution of the lyophilisate with sterile water for injection. The reconstituted solution must be clear, colorless and free from mechanical inclusions.Do not use a turbid solution or solution containing visible particles.

- For reconstitution use only sterile water for injection and a dilution device contained in the package.

- To administer the drug, you need to use a syringe with a Luer tip.

- Use the drug for three hours after reconstitution.

- Do not put the reconstituted product into the refrigerator.

- Any unused product or residue must be disposed of in accordance with established requirements.

- Do not use the device BAKHSHEEKT II if its sterile barrier system or package is damaged, or if you notice any signs of spoilage

Breeding using a device BAKSJECT II

Observe the rules of asepsis!

1. If the drug was stored in the refrigerator until the time of dilution, bring the temperature of the ADVATE drug (lyophilizate) and sterile water for injection (solvent) to room temperature (15 to 25 ° C).

2. Wash your hands using soap and hot water.

3. Remove the caps from the vials with lyophilizate and solvent.

4. Wipe the plugs with alcohol wipes. Place the vials on a flat, clean surface.

5. Open the packaging of the BAXJECT II device by removing the paper membrane, without touching the inner contents of the package (see Figure A). Do not remove the device from the package. Do not use if the device BAXZHECT II, its sterile barrier system or packaging is damaged.

6. Turn the package over and insert a transparent plastic tip into the stopper of the vial with the solvent. Grasping the edges of the package, pull upwards and remove it from the BAKSJECT II device (see Figure B). Do not remove the blue cap from the device BAKXJECT II.

7. To dilute the drug, use only sterile water for injection contained in the package. After attaching BAXZHECT II to the solvent vial, turn the system upside down so that the solvent bottle is on top of the device. Insert a white plastic tip into the tube of the ADVATE bottle. Due to the vacuum, the solvent will flow into the bottle with the ADVATE preparation (see Figure B).

Carefully rotate the vial until the drug dissolves completely. Make sure that ADVEIT has dissolved completely, otherwise the active substance will not pass through the device filter.The preparation dissolves quickly (usually less than 1 minute), the reconstituted solution must be clear, colorless and free of mechanical inclusions.

Introduction of the drug:

Observe the rules of asepsis!

Before use, the reconstituted product must be checked for mechanical inclusions. Use only a clear and colorless solution.

1. Remove the blue cap from the device BAKZHEK'G II. Do not draw air into the syringe! Insert the syringe into BAKSJECT II (see Figure D).

2. Turn the system over (the vial with the drug should be on top). Type the reconstituted solution in the sheer slowly pulling the piston (see Figure D).

3. Disconnect the syringe.

4. Connect the butterfly needle to the width. The solution should be administered intravenously, slowly. The rate of drug administration should not exceed 10 ml per minute. Before and during administration of the ADVATE drug, the patient's pulse rate should be monitored. With a significant increase in heart rate, a decrease in the rate of administration of the drug or a temporary discontinuation of the administration in most cases helps quickly to stop these symptoms.

Side effects:

Security Profile Summary

In clinical trials of ADVATE, 418 patients took part, who received at least one injection of ADVATE. 93 undesirable drug reactions (NLR) were recorded. The most frequently observed NLRs were the appearance of inhibitors (neutralizing antibodies to factor VIII), headache and fever.

Hypersensitivity or allergic reactions (which can include angioedema, burning and itching at the injection site, chills, redness, common urticaria, headache, localized urticaria, hypotension, lethargy, nausea, restlessness, tachycardia, chest tightness, tingling, vomiting, wheezing) were infrequent, but in some cases progressed with the development of severe anaphylaxis (including anaphylactic shock).

The occurrence of antibodies to mouse and / or hamster proteins and associated hypersensitivity reactions can be observed.

In patients with hemophilia A, neutralizing antibodies (inhibitors) can occur to factor VIII. The appearance of such inhibitors manifests itself in the form of an insufficient clinical response.In all such cases, it is recommended to contact a specialized center for hemophilia.

Table 4 presents data on the incidence of adverse reactions reported from clinical trials and from spontaneous reports. Undesirable reactions are classified according to the damage to organs and organ systems; The names of organs and systems of organs are given in accordance with the terminology of the medical vocabulary for regulatory activities (MedDRA).

The incidence of adverse reactions was assessed P according to the WHO classification of NLR for development frequency: very frequent (≥1/10 appointments), frequent (≥1/100 to <1/10 of appointments), infrequent (≥1/1000 to <1/100 of prescriptions), rare (≥1/10000 to <1/1000 assignments), very rare (<1/10000 assignment), the frequency is unknown (can not be determined from available data). Within each frequency gradation, the undesirable effects are presented in order of decreasing severity.

Table 4. Frequency of adverse reactions to systems and organs

Classification of organs and systems of organs (MedDRA)	Unwanted reaction (MedDRA)	Frequency emergence^a
Infectious diseases	Flu	Infrequent
Infectious diseases	Laryngitis	Infrequent
Violations of the blood and lymphatic system	The appearance of factor inhibitors VIII^at	Frequent
Violations of the blood and lymphatic system	Lymphangitis	Infrequent
Immune system disorders	Anaphylactic reaction	Frequency unknown
Immune system disorders	Hypersensitivity^at	Frequency unknown
Disturbances from the nervous system	Headache	Frequent
	Dizziness	Infrequent
	Memory loss	Infrequent
	Fainting	Infrequent
	Tremor	Infrequent
	Migraine	Infrequent
	Dysgeusia	Infrequent
Disturbances on the part of the organ of sight	Inflammation of the eye	Infrequent
Vascular disorders	Hematoma	Infrequent
	Hot flushes	Infrequent
	Pallor	Infrequent
Heart Disease	Heart palpitations	Infrequent
Disturbances from the respiratory system, chest and mediastinal organs	Dispnoe	Infrequent
Disorders from the gastrointestinal tract	Diarrhea	Infrequent
	Pain in the upper abdomen	Infrequent
	Nausea	Infrequent
	Vomiting	Infrequent
Disturbances from the skin and subcutaneous tissues	Itching	Infrequent
	Rash	Infrequent
	Hyperhidrosis	Infrequent
	Hives	Infrequent
General disorders and disorders at the site of administration	Fever	Often
	Peripheral edema	Infrequent
	Chest pain	Infrequent
	Feeling of chest discomfort	Infrequent
	chills	infrequent
	change in state of health	infrequent
	hematoma at the site of the vascular puncture	infrequent
	fatigue	frequency unknown
	reactions at the injection site	frequency unknown
	malaise	frequency unknown
laboratory and instrumental data	activity decrease coagulation factor viii^b	infrequent
	increase in the number of monocytes	infrequent
	hematocrit	infrequent
	abnormalities in laboratory test results	infrequent
trauma, intoxication and complications of manipulation	postprocedural complication	infrequent
	postprocedural complication	infrequent
	reaction at the place of procedure	infrequent

a) the frequency was calculated in relation to the total number of patients receiving the drug advait (n = 418).

b) an unexpected decrease in the activity of factor viii occurred in one patient during continuous infusion of the drug adwait for 10-14 days after surgery. During this period hemostasis was maintained. the activity of the viii factor in the plasma and the clearance were returned to normal values by the 15th day after the operation.Analyzes of the inhibitors to the factor viii, conducted after the end of the continuous infusion and at the end of the study, gave negative results.

c) information on this undesirable reaction is given below.

description of individual undesirable reactions

occurrence of factor viii inhibitors

the immunogenicity of the drug adwait was studied in clinical trials involving 233 patients (children and adults) with severe hemophilia a (factor level viii ≤ 1%) previously treated with viii concentrates (no less than 150 days of drug administration in adults and children aged ≥ 6 years and not less than 50 days of administration in children younger than 6 years). In one patient, after 26 days of adwait preparation, inhibitors appeared in low titer (2.4 units of bee [b] according to the results of the modified betest test). After discontinuation of the patient's participation in the study, the inhibitors were no longer detected.

the median duration of administration of the drug adwait in previously treated patients in all clinical trials was 97 days (range from 1 to 709 days of administration). the overall incidence of inhibitors (with both high and low titers) was 0.4% (in 1 of 233 patients).

in a completed uncontrolled clinical trial 060103, in 16 of 45 (35.6%) of previously untreated patients with severe hemophilia a (factor level viii ≤ 1%) who received the drug adwait for at least 25 days of use, factor viii inhibitors developed. 7 (15.6%) patients showed a high titer of inhibitors and 9 (20%) patients had a low titer of inhibitors (including one patient whose occurrence of inhibitors was classified as transient).

risk factors for development inhibitors in this study were: non-neuropean ethnicity, family history of the appearance of inhibitors to the factor viii and intensive therapy with high doses of the drug adwait in the first 20 days of administration. In 20 patients who did not have these risk factors, the appearance of inhibitors was not observed.

data were obtained on the induction of immune tolerance (iit), in previously untreated patients, in patients who, with the use of the drug adwait, showed inhibitors to the factor viii. in the course of the study in the study 060103 with the participation of patients who had not previously received treatment, iit treatment was documented in 11 patients who had not previously received treatment.In 30 patients with irit (study 060703), a retrospective analysis of medical records was carried out. The collection of data for the patient registry with ith is currently ongoing.

in study 060201, a comparative analysis of two long-term prophylactic treatment regimens was conducted in 53 patients previously treated (rlp): a dosing regimen selected on the basis of individual pharmacokinetic parameters (within the range of 20 to 80 me factor viii per 1 kg of body weight at intervals of 72 ± 6 hours; n= 23), and a standard prophylactic dosage regimen (20 to 40 IU / kg every 48 ± 6 hours; n= 30). The goal of the dosing scheme, selected on the basis of individual pharmacokinetic parameters (and calculated according to a special formula), was to maintain a minimum level of factor viii ≥ 1% at 72-hour intervals between administrations. the data of this study prove that both preventive dosing regimens are comparable in terms of reducing the frequency of bleeding.

undesirable reactions associated with substances used in the production process

of the 229 patients who received adwait treatment and were tested for the presence of antibodies to the proteins of Chinese hamster ovary cells (sleep),a statistically significant increase in antibody titer was noted in 3 patients, stable peaks or transient elevations of antibody titer were detected in 4 patients, and both were noted in one patient. all these changes in antibody titers were not accompanied by clinical manifestations.

of these 229 treated patients who received adwait treatment and were tested for antibodies to murine immunoglobulin g (igg), a statistically significant increase in antibody titer was noted in 10 patients, stable peaks or transient tiger elevations of antibodies were detected in 2 patients, and in both patients, both. In four of these patients, there were isolated cases of urticaria, pruritus, rash, a slight increase in the number of eosinophils (all of these patients received adwit drug repeatedly).

hypersensitivity

Allergic-type reactions included anaphylaxis and were manifested by dizziness, paresthesia, rashes, flushing, face swelling, hives and itching.

use of the drug in children

except for the formation of inhibitors in previously untreated patients and catheter-associated complications,no differences in the incidence of adverse reactions in patients of different ages in clinical trials have been identified.

reports of suspected adverse reactions

information about suspected adverse reactions allows you to constantly monitor the benefit / risk ratio of the drug adwait. doctors using the drug advaita to treat patients with hemophilia a should report suspected adverse reactions that develop after the issuance of the drug registration certificate to the national pharmacovigilance authorities in accordance with the standard procedure.

Overdose:

No cases of overdose of recombinant coagulation factor VIII preparations have been reported. Symptoms of overdose are unknown.

Interaction:

Studies of drug interactions between ADVATE and other drugs have not been conducted.

Special instructions:

Hypersensitivity reactions

With intravenous administration of protein preparations, it is possible to develop allergic reactions. The drug ADVATE is a protein, and also contains trace amounts of proteins of mice and hamsters.

When ADVATE was used, the development of hypersensitivity reactions of the allergic type, including anaphylaxis, was reported, which manifested itself in the form of dizziness, paresthesia, rash, reddening and edema of the face, hives and itching. Patients should be informed of the signs of immediate-type hypersensitivity reactions, such as urticaria, pruritus. generalized rash, angioedema, hypotension (accompanied by dizziness and fainting), shock and acute respiratory distress (feeling tight in the chest, wheezing). Patients should be advised in the event of these symptoms immediately stop using the drug and consult a doctor.

With anaphylactic shock, it is necessary to conduct conventional anti-shock measures.

Formation of inhibitors of factor VIII

The appearance of neutralizing antibodies to factor VIII (inhibitors) is a known complication in the treatment of patients with hemophilia A, which is clinically manifested by a decrease in procoagulant activity of the preparation of factor VIII. Inhibitors are immunoglobulins of class G. The titer of inhibitors is measured in Bethesda Units (BE) per ml of plasma using the modified Bethesda method.

When the appearance of factor VIII inhibitors, patients may have an insufficient clinical response to ADVATE. In this case, it is recommended to contact a specialized center for the treatment of hemophilia. The risk of developing inhibitors correlates with the duration of use of the preparation of factor VIII (the risk is highest during the first 20 days of administration), as well as genetic factors and environmental factors. Rarely, inhibitors may appear after the first 100 days of administration.

There have been cases of re-formation of inhibitors (in low titers) in previously treated patients (who received therapy for more than 100 days of administration) after transferring the patient from one factor VIII drug to another. Therefore, after switching from treatment with one factor VIII drug to another, constant monitoring (both clinical, hack and laboratory) for patients receiving treatment with a factor VIII preparation should be carried out in order to detect inhibitors in a timely manner.

In general, patients treated with coagulation factor VIII drugs should be closely monitored for the appearance of inhibitors by appropriate clinical observation and laboratory tests.If the expected level of activity of factor VIII in plasma nc is reached, or if an adequate dose can not control bleeding, an appropriate analysis should be performed to identify the factor VIII inhibitors. In patients with high levels of factor VIII inhibitors, treatment may be ineffective, and alternative treatment methods should be considered. Treatment of such patients should be performed by a doctor who has experience in treating hemophilia in the presence of factor VIII inhibitors.

ProphylacticraADVATE drug with individualized dose selection

To maintain a basic level of factor VIII ≥ 1% at an inter-dose interval of 72 hours, a single dose of ADVATE can be individually selected by a physician, taking into account the values of individual pharmacokinetic parameters. In a clinical study, it was shown that a prophylactic dosage regimen of 20-40 IU / kg every 48 ± 6 hours had similar clinical efficacy with a regimen of 20-80 IU / kg at an interval of 72 ± 6 hours, with a significant reduction in the frequency of bleeding during preventive treatment compared with treatment on demand.

The standard prophylaxis regimen with the administration of the drug every other day and the individual prophylactic treatment regimen with the choice of dose depending on the pharmacokinetic parameters and with the administration of the drug every third day have comparable efficacy.

Catheter-associated complications in treatment

If a device is required for central venous access, there is a risk of developing catheter-associated complications, such as local infection, bacteremia, thrombosis at the site of the catheter.

Information on excipients

After reconstitution, the drug solution contains 0.45 mmol sodium (10 mg) per vial. This should be taken into account when prescribing the drug to patients on a diet with sodium restriction.

To exclude the possibility of microbiological contamination, the drug should be administered immediately after the preparation of the solution. However, it was shown that the ADWATE solution prepared was chemically and physically stable for 3 hours at a temperature of 25 ° C.

Within the expiry date, the drug can be stored at room temperature (not above 25 ° C) for no more than 6 months.It is necessary to record the start date and the end date of storage of the drug at room temperature on the preparation package. After snoring at room temperature, do not put the drug for further storage in the refrigerator.

It is recommended that the name of the drug and the batch number in the medical documentation be fixed each time the ADVATE drug is administered in order to establish the connection between the patient and the lot of the drug.

Effect on the ability to drive transp. cf. and fur:

ADVATE is not affected by the ability to drive vehicles and the ability to work with machinery.

Form release / dosage:

Lyophilizate for the preparation of a solution for intravenous administration, 250, 500, 1000 or 1500 ME.

Packaging:

In a vial of colorless transparent glass of hydrolytic type I, ukuporenny rubber stopper with aluminum obakkoy and plastic lid, complete with a solvent (water for injection) to 5 ml in a bottle of colorless transparent glass hydrolytic type I, ukuporenny rubber stopper with aluminum obakkoy and plastic cover.

1 vial with lyophilizate, 1 vial with solvent and 1 device for free dilution BACCZHECT II with a built-in filter (15 μm) together with instructions for use will be placed in a cardboard box. In an extra cardboard box, place a butterfly needle, a disposable syringe (10 ml), two alcohol wipes, two plasters. Both cardboard boxes are joined by a band of transparent plastic.

Storage conditions:

Store at a temperature of 2 to 8 ° C. Do not freeze.

Keep out of the reach of children.

Store in a cardboard box to protect against light.

Shelf life:

2 of the year.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002447

Date of registration:05.05.2014/29.01.2016

Expiration Date:05.05.2019

The owner of the registration certificate:Baxter AGBaxter AG Austria

Manufacturer: & nbsp

BAXTER, AG Austria

BAXTER, S.A. Belgium

BAXTER BIOSCIENCE MANUFACTURING, SARL Switzerland

Representation: & nbspBaxter Baxter USA

Information update date: & nbsp23.01.2017

Illustrated instructions

Instructions

Adv (Advate)