Octant

Active material: The human coagulation factor VIII
When ATH: B02BD02
CCF: The preparation of blood coagulation factor VIII
ICD-10 codes (testimony): D66, D68.4
When CSF: 20.01.06
Manufacturer: OCTAPHARMA Pharmaceuticals Produktionsges m.b.H. (Austria)

Pharmaceutical form, composition and packaging

Valium for drug of a solution for / in as a powder or amorphous mass of white or light-yellow.

Excipients: glycine, sodium chloride, sodium citrate, calcium chloride.

Solvent: water d / and – 5 ml.

Glass Bottles (1) – packs cardboard; together with the solvent (fl. 1 PC.) and a set of administration (a disposable syringe, A two needle, Needle filter, needle-butterfly, 2 des. napkins) in a plastic bag and a carton box.

Valium for drug of a solution for / in as a powder or amorphous mass of white or light-yellow.

Excipients: glycine, sodium chloride, sodium citrate, calcium chloride.

Solvent: water d / and – 10 ml.

Glass Bottles (1) – packs cardboard; together with the solvent (fl. 1 PC.) and a set of administration (a disposable syringe, A two needle, Needle filter, needle-butterfly, 2 des. napkins) in a plastic bag and a carton box.

Valium for drug of a solution for / in as a powder or amorphous mass of white or light-yellow.

Excipients: glycine, sodium chloride, sodium citrate, calcium chloride.

Solvent: water d / and – 10 ml.

Glass Bottles (1) – packs cardboard; together with the solvent (fl. 1 PC.) and a set of administration (a disposable syringe, A two needle, Needle filter, needle-butterfly, 2 des. napkins) in a plastic bag and a carton box.

Pharmacological action

Hemostatic drug. It facilitates the transition of prothrombin to thrombin and fibrin clot formation.

Pharmacokinetics

Patients with hemophilia A T_1/2 is 12 no. The activity of factor VIII is reduced by 15% during 12 no. Factor VIII is thermolabile and the temperature rises rapidly destroyed, which reduces the T_1/2.

Testimony

- Treatment and prevention of bleeding in patients (including children under the age of 6 years) with congenital hemophilia A or acquired deficiency of factor VIII, incl. inhibitory forms (using the method of inducing immune tolerance).

Dosage regimen

Octanate introduced in / after dilution with water for injection, located Included in the package. Octanate dose and duration of substitution therapy depend on the degree of deficiency of factor VIII, localization and duration of bleeding, clinical status of the patient.

Dose is expressed in International Units (ME) in accordance with the WHO standards for factor VIII. The activity of coagulation factor VIII in plasma or expressed in percentage (relative to a normal content of factor in human plasma), or ME (on the International Standard for factor VIII).

1 IU of factor VIII is equivalent to its content in 1 ml of normal human plasma. The calculation of the required dose is based on the empirical results obtained, whereby 1 IU / kg of factor VIII increases the level of plasma factor for 1.5-2% from the normal content. To calculate the required dose for the patient determine the initial level of activity of coagulation factor VIII and evaluate, how much is necessary to increase the activity of.

The required dose = weight (kg) x desired increase in factor VIII (%) (ME / dl) x 0.5.

The amount and frequency of administration of the drug should always correspond to clinical efficacy in each individual case,.

In case of subsequent bleeding activity level of coagulation factor VIII should not decrease below baseline in plasma (% from the normal content) at the relevant time. The following table can be used as a guide for selecting a dose of coagulation factor VIII in various bleeding and surgery.

Patients respond to the administration of the drug alone, while there is a different level of in vivo recovery, T_1/2 factor VIII is characterized by variability. Therefore, during the treatment to regulate the applied dose and frequency of administration should control the level. The activity of factor VIII should be monitored during replacement therapy, especially during major surgical procedures.

Doses, indicated in table, are approximate. The required dose and frequency of administration of the drug the doctor sets individually.

With the aim of prevent prolonged bleeding with severe hemophilia A the drug is prescribed in a dose 20-40 IU / kg of body weight every 2-3 day. In some cases, particularly in young patients, you may need to reduce the interval between doses or increasing the dose.

In some patients, after treatment, the formation of inhibitory antibodies a blood coagulation factor VIII, which may affect the effectiveness of further treatment. If the background of the therapy were observed to increase the expected factor VIII activity is not desired or hemostatic effect, we recommend consulting a specialized medical center using test Bethesda. To eliminate the inhibitor for blood clotting factor VIII can be used in therapy of immune tolerance induction. Its basis is the daily administration of factor VIII in a concentration, exceeding the blocking ability of the inhibitor (100-200 IU / kg / day, depending on the inhibitor titer). Factor VIII, performing the function of antigen, provokes a rise in titer of the inhibitor to the development of tolerance, ie. to reduce and subsequent disappearance of the inhibitor. Therapy is continuous and extends from an average of 10 to 18 Months. Such treatment must be carried out only by specialists in the field of antihemophilic therapy.

Rastvorenie lyophilisate

1. Solvent (Water for Injection) and lyophilisate in closed vials recommended to reach room temperature. If a solvent is used to warm the water bath, should closely monitor the, so that the water does not come in contact with the rubber stoppers or the caps of bottles. The temperature of the water bath did not exceed 37 ° C..

2. Remove the protective covers from the vials of lyophilisate and water, disinfect the rubber stoppers of both vials of one of the disinfecting wipes.

3. The short end of the double ended needle to release from plastic packaging, they pierce the cork the bottle with water and press down until it stops.

4. Invert bottle of water with the needle, release the long end of the double ended needle, they pierce the stopper of the vial with lyophilisate and push down until it stops. The vacuum in the vial will draw water with lyophilisate.

5. Bottle with water to separate the needle from the vial with lyophilized. The drug quickly dissolves; To do this, the vial should be gently shake. It is only permitted the use of colorless, clear or slightly opalescent solution without sediment.

Terms of preparation and administration of the solution

As a precaution necessary to control the heart rate before and during administration Octanate. In the case of pronounced acceleration pulse should slow down or stop the introduction of the drug.

After dissolving the concentrate according to the instructions, remove the protective cover from the filter needle and put it in a bottle with the concentrate. Remove the cap from the filter needle and attach the syringe. Turn the bottle with a syringe upside down and draw the solution into the syringe. The injections carried out in accordance with the rules of aseptic and antiseptic. Disconnect the filter needle from the syringe and attach the needle instead butterfly.

The solution should be administered in / slow speed with 2-3 ml / min.

If you use more than one vial Octanate can be used syringe and needle re-butterfly.

Needle filter is designed for single use only. You should always use a needle with a filter for collecting the prepared solution into the syringe.

Any unused solution should be disposed of preparation according to existing rules.

Side effect

Allergic reactions: rarely – angioedema, burning sensation in the area of ​​introduction, chills, tides, hives (incl. generalized), headache, decrease in blood pressure, lethargy, nausea, vomiting, anxiety, tachycardia, sense of compression of the thorax, breathlessness, temperature rise, feeling shivers. Rarely (<1/10 000) These symptoms may progress to severe anaphylaxis, including shock.

Patients with haemophilia A may develop antibodies (inhibitors) a blood coagulation factor VIII (<1/1000). The presence of inhibitors leads to an unsatisfactory clinical response to the drug. In such cases it is advisable to apply to specialized hematology / Haemophilus centers. Neohodimo you examine the patient for the presence of antibodies by appropriate methods (Bethesda test).

Contraindications

- Hypersensitivity to the blood coagulation factor VIII or the drug component.

Pregnancy and lactation

Use of the drug during pregnancy and lactation is possible in cases, when the expected benefit of therapy to the mother outweighs the potential risk to the fetus or infant.

Cautions

In applying the drug may develop hypersensitivity reactions, As with other proteinaceous drugs inektsionnnyh.

In addition to the blood coagulation factor VIII preparation also contains trace amounts of other blood proteins. Early signs of hypersensitivity reactions are hives, sense of compression of the thorax, breathlessness, decrease AD and anaphylaxis (a severe allergic reaction). In case of these symptoms should immediately discontinue administration of the drug. In the case of shock should apply modern methods of antishock therapy.

The use of drugs, derived from human blood or plasma, the possibility of transmitting infectious agents can not be completely ruled. This also applies to pathogens of unknown diseases. Nonetheless, the risk of transmission of infectious agents is reduced by the following measures:

- Selection of donors by a medical interview and examination, and screening pools of plasma for the presence of hepatitis B virus antigens (HBV), HIV antibodies and hepatitis C virus (HCV);

- Analysis of plasma pools for the presence of HCV genetic material;

- Procedures for inactivation / removal, included in the production process, which were confirmed on the viral model. These procedures are effective for HIV, Hepatitis A virus (VGA), HBV and HCV. Procedures for inactivating / removing may have limited efficacy against non-enveloped viruses, one of which is a parvovirus B19. Parvovirus B19 can cause severe reactions in seronegative pregnant women (intrauterine infection), and in individuals with immunodeficiency or increased production of red blood cells (eg, hemolytic anemia).

With the introduction of the concentrate factor VIII, plasma-derived, recommended vaccination against Hepatitis A and Hepatitis B.

In the case of allergic reactions of the patient should be evaluated for the presence of the inhibitor. Patients, with inhibitors of blood coagulation factor VIII, possible increased risk of anaphylactic reactions during the subsequent treatment Octanate. Hence, the first use of this product according to specifications, the attending physician should be conducted under medical supervision in a, ensuring the provision of qualified medical assistance in the event of allergic reactions.

Do not use other drugs during administration Octanate.

For administration Octanate should only be used injection equipment, included in the package. On the internal surface of some injection devices possible adsorption of factor VIII, that reduces the efficiency of treatment.

Overdose

Despite, that the symptoms of an overdose of the blood clotting factor VIII was observed, recommended not to exceed the prescribed dose.

Drug Interactions

Data on Octanate interaction with other drugs not available.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be protected from light and away from children at a temperature of 2 ° to 25 ° C; Do not freeze. Shelf life – 3 year.