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OBIZUR 500 U powder and solvent for solution for injection

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Antihaemophilic factor, Porcine factor viii:c, Susoctocog alfa may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Antihaemophilic factor, Porcine factor viii:c, Susoctocog alfa
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for

OBIZUR contains the active substance susoctocog alfa, antihaemophilic factor VIII, porcine sequence. Factor VIII is necessary for the blood to form clots and stop bleedings. In patients with acquired haemophilia, factor VIII is not working properly because the patient has developed antibodies to his own factor VIII which neutralise this blood clotting factor. OBIZUR is used for the treatment of bleeding episodes in adults with acquired haemophilia (a bleeding disorder caused by lack of factor VIII activity due to antibody development). These antibodies have less neutralising effect against OBIZUR than against human factor VIII. OBIZUR restores this missing factor VIII activity and helps blood to form clots at the site of bleeding. 2.

What you need to know before you take it

OBIZUR

The medicine is for in hospital use only. It requires clinical supervision of the bleeding status of the patient. You must not be given OBIZUR: if you are allergic to susoctocog alfa or any of the other ingredients of this medicine (listed in section 6); if you are allergic to hamster proteins (trace amounts may be present in OBIZUR arising from the manufacturing process); if you have congenital haemophilia A with inhibitors (CHAWI). If you are not sure, talk to your doctor before you are given this medicine. Warnings and precautions Talk to your doctor before you are given OBIZUR. 1

Hypersensitivity There is a rare chance that you may experience an allergic reaction to OBIZUR. You should be aware of the early signs of allergic reactions (see section 4 for signs and symptoms). If any of these symptoms occur, the injection should be stopped. Severe symptoms, including difficulty in breathing and (near) fainting, require emergency treatment in the hospital. Inhibitors Your doctor may check if you have inhibitory antibodies to porcine factor VIII and for increases in these antibodies. Your doctor will check your blood factor VIII to confirm that enough factor VIII is being given to you. Your doctor will also check if the bleeding is adequately controlled. Cardiovascular events Talk to your doctor if you currently have, or have had cardiovascular disease in the past or if you have a known risk of thrombosis (diseases from blood clots in normal vasculature), because the possiblity of developing thromboembolic diseases at high and sustained blood factor VIII levels cannot be excluded. Children and adolescents There is no information on the use of OBIZUR in children and adolescents aged under 18 years of age. Other medicines and OBIZUR Tell your doctor if you are using, have recently used or might use any other medicines. No interactions of OBIZUR with other medicines are known. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Driving and using machines OBIZUR has no influence on your ability to drive and use machines. OBIZUR contains sodium This medicine contains 4.6 mg sodium (main component of cooking/table salt) per milliliter once it is made up. This is equivalent to 0.23% of the recommended maximum daily dietary intake of sodium for an adult. Multiple vials must be taken per dose. Talk to your doctor if you are on a controlled sodium diet. OBIZUR contains polysorbate 80 This medicine contains up to 0.05 mg of polysorbate 80 in each ml of reconstituted solution, which is equivalent to 0.05 mg/ml. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

3.

How to take it

Treatment with OBIZUR will be conducted by a doctor who is experienced in the care of patients with haemophilia (bleeding disorders). Your doctor will calculate your dose of OBIZUR (in units or U) depending on your condition and body weight. The frequency and duration of administration will depend on how well OBIZUR is

2

working for you. Usually, the replacement therapy with OBIZUR is a temporary treatment until bleeding is resolved or the antibodies against your own factor VIII are eradicated. Your doctor will monitor you for antibodies to OBIZUR. The recommended first dose is 200 U per kilogram bodyweight given by intravenous injection. Your doctor will measure your factor VIII activity regularly to decide the subsequent dose and frequency of OBIZUR. The bleeding will usually respond within the first 24 hours, your doctor will adjust the dose and duration of OBIZUR until the bleeding stops. The total volume of reconstituted OBIZUR should be administered at a rate of 1 to 2 mL per minute. If you have any further questions on the use of this medicine, ask your doctor. 4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If severe and sudden allergic reactions occur, the injection must be stopped immediately. You must contact your doctor immediately if you have any of the following early symptoms: –

Swelling of lips and tongue; Burning and stinging at the injection site; Chills, flushing; Hives, generalised itching; Headache, low blood pressure; Lethargy, sickness, restlessness; Rapid beating of the heart, tightness of the chest; Tingling, vomiting; Wheezing.

Very common side effects (may affect more than 1 in 10 people) Development of antibodies and increases in pre-existing antibodies against the medicine, which may result in lack of efficacy with continued bleeding. Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine. 5.

How OBIZUR is stored

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton, on the vial and on the pre-filled syringe after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2°C – 8°C). Do not freeze. Use the reconstituted solution immediately but no longer than 3 hours once the powder is completely dissolved.

3

After reconstitution the solution should be clear and colourless. Do not administer if particulate matter or discoloration is found. Since this medicine is used during hospitalisation, the hospital staff are responsible for the correct storage of this medicine before and during its use, as well as for correct disposal. Name and batch number It is strongly recommended that every time that OBIZUR is used, the name and batch number of the medicine are recorded by the medical professional to maintain a link between your treatment and the batch of the medicine. 6.

Contents of the pack and other information

What OBIZUR contains The active substance is susoctocog alfa (antihaemophilic factor VIII, porcine sequence produced by recombinant DNA technology). Each powder vial contains 500 U of susoctocog alfa. The other ingredients in the powder are polysorbate 80 (E433) ) (see section 2 "OBIZUR contains polysorbate 80"), sodium chloride (see section 2 "OBIZUR contains sodium"), calcium chloride dihydrate (E509), sucrose, trometamol, trometamol hydrochloride, and sodium citrate (E331). The solvent is 1 mL sterilised water for injections. What OBIZUR looks like and contents of the pack One pack contains 1, 5 or 10 of the following: glass vial of OBIZUR 500 U2 white powder with a butyl rubber stopper with fluoropolymer film coating and a flip-off seal; pre-filled glass syringe with a stopper of bromobutyl rubber with fluoropolymer film coating on the contact side of 1 ml sterilised water for injections with a bromobutyl rubber tip cap and a Luer lock adapter; fluid transfer device with an integral plastic spike. Marketing Authorisation Holder Baxalta Innovations GmbH Industriestrasse 67 1221 Vienna Austria Tel: +44 (0)3333 000181 [email protected] Manufacturers Takeda Manufacturing Austria AG Industriestrasse 67 1221 Vienna Austria The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.

4

This leaflet was last revised in June 2025 This medicine has been authorised under 'exceptional circumstances'. This means that because of the rarity of this disease it has been impossible to get complete information on this medicine. The Medicines and Healthcare products Regulatory Agency (MHRA) will review any new information on this medicine every year and this leaflet will be updated as necessary.

————————————————————————————————————————–The following information is intended for healthcare professionals only: INSTRUCTIONS FOR PREPARATION AND ADMINISTRATION Preparation Before starting reconstitution, you will need the following: • Calculated number of powder vials; • Same number of 1 mL solvent syringes and sterile vial adapters; • Alcohol swabs; • Large sterile syringe to contain the final volume of reconstituted product. The procedures below are provided as general guidelines for the preparation and reconstitution of OBIZUR. Repeat following reconstitution instructions for each powder vial to be reconstituted. Reconstitution Use aseptic technique during the reconstitution procedure. 1. 2. 3. 4. 5. 6. 7. 8. 9.

10. 11.

12. 13.

Bring the OBIZUR powder vial and pre-filled diluent solvent syringe to room temperature. Remove the plastic cap from the OBIZUR powder vial (figure A). Wipe the rubber stopper with an alcohol swab (not supplied) and allow it to dry prior to use. Peel back the cover of the vial adapter package (figure B). Do not to touch the Luer lock (tip) in the centre of the vial adapter. Do not remove the vial adapter from the package. Place the vial adapter package on a clean surface with the Luer lock pointing up. Snap off the tamper resistant cap of the pre-filled solvent syringe (figure C). While firmly holding the vial adapter package connect the pre-filled solvent syringe to the vial adapter by pushing the syringe tip down onto the Luer lock in the centre of the vial adapter, and turning it clockwise until the syringe is secured. Do not over tighten (figure D). Remove the plastic package (figure E). Place the OBIZUR powder vial on a clean, flat, hard surface. Place the vial adapter over the OBIZUR powder vial and firmly push the filter spike of the vial adapter through the centre of the OBIZUR powder vial's rubber circle until the clear plastic cap snaps onto the vial (figure F). Push the plunger down to slowly inject all of the diluent from the syringe into the OBIZUR powder vial. Gently swirl (in a circular motion) the OBIZUR powder vial without removing the syringe until all of the powder is fully dissolved /reconstituted (figure G). The reconstituted solution should be inspected visually for particulate matter before administration. Do not use if particulate matter or discoloration is observed. With one hand hold the powder vial and vial adapter, and with the other hand firmly grasp the barrel of the pre-filled solvent syringe and in a counterclockwise motion unscrew the syringe from the vial adapter (figure H). Use OBIZUR immediately and within 3 hours after reconstitution when stored at room temperature. 5

Figure A

Figure B

Figure C

Figure D

Figure E

Figure F

Figure G

Figure H

Administration For intravenous injection only. • •

Inspect the reconstituted OBIZUR solution for particulate matter and discolouration prior to administration. The solution should be clear and colourless in appearance. Do not administer if particulate matter or discolouration is observed. Do not administer OBIZUR in the same tubing or container with other medicinal products for injection.

Using aseptic technique, administer using the following procedure: 1. Once all vials have been reconstituted, connect a large syringe to the vial adapter by gently pushing the syringe tip down onto the Luer lock in the centre of the vial adapter, and turning clockwise until the syringe is secured. 2. Invert the vial; push the air in the syringe into the vial and withdraw the reconstituted OBIZUR into the syringe (figure I). 3. Unscrew the large syringe counterclockwise from the vial adapter, and repeat this process for all reconstituted vials of OBIZUR until the total volume to be administered is reached. 4. Administer the reconstituted OBIZUR intravenously at a rate of 1 to 2 ml per minute. Figure I

The required initial dose of Obizur for a patient is calculated using the following formula: Initial dose (U/kg) ÷ Medicinal product strength (U/vial) × Body weight (kg) = Number of vials E.g. for a 70 kg patient the number of vials for an initial dose will be calculated as follows: 200 U/kg ÷ 500 U/vial × 70 kg = 28 vials

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Dosing The recommended initial dose is 200 U per kilogram bodyweight, given by injection. Type of bleeding

Mild and moderate superficial muscle/no neurovascular compromise and joint bleeding Major moderate to severe intramuscular, retroperitoneal, gastrointestinal, intracranial bleeding

Target factor VIII trough activity (units per dL or % of normal)

Initial dose (units per kg)

>50% 200 >80%

7

Subsequent dose

Frequency and duration of subsequent dosing

Titrate subsequent doses based on clinical response and to maintain target factor VIII trough activity

Dose every 4 to 12 hours, frequency may be adjusted based on clinical response and measured factor VIII activity

Frequently asked questions about OBIZUR 500 U powder and solvent for solution for injection

How do I take OBIZUR 500 U powder and solvent for solution for injection?

OBIZUR 500 U powder and solvent for solution for injection comes as injection. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in OBIZUR 500 U powder and solvent for solution for injection?

The active substance in OBIZUR 500 U powder and solvent for solution for injection is antihaemophilic factor, porcine factor viii:c, susoctocog alfa.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for OBIZUR 500 U powder and solvent for solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get OBIZUR 500 U powder and solvent for solution for injection without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

  • Source: electronic medicines compendium (emc), Datapharm
  • Active substance: antihaemophilic factor, porcine factor viii:c, susoctocog alfa
  • Official document: view the original leaflet on emc →
Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Antihaemophilic factor, porcine factor viii:c, susoctocog alfa (1 medicine)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Treatment of bleeding episodes in patients with acquired haemophilia caused by antibodies to factor VIII.

OBIZUR is indicated in adults.

4.2. Posology and method of administration

Treatment with OBIZUR should be under the supervision of a physician experienced in the treatment of haemophilia (see section 4.4).

Treatment monitoring

The product is for in‑patient administration only. It requires clinical supervision of the bleeding status of the patient.

During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions (see section 4.4). Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries. Dose based on bodyweight may require adjustment in underweight or overweight patients.

In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.

When using an in vitro thromboplastin time (aPTT)-based one-stage clotting assay for determining factor VIII activity in patients' blood samples, plasma factor VIII activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay. Also there can be significant discrepancies between assay results obtained by aPTT-based one-stage clotting assay and the chromogenic assay according to Ph. Eur. This is of importance particularly when changing the laboratory and/or reagents used in the assay.

Posology

The dose, frequency, and duration of the therapy with OBIZUR depend on the location, extent and severity of the bleeding episode, target factor VIII activity, and on the patient´s clinical condition.

The number of units of factor VIII administered is expressed in Units (U) that are derived from an in‑house standard that has been calibrated with the current World Health Organisation (WHO) standard for factor VIII products.

One Unit (U) of factor VIII activity is equivalent to that quantity of factor VIII in one mL of normal human plasma.

The recommended initial dose is 200 U per kilogram bodyweight, given by intravenous injection (see section 6.6).

The required initial dose of OBIZUR for a patient is calculated using the following formula:

Initial dose (U/kg) ÷ Medicinal product strength (U/vial) × Body weight (kg) = Number of vials

E.g. for a 70 kg patient the number of vials for an initial dose will be calculated as follows:

200 U/kg ÷ 500 U/vial × 70 kg = 28 vials

Monitor factor VIII activity and clinical condition 30 minutes after the first injection and 3 hours after administering OBIZUR.

Monitor factor VIII activity immediately prior to and 30 minutes after subsequent doses and refer to the table below for recommended target factor VIII trough levels.

The one‑stage clotting assay for factor VIII is recommended as it has been used in determination of the potency of OBIZUR and the mean recovery rate (see sections 4.4 and 5.2).

The dose and frequency of administration should be based on results of factor VIII activity (to be maintained within recommended limits) and on the clinical response achieved.

If testing of anti-rpFVIII antibodies is negative at baseline, a dose lower than the recommended 200 U/kg may be used as the initial treatment dose. Clinical response should be closely monitored as dosing below 200 U/kg has been associated with a lack of efficacy (see section 4.4).

Efficacy and safety data in patients with acquired haemophilia are limited (see section 5.1).

Initial phase

Type of bleeding

Target factor VIII trough activity (units per dL or % of normal)

Initial dose (units per kg)

Subsequent dose

Frequency and duration of subsequent dosing

Mild and moderate superficial muscle / no neurovascular compromise and joint bleeding

> 50%

200

Titrate subsequent doses based on clinical response and to maintain target factor VIII trough activity

Dose every 4 to 12 hours, frequency may be adjusted based on clinical response and measured factor VIII activity

Major moderate to severe intramuscular, retroperitoneal, gastrointestinal, intracranial bleeding

> 80%

Healing phase

Once bleeding has responded, usually within the first 24 hours, continue OBIZUR with a dose that maintains the trough factor VIII activity at 30‑40% until bleeding is controlled. The maximum blood factor VIII activity must not exceed 200%.

The length of treatment depends on clinical judgement.

Paediatric population

The safety and efficacy of OBIZUR in children and adolescents aged below 18 years have not yet been established. No data are available.

Method of administration

Intravenous use.

The total volume of reconstituted OBIZUR should be administered at a rate of 1 to 2 ml per minute.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

4.3. Contraindications

• Hypersensitivity to the active substance, hamster protein, or to any of the excipients listed in section 6.1.

• Congenital Haemophilia A with Inhibitors (CHAWI) (see section 5.1).

4.4. Special warnings and precautions for use

Traceability

In order to improve traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded.

Dosing

Initial dosing below the recommended 200 U/kg has been associated with lack of efficacy (see section 4.2).

Hypersensitivity

Allergic type hypersensitivity reactions are possible with OBIZUR. The medicinal product contains trace amounts of hamster proteins.

If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal 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.

Inhibitors

It is recommended to test for anti-rpFVIII antibodies prior to initiation of treatment with OBIZUR. Treatment may be started at physician's discretion prior to receiving the result of this test. Treatment decisions can be further supported by monitoring factor VIII levels. Inhibitory antibodies against porcine factor VIII (measured using a modification of the Nijmegen variation of the Bethesda assay) were detected before and after exposure to OBIZUR. Lack of efficacy could be due to inhibitory antibodies to OBIZUR. Inhibitor titres of up to 29 Bethesda units were recorded at baseline yet patients responded positively to OBIZUR. It is recommended that treatment should be based on clinical judgement and not based on detection of inhibitory antibodies by the Bethesda assay.

Anamnestic reactions with rise in human factor VIII and/or porcine factor VIII inhibitors have also been reported in patients treated with OBIZUR. These anamnestic rises may result in lack of efficacy. If such inhibitory antibodies to OBIZUR are suspected and there is a lack of efficacy, consider other therapeutic options.

There is a lack of clinical information on the development of inhibitory antibodies to OBIZUR following repeated administration. Therefore, OBIZUR must only be administered when considered clinically necessary. Extensive cutaneous purpura do not necessarily require treatment.

OBIZUR is produced by recombinant DNA technology in baby hamster kidney cells. Antibodies to baby hamster kidney cell protein were not detected in patients after exposure to OBIZUR.

Cardiovascular events

In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk.

Thromboembolic events

High and sustained factor VIII activity in blood may predispose to thromboembolic events. Those with pre‑existing cardiovascular disease and the elderly are at particular risk.

Treatment monitoring

Factor VIII activity determined by the chromogenic assay is generally lower than factor VIII activity determined by the one‑stage clotting assay. Measurement of factor VIII activity must always be carried out using the same assay methodology on any one patient. The one‑stage assay is recommended because it has been used in determination of the potency and the mean recovery rate of OBIZUR (see sections 4.2 and 5.2).

Excipients

Sodium content

This medicinal product contains 4.6 mg sodium per 1 ml of reconstituted solution in each vial, equivalent to 0.23% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Multiple vials must be taken per dose.

E.g., a 70 kg patient using the recommended 200 U/kg dose would require 28 vials which results in a sodium intake of 128.8 mg per treatment. This is equivalent to 6.44% of the WHO recommended maximum daily intake of 2 g of sodium for an adult.

Polysorbate content

This medicinal product contains 0.05 mg of polysorbate 80 in each vial which is equivalent to 0.05 mg per ml of reconstituted solution. Polysorbates may cause allergic reactions.

4.5. Interaction with other medicinal products and other forms of interaction

No interactions of OBIZUR with other medicinal products have been reported.

4.6. Fertility, pregnancy and lactation

Animal reproduction studies have not been conducted with OBIZUR. Experience regarding the use of OBIZUR during pregnancy and breast‑feeding is not available. Therefore, OBIZUR should be used during pregnancy and lactation only if clearly indicated.

4.7. Effects on ability to drive and use machines

OBIZUR has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Summary of the safety profile:

Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the injection site, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) are possible and may progress to severe anaphylaxis (including shock) (see section 4.4).

Patients with acquired haemophilia may develop inhibitory antibodies to porcine factor VIII. Inhibitory antibodies, including anamnestic responses, may result in a lack of efficacy.

Tabulated list of adverse reactions:

The table presented below is according to the MedDRA system organ classification (SOC and preferred term level). In the clinical study of OBIZUR for acquired haemophilia, 29 adult patients were evaluable for safety. Nineteen subjects did not have a detectable anti-porcine factor VIII inhibitor titer at baseline (< 0.6 BU/ml). Of the 19 subjects, twelve had no detectable anti-porcine factor VIII titer post-treatment, five had an increase in titer (≥ 0.6 BU/ml), and two subjects had no post-treatment samples analysed and seven subjects developed anamnestic reactions with a rise ≥ 10 BU in human factor VIII and/or recombinant factor VIII porcine sequence inhibitors.

Frequencies have been evaluated 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).

System organ class

Adverse reaction

Frequency

Immune system disorders

Anamnestic reaction

Very common

Investigations

Positive test for inhibitory antibodies against porcine factor VIII (see section 4.4)

Common

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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

The effects of higher than recommended doses of OBIZUR have not been characterised.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

⚠ Not the same combination. This medicine contains Antihaemophilic factor, Porcine factor viii:c, Susoctocog alfa. The products below do not contain exactly the same set of active substances — they are not direct substitutes.

  • OBIZUR 500 U prescription partial — not the same combinationSUSOCTOCOG ALFA · injection / infusion

Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.

  • Cluvot 250 j.m.Factor XIII 250 j.m. (200 - 320 j.m.)
  • Cluvot 1250 j.m.Factor XIII 1250 j.m. (1000 - 1600 j.m.)

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →

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Ask anything about OBIZUR 500 U powder and solvent for solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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