Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Nuwiq 250 IU 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 Simoctocog alfa may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Nuwiq contains the active substance human recombinant coagulation factor VIII (simoctocog alfa). Factor VIII is necessary for the blood to form clots and stop bleeding. In patients with haemophilia A (inborn factor VIII deficiency), factor VIII is missing or not working properly. Nuwiq replaces the missing factor VIII and is used for treatment and prevention of bleeding in patients with haemophilia A and can be used for all age groups. 2.
What you need to know before you take it
e Nuwiq
Do not use Nuwiq
- if you are allergic to the active substance simoctocog alfa or any of the other ingredients of this medicine (listed in section 6). If you are unsure about this, ask your doctor. Warnings and precautions Talk to your doctor before using Nuwiq. There is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to Nuwiq. You should be aware of the early signs of allergic reactions as they are listed in section 4 "Allergic reactions". If any of these symptoms occur, stop the injection immediately and contact your doctor. 20240515_pil_139_UK_03.02
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The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all factor VIII medicines. These inhibitors, especially at high levels, stop the treatment working properly and you or your child will be monitored carefully for the development of these inhibitors. If you or your child ́s bleeding is not being controlled with Nuwiq, tell your doctor immediately. Cardiovascular events In patients with existing cardiovascular risk factors, substitution therapy with FVIII may increase the cardiovascular risk. Catheter-related complications If you require a central venous access device (CVAD), risk of CVAD-related complications including local infections, presence of bacteria in the blood and catheter site thrombosis should be considered. It is important to keep a record of the batch number of your Nuwiq. So, every time you get a new package of Nuwiq, note down the date and the batch number (which is on the packaging after Lot) and keep this information in a safe place. Other medicines and Nuwiq Tell your doctor if you are using, have recently used or might use any other medicines. 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 Nuwiq has no influence on your ability to drive and use machines. Nuwiq contains sodium This medicine contains 18.4 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 0.92 % of the recommended maximum daily dietary intake of sodium for an adult.
3.
How to take it
Nuwiq
Treatment with Nuwiq will be started by a doctor who is experienced in the care of patients with haemophilia A. Always use this medicine exactly as your doctor or nurse has told you. Check with your doctor or nurse if you are not sure. Nuwiq is usually injected into a vein (intravenously) by your doctor or a nurse who are experienced in the care of patients with haemophilia A. You or someone else might also give your Nuwiq injection, but only after receiving adequate training. Your doctor will calculate your dose of Nuwiq (in international units = IU) depending on your condition and body weight, and on whether it is used for prevention or treatment of bleeding. How often you need an injection will depend on how well Nuwiq is working for you. Usually, treatment for haemophilia A is a life-long treatment. Prevention of bleeding The usual dose of Nuwiq is 20 to 40 IU per kg body weight, given every 2 to 3 days. However, in some cases, especially in younger patients, more frequent injections or higher doses may be necessary. Treatment of bleeding The dose of Nuwiq is calculated depending on your body weight and the factor VIII levels to be achieved. The target factor VIII levels will depend on the severity and location of the bleeding.
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If you have the impression that the effect of Nuwiq is insufficient, talk to your doctor. Your doctor will perform appropriate laboratory tests to make sure that you have adequate factor VIII levels. This is particularly important if you are having major surgery. Patients developing factor VIII inhibitors If your plasma factor VIII fails to reach expected levels with Nuwiq, or if bleeding is not adequately controlled, it could be due to the development of factor VIII inhibitors. This will be checked by your doctor. You might need a higher dose of Nuwiq or a different product to control bleedings. Do not increase the total dose of Nuwiq to control your bleeding without consulting your doctor. Use in children and adolescents The way Nuwiq is used in children and adolescents does not differ from the way it is used in adults. Because factor VIII products may have to be given more often in children and adolescents, a central venous access device (CVAD) may need to be fitted. A CVAD is an external connector that allows access to the bloodstream through a catheter without injection through the skin. If you use more Nuwiq than you should No symptoms of overdose have been reported. If you have injected more Nuwiq than you should, please inform your doctor. If you forget to use Nuwiq Do not take a double dose to make up for a forgotten dose. Proceed with the next dose immediately and continue as advised by your doctor. If you stop using Nuwiq Do not stop using Nuwiq without consulting your doctor. 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. Please stop using this medicine immediately and seek urgent medical advice if: you notice symptoms of allergic reactions Allergic reactions may include rash, hives, urticaria (itchy rash), including generalized urticaria, swelling of lips and tongue, shortness of breath, wheezing, tightness of the chest, vomiting, restlessness, low blood pressure, and dizziness. These symptoms can be early symptoms of an anaphylactic shock. If severe, sudden allergic reactions (anaphylactic) occur (very rare: may affect up to 1 in 10,000 people), the injection must be stopped immediately, and you must contact your doctor right away. Severe symptoms require prompt emergency treatment. you notice that the medicine stops working properly (bleeding is not stopped or becomes frequent) For children and adolescents not previously treated with factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients). However, for patients who have received previous treatment with factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients). If this happens, your or your child ́s medicines may stop working properly and you or your child may experience persistent bleeding. If this happens, you should contact your doctor immediately. Common side effects may affect up to 1 in 10 people Hypersensitivity, fever. 20240515_pil_139_UK_03.02
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Uncommon side effects may affect up to 1 in 100 people Tingling or numbness (paraesthesia), headache, dizziness, vertigo, dyspnoea, dry mouth, back pain, injection site inflammation, injection site pain, a vague feeling of bodily discomfort (malaise), haemorrhagic anaemia, anaemia, chest pain, non-neutralising antibody positive (in previously treated patients). 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 the national reporting system . 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 to store it
Nuwiq
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 and vial label after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2°C – 8°C). Do not freeze. Store vial in the original package in order to protect from light. Before the Nuwiq powder is reconstituted, it may be kept at room temperature (up to 25°C) for a single period not exceeding 1 month. Record the date from when you start to store Nuwiq at room temperature on the product carton. Do not store Nuwiq in the refrigerator again after it has been stored at room temperature. Use the reconstituted solution immediately after reconstitution. Do not use the medicine in case you notice visible signs of deterioration of the tamper proof of packaging especially of the syringe and/or the vial. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
What Nuwiq contains Powder: The active substance is recombinant human coagulation factor VIII (simoctocog alfa). Each powder vial contains 250, 500, 1000, 1500, 2000, 2500, 3000 or 4000 IU of simoctocog alfa. Each reconstituted solution contains approximately 100, 200, 400, 600, 800, 1000, 1200 or 1600 IU/mL of simoctocog alfa. The other ingredients are sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate and poloxamer 188. See section 2, "Nuwiq contains sodium". Solvent: 20240515_pil_139_UK_03.02
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Water for injections What Nuwiq looks like and contents of the pack Nuwiq is provided as powder and solvent for solution for injection. The powder is a white to off-white powder in a glass vial. The solvent is water for injections in a glass pre-filled syringe. After reconstitution, the solution is clear, colourless and free from foreign particles. Each pack of Nuwiq contains:
- 1 powder vial with 250, 500, 1000, 1500, 2000, 2500, 3000 or 4000 IU simoctocog alfa
- 1 pre-filled syringe with 2.5 mL water for injections
- 1 vial adapter
- 1 butterfly needle
- 2 alcohol swabs Marketing Authorisation Holder and Manufacturer Octapharma Ltd. Glassworks House 32 Shudehill Manchester M4 1EZ United Kingdom Manufacturer Octapharma AB, Lars Forssells gata 23, 112 75 Stockholm, Sweden This leaflet was last revised in May 2024
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————————————————————————————————————————–The following information is intended for healthcare professionals only: On-demand treatment The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case. In the case of the following haemorrhagic events, 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 can be used to guide dosing in bleeding episodes and surgery. Degree of haemorrhage/ Type of surgical procedure
Factor VIII level required (%) (IU/dL)
Frequency of doses (hours)/ Duration of therapy (days)
Haemorrhage Early haemarthrosis, muscle bleeding or oral bleeding
20-40
Repeat every 12 to 24 hours. At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
More extensive haemarthrosis, muscle bleeding or haematoma
30-60
Repeat infusion every 12 to 24 hours for 3 to 4 days or more until pain and acute disability are resolved.
Life threatening haemorrhages
60-100
Repeat infusion every 8 to 24 hours until threat is resolved.
30-60
Every 24 hours, at least 1 day, until healing is achieved.
Surgery Minor surgery including tooth extraction Major surgery
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80-100 (pre- and postoperative)
Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dL).
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INSTRUCTIONS FOR PREPARATION AND ADMINISTRATION 1. Allow the solvent syringe (water for injections) and the powder in the closed vial to reach room temperature. You can do this by holding them in your hands until they feel as warm as your hands. Do not use any other way to heat the vial and pre-filled syringe. This temperature should be maintained during reconstitution. 2. Remove the plastic flip-off cap from the powder vial to expose the central portions of the rubber stopper. Do not remove the gray stopper or metal ring around the top of the vial.
3. Wipe the top of the vial with an alcohol swab. Allow the alcohol to dry. 4. Peel back the paper cover from the vial adapter package. Do not remove the adapter from the package.
5. Place the powder vial on an even surface and hold it. Take the adapter package and place the vial adapter over the centre of the rubber stopper of the powder vial. Press down firmly the adapter package until the adapter spike penetrates the rubber stopper. The adapter snaps to the vial when done.
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6. Peel back the paper cover from the pre-filled syringe package. Hold the plunger rod at the end and do not touch the shaft. Attach the threaded end of the plunger rod to the solvent syringe plunger. Turn the plunger rod clockwise until a slight resistance is felt.
7. Break off the tamper-proof plastic tip from the solvent syringe by snapping the perforation of the cap. Do not touch the inside of the cap or the syringe tip. In case the solution is not used immediately close the filled syringe with the tamper-proof plastic tip for storage.
8. Remove the adapter packaging and discard. 9. Firmly connect the solvent syringe to the vial adapter by turning clockwise until resistance is felt. 20240515_pil_139_UK_03.02
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10. Slowly inject all solvent into the powder vial by pressing down the plunger rod.
11. Without removing the syringe, gently move or swirl the vial in circles a few times to dissolve the powder. Do not shake. Wait until all the powder dissolves completely. 12. Visually inspect the final solution for particles before administration. The solution should be clear and colourless, practically free from visible particles. Do not use solutions that are cloudy or have deposits. 13. Turn the vial attached to the syringe upside down, and slowly draw the final solution into the syringe. Make sure that the entire content of the vial is transferred to the syringe.
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14. Detach the filled syringe from the vial adapter by turning counter clockwise and discard the empty vial. 15. The solution is now prepared for immediate use. Do not refrigerate. 16. Clean the chosen injection site with one of the provided alcohol swabs. 17. Attach the provided infusion set to the syringe. Insert the needle of the infusion set into the chosen vein. If you have used a tourniquet to make the vein easier to see, this tourniquet should be released before you start injecting the solution. No blood must flow into the syringe due to the risk of formation of fibrin clots. 18. Inject the solution into the vein at a slow speed, not faster than 4 mL per minute. If you use more than one vial of powder for one treatment, you may use the same injection needle again. The vial adapter and the syringe are for single use only.
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Frequently asked questions about Nuwiq 250 IU powder and solvent for solution for injection
How do I take Nuwiq 250 IU powder and solvent for solution for injection?
Nuwiq 250 IU powder and solvent for solution for injection comes as injection containing 250iu. 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 Nuwiq 250 IU powder and solvent for solution for injection?
The active substance in Nuwiq 250 IU powder and solvent for solution for injection is simoctocog alfa.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Nuwiq 250 IU 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 Nuwiq 250 IU 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: simoctocog alfa
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Nuwiq can be used for all age groups.
4.2. Posology and method of administration
Treatment should be under the supervision of a physician experienced in the treatment of haemophilia.
Treatment monitoring
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. 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 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 administered is expressed in International Units (IU), which is related to the current WHO concentrate standard for factor VIII products. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or preferably in International Units (relative to an International Standard for factor VIII in plasma).
One International Unit (IU) of factor VIII activity is equivalent to the 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 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by approximately 2% of normal activity or 2 IU/dL. The required dose is determined using the following formula:
Required units = body weight (kg) x desired factor VIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL)
The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
In the case of the following haemorrhagic events, 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 can be used to guide dosing in bleeding episodes and surgery.
Degree of haemorrhage/ Type of surgical procedure
Factor VIII level required (%) (IU/dL)
Frequency of doses (hours)/ Duration of therapy (days)
Haemorrhage
Early haemarthrosis, muscle bleeding or oral bleeding
20–40
Repeat every 12 to 24 hours. At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
More extensive haemarthrosis, muscle bleeding or haematoma
30–60
Repeat infusion every 12 to 24 hours for 3 to 4 days or more until pain and acute disability are resolved.
Life threatening haemorrhages
60–100
Repeat infusion every 8 to 24 hours until threat is resolved.
Surgery
Minor surgery including tooth extraction
30–60
Every 24 hours, at least 1 day, until healing is achieved.
Major surgery
80–100
(pre- and postoperative)
Repeat infusion every 8–24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dL).
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. The regimen may be adjusted based on patient response.
In some cases, especially in younger patients, shorter dose intervals or higher doses may be necessary.
Paediatric population
The posology is the same in adults and children and adolescents, however, shorter dose intervals or higher doses may be necessary for children and adolescents. Currently available data are described in sections 4.8, 5.1 and 5.2.
Method of administration
Nuwiq is for intravenous use.
It is recommended that not more than 4 mL per minute be administered.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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 product should be clearly recorded.
Hypersensitivity
As with any intravenous protein product, allergic type hypersensitivity reactions are possible. Nuwiq contains traces of human host cell proteins other than factor VIII. 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
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 50 exposure days but continues throughout life although the risk is uncommon.
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.
Cardiovascular events
In patients with existing cardiovascular risk factors, substitution therapy with FVIII may increase the cardiovascular risk.
Catheter-related complications
If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Paediatric population
The listed warnings and precautions apply both to adults and children and adolescents.
Excipient related considerations (sodium content)
This medicinal product contains 18.4 mg sodium per vial, equivalent to 0.92 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with Nuwiq.
4.6. Fertility, pregnancy and lactation
Animal reproduction studies have not been conducted with factor VIII.
Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast feeding is not available. Therefore, factor VIII should be used during pregnancy and breast-feeding only if clearly indicated. There are no fertility data available.
4.7. Effects on ability to drive and use machines
Nuwiq has no 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 angiooedema, burning and stinging at the infusion site, chills, flushing, headache, hives, hypotension, lethargy, nausea, rash, restlessness, tachycardia, tightness of the chest, tingling, urticaria, including generalised urticaria, vomiting, wheezing) have rarely been observed with FVIII preparations and may in some cases progress to severe anaphylaxis (including shock).
Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Nuwiq. 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 list of adverse reactions
Table 1 presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies are based on reports from clinical trials with a total of 355 unique subjects with severe haemophilia A, of which 247 were previously treated patients (PTPs) and 108 were previously untreated patients (PUPs).
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).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1 . Frequency of adverse reactions in clinical studies
MedDRA Standard System Organ Class
Adverse reactions
Frequency
Blood and lymphatic system disorders
Anaemia
Factor VIII inhibition
Haemorrhagic anaemia
Uncommon*
Uncommon (PTPs) #
Very common (PUPs)#
Uncommon*
Immune system disorders
Hypersensitivity
Common*
Nervous system disorders
Dizziness
Headache
Paraesthesia
Uncommon*
Uncommon*
Uncommon*
Ear and labyrinth disorders
Vertigo
Uncommon*
Respiratory, thoracic and mediastinal disorders
Dyspnoea
Uncommon*
Gastrointestinal disorders
Dry mouth
Uncommon*
Musculoskeletal and connective tissue disorders
Back pain
Uncommon*
General disorders and administration site conditions
Pyrexia
Chest pain
Injection site inflammation
Injection site pain
Malaise
Common*
Uncommon*
Uncommon*
Uncommon*
Uncommon*
Investigations
Non-neutralising antibody positive (in PTPs)
Uncommon*
* Calculated as patients with adverse reactions per total number of 355 study patients, of which 247 previously treated patients (PTPs) and 108 previously untreated patients (PUPs).
# 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
A non-neutralizing anti-factor VIII antibody was detected in one adult patient (see Table 1). The sample was tested by the central laboratory at eight dilutions. The result was positive only at dilution factor 1 and the antibody titre was very low. Inhibitory activity, as measured by the modified Bethesda assay, was not detected in this patient. Clinical efficacy and in vivo recovery of Nuwiq was not affected in this patient.
Paediatric population
Frequency, type and severity of adverse reactions in children and adolescents are assumed to be the same as in adults.
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 national reporting system.
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
No cases of overdose have been reported.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Simoctocog alfa. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- NUWIQ 1000UI prescription partial — not the same combinationSIMOCTOCOG ALFA (FACTOR VIII DE COAGULARE) · injection / infusion
- NUWIQ 2000UI prescription partial — not the same combinationSIMOCTOCOG ALFA (FACTOR VIII DE COAGULARE) · injection / infusion
- NUWIQ 250UI prescription partial — not the same combinationSIMOCTOCOG ALFA (FACTOR VIII DE COAGULARE) · injection / infusion
- NUWIQ 500UI prescription partial — not the same combinationSIMOCTOCOG ALFA (FACTOR VIII DE COAGULARE) · 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
⚠ Not the same combination. This medicine contains Simoctocog alfa. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- Nuwiq partial — not the same combinationSimoctocogum alfa. Czynnik VIII krzepnięcia krwi ludzki, rekombinowany · injection / infusion
- Vihuma partial — not the same combinationSimoctocogum alfa. Czynnik VIII krzepnięcia krwi ludzki. · 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. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Nuwiq 250 IU 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.