NovoThirteen – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine NovoThirteen, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
ℹ️ 1. What NovoThi rteen is and wh at it is used for
What NovoThi rteen is NovoThirte en contains the active sub stanc e catridecacog, which is identical to human coagulation factor XIII, an enzyme necessary for blood clotting . NovoThirteen replaces the miss ing factor XIII and helps to stabili se the initial blood clot by pr oducing a mesh arou nd the clot.
What NovoThi rteen is used for
NovoThirt een is used to prevent bleeding in patients who do not have enough or are missing part of factor XIII (that is called A-subunit) .
⚠️ 2. Wha t you need to know before you use NovoTh irteen
It is important t hat you use NovoThirteen f or injection immediately af ter preparation.
Do not use NovoThirteen
- If you are allergic to catridecacog or any of the other ingredients of this medicine (listed in section 6 ).
If yo u are not sure, ask your doctor before using this me dicine.
Warnings a nd pr ecautions Talk to your doctor before using NovoThirteen :
- If you have or have ever had a higher risk of blood clots forming (thrombosis) , as NovoThirteen may i ncrease the severity of a pre-existing b lood c lot.
- If you have or have ever had l iver dam age.
Contact your doctor i mme diately:
- If you experience bleeding during your treatment with NovoThirteen occurring spontaneously and/or requi ring treatment.
24 • If you experience an allergi c reaction to NovoThirteen . The signs may include: hives, i tching, swelling, difficulty breathing, low blood pressure (signs include palen ess and col dness of skin, rapid heartbea t), feeling dizzy and swe ating.
Other medicines and Nov oThirteen
Tell your do ctor if you are using , have recently used or might use any other medicines .
It is not recommended to use NovoThirteen and recombinant coag ulation factor VIIa (anot her blood clotting fa ctor) together.
Pregnancy and breast -feeding If you are pregnant or breast-feeding, or if you think you may be pregnant or are planning to have a baby, a sk your doctor for advice before ta king this medicine.
NovoThirtee n contain s sod ium This medici ne contains less than 1 mmol sod ium (23 mg) per inj ectio n, i.e. essentially ‘s odium-free’.
💊 3. How to us e NovoThirteen
Your treatment with NovoThirteen should be initiated by a doctor experienc ed in the treatment o f rare bleeding disorders .
Always use this med icine exactly as yo ur doctor has told you. C heck w ith your doctor if you are not sure.
Before you can use NovoThirteen for injection you need to reconstitute the product. Please see NovoTh irteen user instructi ons.
NovoT hirteen is giv en as an inject ion in to a vein. Your dos e will depend on your body weig ht. The usual dose for prevention of bleeds is 35 IU for each kilogram of body weight. The injections are given once a month (every 28 ± 2 days) .
If you experie nce a bleed , you should c ontact your doctor wh o will decide if an inject ion is needed .
NovoThir teen should be injecte d at a rate not higher than 2 ml/minute.
Based on the concentration of NovoThirteen solution, t he dose volume to be injected ( in millilit res) can be calculat ed from this formula :
Dose volume in millili tres = 0.042 x your body w eight in kilo grams .
You sh ould only use the prescribe d dose calculated by your doctor from this formula considering that the usual dose and the concentration of Novo Thirteen a re different f rom those of the othe r products which co ntain f actor XIII.
Your d octor may adapt the dose if this is deemed necessary.
Use in small children For child ren weighing less than 24 kg the reconstituted NovoThirtee n should be further diluted with 6 ml of sodiu m chloride 0.9% , solu tion for injection to be a ble to handle the d osing of small children.
For more information see sect ion ‘NovoThirteen user instructions – Instructions of how to dilute the reconstituted Novo Thirteen ’.
The dose v olume for the recon stituted NovoT hirtee n dilu ted with 6 ml sodiu m chlor ide 0.9%, solution for injection can be calcul ated from this formula :
Dose volume in millilitres = 0.117 x body weight in kilograms.
Use in children and adolescents (weighing more th an 24 kg) NovoT hirteen ca n be used in children and adolescents in the sa me way as in adults for both prevention of ble eds and if you experience a bleed .
25 If you use more NovoThirteen than you should There is limited information on over dose with NovoThirtee n. None of the reported cases have shown any s igns of illness. Contact y our doctor i f you have i njected more NovoThirt een than you have been instructed .
If you forget to use NovoThirteen
If you forget an injection of NovoThirteen , talk to your doctor . Do not take a doub le do se to make up for a forgot ten dose.
If you s top usi ng NovoThirteen If you s top using NovoThirteen , you are not protected aga inst bleeding. Do not stop using NovoThirteen without talking to your doctor. Your doctor will explain what mig ht happen i f you sto p treatment and disc uss ot her options with you.
If you have any furthe r que stions on the use of t his medicine, ask your doct or.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybod y gets them .
Side e ffect s include:
Comm on (may affect up to 1 in 10 people):
- Headache (most common side effect)
- Pain where the injection is given
- Pain in the legs and arms
- Increase d amount of small protein fragments caused by break down of blood c lots
- A drop in the numb er of some type s of w hite blood cells. T his mea ns your body may be more prone to infections
- Developm ent of antibodies against factor XIII which have no influence on the effect of the drug.
Side effects in ch ildren:
The side effec ts observe d in children are the same as also observed in adults but the side effects may be mor e common in children t han in adults.
Reporting o f side effects If you get any side effects , talk to your doctor , pharmacist or nurse . This includes any possibl e side effects not listed in this leafle t. You can also report si de effe cts directly via th e nat ional reporting system listed in Appendix V . By rep orting side effects you c an help provide more information on the safety of this medicine.
🌡️ 5. How to store N ovoThirte en
Keep this medicine out of the sight and reach of children .
Do not use this medicine after the expiry date which i s stated on the label and the ou ter carto n after ‘EXP.’. The expiry date refers to the last d ay of that month .
Store in a refrigerator (2°C–8°C).
Do not freeze .
Store in the original package in order to protect from light.
Once prepared, NovoThirteen for inject ion should be u sed immedi ately.
The so lution is clear and c olourless. Do not u se this medicine if there are p articles in it or it i s discoloured when reconsti tuted .
26 Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw awa y medicines you no longer use. These mea sures will help protect t he envi ronment.
📦 6. Conte nts o f the pack and other i nformation
What NovoThirte en contains
- The active substance is catridecacog (recombinant coagulation factor XIII : 2500 IU/3 ml, a fter reconstitutio n, corres pondi ng to a concent ration of 833 IU/ml .
- The other ingredients are fo r the powder sodium chlori de, sucrose and polysorbate 20, L-histidine , hydrochloric acid (for pH -adjustment), sodium hydroxide (for pH adjustmen t) and for the solven t water for injectio ns.
What Novo Thirte en looks like and content s of th e pack NovoThirteen is supplied as a powder and s olvent for solution for injection (2500 IU powder in a vial and 3.2 ml solvent in a vial, with a vial adapter ).
Pack size of 1 .
The po wder is white and th e solvent is clear and colourless .
Marketing Author isation Holder and Manuf acturer Novo Nordisk A /S Novo A llé DK-2880 Bagsvæ rd Denmark
This leaflet was last revised in
Detailed information on this medicine is a vailable on the Europe an Medicin es Agency web site: http://www.ema.euro pa.eu 27 NovoThirteen user instructions To reconstit ute and administer this product the following tools are needed : a 10 ml syringe or a syrin ge of a convenient size accordin g to injection volume, alcoho l swab s, the included vial adapt er and an infusion set (tubing, butterfly needle) .
Preparing the solution Always use an aseptic technique. Before starting, the hand s should be washed. Bring the po wder and solve nt vials to a temperature not above 25°C , by ho lding them in the hands until they feel as war m as your hands. Remove the plastic caps from the 2 vials. If the caps are loose or missing, do not use the vials. Cl ean the rubber stoppe rs on the v ials with alcohol swabs and a llow t hem to dry before u se.
The product is reconstituted using the vi al adapter included.
Remove the protective paper from the vial adapter without taking the vial adapter out of the pr otective cap. Attach the vial adapter to the solvent vial ( water for inj ections). Take care not to touch the spike on the vial adapter.
Once att ached, remove the protective cap from the vial adapter .
Pull the plunger to draw i n a volume of air equal to the total am ount o f solvent in the solvent via l.
Screw the s yringe tightly onto the via l adapter on the solvent vial. Inject air into the vial by pushing the plunger until you f eel a clear resistanc e.
Hold th e syri nge with the solven t vial upside down. Pull the pl unger to draw the solvent into the syringe .
Remove the empty solvent vial by tipping the syringe with the via l adapter.
Click the vial adapt er, st ill attached to the syring e onto the powder v ial. Hold the syringe slightly tilted with the vial fa cing downwards. Push the plun ger slowly to inject the solvent into the powder vial.
Make s ure not to aim the st ream of sol vent directly at the powder a s this will cause foaming .
Gently swirl the vial until all the powder is di ssolved. Do not shake the vial as this will cause foaming.
NovoThirteen should be inspect ed visually for extra neous (for any foreign) p articulate matt er and discoloration prior to ad ministration. In th e eve nt of either being obs erved, discard the medicina l product.
Reconstituted NovoThirteen is a clear, colourless solution.
If a larger dose is needed , repeat the p rocedure i n a separ ate syringe until the required dose is reache d.
Important information Once prepared , NovoThirtee n for injec tion should be u sed immediately .
In case a dilution of the reconstituted NovoThirteen is needed proceed t o the section ‘Dilutio n of the recon stituted p roduct with sodium ch loride 0.9%, soluti on for injection’.
Ensure that the plunger is pus hed all the way in before turning the syringe upside down (it may have been pushed out by the pressure in the vial). Hold the syrin ge wi th the vial ups ide do wn and pull the plunger to draw up the amount calculated for the injecti on.
Unscrew the vial adapter with the vial.
The product is now ready for injection in the vein . Follow the i njection p rocedure as instructed by your doct or.
After the inje ction Safely dispose of the syringe, vial adapter, infusion set and vials. Any unused medicinal product or waste material should be disposed of in accordance wit h local req uirements .
31 Instructions of how to dilute the reconsti tuted N ovoTh irteen To dil ute the reconstituted NovoT hirteen the following tools are needed: a vial containing sodium chloride 0.9%, solution for injection, a 10 ml syrin ge and alcohol swabs.
General i nstructio ns fo r dilution The dilution should be perfo rmed in accordance with as eptic rules.
Carefully draw exactly 6 ml sodium chlori de 0.9%, solution for injection, into the 10 ml syringe.
Slowly inject the 6 ml sodium chloride 0.9%, solution for inject ion, into the reconstituted NovoT hirteen vial.
Gently swirl t he vial to mix the solution.
The diluted solut ion is a cl ear, colourless solution. Check the injection solu tion for particulate matter and for discolouration. If either is noticed, ple ase discard.
After dilution proceed to step H.
Any residual mat erial of the diluted produ ct has to be discarded imme diately.
In case of any questions ask your doctor or nurse.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information NovoThirteen (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/12/775).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.