Coagadex

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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This medicinal product is subject to additional monitoring. This will allow quick identification of new 
safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 
4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Coagadex 250 IU powder and solvent for solution for injection.   
Coagadex 500 IU powder and solvent for solution for injection. 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
 Each vial contains nominally 250 IU or 500 IU human coagulation factor X. 
 
Coagadex contains approximately 100 IU/mL human coagulation factor X after reconstitution with 2.5 mL 
(250 IU) or 5 mL (500 IU) sterilised water for injections.  
 
Produced from the plasma of human donors. 
 
Excipients with known effect: 
Coagadex contains up to 0.4 mmol/mL (9.2 mg/mL) of sodium.  
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder and solvent for solution for injection. 
 
Powder vial containing white or off-white powder.  
 
Solvent vial containing clear colourless liquid. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Coagadex is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative 
management in patients with hereditary factor X deficiency.  
 
Coagadex is indicated in all age groups 
 
4.2 Posology and method of administration 
 
Treatment should be initiated under the supervision of a physician experienced in the treatment of rare 
bleeding disorders. 
 
Posology 
The dose and duration of the treatment depend on the severity of the factor X deficiency (i.e. the patient’s 
baseline factor X level), on the location and extent of the bleeding and on the patient’s clinical condition.  
Careful control of replacement therapy is especially important in cases of major surgery or life-threatening 
bleeding episodes. 
 
Not more than 60 IU/kg daily should be administered in any age group. 



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In adults and adolescents at least 12 years of age, the expected in vivo peak increase in factor X level expressed 
as IU/dL (or % of normal) can be estimated using the following formulae: 

 
Dose (IU) = body weight (kg) x desired factor X rise (IU/dL or % of normal) x 0.5  

                        

OR 

 
Increase in factor X level (IU/dL or % of normal) = [total dose (IU)/body weight (kg)] x 2  

       
The following examples assume the patient’s baseline factor X level is <1 IU/dL: 

1. A dose of 2000 IU Coagadex administered to a 70 kg patient should be expected to result in a peak post-
infusion factor X increase of 2000 x {[2 IU/dL]/[IU/kg]}/[70 kg] = 57 IU/dL (i.e. 57% of normal) 

2. A peak factor X level of 90% of normal is required in a 70 kg patient.  In this situation, the appropriate 
dose would be: 

   70 kg x 90 IU/dL/{[2 IU/dL]/[IU/kg]} = 3150 IU. 

The dose and frequency should be based on the individual clinical response.  P atients may vary in their 
pharmacokinetic (e.g. half-life, in vivo recovery) and clinical responses to Coagadex.  Although the dose can 
be estimated using the calculations above, whenever possible appropriate laboratory tests, such as serial factor 
X assays, should be performed to guide dose adjustments. 
 
Control of Bleeding Episodes 
Adults and adolescents aged 12 years or more for treatment of bleeding episodes: 25 IU/kg Coagadex should 
be injected when the first sign of bleeding occurs or just before the expected onset of menstrual bleeding.  
Repeat at intervals of 24 hours until the bleed stops.  Judge each individual bleed on its own severity.   
 
For secondary prophylaxis against re-bleeding or short-term prophylaxis prior to anticipated physical activity 
or dental appointments: 25 IU/kg Coagadex should be injected and repeated as required. 
 
Routine prophylaxis of bleeding episodes 

Due to inter-and intra-patient variability, it is recommended that trough blood levels of Factor X should be 
monitored at intervals, especially in the first weeks of therapy or after dosage changes.  Adjust dosage 
regimen to clinical response and trough levels of Factor X of at least 5 IU/dL.  
 
There are limited data on the use of Coagadex for long periods of prophylaxis in adults. There are no data 
available on routine prophylaxis in paediatric patients aged >12 to <18 years. 25 IU/kg twice weekly is the 
proposed starting dose for prophylaxis in patients >12 years of age with dose levels and dosing intervals to 
be adjusted as clinically indicated.  Depending on individual clinical response, longer intervals, e.g. once 
weekly, might be adequate (see section 5.1). 
 
Perioperative Management (Adults and adolescents aged at least 12 years of age) 
Pre-surgery: calculate dose of Coagadex to raise plasma factor X levels to 70-90 IU/dL.  The careful control 
of dose and duration of treatment is especially important in cases of major surgery. 

Required dose (IU) = body weight (kg) x desired factor X rise (IU/dL) x 0.5 

The desired factor X rise is the difference between the patient’s plasma factor X level and the desired level, 
and based on the observed recovery of 2 IU/dL per IU/kg. 

Example:  to raise plasma factor X level from 15 IU/dL to 90 IU/dL in a 70 kg patient, the appropriate dose is:  

70 x (90-15) x 0.5 = 2,625 IU. 

Post-surgery: dose as necessary to maintain plasma factor X levels at a minimum of 50 IU/dL until the 
subject is no longer at risk of bleeding due to surgery.  



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It is recommended that post-infusion plasma factor X levels are measured for each patient before and after 
surgery, to ensure that haemostatic levels are obtained and maintained. 
 
 
Elderly 
No dose adjustment is necessary. 
 
Renal impairment 
No dose adjustment is necessary. 
 
Hepatic impairment 
No dose adjustment is necessary. 
 
 
Paediatric population (less than 12 years of age) 
For on-demand control of bleeding in children aged less than 12 years: 30 IU/kg Coagadex should be 
injected when the first sign of bleeding occurs. Repeat at intervals of 24 hours until the bleed stops. Judge 
each individual bleed on its own severity.   
 
For secondary prophylaxis against re-bleeding or short-term prophylaxis prior to anticipated physical activity 
or dental appointments: 30 IU/kg Coagadex should be injected and repeated as required. 

For routine prophylaxis of bleeding episodes in children aged less than 12 years: 40 IU/kg twice weekly. 
Due to inter-and intra-patient variability, it is recommended that trough blood levels of Factor X should be 
monitored at intervals, especially in the first weeks of therapy or after dosage changes. Adjust dosage 
regimen to clinical response and trough levels of Factor X of at least 5 IU/dL. Some patients may achieve 
desired FX trough levels on once weekly prophylactic therapy (see section 5.1). 
 
For perioperative management in children aged less than 12 years: Pre-surgery: calculate dose of 
Coagadex to raise plasma factor X levels to 70-90 IU/dL.  The careful control of dose and duration of 
treatment is especially important in cases of major surgery. 
 
The expected in vivo peak increase in factor X level expressed as IU/dL (or % of normal) can be estimated 
using the following formulae: 

 
Dose (IU) = body weight (kg) x desired factor X rise (IU/dL or % of normal) x 0.6  

                        

OR 

 
Increase in factor X level (IU/dL or % of normal) = [total dose (IU)/body weight (kg)] x 1.7  

 

Post-surgery: dose as necessary to maintain plasma factor X levels at a minimum of 50 IU/dL until the 
subject is no longer at risk of bleeding due to surgery.  

It is recommended that post-infusion plasma factor X levels are measured for each patient before and after 
surgery, to ensure that haemostatic levels are obtained and maintained. 
 
 
Method of administration  
Intravenous use. 
 
After reconstitution, the product should be administered by the intravenous route at a suggested rate of 
10 mL/min, but no more than 20 mL/min. 
 
For home therapy, the patient should be given appropriate training and reviewed at intervals. 
 



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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  
 
Hypersensitivity 
Allergic type hypersensitivity reactions, including anaphylaxis, are possible. Coagadex contains traces of 
human proteins other than factor X. Patients should be informed of the early signs of hypersensitivity 
reactions including angioedema, infusion site inflammation (e.g. burning, stinging, erythema), chills, cough, 
dizziness, fever, flushing, generalised urticaria, headache, hives, hypotension, lethargy, musculoskeletal 
pains, nausea, pruritus, rash, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing. If 
any of these symptoms occur, they should be advised to discontinue use of the product immediately and 
contact their physician.  In case of shock, the current medical standards for shock treatment should be 
observed. 
 
Inhibitors 
The formation of neutralising antibodies (inhibitors) to factor X is a possible complication in the management 
of individuals with factor X deficiency.  
 
In general, all patients treated with Coagadex should be carefully monitored for the development of inhibitors 
by appropriate clinical observations and laboratory tests.  If expected factor X activity levels are not attained, 
or if bleeding is not controlled with an expected dose, perform an assay that measures factor X inhibitor 
concentration. 
 
Transmissible Agents 
Standard measures to prevent infections resulting from the use of medicinal products prepared from human 
blood or plasma include selection of donors, screening of individual donations and plasma pools for specific 
markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of 
viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the 
possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or 
emerging viruses and other pathogens. 

 
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the 
non-enveloped viruses HAV and parvovirus B19. 
 
Vaccination against hepatitis A and B in patients who regularly or repeatedly receive human plasma-derived 
Factor X products may be warranted. 
 
It is strongly recommended that every time that Coagadex is administered to a patient, the name and batch 
number of the product are recorded in order to maintain a link between the patient and the batch of the product. 
 
Sodium Content 
Coagadex contains up to 0.4 mmol/mL (9.2 mg/mL) of sodium. To be taken into consideration for patients 
on a controlled sodium diet. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Coagadex is likely to be counteracted by factor Xa inhibitors, direct or indirect. These antithrombotic agents 
should not be used in patients with factor X deficiency. Coagadex should not be used as an antidote to the 
effects of direct oral anti-coagulants (DOACs) in patients who do not have factor X deficiency. 
 
4.6 Fertility, pregnancy and lactation 
 



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Pregnancy 
Due to the rarity of hereditary factor X deficiency, experience regarding the use of Coagadex during pregnancy 
and breast-feeding is not available. Therefore, Coagadex should be used during pregnancy only if clearly 
indicated. 
 
Breast-feeding 
Due to the rarity of hereditary factor X deficiency, experience regarding the use of Coagadex during pregnancy 
and breast-feeding is not available. Therefore, Coagadex should be used during breast-feeding only if clearly 
indicated. 
 
Fertility 
Animal reproduction studies have not been conducted with Coagadex.  
 
4.7 Effects on ability to drive and use machines 
 
Coagadex has no or negligible influence on the ability to drive and use machines.  
 
4.8 Undesirable effects 
 
Summary of safety profile 
 
The adverse reactions that occurred in the highest frequency were infusion site erythema, infusion site pain, 
fatigue, and back pain.  
 
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion 
site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, 
tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely with treatment of 
other haemophilias and may in some cases have progressed to severe anaphylaxis (including shock). 
Hypersensitivity reactions, allergic reactions, and anaphylaxis have not been reported in Coagadex clinical 
trials. 
 
Tabulated list of adverse reactions 
 
The following adverse reactions have been reported in clinical studies involving 27 patients treated with 
Coagadex.  Frequencies have been evaluated according to the following convention: very common (≥1/10 
subjects); common (≥1/100 to <1/10).  Frequencies of uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to 
<1/1,000) or very rare (<1/10,000) cannot be estimated from the available data. 
 
 
List of adverse reactions (ADRs) in 27 treated subjects 

MedDRA System Organ Class Adverse reaction  Frequency 
Musculoskeletal and connective tissue disorders Back pain Common 
General disorders and administration site conditions Infusion site erythema 

Fatigue 
Infusion site pain 

Common 

 
Paediatric population 
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults (see 
section 5.1). 
 
For safety information with respect to transmissible agents, see section 4.4. 
 
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 



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professionals are asked to report any suspected adverse reactions via the national reporting system listed in 
Appendix V. 
 
4.9 Overdose 
 
One case of accidental overdose was reported in the clinical trials, in which a subject received approximately 
80 IU/kg Coagadex to treat a bleed.  No adverse events were reported relating to this overdose. There is a 
potential for thromboembolism with overdose. 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Anti-haemorrhagics, vitamin K and other haemostatics, coagulation factor X, 
ATC code: B02BD13. 
 
Mechanism of action 
Factor X is an inactive zymogen, which can be activated by factor IXa (via the intrinsic pathway) or by factor 
VIIa (via the extrinsic pathway).  Factor X is converted from its inactive form to the active form (factor Xa) 
by the cleavage of a 52-residue peptide from the heavy chain.  Factor Xa associates with factor Va on a  
phospholipid surface to form the prothrombinase complex, which activates prothrombin to thrombin in the 
presence of calcium ions. Thrombin then acts upon soluble fibrinogen and factor XIII to generate a cross-
linked fibrin clot. 
 
Pharmacodynamic effects 
Coagadex is derived from human plasma and used as a replacement for the naturally existing coagulation factor 
X in patients with hereditary factor X deficiency. 
 
Clinical efficacy 
 
In a multicentre, open-label, non-randomised clinical trial to evaluate the pharmacokinetics, safety and efficacy 
of Coagadex, 16 subjects (aged 12 years and above) with moderate to severe hereditary factor X deficiency 
(FX:C < 5 IU/dL) received a dose of 25 IU/kg Coagadex to treat spontaneous, traumatic and menorrhagic 
bleeding episodes. 
 
The efficacy of Coagadex in treating bleeding episodes was assessed by the subject and/or investigator for 
each new bleeding episode, using a pre-determined bleed-specific ordinal rating scale of excellent, good, poor 
and unassessable. Of the 208 bleeding episodes treated with Coagadex, 187 bleeding episodes in 15 subjects 
were evaluated for efficacy. Ninety eight (53%) were major bleeding episodes, and 88 (47%) were minor 
bleeds (one bleed was not assessed). Coagadex was considered to be good (7%) or excellent (91%) in treating 
98% of bleeding episodes. Of the 187 bleeding episodes in the efficacy analysis, 155 bleeds (83%) were treated 
with one infusion, 28 bleeds (15%) with two infusions, 3 bleeds (2%) with three infusions and 1 bleed (0.5%) 
with four infusions. The mean dose per infusion and total dose of Coagadex were 25.4 IU/kg and 30.4 IU/kg, 
respectively. Four bleeding episodes in two subjects were considered treatment failures. The recommended 
dose of 25 IU/kg Coagadex to treat a bleed was maintained during the study for 14 of the 16 subjects. The 
other two subjects used doses up to 30 IU/kg and 33 IU/kg.  

A total of 184 infusions of Coagadex were given as a preventative measure. Routine prophylaxis was used 
by two subjects. One subject, aged 58 years, used 28 IU/kg once weekly for 8 weeks and, later, 25 IU/kg 
every 2 weeks for more than 5 months. The other subject, aged 22 years, used 24.6 IU/kg once weekly for 
8.5 months. Neither subject had any bleeds during these periods.  

 

Prophylaxis of Bleeding Episodes 



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The third study evaluated the use of Coagadex in routine prophylaxis of bleeding episodes in nine children 
aged less than 12 years of age. The mean age was 7.3 (range 2.6 to 11.9) years. Eight subjects had severe FX 
deficiency,  the other had moderate deficiency. Four subjects were aged 0 to 5 years and five were aged 6 to 
11 years inclusive. Routine prophylaxis was started with unit doses of 40-50 IU/kg and during the first 6 weeks 
trough levels of Factor X were measured to adjust the dosage regimen to maintain a trough level of at least 5 
IU/dL. A total of 537 ( mean 59.7 per subject) prophylactic infusions were administered. The median 
prophylactic dose per infusion per subject was 39.60 IU/kg (mean 38.76 IU/kg), and ranged from 18.0 to 47.3 
IU/kg. Median and mean doses per infusion in the four children less than 6 years of age were both 40.1 IU/kg 
(95% CI 30.70, 49.57) and in the five children 6 to 11 years of age inclusive, median dose was 39.6 IU/kg and 
mean dose was 37.7 IU/kg (95% CI: 23.42, 51.91). The median dosing interval for all of the nine children was 
3 days (range 2 to 8 days).  Six children (66.7%) remained free of bleeds during routine prophylaxis. Three 
children (33.3%), one in the 0-5 years age group and two in the 6-11 years age group had a total of 10 bleeds 
due to epistaxes, trauma or menorrhagia. All were treated with a single infusion of Coagadex; mean and median 
doses 31.7 IU/kg (range 24.6 to 38.8 IU/kg) and all recorded efficacy ratings were categorized as excellent. 
There were no adverse drug reactions in this study in children less than 12 years of age. 

 
Surgical haemostasis 
The safety and efficacy of Coagadex for perioperative management was evaluated in five subjects aged 14 to 
59 years with mild (n=2), moderate (n=1), and severe (n=2) disease, who underwent a total of seven surgical 
procedures. 
 
For all surgical procedures, Coagadex was assessed as excellent (no post-operative bleeding, no requirement 
of blood transfusions, and blood loss was no more than ‘as expected’) in controlling blood loss during and 
after surgery. For major surgery, a median of 13 infusions (range 2 to 15 infusions) and a median cumulative 
dose of 181 IU/kg (range 45 to 210 IU/kg) were required to maintain haemostasis. For minor surgery, a median 
of 2.5 infusions (range 1 to 4 infusions) and a median cumulative dose of 89 IU/kg (range 51 to 127 IU/kg) 
were used to maintain haemostasis. 
 
 
5.2 Pharmacokinetic properties 
 
In a clinical study of Coagadex in subjects with severe or moderate factor X deficiency (basal FX:C <5 IU/dL), 
the pharmacokinetics of Coagadex were assessed in 16 subjects after administration of a nominal dose of 25 
IU/kg. Pharmacokinetic (PK) parameters were calculated from plasma factor X:C (one-stage clotting assay) 
activity measurements after subtraction of the pre-dose value.  Combining IR values for FX:C at the baseline 
visit (n=16) and the Repeat PK assessment (n=15) gave an overall geometric mean IR of 2.07 IU/dL per IU/kg 
administered (n=31). Similarly, combining t½ values at the Baseline Visit and the Repeat PK assessment gave 
an overall geometric mean t½ of 29.36 hours. Systemic exposure to FX:C at the Repeat PK visit (at least 6 
months later) was equivalent to that at baseline, since repeat/baseline ratios for all PK parameters were within 
the range of 90% to 110%.  
 
The mean (CV%) for incremental recovery was 2.08 (18.1). The mean (CV%) maximum plasma concentration 
(Cmax) was 0.504 (17.2) IU/mL.  
The mean (CV%) for area under the curve (AUC 0-144h) was 17.1 (21.0) IU.hr/mL.  
Human coagulation factor X is largely retained within the vascular compartment: mean apparent volume of 
distribution (Vss) was 56.3 (24.0) mL/kg. 
The mean (CV%) half-life of human coagulation factor X was 30.3 (22.8) hr and clearance was 1.35 (21.7) 
mL/kg/hr. 
 
 
 
Renal impairment 
No pharmacokinetic studies have been conducted but there is no anticipated effect of gender or renal function 
on the pharmacokinetic profile of Coagadex. 



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Hepatic impairment 
No pharmacokinetic studies have been conducted but there is no anticipated effect of gender or hepatic function 
on the pharmacokinetic profile of Coagadex. 
 
Elderly 
No pharmacokinetic studies have been conducted but there is no anticipated effect of age on the 
pharmacokinetic profile of Coagadex. 
 
Paediatric population 
Pharmacokinetic studies have not been performed in children under the age of 12 years. The study in young 
children (see section 5.1) measured incremental recovery at 30 min (IR30min) after the first dose and after the 
last dose in the study (approximately 6 months later) (see section 5.1) Combining IR30min values for FX:C at 
the baseline visit (n=9) and the Repeat PK assessment (n=9) gave an overall geometric mean IR of 1.74 (range 
1.3-2.2) IU/dL per IU/kg administered (n=9). For the subgroup aged 6-11 years (n=5), the geometric mean 
IR30min was 1.91 (range 1.6 -2.2) IU/mL per IU/kg and for the youngest subgroup, 0-5 years (n=4) was 
1.53range 1.3-1.8) IU/mL per IU/kg. 
Trough levels of FX:C were measured during the first 6 weeks of the study to individualise the dosage regimen 
and to maintain a trough level of at least 5 IU/dL. During the dose-adjustment phase, two trough levels were 
<5 IU/dL but thereafter none were below this threshold. 
 
 
5.3 Preclinical safety data 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, 
single and repeat-dose toxicity, thrombogenicity and local tolerability. 
 
No investigations on genotoxicity, carcinogenicity and reproductive or developmental toxitcity have been 
conducted since human plasma coagulation factor X (as contained in Coagadex) is an endogenous protein. 
 
 
6. PHARMACEUTICAL PARTICULARS 

 
6.1 List of excipients 
 
Powder 
Citric acid 
Sodium hydroxide (for pH adjustment) 
Disodium phosphate dihydrate 
Sodium chloride 
Sucrose 
 
Solvent 
Water for injections 
 
6.2 Incompatibilities 
 
In the absence of compatability studies, this medicinal product must not be mixed with other medicinal 
products. 
 
The product should only be reconstituted using the Mix2Vial that is provided in the pack. 
 
6.3 Shelf life 
 
3 years. 
 
After reconstitution, from a microbiological point of view, the product should be used immediately. 



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However, chemical and physical in-use stability has been demonstrated for 1 hour at room temperature (up to 
25°C +/-2°C). 
 
6.4 Special precautions for storage 
 
Do not store above 30°C.   
 
Do not freeze.  
 
Keep container in the outer carton in order to protect it from light. 
 
For storage conditions after reconstitution of the medicinal product, see section 6.3. 
 
 
 
6.5 Nature and contents of container  
 
Immediate containers 
Powder vial:  250 IU or 500 IU of human coagulation factor X in a type I glass vial stoppered with a halobutyl 
rubber stopper, oversealed with a snap-off polypropylene cap and aluminium lacquered skirt. 
Solvent vial:  2 .5 mL or 5 mL solution in a type I glass vial sealed with a halobutyl rubber stopper and an 
overseal. 
Transfer Device (Mix2Vial). 
 
Pack sizes 
Coagadex 250 IU 
1 vial 250 IU human coagulation factor X powder for solution for injection 
1 vial 2.5 mL water for injections 
1 Transfer Device (Mix2Vial) 
 
Coagadex 500 IU 
1 vial 500 IU human coagulation factor X powder for solution for injection 
1 vial 5 mL water for injections 
1 Transfer Device (Mix2Vial) 
 
Not all pack sizes may be marketed. 
 

 
6.6 Special precautions for disposal and other handling 
 
The powder should only be reconstituted with the water for injections provided in the pack.  The 250 IU and 
500 IU presentations should be reconstituted using 2.5 mL and 5 mL water for injections, respectively. 
 
Do not use the water for injections if signs of particulate matter are visible. 
 
The vials should be brought to room temperature (not above 30oC) prior to the removal of the snap-off cap 
closure from the powder vial. 
 

  



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 Step 1:   Remove the cap from the powder vial and clean the top of the stopper with 
an alcohol swab.   

 Repeat this step with the solvent vial.   
 Peel back the top of the transfer device package but leave the device in the package. 
 

  
 
 
Step 2:   Place the blue end of the transfer device on the solvent vial and push 
straight down until the spike penetrates the rubber stopper and snaps into place. 
Remove the plastic outer packaging from the transfer device and discard it, taking 
care not to touch the exposed end of the device. 

 
 
 
 
 
 
 

Step 3:   Turn the solvent vial upside down with the transfer device still attached. 
Place the clear end of the transfer device on the powder vial and push straight down 
until the spike penetrates the rubber stopper and snaps into place. 

 
 
 
 
 
 

Step 4:   The solvent will be pulled into the powder vial by the vacuum contained 
within it.   
Gently swirl the vial to make sure the powder is thoroughly mixed.  Do not shake 
the vial.   
A clear or slightly pearl-like solution should be obtained, usually in less than 1 
minute (5 minutes maximum). 

 
 
 

Step 5:   Separate the empty solvent vial and blue part from the clear part by 
unscrewing anti-clockwise.   
Draw air into the syringe by pulling the plunger to the volume of water added.  
Connect the syringe to the clear part of the transfer device and push the air into the 
vial. 
 
 

 
 
 

Step 6:   Immediately invert the vial of solution, which will be drawn into the 
syringe.   
Disconnect the filled syringe from the device.   
Follow the normal safety practices to administer the medicine. 

 
 
 
 
 



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Note:   If you have more than one vial to make up your dose, repeat steps 1 through 6 withdrawing the 
solution in the vial into the same syringe. 

 
The transfer device supplied with the product is sterile and cannot be used more than once. When the 
reconstitution process is complete, the used transfer device should be disposed of it in the ‘sharps box’. 
 
The solution should be colourless, clear or slightly opalescent when administered. Do not use solutions that 
are cloudy or have deposits. Reconstituted products should be inspected visually for particulate matter and 
discolouration prior to administration. 
 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
7. MARKETING AUTHORISATION HOLDER 
 
BPL Bioproducts Laboratory GmbH 
Dornhofstraße 34, 63263 Neu-Isenburg 
Germany 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/16/1087/001 
EU/1/16/1087/002 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation:   16 March 2016 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 



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ANNEX II 

 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE  

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 

 



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A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER 
RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer of the biological active substance  

Bio Products Laboratory Limited 
Dagger Lane, 
Elstree, 
Borehamwood, 
WD6 3BX, 
United Kingdom 
 
Name and address of the manufacturer responsible for batch release 

PNR Pharma Services Limited 
Skybridge House 
Corballis Road North 
Dublin Airport 
Swords 
Co. Dublin 
K67 P6K2 
Ireland 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 

• Official batch release  
 

In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a 
state laboratory or a laboratory designated for that purpose. 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION  
 

• Periodic safety update reports  
 

The requirements for submission of periodic safety update reports for this medicinal product are set out in 
the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC 
and any subsequent updates published on the European medicines web-portal. 

The marketing authorisation holder shall submit the first periodic safety update report for this product 
within 6 months following authorisation. 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE 

OF THE MEDICINAL PRODUCT 
 

• Risk Management Plan (RMP) 
 

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed 



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RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the 
RMP. 

An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 

• Whenever the risk management system is modified, especially as the result of new information 
being received that may lead to a significant change to the benefit/risk profile or as the result of an 
important (pharmacovigilance or risk minimisation) milestone being reached.  

 

• Additional risk minimisation measures  
 

Not applicable. 

 

 
  



16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 

  



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 250 IU  
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Coagadex 250 IU  
powder and solvent for solution for injection 
human coagulation factor X  
  
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
250 IU human coagulation factor X, approximately 100 IU/mL   
 
3. LIST OF EXCIPIENTS 
 
Also contains: 
Powder vial: citric acid, sodium hydroxide, disodium phosphate dihydrate, sodium chloride, sucrose. 
 
Solvent vial: water for injections. 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection. 
 
Each pack contains: 
1 powder vial  
1 transfer device 
1 solvent vial of 2.5 mL water for injections 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For intravenous use after reconstitution 
 
Read the package leaflet before use.  
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP: 
Use within 1 hour of reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C.  



19 

Do not freeze. 
Keep the vial in the outer carton to protect from light. 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
BPL Bioproducts Laboratory GmbH 
63263 Neu-Isenburg 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/16/1087/001 
 
13. BATCH NUMBER 
 
Lot: 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
 

 
16. INFORMATION IN BRAILLE 
 
coagadex 250 iu 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 
  



20 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 500 IU  
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Coagadex 500 IU 
powder and solvent for solution for injection 
human coagulation factor X 
  
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
500 IU human coagulation factor X, approximately 100 IU/mL   
 
3. LIST OF EXCIPIENTS 
 
Also contains:  
Powder vial:  citric acid, sodium hydroxide, disodium phosphate dihydrate, sodium chloride, sucrose. 
 
Solvent vial: water for injections. 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection. 
 
Each pack contains: 
1 powder vial  
1 transfer device 
1 solvent vial of 5 mL water for injections 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For intravenous use after reconstitution 
 
Read the package leaflet before use. 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP: 
Use within 1 hour of reconstitution. 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C.  
Do not freeze. 
Keep the vial in the outer carton to protect from light. 



21 

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
BPL Bioproducts Laboratory GmbH 
63263 Neu-Isenburg 
Germany 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/16/1087/002  
 
13. BATCH NUMBER 
 
Lot: 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 

 
16. INFORMATION IN BRAILLE 
 
coagadex 500 iu 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 
 
  



22 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL 250 IU 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Coagadex 250 IU  
powder for solution for injection 
human coagulation factor X 
 
2. METHOD OF ADMINISTRATION 
 
For i.v. use after reconstitution. 
 
Read the package leaflet before use. 
 
3. EXPIRY DATE 
 
EXP: 
 
4. BATCH NUMBER> 
 
Lot: 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
250 IU 
 
6. OTHER 
 
 
  



23 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL 500 IU 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Coagadex 500 IU  
powder for solution for injection  
human coagulation factor X 
 
2. METHOD OF ADMINISTRATION 
 
For i.v. use after reconstitution 
 
Read the package leaflet before use 
 
3. EXPIRY DATE 
 
EXP: 
 
4. BATCH NUMBER> 
 
Lot: 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
500 IU 
 
6. OTHER 
 
 
  



24 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL 2.5 mL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Water for injections 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP: 
 
4. BATCH NUMBER 
 
Lot: 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
2.5 mL 
 
6. OTHER 
 
 
  



25 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL 5 mL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Water for injections 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP: 
 
4. BATCH NUMBER 
 
Lot: 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
5 mL 
 
6. OTHER 
 
 

  



26 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



27 

Package leaflet: Information for the patient 
 

Coagadex 250 IU 
Coagadex 500 IU 

 powder and solvent for solution for injection  
 

human coagulation factor X 
 

This medicine is subject to additional monitoring. This will allow quick identification of new safety 
information. You can help by reporting any side effects you may get. See the end of section 4 for how to 
report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains important 
information for you. 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if 
          their signs of illness are the same as yours.  
-     If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side  
          effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Coagadex is and what it is used for  
2. What you need to know before you use Coagadex   
3. How to use Coagadex 
4. Possible side effects  
5. How to store Coagadex   
6. Contents of the pack and other information 
 
 
1. What Coagadex is and what it is used for 
Coagadex is a  concentrate of human coagulation factor X, a protein that is needed for blood to clot. The 
factor X in Coagadex is extracted from human plasma (the liquid part of blood). It is used to treat and 
prevent bleeding in patients with hereditary factor X deficiency, including during surgery.  
 
Patients with factor X deficiency do not have sufficient factor X for their blood to clot properly, leading to 
excessive bleeding. Coagadex replaces the missing factor X and allows their  blood to clot normally.  
 
2. What you need to know before you use Coagadex 
 
Do not use Coagadex: 
- if you are allergic to human coagulation factor X or any of the other ingredients of this medicine 

(listed in section 6).  
Check with your doctor if you think this applies to you. 
 
Warnings and precautions  
Talk to your doctor, pharmacist or nurse before using Coagadex:   
 
-if you have a larger or longer bleed than usual and the bleeding does not stop after an injection of Coagadex. 
 
Some patients with a shortage of factor X may develop inhibitors (antibodies) to factor X during treatment. 
This could mean that the treatment will not work properly. Your doctor will check regularly for the 
development of these antibodies, and especially before an operation. Both before and after treatment with this 
medicine, particularly for your first course of treatment, your doctor will probably carry out tests to check the 
level of factor X in your blood. 
 



28 

Virus safety 
When medicines are made from human blood or plasma, certain measures are put in place to prevent 
infections being passed on to recipients. These include: 
 
– careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, 
– the testing of each donation and pools of plasma for signs of virus/infections, 
– the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses. 
 
The measures taken are considered effective for the following viruses: human immunodeficiency virus 
(HIV), hepatitis B virus, hepatitis C virus, hepatitis A virus and parvovirus B19. Despite these measures, 
when medicines prepared from human blood or plasma are administered, the possibility of passing on an 
infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of 
infections. 
 
 
It is strongly recommended that every time you receive a dose of Coagadex, the name and batch number of 
the product are recorded in order to maintain a record of the batches used. 
 
Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly or 
repeatedly receive human plasma-derived factor X products. 
 
Children and adolescents 
The listed warnings and precautions for adults also apply to children (aged 2 to 11 years) and adolescents 
(aged 12 to 18 years). 
 
Other medicines and Coagadex 
Tell your doctor if you are taking, have recently taken or might take any other medicines. Certain 
anticoagulants including those blocking a blood clotting factor (factor Xa) should not be used in patients 
with factor X deficiency receiving Coagadex due to a risk of blood clots. 
 
Pregnancy, breast-feeding and fertility 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your 
doctor or pharmacist for advice before using this medicine. 
 
Driving and using machines 
There are no known effects of this medicine on the ability to drive or operate machinery. 
 
Coagadex contains sodium 
This medicinal product contains up to 0.4 mmol/mL (9.2 mg/mL) of sodium. This should be taken into 
consideration by patients on a controlled sodium diet. 
 
3. How to use Coagadex 
Your treatment should be initiated by a doctor who is experienced in the treatment of bleeding disorders. 
 
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or 
pharmacist if you are not sure.  
 
Coagadex should be injected directly into a vein. Before injecting this medicine at home, you should have 
received training by your healthcare professional on how to do so.  
 
Your doctor will explain to you how much you should use, when you should use it and for how long. Your 
doctor will usually tell you your dose in terms of the number of full vials that supply the dose most suited to 
you. Not more than 60 IU/kg daily should be administered in any age group. 
 



29 

Adult 
 
How much Coagadex is given to treat a bleed or prevent further bleeding? 
Your doctor will tell you how much Coagadex to administer to treat a bleed and to prevent further bleeding; 
the dose required will depend on your normal blood level of factor X 
 
How much is given before, during and after major surgery? 
Before: The dose of Coagadex used should be sufficient to raise your blood factor X level to between 70 and 
90 units/dL. The dose you need will depend on your normal blood level of factor X and will be calculated by 
your doctor. 
 
After: During the first few days after the operation, your plasma factor X concentration will be checked 
regularly. It is recommended that your blood factor X level is kept above 50 units/dL. The dose you need 
will be calculated by your doctor. 
 
If your blood factor X concentration is too low (this will be tested by your doctor), or if it decreases faster 
than expected, an inhibitor to factor X may be present which stops Coagadex from working properly. Your 
doctor will arrange for the appropriate laboratory tests to see if this is the case. 
 
How much is given regularly for long-term prevention of bleeds? 
Your doctor will advise if this use is suitable for you and, if so, of the appropriate dose. 
 
Use in children and adolescents 
Your doctor will recommend an appropriate dose for you. Generally the doses for children less than 12 years 
old are larger than doses for adolescents which should follow those in adults. 
 
When to inject Coagadex 
• The medicine should be injected when the first sign of bleeding occurs 
• The injection should be repeated as necessary to stop the bleeding 
• Each individual bleed should be judged on its own severity 
• If you are using this medicine for the first time, your doctor will supervise you 
 
Dissolving your medicines before use 
Your medicine must only be dissolved in the solvent provided with the product. 
 

Quantity of Coagadex Volume of solvent 
250 IU 2.5 mL 
500 IU 5 mL 

 
Coagadex is supplied with the amount of solvent as shown in the table. 
 
You can dissolve Coagadex using the needle-free Mix2Vial transfer device included within each pack.  
Bring the containers of Coagadex to room temperature before mixing. 
Make up the medicine as follows: 
  



30 

 Step 1 
• Remove the cap from the powder vial and clean the top of the 
stopper with an alcohol swab. 
• Repeat this step with the vial of solvent. 
• Peel back the top of the transfer device package but leave the device in the 
package. 
 
 
 

 
Step 2 
• Place the blue end of the transfer device on the solvent vial and push straight 
down until the spike penetrates the rubber stopper and snaps into place. 
• Remove the plastic outer packaging from the transfer device and discard it, 
taking care not to touch the exposed end of the device. 
 
 

 
Step 3 
• Turn the solvent vial upside down with the device still attached. 
• Place the clear end of the transfer device on the powder vial and push 
straight down until the spike penetrates the rubber stopper and snaps into 
place. 
 
 
 

 Step 4 
• The solvent will be pulled into the powder vial by the vacuum contained 
within it. 
• Gently swirl the vial to make sure the powder is thoroughly mixed. Do not 
shake the vial. 
• A clear or slightly pearl-like solution should be obtained, usually in about 1 
minute (5 minutes maximum). 
 

 
Step 5 
• Separate the empty solvent vial and blue part from the clear part by 
unscrewing anti-clockwise. 
• Draw air into the syringe by pulling the plunger to the required volume of 
water added. 
• Connect the syringe to the clear part of the transfer device and push the air 
in the syringe into the vial. 

  
Step 6 
• Immediately invert the vial of solution, which will be drawn into the 
syringe. 
• Disconnect the filled syringe from the device. 
• The product is now ready for use. Follow the normal safety practices for 
administration. Make sure you use the product within an hour after it has been 
made up. 
 

 



31 

Do not use this medicine: 
 
- if the solvent is not pulled into the vial (this indicates loss of vacuum in the vial, so the 

powder must not be used). 
 
- if the dissolved powder and solvent form a gel or a clot (if this happens please tell your healthcare 

provider, reporting the batch number printed on the vial). 
 

If you use more Coagadex than you should 
If you administer more Coagadex than your doctor prescribed, it is possible you might develop a blood clot. 
If you think you may be using too much, stop the injection and tell the doctor, pharmacist or nurse. If you 
know you have used too much, tell the doctor, pharmacist or nurse as soon as possible.  
  
If you forget to use Coagadex 
Do not use a double dose to make up for a forgotten dose. Inject your normal dose as you remember and then 
continue dosing as instructed by your doctor. 
 
If you stop using Coagadex 

Always consult your doctor before deciding to stop your treatment. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
4. Possible side effects 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Allergic reactions (hypersensitivity reactions) have occurred rarely in the treatment of bleeding disorders 
with similar medicines (affecting up to 1 in 1,000 people), and sometimes progress to shock.  Signs of these 
may include skin rash (including hives), tingling, flushing, nausea, vomiting, headache, cough, wheezing, 
tightness of the chest, chills, fast heart rate, dizziness, lethargy, restlessness, swelling of the face, tightness of 
the throat, discomfort at the site of injection.  
If you get any of these contact your doctor.  
 
The following side effects have been reported with Coagadex. 
 
Common (may affect up to 1 in 10 people): 

• pain or redness at site of injection 
• tiredness 
• back pain 

 
Side effects in children and adolescents 
Side effects in children are expected to be the same as in adults. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 
(UK). HPRA Pharmacovigilance Website: www.hpra.ie (IE). ADR Reporting Website: 
www.medicinesauthority.gov.mt/adrportal (MT). 
 
By reporting side effects you can help provide more information on the safety of this medicine. 
 
5. How to store Coagadex 

 
Keep this medicine out of the sight and reach of children. 
 



32 

Do not use this medicine after the expiry date which is stated on the containers after “EXP”.  The expiry date 
refers to the last day of that month. 
 
Do not store above 30°C.   

 
Do not freeze.  

 
Keep container in the outer carton in order to protect it from light. 
 
Do not use this medicine if you notice small bits in the dissolved product. Once made up, Coagadex must be 
used within one hour.  
 
Do not throw away any medicines via wastewater or household waste. Your treatment centre will provide a 
special container to dispose of any solution that remains, any used syringes, needles and empty containers. 
These measures will help protect the environment. 
 
6. Contents of the pack and other information 
 
What Coagadex contains  
- The active substance is human coagulation factor X.  One vial contains nominally 250 IU or 500 IU 

human coagulation factor X. 
- The other ingredients are: citric acid, disodium phosphate dihydrate, sodium chloride,  

sodium hydroxide and sucrose (see section 2 for further information about ingredients).  
- Solvent:  water for injections. 
 
What Coagadex looks like and contents of the pack 
Coagadex is a white or off-white powder and is packed in quantities of 250 IU and 500 IU. After being made 
up, the solution is colourless, clear or pearl-like (opalescent).  Before injection, look at the solution. If the 
solution is cloudy or has any particles, do not use it. 
 
A transfer device called Mix2Vial is also provided. 
 
Presentations 
1 vial 250 IU powder 
1 vial 2.5 mL water for injections 
1 Transfer Device (Mix2Vial) 
 
or 
 
1 vial 500 IU powder 
1 vial 5 mL water for injections 
1 Transfer Device (Mix2Vial) 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
BPL Bioproducts Laboratory GmbH 
Dornhofstraße 34, 63263 Neu-Isenburg 
Germany 
 
Manufacturer 
PNR Pharma Services Limited, Skybridge House, Corballis Road North, Dublin Airport, Swords, Co. 
Dublin, K67 P6K2, Ireland 
 
 
 



33 

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Bio Products Laboratory Ltd 
Tél/Tel: + 44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk  
(Royaume-Uni/Verenigd 
Koninkrijk/Großbritannien) 
 

Lietuva 
Bio Products Laboratory Ltd 
Tel: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Jungtinė Karalystė) 
 

България 
Bio Products Laboratory Ltd 
Teл.: + 44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk  
(Обединено кралство) 
 

Luxembourg/Luxemburg 
Bio Products Laboratory Ltd 
Tél/Tel: + 44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk  
(Royaume-Uni/Verenigd 
Koninkrijk/Großbritannien) 
 

Česká republika 
Bio Products Laboratory Ltd 
Tel: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Velká Británie) 
 

Magyarország 
Bio Products Laboratory Ltd 
Tel: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Egyesült Királyság) 
 
 

Danmark 
Bio Products Laboratory Ltd 
Tfl: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Storbritannien) 
 

Malta 
Bio Products Laboratory Ltd 
Tel: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Ir Renju Unit) 
 

Deutschland 
BPL Bioproducts Laboratory GmbH  
Tel: +49 (0) 2408 146 0245 
e-mail: bpl@medwiss-extern.de 
Deutschland 
 

Nederland 
Bio Products Laboratory Ltd 
Tel: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Verenigd Koninkrijk) 
 

Eesti 
Bio Products Laboratory Ltd 
Tel: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Ühendkuningriik) 
 

Norge 
Bio Products Laboratory Ltd 
Tlf: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Storbritannia) 
 

Ελλάδα 
Bio Products Laboratory Ltd 
Τηλ: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Ηνωμένο Βασίλειο) 
 

Österreich 
Bio Products Laboratory Ltd 
Tel: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Großbritannien) 

España 
Bio Products Laboratory Ltd 
Tel: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Reino Unido) 
 

Polska 
Bio Products Laboratory Ltd 
Tel: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Wielka Brytania) 
 

France 
Bio Products Laboratory Ltd 
Tél: +44 (0) 20 8957 2255 

Portugal 



34 

e-mail: medinfo@bpl.co.uk 
(Royaume-Uni) 

Bio Products Laboratory Ltd 
Tel: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Reino Unido) 
 

Hrvatska 
Bio Products Laboratory Ltd 
Tel: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Ujedinjeno Kraljevstvo) 
 

România 
Bio Products Laboratory Ltd 
Tel: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Marea Britanie) 

Ireland 
Bio Products Laboratory Ltd 
Tel: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(United Kingdom) 

Slovenija 
Bio Products Laboratory Ltd 
Tel: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Združeno kraljestvo) 

Ísland 
Bio Products Laboratory Ltd 
Sími: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Bretland) 
 

Slovenská republika 
Bio Products Laboratory Ltd 
Tel: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Spojené kráľovstvo) 
 

Italia 
Bio Products Laboratory Ltd 
Tel: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Regno Unito) 
 

Suomi/Finland 
Bio Products Laboratory Ltd 
Puh/Tel: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Iso-Britannia) 
 

Κύπρος 
Bio Products Laboratory Ltd 
Τηλ: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Ηνωμένο Βασίλειο) 
 

Sverige 
Bio Products Laboratory Ltd 
Tel: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Storbritannien) 
 

Latvija 
Bio Products Laboratory Ltd 
Tel: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
(Lielbritānija)  

United Kingdom 
Bio Products Laboratory Ltd 
Tel: +44 (0) 20 8957 2255 
e-mail: medinfo@bpl.co.uk 
United Kingdom 

 
This leaflet was last revised in  
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET