Nuwiq

Nchi: Umoja wa Ulaya

Lugha: Kiingereza

Chanzo: EMA (European Medicines Agency)

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
07-11-2022
Tabia za bidhaa Tabia za bidhaa (SPC)
07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma (PAR)
17-01-2018

Viambatanisho vya kazi:

simoctocog alfa

Inapatikana kutoka:

Octapharma AB

ATC kanuni:

B02BD02

INN (Jina la Kimataifa):

simoctocog alfa

Kundi la matibabu:

Blood coagulation factors

Eneo la matibabu:

Hemophilia A

Matibabu dalili:

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).Nuwiq can be used for all age groups.

Bidhaa muhtasari:

Revision: 13

Idhini hali ya:

Authorised

Idhini ya tarehe:

2014-07-22

Taarifa za kipeperushi

                                45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE USER
NUWIQ 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NUWIQ 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NUWIQ 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NUWIQ 1500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NUWIQ 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NUWIQ 2500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NUWIQ 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NUWIQ 4000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
simoctocog alfa (recombinant human coagulation factor VIII)
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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Nuwiq is and what it is used for
2.
What you need to know before you use Nuwiq
3.
How to use Nuwiq
4.
Possible side effects
5.
How to store Nuwiq
6.
Contents of the pack and other information
1.
WHAT NUWIQ IS AND WHAT IT IS USED 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 USE 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 
                                
                                Soma hati kamili

Tabia za bidhaa

                                1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Nuwiq 250 IU powder and solvent for solution for injection
Nuwiq 500 IU powder and solvent for solution for injection
Nuwiq 1000 IU powder and solvent for solution for injection
Nuwiq 1500 IU powder and solvent for solution for injection
Nuwiq 2000 IU powder and solvent for solution for injection
Nuwiq 2500 IU powder and solvent for solution for injection
Nuwiq 3000 IU powder and solvent for solution for injection
Nuwiq 4000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nuwiq 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU human coagulation factor VIII
(rDNA), simoctocog alfa.
Nuwiq 250 IU contains approximately 100 IU/mL of human coagulation
factor VIII (rDNA),
simoctocog alfa after reconstitution.
Nuwiq 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU human coagulation factor VIII
(rDNA), simoctocog alfa.
Nuwiq 500 IU contains approximately 200 IU/mL of human coagulation
factor VIII (rDNA),
simoctocog alfa after reconstitution.
Nuwiq 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU human coagulation factor VIII
(rDNA), simoctocog alfa.
Nuwiq 1000 IU contains approximately 400 IU/mL of human coagulation
factor VIII (rDNA),
simoctocog alfa after reconstitution.
Nuwiq 1500 IU powder and solvent for solution for injection
Each vial contains nominally 1500 IU human coagulation factor VIII
(rDNA), simoctocog alfa.
Nuwiq 1500 IU contains approximately 600 IU/mL of human coagulation
factor VIII (rDNA),
simoctocog alfa after reconstitution.
Nuwiq 2000 IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU human coagulation factor VIII
(rDNA), simoctocog alfa.
Nuwiq 2000 IU contains approximately 800 IU/mL of human coagulation
factor VIII (rDNA),
simoctocog alfa after reconstitution.
Nuwiq 2500 IU powder and solvent for solution for injection
Ea
                                
                                Soma hati kamili

Bidhaa zinazofanana

Viambatanisho vya kazi simoctocog alfa

simoctocog alfa

ATC kanuni B02BD02

B02BD02

Mzalishaji au wazalishaji wadogowadogo Octapharma AB

Octapharma AB

INN (Jina la Kimataifa) simoctocog alfa

simoctocog alfa

Nyaraka katika lugha zingine

Taarifa za kipeperushi Taarifa za kipeperushi Kibulgaria 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kibulgaria 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kibulgaria 17-01-2018
Taarifa za kipeperushi Taarifa za kipeperushi Kihispania 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kihispania 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kihispania 17-01-2018
Taarifa za kipeperushi Taarifa za kipeperushi Kicheki 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kicheki 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kicheki 17-01-2018
Taarifa za kipeperushi Taarifa za kipeperushi Kidenmaki 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kidenmaki 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kidenmaki 17-01-2018
Taarifa za kipeperushi Taarifa za kipeperushi Kijerumani 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kijerumani 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kijerumani 17-01-2018
Taarifa za kipeperushi Taarifa za kipeperushi Kiestonia 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kiestonia 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiestonia 17-01-2018
Taarifa za kipeperushi Taarifa za kipeperushi Kigiriki 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kigiriki 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kigiriki 17-01-2018
Taarifa za kipeperushi Taarifa za kipeperushi Kifaransa 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kifaransa 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kifaransa 17-01-2018
Taarifa za kipeperushi Taarifa za kipeperushi Kiitaliano 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kiitaliano 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiitaliano 17-01-2018
Taarifa za kipeperushi Taarifa za kipeperushi Kilatvia 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kilatvia 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kilatvia 17-01-2018
Taarifa za kipeperushi Taarifa za kipeperushi Kilithuania 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kilithuania 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kilithuania 17-01-2018
Taarifa za kipeperushi Taarifa za kipeperushi Kihungari 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kihungari 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kihungari 17-01-2018
Taarifa za kipeperushi Taarifa za kipeperushi Kimalta 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kimalta 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kimalta 17-01-2018
Taarifa za kipeperushi Taarifa za kipeperushi Kiholanzi 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kiholanzi 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiholanzi 17-01-2018
Taarifa za kipeperushi Taarifa za kipeperushi Kipolandi 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kipolandi 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kipolandi 17-01-2018
Taarifa za kipeperushi Taarifa za kipeperushi Kireno 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kireno 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kireno 17-01-2018
Taarifa za kipeperushi Taarifa za kipeperushi Kiromania 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kiromania 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiromania 17-01-2018
Taarifa za kipeperushi Taarifa za kipeperushi Kislovakia 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kislovakia 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kislovakia 17-01-2018
Taarifa za kipeperushi Taarifa za kipeperushi Kislovenia 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kislovenia 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kislovenia 17-01-2018
Taarifa za kipeperushi Taarifa za kipeperushi Kifinlandi 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kifinlandi 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kifinlandi 17-01-2018
Taarifa za kipeperushi Taarifa za kipeperushi Kiswidi 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kiswidi 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiswidi 17-01-2018
Taarifa za kipeperushi Taarifa za kipeperushi Kinorwe 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kinorwe 07-11-2022
Taarifa za kipeperushi Taarifa za kipeperushi Kiaisilandi 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kiaisilandi 07-11-2022
Taarifa za kipeperushi Taarifa za kipeperushi Kroeshia 07-11-2022
Tabia za bidhaa Tabia za bidhaa Kroeshia 07-11-2022
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kroeshia 17-01-2018

Tafuta arifu zinazohusiana na bidhaa hii

Taadhari Nuwiq simoctocog alfa

Nuwiq simoctocog alfa

Tazama historia ya hati

Historia ya nyaraka Historia ya nyaraka

Nuwiq