VANQUORAL 100 Milligram Capsules, Soft

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

CICLOSPORIN

Pieejams no:

Teva Pharma B.V.

ATĶ kods:

L04AD01

SNN (starptautisko nepatentēto nosaukumu):

CICLOSPORIN

Deva:

100 Milligram

Zāļu forma:

Capsules, Soft

Receptes veids:

Product subject to prescription which may be renewed (B)

Ārstniecības joma:

Calcineurin inhibitors

Autorizācija statuss:

Authorised

Autorizācija datums:

2013-08-23

Lietošanas instrukcija

1

PACKAGE LEAFLET 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

VANQUORAL 10 MG CAPSULES, SOFT 
VANQUORAL 25 MG CAPSULES, SOFT 
VANQUORAL 50 MG CAPSULES, SOFT 
VANQUORAL 100 MG CAPSULES, SOFT 

CICLOSPORIN 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING 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 or pharmacist. 
- 
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 or pharmacist.
This includes any possible side effects 
not listed in this leaflet. See section 4 

WHAT IS IN THIS LEAFLET:  
1. 
What Vanquoral is and what it is used for 
2. 
What you need to know before you take Vanquoral 
3. 
How to take Vanquoral 
4. 
Possible side effects 
5. 
How to store Vanquoral 
6. 
Contents of the pack and other information 

1. 
WHAT VANQUORAL IS AND WHAT IT IS USED FOR 

WHAT VANQUORAL IS 
The name of your medicine is Vanquoral. It contains the active
substance ciclosporin. This belongs to a 
group of medicines known as immunosuppressive agents. These
medicines are used to lower the body’s 
immune reactions. 

WHAT VANQUORAL IS USED FOR AND HOW VANQUORAL WORKS 

  IF YOU HAVE HAD AN ORGAN TRANSPLANT, BONE
MARROW AND STEM CELL TRANSPLANTATION, the function of 
Vanquoral is to control your body’s immune
system. Vanquoral prevents rejection of transplanted 
organs by blocking the development of certain cells which would
normally attack the transplanted 
tissue. 

  IF YOU HAVE AN AUTOIMMUNE DISEASE, in which your body’s immune
response attacks your body’s own 
cells, Vanq

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vanquoral 100 mg Capsules, soft
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 100 mg ciclosporin.
Excipient(s) with known effect:
Each 100 mg soft capsule contains approximately 160 mg of anhydrous ethanol, 28.83 mg 70% sorbitol and 434.00 mg
macrogolglycerol hydroxystearate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft.
Opaque brown soft gelatin capsules (Oblong 20, approx. 24.7 x 9.9 mm) containing colourless to slightly yellowish
oily liquid, with printing the IVAX “hourglass” logo “100 mg”. 
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Transplantation indications
_Solid organ transplantation_
Prevention of graft rejection following solid organ transplantation.
Treatment of transplant cellular rejection in patients previously receiving other immunosuppressive agents.
_Bone marrow transplantation_
Prevention of graft rejection following allogeneic bone marrow and stem cell transplantation.
Prevention or treatment of graft-versus-host disease (GVHD).
Non-transplantation indications
_Endogenous uveitis_
Treatment of sight-threatening intermediate or posterior uveitis of non-infectious aetiology in patients in whom
conventional therapy has failed or caused unacceptable side effects.
Treatment of Behçet uveitis with repeated inflammatory attacks involving the retina in patients without neurological
manifestations.
_Nephrotic syndrome_
Steroid-dependent and steroid-resistant nephrotic syndrome, due to primary glomerular diseases such as minimal
change nephropathy, focal and segmental glomerulosclerosis, or membranous glomerulonephritis.
Vanquoral can be used to induce and maintain remissions. It can also be used to maintain steroid-induced remission,
allowing withdrawal of s