Modigraf 1mg granules sachets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Tacrolimus monohydrate

Dostopno od:

Astellas Pharma Ltd

Koda artikla:

L04AD02

INN (mednarodno ime):

Tacrolimus monohydrate

Odmerek:

1mg

Farmacevtska oblika:

Granules

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 08020200; GTIN: 5013346088491

Navodilo za uporabo

Modigraf because the active substance in Modigraf may stick to PVC.
Carefully open the prescribed number of sachets, e.g. with a pair of
scissors at the point indicated with an arrow.
Hold the opened sachet between thumb and index finger above the cup
with the open side of the sachet facing
downwards. Gently tap on the closed end of the sachet and pour the
contents of each sachet into the glass or cup
containing the water. Do not use any utensils or liquids to empty the
sachet. If you follow these instructions, you will
get the right amount of granules from the sachet. It is normal that
some granules stay behind; the sachet was
designed that way.
Stir, or swirl gently until the granules have been suspended
completely. The suspension can be drawn up with
a syringe or swallowed directly by the patient. The liquid has a sweet
taste. Rinse the glass or cup once with the
same amount of water and drink this, too. The liquid should be drunk
immediately after preparation.
IF YOU TAKE MORE MODIGRAF THAN YOU SHOULD
If you have accidentally taken too much Modigraf, contact your doctor
or nearest hospital emergency department
immediately.
IF YOU FORGET TO TAKE MODIGRAF
Do not take a double dose to make up for forgotten individual doses.
If you have forgotten to take your Modigraf, wait until it is time for
the next
dose, and then continue as before.
IF YOU STOP TAKING MODIGRAF
Stopping your treatment with Modigraf may increase the risk of
rejection
of your transplanted organ.
Do not stop your treatment unless your doctor tells you to do so.
If you have any further questions on the use of this medicine, ask
your
doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Modigraf reduces your body’s defence mechanism (immune system),
which will not be as good at fighting infections.
Therefore, you may be more prone to infections while you are taking
Modigraf.
Severe effects may occur, including allergic and anaphylactic
reactions (a very serious

Lastnosti izdelka

OBJECT 1
MODIGRAF 0.2MG GRANULES FOR ORAL SUSPENSION
Summary of Product Characteristics Updated 07-Aug-2015 | Astellas
Pharma Ltd
1. Name of the medicinal product
Modigraf 0.2 mg granules for oral suspension
Modigraf 1 mg granules for oral suspension
2. Qualitative and quantitative composition
MODIGRAF 0.2 MG GRANULES FOR ORAL SUSPENSION
Each sachet contains 0.2 mg tacrolimus (as monohydrate).
Excipient with known effect:
Each sachet contains 94.7 mg lactose (as monohydrate).
MODIGRAF 1 MG GRANULES FOR ORAL SUSPENSION
Each sachet contains 1 mg tacrolimus (as monohydrate).
Excipient with known effect:
Each sachet contains 473 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Granules for oral suspension.
White granules.
4. Clinical particulars
4.1 Therapeutic indications
Prophylaxis of transplant rejection in adult and paediatric, kidney,
liver or heart allograft recipients.
Treatment of allograft rejection resistant to treatment with other
immunosuppressive medicinal products
in adult and paediatric patients.
4.2 Posology and method of administration
This medicinal product should only be prescribed, and changes in
immunosuppressive therapy initiated,
by physicians experienced in immunosuppressive therapy and the
management of transplant patients.
Modigraf is a granular formulation of tacrolimus, for twice-a-day
administration. Modigraf therapy
requires careful monitoring by adequately qualified and equipped
personnel.
Posology
The recommended initial doses presented below are intended to act
solely as a guideline. Modigraf is
routinely administered in conjunction with other immunosuppressive
agents in the initial post-operative
period. The dose may vary depending upon the immunosuppressive regimen
chosen. Modigraf dosing
should primarily be based on clinical assessments of rejection and
tolerability in each patient individually
aided by blood level monitoring (see below under “Therapeutic drug
monitoring“). If clinical signs of
rejection are apparent, alterati