TACROGRAF tacrolimus 5 mg capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tacrolimus monohydrate, Quantity: 5.112 mg (Equivalent: tacrolimus, Qty 5 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

tacrolimus monohydrate

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: hypromellose; lactose monohydrate; croscarmellose sodium; magnesium stearate; Gelatin; purified water; sodium lauryl sulfate; brilliant blue FCF; phloxine B; titanium dioxide; quinoline yellow; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; ethanol absolute

Administration route:

Oral

Units in package:

100 capsule, 50 capsule

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adjunct to liver, kidney, lung or heart allograft transplantation in adults and children.

Product summary:

Visual Identification: No 4 hard gelatin capsules with teal opaque body and cap, printed "SAL" on cap and "722" on body in black ink; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2011-08-18

Patient Information leaflet

TACROGRAF CAPSULES
_Tacrolimus (as monohydrate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
TACROGRAF capsules. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
TACROGRAF against the
benefits this medicine is expected
to have for you.
If you have any concerns about
using TACROGRAF ask your
doctor or pharmacist.
Keep this leaflet with your
medicine. You may need to read
it again.
WHAT TACROGRAF IS
USED FOR
You have been given a new
transplanted liver or kidney, lung
or heart from another person
because your own was no longer
healthy. Your body recognises
that this new organ is different
from your organs and will try to
reject it by attacking it in the
same way that it would attack
germs that enter your body. This
could make you become ill again.
TACROGRAF stops this attack;
it is very important to take
TACROGRAF given to you by
your doctor regularly so that your
new liver, kidney, lung or heart
will not be attacked or rejected.
If you have been taking other
medicines for this purpose, but
are still feeling unwell, your
doctor may change your
treatment and begin giving you
TACROGRAF.
TACROGRAF is an
immunosuppressive agent.
Your doctor may have prescribed
TACROGRAF for another
reason.
Ask your doctor if you have any
questions about why this
medicine has been prescribed for
you.
BEFORE YOU USE
TACROGRAF
_When you must not use it _
Do not use TACROGRAF if you
have an allergy to
TACROGRAF, other macrolides
(these are antibiotics of the
erythromycin family - trade
names are Eryc, EES, Klacid,
Zithromax, Rulide and Biaxsig)
or any of the ingredients
contained in the capsules. See
Product Description at the end of
this leaflet for a list of
ingredients.
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty
breathing
•
swelling of the face, lips,
tongu

Summary of Product characteristics

1
AUSTRALIAN PI – TACROGRAF (TACROLIMUS AS MONOHYDRATE)
CAPSULES
1
NAME OF THE MEDICINE
Tacrolimus (as monohydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TACROGRAF 0.5mg hard gelatin capsules contain tacrolimus monohydrate
equivalent to tacrolimus
0.5mg.
TACROGRAF 1mg hard gelatin capsules contain tacrolimus monohydrate
equivalent to tacrolimus
1mg.
TACROGRAF 5mg hard gelatin capsules contain tacrolimus monohydrate
equivalent to tacrolimus
5mg.
TACROGRAF capsules contain sugars as lactose monohydrate. For the full
list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
TACROGRAF 0.5mg hard gelatin capsules have a red opaque cap and red
opaque body, printed SAL
on cap and 720 on body in black ink.
TACROGRAF 1mg hard gelatin capsules have a green opaque cap and green
opaque body, printed
SAL on cap and 721 on body in black ink.
TACROGRAF 5mg hard gelatin capsules have a teal opaque cap and teal
opaque body, printed SAL on
cap and 722 on body in black ink.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
TACROGRAF capsules are indicated for use as an adjunct to liver,
kidney, lung or heart allograft
transplantation in adults and children.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
The dosage recommendations given below for oral and intravenous
administration should act as a
guideline. Tacrolimus doses should be adjusted according to individual
patient requirements.
If allograft rejection or adverse events occur, alteration in the
immunosuppressive regimen should
be considered.
METHOD OF ADMINISTRATION
It is recommended that the oral daily dose be taken in two divided
doses, in the morning and in the
evening.
The capsules should generally be taken on an empty stomach or at least
1 hour before or 2 to 3
hours after a meal to achieve maximal absorption (See SECTION 5.2 –
PHARMACOKINETIC PROPERTIES -
ABSORPTION).
The capsules should be swallowed with fluid, preferably water.
Oral administration of tacrolimus should commence as soon as
practicable. In some liver
transplantation patients, t