PROGRAF XL tacrolimus 3 mg prolonged-release capsules blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

tacrolimus, Quantity: 3 mg

Διαθέσιμο από:

Astellas Pharma Australia Pty Ltd

Φαρμακοτεχνική μορφή:

Capsule

Σύνθεση:

Excipient Ingredients: hypromellose; ethylcellulose; lactose monohydrate; magnesium stearate; titanium dioxide; iron oxide yellow; iron oxide red; Gelatin; sodium lauryl sulfate; hyprolose; butan-1-ol; purified water; industrial methylated spirit; simethicone; lecithin; ethanol; Shellac; strong ammonia solution; sulfuric acid

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

50

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

Indicated for use as an adjunct to liver, kidney, lung or heart allograft transplantation in adults and children.

Περίληψη προϊόντος:

Visual Identification: oblong capsules with an orange cap imprinted with "3 mg" and an orange body imprinted with "637"; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2019-07-19

Αρχείο Π.Χ.Π.

1
AUSTRALIAN PRODUCT INFORMATION PROGRAF
® (TACROLIMUS) CAPSULES AND CONCENTRATED INJECTION
PROGRAF
® XL (TACROLIMUS) PROLONGED-RELEASE CAPSULES
1
NAME OF THE MEDICINE
Tacrolimus
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PROGRAF CAPSULES
Each 0.5 mg capsule contains 0.5 mg tacrolimus
Each 1 mg capsule contains 1 mg tacrolimus
Each 5 mg capsule contains 5 mg tacrolimus
Contains: lactose
The printing ink used to mark the capsule contains trace amounts of
soya lecithin
For the full list of excipients, see Section 6.1 List of excipients.
PROGRAF XL PROLONGED-RELEASE CAPSULES
Each 0.5 mg prolonged-release capsule contains 0.5 mg tacrolimus
Each 1 mg prolonged-release capsule contains 1 mg tacrolimus
Each 3 mg prolonged-release capsule contains 3 mg tacrolimus
Each 5 mg prolonged-release capsule contains 5 mg tacrolimus
Contains: lactose
The printing ink used to mark the capsule contains trace amounts of
soya lecithin
For the full list of excipients, see Section 6.1 List of excipients.
PROGRAF CONCENTRATED INJECTION
Each mL of Concentrated Injection contains 5 mg tacrolimus.
Contains: ethanol
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
PROGRAF CAPSULES
Capsule
Supplied as:
PROGRAF capsules 0.5 mg: light yellow hard gelatine capsules with
‘0.5 mg’ and ‘[f]607’ printed in red.
PROGRAF capsules 1 mg: white, hard gelatine capsules with '1 mg' and
'[f]617' printed in red.
2
PROGRAF capsules 5 mg: greyish-red, hard gelatine capsules with '5 mg'
and '[f]657' printed in white.
PROGRAF XL PROLONGED-RELEASE CAPSULES
Prolonged release capsule
Supplied as:
PROGRAF XL 0.5 mg prolonged-release capsules: oblong capsules with a
light yellow cap imprinted
with “0.5 mg” and an orange body imprinted with “
647”.
PROGRAF XL 1 mg prolonged-release capsules: oblong capsules with a
white cap imprinted with
“1 mg” and an orange body imprinted with “
677”.
PROGRAF XL 3 mg prolonged-release capsules: oblong capsules with an
orange cap imprinted with
“3 mg” and an oran