Astellas Pharma International B.V., Israel

Calcineurin Inhibitors, Immunosuppressant. Tacrolimus 0.5, 1, 3, 5 mg.
P.R. HARD CAPS.: 30, 50, 100.
Prophyl. of kidney transplant reject. init.
0.20 - 0.30 mg/kg/d once dly. in the
morning. Administ. should init. within 24
h. after the complet.of surgery.
Prophyl. of liver transplant reject. : init.
0.10 - 0.20 mg/kg/day once dly. in the
morning. Administ. should init. approx.
12-18 h. after the complet. of surgery
Dosage must. be ajust. individ. Once
dly, in the morning, on empty stomach
(at least 1 h. bef. or 2-3 h after a meal).
See lit.
Prophyl. of transplant reject. in adult
kidney or liver allograft recip. Tmt. of
allograft reject. resistant to tmt. with
other immunosuppres. med. in adult
kidney or liver allograft recip. pts.
C/I: Hypersens., hypersens. to other
macrolides.

Urinary Antispasmodic. Mirabegron 25 mg, 50 mg.
PROLONG REL. TABS.: 30×25, 50 mg.
Adult. (include. elder. pts.) 50 mg once
daily with/without food.
Sympt. tmt. of urgency, incr. micturition
freq. and/or urgency incont. as may occur
in adult pts. with OAB syndr.
C/I: Hypersens.

Antibiotics. Fidaxomicin 200 mg.
F.C. TAB.:20. 200 mg×2/d for 10d. See lit.
Tmt. of Clostridium difficile infec. (CDI) also known as C. difficile-assoc. diarrhoea (CDAD).
C/I:Hypersens.

Gonadotropin Releasing Hormone Analogues. Leuprorelin Acetate 7.5, 22.5, 45 mg.
PRE-FILLED SYR. (1 pwdr. for inj. + 1 solv. cyclic olefin copolymer): 1.
7.5 mg is admin. as a single SC inject. every month. The inject. sol. forms a solid med. product deliv. depot and provides cont. release of leuprorelin acetate for 1 month. 22.5 mg  is admin. as a single SC inject. every 3 mnths. The inject. sol. forms a solid med. product deliv. depot and provides cont. release of leuprorelin acetate over a 3 -month period. 45 mg is admin. as a single SC inject. every 6 mnths. The inject. sol. forms a solid med. product deliv. depot and provides cont. release of leuprorelin acetate over a 6 -month period. See lit.
Tmt. of hormone depend. advanced prostate cancer.
C/I: Use in women. Paed.  pts. Hypersens.  to leuprorelin acetate, to other GnRH agon. In pts. who prev. underwent orchiectomy (as with other GnRH agon., Leuprorelin Acetate does not result in further decr. of serum testoster. in case of surg. castration). As sole tmt. in prostate cancer pts. with spinal cord compres. or evidence of spinal metastases.

Antifungal. Micafungin (as Sodium) 50 mg, 100 mg.
GLASS VIAL( pwdr. for sol. for infus.): 1x10ml. Use in adult, adolesc. (≥ 16 yrs.), elderly, Bdy. wt. > 40 kg, Bdy. wt. ≤ 40 kg. Tmt. of invasive candidiasis:  100 mg/d*, Bdy. wt ≤ 40 kg:  2 mg/kg/d*. Tmt. of oesophageal candidiasis: 150 mg/d, Bdy. wt ≤ 40 kg : 3 mg/kg/d. Prophylax. of Candida infect.:  50 mg/d., Bdy. wt ≤ 40 kg: 1 mg/kg/day.  *If the pt’s. response is inadeq. , e.g. persist. of cultures/clin. cond.  does not improve, the dose may be incr.to 200 mg/d. in pts. wt.> 40 kg or 4 mg/kg/d in pts. ≤ 40 kg.
Adult., adolesc. ≥ 16 yrs. of age & elderly: Tmt.  of invasive candidiasis. Tmt.  of oesophageal  candidiasis in pts. for whom IV ther. is appropriate. Prophylaxis of Candida infec. in pts.  undergoing allogeneic haematopoietic stem cell transplant.. Child.  (includ.  neonates, adolesc. < 16 yrs. of age: Tmt. of invas. candidiasis. Prophylax.  of Candida infec.  in pts.  undergoing allogeneic haematopoietic stem cell transplant. The decision to use Micafungin should take into account a potential risk for the develop. of  liver. Micafungin should therefore only be used if other antifungals are not appropriate.
C/I: Hypersens.

Alkylating Agent. Bendamustine Hydrochloride 25 mg, 100 mg.
VIAL (PWDR. CONC. FOR SOL. FOR IFUS.):
1,5×100 mg, 5x25 mg.
For IV infus. over 30-60 min: Monother.
for CLL 100 mg/m² body surface area
1st day and 2nd ; every 4 weeks.
Monother. for indolent non-Hodgkin’s
lymph. refractory to rituximab 120 mg/
m² body surface area on 1st and 2nd;
every 3 weeks. Tmt. should be termin.
or delayed if leukocyte and/or platelet
values drop. to < 3,000/μl or < 75,000/
μl, respectively. Tmt. can be cont. after
leukocyte values have incr.to > 4,000/
μl and platelet values to > 100,000/μl.
See lit.
1st -line tmt. of CLL (Binet stage B or C) in
pt. for whom fludarabine comb.
chemother. is not appropriate. Indolent
non-Hodgkin’s lymph. as monother. in pts.,
who have progressed during or within 6
months follow. tmt. with rituximab or a
rituximab contain.regimen.
C/I: Hypersens., lact.; Severe hep. impair.
(serum bilirubin > 3.0 mg/dl); Jaundice;
Sev. bone marrow suppres. and sev.
blood count alter. (LEU and/or PLT
values dropped to < 3,000/μl or <
75,000/μl, respectively); Major surgery <
30 days before start of tmt.; Infect.,
especially invol. leukocytopenia; Yellow
fever vaccin.