Novartis Israel Ltd

Bisphosphonate. Zoledronic Acid 5 mg / 100 ml.
SOL. FOR INFUS: 1 x 100 ml.
Single I.V. infus. 5 mg x 1 yr. See lit.
Tmt. Paget’s dis. of bone. Tmt. osteoporos.
post-menopaus. women, men at incr. risk
fracture, incl. recent low trauma hip
fracture. Tmt./prevent. glucocorticoidinduc.
osteoporos. Prevent. post
menopaus. osteoporos. in women when
biphosphonate ther. indicat.
C/I: Hypersens. to excips. or any
bisphosphonates, hypocalcem., pregn.,
lact., sev. ren. impair. (CLcr<35 mL/min).

Protein Kinase Inhibitor. Everolimus 2.5, 5, 10 mg.
TABS: 30 x 2.5 mg, 5 mg, 10 mg. Tmt. to
be initiated by physician experienced
in the use of anticancer ther. Orally
once dly., at the same time ev. d. See
lit.
Tmt. pts. with advanced ren. cell
carcinoma aft. fail. of tmt. with sunitinib or
sorafenib. Tmt. pts. with SEGA assoc. with
tuberous sclerosis complex who req. ther.
intervent.
but not candidates for curative surg.
resect. Effect. based on analys. of change
in SEGA vol. Clin. benefit in improvement
dis.-relat,. sympts/increase in overall
survival has not been demonstrat. Tmt.
progress. neuroendocrine tumors
pancreat. origin in pts. with unresect.,
locally advanced/metastat. dis. Safety/
effectivenss in tmt. carcinoid tumors have
not been established. Tmt. of horm.
receptor-pos., HER2/neu neg. advanc.
breast canc. in combi. with exemestane in
postmen. women w/o symp. visceral dis.
after recur. or progress. following nonsteroid.
aromat. inh.. Tmt. of adult pts.
with renal angiomyolipoma and tuberous
sclerosis comp., nor req. immediate surg.
Effectiv. of the drug in tmt. of renal
angiomyolipoma based on an analysis of
durable obj. respons. in pts. treat. for a
median of 8.3 mnths. Further follow-up of
pts. is req. to determine long-term
outcomes.
Tmt. of unresect., local. advanc. /metastat.,
well-different. (Grade 1/ Grade 2) nonfunct.
neuroendocrine tumour. of GI or
lung origin in adults with progress. dis.
C/I: Hypersens. to active substances,
other rapamycin derivs., excips.

CGRP, Human Monoclonal Antibody. Erenumab 70 mg.
PRE-FILL. SYR (sol. for S.C. inj.): 1
PRE- FIL. PEN (sol. for S.C. inj.): 1
Tmt. is intend. for pts. with at least 4 migraine days per month when initiat. tmt. with erenumab.
The recomm. dose is 70 mg erenumab every 4 wks. Some pts. may benefit from a dose of 140 mg every 4 wks.
Each 140 mg dose is given as two S.C. inj. of 70 mg. See lit.
Tmt. should be initiat. by physicians experienced in the diagnosis and tmt. of migraine.
C/I: Hypersens.

Pyrimidine Analogues. Cytarabine 20 mg/ml, 50 mg/ml.
VIAL (ready for use): 1 x 100 mg (5 ml);
500 mg (10 ml); 1,000 mg (20 ml), 2,000
mg (40 ml). See lit.
Neoplastic dis.
C/I: Known hypersens. to drug, bone
marrow suppress.

Antimetabolite. Nelarabine 5 mg/ml.
VIALS: 6 x 50 ml x 250 mg/vial. Only
under vis. of physician experienced in
cytotox. agents. Adults and adolesc.
(16 yrs and older): 1,500 mg/m2 I.V.
over 2 hrs on days 1, 3 and 5. Repeat
every 21 days. Child and adolesc. (21
yrs and younger): 650 mg/m2 I.V. over 1
hr. dly for 5 consec. days. Rpt. aft. 21
days.
Tmt. T-ALL, T-LBL whose dis. not respond./
relapsed foll. tmt. with at least 2
chemother. regimens. Informat. based on
limited data due to small pt. populat.
C/I: Hypersens.

Carbonic Anhydrase Inhibitor, Nonselective β-Blocker. Brinzolamide 10 mg/ml, Timolol Maleate 5 mg/ml.
BOTTLE: 5 ml. 1 dr ×2/d in conjunctival sac of the affected eye(s). See lit.
Decrease of intra-ocular pressure (IOP) in adult pts. with open-ang. glauc. or ocular hypertens. for whom monother. provides insuffic. IOP reduct.
C/I: Hypersens. Hypersens. to other β-block. Hypersens. to sulphonamides.
Reactive airway dis. include. bronch. asthma/history of bronch. asthma, or severe COPD. Sinus bradycardia, sick sinus synd., sino-atrial block, 2^nd/3^rd degree AV block not control. with pace-maker. Overt CF, cardiogenic shock. Severe allergic rhinitis. Hyperchloraemic acidosis. Sev. renal impair.