AbbVie Biopharmaceuticals Ltd

Cannabinoids, Specific Immunoglobulin. Palvizumab 50 mg, 100 mg.
VIAL(PWDR) + DILUENT: 1 X 50 mg+ 4 ml
diluent, 100 mg + 10 ml diluent.
15 mg/kg by I.M. inject. 1 x mthly
during course of RSV season. See lit.
Preven. of serious lower resp. tract dis.
requir. hospitalis. caused by RSV in child.
at high risk for RSV dis.:
Child. born at 35 wks. of gestation or less
and less than 6 mths. of age at the onset
of the RSV season. Child. less than 2 yrs. of age and requir.
tmt. for bronchopulm. dysplasia within
the last 6 mths.
Children less than 2 yrs. of age and with
haemodyn. signif.congen. heart dis.
C/I: Hypersens. to palvizumab or any
compon. of formula, or other humanized
monoclonal antibodies.

Decarboxylase Inhibitor, Dopamine Precursor. Carbidopa (as monohydrate) 5 mg/ml, Levodopa 20 mg/ml.
INTEST. GEL (cassettes): 7 x 100 ml.
Total dly dose div. into 3 individ.
adjust.
doses: Morn. bolus dose, cont. maint.
dose & extra bolus doses. Aft. initial
dose set. fine adjusts. of all 3 settings
to be carried out over a few wks. If
medically. justified, admin. dur. night.
Tmt. advanced levodopa respons.
Parkinson’s dis. with severe motor flucts.
and severe hyper-dyskines. when avail.
combinats. Parkinson products not given
satisfact. results. +tive test clin. response to
duodopa admin. via temp. nasoduoden.
tube reqd. bef. perm. tube insert.
C/I: Hypersens. to levodopa, carbidopa,
any excips. Narrow angle glauc., severe
hepat./ren. insuffic., severe heart fail,
severe card. arrhythm. Acute stroke,
non-select MAOIs, select MOA type A
inhibits. not to be given concom. & to be
withdrawn at least 2 wks bef. initiat. ther.
Condit. in which adrenergics are
contraind., e.g.
pheochromocyt., hyperthyroid.,
Cushing’s synd.
Pts. with suspic. undiagnos. skin lesions
or a hist. of melanoma.

TNF Blocking Agent. Adalimumab 20 mg / 0.2 ml, 40 mg / 0.4 ml, 80 mg / 0.8 ml.
PRE-FILLED SYRINGE: 2 (20 mg/0.2 mL, 40mg/0.4ml, 80 mg/0.8 mL).
PRE-FILLED PEN: 2. (40mg /0.4ml, 80 mg/0.8 mL).
VIAL (with adaptor): 2. S.C. Dosage must be adjust. individ. accord. to pt. med. cond.
RA: In comb. with methotrexate: The tmt. of moder.- sev., active RA in adult pts.
when the response to dis.-modif. anti-rheumatic drugs include. methotrexate has been inadequate.
The tmt. of severe, active and progres. RA in adults not prev. treated with methotrexate. Can be given as monother. in case of intoler. to methotrexate or when continued tmt. with methotrexate is inapprop.
This drug has been shown to reduce the rate of progres. of joint damage as measured by X-ray and to improve physic. funct., when given in comb. with methotrexate.
Juvenile idiopat. arthritis Polyarticular juvenile idiopat. arthritis: In comb. with methotrexate- tmt. of active polyarticular juvenile idiopat. arthritis, in pts. from the age of 2 yrs. who have had an inadequate response to one or more DMARDs. Adalimumab can be given as monother. in case of intoler. to methotrexate or when continued tmt. with methotrexate is inapprop. (for the efficacy in monother.). Adalimumab has not been studied in pts. aged less than 2 yrs.
Axial spondyloarthritis, Ankylosing spondylitis (AS): Tmt. of adults with sev. act.  ankylos. spondylitis who have had an inadequate response to convent. ther.
Axial spondyloarthritis without radiographic evidence of AS: Tmt. of adults with severe axial spondyloarthritis without radiograp. evidence of AS, but with object. signs of inflame. by radiolog. and/or lab.tests includ. MRI and serum CRP levels, who have had an inadequate response to, or are intoler. to, non-steroidal anti-inflam. drugs.
Psoriatic arthritis: Tmt. of active and progres. psoriat. arthritis in adult. when the response to previous dis.-modif. anti-rheum. drug ther. has been inadequate. Adalimumab has been shown to reduce the rate of progres. of periph. joint damage as measured by X-ray in pts. with polyarticular symmetr. subtypes of the dis. and to improve physic. funct.
Psoriasis: Tmt. of moder.- sev. chron. plaque psoriasis in adult pts. who are candidates for systemic ther.
Ped. plaque psoriasis: Tmt. of sev. chron. plaque psoriasis in child. and adolesc. from 4 yrs. of age who have had an inadequate response to or are inappropr. candidates for topical ther. and phototherapies. Hidradenitis suppurativa (HS): Tmt. of active moder.- sev. HS (acne inversa) in adult, adolesc. from 12 yrs. of age with an inadequate response to convent. syst. HS ther.
Crohn’s dis.: Indic. for reduc. signs and sympt. and induc. and maintain. clin. remiss. in adult pts. with moder. - sev. active Crohn’s dis. who have had an inadequate response to conven. ther. The drug is indic. for reduc. signs and sympt. and induc. clin. remiss. in these pts. if they have also lost response to or are intoler. to infliximab.
Ped.Crohn's dis.: Tmt. of moder. – sev. active Crohn's dis. in ped. pts. (from 6 yrs. of age) who have had an inadequate response to convent. ther. include. prim. nutrition ther. and corticosteroid, and/or an immunomodulator, or who are intoler. or have contraindic. for such ther.
Ulcer. colit.: Tmt. of moder.- sev. active ulcer. colit. in adult pts. who have had an inadequate response to conven. ther.  include. corticoster. and 6-mercaptopurine or azathioprine, or who are intoler. to or have med. contraind. for such therap.
Enthesitis-related arthritis: Tmt. of active enthesitis-related arthritis in pts., 6 yrs. of age and older, who have had an inadequate response to, or who are intoler. of conven.  ther.
Uveitis: Tmt. of non-infec. intermediate, posterior and panuveitis in adult pts. who have had an inadequate response to corticosteroid., in pts. in need of corticosteroid sparing, or in whom corticosteroid tmt. is inappropriate.
Intestinal Behcet's dis.: Tmt. of intestinal Behcet’s dis. in pts. who have had an inadequate response to convent. ther.
C/I: Hypersens. Active tuberc., other severe  infec. such as sepsis, and opportun. infec. Moder. - severe HF(NYHA class III/IV).

Protease Inhibitors. Lopinavir 100 mg, 200 mg, 80 mg/ml, Ritonavir 25 mg, 50 mg, 20 mg/ml.
F.C. TABS: 120 x 200 / 50 mg; 60 x 100 / 25 mg.
ORAL SOL.: 60 ml x 80 / 20 mg/ml.
Adult: 400 mg/100 mg (2 tabs of 200/50) 2 x dly with/out food; or 5 ml soln. 2 x dly with food.
Child: 6 mths-18 yrs: Calc. acc. to weight: <15 kg: 12/3 mg/kg; >15-40 kg: 10/2.5 mg/kg, both 2 x dly. Calc. acc. to BSA: See lit. Should not exceed recommend. adult dose. Dosage adjustment according to presc. info.
In comb. with other antiretroviral agents for HIV-1 infect.
C/I: Pts. with prev. demonstrat. clinical.  signific. hypersens. (e.g., toxic epiderm. necrolysis, Stevens-Johnson syndr., erythema multiforme, urticaria, angioedema) to any of its ingred., includ. ritonavir. Concom. use with drugs that are highly dependent on CYP3A for clear. and for which elevated plasma conc. are assoc. with serious and/or life-threat. react. (e.g. alfuzosin, ranolazine, dronedarone, colchicine, lurasidone, pimozide dihydroergotamine, ergotamine, methylergonovine, cisapride, elbasvir/grazoprevir, lovastatin, simvastatin, lomitapide, sildenafil -when used for the tmt. of pulm. arterial hyperten., triazolam, oral. admin. midazolam).
Concom. use with drugs that are potent CYP3A induc. where signific. reduced lopinavir plasma conc. may be assoc. with the potential for loss of virologic response and possible resistance and cross-resist. (e.g. Rifampin, St. John's Wort -hypericum perfor.) See lit.

GnRH Agonist. Leuprorelin Acetate 11.25 mg.
PREFILLED DUAL CHAMBER SYRINGE
(PDS): 1 x 3.75 mg, 11.25 mg/vial.
3.75 mg mthly.; 11.25 mg/vial: every 3
mths. Both I.M. or S.C. See lit.
Prostat. carcinoma, endometrios., uterine
fibroids (for up to 6 mths.). Tmt breast
cancer in pre/peri-menopaus. women in
whom hormone ther. is specified.
C/I: Hypersens. to the product or similar
nonapeptides; Anaphylaxis; Undiagn.
abnorm. vag. bleed.; Pregn.; Lact.
Additionaly, the 11.25 mg formulation:
pts follow. an orchiectomy.

GnRH Agonist. Leuprorelin Acetate 3.75 mg.
PREFILLED DUAL CHAMBER SYRINGE
(PDS): 1 x 3.75 mg, 11.25 mg/vial.
3.75 mg mthly.; 11.25 mg/vial: every 3
mths. Both I.M. or S.C. See lit.
Prostat. carcinoma, endometrios., uterine
fibroids (for up to 6 mths.). Tmt breast
cancer in pre/peri-menopaus. women in
whom hormone ther. is specified.
C/I: Hypersens. to the product or similar
nonapeptides; Anaphylaxis; Undiagn.
abnorm. vag. bleed.; Pregn.; Lact.
Additionaly, the 11.25 mg formulation:
pts follow. an orchiectomy.