Pharmacological Index

General Anesthetic. Isoflurane 100%.
LIQ FOR INH: 6 X 100 ml. Inspired
conc. 1.5-3.0% produce surg. anesth. in
7-10 mins. See lit.
Induct. and maint. gen. Anesthes.
C/I: Hypersens. to Isoflurane or other
halogenated anaesthetics,
pts with known or susp. genetic
susceptib. to malignant hyperthermia.

Anesthetic. Chloroprocaine hydrochloride 10 mg/ml.
Sol for intrathecal inj.10X5ml: Dose to be establ. on an indiv. basis taking  into consider. patient's phys. condit. and the concomitant medic. products. Duration of action is dose-dependent. Max. recomm. dose is 50 mg. See lit.
Spinal anaesth. in adlts where planned surg. proced. should not exceed 40 min.
C/I:Hypersens. Gral. and specific C/I to spinal anaesth. regardless of the local anaesthetic used, should be taken into account (e.g. decompens. cardiac insuffic., hypovolemic shock….)• IV regional anaesth. (anesthetic agent is introduc. into limb and allowed to set in while tourniquets retain the agent within the desired area)
• serious probl. with cardiac conduction• severe anaemia

Sugammadex 100 mg/ml.
VIALS: 10 x 2 ml, 5 ml. Dose depends on
level of neuromusc. block induced by
rocuronium/vecuronium.

General Anesthetic. Propofol 10 mg/ml.
VIALS: 50 ml, 100 ml x 10 mg/ml. See lit.
Induc. and mainten. of gener.
anaesthesia In adults and child. > 1 m.
Sedat. Of ventilated pts.> 16 yrs. Of age
In the intens. care unit. Sedat. for
diagnos. and surg. proced., alone or in
comb. With local or regional anaesthesia
in Adults & children > 1 mnth.
C/I: Hypersens. to the active substance
or to any of the excipients. Pts. WITH
hypersens. to peanut or soya. Pts. of 16
yrs. of age or younger for sedation in
intens. care.

General Anesthetic. Propofol 20 mg/ml.
VIALS (emuls. for I.V. inject.): 50 ml, 100
ml. See lit.
Induct. and mainten. of general
anesthesia in adult. &child. > 3 yrs.
Sedat. of ventilated pts. >16 years of age
in the intens. care unit. Sedat. for diagn.
and surg. procedures, alone or in comb.
with local or regional anaesthesia in
adult/child. > 3 years.
C/I: Hypersens., to the active substance
or To any of the excipients. Pts. with
hypersens. to peanut or soya. Pts. of 16
yrs. of age or younger for sedation in
intens. care.

Non-Depolarising Muscle Relaxant. Rocuronium Bromide 10 mg/ml.
VIALS: (I.V. Soln): 12 x 50 mg (5 ml). See
lit.
Neuromusc. agent for rapid intubat.

Anticholinergic agent. Atropine Sulphate 1 mg/ml.
AMP. (sol. for IM, IV inj.): 5×1ml. Pre-anesthet. med.: Adults: 0.3-0.6 mg by IV inj. immed. before the anesthes. induct. or by IM inj. 30-60 min. before the induc.
Child.: 0.02 mg/kg (max. dose 0.6 mg).
Tmt. of sinus bradycard.: 0.3 and 1.0 mg IV.
Antidote in poison. by organophosphorus:
Adult.: 2 mg (IM or IV, taking into account the sever. of the poison.) every 5-10 min., until the skin becomes red and dry, the pupils dilate and tachycard. appears.
Child.: The 0.02 mg/kg.
Preanesthetic medication to decrease excessive salivation and secretions of the respiratory tract. Treatment of sinus bradycardia, particularly if complicated by hypotension.
Antidote in poisoning by organophosphorus.
C/I: Hypersens. Clos. ang. glauc., esophag. reflux, pyloric stenosis, GI obstruct., ulcerat. colit., prostat. hypertrophy, paralytic ileus, intest. atony.

Alkylating Agent. Calcium Folinate 10 mg/ml.
VIALS (sol. for inj.): 1 x 100 mg/10 ml, 200 mg/20 ml, 500 mg/50 ml, 1000 mg/100 ml.
I.V./I.M. only. If use I.V: No more than
160 mg/min, diluted with 0.9% sod.
chlor. sol. or 5% glucose sol. See lit.
To diminish the toxic. and counteract the
action of folic acid antagonists in
cytotoxic ther. As Leucovorin-Fluorouracil
chemotherapy comb. for cancer tmt.
C/I: Hypersens., pernicious anem., other
anem. due to B12 defic.

Iron Chelating Agent. Deferasirox 125mg, 250 mg, 500 mg.
Dispers. tabs. X 28.Transfusional iron overload: recomm. initial daily dose is 20 mg/kg body weight.
Non-transfusion-dependent thalassemia syndromes: recomm. initial daily dose is 10 mg/kg body weight. 
Chron. iron overload caused by blood transfus. (transfusional haemosiderosis) in ault and paed pts. (aged 2 years and over).
Chron. iron overload in pts with non-transfus.-depend. thalassaemia syndr. aged 10 years and older.
Chelat. ther. should only be init. when evident iron overload (liver iron concentr. [LIC] ≥5 mg Fe/g dry weight [dw] or serum ferritin consist. >800 μg/l). LIC is the preferred method of iron overload determin.
C/I: Hypersens. to the act. sub. or any excip. Combin. with other iron chelator therap. Pts with estim.creatinine clear. <60 ml/min. See lit.

Chelating Agent. Deferoxamine Mesylate 0.5 g.
VIALS: 10 x 500 mg. I.M. inject., I.V./S.C.
infus: 20-60 mg dly. See lit.
Chronic iron overload; acute iron
poisoning; diagn. test for iron overload,
chron. alumin. overload in renal fail. in
maint. dialysis, aluminum-related bone
dis., dialysis enceph., anem. Diagnosis iron
overload.
C/I: Hypersens., pregn., lact.

Sympathomimetic. Epinephrine 0.3 mg /0.3 ml.
AUTO-INJECTOR: (for intramusc. use for
immediate self-admin.) Single units.
Delivers a single dose of 0.3 mg for
adults and child over 30 kg.
Severe allerg. react. (anaphylaxis) to
hymenoptera stings, foods and other
allergens and in life threatening
situations
caused by asth. attack.
C/I: See lit. (In life-threat. sit. no
absolute C.I.).

Sympathomimetic. Epinephrine 0.15 mg / 0.3 ml.
AUTO-INJECTOR: (for intramusc. use for
self-admin.) Single unit. Delivers a
single dose of 0.15 mg as support. ther.
Child (over 15 kg): 0.01 mg/kg bdy. wt.
Severe allerg. react. (anaphylaxis) to
hymenoptera stings, foods and other
allergens and in life threat. situations
caused by asth. attack.
C/I: See lit. (In life-threat. sit. no absolute
C.I.).

Bradykinin β-2 Receptor antagonist. Icatibant (as acetate) 30 mg / 3 ml.
PREFILL. SYR. (sol. for inject.): 1 ×3 ml.
1 x 30 mg S.C. inj. in abd. area given
slowly. 1 inj. should suffic. In case of
recur. in adults can admin. 2nd inject aft. 6 hrs. or a 3^rd
inj. aft. another 6 hrs. max. 3 inj. in 24 hrs. See lit.
Sympt. tmt. acute attacks hereditary
angioedema (HAE) in adults, adolesc. & child. aged 2 yrs and old. with
C1-esterase-inhib. defic.
C/I: Hypersens.

Bradykinin B2 Receptor Antagonist. Icatibant (as acetate) 30 mg / 3 ml.
SYR. (Sol. for S.C. inj.).: 1. One S.C. inj. of Icatibant (3 ml/30 mg), as soon as signs of attack are detected (e.g. swelling of the skin, especially in the area of the face and neck, or increas. abdom. pain).
If the condition is not improved in 6 hrs., another 3 ml dose may be admin.
If there is still no improv., a 3^rd dose may be admin. after another 6 hrs.
No more than 3 doses in 24 hrs. and no more than 8 inj. of icatibant in one month. Child.& adolesc. 2-17 yrs. of age:  1 ml up to a max. of 3 ml, inject. S.C. accord. to bdy. wt. (one syr.  contains 3 ml), as soon as signs of angioedema attack develop (e.g. incr.swell. of the skin, especially in the area of the face and neck, or increas. abd. pain). See lit.
Symptomat. tmt .of acute attacks of hereditary angioedima (HAE) in adult., adolesc. & child. aged 2 yrs. and older, with C1-esterase-inhib. defic.
C/I: Hypersens.

Antiepileptics. Cenobamate 12.5 mg, 25 mg, 50 mg, 100 mg, 200 mg.
TABS + FC TABS. (combined pack): 12.5 mg X 14 + 25 mg X 14
FC TABS: 50/100/200 mg X 30
Adlts: recomm. start. dose is 12.5 mg /d, titr. grad. to the recomm. target dose of 200 mg/d. Based on clin. response, dose may be incr. to a max of 400 mg/d. See lit. for recommen. titrat. sched. which should not be exceeded because of  potent. ser. adv. reactions.
For the adjunctive tmt. of focal-onset seizures with or w/o sec. generalisation in adlt. ptts. with epilepsy who have not been adeq. controlled despite tmt. with at least 2 anti-epil. medic. prod.
C/I: Hypersens. Familial Short-QT syndr.
See lit

Urea with enriched ¹³C , 75 mg.
TAB: 1. 1 tab dissolved accord. instructs.
Qualitat. detect urease assoc. with H.
pylori in human stomach, aid in initial
diagn., post tmt. monitor H. pylori infect.
in adults.

Perfluoropropane 1.1 mg/ml.
VIALS: 2 ml. I.V. bolus/infus. See lit.
Echocard. of card. structures (ventric.
chambers, endocard. borders) function
(regional wall motion) in adult pts. with
suboptimal echocardiograms. Abdom.
ultrasound: Liver and kidneys in adult pts.
to improve evaluation of pathology.
C/I: Hypersens., pts. with card. shunts.

Gradoteric Acid 27.932 g / 100 ml.
VIALS: 10 ml, 15 ml, 20 ml.
PREFILLED SYRINGES: 15 ml, 20 ml. 0.1
mmol/kg i.e. 0.2 ml/kg for adults and
child by I.V. inject. only.
Enhancement of contrast in magnet.
resonance imaging in enceph. and spinal
path., abdom. path., ostes-artic. path. To
be admin. I.V. only.

Barium Sulphate 4.9% w/v.
SUSP: 225 ml. 350-450 ml diluted susp. 30
mins. prior to scan and same vol. 5 mins.
prior to scan. Child: Depend. on age and
wt.
Opacificat. gastro-intest. tract prior to CAT.
C/I: Known gastro-intest. perforat.,
hypersens. to barium sulph.

Sodium Bicarbonate 55.14% w/w, Citric Acid (anhydrous) 38.21% w/w, Simethicone 1% w/w.
EFFERVES. GRANULES (SACHETS): 50 x 4
g. 4 g sachet on back of tongue and
washed down with 15 ml water. Child:
Depend. on age and wt.
For the relief of heartburn, sour stomach,
acid indigestion and upset stomach and
gas associated with these symptoms.
C/I: Pts. on sod. restrict. diet under vis.
of physician.

Barium Sulphate 98% w/w.
PWDR: 340 g. See lit.
For contrast radiography of oesphagus,
stomach, duod. X-ray institutes only.

Isotonic solution. Anhydrouse Glucose 1.36%, 2.27%, 3.86%, Sodium Chloride 0.538%, Sodium Lactate 0.448%, Calcium Chloride 0.0184%, Magnesium Chloride 0.0051%.
PLASTIC BAG (Periton. dialysis Sol.): 1.5, 2, 2.5, 3, 5 L. Dosage adjust. individ.
Indicated whenever periton. dialysis is employed include. acute and chron. ren. fail., sev. water retent., electrolyte disor., drug intoxic..
C/I: hypersens. Pts. with pre-exist. severe lactic acidosis. Pts. with uncorrectab.  mechanical defects that prevent effective PD or incr. the risk of infect. Pts. with documented loss of peritoneal function or extensive adhesions that compromise peritoneal funct.

Blood Substitutes and Plasma Protein Fractions. Icodextrin 75 g/l, Sodium Chloride 5.4 g/l, Sodium Lactate 4.5 g/l, Calcium Chloride Dihydrate 0.257 g/l, Magnesium Chloride Hexahydrate 0.051 g/l.
PVC BAG: 2,2.5 L. Dosage ajust. individ.
Recomm. as a once dly. replacem. for a single glucose exchange as part of a contin. ambulat. periton. dialysis (CAPD) or automated periton. dialysis (APD) regimen for the tmt. of chron. ren. fail., particul. for pts. who have lost ultrafiltration on glucose solutions, because it can extend time on CAPD ther. in such pts.
C/I: Hypersens. Pts. with a known allergy to starch based polymers (e.g. maize starch) and/or icodextrin. Pts. with maltose or isomaltose intoler. Pts. with glycogen storage dis. Pts. with pre-exist. severe lactic acidosis. Pts. with uncorrectable mechanic. defects that prevent effective PD or incr. the risk of infect. Pts. with Documented loss of peritoneal function or extensive adhesions that compromise periton. funct.

Solutions for Parenteral Nutrition. Amino Acids 1.1%, Sodium Chloride 5.38 g/l, Calcium Chloride Dihydrate 0.184 g/l, Magnesium Chloride Hexahydrate 0.051 g/l, Sodium Lactate 4.48 g/l.
PLASTIC BAG (Sol. for Periton. Dialys.): 2,2.5L. Dosage ajust. individ.
Nutritional supplem. for malnourished renal fail. pts. (albumin concentrat. lower then 35 g/liter) being maintain. on peritoneal dialysis.
C/I: Known hypersens. to any amino acids. Pts. with serum urea level above 38 mmol/L. Pts. with Uremic sympt. Pts. with metabol. acidosis. Pts. with inborn errors of amino acid metabolism. Pts. with liver insuffic. Pts. with severe hypokalaem. Pts. with uncorrectab. mechanic. defects that prevent effective PD or increase the risk of infec. Pts. with Documented loss of peritoneal funct. or extensive adhesions that compromise peritoneal funct.

Isotonic solution. Anhydrouse Glucose 1.36 g/l, 22.7 g/l, 38.6 g/l, Sodium Chloride 5.38 g/l, Calcium Chloride Dihydrate 0.184 g/l, Magnesium Chloride Hexahydrate 0.051 g/l, Sodium Bicarbonate 2.10 g/l, Sodium Lactate 1.68 g/l.
PVC BAG: 1.5, 2, 2.5 L. Dosage ajust. individ.
Indicated whenever peritoneal dialysis is employed include.: Acute&chron. renal fail.; Severe water retent.; Severe electrolyte imbalance; Drug intoxicat. with dialysable substanc. when a more adequate therapeut. alternative is not available. Bicarbonate/Lactate based physioneal peritoneal dialysis solutions with a physiology. pH are particul. indicated in pts. in whom solut. based on lactate buffer only with a low pH cause abdom. inflow pain or discomfort.
C/I: Pts. with: uncorrectab. mechan. defects that prevent effective PD or incr. the risk of infec., documented loss of periton. funct. or extensive adhesions that compromise periton. funct.

Ferrous Gluconate 35 mg / 5 ml.
SYR: 120 ml. Child: 4-6 mths: 2.5 ml dly;
6-12 mths: 5 ml dly. Over 1 yr: As reqd.
See lit.
Nutritional supplement.

Ferrous Gluconate 50 mg / 5 ml.
SYR: 300 ml. 0.5 mg/kg/day.
Nutritional supplement.

Ferrous Sulphate 113.85 mg, Folic Acid 0.5 mg, Serine 129 mg.
CAPS: 30. 1-2 caps dly. bef. food.
Nutritional supplement.

Omega-3 300 mg (DHA 120 mg, EPA 180 mg).
CAPS: 210. 1 cap dly, dur.
meal.
Nutritional supplement.
C/I: Hypersens.

Omega-3 704 mg (DHA 300 mg, EPA 100 mg), Folic Acid 400 mcg.
CAPS: 60. 1 cap dly, during meal.
Nutritional supplement.
C/I: Hypersens.

Omega-3 600 mg.
CAPS: 120. 1-3 caps dly, dur. meal.
Nutritional supplement.
C/I: Hypersens.

Enzyme Replacement Therapy. Laronidase 500 U / 5 ml.
VIAL: 1. See lit.
Long-term enzyme replace. ther. in
confirm. mucopolysaccharidos. I
(MPS I, alfa-I-iduronidase defic.) for nonneurolog. manifests. of the dis.

Enzyme Replacement Therapy. Imiglucerase 400 U/Vial.
VIAL (lyophilized pwdr. for infus.): 1.
See lit.
Long term enzyme replace. ther. in
confirmed diagn. type 1 Gaucher dis.

Alimentary tract and metabolism enzymes. Idursulfase 2 mg/ml.
VIAL (sol. for infus.): 1 x 3 ml. See lit.
Long-term tmt. Hunter Syndr. (MPS II).
C/I: Hypersens.

Enzymes. Taliglucerase Alfa 200 U/vial.
VIAL: 1× 200 U. The recomm. dosage for
tmt.-naïve adult &ped. pts. above 2 yrs.
of age and older is 60U/ kg of bdy. wt.
admin. every other wk. as a 60 to 120
min. IV. See lit.
Indic. for long-term enzyme replac. ther.
(ERT) for adult. & ped. pts. above 2 yrs.
with a confirm. diagnos. of Type 1
Gaucher dis.
C/I: Hypersens.

Enzyme Replacement Therapy. Agalsidase Beta 5 mg/ml, 35 mg/7ml.
PWDR. FOR INFUS: 1 x 5 mg/ml,
35 mg/ml. See lit.
Long-term enzyme replace. ther. in
confirmed diagnos. Fabry dis. (alfagalactosidase A defic.).

Enzyme Replacement Therapy. Velmanase alfa 10 mg/vial.
Pwder for sol. for infus.: 10 mg/vial.
Dose 1 mg/kg of BW admin. once / week by IV infus. at a contr. speed .
 Enzyme replac. ther. for the trt. of non-neurol. manifest. in pts. with mild to mod. alpha-mannosidosis
C/I:Hypersens.

Sodium Chloride 7.44 mg/ml, Potassium Chloride 0.395 mg/ml, Sodium Phosphate (dibasic) 0.433 mg/ml, Sodium Bicarbonate 2.19 mg/ml, Calcium Chloride Dihydrate 3.85 mg/ml, Magnesium Chloride Hexahydrate 5 mg/ml, Dextrose 23 mg/ml, Glutathione Disulfide 4.6 mg/ml.
PHYSIOLOG. IRRIGAT. SOLN: 480ml Part I + 20ml Part II.
Intraoc. irrigat. sol. during intraoc. surg.
involv. perfus. of eye.

Medical Device. Carboxymethyl beta-glucan , Polycarbophyl .
Vag. Spray Gel, 20 ml. 5 actuations/day bef. bedtime, 20 days/mo. for 3 mo.
Prevent. and trt. of cerv. lesions caused by HPV, by ctrol. of physio. cond. on the cervico-vaginal transform. zone.
C/I: Hypersens.

Medical Device. Diosmectite 1.5 gr.
Sachets:12X 15 g. Childr. aged 2-6: 1 sachet, 1-2 /day.
Childr. aged 6-12; 1 sachet, 2-3 /d
Adults and childr. over 12 years: 1 sachet, 3/d
Ac. and chron. tmt. of diarrhea, stomach ache. Ac. and chron. tmt. of diarrhea, stomach ache up to3 days in children and up to10 d. in adults. If after this period no improve. achieved, other tmt. to be considered.  Tmt. of ac. diarrhea to be accomp. by admin. of oral rehydrat. solut. (ORS) to avoid dehydrat.
C/I: age under 2 years old, hypersens.,
pregn. or breast-feed.,
gastric or intest. lesions,
chron. constipat, intest. irrit.,
intest. blockage.
Cont. alumin. resulting from diosmectite:
its adsorbing effect may advers. affect the effic.
of concom. oral drugs

Medical Device. Hyaluronic Acid , Aloe Vera , BioEcolia .
Vag. gel  cannula 8 X5 ml
Twice/w for 3 months
To improve symptoms of vaginal dryness
C/I:  Hypersens.

Medical Device. Polysiloxanes , Silicone Dioxide .
GEL: 15 g. Apply thin coat 2 x
dly and allow to dry for 2-3 mins.
Prevent. scars, aid. in skin heal. foll. surg./
injury, maint. skin moist., elasticity.

Medical Device. Polysiloxanes , Silicone Dioxide .
SPRAY: 100 ml. Apply thin coat 2 x
dly and allow to dry for 2-3 mins.
Prevent. scars, aid. in skin heal. foll. surg./
injury, maint. skin moist., elasticity.

Androgen Biosynthesis Inhibitor. Abiraterone Acetate 250 mg.
Tab 120 X 250 mg
1000 mg/d (4 tab.), once/d in comb. with oral prednisone 5 mg (twice/d for metast. CRPC and once/d for High risk mHSPC)
In comb. with prednisone for tmt. of metast. castr.-resist. prostate cancer (CRPC)
newly diagn. high risk metast. hormone-sensit. prostate
cancer (mHSPC) in adlt men in comb. with androgen depriv. ther.(ADT).  
C/I: Hypersens./Women/Sev. liver damage/In comb. with Ra-223

Immunoglobulins. Trastuzumab deruxtecan 20 mg/ml.
mAb linked to DXd, an exatecan deriv. and a
topoisomerase I inhibit.
Vial, 100 mg. Powd. for concentr. for sol. for inf.
 Breast or Lung cancer: 5.4 mg/kg bw once every 21 days
Gastric cancer: 6.4 mg/kg once every 21 days.
Do not substitute with trastuzumab or ado-trastuzumab emtansine.
HER2-Posit. Metast. Breast Cancer ; HER2-Low Metast. Breast Cancer; Unresect. or Metast. HER2-Mutant Non-Small Cell Lung Cancer; Locally Adv. or Metast. Gastric Cancer. See Lit
C/I:  Hypersens.

Monoclonal Antibody. Trastuzumab 150 mg, Trastuzumab 420 mg.
Vial:Pwd. for conc. for sol for infus.
Load: 4-8 mg/kg BW
Maint. 2-6 mg/kg BW weekly or at 3 weekly interval, see lit.
Tmt. of pts. with metast. breast cancer who have tumours that overexpress HER2; 1. As a sgle. agent, for the tmt. of those pts. who have received one or more chemother. regimens for their metast. dis..2. In combin. with Paclitaxel or Docetaxel for the tmt. of those pts. who have not received chemother. for their metastatic dis..3. In comb. with an aromatase inhib. for tmt. of postmenopausal ptt. with hne.-receptor posit. metast. breast cancer. See Lit
C/I: Hypersens. Sev. dyspnea at rest.

Human Monoclonal Antibody, Immunoglobulins. Durvalumab 50 mg/ml.
Vial:  Sol for inf.120/500 mg
Dosage and freq. depend on patient weight, disease type and monoor combined ther. See lit.
Urothelial Carcinoma: for pts with PD-L1 high (Tumor cell ≥25% or IC ≥25%) locally adv. or metast. urothelial carcinoma who:
- have dis. progr. during or following platinum-contain. chemother
. - have dis. progr. within 12 months of neoadj. or adj. tmt with platinum cont. chemother..
Non-Small Cell Lung Cancer - for pts with unresect. Stage III non-small cell lung cancer (NSCLC) whose dis. has not progr. following concurr.platinum-based chemother. and radiation ther.- in comb. with tremelimumab and platinum-based chemother. for the first-line tmt. of adlts with metast. NSCLC with no sensit. EGFR mutat. or ALK pos. mut..
Small Cell Lung Cancer, in combin. with etoposide and either carboplatin or cisplatin, for the first-line tmt. of adlt pts. with extens.-stage small cell lung cancer (ES-SCLC).
Biliary Tract Cancers: in comb. with gemcitabine and cisplatin for the first-line tmt of adlts with locally adv., unresect., or metast. biliary tract cancer (BTC).
Hepatocellular Carcinoma: in comb. with tremelimumab for the first line tmt of adlts with adv. or unresect. hepatocellular carcinoma (HCC).
C/I:  Hypersens.

Engineered Autologous T Cell Immunotherapy product. Tisagenlecleucel .
Dispers. for IV inf.  cont. 10-30 ml or 30-50 ml.
Dosage in paed. and young adlt. CD19+ B-cell ALL pts. - For pts.  under 50 kg : 0.2 to 5 x 10⁶ CAR-posit. viable T cells/kg BW. - For pts. above 50 kg: 0.1 to 2.5 x 10⁸ CAR-positive viable T cells (non-weight based). Dosage in adlt. DLBCL and FL pts. - 0.6 to 6.0 x 10⁸ CAR-posit. viable T cells (non-weight based).
Paed. and young adlt. pts. up to and incl. 25 years of age with CD19+ B-cell acute lymphoblastic leukaemia (ALL) refract., in relapse post-transpl. or in second or later relapse. – Adlt. pts. with relapsed or refract. diffuse large B-cell lymphoma (DLBCL) after two or more lines of syst. ther. Limit of Use: not for tmt. of pts. with prim. or second. CNS lymphoma- Adlt. pts. with relapsed or refract. follicular lymphoma (FL) after two or more lines of syst. ther.
C/I: Hypersens. Also consider C/I of the lymphodepleting chemother.

Anti-Androgen. Darolutamide 300 mg.
FC Tab X 112
600 mg (two tab. of 300 mg) taken 2Xd, equiv. to a total dly dose of 1200 mg
In combin. with ADT for the tmt. of adlt. men with non- metast. castr. resist. prostate cancer (nmCRPC) at high risk of develop. metast. dis. Indicat. for the tmt. of adlt. ptts. with metast. horm.-sensit. prostate cancer (mHSPC) in combin. with docetaxel.
C/I:  Hypersens. Women who are or may become pregn.

Alkylating Agent (platinum analog). Cisplatin 1 mg/ml.
VIALS: 1 x 100 ml, 50 ml. See lit.
Palliative in add. to other modalities
in
tmt. metastat. testic. and ovar. cancer,
advanced bladder cancer.

Androgen Biosynthesis Inhibitor. Abiraterone Acetate 250 mg , 500 mg.
TABS.: 250 mg x 120 , 500 mg x 60.
Intended  for male pts. only. 1,000 mg (4×250mg tabs. or 2x500mg tabs.) once dly.
 1. in combin. with prednisone for metast. castrat.-resist. prostate cancer.
2. For newly diag. high risk metast. hne. sensit. prostate cancer (mHSPC) in adlt. men in combinat. with androgen depriv. ther.(ADT) and in combin. with prednisone.
C/I:  Hypersens./ by pregn. females or who may be potent. pregn../sev. hepat. impairm./ in combin. with Ra-223 if given with prednisone.

Folic Acid Analog. Methotrexate 25 mg/ml.
VIAL (sol. for inj.): 25 mg/ ml X 2 ml, 4 ml,
8 ml, 20 ml, 40 ml. Dose must be ajust.
individ. for each pt. accord. to med.
cond. See lit.
Antineopl. Chemother.
Tmt. of gestational choriocarcinoma,
chorioadenoma destruens and
hydatidiform mole. Palliation of ALL. Tmt.
and proph. of menin. leukemia.
Greatest effect has been observed in
palliation of acute lymphoblast.(stemcell)
leukemias in child. In comb. with
other anticancer agents, may be used for
the induc. of remis.,but is most common.
used in the mainten. of induced remis.
May be used alone, or in comb. with other
antineoplastic drugs, in the manag. of
breast canc., epidermoid cancers of the
head and neck, lung cancer (partic.
squamous cell ,small cell types), bladder
cancer and osteogenic cancer. Tmt. of the
advan.stages (III and IV, Peter’s Staging
system) of lymphosarcoma, partic. in
child., and in advanced cases of mycosis
fungoides.
Psoriasis. Indic. only in the sympt. control
of sev. recalcitrant, disabling psoriasis
which is not adeq. responsive to other
forms of therapy, and only when the diag.
has been established, as by biopsy and/or
after dermat. consult. RA:Tmt. of selec.
adul.with sev. RA, only when the diag. has
been well established accord. to rheumat.
standards, with inadeq. response to other
forms of antirheum. ther., includ. full dose
NSAIDs and usually a trial of at least one
or more dis.-modif. antirheum. drugs.
C/I: Pregnancy, lact., pts. in poor state of
nutrition, sev. ren. impair. (crCL <20 ml/
min), sev. liver impair., bone marrow
hypoplasia, leucopenia,
thrombocytopenia, anemia, alcohol
abuse, hypersens. and lung toxic.due to
methotrexate, serious, acute or chronic
infect. such as tuberculosis and HIV,
ulcers of the oral cavity and known
active GI ulcer dis. Concur. vaccin. with
live vaccines.

Monoclonal Antibody. Brentuximab Vedotin 50 mg.
VIAL (Pwdr. for conc. for solution for IV infus.): 1 x 50 mg. Previous. Untreat. HL: The recom. dose in comb. with chemother. (doxorubicin [A], vinblastine [V] and dacarbazine [D] [AVD]) is 1.2 mg/kg admin. as an IV infus. over 30 min. on days 1 and 15 of each 28-day cycle for 6 cycles.
Primary prophylaxis with growth factor support (G-CSF), begin. with the 1^ST dose, is recom. for all pts. with prev. untreat. HL receiv. comb. ther.
HL at incr. risk of relapse or progression: 1.8 mg/kg admin. as an IV infus. over 30 min. every 3 wks.
Tmt. should start follow. recovery from ASCT based on clinical judgment. These pts. should receive up to 16 cycles.
Relapsed or refract. HL: 1.8 mg/kg admin. as an IV infus. over 30 min. every 3 wks. dose for the retreatment of pts. who have previously responded to tmt. -1.8 mg/kg admin. as an IV infus. over 30 min. every 3 wks.. Alternatively, tmt. may be started at the last tolerated dose.
Previous. untreated sALCL or other CD30-express. peripheral T-cell lymphomas: in comb. with chemother. (cyclophosphamide [C], doxorubicin [H]& prednisone [P] [CHP]) is 1.8 mg/kg admin. as an IV infus. over 30 min. every 3 wks for 6 to 8 cycles.
Primary prophylaxis with G-CSF, beginning with the first dose, is recom. for all pts. with prev. untreated sALCL or other CD30-expressing peripheral T-cell lymphomas, receiving comb. ther.
Refer to the SmPCs of chemotherapy agents given in comb. with ADCETRIS for pts. with prev. untreated sALCL or other CD30-expressing peripheral T-cell lymphomas.
Relapsed or refractory sALCL: 1.8 mg/kg admin. as an IV infus. over 30 min. every 3 wks.
Init. dose for the retreatment of pts. who have prev. responded to tmt. with Brentuximab vedotin is 1.8 mg/kg admin. as an IV infus. over 30 min. every 3 wks. See lit.
Tmt. of adult pts. with previos. untreated Stage III or IV classical Hodgkin lymphoma (cHL), in comb. with doxorubicin, vinblastine, and dacarbazine.
Tmt. of adult pts. with CD30+ HL at incr. risk of relapse or progress. follow. autologous stem cell transplant (ASCT).
Tmt. of adult pts. with relapsed or refractory CD30+ Hodgkin lymphoma (HL): ASCT, or at least two prior therapies when ASCT or multi-agent chemother. is not a tmt. option.
Syst. anaplastic large cell lymphoma & Peripheral T-cell lymphomas (PTCL).
Tmt. of adult pts. with previously untreated system. anaplastic large cell lymphoma (sALCL) or other CD30-expres. peripheral T-cell lymphomas (PTCL), includ. angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in comb. with cyclophosphamide, doxorubicin, and prednisone.
Tmt. of adult pts. with relapsed or refract. sALCL.
Tmt. of adult pts. with CD30+ cutan. T-cell lymphoma (CTCL) after at least 1 prior system. ther.
C/I: Hypersens., comb. use with Bleomycin.

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.

Protein Kinase Inhibitor. Alectinib 150 mg.
HARD CAPS.:240.
600 mg (4×150 mg caps.) ×2/d with food , max. dly. dose of 1200 mg). See lit.
Tmt. of pts. with ALK posit., local. advanc. or metast. non-small cell lung cancer (NSCLC) who progres. on or are intolerant to crizotinib. Alectinib as monother. - for the 1^st -line tmt. of adult pts. with anaplastic lymphoma kinase (ALK)-posit. advanc. non-small cell lung cancer. (NSCLC).
C/I: Hypersens.

Alkaloid. Nicotine 2 mg, 4 mg.
GUM (Fruit and mint): 48, 204 x 2 mg; 48
x 4 mg. 1 piece of gum on urge to
smoke. Usually 8-12 pieces req. dly.
Max: 25 pieces of 2 mg dly; 15 pieces of
4 mg dly.
Aid to smoking cessation.

Alkaloid. Nicotine 1 mg, 2 mg.
Lozenges: 36 x 1 mg, 2 mg. 1-2 loz. every
1-2 hrs. Recommend: 8-12 loz dly. Max.
30 x 1 mg/15 x 2 mg dly.
For adults > 18 yrs. Aid to smoking
cessation. Also as part of program to
reduce smoking prior to stopping
completely. 1 mg: for smokers of < 20
cigarettes dly; 2 mg: for smokers of > 20
cigarettes dly.
C/I: Hypersens., non-smokers, <18 yrs,
phenylketonuria.

Drugs used in Alcohol Dependence. Nalmefene 18.06 mg (as hydrochloride dihydrate).
F.C. TABS: 14. Administ. should be adjust.
individ, for each pt. accord. to its clin.
status, alcohol depend., level of alcohol
consump. Therap. must cont. under
const. superv. of specialist.
Max. Dose is 18.06 mg ×1/d, before or
after meal.
Reduc. of alcohol consump. in adult pts.
with alcohol depend. who have a high DRL,
without phys. withdrawal sympt. and who
do not require immed. detoxif.
Should only be used in conjunct.with
contin. psychosoc. support focused on tmt.
adherence and reduc. alcohol consump.
Should be init. only in pts. who cont. to have a high DRL two weeks after init.
assessment.
C/I: Hypersens. Pts. taking opioid agon. (e.g. opioid analg., opioids for substit. ther. with
opioid agon. (e.g. methadone) or part.
agon. (e.g. buprenorphine). Pts. with curr., recent opioid addic. Pts. with acute sympt. of opioid withdrawal. Pts. suspect. in recent use of opioids. Sev. hep.impair. Sev. ren. impair. (eGFR<30 ml/min per 1.73 m²).
Recent hist. of acute alcohol withdrawal
synd. (include. hallucin. seiz., delir.
tremens).

Opiod Dependency. Buprenorphine 8.64 mg, Naloxone HCl 2.44 mg.
S.L. TAB. 7, 28.
The recommend. start. dose in adult.,
adolesc. over 15 yrs.: 1-2 tabs. of 2
mg/0.5 mg. An addit. 1-2 tabs. 2 mg/0.5
mg may be administ. on day one
depend. on the individ. pts. requirem.
Dose titrat. in steps of 2-8 mg is guided
by reassess. of the clinic. & psycholog.
status of the pt., and should not exceed
a max. single dly. dose of 24 mg.
Substit. tmt. for opioid drug dependence,
within a framework of med., social and
psycholog. tmt. in adult., adolesc. over 15
yrs. who have agreed to be treated for
addiction.
C/I: Hypersens., severe resp. insuffic.,
severe hepat. impair, acute alcoholism or
delirium tremens.

Partial Opioid Agonist/Antagonist. Buprenorphine (as HCl) 2 mg, 8 mg.
TABS: 7 x 2 mg, 8 mg. See lit.
Substitut. tmt. opioid depend. within
framework of medical, social and
psycholog. tmt.
C/I: Hypersens., severe respir. insuffic.,
severe hepat. insuffic., acute alcoholism.,
delirium tremens, under 16 yrs., lact.