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
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
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.
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
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
caused by asth. attack.
C/I: See lit. (In life-threat. sit. no
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
Iron Chelating Agent. Deferasirox 125, 250, 500 mg. DISPERS. TABS: 28. See lit.
Tmt. of chronic iron overload due to blood
transfuse. in adult & pediat. pts. (2 yrs and
over). Tmt. of chronic iron overload in pts.
with non-transfus.-depend. thalassemia
syndr. aged 10 yrs and older. Chelation ther.
should only be init. when there is evidence of iron overload (liver iron concentration [LIC] 5 mg Fe/g [dw] or serum ferritin consist. >800 g/l). LIC is the pref. method of iron overload determin. and should be used wherever available.
C/I: Hypersens. to the product. High risk
myelodysplastic syndrome pts. and pts.
with other hematology. and nonhematolog.
malign. who are not
expected to benefit from chelation ther.
due to the rapid progress. of their
disease. CLcr < 60 mL/min or serum cr >2
times the age-appropr. ULN. PLT counts
<50 x 109/L.
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.
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.
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.
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
Enzyme Replacement Therapy. Alglucoside Alfa 50 mg. VIAL (pwdr. for conc. infus. sol.): 1.
20 mg/kg bdy wt I.V. infus. every 2 wks.
Initial rate: 1 mg/ kg/hr. Grad. incr. by 2
mg/kg/ hr. every 30 mins. if no signs
IARs, incr. until max. rate: 7 mg /kg/hr.
Tmt. by physician experienced in manage.
Pompe dis. or other inherited
Long-term enzyme replace. ther. (ERT) in
comfirmed Pompe dis.(acid alphaglucosidase
The benefits in pts with late-onset Pompe
dis. have not been establ.
C/I: Life-threat. hypersens., when rechall.
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.
Anti-Androgen. Abiraterone Acetate 250 mg. TABS.: 120.
Intended for male pts. only. 1,000 mg (4×250mg tabs.) once dly. in comb. with prednisone.
Indicated in comb. with prednisone for the tmt. of pts. with metastat. castration-resist. prostate cancer.
C/I: Hypersensitivity to active substance or any of its excipients. Use in female patients. Severe hepatic impairment.
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.
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
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
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
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 1ST 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
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.
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
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 1st -line tmt. of adult pts. with anaplastic lymphoma kinase (ALK)-posit. advanc. non-small cell lung cancer. (NSCLC).
Nicotine Receptor Partial Agonist. Varenicline (as tartrate) 0.5 mg, 1 mg. Health basket inclusion: Champix will be given to the treatment of smoking cessation parallel to supportive means.
TABS: 55 x 0.5 mg, 56 x 1 mg; starter pack: 11 x 0.5 mg + 14, 28 x 1 mg.
Days 1 – 3: 0.5 mg ×1/d.
Days 4– 7: 0.5 mg ×2/d.
Day 8 – end of tmt.: 1 mg ×2/d.
Pts. should be treated with Varenicline for 12 wks. For pts. who have successf. stopped smok. at the end of 12 wks., an addit. course of 12 wks. tmt. with Varenicline is recomm. to further incr. the likelihood of long-term abstinence.
Pts. with ren. impair. No dosage adjust. is necessary for pts. with mild- moder. renal impair. For pts. with sev. renal impair. (estimated CrCl <30 mL/min), the recomm. start. dose of Varenicline is 0.5 mg ×1/d. The dose may then be titrated as needed to a max. dose of 0.5 mg×2/d. For pts. with end-stage renal dis. underg. hemodialysis, a max. dose of 0.5 mg mg×/d may be admin. if toler.
Aid to smoking cessat. for adults over 18
C/I: Not to pts. under 18 yrs., hypersens.
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
C/I: Hypersens., non-smokers, <18 yrs,
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
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.
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.
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
C/I: Hypersens., severe resp. insuffic.,
severe hepat. impair, acute alcoholism or
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
C/I: Hypersens., severe respir. insuffic.,
severe hepat. insuffic., acute alcoholism.,
delirium tremens, under 16 yrs., lact.