All the Therapeutic System Drugs
Advanced Therapy. Darvadstrocel 30 million cells/vial. VIAL (suspens. for inj): 1×30 million cells. A single dose of Alofisel consists of 120 million cells supplied. in 4 vial. Each vial contains 30 million cells in 6 mL of susp. The full content of the 4 vial. must be admin. for the tmt. of up to two intern. openings and up to three exter. openings. This means that with a dose of 120 million cells it is possible to treat up to three fistula tracts that open to the perianal area. The efficacy or safety of repeat admin. of this drug has not been established.
Tmt. of complex perianal fistulas in adult pts. with non-active/mildly active luminal Crohn’s dis., when fistulas have shown an inadeq. response to at least one convention. or biologic ther. The durg should be used only after conditioning of the fistulas.
C/I: Hypersens. to the active subst. or to excipients or to bovine serum.
CCB, Local Anesthetic. Lidocaine HCl 1.5%, Nifedipine 0.3%. RECTAL CR.: 30g. Should be applied twice dly. for at least 3 wks. See lit.
Tmt. of anal fissures and proctolog. general. associate. with anal sphincter hypertonia.
C/I: Hypersens. to the active ingred., partic. to Lidocaine (& other local anesthet. with a similar amidic type structure). Presumed or ascertained preg. & lact.
5-Aminosalicylic Acid Derivative. Mesalazine 400 mg, 800 mg. TABS: 100 x 400 mg. 3-6 tabs. dly. in div.
doses bef. meals.
TABS: 60 x 800 mg. Ulc. colit: Maint.
remission: 1.2-2.4 g dly in div. doses
bef. meals. Chron’s dis: 2.4 g dly in div.
doses bef. meals. Child: No specif.
Maint. remission in ulcerat. colit., acute
episodes Crohn’s dis.
C/I: Hypersens. to salicylates, liver and
kidney funct. disords., gastric or duod.
ulc., pregn., lact., diabetes.
Cannabinoids. THC 0.3, 0.9, 1.5, 3, 4.5, 6 mg/drop, CBD 0.6, 0.9, 1.2, 3, 4.5, 6 mg/drop. *This product requires a license for medical cannabis.
BOTTLE. (sublingual drop.): 10gr (330 drops). Dosage should be adjust. individual.
The Israel MOH has outlined in Guidance 106 the 12 indicat. for which med. cannabis is indicated. Accord. to this guidance, the 11 indicat. for this product are:
Chemother-induc. nausea and vomit. (CINV)/ chemother induc. pain.
Metastat. cancer pain.
Spastic. of MS.
Pain in Parkinson's dis.
Cachexia in AIDS.
Recalcitrant epilep. in adult. (Note: Accord. to Guidance 106, med. cannab. is also indic. for recalcitrant epilep. in ped. pts. but this is not an indicat. for this product)
Palliative care for termin. ill pts.
Post- traum. stress disord.
In general, the use of med. cannabis is indicated in pts. who have adequate. tried and failed convent. ther.
Please refer to Guidance 106 for details.
In addition, for an individ. pt. with a clinical. signific. med. condit. that cannot be adequate. managed by convent. ther. and which is not includ. as one of the 12 approved indicat. (eg autism, fibromyalgia), the physician can appeal to the MOH Committee for Med. Cannabis to ask for approval on an individ. exception. basis.
C/I: Prior, current/ family history (1st degr. relative) of psychos. or schizophr. or schizoaffective disord., a hist. of addict. or substance abuse (include. cannabis use disord.or addict. to alcohol), use in preg.or lact., use in pts. <18 yrs. old, bipol.disord., hypersens. to cannabis, coconut oil, palm kernel oil.
In pts. with hepat. cancer, it is recommend. not to use med. cannab. that contains THC.
Corticosteroid. Budesonide 3 mg. Gastro-Resist. CAPS: 100. Swallow with
glass of water about 1/2 hr bef. meals:
Crohns: 9mg/d: 3 caps in morning or 1
cap X 3/d. Collag. colitis: 9mg/d: 3 caps
once dly in the morning. Autoimm.
hepat.: Induct. of remiss.: 1 cap X 3/d.
Maint. of remiss.: 1 cap X 2/d.
Acute mild - moderate Crohn’s dis. with
involv. of the ileum (twisted intest.) and/
or ascend. colon (part of large bowel).
Collagenous colitis. Autoimmune
C/I: Hypersens., hepatic cirrhosis.
TNF-A Inhibitors. Certolizumab Pegol 200 mg/ml. PRE-FILL. SYR. (sol. for S.C. inj.): 2, 6×1ml. The recomm. init. dose adult pts. is 400 mg (given as 2 s.c. inj. of 200 mg each) at wks. 0, 2 and 4. For RA, MTX should be cont. during tmt. with Certolizumab pegol where approp.
Mainten. dose: RA: After the init. dose, the recomm. mainten. dose of Certolizumab pegol for adult pts. with RA is 200 mg every 2 wks. MTX should be cont. during tmt. with Certolizumab pegol where appropr.
Axial spondyloarthritis: After the init. dose, the recomm. mainten. dose of Certolizumab pegol for adult pts. with Axial spondyloarthrit. is 200 mg every 2 wks. or 400 mg every 4 wks.
For the above indicat., available data suggest that clinical response is usually achieved within 12 wks. of tmt. Continued ther. should be carefully reconsid. in pts. who show no evidence of therapeutic benefit within the first 12 wks. of tmt.
Crohn’s Dis.: After the init. dose, in pts. who obtain a clinical response, the recomm. mainten. dose is 400 mg every 4 wks.
Missed dose: Pts. who miss a dose should be advised to inject the next dose of Certolizumab pegol as soon as they remember and then cont. inject. subseq. doses as instructed.
RA: In comb. with methotrexate (MTX), is indic. for: The tmt. of moder. to sev., active RA in adult pts. when the response to dis.-modifying antirheum. drugs (DMARDs) includ. methotrexate, has been inadequate.
Can be given as monother. in case of intoler. to MTX or when cont. tmt. with MTX is inappropr.
Certolizumab pegol has been shown to reduce the rate of progres. of joint damage as measured by X-ray and to improve physic. func., when given in comb. with MTX.
Axial spondyloarthritis: Tmt. of adult pts. with sev. active axial spondyloarthritis, compris.: Ankylosing spondyl. (AS): Adults with sev. active AS who have had an inadeq. response to, or are intoler. to NSAIDs.
Axial spondyloarthritis without radiograp. evidence of AS: Adult. with sev. active AS without radiograph. evidence of AS but with object. signs of inflamm. by elevated CRP and/or MRI, who have had an inadeq. response to, or are intoler. to NSAIDs.
Crohn’s Dis.: Indic. for reduc. signs and sympt. of Crohn’s dis. and maintain. clinic. response in adult pts. with moderat. to sev. active dis. who have had an inadequ. response to convent. ther.
C/I: Hypersens. Active tuberculosis or other sev. infec. such as sepsis or opportunist. infect. Moder-to sev. heart fail. (NYHA classes III/IV).