Anti-Parathyroid Agent. Etelcalcetide 5 mg/ml.
VIAL (Sol. for inj.): 6×0.5,1,2. The recomm. init. dose of etelcalcetide is 5 mg admin. by bolus inj. 3 times/wk. Corrected serum calcium should be at or above the lower limit of the normal range prior to admin. of first dose of etelcalcetide, a dose incr., or reinitiation after a dose stop (see also dose adjust. based on serum calcium levels). Etelcalcetide should not be admin. more frequen. than 3 times/wk.
Dose titration: Etelcalcetide should be titrated so that doses are individ. betwn. 2.5 mg and 15 mg. The dose may be incr. in 2.5 mg or 5 mg increm. no more frequent. than every 4 wks. to a max. dose of 15 mg 3 times/wk. to achieve the desired parathyroid hormone (PTH) target.
Dose adjust. based on PTH levels: PTH should be measured after 4 wks. from init. or dose adjust. of etelcalcetide, and approx. every 1-3 mnths. during mainten. Dose adjust. may be necessary at any time during tmt. includ. the maintenan. phase. See lit.
Treatment of secondary hyperparathyroidism (SHPT) in adult patients with chron. kidney disease (CKD) on hemodialysis ther.
C/I: Hypersens. Pts. with level of the calcium less than the lower limit of the normal range.

CGRP Antagonist, Monoclonal Antibody. Fremanezumab 225 mg.
PREFILLED SYR (sol. for SC inj.): 1,3× 1.5ml. Tmt. is intended for pts. with at least 4 migraine days/month when initiat. tmt.  with fremanezumab.
Two dosing options are available:
225 mg once mnthly. (mnthly. dosing) or 675 mg every three mnths. (quarterly dosing).
When switching dosing regimens, the first dose of the new regimen should be admin. on the next scheduled dosing date of the prior regimen.
When initiat. tmt. with fremanezumab, concom. migraine prevent. tmt. may be continued if consid. necessary by the prescriber.
The tmt. benefit should be assessed within 3 mnths. after init. of tmt. Any further decision to continue tmt. should be taken on an individ. pt. basis. Evaluation of the need to continue tmt. is recomm. regularly thereafter.
Missed dose: If a fremanezumab inject. is missed on the planned date, dosing should resume as soon as possible on the indicated dose and regimen. A double dose must not be admin. to make up for a missed dose.
Indicat. for prophylaxis of migraine in adult. who have at least 4 migraine days per month.
C/I: Hypersens.

Neuromuscular Blocker Agent. Botilium Toxin (type A (150 kDa), free from complexing proteins) 50 U, 100 U.
VIAL (pwdr. for sol. for inj.): 1,2,3,6 ×50, 100 Units. Dosage should be ajust. individ.
Symptomatic treatment of blepharospasm, cervical dystonia of a predominantly rotational form (spasmodic torticollis) and of post-stroke spasticity of the upper limb presenting with flexed wrist and clenched fist in adults.
Indicated for the temporary improvement in the appearance of moder.-severe vertic. lines betwn. eyebrows seen at frown (glabellar frown lines) in adults below 65 years when the severity of these lines has an important psychological impact for the pt.
C/I: Hypersens. Generalised disord. of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndr.). Infect. or inflamm. at the proposed inj. site.

Immunoglobulins. Human Normal Immunoglobulin 100 g/l.
VIAL (sol. for infus.): 1x10 ml, 25 ml, 50 ml, 100 ml, 200 ml. Replacement ther. in primary immunodefic., init. dose: 0.4-0.8 g/kg, thereafter 0.2-0.8 g/kg every 3-4 wks. to obtain IgG trough level of at least 5-6 g/l.
Replacem. ther. in second. immunodefic.: 0.2-0.4 g/kg, every 3-4 wks. to obtain IgG trough level of at least 5-6 g/l.
Congenit. AIDS: 0.2-0.4 g/kg, every 3-4 wks.
Hypogammaglobulinaemia (<4 g/l) in pts. after allogeneic haematopoietic stem cell transplant.: 0.2-0.4 g/kg, every 3-4 wks. to obtain IgG trough level above 5 g/l.
Prim. immune thrombocytop.: 0.8-1 g/kg on day 1, possibly repeated once within 3 days, or 0.4 g/kg/d for 2-5 d.
Guillain Barré syndr.: 0.4 g/kg/d for 5 d.
Kawasaki dis.: 1.6-2 g/kg in divided doses over 2-5 d. in assoc. with acetylsalic. acid or 2 g/kg in one dose in assoc. with acetylsalic. acid.
Method of admin.: initial rate of not more than 1.4 ml/kg/h for 30 min.
If well toler., the rate of admin. may gradual. be incr. to a max. of 1.9 ml/kg/h for the remainder of the infus.
Replacement Therapy: In pts. who have tolerated the infus. rate of 1.9 ml/kg/h well, the rate may be gradual. incr.to 6 ml/kg/h and if still tolerat. well, it may be further incr. gradual. to a max. of 8 ml/kg/h.
In general, dosage and infus. rates have to be individ. tailor. accord.to the pt's needs.
Replacem. ther. in adult., and child. & adolesc. (0-18 yrs.) in:
Primary immunodefic. syndr. with impair. antibod. product.
Hypogammaglobulinaemia and recur. bact. infec. in pts. with chron. lymphocytic leukaemia, in whom prophylact. antibiotics have failed.
Hypogammaglobulinaemia and recur. bact. infec. in plateau phase multiple myeloma pts. who have failed to respond to pneumococcal immunisat.
Hypogammaglobulinaemia in pts. after allogen. haematop. stem cell transplant. (HSCT).
Congen. AIDS with recur. bact. infec.
Immunomodulat. in adul., and child. and adolesc. (0-18 yrs.) in:
Prim. immune thrombocytop. (ITP), in pts. at high risk of bleed. or prior to surg. to correct the platelet count.
Guillain Barré syndr.
Kawasaki dis.
C/I: Hypersens. Pts. with selective IgA defic. who develop. antibod. to IgA, as admin. an IgA-contain. product can result in anaphylax.

Nonselective β-Blocker. Propranolol (HCl) 3.75 mg/mL.
GLASS BOTTLE (oral sol.): 120ml. For oral use. It should be admin. directly into the child's mouth using the graduated oral syr., calibr. in mg of propranolol base, suppl. with the oral sol. bottle, during/ right after meal. to avoid the risk of hypoglycaemia. The posology is expressed in propranolol base.
Init. dose is 1 mg/kg/d. which is divided into two separate doses of 0.5 mg/kg. It is recom. to incr. the dose up to the therap. dose under med. supervis. as follows: 1 mg/kg/d for 1 wk., then 2 mg/kg/d for 1 wk. and then 3 mg/kg/d as a mainten. dose.
The therap. dose is 3 mg/kg/d., which is to be admin. into 2 separate doses of 1.5 mg/kg, one in the morn. and one in late afternoon, with a time interv. of at least 9 hrs. betwn. two intakes.
If the child is not eating or is vommit.-skip the dose. In case the child spits up a dose or does not take all of the med., no other dose should be given before the next scheduled dose.
During the titrat. phase, each dose incr. must be manag. and monitor., by a physician in the same condit. as the admin. of the init. dose. After the titrat. phase, the dose will be readjust. by the physician accord. to the changes in the child’s weight.
Clinical monitor. of the child condition, and dose readjust., need to be performed at least mnthly.
Durat. of tmt.: This med. should be admin. for a 6-month period.
Discontinuat. of tmt. does not require a progres. decr. in the dose.
In the minor, of pts. show. a relapse of sympt. after tmt. discont. tmt. may be re-initiat. under the same condit. with a satisfact. response.
The bottle should not be shaken before use.
Tmt. of proliferat. infantile haemangioma requiring system. ther.:
Life- or funct.-threatening haemangioma,
Ulcerated haemangioma with pain and/or lack of response to simple wound car measures, Haemangioma with a risk of permanent scars or disfigurement.
It is to be initiated in infants aged 5 wks.-5 mnths.
C/I: Premature infants, for whom the corrected age of 5 weeks has not been reached (the corrected age being calculated by subtracting the number of weeks of prematurity from the actual age). Breastfed infant., if the mother is treated with meds. contraindic. with propranolol. Hypersens. Asthma/hist. of bronchospasm. 2^nd/3^rd -degree AV blocks. Dis. of the sinus node (includ. sinoatrial block). Bradycardia below the follow. limits: child(0-3 mnths.) whose heart beat.=100, child(3-6 mnths.) whose heart beat.=90, child(6-12 mnths.) whose heart beat.=80. Low blood press. below the follow. limits: child(0-3 mnths.) whose blood press. (mmhg)=65/40, child(3-6 mnths.)  whose blood press. (mmhg)=70/50, child(6-12 mnths.) whose blood press. (mmhg)=80/55.

TNF-A Inhibitors. Infliximab 100 mg.
VIAL: 1,2,3,5×15 ml. Dosage should be ajust. individ. according to the pt. medical cond. See lit.
RA: In comb. with methotrexate- reduct. of signs and sympt. as well as the improve. in physical funct. in:
Adult pts. with active dis. when the response to dis. modif. antirheum. drugs (DMARDs), includ. methotrexate, has been inadeq.
Adult pts. with severe, active and progress. dis. not previous. treated with methotrexate or other DMARDs. In these pt. populations, a reduct. in the rate of the progres. of joint damage, as measured by X ray, has been demonstr.
Ankylosing spondylitis: Tmt. of severe, active ankylos. spondylitis, in adult pts. who have responded inadeq. to convent. ther.
Psoriatic arthritis: Tmt. of active and progres. psoriat. arthritis in adult pts. when the response to previous DMARD ther. has been inadeq. the drug should be admin. in comb. with methotrexate or alone in pts. who show intoler. to methotrexate or for whom methotrexate is contraind.
Infliximab has been shown to improve physical func. in pts. with psoriat. arthrit., and to reduce the rate of progress. of peripher. joint damage as measured by X ray in pts. with polyarticular symmetry. subtypes of the dis.
Psoriasis: Tmt. of moder. to sev. plaque psorias. in adult pts. who failed to respond to, or who have a contraindicat. to, or are intolerant. to other system. ther. include, cyclosporine, methotrexate or psoralen ultra-violet A (PUVA).
Adult Crohn’s dis.: Moder. to sever. active Crohn’s dis., in adult pts. who have not respond. despite a full and adequate course of ther. with a corticosteroid and/or an immunosuppressant; or who are intoler. to or have med. contraindicate. for such therapies. Tmt. of fistulising, active Crohn’s dis., in adult pts. who have not responded despite a full and adequate course of ther.  with convent. tmt. (includ. antibiotics, drainage and immunosuppressive ther.).
Ulcer. colitis: Tmt. of moder. to sever. active ulcerat. colitis in adult pts. who have had an inadeq, response to convent. ther. includ. corticosteroids and 6 mercaptopurine (6 MP) or azathioprine (AZA), or who are intoler. to or have medical contraindicat. for such therapies.
C/I: Hypersens. the active substance, to other murine proteins. Pts. with tuberculosis or other severe infec. such as sepsis, abscesses, and opportunis. infec. Pts. with moder. /severe HF (NYHA class III/IV).