Merck Serono Ltd

Human Monoclonal Antibody. Avelumab 20 mg / ml.
VIAL (conc. For sol. For infus.) 1 x 10 ml. MCC or UC: 800 mg or 10 mg/kg body weight, accord. to treat. Physician's discretion, admin. as a IV infus. over 60 min. every 2 wks. until dis. progress. or unacceptab. toxicity.
RCC: 800 mg or 10 mg/kg body weight, accord. to treat. Physician's discretion, admin. as a IV infus. over 60 min. every 2 wks. in comb. with axitinib 5 mg oral. taken twice daily until dis. progress. or unacceptab. toxicity. see lit.
Tmt. of adlt.pts. with metastat. Merkel cell carcinoma (MCC).
Maint. tmt. of pts. with local. adv. or metastat. urothelial carcinoma (UC) that has not progress. with first-line platinum-containing chemother.
Tmt. of pts. with local. adv. or metastat. urothelial carcinoma (UC) who:
- Have dis. progress. during or follow. platinum-containing chemother.
- Have dis.  progress. within 12 months of neoadjuvant or adjuvant tmt.
  with platinum-containing chemother.
First-line tmt. of pts. with adv. renal cell carcinoma (RCC) in comb. with axitinib.
C/I: Hypersens.

GnRH Antagonist. Cetrorelix (as acetate) 0.25 mg/vial.
Powder and solv. for SC. inj. 0.25 mg/ vial . Once daily, first dose to be admin. under med. supervision.
Preven. of premat. ovul. in pts. undergoing a contr. ovarian stimul. for IVF.
C/I: Hypersens. to the act. subst. or any struct. analogues of GnRH, extrins. pept. hnes., mannitol.
• pregn. and lact.
• sev. renal impair

β1 Blocker. Bisoprolol Fumarate 1.25 mg, 2.5 mg , 5 mg, 10 mg.
FC tabs, 30X1.25/2.5/5/10 mg. Dosage for Chron. Heart Fail.:start uptitr.:
- 1.25 mg 1/d for 1 week, if well tol. incr. to
- 2.5 mg 1/d for a further week, if well tol. incr. to
- 3.75 mg 1/d for a further week, if well tol. incr. to
- 5 mg 1/d for 4 foll. weeks, if well tol. incr. to
- 7.5 mg 1/d for 4 foll. weeks, if well tol. incr. to
- 10 mg 1/d for maint. ther. (max recomm. dose.)
Dosage for Hypertension: 2.5-10 mg 1/d, see lit.
Dosage for Coronary heart dis. (angina pect.):5-10 mg 1/d
max. recomm. dose: 20 mg/d
Treat. of stable chr., moder. to sev. heart fail.
with impaired systol. ventric. function
(EF < 35 %, by echocardiography) in addit.
to ACE inhibit. and diuret., and option. cardiac glycosides.
For 5mg and 10 mg doses:
Hypertension
Coronary heart disease (angina pectoris)
C/I: ac. HF or during episodes of decompens. req. i.v. inotropic ther./ cardiogenic shock /second or third degree AV block /sick sinus syndr./ sinoatrial block/ sympt. bradyc./ sympt. hypotens. / sev. bronchial asthma / sev. forms of peripheral arterial occlusive dis. or sev. forms of Raynaud's syndr./
untreat. phaeochromocytoma (see prescr. inform.) / metabolic acidosis/ hypersens.

EGFR Inhibitor, Monoclonal Antibody. Cetuximab 5 mg/ml.
VIAL (I.V. infus.): 20 ml, 100 ml. Initial: 400 mg/m², foll. by 1 x wkly. dose of 250 mg/m². See lit.
Tmt. of pts. with (EGFR)-expressing, RAS
wild-type metast. colorectal canc. in
comb. with irinotecan-based chemot., in
1st -line in comb. with FOLFOX, as a single
agent in pts. who have failed oxaliplatin and irinotecan- based ther. and who
are intoler. to irinotecan. Tmt. of pts. with
squamous cell canc. of the head and neck
(SCCHN), in comb. with rad. ther. for
local. advanced dis., in comb. with
platinum-based chemo. for recur. and/
or metast. dis., as a single agent after fail.
of platinum-based chemo. for recur.
and/or metast. dis.
C/I: Severe hypersens, The comb. with
oxaliplatin-cont. chemot. is contraindic.
for pts. with mutant RAS metast.
colorectal canc. (mCRC) or for whom
RAS mCRC status is unknown.
Contraind. for concom. used chemot.
agents or rad. ther. must be
considered before init. of comb. tmt.

Thyroid Hormones. Levothyroxine Sodium 25 mcg, 50 mcg, 100 mcg.
SCORED TABS: 100 x 25 μg, 100 x 50 μg, 100 x 100 μg.
Start with low dose, increase grad.
every 2-4 wks until full replace. dose
reached, see lit.
Benign euthyroid goitre, prophylax.
relapse aft. surgery for euthyroid goitre,
hypothyroidism., supp. ther. thyroid
cancer, during anti-thyroid drug tmt.,
diagnost. use, See lit.
C/I: Hypersens., untreated adrenal and/
or pituitary insuffic., untreat.
thyrotoxicos., acute MI, acute
myocarditis, acute pancarditis.
Combination therapy of levothyroxine and an antithyroid agent for hyperthyroidism is not indicated during pregnancy. See lit.

Gonadotropin. Follitropin Alfa 600 IU/ml.
PRE-FILLED PEN: Follitropin alfa 600 IU/
ml (eq. 44 μg/ml) for S.C. inj. 1 x 300 IU (eq. to 22
μg)/0.5ml; 1 x 450 IU (eq. to 33 μg)/0.75ml
1 x 900 IU (eq. to 66 μg)/1.5ml. 
Women with anovul. (incl. polycystic ovar. syndr.):
Admin. as a course of daily inject. In menstr. women tmt. should start within the first 7 days of cycle. Common regim. starts at 75 to 150 IU FSH daily and is incr. prefer. by 37.5 or 75 IU at 7- or prefer. 14-days intervals if necessary, to obtain an adeq., but not excess., response. Tmt. should be tailored to patient's respon. by measur. follicle size by US and/or estrog. secret. The max. daily dose is usually not higher than 225 IU FSH. See prescr. details
Women undergoing ovar. stimul. for mult. follicular develop. prior to IVF or other assisted reprod. techn.:
Common regim. for superovul. is 150 to 225 IU/d, start on days 2 or 3 of cycle. Tmt. is cont. until adeq. follicular dev. (as by US and/or serum estrogen concentr.) achieved, with dose adjust. to patient's resp., to usually not higher than 450 IU/d. See prescr. details.
Women with anovul. result. from sev. LH and FSH defic.:
In LH and FSH defic. women (hypogonadotrophic hypogonadism), the object. of this ther. in assoc. with lutropin alfa is to develop single mature Graafian follicle from which the oocyte will be liberated after administr. of human chorionic gonadotrophin (hCG). This tmt. should be given as a course of daily inject. simultan. with lutropin alfa. Since pts. are amenorrhoeic and have low endogen. estrogen secret., tmt. can commence any time. Recommend. regimen starts at 75 IU of lutropin alfa daily with 75 to 150 IU FSH. Tmt. should be tailored to ptt's respon. by measur. follicle size by US and estrog. respon. See prescr. details.
Men with hypogonadotrophic hypogonadism:
Admin. 150 IU 3/w, concom. with hCG, for a min. of 4 months. If no resp. achieved, combin. tmt. for 18 months may be necessary to achieve spermatogen.
See prescr. details.
In adult women:
Anovulat. (incl. polycystic ovarian syndr.) in women unrespon. to clomiphene citrate  tmt.
Stimul. of multifollicular dev. in pts. undergoing superovulat. for assisted reprod. techn. (ART) such as in vitro fertil. (IVF), gamete and zygote intra-fallopian transfer (GIFT and ZIFT).
in assoc. with a lutein. horm. (LH) prepar. for the stimul. of follicular dev. in women with sev. LH and FSH defic. In clin. trials these pts. were defined by an endog. serum LH level < 1.2 IU/L.
In adult men:
Stimul. of spermatogen. in men with congen. or acquired hypogonadotrophic hypogonadism with concom. human chorion. gonadotrophin (hCG) therapy.
C/I: hypersens.• tumours of the hypothal. or pituitary gland • ovarian enlargem. or ovar. cyst unrel. to polycystic ovar. dis. and of unknown origin • gynaec. haemorrhages of unkn. origin • ovar., uterine or mammary carc.
must not be used when an effect. resp. cannot be obtained, such as:
• primary ovar. fail. • malform. of sexual organs incompat. with pregn.
• fibroid tumours of the uterus incompat. with pregn. • prim. testic. insuff.