Israel - Englisch - Ministry of Health

j-c health care ltd - recombinant human erythropoietin - solution for injection - recombinant human erythropoietin 3000 iu / 0.3 ml - erythropoietin - treatment of severe anemia associated with chronic renal failure, anemia in zidovudine treated hiv infected patients, anemia in cancer patients on chemotherapy.to increase the yield of autologous blood from patients in a predonation programme initiated to avoid the use of homologous blood. treatment is indicated in patients with moderate anemia (packed cell volume (pcv) approximately 33 to 39% , no iron deficiency) if blood conserving procedures are not available or insufficient either: a: when the scheduled major elective surgery requires a large volume of blood ( 4 or more units of blood for females or 5 or more units for males) or b: when the period necessary to obtain the required volume of autologous blood is too short. perisurgery: reduction of allogeneic blood transfusion in surgery patients : eprex is indicated for the treatment of anemic patients (hemoglobin 9-11 g/dl) scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions. eprex is indicated for patients at high risk for periopertive transfusions with significant, anticipated blood loss. eprex is not indicated for anemic patients who are willing to donate autologous blood. the safety of the perioperative use of eprex has been studied only in patients who are receiving anticoagulant prophylaxis. eprex is indicated before surgerios known be associated with excessive blood loss (at least 2 units ).

Vereinigtes Königreich - Englisch - MHRA (Medicines & Healthcare Products Regulatory Agency)

recombinant) solution for injection 0.5ml pre-filled syringes (imported (united states) - recombinant haemagglutinin proteins - solution for injection

Kenia - Englisch - Pharmacy and Poisons Board

arwan pharmaceutical industries lebanon s.a.l jadra alchouf, mount lebanon, p.o.box: 613 – - recombinant human erythropoietin alfa - injection - each vial contains 4000iu/ml erythropoietin - erythropoietin

Israel - Englisch - Ministry of Health

merck serono ltd - follitropin alfa - powder for solution for injection - follitropin alfa 5.5 mcg/dose - follitropin alfa - follitropin alfa - 1) gonal-f followed by chorionic gonadotrophin (hcg) is recommended for the stimulation of follicular development and ovulation in women with hypothalamic-pituitary dysfunction who present with either oligomenorrhoea or amenorrhoea. these women are classified as w.h.o group ii patients and usually receive clomiphene citrate as primary therapy. they have evidence of endogenous oestrogen production and thus will either spontaneously menstruate or experience withdrawal bleeding after progestagen administration. polycystic ovarian disease (pcod) is part of the who ii classification and is present in the majority of these patients. 2) gonal-f is indicated for stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (art) such as in vitro fertillization (ivf) gamete intra-fallopian transfer (gift) and zogote intra-fallopian transfer (zift). 3) gonal-f is indicated with concomitant human chorionic gonadotrophin (hcg) therapy for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism.

Israel - Englisch - Ministry of Health

merck serono ltd - follitropin alfa - solution for injection - follitropin alfa 600 iu/ml - follitropin alfa - follitropin alfa - in adult women:• anovulation (including polycystic ovarian disease, pcod) in women who have been unresponsive to treatment with clomiphene citrate.• stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (art) such as in vitro fertilisation (ivf), gamete intra-fallopian transfer (gift) and zygote intra-fallopian transfer (zift).• follitropin alfa in association with a luteinising hormone (lh) preparation is recommended for the stimulation of follicular development in women with severe lh and fsh deficiency. in clinical trials these patients were defined by an endogenous serum lh level < 1.2 iu/l.in adult men:• follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hcg) therapy.

Singapur - Englisch - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - alglucosidase alfa - injection, powder, lyophilized, for solution - 52.5 mg - alglucosidase alfa 50 mg/vial

Europäische Union - Englisch - EMA (European Medicines Agency)

pharming group n.v. - recombinant human c1-inhibitor - angioedemas, hereditary - drugs used in hereditary angioedema, other hematological agents - ruconest is indicated for treatment of acute angioedema attacks in adults with hereditary angioedema (hae) due to c1-esterase-inhibitor deficiency.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

alexion pharmaceuticals australasia pty ltd - asfotase alfa, quantity: 40 mg/ml - injection, solution - excipient ingredients: sodium chloride; dibasic sodium phosphate heptahydrate; water for injections; monobasic sodium phosphate monohydrate - strensiq (asfotase alfa, rch) is indicated as enzyme replacement therapy in patients with paediatric-onset hypophosphatasia.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

alexion pharmaceuticals australasia pty ltd - asfotase alfa, quantity: 40 mg/ml - injection, solution - excipient ingredients: sodium chloride; dibasic sodium phosphate heptahydrate; water for injections; monobasic sodium phosphate monohydrate - strensiq (asfotase alfa, rch) is indicated as enzyme replacement therapy in patients with paediatric-onset hypophosphatasia.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

alexion pharmaceuticals australasia pty ltd - asfotase alfa, quantity: 40 mg/ml - injection, solution - excipient ingredients: sodium chloride; dibasic sodium phosphate heptahydrate; water for injections; monobasic sodium phosphate monohydrate - strensiq (asfotase alfa, rch) is indicated as enzyme replacement therapy in patients with paediatric-onset hypophosphatasia.