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  ű ǰ, ǰ ǰ : DMXT100  ۼ

					

					

HL 22-59

ǰ

 

ű ǰ, ǰ ǰ ˷帮 ῡ Ͻñ ٶϴ.

 

212. ƿ

Mexiletine hydrochloride

DMXT100 100mg/Cap Mexilen Cap(߽Ƿ ĸ)(ڷ) (212)

[] Class IB ׺ Na ϰ, ȿ Ȱ ӽð Ŵ.

[ȿ] ɽǼ, Ż ɽǼ, Ư߼ɽǼ ܼ, ޼ɱٰ ɽǼ.

[] ʱ Ͽ뷮 : ߽Ƿƾ꿰 400mg(ִ 600mg, ޼ɱٰ ), 1ȸ 200-250mg, 1 3~4ȸ .

[] , ɽǺ, , , QRS, л, ɰ, , ξйڰ, , , Ŀ, κ谨, 󺹺, , , , ظ, ȭҷ, ۿ, , , , , Ҹ, , ̸, , , , , , , ȯ, , ÷ºҼ, ȫ, , ߿, Ź, ȫ, , ȣ߼ , , ǰ, ȣ걸, , , ˷, , ̰̻, ̻, , εȭ, , .

[ݱ] Ǵ Ҹ(ī) , ڱ( 2, 3 ), ޼ ɺ, μ , ɱ 3 ȯ, ϴ ȯڸ ȯ, ҳ.

[] ΰڵ(̽Ŀ) Ǵ Ͻ ڵ ǽ ȯ. ȯ(ɱٰ, Ǹ, ɱ), ڱ(ҿ Ǻ, ), (), (, ), , ɺ, , Ųı, , ûĮ ȯ. ׸䳪, ƽ׹ . ī, īξƹ̵, ϵ, Į, -, , Ʈ, ȭ׳׽, ȭ˷̴, ϴ , øƼ, ǽ, , ٸŻ, ׿ʸ, ī, ٸ ׺,  ġ ๰, ȿҿ ִ , 꼺ȭŰų Įȭ Ű ๰ . Ӻ/Ӻ, , /Ҿ. , ǿ(1~30).

[Ӻ] Ȯ.

 

 

341. ΰ

CDSA Powder 0.1%

DHD-CDSA 29.273 , Sodium chloride 21.27, Potassium chloride 0.522, Magnesium chloride hydrate 0.356, Calcium chloride hydrate 0.772, Sodium acetate hydrate 2.853, Glucose 3.5(𿡽 0.1%)(̾) (341)

[] ̿ Ȯ ϰ ̸ ѿ .

[ȿ] ź Ǵ ΰ : 1. ԵǾ ʴ δ ġ ȯ, 2. ٸ ź δ Į, ׳׽ Ǵ Į ų ִ .

[] ȯ ϴ ΰ ΰ ⼺ Ͽ Ͽ .

60~72L ȥտ⿡ ִ´.

(ƼƮ곪Ʈȭ)1 õõ ְ ´.

ȸ(ȭƮ)3, Ķ(ȭ׳׽ȭ)1, (ȭĮȭ)1, (ȭĮ)1, () 1 ܰ ȥտ⿡ ִ´.

100L ǵ ߰ Ѵ.

簡 Ѵ.

[] , , ü, л°, Į̻, ұı(, , , , ǽȥŹ, , °), , .

[ݱ] ֻ糪

[] Ǵ 索 ʻ , Ż ü . ΰ װ źҳƮ ܵ ؼ ȵǸ ħ Ƿ ľ ȥ . 񼮾 ؾ ϸ 񼮳, , , pH(7.27.4), µ Ȯ. , (ȥ 38 2ð ʰϴ , ҿ뼺 ̹ ߻ǰ ̷ ؼ ȵ). ǿ(1~30 ).

[Ӻ] Ȯ.

[] DHD-CDSC(𿡽 ) ü.

 

 

421. ׾Ǽ

Capmatinib hydrochloride

DC-CMNB150 183mg(150mg as capmatinib)/Tab Tabrecta Tab 150mg(Ÿ귺Ÿ 150mg)(Ƽ) (421) ޿

DC-CMNB200 244mg(200mg as capmatinib)/Tab Tabrecta Tab 200mg(Ÿ귺Ÿ 200mg)(Ƽ) (421) ޿

[] MET(mesenchymal-epithelial transition) Tyrosine Kinase ü λȭȿ MET λȭ ϰ MET ֿ ȣ θ Ȱȭϴ MET 14 Ǵ MET ̴ Ͽ ϰ ̸ Ŵ.

[ȿ] MET 14 Ȯε ༺ Ǵ ̼ Ҽ ġ.

[] 1ȸ 400mg, 1 2ȸ. ๰ ̻ 1 (1ȸ 300mg, 1 2ȸ), 2 (1ȸ 200mg, 1 2ȸ).

[] ȣ, , , ǰ ȭ, , ʺ, Ƿ, ALT/AST , ũƼ , , , , ɺ, ǰ ȭ, ILD/, ľ , , , Ŀ , λ, Ʈ , ħ, , , ƹж , ޼忰, ˺ι , Ҿ, , ε巯, ޼ ջ, , - , ߿, ü .

[ݱ] п .

[] Ǵ ÷ῡ MET 14 (skipping) Ȯؾ . (ALT, AST, ), ƹж, ľ ͸. CYP3A (Ŭθ̽, ε𳪺, Ʈڳ) CYP3A (, ǽ ƮƮ), ߵ CYP3A (ĺ), pH Ű ๰( , H2-ü , ) . ΰ 輺(ڿܼ ). Ӻ, , /Ҿ. м Ұ. 25 Ͽ .

[Ӻ] Ȯ.

[] Ǿǰ.

 

 

Lorlatinib

DC-LLNB100 100mg/Tab Lorviqua Tab 100mg(κť 100mg)(ȭ) (421)

DC-LLNB25 25mg/Tab Lorviqua Tab 25mg(κť 25mg)(ȭ) (421)

[] ALK/ROS1 缺 Ͽ ϴ ALK(Anaplastic Lymphoma Kinase) ROS1(C-ROS Oncogene 1) ǥ ϴ ̰ 3 tyrosine kinase kinase Ͽ ȣ Ͽ ALK ROS1 ϴ ļ .

[ȿ] λȭȿ(ALK)-缺 ̼ Ҽ(NSCLC) ȯ ġ.

[] 1ȸ 100mg, 1 1ȸ 汸 , ̻ ༺ ٰϿ 1 (1ȸ 75mg, 1 1ȸ), 2 (1ȸ 500mg, 1 1ȸ).

[] ݷ׷, ߼, , ʽŰ溴, ü, , Ƿ, , , п, , ź , Żºȭ, þ, , , ü, .

[ݱ] п , CYP3A4/5 , ҳ.

[] ġ ALK . ȯ(ILD)/. CYP3A4/5 (Ʈڳ, ڳ, ڳ) CYP3A (ǽ, īٸ, , ƮƮ) . Ӻ, , /Ҿ. . м Ұ( Ұ). ǿ(1~30).

[Ӻ] Ȯ.

[] Ǿǰ.

 

 

Triptorelin pamoate

DH-DGR22.5J 31mg(22.mg as triptorelin)/Vial Diphereline SR Inj(22.5mg)(Լ) (421)

[] GnRH ռ ü ʱ⿡ LH, FSH к ϳ 2 ϼü GnRH ü down regulation ȣ к .

[ȿ] 1. ȣ ༺ Ǵ ̼ , 2. ߼ .

[] 1̾ 6(24) ȸ ֻ.

[] , , ٸ̻, , ߱( , ), , ȸȫ, , , ֻ(, ), , , ü , ٰݰ , , , , , , кȭ, , , (, , ڱ, к, ), , .

[ݱ] GnRH ü Ǵ ÷ , Ӻ/Ӻ, , ȣ ȯ, ȯ ࿡ ̻ ׽佺׷ Ҹ ȯ, ӻ ٰ Ǵ е Ͽ ٰ , ܵ ϼü ȯ.

[] ȯ. ٰ ߰ Ұ ִ ȯ. ߻ , ޴ ȯڴ ֻ . ζƾ ġ Ű ๰, ڱȣ к ȭô ๰, QT Ű ๰(ϵ, ƹ̿ٷ, Ÿ, Class IA(ϵ, Ƕ̵), Class (ƹ̿ٷ, Ÿ, ƿ̵, ̺ƿ̵), ׺ ๰, Ÿ, ÷ϻ, ź . Ӻ, , /Ҿ. (ֻ 2mL) Ͽ Źϰ 1ȸθ . . 25 .

[Ӻ] Ӻαݱ 1.

[] DH-LPR22.5J(DPS 22.5mg ü).

 

ǰ

ڵ

Է

ǰ

(ȸ)

ǽ

DNB-ITR

Ipratropium Br 500mcg/2ml BTL

Aventro Injalation Soln

ƺƮ Ծ

()

ߴ

ü:

DNB-BJITR

ƮκƮ

DHD-CDSC

(1Box=8) 3 Sodium chloride 22.5, 1 Calcium chloride hydrate 0.644, 1 Potassium chloride 0.522, Ȳ 1 Magnesium chloride hydrate 0.356, 1 Citric acid hydrate 0.49, 1 Glucose 3.5

CDSC POWD

𿡽

(̾)

ߴ

ü:

DHD-CDSA

𿡽 0.1%

 

DALRX2000J

Eftrenonacog alfa 2081IU (Recombinant factor IX Fc-fusion protein)/Vial

Alprolix Inj 2000IU

θ 2000IU

( ƺƼ)

Ͻǰ

ü :

DALRX2155J

 

ǰ

ڵ

Է

ǰ

(ȸ)

ǽ

DE-OF

Ofloxacin 0.3%/5mL Btl

Tarivid Otic Soln

Ÿ ̿

()

2022.10.27

ű

ڵ

Է

ǰ

(ȸ)

ǽ

DNB-BJITR

Ipratropium Br 500mcg/2ml BTL

Atrovent UDV Sol.

ƮκƮ Ծ UDV

(ΰ)

DNB-ITR

ü

 

2022.10.27

DALRX2155J

Eftrenonacog alfa 2155IU (Recombinant factor IX Fc-fusion protein)/Vial

Alprolix inj.2000IU

θ2000

( ƺƼ)

DALRX2000J ü

 

 

2022. 10. 27.

ǰ ( 9561)