Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
721 Glycine 1.5% Irrigation Solution B05CX03000H3001XX A Bladder irrigation during genitourinary surgery The dosage depends on the extent of the procedure and its duration
722 Glycopyrrolate 200 mcg/ml Injection A03AB02-320-P30-01-XXX A* i) To reduce secretions (respiratory tract) for certain types of surgery
ii) Reversal of neuromuscular block in patients where atropine is contraindicated		 None i) ADULT: Pre-op: 4 mcg/kg via IM administration 30-60 mins before procedure. Intraoperative: 100 mcg via IV administration, repeat at 2-3 min intervals when needed. Max: 400 mcg/dose.
CHILD: 4 to 8 mcg/kg IM or IV (maximum 200mcg), may be repeated if necessary, during operation;

ii) ADULT: 200 mcg by IV for each 1 mg of neostigmine or 5 mg pyridostigmine
CHILD: 10 mcg/kg IV for each 50 mcg/kg neostigmine or equivalent dose of pyridostigmine.

Dosing is individualised and according to product insert/protocol
723 Glycopyrronium 50mcg, Inhalation Powder Hard Capsules R03BB06-320-A20-01-XXX A/KK For maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). The diagnosis of COPD should be confirmed by spirometry. One capsule daily.
The recommended dose is the inhalation of the content of one capsule once daily using inhaler.
It is recommended to be administered, at the same time of the day each day.
No relevant use of glycopyrronium in pediatric population (<18 years) for COPD.
724 Golimumab 100mg/ml Solution for Injection L04AB06000P5001XX A* i) Rheumatoid arthritis (RA): In combination with methotrexate (MTX), is indicated for: - The treatment of moderate to severe active rheumatoid arthritis in adult patients when the response to DMARD therapy including MTX has been inadequate. - The treatment of active, severe and progressive rheumatoid arthritis in adult patients not previously treated with MTX.
ii) Psoriatic arthritis (PsA): Golimumab alone or in combination with MTX, is indicated for: The treatment of active psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
iii) Ankylosing spondylitis (AS): Golimumab (used alone) is indicated for: The treatment of active ankylosing spondylitis in adult patients when the response to conventional therapy has been inadequate.		 i) Rheumatoid arthritis 50mg given as a subcutaneous injection once a month, on the same date each month.
ii) Psoriatic arthritis 50mg given as a subcutaneous injection once a month, on the same date each month.
iii) Ankylosing spondylitis 50mg given as a subcutaneous injection once a month, on the same date each month.
725 Goserelin 10.8 mg Depot Injection L02AE03000P2002XX A Androgen deprivation therapy in prostate cancer. One 10.8 mg depot injected subcutaneously into the anterior abdominal wall, every 12 weeks.
726 Goserelin 3.6 mg Depot Injection L02AE03000P2001XX A Androgen deprivation therapy in prostate cancer, endometriosis,leiomyoma uteri and assisted reproduction,breast cancer in premenopausal and perimenopausal women suitable for hormonal manipulation One 3.6 mg depot injected subcutaneously into the anterior abdominal wall, every 28 days.
727 Granisetron HCl 1mg Tablet A04AA02-110-T10-01-XX A Prevention and treatment of nausea and vomiting associated with chemotherapy and radiotherapy None ADULT 1 mg twice daily or 2 mg once daily with the first dose to be administered within 1 hour prior to cytostatic therapy and can be given for up to 1 week following radiotherapy. Maximum 9 mg/day
728 Granisetron HCl 1mg/ml Injection A04AA02-110-P30-01-XX A i) Prevention and treatment of nausea and vomiting associated with chemotherapy and radiotherapy ii) Post-operative nausea and vomiting None i) ADULT 1-3 mg as an IV bolus not not less than 30 seconds; maximum 9 mg/day. CHILD over 2 years; single dose of 10-40 mcg/kg as an IV infusion; maximum 3 mg/day ii) ADULT 1 mg by slow IV injection over 30 seconds prior to induction of anaesthesia
729 Griseofulvin 125mg Tablet D01BA01-000-T10-01-XXX B Dermatophyte infections of the skin, scalp, hair and nails, where topical therapy has failed or inappropriate None ADULT: 500mg-1000mg daily, taken as a single dose or in divided;
CHILD: 10mg-20mg/kg daily in divided doses.

The dosing is individualized according to product insert / protocol
730 Guselkumab 100mg/ml Solution for Injection L04AC16-000-P30-01-XXX A* Guselkumab is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis - As third-line therapy (after failing/intolerant/contraindicated to standard systemic drugs and/or phototherapy and/or IL-17 inhibitors)
- To be prescribed by Dermatologists only
 100 mg to be given as subcutaneous injection at week 0, week 4 and every 8 weeks thereafter.

Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment
731 Haemato Polyvalent Snake Antivenom Injection Nil B Passive immunisation against poisonous of a range of haematotoxic snakebites or neurotoxic snakebites, based on the type of snake identified. For initial does, at least 20mL of reconstituted serum should be given by slow intravenous infusion (not more than 1mL/minute). If symptoms still persist, the second dose should be repeated 2 hours or even earlier after the initial dose. The further dose should be repeated every 6 hours according to the clinical symptoms.

Administration: Draw 10mL of the sterile water for injection to the freeze-dried antivenin, shake well to dissolve the contents until the serum became clear colourless or pale yellow liquid, ready for administration.
732 Haemodialysis Concentrate with Acetate B05ZA00908H1001XX A For acute renal failure, chronic renal failure, overhydration, intoxication, adjustment of acid-base and electrolyte balance Dose depending on clinical cases
733 Haemodialysis Concentrate with Bicarbonate B05ZA00908H1002XX A For acute renal failure, chronic renal failure, overhydration, intoxication, adjustment of acid-base and electrolyte balance Dose depending on clinical cases
734 Haemophilus Influenza Type B Conjugate Vaccine Injection J07AG01000P4001XX C+ Immunisation of infants against Haemophilus Influenzae Type B 0.5ml by IM. In patients with thrombocytopenia or bleeding disorders, vaccine can be administered by SC.
735 Haloperidol 1.5 mg Tablet N05AD01-000-T10-01-XXX B i) Psychotic disorder – management of acute and chronic psychotic disorders including schizophrenia, manic states and drug-induced psychoses
ii) Management of aggressive and agitated patients, including patients with chronic brain syndrome or mental retardation.
iii) Gilles de la Tourette’s syndrome - for the control of tics and vocalisations of Tourette’s syndrome in children and adults.		 None ADULT: moderate symptoms: 0.5mg to 2.0mg bid/tid; severe symptoms, chronic or resistant: 3.0mg to 5.0mg bid/ tid
Geriatric / dehabilitated : 0.5mg to 2.0mg bid/tid maximum up to 100mg daily

CHILD: 3-13 years old (15 to 40 kg): 0.5mg/day increase by 0.5mg at 5 to 7 days in bid/tid, dosing range 0.05mg/kg/day to 0.15mg/kg/day

Dosing is according to product insert.
736 Haloperidol 5 mg Tablet N05AD01-000-T10-02-XXX B i) Psychotic disorder – management of acute and chronic psychotic disorders including schizophrenia, manic states and drug-induced psychoses
ii) Management of aggressive and agitated patients, including patients with chronic brain syndrome or mental retardation.
iii) Gilles de la Tourette’s syndrome - for the control of tics and vocalisations of Tourette’s syndrome in children and adults.		 None ADULT: moderate symptoms: 0.5mg to 2.0mg bid/tid; severe symptoms, chronic or resistant: 3.0mg to 5.0mg bid/ tid
Geriatric / dehabilitated : 0.5mg to 2.0mg bid/tid maximum up to 100mg daily

CHILD: 3-13 years old (15 to 40 kg): 0.5mg/day increase by 0.5mg at 5 to 7 days in bid/tid, dosing range 0.05mg/kg/day to 0.15mg/kg/day

Dosing is according to product insert.
737 Haloperidol 5 mg/ml Injection N05AD01-000-P30-01-XXX B i) Management of acute psychotic disorders including schizophrenia, manic states, and drug-induced psychosis.
ii) Management of aggressive and agitated patients, including patients with chronic brain syndrome or mental retardation.		 None ADULT: IM or IV , 2 mg - 10 mg then every 4 - 8 hours according to response to total maximum 18 mg daily.
Use in child is not recommended
738 Heparin 1000 units/ml Injection B01AB01520P3001XX B i) Prophylaxis and treatment of venous thrombosis and pulmonary embolism.
ii) Treatment of myocardial infarction and arterial embolism.
iii) Prevention of clotting in arterial and heart surgery and for prevention of cerebral thrombosis		 i) By IV injection, loading dose of 5000 units (10,000 units in severe pulmonary embolism) followed by continuous infusion of 15-25 units/kg/hr. By SC injection (for DVT) of 15,000 units every 12 hours (laboratory monitoring on daily basis essential to adjust dose). Small adult or child, lower loading dose then, 15-25 units/kg/hr by IV infusion, or 250 units/kg every 12 hours by SC injection. ii) As i), for unstable angina and acute peripheral arterial occlusion. iii) Prophylaxis in general surgery, by SC injection, 5000 units 2 hour before surgery, then every 8-12 hours for 7 days or until patient is ambulant, during pregnancy (with monitoring), 5000-10000 units every 12 hours. An adjusted dose regimen may be used for major orthopaedic surgery or low molecular weight heparin may be selected
739 Heparin 5000 units/ml Injection B01AB01520P3002XX B i) Prophylaxis and treatment of venous thrombosis and pulmonary embolism.
ii) Treatment of myocardial infarction and arterial embolism.
iii) Prevention of clotting in arterial and heart surgery and for prevention of cerebral thrombosis		 i) By IV injection, loading dose of 5000 units (10,000 units in severe pulmonary embolism) followed by continuous infusion of 15-25 units/kg/hr. By SC injection (for DVT) of 15,000 units every 12 hours (laboratory monitoring on daily basis essential to adjust dose). Small adult or child, lower loading dose then, 15-25 units/kg/hr by IV infusion, or 250 units/kg every 12 hours by SC injection.
ii) As i), for unstable angina and acute peripheral arterial occlusion.
iii) Prophylaxis in general surgery, by SC injection, 5000 units 2 hour before surgery, then every 8-12 hours for 7 days or until patient is ambulant, during pregnancy (with monitoring), 5000-10000 units every 12 hours. An adjusted dose regimen may be used for major orthopaedic surgery or low molecular weight heparin may be selected
740 Heparin Sodium 50 units in Sodium Chloride Injection B01AB01930P3001XX B To maintain patency of peripheral venous catheters Flush with 5 ml (50 units) every 4 hours or as required
741 Hepatitis A Vaccine Injection J07BC02000P5001XX A Immunisation against Hepatitis A. 0.5 – 1.0 ml by IM. Dosing is according to product insert.
742 Hepatitis B Immunoglobulin (Human) Injection J06BB04000P3001XX A i) For post-exposure prophylaxis of hepatitis B
ii) Prophylaxis against recurrence of hepatitis B infection in chronic hepatitis B post liver transplantation		 i) Adults: Recommended Dose: 1000-2000 IU IM and if necessary, the dose should be increased or repeated. Children: Inject 32-48 IU/kg of body weight, should be administered within 7 days after exposure to HBsAg (preferably within 48 hrs). Neonates: Recommended Initial Dose: 100-200 IU. The 1st dose should be administered within 5 days after birth (preferably within 48 hrs) and booster dose should be 32-48 IU/kg body weight. The booster dose should be administered between 2 and 3 months after the 1st administration.

ii) Different regimens depending on hepatitis B virus (HBV) DNA positivity
743 Hepatitis B Vaccine Injection J07BC01000P4001XX C+ Immunisation against infections caused by Hepatitis B virus. 0.5 – 1.0 ml by IM. Dosing is according to Immunisation Schedule under NIP and product insert.
744 Homatropine 2% Eye Drops S01FA05-330-D20-03-XXX B i) Mydriasis and cycloplegia for refraction
ii) Treatment of anterior segment inflammation		 None i) Adult: Instill 1 or 2 drops of 2% solution immediately before the procedure, repeat at 5-10-minute intervals if necessary. Child: Instill 1 drop of 2% soln immediately before the procedure, repeat at 10-min intervals if necessary.

ii) Adult: Instill 1-2 drops of 2% bd-tds up to every 3-4 hr as needed. Child: 3 mth- 2 yr: instill 1 drop of 0.5% soln once daily or on alternate days. >2 yr: instill 1 drop of 1% or 2% soln bd.
745 Human Albumin Injection B05AA01000P3001XX B i) Acute hypovolemic shock
ii) Hypoproteinaemia
iii) Restoration and maintenance of circulating blood volume in cases of volume deficiency where the use of a colloid is indicated.		 Dosing is according to product insert/ protocol.
746 Human Normal Globulin Injection J06BA02-000-P30-01-XXX A i. Replacement therapy such as:
a) Primary immunodeficiency syndromes
b) Severe secondary hypogammabulinaemia and recurrent infections
c) Congenital or acquired immune deficiency syndrome with recurrent infections
d) Allogeneic haematopoietic stem cell transplantation (HSCT)

ii. Immunomodulation such as:
a) Immune thrombocytopenic purpura (ITP) in children or adults at high risk of bleeding or prior to surgical interventions to correct the platelet count
b) Guillain-Barre syndrome
c) Kawasaki disease		 0.2-2g/kg as required

Dosing and frequency of administration are according to product insert and protocol.
747 Human Papillomavirus (Types 16, 18) Vaccine Injection J07BM02000P3001XX C+ For the prevention of cervical cancer due to papilloma virus. To be used as part of NIP only. Given by IM into deltoid region. ADULT and CHILD 10 - 25 years, 3 doses of 0.5 mL, at 0, 1 and 6 months
748 Human Papillomavirus (Types 6, 11, 16, 18) Vaccine Injection J07BM01000P3001XX C+ For the prevention of cervical cancer due to papilloma virus. To be used as part of NIP only. Given by IM into deltoid region or higher anterolateral thigh. ADULT and CHILD 9 - 26 years, 3 doses of 0.5 mL, at 0, 2 and 6 months
749 Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine Injection J07BM03-963-P50-01-xxx C+ For the prevention of cervical cancer due to the papillomavirus. To be used as part of the National Immunisation Programme (NIP) only As per the National Immunisation Programme (NIP)
750 Hydralazine HCl 20mg Injection C02DB02-110-P30-01-XX B Hypertensive crisis in pregnancy None i) Slow IV injection, ADULT: 5-10 mg diluted with 10ml sodium chloride 0.9%. May be repeated after 20-30 minutes if necessary. ii) IV infusion 200-300 mcg/minutes. Maintenance dose 50-150 mcg/minutes

Pages