HUMALOG MIX50 KWIKPEN 100 UNITS/ML

LILLY FRANCE - FRANCEELI LILLY ITALIA S.P.A. (ITALY)🇸🇬 Health Sciences Authority

Approval Date: Oct 5, 2011
Approval ID: a3139a3be0feb85b
Company: LILLY FRANCE - FRANCEELI LILLY ITALIA S.P.A. (ITALY)
Type: Therapeutic

Approval Details

Approval Id: a3139a3be0feb85b
Drug Name: HUMALOG MIX50 KWIKPEN 100 UNITS/ML
Product Name: HUMALOG MIX50 KWIKPEN 100 UNITS/ML
Approval Number: SIN14025P
Approval Date: 2011-10-05
Registrant: DKSH SINGAPORE PTE. LTD.
Licence Holder: DKSH SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION
Dosage: 4.2 Posology and method of administration Posology The dosage should be determined by the physician, according to the requirement of the patient. Humalog Mix50 may be given shortly before meals. When necessary, Humalog Mix50 can be given soon after meals. Humalog Mix50 should only be given by subcutaneous injection. Under no circumstances should Humalog Mix50 be given intravenously. The rapid onset and early peak of activity of Humalog itself is observed following the subcutaneous administration of Humalog Mix50. This allows Humalog Mix50 to be given very close to mealtime. The duration of action of the insulin lispro protamine suspension component of Humalog Mix50 is similar to that of a basal insulin (NPH). The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual. As with all insulin preparations, the duration of action of Humalog Mix50 is dependent on dose, site of injection, blood supply, temperature, and physical activity. Special populations Renal impairment Insulin requirements may be reduced in the presence of renal impairment. Hepatic impairment Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for gluconeogenesis and reduced insulin breakdown; however, in patients with chronic hepatic impairment, an increase in insulin resistance may lead to increased insulin requirements. Paediatric population The safety and effectiveness of Humalog Mix50 in patients less than 18 years of age have not been established. Method of administration Subcutaneous administration should be in the upper arms, thighs, buttocks, or abdomen. Use of injection sites should be rotated so that the same site is not used more than approximately once a month, in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see section 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). When administered subcutaneously care should be taken when injecting Humalog Mix50 to ensure that a blood vessel has not been entered. After injection, the site of injection should not be massaged. Patients must be educated to use the proper injection techniques. KwikPen The KwikPen delivers 1 – 60 units in steps of 1 unit in a single injection. The needed dose is dialled in units. The number of units is shown in the dose window of the pen.
Route Of Administration: SUBCUTANEOUS
Indication Info: 4.1 Therapeutic indications Humalog Mix50 is indicated for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.
Contraindications: 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Hypoglycaemia.
Atc Code: A10AB04
Atc Item Name: insulin lispro
Pharma Manufacturer Name: DKSH SINGAPORE PTE. LTD.

Active Ingredients

Insulin lispro protamine suspension

50%

Insulin lispro solution

50%

INSULIN LISPRO PROTAMINE SUSPENSION

50%

INSULIN LISPRO SOLUTION

50%

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Oct 5, 2011

Approval ID

a3139a3be0feb85b

Type

Therapeutic

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