Mixtard 30 Flexpen Suspension for injection 100

Pays: Tanzanie

Langue: anglais

Source: Tanzania Medicinces & Medical Devices Authority

Ingrédients actifs:

Insulin

Disponible depuis:

Novo Nordisk A/S, DENMARK

Code ATC:

Insulins and other paranterals

DCI (Dénomination commune internationale):

Insulin

Dosage:

100

forme pharmaceutique:

Suspension for injection

Fabriqué par:

Novo Nordisk, DENMARK

Descriptif du produit:

Physical description: Cloudy, white and aqueous suspension; Local technical representative: Salama Pharmaceuticals Limited (9410)

Statut de autorisation:

Registered/Compliant

Date de l'autorisation:

2022-09-10

Résumé des caractéristiques du produit

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
MIXTARD® 30 FlexPen®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains: 100 IU corresponds to 0.035 mg of anhydrous human
insulin produced by
recombinant DNA technology in Saccharomyces cerevisiae.
1 pre-filled pen contains 3 ml equivalent to 300 IU.
MIXTARD® 30 is a mixture of dissolved insulin and isophane (NPH)
insulin.
MIXTARD® 30 consists of 30% dissolved insulin and 70% isophane
insulin.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Suspension for injection in pre-filled pen.
The suspension is cloudy, white and aqueous.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MIXTARD® 30 is indicated for treatment of diabetes mellitus in
adults, adolescents and children
aged 10 years and above.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Mixtard® is a dual-acting insulin. It is a biphasic formulation
containing both fast-acting and
long-acting insulin.
Premixed insulin products are usually given once or twice daily when a
rapid initial effect
together with a more prolonged effect is desired.
Dosage adjustment
Concomitant illness, especially infections and feverish conditions,
usually increases the patient’s
insulin requirement. Concomitant diseases in the kidney, liver or
affecting the adrenal, pituitary
or thyroid gland can require changes in the insulin dose. Adjustment
of dosage may also be
2
necessary if patients change physical activity or their usual diet.
Dosage adjustment may be
necessary when transferring patients from one insulin preparation to
another
METHOD OF ADMINISTRATION
For subcutaneous use. Insulin suspensions are never to be administered
intravenously.
Mixtard® is administered subcutaneously in the thigh or abdominal
wall. If convenient, the
gluteal
region
or
the
deltoid
region
may
also
be
used.
Subcutaneous
injection
into
the
abdominal wall ensures a faster absorption than from other injection
sites. For detailed user
instructions, please refer to the package leaflet.
Mi