Insulin Human Winthrop
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
30-04-2018
Fachinformation
(SPC)
30-04-2018
Öffentlichen Beurteilungsberichts
(PAR)
30-04-2018
Wirkstoff:
Insulin human
Verfügbar ab:
sanofi-aventis Deutschland GmbH
ATC-Code:
A10AB01
INN (Internationale Bezeichnung):
insulin human
Therapiegruppe:
Drugs used in diabetes
Therapiebereich:
Diabetes Mellitus
Anwendungsgebiete:
Diabetes mellitus where treatment with insulin is required. Insulin Human Winthrop Rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and postoperative stabilisation in patients with diabetes mellitus.
Produktbesonderheiten:
Revision: 15
Berechtigungsstatus:
Withdrawn
Berechtigungsdatum:
2007-01-17
Gebrauchsinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
_ _
Insulin Human Winthrop Rapid 100 IU/ml solution for injection in a
vial
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Each vial contains 5 ml of solution for injection, equivalent to 500
IU insulin, or 10 ml of solution for
injection, equivalent to 1000 IU insulin. One IU (International Unit)
corresponds to 0.035 mg of
anhydrous human insulin.
Insulin Human Winthrop Rapid is a neutral insulin solution (regular
insulin).
Human insulin is produced by recombinant DNA technology in
_Escherichia coli_
.
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Solution for injection in a vial.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Diabetes mellitus where treatment with insulin is required. Insulin
Human Winthrop Rapid is also
suitable for the treatment of hyperglycaemic coma and ketoacidosis, as
well as for achieving pre-,
intra- and post-operative stabilisation in patients with diabetes
mellitus.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The desired blood glucose levels, the insulin preparations to be used
and the insulin dose regimen
(doses and timings) must be determined individually and adjusted to
suit the patient’s diet, physical
activity and life-style.
_Daily doses and timing of administration _
There are no fixed rules for insulin dose regimen. However, the
average insulin requirement is often
0.5 to 1.0 IU per kg body weight per day. The basal metabolic
requirement is 40% to 60% of the total
daily requirement. Insulin Human Winthrop Rapid is injected
subcutaneously 15 to 20 minutes before
a meal.
In the treatment of severe hyperglycaemia or ketoacidosis in
particular, insulin administration is part
of a complex therapeutic regimen which includes measures to protect
patients from possible severe
complications of a relatively rapid lowering of blood glucose. T
Lesen Sie das vollständige Dokument
Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
_ _
Insulin Human Winthrop Rapid 100 IU/ml solution for injection in a
vial
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Each vial contains 5 ml of solution for injection, equivalent to 500
IU insulin, or 10 ml of solution for
injection, equivalent to 1000 IU insulin. One IU (International Unit)
corresponds to 0.035 mg of
anhydrous human insulin.
Insulin Human Winthrop Rapid is a neutral insulin solution (regular
insulin).
Human insulin is produced by recombinant DNA technology in
_Escherichia coli_
.
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Solution for injection in a vial.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Diabetes mellitus where treatment with insulin is required. Insulin
Human Winthrop Rapid is also
suitable for the treatment of hyperglycaemic coma and ketoacidosis, as
well as for achieving pre-,
intra- and post-operative stabilisation in patients with diabetes
mellitus.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The desired blood glucose levels, the insulin preparations to be used
and the insulin dose regimen
(doses and timings) must be determined individually and adjusted to
suit the patient’s diet, physical
activity and life-style.
_Daily doses and timing of administration _
There are no fixed rules for insulin dose regimen. However, the
average insulin requirement is often
0.5 to 1.0 IU per kg body weight per day. The basal metabolic
requirement is 40% to 60% of the total
daily requirement. Insulin Human Winthrop Rapid is injected
subcutaneously 15 to 20 minutes before
a meal.
In the treatment of severe hyperglycaemia or ketoacidosis in
particular, insulin administration is part
of a complex therapeutic regimen which includes measures to protect
patients from possible severe
complications of a relatively rapid lowering of blood glucose. T
Lesen Sie das vollständige Dokument
