HUMULIN I Suspension for injection in a vial (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Humulin I (Isophane) 100 IU/ml suspension for injection in vial.
Qualitative and quantitative composition
1 ml contains 100 IU insulin human (produced in E. coli by recombinant DNA technology). One vial contains 10 ml equivalent to 1000 IU of isophane insulin. For a full list of excipients, see section 6.1. ...
Pharmaceutical form
A suspension for injection in a vial. Humulin I is a sterile suspension of a white, crystalline precipitate of isophane human insulin in an isotonic phosphate buffer.
Therapeutic indications
For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis.
Posology and method of administration
Posology The dosage should be determined by the physician, according to the requirement of the patient. Paediatric population No data are available. Method of administration Humulin I should be given by ...
Contraindications
Hypoglycaemia. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, unless used as part of a desensitisation programme. Under no circumstances should any Humulin ...
Special warnings and precautions for use
Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (soluble, isophane, mixture), species (animal, ...
Interaction with other medicinal products and other forms of interaction
A number of medicinal products are known to interact with glucose metabolism and therefore the physician should be consulted when using other medications in addition to human insulin (see section 4.4). ...
Pregnancy and lactation
It is essential to maintain good control of the insulin treated (insulin-dependent or gestational diabetes) patient throughout pregnancy. Insulin requirements usually fall during the first trimester and ...
Effects on ability to drive and use machines
The patients ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car ...
Undesirable effects
Hypoglycaemia is the most frequent undesirable effect of insulin therapy that a patient with diabetes may suffer. Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death. No ...
Overdose
Insulin has no specific overdose definitions, because serum glucose concentrations are a result of complex interactions between insulin levels, glucose availability and other metabolic processes. Hypoglycaemia ...
Pharmacodynamic properties
Pharmacotherapeutic group: Insulins and analogues for injection, intermediate-acting ATC code: A10A C01 Humulin I is an intermediate acting insulin preparation. The prime activity of insulin is the regulation ...
Pharmacokinetic properties
The pharmacokinetics of insulin do not reflect the metabolic action of that hormone. Therefore, it is more appropriate to examine glucose utilisation curves (as discussed above) when considering the activity ...
Preclinical safety data
Humulin is human insulin produced by recombinant technology. No serious events have been reported in subchronic toxicology studies. Human insulin was not mutagenic in a series of in vitro and in vivo genetic ...
List of excipients
m-cresol Glycerol Phenol Protamine sulfate Dibasic sodium phosphate 7H<sub>2</sub>O Zinc oxide Water for injections The following may be used to adjust pH; hydrochloric acid and/or sodium hydroxide.
Incompatibilities
Humulin preparations should not be mixed with insulins produced by other manufacturers or with animal insulin preparations.
Shelf life
<u>Unopened vials:</u> 3 years. <u>After first use:</u> 28 days.
Special precautions for storage
Do not freeze. Do not expose to excessive heat or direct sunlight. <u>Unopened vials:</u> Store in a refrigerator (2°C-8°C). <u>After first use:</u> Store below 30°C.
Nature and contents of container
10 ml of suspension in a vial (type I glass) with a stopper (rubber) sealed with a seal (aluminium) combined with a flip top (plastic). Pack size 1 or 2 or 5 (5 1). Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
Do not reuse needles. Dispose of the needle in a responsible manner. Needles must not be shared. Vials can be used until empty, then properly discard. Any unused medicinal product or waste material should ...
Marketing authorization holder
Eli Lilly and Company Limited, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL
Marketing authorization number(s)
PL 00006/0666
Date of first authorization / renewal of the authorization
30 July 2019
Date of revision of the text
30 July 2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
