natgillin/translations-raw huggingface dataset:
Μεταφέρετε με ένεση όλο το περιεχόμενο της προγεμισμένης σύριγγας στο φιαλίδιο που περιέχει την κόνι.
. Inject the entire content of the syringe into the vial containing the powder.
Το ανασυσταμένο εμβόλιο δεν πρέπει να χρησιμοποιηθεί εάν παρατηρηθεί οποιοδήποτε σωματίδιο ή εάν η όψη του εμβολίου διαφέρει από εκείνη που περιγράφεται πιο πάνω.
Do not use the reconstituted vaccine if you notice any particulate matter or if the appearance of the vaccine differs from that described above.
Βλέπε επίσης την παράγραφο 3 ΠΩΣ ΝΑ ΧΡΗΣΙΜΟΠΟΙΗΣΕΤΕ ΤΟ ProQuad.
55 See also section 3 HOW TO USE ProQuad.
Τι είναι το Protaphane; Το Protaphane είναι µια σειρά ενέσιµων εναιωρηµάτων ινσουλίνης.
Protaphane is a range of insulin suspensions for injection.
Το Protaphane παρέχεται σε φιαλίδια, φυσίγγια (Penfill) ή προγεµισµένες συσκευές τύπου πένας (InnoLet, NovoLet και FlexPen).
Protaphane is supplied in vials, cartridges (Penfill), or pre-filled pens (InnoLet, NovoLet and FlexPen).
Το Protaphane περιέχει τη δραστική ουσία ανθρώπινη ινσουλίνη (rDNA).
Protaphane contains the active substance insulin human (rDNA).
Σε ποιες περιπτώσεις χρησιµοποιείται το Protaphane; Το Protaphane χορηγείται σε ασθενείς µε διαβήτη.
Protaphane is used in patients with diabetes.
Πώς χρησιµοποιείται το Protaphane; Το Protaphane χορηγείται υποδορίως (κάτω από το δέρµα) µε ένεση συνήθως στον µηρό.
Protaphane is given subcutaneously (under the skin) by injection, usually in the thigh.
Εάν εξυπηρετεί, µπορεί επίσης να χορηγηθεί στο κοιλιακό τοίχωµα (κοιλιά), την περιοχή των γλουτών ή την περιοχή του δελτοειδούς µυός (ώµος).
If convenient it may also be given in the abdominal wall (tummy), the gluteal region (buttocks) or the deltoid region (shoulder).
Η γλυκόζη (σάκχαρο) στο αίµα του ασθενούς πρέπει να ελέγχεται τακτικά προκειµένου να καθοριστεί η χαµηλότερη αποτελεσµατική δόση.
The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose.
Το Protaphane είναι ινσουλίνη µακράς δράσης και µπορεί να χορηγείται µε ένεση µία ή δύο φορές την ηµέρα, µε ή χωρίς ινσουλίνη ταχείας δράσης (µε τα γεύµατα), σύµφωνα µε τις οδηγίες του γιατρού.
Protaphane is a long-acting insulin, it can be given as a once- or twice-daily injection, with or without a fast-acting insulin (at meal times), according to the doctor’ s recommendation.
Πώς δρα το Protaphane; Ο διαβήτης είναι µια νόσος στην οποία ο οργανισµός δεν παράγει επαρκή ινσουλίνη προκειµένου να ελέγχει τα επίπεδα γλυκόζης στο αίµα.
Diabetes is a disease in which the body does not produce enough insulin to control the blood glucose.
Το Protaphane είναι ανάλογο ινσουλίνης παρόµοιο µε την ινσουλίνη που παράγεται από το πάγκρεας.
Protaphane is a replacement insulin which identical to the insulin made by the pancreas.
Η δραστική ουσία του Protaphane, η ανθρώπινη ινσουλίνη (rDNA), παράγεται µε µια µέθοδο η οποία είναι γνωστή ως τεχνολογία ανασυνδυασµού · η ινσουλίνη παράγεται µε τη χρήση ζυµοµύκητα που έχει λάβει γονίδιο (DNA), το οποίο του επιτρέπει να παράγει ινσουλίνη.
The insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
Το Protaphane περιέχει ινσουλίνη αναµεµειγµένη µε µια άλλη ουσία, την προταµίνη, σε ισοφανική µορφή, η οποία απορροφάται µε αργότερο ρυθµό κατά τη διάρκεια της ηµέρας.
Protaphane contains insulin mixed with another substance, protamine, in an ‘ isophane’ form which is absorbed much more slowly during the day.
Έτσι το Protaphane έχει µεγαλύτερη διάρκεια δράσης.
This gives Protaphane a longer duration of action.
Το ανάλογο ινσουλίνης ενεργεί κατά τον ίδιο τρόπο µε την φυσικά παραγόµενη ινσουλίνη και διευκολύνει τη διείσδυση της γλυκόζης στα κύτταρα από το αίµα.
The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Με τον έλεγχο των επιπέδων γλυκόζης στο αίµα επιτυγχάνεται µείωση των συµπτωµάτων και των επιπλοκών του διαβήτη.
By controlling the blood glucose, the symptoms and complications of diabetes are reduced.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Ποιες µελέτες εκπονήθηκαν για το Protaphane; Το Protaphane µελετήθηκε σε 4 κύριες κλινικές δοκιµές που περιελάµβαναν συνολικά 557 ασθενείς µε διαβήτη τύπου 1, όπου το πάγκρεας αδυνατεί να παράγει ινσουλίνη (2 µελέτες µε τη συµµετοχή 81 ασθενών) ή διαβήτη τύπου 2, όπου το σώµα αδυνατεί να κάνει αποτελεσµατική χρήση της ινσουλίνης (2 µελέτες µε τη συµµετοχή 476 ασθενών).
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Protaphane been studied?
Στους περισσότερους ασθενείς, πραγµατοποιήθηκε σύγκριση του Protaphane µε άλλους τύπους ανθρώπινης ινσουλίνης ή ανάλογα ινσουλίνης.
Protaphane has been studied in four main clinical trials, which included a total of 557 patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 81 patients), or type 2 diabetes, when the body is unable to use insulin effectively (two studies involving 476 patients).
Στις µελέτες µετρήθηκαν τα επίπεδα της γλυκόζης νηστείας ή µιας ουσίας ονοµαζόµενης γλυκοσυλιωµένη αιµοσφαιρίνη (HbA1c), η οποία δίνει µια ένδειξη της αποτελεσµατικότητας του ελέγχου της γλυκόζης του αίµατος.
The studies measured the level of fasting blood glucose or a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Πραγµατοποιήθηκαν περαιτέρω µελέτες σε 225 ασθενείς συγκρίνοντας την έγχυση του Protaphane µε τη χρήση σύριγγας ή προγεµισµένη συσκευής τύπου πένας (InnoLet, NovoPen ή FlexPen).
Further studies were also carried out in 225 patients comparing injecting Protaphane using a syringe, or using a pre-filled pen (InnoLet, NovoPen or FlexPen).
Ποιο είναι το όφελος του Protaphane σύµφωνα µε τις µελέτες; Το Protaphane οδήγησε σε µείωση των επιπέδων της HbA1c, υποδηλώνοντας ότι το επίπεδο ελέγχου της γλυκόζη στο αίµα ήταν παρόµοιο µε εκείνο που επιτεύχθηκε µε την ανθρώπινη ινσουλίνη.
Protaphane led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulin.
Το Protaphane υπήρξε αποτελεσµατικό τόσο για τον διαβήτη τύπου 1 όσο και για τον διαβήτη τύπου 2, τόσο µε τη χρήση σύριγγας όσο και µε τη χρήση µίας από τις προαναφερόµενες συσκευές τύπου πένας.
Protaphane was effective for both type 1 and type 2 diabetes, and when using a standard injection or one of the pens.
Ποιοι κίνδυνοι συνδέονται µε το Protaphane; Όπως όλες οι ινσουλίνες, το Protaphane ενδέχεται να προκαλέσει υπογλυκαιµία (χαµηλά επίπεδα γλυκόζης στο αίµα).
As with all insulins, Protaphane may cause hypoglycaemia (low blood glucose).
Ο πλήρης κατάλογος όλων των ανεπιθύµητων ενεργειών που αναφέρθηκαν µε το Protaphane περιλαµβάνεται στο φύλλο οδηγιών χρήσης.
For the full list of all side effects reported with Protaphane, see the Package Leaflet.
Το Protaphane δεν πρέπει να χορηγείται σε ασθενείς που ενδέχεται να παρουσιάσουν υπερευαισθησία (αλλεργία) στην ανθρώπινη ινσουλίνη (rDNA) ή σε κάποιο από τα άλλα συστατικά.
Protaphane should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients.
Επίσης, ενδέχεται να απαιτηθεί προσαρµογή της δοσολογίας του Protaphane όταν αυτό χορηγείται παράλληλα µε σειρά άλλων φαρµάκων που ενδέχεται να επηρεάζουν τα επίπεδα γλυκόζης στο αίµα.
Protaphane doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood glucose.
Για ποιους λόγους εγκρίθηκε το Protaphane; Η Επιτροπή Φαρµάκων για Ανθρώπινη Χρήση (CHMP) έκρινε ότι τα οφέλη του Protaphane υπερτερούν των κινδύνων που συνδέονται µε αυτό για τη θεραπεία του διαβήτη, και εισηγήθηκε τη χορήγηση άδειας κυκλοφορίας για το Protaphane.
The Committee recommended that Protaphane be given marketing authorisation.
Λοιπές πληροφορίες για το Protaphane:
Other information about Protaphane:
Στις 7 Οκτωβρίου 2002 η Ευρωπαϊκή Επιτροπή χορήγησε άδεια κυκλοφορίας, η οποία ισχύει σε ολόκληρη την Ευρωπαϊκή Ένωση, στην Novo Nordisk A/ S για το Protaphane.
The European Commission granted a marketing authorisation valid throughout the European Union for Protaphane to Novo Nordisk A/ S on 7 October 2002.
Η πλήρης δηµόσια έκθεση αξιολόγησης (EPAR) του Protaphane διατίθεται εδώ.
The full EPAR for Protaphane is available here.
EU/ 1/ 02/ 234/ 001
EU number
Protaphane
Invented Name
40 ∆Μ/ ml
Strength
Υποδόρια χρήση
Pharmaceutical form
Φιαλίδιο (γυάλινο)
Route of administration Packaging
10ml (1, 4 mg/ ml)
Content (concentration)
40 ∆Μ/ ml
40 IU/ ml 40 IU/ ml
100 ∆Μ/ ml
Suspension for injection Suspension for injection
Υποδόρια χρήση
Subcutaneous use Subcutaneous use
Φιαλίδιο (γυάλινο)
Vial (glass) Vial (glass)
1 φιαλίδιο
1 vial 5 vials
EU/ 1/ 02/ 234/ 005
EU/ 1/ 02/ 234/ 003 EU/ 1/ 02/ 234/ 004 EU/ 1/ 02/ 234/ 005 EU/ 1/ 02/ 234/ 006 EU/ 1/ 02/ 234/ 007
Φυσίγγιο (γυάλινο)
100 IU/ ml Suspension for injection 100 IU/ ml Suspension for injection 100 IU/ ml Suspension for injection 100 IU/ ml Suspension for injection 100 IU/ ml Suspension for injection
Υποδόρια χρήση
Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use
Φυσίγγιο (γυάλινο)
Vial (glass) Vial (glass) Cartridge (glass) Cartridge (glass) Cartridge (glass)
Φυσίγγιο (γυάλινο)
10 ml (3.5 mg/ ml) 10 ml (3.5 mg/ ml) 3 ml (3.5 mg/ ml) 3 ml (3.5 mg/ ml) 3 ml (3.5 mg/ ml)
10 φυσίγγια
1 vial 5 vials 1 cartridge 5 cartridges 10 cartridges
100 ∆Μ/ ml
Protaphane NovoLet 100 IU/ ml Suspension for injection
Φυσίγγιο (γυάλινο) σε προγεµισµένη συσκευή τύπος πένας
Cartridge (glass) in pre-filled pen
5 προγεµισµένες συσκευή τύπος πένες
5 pre-filled pens
10 προγεµισµένες συσκευή τύπος πένες
10 pre-filled pens
Protaphane InnoLet 100 ∆Μ/ ml
Protaphane InnoLet 100 IU/ ml Suspension for injection
1 προγεµισµένη συσκευή τύπος πένα
1 pre-filled pen
Protaphane FlexPen 100 ∆Μ/ ml
Protaphane FlexPen 100 IU/ ml Suspension for injection
1/ 2 EU/ 1/ 02/ 234/ 015
EU/ 1/ 02/ 234/ 015
Protaphane 40 ∆Μ/ ml
Protaphane 40 IU/ ml Suspension for injection Protaphane 100 IU/ ml Suspension for injection
10 ml (1. 4 mg/ ml)
10 ml (1.4 mg/ ml) 10 ml (3.5 mg/ ml)
5 x (1 x 10 ml) φιαλίδιο
5 x (1 x 10 ml) vials 5 x (1 x 10 ml) vials
Protaphane 40 IU/ ml 100 IU/ ml
NAME OF THE MEDICINAL PRODUCT
.
Protaphane 40 IU/ ml suspension for injection in a vial.
, - DNA (DNA Saccharomyces cerevisiae).
Insulin human, rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae).
1 ml 1
1 ml contains 40 IU of insulin human.
Protaphane!.
Protaphane is a suspension of isophane (NPH) insulin.
(NPH)
For a full list of excipients, see section 6.1.
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Cloudy, white, aqueous suspension.
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4.1 Therapeutic indications
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Treatment of diabetes mellitus.
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4.2 Posology and method of administration
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The daily insulin requirement may be higher in patients with insulin resistance (e. g. during puberty or due to obesity) and lower in patients with residual, endogenous insulin production.
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The physician determines whether one or several daily injections are necessary.
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Close blood glucose monitoring is therefore recommended.
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Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
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Renal or hepatic impairment may reduce insulin requirement.
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2 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
Protaphane!,!
Protaphane is administered subcutaneously in the thigh.
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Protaphane.
Protaphane is accompanied by a package leaflet with detailed instruction for use to be followed.
6. 1)...
4.3 Contraindications
4. 4
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
#
4.4 Special warnings and precautions for use
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In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
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Usual warning symptoms may disappear in patients with longstanding diabetes.
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Insulin suspensions are not to be used in insulin infusion pumps.
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4.5 Interaction with other medicinal products and other forms of interaction
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Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol.
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Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia.
.
Octreotide/ lanreotide may both decrease and increase insulin requirement.
/
Alcohol may intensify and prolong the hypoglycaemic effect of insulin.
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4.6 Pregnancy and lactation
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After delivery, insulin requirements return rapidly to pre-pregnancy values.
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Insulin treatment of the nursing mother presents no risk to the baby.
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4.7 Effects on ability to drive and use machines
,
This is particularly important in those who have reduced or absent awareness of the warning signs of
Protaphane.
The advisability of driving should be considered in these circumstances.
!. (
Severe hypoglycaemia may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or even death.
!:
Frequencies of adverse drug reactions from clinical trials that are considered related to Protaphane are listed below.
(< 1/ 10. 000
The frequencies are defined as: uncommon (1/ 1,000 to < 1/ 100).
!
Nervous system disorders Very rare - Peripheral neuropathy Fast improvement in blood glucose control may be associated with a condition termed “ acute painful neuropathy”, which is usually reversible.
!!!!!,
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy.
!.
Skin and subcutaneous tissue disorders Uncommon - Lipodystrophy Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
!
Most reactions are transitory and disappear during continued treatment.
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5 4.9 Overdose
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Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
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PHARMACOLOGICAL PROPERTIES
1 mg)
5.1 Pharmacodynamic properties
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The blood glucose lowering effect of insulin is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
,
5.2 Pharmacokinetic properties
4- 12!
The pharmacokinetics of insulin products are therefore affected by significant intra- and inter-individual variation.
6
Absorption The maximum plasma concentration of the insulin is reached within 2-18 hours after subcutaneous administration.
5. 2
Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
. $
A number of cleavage (hydrolysis) sites on the human insulin molecule have been proposed; none of the metabolites formed following the cleavage are active.
+
Trials have indicated a t½ of about 5-10 hours.
(+
5.3 Preclinical safety data
#
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
. 6
6.
Protaphane
6.1 List of excipients
#
Zinc chloride Glycerol Metacresol Phenol Disodium phosphate dihydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Protamine sulphate Water for injections
6. 1 - $'
6.2 Incompatibilities
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Insulin suspensions should not be added to infusion fluids.
64 *
6.3 Shelf life
30 '2°C – 8°C.
30 months when stored between 2°C - 8°C.
6. 4
4 weeks when used or stored at room temperature (below 25°C).
- +, 2 & "$+
6.4 Special precautions for storage
(2°C - 8°C). * '
Before use: store in a refrigerator (2°C - 8°C).
* '.
Do not freeze.
25ºC.
During use: do not refrigerate.
*!.
Do not store above 25°C.
!.
Protect from excessive heat and sunlight.
10 ml
6.5 Nature and contents of container
.
10 ml glass vial (type 1) closed with a bromobutyl/ polyisoprene rubber stopper and a protective tamper-proof plastic cap.
: 1
Pack sizes:
5 x (1 x 10 ml)
1 and 5 vials x 10 ml and a multipack with 5 x (1 x 10 ml) vials.
Protaphane
Not all pack sizes may be marketed.
*
7 6.6 Special precautions for disposal and other handling
!
After removing Protaphane vial from the refrigerator it is recommended to allow the vial to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
!
Insulin suspensions should not be used if they do not appear uniformly white and cloudy after resuspension.
(
Any unused product or waste material should be disposed of in accordance with local requirements.
3
Date of first authorisation:
07 (
07 October 2002
#
Date of latest renewal:
Protaphane 100 IU/ ml
Protaphane 100 IU/ ml suspension for injection in a vial.
100 IU 10 ml
1 ml contains 100 IU of insulin human.
1000 IU.
1 vial contains 10 ml equivalent to 1000 IU.
$.
Suspension for injection in a vial.
.)
In patients with diabetes mellitus optimised glycaemic control delays the onset of late diabetic complications.
4. 4).
Close blood glucose monitoring is therefore recommended.
.
Dosage adjustment Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
'
Adjustment of dosage may also be necessary if patients change physical activity or their usual diet.
'
9 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
Protaphane!,!
Administration For subcutaneous use.
Protaphane.
Protaphane is administered subcutaneously in the thigh.
4. 3! "
Subcutaneous injection into the thigh results in a slower and less variable absorption compared to the other injection sites.
..
Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy.
(#
When two types of insulin are mixed, draw the amount of fast-acting insulin first, followed by the amount of long-acting insulin.
6. 1).
Protaphane is accompanied by a package leaflet with detailed instruction for use to be followed.
- +) *% +
4.3 Contraindications
&
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
(!
10 A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
.
The physician must therefore take possible interactions into account and should always ask his patients about any medicinal products they take.
4. 5
Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective beta- blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids and sulphonamides.
& + &
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol.
&
Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia.
/ lanreotide
Octreotide/ lanreotide may both decrease and increase insulin requirement.
'
Alcohol may intensify and prolong the hypoglycaemic effect of insulin.
0
4.6 Pregnancy and lactation
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Insulin treatment of the nursing mother presents no risk to the baby.
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This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
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The advisability of driving should be considered in these circumstances.
1 mg)
12 4.9 Overdose
,
Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
5. 2
Absorption The maximum plasma concentration of the insulin is reached within 2-18 hours after subcutaneous administration.
. $
Distribution No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
+
A number of cleavage (hydrolysis) sites on the human insulin molecule have been proposed; none of the metabolites formed following the cleavage are active.
(+
Trials have indicated a t½ of about 5-10 hours.
Protaphane
5.3 Preclinical safety data
6. 1 - $'
6.1 List of excipients
& $
Zinc chloride Glycerol Metacresol Phenol Disodium phosphate dihydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Protamine sulphate Water for injections
(+ 5
6.2 Incompatibilities
,
Insulin suspensions should not be added to infusion fluids.
25°C).
6 weeks when used or stored at room temperature (below 25°C).
- 8°C) * '
Before use: store in a refrigerator (2°C - 8°C).
:
During use: do not refrigerate.
25°C.
Do not store above 25°C.
3
Protect from excessive heat and sunlight.
*
14 6.6 Special precautions for disposal and other handling
Protaphane Penfill 100 IU/ ml
Protaphane Penfill 100 IU/ ml suspension for injection in a cartridge.
100 IU 3 ml
1 ml contains 100 IU of insulin human.
$
Suspension for injection in a cartridge.
&
In intensive insulin therapy the suspension may be used as basal insulin (evening and/ or morning injection) with fast-acting insulin given at meals.
'
Close blood glucose monitoring is therefore recommended.
'
Renal or hepatic impairment may reduce insulin requirement.
'0, 3
16 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
1, 0 IU/ kg /
Administration For subcutaneous use.
. (
If convenient, the abdominal wall, the gluteal region or the deltoid region may also be used.
(..
Subcutaneous injection into the thigh results in a slower and less variable absorption compared to the other injection sites.
#,
Detailed instruction accompanying the delivery system must be followed.
.)
Hypoglycaemia.
o
Usual warning symptoms may disappear in patients with longstanding diabetes.
! #
If an adjustment is needed when switching the patients to Protaphane, it may occur with the first dose or during the first several weeks or months.
.
On rare occasions, injection site reactions may require discontinuation of Protaphane.
(#
17 A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
/
Before travelling between different time zones, the patient should be advised to consult the physician, since this may mean that the patient has to take insulin and meals at different times.
)
Insulin suspensions are not to be used in insulin infusion pumps.
#, #
Protaphane contains metacresol, which may cause allergic reactions.
'!
4.5 Interaction with other medicinal products and other forms of interaction
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The physician must therefore take possible interactions into account and should always ask his patients about any medicinal products they take.
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Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective beta- blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids and sulphonamides.
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Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol.