Quick Humalog Mix50 Pen 300 IU

Quick Humalog Mix50 Pen 300 IU
€ 169.00
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Other drugs with: lispro mixHumalog Mix25 (Eli Lilly) 100 U / ml, 3ml. suspension in preloade pen or cartridge
Humalog Mix50 (Eli Lilly) 100 U / ml, 3ml.suspension in preloaded pen Kwik pen or cartridge
Formulations
Suspension for injection.
Humalog Mix50 is a white, sterile suspension

Quick Humalog Mix50 Pen 300 IU
Quick Humalog Mix50 Pen 300 IU * 5
GENERIC NAME OF THE MEDICINAL PRODUCT
lispro mix
Other drugs with: lispro mixHumalog Mix25 (Eli Lilly) 100 U / ml, 3ml.inzhektsionna suspension in preloaded pen Kwik pen or cartridge
Humalog Mix50 (Eli Lilly) 100 U / ml, 3ml.inzhektsionna suspension in preloaded pen Kwik pen or cartridge
Formulations
Suspension for injection.
Humalog Mix50 is a white, sterile suspension.

Qualitative and quantitative composition:
One ml contains 100U (equivalent to 3,5 mg) insulin lispro (insulin
lispro) (recombinant DNA origin produced in E.coli). Each pack contains 3ml,
equivalent to 300U insulin lispro.
Humalog Mix 25 contains 25% insulin lispro solution and 75% insulin lispro protamine
suspension.
umalog Mix 50 contains 50% insulin lispro solution and 50% insulin lispro protamine suspension.

- CLINICAL DATA

- Indications
Humalog Mix50 is indicated for the treatment of patients with diabetes mellitus who require
insulin to maintain normal glucose homeostasis.  

- Dosage and administration

The dosage should be determined by the doctor according to the patient's needs.
Humalog Mix50 may be given immediately before a meal. Where necessary, the
Humalog Mix50 may be given soon after meals. Humalog Mix50tryabva to
administered by subcutaneous injection. Under no circumstances should Humalog Mix50 be
administered intravenously.
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 once a month.
Following subcutaneous injection of Humalog Mix50 should be taken not to penetrate the
blood vessel. After injection, the site of injection should not be massaged.
Patients should be educated to use proper injection techniques.
The rapid onset and early peak of activity of Humalog itself is observed after
the subcutaneous administration of Humalog Mix50. This allows to Humalog Mix50
given shortly before meals. The duration of action of insulin
lispro protamine suspension (BASAL) in Humalog Mix50 is similar to that of basal insulin
(NPH).
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
duration of action of Humalog Mix50 is dependent on dose, site of injection,
blood supply, temperature, and physical activity.

- Contraindications

Hypersensitivity to insulin lispro or any of the excipients.
Hypoglycemia.

- Special precautions for use

Humalog Mix50 should under no circumstances be administered intravenously.
Transferring a patient to another type or brand of insulin should be done under strict
medical supervision. Changes in the activity, the type (manufacturer), type (regular, NPH,
tape, etc.) and source (animal, human, insulin analogue) and / or the method of
manufacture (recombinant DNA versus animal-source insulin) may require a change in
dosage.
Conditions under which the early warning symptoms of hypoglycaemia may
different or less pronounced include long duration of diabetes, intensive insulin
therapy, nerve disease or diabetes medications such as
beta-blockers.
The small number of patients who have experienced hypoglycaemic reactions after transfer from
animal insulin to human insulin have reported that early warning symptoms of
hypoglycaemia were less pronounced or different from those experienced with their previous
insulin. Uncorrected hypoglycaemic or hyperglycaemic reactions can
cause loss of consciousness, coma or death.
Applying the wrong dose or discontinuation of treatment, especially in insulin-
dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions
which are potentially lethal.
Insulin requirements may be reduced in renal impairment.
Insulin requirements may be reduced in patients with hepatic impairment
due to reduced capacity for gluconeogenesis and reduced insulin degradation,
while patients with chronic liver disease increased insulin
resistance may lead to increased insulin requirements.
Insulin requirements may be increased during illness or emotional
disorders.
Dose adjustments may be necessary if patients undertake increased physical activity or change
usual diet. Exercise immediately after a meal may increase
risk of hypoglycemia.
Administration of insulin lispro in children under 12 years old should only be considered
in cases where the expected benefit when compared to regular insulin.

- Interactions

Insulin requirements may be increased by substances with hyperglycaemic activity, such as oral
contraceptives, corticosteroids or replacement therapy of thyroid
gland, danazol, beta 2 stimulants (such as ritodrine, salbutamol, terbutaline).
Insulin requirements may be reduced in the presence of substances with hypoglycaemic activity
such as oral hypoglycemics, salicylates (eg aspirin)
antibiotics, sulpha group, certain antidepressants (monoamine oxidase 30
inhibitors, selective inhibitors of serotonin reuptake) set
Angiotensin converting enzyme inhibitors (captopril, enalapril) blockers
angiotensin II receptor antagonists, beta-blockers, octreotide or alcohol.
Mixing Humalog Mix50 with other insulins has not been studied.
When using other medications in addition to Humalog Mix50, should be sought
medical attention.

- Use during pregnancy and lactation

Data on a large number of exposed pregnancies do not occur
any adverse effect of insulin lispro on pregnancy or on the health of
fetus / newborn.
During pregnancy, it is essential to maintain good control of patients
the insulin therapy (insulin-dependent or gestational diabetes). Needs
Insulin requirements usually fall during the first trimester of pregnancy and increased
during the second and third trimesters. Patients with diabetes should be advised to
notify their physician if they are pregnant or are contemplating pregnancy. It is important for pregnant women
patients with diabetes careful monitoring of glucose control and overall
health.
Patients with diabetes who are breastfeeding may require dose adjustment of insulin
diet or both.
- Effects on ability to drive and use machines
The patient's 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
importance (eg driving a car or operating machinery).
Patients should be advised to take precautions to avoid
hypoglycemia while driving, which is especially important in those who have reduced or
absent awareness of the warning signs of hypoglycaemia or have frequent episodes
of hypoglycaemia. Under these circumstances, it is advisable to avoid driving.  

- Undesirable effects

Hypoglycemia is the most common adverse effect of insulin therapy, which can be
found in patients with diabetes. Severe hypoglycaemia may lead to unconsciousness,
and in extreme cases, death. No specific frequency for hypoglycaemia,
since hypoglycaemia is a result of insulin dose and other factors such as diet
patient and exercise.
Local allergic reactions are common. Redness, swelling, and itching can be
occur at the site of injection of insulin. This condition usually resolves
several days to several weeks. In some cases, this condition may be due to different
factors than insulin, such as irritants in the skin cleansing agent or poor technique
injection. Systemic allergy, which is a rare but potentially
more serious, is generalized allergy to insulin. It can cause a rash over the whole
body, breathlessness, wheezing, low blood pressure, fast pulse, or sweating. Severe
cases of generalized allergy may be life threatening.
Lipodystrophy at the injection site is uncommon.
- Overdose.
No specific symptoms of an overdose of insulin, because serum glucose
concentrations are the result of complex interactions between insulin levels, the presence of
glucose and other metabolic processes. Hypoglycemia may occur as a result of excess
of insulin activity relative to food intake and energy expenditure.
Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache,
sweating and vomiting.
Mild hypoglycaemic episodes will respond to oral administration of glucose or other
sugar or sweetened products.
Correction of moderately severe hypoglycemia can be achieved by intramuscular or
subcutaneous administration of glucagon, followed by oral carbohydrate when
patient recovers sufficiently. Patients who do not respond to glucagon must
given glucose solution intravenously.
If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously. If there is no
glucagon or the patient does not meet the glucagon should be administered intravenously
glucose solution. The patient should be given a meal as soon recover
consciousness.
Sustained carbohydrate intake and observation, since hypoglycaemia
may recur after apparent clinical recovery.  

- Pharmacological

- Pharmacokinetic properties:
The pharmacokinetics of insulin lispro reflect a compound that is rapidly absorbed and reaches
peak blood levels 30 to 70 minutes after subcutaneous injection. The pharmacokinetics of
insulin lispro protamine suspension is compatible with that of insulin with intermediate
action as NPH. The pharmacokinetics of Humalog Mix50 are representative of the
individual pharmacokinetic properties of the two components. When considering the
The clinical relevance of these kinetics, it is more appropriate to examine the utilization curves
of glucose
Insulin lispro maintains more rapid absorption when compared to soluble human
insulin in patients with renal impairment. In patients with type 2 diabetes in a wide
range of renal function, the pharmacokinetic differences between insulin lispro and
soluble human insulin in most cases have been maintained and shown to be independent of
renal function. Insulin lispro maintains more rapid absorption and elimination in
compared to soluble human insulin in patients with hepatic impairment.  

- Pharmacodynamic properties:

- Pharmacotherapeutic group: Drugs used to treat diabetes. Injectable insulin and
analogues, intermediate combined with fast-acting.
Humalog Mix50 is a premixed suspension of insulin lispro (fast
acting human insulin analogue) and insulin lispro protamine suspension (analogue
human insulin with an average duration of action).
The principal action of insulin lispro is the regulation of glucose metabolism.
In addition, insulins have several anabolic and anti-catabolic actions on different
tissues. In muscle tissue increases glycogen, fatty acids, glycerol and
protein and amino acid uptake, while suppress
glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and
separation of amino acids.
Insulin lispro has a rapid onset of action (approximately 15 minutes), allowing it to be
administered immediately before a meal (within zero to 15 minutes before a meal) compared with
insulin (30 to 45 minutes before meals). Rapid onset of action and
early peak of activity of insulin lispro were observed after subcutaneous
Humalog Mix50. The profile of activity of Humalog BASAL for a period of approximately 15 hours
characteristics similar to that of basal insulin (NPH).
Glucodynamic response to insulin lispro is not affected by renal or
liver function. Glucodynamic differences between insulin lispro and soluble
human insulin measured during a glucose levels were maintained
over a wide range of renal function.
Insulin lispro is equipotent to human insulin on a molar basis, but its effect is more rapid
and has a shorter duration.
 
Preclinical safety data
In tests in vitro, including binding to insulin receptor sites for insulin
effects on growing cells, insulin lispro act in a way that is very similar to
human insulin. Studies also show that the dissociation of binding
insulin receptor of insulin lispro e equivalent to human insulin. In
toxicological studies, one month and twelve months, no
significant toxicity.
In animal studies insulin lispro does not cause impairment of fertility,
embryotoxicity or teratogenicity.

- PHARMACEUTICAL PARTICULARS

- List of ingredients and their quantities
Protamine sulfate
m-cresol {1,76 mg / ml}
Phenol {0,80 mg / ml}
Glycerol
Dibasic sodium phosphate.7H2O
Zinc Oxide
Water for injection
Hydrochloric acid and sodium hydroxide may be used to adjust pH to 7.0 to 7.8.
- Incompatibilities
Mixing Humalog Mix50 with other insulins has not been studied. In the absence of comparative
studies, this medicinal product must not be mixed with other medicinal products.
4.3. Expiration date
Unopened cartridges 3 years. After inserting the cartridge 28 days.

- Special precautions for storage


Unopened cartridges
Store in a refrigerator (2 ° C - 8 ° C). Do not freeze. Do not expose to excessive
heat or direct sunlight.
 
After inserting the cartridge
Do not store above 30 ° C. Do not refrigerate. Pen with a cartridge
should be stored with a needle attached.
 
 
€ 169.00
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