LANTUS SOLOSTAR PEN 300 IU 3 ml. 5 pen
Each pen contains 3 ml of solution for injection, equivalent to 300 units
Insulin glargine is produced by recombinant DNA technology in Escherichia coli.
LANTUS SOLOSTAR PEN 300 IU 3 ml. 5 pen
Qualitative and quantitative composition
Each ml contains 100 units insulin glargine (equivalent to 3,64 mg).
Each pen contains 3 ml of solution for injection , equivalent to 300 units
Insulin glargine is produced by recombinant DNA technology in Escherichia coli.
2 . CLINICAL DATA
For the treatment of diabetes mellitus in adults , adolescents and children of 6 years or above , who require treatment with insulin.
2.2 . Dosage and method of administration
Lantus contains insulin glargine , an insulin analogue with a prolonged duration of action .
Lantus is to be administered once a day at any time , but each day at the same time .
Dosing regimen of Lantus ( dosage and time of administration) must be conducted
individually. In patients with type 2 diabetes mellitus , Lantus can be used also in
combination with oral antidiabetic agents .
The activity of this product is expressed in units. These units are
exclusively Lantus and are not the same as IU or units used to express the
activity of other insulin analogues . See section 5.1 ( Pharmacodynamics ) .
Polpulatsiya elderly (> 65 years)
In the elderly, progressive deterioration of renal function may
lead to a steady decrease in insulin requirements .
In patients with renal impairment , insulin requirements may be diminished due to
reduced insulin metabolism .
In patients with hepatic impairment , insulin requirements may be diminished due to
reduced capacity for gluconeogenesis and reduced insulin metabolism . 3
Safety and efficacy of Lantus have been established in adolescents and children of 6 years and above .
In children, efficacy and safety of Lantus have only been demonstrated when used at night.
Due to limited experience on the efficacy and safety of Lantus in children under 6
years , Lantus can be used in this age group under careful medical
Transition from other insulins to Lantus
When changing from a treatment regimen with insulin intermediate-acting
or long-acting this to a regimen with Lantus, you may need a change in
basal insulin dose adjustment and the concomitant antidiabetic treatment
(dose and timing of additional regular insulins or analogues
acting insulin doses or with oral antidiabetic drugs
To reduce the risk of nocturnal and early morning hypoglycaemia , patients who changed
primary treatment of insulin twice daily NPH ( insulin medium
duration of effect) of Lantus once daily needs during the first weeks
treatment to reduce their daily dose of basal insulin by 20-30%. During the first
weeks the reduction should be at least partly offset by increasing the dose of
insulin with meals , after which time the system must be adjusted
As with other insulin analogues , patients with high doses of insulin due
antibody to human insulin may have an improved response to the insulin
when using Lantus.
During the passage , and the first few weeks after it is recommended strict metabolic
With improved metabolic control and resulting increase of
insulin sensitivity may require further adaptation of
dose regimens. Dose adjustment may also be required , for example, if the weight of
patient or life-style changes, change of timing of insulin
or if other circumstances arise that increase susceptibility to hypo-or
Method of administration
Lantus is administered subcutaneously.
Lantus should not be administered intravenously. The prolonged effect of Lantus is dependent on
injection into subcutaneous tissue. Intravenous administration of the usual subcutaneous
dose may result in severe hypoglycemia .
No clinically significant differences in plasma levels of insulin or blood sugar levels
after administration of Lantus abdominal , deltoid or thigh. sites
injection sites should be rotated within a given area of injection for each
Lantus must not be mixed with any other insulin or does not need to be diluted .
Mixing or diluting can change its time / action profile and
mixing can cause precipitation.
2.3 . Contraindications
Hypersensitivity to the active substance or to any of the excipients.
2.4 . Special precautions for use
Lantus is not the insulin of choice for the treatment of diabetic ketoacidosis. Instead, in such
cases an intravenous regular insulin .
In case of insufficient glucose control or a tendency to hyper -or hypoglycaemic
episodes, 's adherence to the prescribed treatment regimen the patient injection
sites and proper injection technique and all other relevant factors before taking account
Transferring a patient to another type or brand of insulin should be done
under strict medical supervision. Changes in strength, brand ( manufacturer)
type (regular , NPH, lente, long-acting , etc.) , origin (animal, human, human
insulin analogue) and / or method of production, may lead to a need for change
Insulin administration may cause the formation of insulin antibodies . In rare
cases, the presence of such insulin antibodies may necessitate adjustment in dosage
insulin to correct a tendency to hyper- or hypoglycemia
The time of occurrence of hypoglycaemia depends on the action profile of the used
insulin , so it can be changed with a change in the treatment regimen . Due -
delayed submission of basal insulin Lantus, can expect less nocturnal but
more early morning hypoglycaemia .
Tryavba to pay special attention and recommended intensive monitoring
blood glucose levels in patients in whom hypoglycaemic episodes might be of particular
clinical importance , such as in patients with a significant stenosis in the coronary arteries
or vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well
and patients with proliferative retinopathy, particularly treated with photocoagulation ( risk of
transient amaurosis following hypoglycaemia).
Patients should be aware of circumstances where warning symptoms
hypoglycaemia are diminished. The warning symptoms of hypoglycaemia may
be changed, be less pronounced or be absent in certain risk groups. they
- In whom glycemic control is markedly improved,
- In whom hypoglycaemia develops gradually,
- Who are elderly,
- After transfer from animal insulin to human insulin,
- In which there is autonomic neuropathy ,
- With long-term diabetes
- Suffering from mental illness
- Receiving concurrent treatment with certain other medicinal products ( see section 4.5).
Such situations may result in severe hypoglycaemia (and possibly loss of consciousness)
before the patient 's awareness of hypoglycaemia .
The prolonged effect of subcutaneous insulin glargine may time
recovery from hypoglycemia.
If normal or decreased values for glycated hemoglobin should be
Given the possibility of recurrent , unrecognized ( especially nocturnal ) episodes of
Adherence of the patient to the dose regimen and dietary regimen , correct application of
insulin sensitivity and hypoglycaemia symptoms are essential to reduce
the risk of hypoglycemia. Factors increasing the susceptibility to hypoglycaemia require
particularly close monitoring and may require dose adjustment. These include:
- Change in the injection area,
- Improved insulin sensitivity (eg by removal of stress factors) ,
- Unaccustomed, increased or prolonged physical activity,
- Intercurrent illness (eg vomiting , diarrhea),
- Inadequate food intake ,
- Skipping meals ,
- Alcohol consumption ,
- Certain uncompensated endocrine disorders (eg in hypothyroidism and in anterior
pituitary or adrenocortical insufficiency)
- Concomitant treatment with certain other medicinal products.
Intercurrent illness requires intensive metabolic monitoring. In many cases,
shows urinalysis for ketone bodies , and it is often necessary to adjust the dose
insulin. Insulin requirement is often increased . Patients with type 1 diabetes must continue
to regularly consume at least a small amount of carbohydrates, even if they are able to
eat only little or no food , or are vomiting etc., should never be
omit insulin entirely .
A number of substances affect glucose metabolism and may require adjustment
the dose of human insulin.
Substances that may enhance the blood glucose lowering effect and increase
hypoglycaemia include oral antidiabetic medicinal products
angiotensin converting enzyme (ACE), disopyramide , fibrates , fluoxetine,
monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene , salicylates and
sulfonamide antibiotics .
Substances that may reduce the blood- glucose -lowering effect include
corticosteroids , danazol , diazoxide , diuretics , glucagon , isoniazid, oestrogens and
progestogens , phenothiazine derivatives , somatropin , sympathomimetic drugs
products (e.g., epinephrine [ adrenaline ] , salbutamol, terbutaline ) , thyroid hormones,
atypical antipsychotics ( napr.klozapin olanzapine ) and protease
Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the
blood glucose lowering effect of insulin. Pentamidine may cause
hypoglycaemia, which may sometimes be followed by hyperglycaemia .
In addition , under the influence of sympatholytic drugs such as
e. beta- blockers, clonidine, guanethidine and reserpine, the signs of adrenergic
counter-regulation may be reduced or absent.
Based on data that became available after the first authorization
for use , the Committee for Medicinal Products for Human Use ( CHMP ) considered that
benefit-risk balance of Lantus remains positive, but believes that his profile
Safety should be closely monitored for the following reasons :
- Since the publication of four epidemiological studies on cancer risk ( of
breast ) in the use of insulin glargine in the scientific journal Diabetologia , emerged
concerns about the safety of insulin glargine in this regard. At this
now been launched three post-marketing epidemiological study by the MAH for
ponatatachno study the possible increased risk of cancer associated with the use of insulin
glargine . These studies is planned to be completed over the next three years.
Based on this and in accordance with Article 14.3 of the EC Regulation (N0) 726/2004 , CHMP is
believes that further 5 year renewal based on the opinion
- CHMP decided that the MAH should continue to submit yearly PSURs .
Therefore , based on the safety profile of Lantus, which requires the submission
annual PSUR , CHMP concluded that the MAH should submit an application for an additional
renewal period of 5 years.
2.6. Use during pregnancy and lactation
For insulin glargine no clinical data from controlled clinical trials are
pregnant women . Limited amount of data on pregnant women ( between 300 -
1000 outcome of pregnancy ) with exposure to marketed insulin glargine indicate no
adverse effect of insulin glargine on pregnancy and lack of teratogenicity and
fetal / neonatal toxicity of insulin glargine .
Daniel from studies in animals have shown reproductive toxicity.
If necessary, you should discuss the use of Lantus in pregnancy .
Patients with pre-existing diabetes, pregnancy or gestational diabetes
to maintain good metabolic control throughout pregnancy. During
first trimester , insulin requirements may be reduced and generally increase
During the second and third trimesters. Immediately after delivery, insulin requirements
dramatically decreased ( increased risk of hypoglycaemia). Careful monitoring of blood glucose
It is unknown whether insulin glargine is excreted in human milk. No metabolic
effects of ingested insulin glargine on the breastfed newborn / child as insulin glargine
such peptide is degraded to amino acids in the human gastrointestinal tract. breastfeeding
women may require adjustments in insulin dose and diet .
Animal studies do not indicate direct harmful effects with respect to
2.7. Effects on ability to drive and use machines
The patient's ability to concentrate and react may be impaired as a result of
hypoglycaemia or hyperglycaemia or, for example as a result of visual impairment. this can
constitute a risk in situations where these abilities are of special importance (eg
driving a car or operating machinery) .
Patients should be advised to take precautions to avoid hypoglycaemia while
driving. This is particularly important in those who have reduced or absent awareness of the
hypoglycaemia or have frequent episodes of hypoglycaemia.
It should be considered whether it is advisable to drive or operate machines in
2.8. Undesirable effects
Hypoglycaemia, in general the most frequent undesirable effect of insulin therapy, may
occur if the insulin dose is too high in relation to the insulin requirement. Frequency :
Very common: Hypoglycaemia
Common: Reactions at the injection site , Lipohypertrophy
Rare: Allergic reactions, visual impairment , retinopathy, edema
Very rare : myalgia , myalgia
Metabolism and nutrition
Severe hypoglycaemic attacks , especially when repeated , can cause
neurological damage. Prolonged or severe hypoglycaemic episodes may be
In many patients, the signs and symptoms of neuroglycopenia are preceded by signs
of adrenergic counter . Generally, the greater and more rapid the fall in
blood sugar , the more marked is the phenomenon of counter-regulation and its symptoms.
Immune System Disorders
Allergic immediate reactions to insulin are rare . Such reactions to insulin
(including insulin glargine ) or the excipients may, for example be linked to the
generalized skin reactions , angioedema, bronchospasm, hypotension and shock, and may be
Insulin administration may cause the formation of insulin antibodies . during
clinical trials , antibodies that cross-react with human insulin and insulin
glargine were observed with similar frequency in both treatment groups with
NPH insulin and insulin glargine in rare cases, the presence of such insulin antibodies may
require adjustment of the insulin dose in order to correct a tendency to hyper - or
A marked change in glycemic control may cause temporary visual impairment ,
due to temporary alteration in the turgidity and refractive index of the lens .
Long-term improved glycemic control decreases the risk of progression of diabetic
retinopathy. Intensification of insulin therapy with abrupt improvement in
glycaemia , however , can also cause a temporary worsening of diabetic retinopathy.
In patients with proliferative retinopathy , especially if not treated with photocoagulation,
severe hypoglycaemic episodes may result in transient amaurosis .
Skin and subcutaneous tissue disorders
As with any insulin therapy , the injection site can occur
lipodystrophy and local insulin absorption is delayed . Continuous rotation of
injection site within the given injection area may help to reduce
or to prevent these reactions.
General disorders and administration site conditions
The reactions at the injection site include redness , pain, itching, hives, edema ,
or inflammation. Most minor reactions to insulins at the injection site usually
resolve in a few days to a few weeks.
Rarely , insulin may cause sodium retention and edema, particularly if previously poor
metabolic control is improved by intensified insulin therapy.
In general , the safety profile in children and adolescents (< 18 years) is similar to
the safety profile in adults.
The adverse reactions obtained from postmarketing surveillance
include relatively frequent injection site reactions (pain at the injection