Genotropin - instructions for use, dose, side effects, contraindications

auxiliary substances: mannitol - 1.8 mg, glycine - 2.3 mg, sodium dihydrogen phosphate anhydrous (in the form of monohydrate) - 0.33 mg, sodium hydrophosphate anhydrous (in the form of dodecahydrate) - 0.32 mg.

2. The second section of the cartridge contains a solvent: m-cresol - 3.4 mg, mannitol - 45 mg, water for injection - up to 1.14 ml.

The cartridge for a reusable injector Genotropin Pen 12 consists of two sections:

1.In one section of the two-compartment cartridge contains lyophilizate: active substance: recombinant somatropine 13.8 mg (41.4 IU);

auxiliary substances: mannitol - 14 mg, glycine - 2.3 mg, sodium dihydrogen phosphate anhydrous (in the form of monohydrate) - 0.47 mg, sodium hydrophosphate anhydrous (as dodecahydrate) 0.46 mg,

2. The second section of the cartridge contains a solvent: m-cresol 3.4 mg, mannitol 32 mg, water for injection up to 1.13 ml.

The composition of the solution of Genotropin® 5.3 mg (16 ME) obtained after mixing the contents of both sections of the cartridge by 1 ml:

Active substance: recombinant somatropine 5.3 mg (16 IU)

Auxiliary substances: mannitol - 41 mg, glycine 2.0 mg, sodium dihydrogen phosphate anhydrous (as monohydrate) 0.29 mg, sodium hydrophosphate anhydrous (as dodecahydrate) 0.28 mg, m-cresol 3.0 mg, water for injection - up to 1 ml.

The composition of the solution of Genotropin® 12 mg (36 IU) obtained after mixing the contents of both sections of the cartridge by 1 ml:

Active substance: recombinant somatropin - 12 mg (36 IU)

Auxiliary substances: mannitol - 40 mg, glycine - 2.0 mg, sodium dihydrogenphosphate anhydrous (in the form of monohydrate) - 0.41 mg, sodium hydrophosphate anhydrous (as dodecahydrate) - 0.40 mg, m-cresol 3.0 mg, water for injection - up to 1 ml.

Description:

Powder of white color.

Solvent is a colorless clear solution. The prepared solution is a clear or slightly opalescent solution that is colorless or with a barely noticeable brown tinge.

Pharmacotherapeutic group:Homatotropic hormone

ATX: & nbsp

H.01.A.C Somatropin and its analogues

H.01.A.C.01 Somatropin

Pharmacodynamics:

Genotropin® contains synthesized with the help of recombinant technologies somatropin, identical to the human growth hormone. In children with insufficient endogenous growth hormone and Prader-Willi syndrome somatropin strengthens and accelerates the linear growth of the skeleton. Both in adults and in children somatropin maintains a normal body structure, stimulating muscle growth and facilitating the mobilization of fat. Visceral adipose tissue is particularly sensitive to somatropin. In addition to stimulating lipolysis, somatropin reduces the flow of triglycerides to fat stores.

Somatropin increases the concentration of insulin-like growth factor (IRP-I) and IRP-binding protein (IRFSB-3) in serum.

In addition to the above properties, the following effects of somatropin were shown:

Lipid exchange

Somatropin stimulates the hepatic receptors of low density lipoproteins (LDL) and affects the profile of lipids and lipoproteins in the blood serum. In general, the use of somatropin in patients with growth hormone deficiency leads to a decrease in the concentration of LDL and apolipoprotein B in serum. There may also be a decrease in the concentration of total cholesterol.

Exchange of carbohydrates

Somatropin increases the concentration of insulin, however, the fasting glucose concentration usually does not change. Children with hypopituitarism may have fasting hypoglycaemia. Somatropin Copies this state.

Water-salt exchange

The lack of growth hormone is associated with a decrease in the volume of plasma and tissue fluid. Both these indicators increase rapidly after treatment with somatropin. Somatropin promotes the retention of sodium, potassium and phosphorus.

Bone Metabolism

Somatropin stimulates bone metabolism. In patients with growth hormone deficiency and osteoporosis, prolonged treatment with somatropin leads to the restoration of mineral composition and bone density.

Physical performance

Treatment with somatropin increases muscle strength and physical endurance. Somatropin also increases cardiac output, but the mechanism of this effect has not yet been elucidated. A certain role in this may play a decrease in peripheral vascular resistance.

Mental status

In patients with growth hormone deficiency, there may be a decrease in mental abilities and changes in mental status. Somatropin increases vitality, improves memory and affects the balance of neurotransmitters in the brain.

Pharmacokinetics:

Suction

As in healthy individuals, and in patients with insufficiency of growth hormone, approximately 80% of the administered scatomatropine is absorbed. After subcutaneous administration

Somatropin at a dose of 0.1 IU / kg the maximum concentration and time of its attainment in blood plasma are 13-35 ng / ml and 3-6 hours respectively.

The average volume of distribution is 1.3 l / kg.

Excretion

The average half-life after intravenous administration of somatropin in patients with growth hormone deficiency is about 0.4 hours. With subcutaneous administration of the drug, the half-life period reaches 2-3 hours. The observed difference is probably associated with a slower absorption with subcutaneous injection.Metabolized in the kidneys and liver, about 0.1% in unchanged form is excreted with bile.

Subpopulations

Absolute bioavailability of somatropin with subcutaneous injection is the same in males and females.

Indications:

Children

Growth retardation with insufficient growth hormone secretion.

Growth retardation in the Shereshevsky-Turner syndrome.

Growth retardation in chronic renal failure.

Intrauterine growth retardation (in children who have not reached the normative growth rates until the age of 2 years).

Growth retardation in patients with Prader-Willi syndrome.

Adults

A confirmed expressed congenital or acquired growth hormone deficiency (as a substitute therapy) in patients who meet one of the following two criteria:

manifestation of the disease in adults: patients who have only a deficiency of growth hormone or in combination with the deficiency of other hormones (hypopituitarism), as a consequence of pituitary, hypothalamic, surgical, radiotherapy or trauma.

manifestation of the disease in children: patients who had a deficiency of growth hormone in childhood, in connection with congenital, genetic,acquired or idiopathic causes.

Contraindications:

Hypersensitivity to any of the components of the drug.

Presence of symptoms of tumor growth, including uncontrolled growth of a benign intracranial tumor. Antitumor therapy should be completed before starting treatment with Genotropin ®.

Active malignant neoplasms of any localization.

Critical condition, acute development in patients as a result of open heart or abdominal surgery, multiple trauma and acute respiratory failure.

If during the replacement therapy with growth hormone a patient has a critical condition for any reason, the risk-benefit ratio should be evaluated from the continuation of treatment in this case.

Heavy forms of obesity (weight / height ratio exceeds 200%) or severe respiratory disorders (see section "Special instructions") in patients with Prader-Willi syndrome.

Stimulation of growth in children after the closure of the growth zones of the epiphyses of tubular bones.

Pregnancy.

Carefully:

Diabetes mellitus, intracranial hypertension (see section "Side effect"), hypothyroidism (see p.section "Special instructions"), the period of breastfeeding, concomitant therapy with glucocorticosteroids, Prader-Willi syndrome.

Pregnancy and lactation:

Clinical experience in pregnant women is limited. Animal studies have not shown any adverse effects on the fetus, which, however, does not mean that similar results will be obtained with the use of the drug Genotropin® in humans, so the use of Genotropin® during pregnancy is contraindicated.

At normal course of pregnancy the level of pituitary growth hormone noticeably decreases after 20 weeks, replacing almost completely placental by the 30th week. In view of this, the need to continue substitution therapy with Genotropin® in the third trimester of pregnancy seems unlikely.

Reliable information about the possibility of excretion of somatropin with breast milk is absent, however, in any case, the absorption of intact protein in the child's gastrointestinal tract is extremely unlikely. Nevertheless, during the period of breastfeeding, the drug should be used with caution.

Dosing and Administration:

The dose of the drug should be selected individually for each patient.

Injections should be administered subcutaneously, in order to prevent lipoatrophy, the injection site should be changed.

Recommended dose for pediatric use

Indications	The daily dose
	mg / kg of weight	IU / kg	2 mg / m	IU / m²
	bodies	body weight	square	square
			surfaces	surfaces
			bodies	bodies
Insufficient secretion	0,025 - 0,035	0,07-0,10	0,7-1,0	2,1-3,0
growth hormone
Syndrome Shereshevsky-Terner	0,045-0,050	0,14	1,4	4,3
Chronic Renal Disease	0,045-0,050	0,14	1,4	4,3
failure
The Prader-	0,035	0,10	1,0	3,0
Willie
Intrauterine	0,033-0,067	0,10-0,20	1,0-2,0	3,0-6,0
growth retardation

The recommended dose for adults with growth hormone deficiency

The dose is selected individually. It is recommended to start with a dose of 0.15 to 0.30 mg (0.45-0.90 IU) per day. The final dose should be selected individually according to age and sex. The daily maintenance dose rarely exceeds 1.3 mg (4 IU) per day. Women may need a higher dose than men. Since the normal physiological production of growth hormone decreases with age, the dose corresponding to age can be reduced. Clinical and

side effects, as well as the determination of the concentration of serum IGF-I can be used as a guide in the selection of a dose.

Administration of the drug

Genotropin® 5.3 mg (16 ME) and 12 mg (36 IU) is administered subcutaneously with the use of multiple injectors Genotropin® Pen 5.3 and Genotropin® Pen 12, respectively. After the cartridge is inserted into the reusable injector, the drug is diluted automatically. When diluting the drug, the solution should not be shaken.

Side effects:

A deficiency of extracellular fluid is typical for patients with growth hormone deficiency. After the initiation of treatment with Genotropin, this deficit is quickly restored. Adult patients are characterized by side effectsFaults due to fluid retention, such as peripheral edema, rigidity of skeletal muscles, arthralgia. myalgia and paresthesia (> 1/100 and <1/10). These phenomena are usually mild or moderate, manifest during the first months of treatment and decrease spontaneously or after a decrease in the dose of the drug. The frequency of these side effects depends on the dose of Genotropin, the age of the patients, and possibly inversely proportional to the age at which growth hormone deficiency occurs. In children, these side effects are rare (> 1/1000 and <1/100).

There may be transient reactions at the injection site: rash, itching, soreness, numbness, hyperemia, swelling, lipoatrophy (> 1/100 and <1/10).In rare cases, benign intracranial hypertension develops and type 2 diabetes mellitus (<1/10000 and <1/1000).

Reduces the concentration of cortisol in the blood serum. The clinical significance of this phenomenon is limited.

Very rare cases (<1/10000) of leukemia in children with growth hormone deficiency receiving therapy with Genotropin, but the incidence of leukemia does not differ from that in children without growth hormone deficiency.

The undesirable reactions distributed according to the system-standard classes and frequency are listed below: very often (> 1/10), often (> 1/100, but <1/10), infrequently (> 1/1000, but <1/100), rarely (> 1/10 000, but <1/1000), very rarely (<1 / 10,000). frequency is unknown - it is impossible to estimate the frequency based on the available data.

Side effect somatropinsh g children with growth retardation in the Shereshevsky-
Turner
Systematically organ grade	Very often> 1/10	Often >1/100 before <1/10	Infrequently >1/1000 before <1/100	Rarely > 1 / 10,0 00 to <1/100 0	Highly rarely <1/10,0 00	Frequency unknown (impossible estimate the frequency at basis of available data)
Benign and, malignant and unexperienced newly formed !! I (including cysts and polyps)						leukemia^t
Disorders from the metabolism and nutrition						type 2 diabetes mellitus
Disturbances from the nervous system						paresthesia *, benign intracranial hypertension
Disturbances from the musculoskeletal and	arthralgia*					myalgia . rigidity of skeletal muscles
connective fabrics

Side effect of somatropin g children with growth retardation with insufficient secretion
growth hormone
System- organ grade	Very often> 1/10	Often >1/100 before <1/10	Infrequently >1/1000 BEFORE <1/100	Rarely > 1 / 10.00 0 to <1/1000	Highly rarely <1/10,000	The frequency is unknown (it is impossible to estimate the frequency based on the available data)
Benign and, malignant and unspecified neoplasms (including cysts and polyps)			leukemia^t
Disorders from the metabolism and nutrition						type 2 diabetes mellitus
Disturbances from the nervous system						paresthesia *. benign intracranial hypertension
Violations from hand skeletal- muscular and connective fabrics			arthralgia*			myalgia , rigidity of skeletal muscles

Are common

disorders and disorders at the site of administration

reactions at the injection site (rash, skin itch, tenderness, numbness, hyperemia, swelling, schoatrophy, pain at the injection site)⁵

peripheral

swelling *

Laboratory and instrumental data

a decrease in the concentration of cortisol in the blood plasma *

* In general, these reactions of mild or moderate severity occur during the first months of therapy and disappear spontaneously or against a background of decreasing dosage of somatropin. The incidence of these side effects depends on the dose of somatropin and, possibly, is inversely related to the age of the patients in whom they have a debut of the growth hormone deficiency.

⁵ There have been reports of cases of development of transient reactions at the site of administration in children, j The clinical significance of this effect is unknown.

t These reactions were observed in children with growth hormone deficiency receiving somatropin therapy, however, the incidence was the same as in children without growth hormone deficiency.

Are common

disorders and disorders at the site of administration

peripheral

edema *,

reactions at the site of administration⁵ (rash, skin itching, soreness, numbness, hyperemia, swelling, lipoatrophy, pain at the injection site)

Laboratory and

instrumental

data

a decrease in the concentration of cortisol in the blood plasma *

* In general, these reactions are mild or moderate, occur during the first months of therapy and disappear spontaneously or against the background of a decrease in the dose of somatropin.The frequency of these side effects depends on the dose of somatropin and, possibly, is inversely related to the age of the patients in whom they have a debut of growth hormone deficiency. ^s Cases of development of transient reactions at the place of administration in children have been reported.

X The clinical significance of this effect is unknown.

+ These reactions were observed in children with growth hormone deficiency receiving somatropin therapy, however, the incidence was the same as in children without growth hormone deficiency.

Side effect of somatropin g children with growth retardation in chronic renal
insufficiency
System-	Highly	Often	Infrequently	Rarely	Highly	Frequency
organ	often				rarely	unknown
grade	>1/10	> 1/100 to	>1/1000	>1/10,0		(impossible
		<1/10	BEFORE	00 to	<1/10,0	estimate the frequency at
			<1/100	<1/100	00	basis of
				0		available
						data)

Benign, malignant ne unspecified neoplasms (including cysts and polyps)		pt leukemia
1 [metabolic and nutritional disorders		type 2 diabetes mellitus
Violations from the nerves! systems		paresthesia *, benign intracranial hypertension
Violations from hand skeletal- muscular and connective fabrics		arthralgia , myalgia , rigidity of skeletal muscles *
Are common disorders and disorders at the site of administration	reactions at the site of administration⁵(rash, itchy skin, soreness, numbness, hyperemia. swelling, lipoatrophy, pain in place introduction)	peripheral swelling *
Laboratory and instrumental aannye		a decrease in the concentration of cortisol in the blood plasma *

* In general, these reactions are mild or moderate, occur during the first months of therapy and disappear spontaneously or against the background of a decrease in the dose of somatropin. The incidence of these side effects depends on the dose of somatropin and. may be inversely related to the age of the patients in whom they have a debut of the growth hormone deficiency. ^s Cases of development of transient reactions at the place of administration in children have been reported.

X The clinical significance of this effect is unknown.

t These reactions were observed in children with growth hormone deficiency receiving somatropic therapy, however, the incidence was the same as in children without deficiency growth hormone.

Somatpott side effect g children with intrauterine delay
growth
System- organ grade	Highly often >1/10	Often > 1/100 to <1/10	Infrequently > 1/1000 to <1/100	Rarely £ 1 / 10,000 to <1/100 0	Highly rarely <1/10,0 00	The frequency is unknown (it is impossible to estimate the frequency based on the available data)
Benign and, malignant and unspecified neoplasms (including cysts and polyps)						leukemia^t
Disorders from the metabolism and nutrition						type 2 diabetes mellitus
Disturbances from the nervous system						paresthesia *. benign intracranial hypertension

Violations from hand skeletal- muscular n connective fabrics		arthralgia*	myalgia , rigidity of skeletal muscles
Are common disorders and disorders at the site of administration	reactions in place introduction of⁵ (rash. itching, soreness, numbness, hyperemia. swelling, lipoatrophy, pain in place introduction)		peripheral swelling *
Laboratory and instrumental data			a decrease in the concentration of cortisol in the blood plasma *
* AT In general, these reactions are mild or moderate, occur during the first months of therapy and disappear spontaneously or against the background of a decrease in the dose of somatropin. The frequency of these side effects depends on the dose of somatropin and, possibly, is inversely related to the age of the patients in whom they have a debut of growth hormone deficiency. ^s Cases of development of transient reactions at the place of administration in children have been reported. % The clinical significance of this effect is unknown. t These reactions were observed in children with growth hormone deficiency receiving somatropin therapy, however, the incidence was the same as in children without a growth hormone deficiency.

Side effect somshshropshsh g children with the syndrome Prideri-Viali

System-	Highly	Often	Infrequently	Rarely	Highly	Frequency unknown
organ	often				rarely	(impossible
grade	>1/10	> 1/100 to <1/10	>1/1000 before	> 1/10, 000 to	<1/10,	estimate the frequency based on
			<1/100	<1/100 0	000	available data)

Benign and, malignant n unspecified neoplasms (including cysts and polyps)		leukemia *
Disorders from the metabolism and nutrition		type 2 diabetes mellitus
Disturbances from the nervous system	paresthesia *, benign intracranial hypertension
Violations from hand skeletal- muscular and connective fabrics	arthralgia*, myalgia	rigidity of skeletal muscles *
Are common disorders and disorders at the site of administration	peripheral swelling *	reactions at the injection site * (rash, itching, soreness, numbness, hyperemia, swelling, lipoatrophy.pain at the injection site)
Laboratory and instrumental data		a decrease in the concentration of cortisol in the blood plasma *

* In general, these reactions are mild or moderate, occur during the first months of therapy and disappear spontaneously or against the background of a decrease in the dose of somatropin. The incidence of these side effects depends on the dose of somatropin and. may be inversely related to the age of the patients in whom they have a debut of the growth hormone deficiency. ^s Cases of development of transient reactions at the place of administration in children have been reported.

X The clinical significance of this effect is unknown.

t These reactions were observed in children with growth hormone deficiency receiving somatropin therapy, however, the incidence was the same as in children without deficiency growth hormone.

Side effect g adult patients with fasting hormone deficiency.
receiving substitution therapy with somatropin

Systematically organ grade	Very often> 1/10	Often > 1/100 to <1/10	Infrequently > 1/1000 then <1/100	Rarely S1 / 10, 000 before <1/10 00	Highly rarely <1/10.0 00	The frequency is unknown (it is impossible to estimate the frequency based on the available data)
Disorders from the metabolism and nutrition						type 2 diabetes mellitus
Disturbances from the nervous system		paresthesia *				benign intracranial hypertension, carpal tunnel syndrome
Violations from hand skeletal- muscular and connective fabrics	arthralpia *	myalgia . rigidity skeletal muscles

eeeeeeee

Are common

disorders and disorders at the site of administration

peripheral edema *

reactions at the site of administration⁵ (rash, skin itching, soreness, numbness, hyperemia, swelling, lipoatrophy, pain at the injection site)

Laboratory and

instrumental

data

a decrease in the concentration of cortisol in the blood plasma *

* In general, these reactions are mild or moderate, occur during the first months of therapy and disappear spontaneously or against the background of a decrease in the dose of somatropin. The frequency of these side effects depends on the dose of somatropin and, possibly, is inversely related to the age of the patients in whom they have a debut of growth hormone deficiency. ^s Cases of development of transient reactions at the place of administration in children have been reported. The value of this effect is unknown.

Allergic reactions, including skin rash and itching, may occur.myositis (caused by m-cresol), it is also possible to progress the scoliosis, the formation of antibodies to the drug, headache, insomnia, glucosuria, a decrease in T4 concentration and an increase in serum TK, limping, hip and knee pain (see "Special instructions ").

There are reports of the development of edema of the optic nerve.

LS-000066-230315

During a nostregistrant study, there were rare cases of sudden death of patients receiving somatropin therapy, although there was no direct relationship between these cases and the administration of the drug.

There have been reports of epiphysiolysis of the femoral head and Legg-Calves-Pertss disease in children who received somatropin. Causative association with somatotropin has not been demonstrated

Overdose:

Cases of overdose or intoxication are unknown.

Acute overdose can lead to hypoglycemia and then to hyperglycemia. A prolonged overdose may be manifested by symptoms associated with known effects of excess human growth hormone (acromegaly, gigantism). Treatment: withdrawal of the drug, symptomatic therapy.

Interaction:

Somatropin can increase the clearance of compounds metabolized by cytochrome P4503A4 (sex hormones, glucocorticosteroids, antiepileptics and ciclosporin). The clinical significance of this effect has not been studied.

Also, see the "Side effect" and "With caution" provisions regarding diabetes and thyroid dysfunction.

Glucocorticosteroids with simultaneous application reduce the stimulating effect on the growth process.

Patients receiving thyroxine as a substitute therapy may develop moderate hyperthyroidism. In this regard, it is recommended to investigate the function of the thyroid gland after the initiation of treatment with the drug Genotropin® and after changing its dose.

Special instructions:

Cases of deaths have been reported against the use of growth hormone in children with Prader-Willi syndrome with one or more of the following risk factors: severe obesity, respiratory disorders, sleep apnea, or unidentified respiratory infections. Another possible risk factor may be the male sex of the patient. Patients with Prader-Willi syndrome should be examined for obstruction of the upper respiratory tract prior to initiation of therapy.If, during treatment, the patient develops signs of obstruction of the upper respiratory tract (including the appearance and / or strengthening of snoring, obstructive sleep apnea or similar clinical symptoms), treatment should be discontinued. All patients with Prader-Willi syndrome should be examined for sleep apnea and be closely monitored if a disorder is suspected. These patients should also monitor body weight and signs of respiratory infections, which should be diagnosed as early as possible, and the maximum active treatment should be prescribed (see "Contraindications"),

A very rare side effect is myositis, which can be caused by the action of the preservative of m-cresol, which is part of the preparation Genotropin®. In the case of myalgia or increased pain at the injection site, myositis should be assumed. In case of confirmation, it is necessary to use the form of somatropin without m-cresol. In rare cases, therapy with Genotropin® may lead to the development of type 2 diabetes, since Genotropin® may reduce the sensitivity of peripheral receptors to insulin and, therefore, patients should be examined for reduced glucose tolerance.The risk of developing diabetes during treatment with the drug Genotropin® is greatest in patients with other risk factors for developing type 2 diabetes, such as overweight, cases of diabetes mellitus among relatives, steroid hormone therapy, or a previously known impairment of glucose tolerance. In patients with diabetes, it may be necessary to change the dose of hypoglycemic drugs.

Usually, during therapy with Genotropin, "the concentration of thyroid hormones in the peripheral blood remains within normal limits, however, during the therapy, the conversion of the hormone T4 into T3 is activated, which leads to a decrease in T4 concentration and an increase in serum TK concentration." This effect of Genotropin® have clinical significance in patients with a hidden subclinical form of central hypothyroidism.At the same time, patients receiving substitution therapy with thyroxine may develop hypertension It is recommended to control the concentration of thyroid hormones immediately after starting therapy with somatropin and after choosing a dose.

With a secondary deficiency of growth hormone due to the treatment of malignant neoplasm, a more thorough observation is recommended for the development of symptoms of tumor recurrence.

Dislocations and subluxations of the femoral head (limping, pain in the thigh and knee) can be more often observed in patients with endocrine disorders, including a deficiency of growth hormone. Children receiving somatropin, in whom lameness is noted, should be carefully examined.

In case of severe or recurring headaches, visual disturbances, nausea and / or vomiting, examination of the fundus is recommended for the detection of edema of the optic disc. In case of confirmation of the edema of the optic nerve disc, it is necessary to assume the presence of benign intracranial hypertension. If necessary, treatment with somatropin should be discontinued. Currently, there is no specific recommendation on whether to resume therapy with somatropin after the elimination of intracranial hypertension. When you resume treatment, you need careful monitoring of this condition.

Possible progression of scoliosis (Genotropin® enhances growth rate),the doctor should be ready to develop such an effect against the background of treatment with the drug Genotropin. " Scoliosis is mainly observed in patients with Prader-Willi syndrome.

In patients with chronic renal failure, the drug Genotropin ® is used only with a decrease in kidney function by more than 50%. To confirm growth disorders, this indicator should be monitored against the background of Genotropin® during the year. During treatment with Genotropin®, conservative treatment of renal failure should be continued. Somatropin should be abolished with kidney transplantation.

According to publications, against the background of the application of somatropin produced by other companies, there was an increase in the incidence of otitis media, cardiovascular disorders (stroke, aortic aneurysm, increased blood pressure) in patients with Shereshevsky-Turner syndrome. Gynecomastia, rare cases of pancreatitis and growth of existing nevi were also observed in patients treated with somatropin; This was not noted against the background of the use of the drug Genotropin®, (a drug by Pfizer), but all of the above should be borne in mind when prescribing treatment.

It is possible the formation of antibodies to the drug, the study of antibody titer to somatropin should be carried out in those cases when the patient does not respond to therapy.

The drug is not effective if the body does not synthesize growth factors or lacks receptors for growth factors.

In patients aged 65 years and older, clinical trials have not established the efficacy and safety of Genotropin. Elderly patients may be more sensitive to the action of Genotropin®, so they may be more likely to develop side effects. In this regard, patients of this group should begin therapy with lower doses of the drug, as well as adjust the dose with a shorter interval

The patient can be stored for one month at room temperature not higher than 25 ° C before dilution.

Effect on the ability to drive transp. cf. and fur:

Genotropin® does not affect the ability to drive vehicles and work with mechanical means.

Form release / dosage:

Lyophilizate for the preparation of a solution for subcutaneous injection 5.3 mg and 12 mg.

Packaging:For 6.1 mg (18.4 IU) or 13.8 mg (41.4 IU) of active substance in one section of a two-compartment cartridge and 1.14 ml or 1.13 ml of solvent, respectively, in the second section. 1 cartridge with instructions for use in a cardboard pack.

Storage conditions:

In the dark place at a temperature of 2 to 8 ° C.

The finished solution can be stored in the refrigerator (at a temperature of 2 to 8 ° C) for 4 weeks. Do not freeze the cartridge, nor the finished solution. Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-000066

Date of registration:25.02.2010

The owner of the registration certificate:Pfizer IFG Belgium N.V.Pfizer IFG Belgium N.V. Belgium

Manufacturer: & nbsp

Vetter Pharma-Fertigung, GmbH & Co. KG. KG Germany

PFIZER MFG. BELGIUM, N.V. Belgium

Representation: & nbspPfizer LtdPfizer LtdUSA

Information update date: & nbsp16.08.2015

Illustrated instructions

Instructions

Genotropin® (Genotropin® )