Buy Increlex 10mg Online

     Increlex IGF-1 10mg/ml 4ml Vial Your child should not receive this drug if your child: is allergic to mecasermin or any of the ingredients in INCRELEX: has finished growing; has any cancerous tumors or growths; or has a history of cancer. Your child should never receive Buy Increlex 10mg Online through a vein.

Tell your child’s doctor about all of your child’s medical conditions, including if your child has diabetes; a curved spine (scoliosis); or is pregnant or breast-feeding.

Tell your child’s doctor about all the medicines (prescription and over-the-counter), vitamins, and herbal supplements your child takes. Especially tell your child’s doctor if your child takes insulin or other anti-diabetes medicines; a change in dose may be needed.

Buy Increlex 10mg Online may cause serious side effects, including:

Low blood sugar (hypoglycemia). Buy Increlex 10mg Online may lower blood sugar levels. It is important to only give your child INCRELEX 20 minutes before or 20 minutes after a meal or snack to reduce the chances of low blood sugar. Do not give your child INCRELEX if your child cannot eat. Signs of low blood sugar include: dizziness; tiredness; restlessness; hunger; irritability; trouble concentrating; sweating; nausea; and fast or irregular heartbeat. Severe low blood sugar may cause unconsciousness, seizures, or death. Your child should avoid participating in high risk activities (e.g. driving, exercise, etc.) within 2 to 3 hours after an INCRELEX injection, especially at the beginning of treatment. Your child should always have a source of sugar such as orange juice, glucose gel, candy, or milk available in case symptoms of low blood sugar happen. For severe low blood sugar, if your child is not responsive and cannot drink sugar-containing fluids, you should get emergency medical help for your child right away.

Allergic reactions are a serious but common side effect of INCRELEX. Call your child’s doctor right away if your child gets a rash or hives, which generally appear minutes to hours after the injection and may sometimes occur at many places on the skin. Stop taking Buy Increlex 10mg Online and get medical help right away if your child has trouble breathing or goes into shock, with symptoms like dizziness, pale, clammy skin or passing out. INCRELEX can also cause reactions at the injection site including: loss of fat (lipoatrophy); increase of fat (lipohypertrophy); pain; redness; or bruising.

Increased pressure in the brain (intracranial hypertension). INCRELEX, like growth hormone, can sometimes cause a temporary increase in pressure within the brain. Symptoms include persistent headache and nausea with vomiting.

Enlarged tonsils. Signs include: snoring, difficulty breathing, sleep apnea (a condition where breathing stops briefly during sleep), or fluid in the middle ear.

A bone problem called slipped capital femoral epiphysis, when the top of the upper leg bone (femur) slips apart. Get medical help right away if your child develops a limp or has hip or knee pain.

Worsened scoliosis (caused by rapid growth).

Tumor Growths. Several cases of cancerous tumors have been observed in children who received INCRELEX. Tell your doctor immediately if your child develops any new growths or symptoms of cancer.

Benzyl alcohol toxicity. Benzyl alcohol, a preservative in INCRELEX, can cause serious side effects, including death in infants.

The most common side effects of INCRELEX include: low blood sugar (hypoglycemia), injection site reactions, allergic reactions and enlarged tonsils.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

INCRELEX 10 mg/ml solution for injection

Each ml contains 10 mg of mecasermin*.

Each vial of 4ml contains 40 mg of mecasermin.

*Mecasermin is a recombinant DNA-derived human insulin-like growth factor-1(IGF-1) produced in Escherichia coli.

One ml contains 9 mg of benzyl alcohol.

3. Pharmaceutical form

Solution for injection (injection).

Aqueous, clear and colourless solution.

4. Clinical particulars

For the long-term treatment of growth failure in children and adolescents from 2 to 18 years with severe primary insulin-like growth factor-1 deficiency (Primary IGFD).

Severe Primary IGFD is defined by:

• height standard deviation score ≤ –3.0 and

• basal IGF-1 levels below the 2.5th percentile for age and gender and

• GH sufficiency.

• Exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.

Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment. It is recommended to confirm the diagnosis by conducting an IGF-1 generation test.

Treatment with INCRELEX should be directed by physicians who are experienced in the diagnosis and management of patients with growth disorders.

The safety and efficacy of Buy Increlex 10mg Online in children below age of 2 have not been established. No data are available.

Therefore INCRELEX is not recommended in children below age of 2.

Method of administration

Increlex IGF-1 10mg/ml 4ml Vial should be administered by subcutaneous injection shortly before or after a meal or snack. If hypoglycaemia occurs with recommended doses, despite adequate food intake, the dose should be reduced. If the patient is unable to eat, for any reason, INCRELEX should be withheld. The dose of mecasermin should never be increased to make up for one or more omitted doses.

Injection sites should be rotated to a different site with each injection.

Increlex IGF-1 10mg/ml 4ml Vial should not be administered intravenously.

Precaution to be taken before manipulating or administering the product

The solution should be clear immediately after removal from the refrigerator. If the solution is cloudy, or contains particulate matter, it must not be injected

INCRELEX should be administered using sterile disposable syringes and injection needles. The syringes should be of small enough volume that the prescribed dose can be withdrawn from the vial with reasonable accuracy.

Hypersensitivity to the active substance or to any of the excipients listed in section

Active or suspected neoplasia. Therapy should be discontinued if evidence of neoplasia develops.

As INCRELEX contains benzyl alcohol, it must not be given to premature babies or neonates.

Thyroid and nutritional deficiencies should be corrected before initiating INCRELEX treatment.

INCRELEX is not a substitute for GH treatment.

INCRELEX should not be used for growth promotion in patients with closed epiphyses.

INCRELEX should be administered shortly before or after a meal or snack, because it may have insulin-like hypoglycaemic effects. Special attention should be paid to young children, children with a history of hypoglycaemia and children with inconsistent food intake. Patients should avoid engaging in any high-risk activities within 2-3 hours after dosing, particularly at the initiation of INCRELEX treatment, until a well tolerated dose of INCRELEX has been established. If a person with severe hypoglycemia is unconscious or otherwise unable to ingest food normally, an injection of glucagon may be required. Persons with a history of severe hypoglycemia should have glucagon available. At the time of initial prescription, physicians should educate parents on the signs, symptoms and treatment of hypoglycaemia, including injection of glucagon.

Doses of insulin and/or other hypoglycaemic medicinal products may need to be reduced for diabetic subjects using INCRELEX.

Treatment should be reconsidered if after a year patients remain non-responsive.

Persons who have allergic reactions to injected IGF-1, who have unexpectedly high blood values of IGF-1 after injection, or who fail to show a growth response without any identified cause may be having an antibody response to injected IGF-1. This may be through the production of anti-IGF IgEs, sustaining antibodies or neutralising antibodies respectively. In such instances, instructions for antibody testing should be considered.

A negative pregnancy test is recommended for all women of child bearing potential prior to treatment with INCRELEX. It is also recommended that all women of childbearing potential use adequate contraception during treatment.

There are no or limited amount of data for the use of mecasermin in pregnant women.

Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). The potential risk for humans is unknown.

INCRELEX should not be used during pregnancy unless clearly necessary.

INCRELEX (mecasermin) is a prescription medicine used to treat children who are very short for their age because their bodies do not make enough insulin-like growth factor-1 (IGF-1). This condition is called severe primary IGF-1 deficiency. INCRELEX should not be used instead of growth hormone. It is not known if INCRELEX is safe and effective in children under 2 years of age.