Valtropin

Основна информация

  • Търговско наименование:
  • Valtropin
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Valtropin
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
  • Терапевтична област:
  • Turner Syndrome, Dwarfism, Pituitary
  • Терапевтични показания:
  • Paediatric poulationLong-term treatment of children (2 to 11 years old) and adolescents (12 to 18 years old) with growth failure due to an inadequate secretion of normal endogenous growth hormone.Treatment of short stature in children with Turner syndrome, confirmed by chromosome analysis.Treatment of growth retardation in pre-pubertal children with chronic renal insufficiency.Adult patientsReplacement therapy in adults with pronounced growth hormone deficiency of either childhood- or adult-onset aetiology.Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone not being prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a growth hormone deficiency. In patients with childhood-onset isolated growth hormone deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, e
  • Каталог на резюме:
  • Revision: 5

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Withdrawn
  • Номер на разрешението:
  • EMEA/H/C/000602
  • Дата Оторизация:
  • 23-04-2006
  • EMEA код:
  • EMEA/H/C/000602
  • Последна актуализация:
  • 31-03-2019

Доклад обществена оценка

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.

EMA/185537/2011

EMEA/H/C/000602

EPAR summary for the public

Valtropin

somatropin

This is a summary of the European public assessment report (EPAR) for Valtropin. It explains how the

Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in

favour of granting a marketing authorisation and its recommendations on the conditions of use for

Valtropin.

What is Valtropin?

Valtropin is a powder and solvent that are made up into a solution for injection. Valtropin contains the

active substance somatropin.

Valtropin is a ‘biosimilar’ medicine. This means that Valtropin is similar to a biological medicine (the

‘reference medicine’) that is already authorised in the European Union (EU) and that Valtropin and the

reference medicine contain the same active substance. The reference medicine for Valtropin is

Humatrope. For more information on biosimilar medicines, see the question-and-answer document

here

What is Valtropin used for?

Valtropin is used to treat children in the following situations:

children from two years of age and adolescents who fail to grow because they lack growth

hormone (replacement therapy);

children who are short because of Turner syndrome (a rare genetic disorder affecting girls),

confirmed by chromosome analysis (DNA testing);

children before puberty, who fail to grow because of longstanding kidney disease (chronic renal

insufficiency).

Medicinal product no longer authorised

Valtropin is also used to treat adults with pronounced growth hormone deficiency, which has started in

adulthood or childhood and needs to be confirmed by testing before treatment (replacement therapy).

The medicine can only be obtained with a prescription.

How is Valtropin used?

Valtropin treatment should be supervised by a doctor experienced in the management of patients with

growth disorders. Valtropin is given by injection under the skin, once a day. The patient or caregiver

can inject Valtropin after training by a doctor or a nurse. The doctor calculates the dose for each

patient individually, depending on the body weight and condition, and may need to adjust it over time,

depending on changes in body weight and response. The site of injection must be varied to avoid

lipoatrophy (loss of fat below the skin).

How does Valtropin work?

Growth hormone is a substance secreted by a gland located at the base of the brain called the pituitary

gland. It promotes growth during childhood and adolescence, and also affects the way the body

handles proteins, fat and carbohydrates. The active substance in Valtropin, somatropin, is identical to

human growth hormone. It is produced by a method known as ‘recombinant DNA technology’: the

hormone is made by a yeast that has received a gene (DNA) that makes it able to produce somatropin.

Valtropin replaces the natural hormone.

How has Valtropin been studied?

Valtropin was studied to show that it is comparable to the reference medicine, Humatrope. Valtropin

was compared with Humatrope in 149 children with a lack of growth hormone and who had not been

treated before. The study lasted 12 months, and measured the children’s height at the beginning and

the end of the study, and the speed of growth during the study.

What benefit has Valtropin shown during the studies?

After 12 months, treatment with Valtropin and Humatrope brought about similar increases in height

and speed of growth (speed of +11.4 and +10.5 cm per year, respectively). This was considered

sufficient to demonstrate that the benefits of Valtropin are comparable to those of the reference

medicine.

What is the risk associated with Valtropin?

The most common side effects with Valtropin are reactions at the site of injection and hormonal

changes, and, in adults, headache, paraesthesia (unusual sensation like pins and needles), arthralgia

(joint pain) and joint disorders. For the full list of all side effects reported with Valtropin, see the

package leaflet.

Valtropin should not be used in people who may be hypersensitive (allergic) to somatropin or any of

the other ingredients (the solvent for Valtropin contains metacresol). Valtropin must not be used when

the patient suffers from an active tumour, or a life-threatening illness. Valtropin must not be used for

growth promotion in children with closed epiphyses (the state of the large bones when they have

finished growing). For the full list of restrictions, see the package leaflet.

Valtropin

Medicinal product no longer authorised

Valtropin

Why has Valtropin been approved?

The CHMP decided that, in accordance with EU requirements, Valtropin has been shown to have a

comparable quality, safety and efficacy profile to Humatrope. Therefore, the CHMP’s view was that, as

for Humatrope, the benefit outweighs the identified risks.

Other information about Valtropin

The European Commission granted a marketing authorisation valid throughout the European Union for

Valtropin to BioPartners GmbH on 24 April 2006. After five years, the marketing authorisation was

renewed for a further five years.

The full EPAR for Valtropin can be found on the Agency’s website: ema.europa.eu/Find

medicine/Human medicines/European Public Assessment Reports. For more information about

treatment with Valtropin, read the package leaflet (also part of the EPAR) or contact your doctor or

pharmacist.

This summary was last updated in 03-2011.

Medicinal product no longer authorised

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

Medicinal product no longer authorised

PACKAGE LEAFLET: INFORMATION FOR THE USER

Valtropin 5 mg/1.5 ml powder and solvent for solution for injection

Somatropin

Read all of this leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even

if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,

please tell your doctor or pharmacist.

In this leaflet:

What Valtropin is and what it is used for

Before you use Valtropin

How to use Valtropin

Possible side effects

How to store Valtropin

Further information

1.

WHAT Valtropin IS AND WHAT IT IS USED FOR

Your medicine is called Valtropin. It is a human growth hormone, also called somatropin. It has the

same structure as the growth hormone that the body produces in the pituitary glands (glands located at

the base of the brain). Growth hormone regulates the growth and development of cells. When it

stimulates growth of cells in the long bones of the legs and spine, it causes an increase in height.

Valtropin is used

to treat children

(2 to 11 years old) and teenagers (12 to 18 years old) who do not develop to

their normal height because of poor bone growth caused by growth hormone deficiency (relative

lack of growth hormone), Turner syndrome, or ‘chronic renal insufficiency’ (a condition in

which the kidneys gradually lose their ability to perform their normal functions, such as the

removal of wastes and extra fluid from the body).

to treat adults

with severe growth hormone deficiency who already had growth hormone

deficiency when they were children or who do not have enough growth hormone during their

adult years for some other reason.

In this leaflet the patient is addressed as ‘you’. Caregivers administering Valtropin to their children

should consider that ‘you’ refers to the child.

2.

BEFORE YOU USE Valtropin

Do not use Valtropin

if you are

allergic (hypersensitive) to somatropin or any of the other ingredients of the

powder or solvent of Valtropin

, e.g. metacresol (see section 2, ‘Take special care with

Valtropin – Occurrence of certain side effects’)

and tell your doctor if you have

an active tumour

. Tumours must be inactive and you must

have finished your anti-tumour treatment before you start your treatment with Valtropin.

for growth promotion in children who have already

stopped growing

if you have had a

serious heart or abdominal operation

if you are

being treated for more than one injury following a serious accident

if you have

sudden serious breathing problems

Medicinal product no longer authorised

Take special care with Valtropin

Examinations before starting treatment

A specialist doctor trained in hormone disorders must examine you to decide if it is safe to use

Valtropin.

If you have had a brain tumour a specialist doctor trained in hormone disorders must examine

your pituitary function to decide if it is safe to use Valtropin.

Before children are treated for growth hormone deficiency due to kidney problems, the doctor

should observe the child for one year before starting growth hormone treatment.

If adults have been treated with growth hormone during childhood, they should be re-evaluated

for growth hormone deficiency before starting any further treatment with growth hormones.

Patients with Prader-Willi syndrome should not be treated with Valtropin unless they are also

suffering from growth hormone failure.

During or after serious illness

If you have had a brain tumour, you should be re-examined frequently to make sure that the

tumour has not come back.

If you had cancer as a child. A higher risk for having a second tumour (benign and malignant)

has been reported in patients that survived their cancer and were treated with somatropin. Of

these second tumours, in particular, brain tumours were the most common.

If children have had a kidney transplant, growth hormone treatment will be stopped.

If the child has Turner syndrome, the child’s doctor should carefully check for ear infections

such as otitis media, because Turner syndrome patients have an increased risk of ear or other

hearing disorders.

Occurrence of certain side effects

If symptoms like headache (severe and recurrent), visual changes, nausea and/or vomiting

occur, please ask your doctor for advice.

If you have injected Valtropin by mistake into the muscle instead of under the skin, your blood

sugar may become too low (hypoglycaemia). Please contact your doctor for further advice.

If the child begins to limp under treatment with Valtropin, please ask your doctor for advice.

If you are a child and you are treated with somatropin. You have an increased risk of developing

an inflammation of your pancreas (pancreatitis) compared to adults treated with somatropin.

Although rare, pancreatitis should be considered in somatropin-treated children who develop

abdominal pain.

Too much growth hormone can cause greater than normal growth of ears, nose, lips, tongue and

cheekbone (acromegaly), high blood sugar (hyperglycaemia) and presence of sugar in the urine

(glucosuria). Always use Valtropin as recommended by your doctor.

If an allergic reaction to solvent occurs, the vials should be reconstituted with water for

injections without preservative (metacresol) and used as a single use vial (see section 5 ‘How to

store Valtropin’).

Do not use the supplied solvent if you have a known allergy to metacresol

preservative

Monitoring during treatment by your doctor

Valtropin may affect the way your body handles sugar from food and drink. Your doctor may

check the amount of sugar in your urine or blood.

Valtropin can affect the amount of thyroid hormone in the blood, so you must have thyroid

function tests from time to time. If the thyroid is not working properly, Valtropin may not work

as well as it should.

Medicinal product no longer authorised

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,

including medicines obtained without a prescription.

Tell especially your doctor if you are taking

adrenal steroid hormone such as cortisone or prednisolone

insulin

oral oestrogen

sex hormones, medicines to treat stress response or inflammation (corticosteroids), medicines to

treat epilepsy (e.g. carbamazepin)or cyclosporine (a medicine to suppress the immune system).

Your doctor may need to adjust the dose of Valtropin or of the other medicine.

Pregnancy

Valtropin should not be used during pregnancy unless clearly necessary. If you become pregnant, tell

your doctor immediately.

Breast-feeding

If you are breast-feeding or intend to breast-feed, please ask your doctor for advice before using

Valtropin.

Ask your doctor or pharmacist for advice before taking any medicines.

Driving and using machines

Valtropin has no or negligible effect on the ability to drive and use machines.

Important information about some of the ingredients of Valtropin

The accompanying solvent of Valtropin contains metacresol. Do not use this solvent if you are allergic

to metacresol (see section 2,

Do not use Valtropin’). If an allergic reaction to the solvent occurs, the

vials should be reconstituted with water for injections and used as a single use vial (see section 5 ‘How

to store Valtropin’).

3.

HOW TO USE Valtropin

Always use Valtropin exactly as your doctor has told you. You should check with your doctor or

pharmacist if you are not sure. Do not inject Valtropin yourself if you are not sure about the dose.

Dosage

Your doctor will tell you how much to use. This will vary according to your disease. Please do not

change the dosage without consulting your doctor.

The accuracy of the Valtropin dose should be checked every 6 months by your doctor.

In general the dosage will be calculated as described below. However, individual doses may vary, and

the doctor may change your dose based on your specific need.

Children

Growth hormone deficiency in children

Inject 0.025 - 0.035 milligrams (mg) for each kilogramme of body weight once daily under the skin

(subcutaneously).

Children with Turner syndrome

Inject 0.045 - 0.050 milligrams (mg) for each kilogramme of body weight once daily under the skin

(subcutaneously).

Medicinal product no longer authorised

Children before puberty, who suffer from long-term kidney problems

Inject 0.045 - 0.050 milligrams (mg) for each kilogramme of body weight once daily under the skin

(subcutaneously).

Adults

Growth hormone deficiency in adults

Inject 0.15 - 0.30 milligrams (mg) once daily under the skin (subcutaneously). A lower starting dose

may be necessary if you are older or overweight.

If necessary, your doctor will gradually increase this dose according to your individual requirements

based on the clinical outcome and measurement of your blood levels of a so called “growth factor”

(known as IGF-1). The total daily dose usually does not exceed 1 mg. IGF-1 concentrations need to be

regularly measured and should be maintained below the upper limit of the normal range for your age

and sex.

Your doctor will always prescribe the minimum effective dose to be used.

Dosage adjustment

In elderly patients a dose reduction may be necessary.

The dosage of somatropin should be reduced in cases of long lasting swelling (oedema) or severe

abnormal sensation (paresthesia), in order to avoid the development of a rare side effect called carpal

tunnel syndrome (hand numbness and pain).

Following use of the medicine for some time, it may be necessary to reduce the dose, particularly in

men.

When using other medicines the dose of Valtropin or of the other medicine may need to be adjusted

(see section 2, ‘Using other medicines’).

Administration

Valtropin is intended for subcutaneous use after reconstitution. This means that after reconstitution of

the powder with the solvent provided the solution is injected with a short needle into the fatty tissue

just under the skin.

If you are injecting this medicine yourself you will be instructed how to prepare and give the injection.

Do not inject Valtropin yourself unless you have received training.

Detailed instructions for subcutaneous administration are provided with this leaflet (see section

‘Information on how to self-inject Valtropin’ at the end of this leaflet).

If you use more Valtropin than you should

In case more Valtropin was used than recommended, please consult your doctor.

If you have used too much Valtropin, initially your blood sugar may decrease and become too low

(hypoglycaemia) and subsequently increase and become too high (hyperglycaemia). If you have used

too much Valtropin over a longer period, this may result in a greater than normal growth of ears, nose,

lips, tongue and cheekbone (acromegaly).

If you forget to use Valtropin

Do not take a double dose to make up for forgotten doses. Continue with the prescribed dosage

regimen. If you have any doubts, please contact your doctor.

Medicinal product no longer authorised

If you stop using Valtropin

Please ask your doctor for advice before stopping treatment. Interruption or early stopping of

treatment with Valtropin may impair the success of the growth hormone therapy.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Valtropin can cause side effects, although not everybody gets them.

The side effects of medicines are classified as follows:

very common

affects more than 1 user in 10

common

affects 1 to 10 users in 100

uncommon

affects 1 to 10 users in 1,000

rare

affects 1 to 10 users in 10,000

very rare

affects less than 1 user in 10,000

not known

Frequency cannot be estimated from the available data

You may experience any of the following side effects after administration of Valtropin:

Very common

Headache in adults

Abnormal sensation, such as pricking, tingling, or

itchiness (paresthesia) in adults

Joint pain (arthralgia) in adults

Tissue swelling caused by accumulation of fluid in tissue

(oedema) in adults

Common

Development of proteins that bind other substances

(antibody building)

Underactive thyroid gland (hypothyroidism)

Impaired ability to reduce sugar levels (glucose tolerance)

Mild increase of blood sugar levels (mild hyperglycaemia)

(1% in children; 1% - 10% in adults)

Abnormal increase of muscle tone (hypertonia)

Sleeplessness (insomnia) in adults

Increased blood pressure (hypertension) in adults

Shortness of breath (dyspnoea) in adults

Temporary interruption of breathing during sleep (sleep

apnoea) in adults

Numbness and tingling in fingers and palm of the hand

due to squeezed nerve at hand wrist (carpal tunnel

syndrome) in adults

Joint pain (arthralgia) in children

Muscle pain (myalgia)

Tissue swelling caused by accumulation of fluid in tissue

(oedema) in children

Injection site reactions, weakness (asthenia)

Uncommon

Increased growth of new tissue (cancer, neoplasm)

Lack of red blood cells (anaemia)

Too little sugar in the blood (hypoglycaemia),

Blood phosphate level above normal (hyperphosphatemia)

Medicinal product no longer authorised

Personality disorder

Rapid uncontrollable movement of the eyes (nystagmus)

Swelling of the optic nerve head (papilloedema)

Double vision (diplopia)

Dizziness (vertigo)

Accelerated heart beat (tachycardia)

Vomiting

Stomach pain (abdominal pain), wind (flatulence)

Nausea

Fat tissue decrease (lipodystrophy), thinning of the skin

(skin atrophy), inflammation and peeling of skin

(exfoliative dermatitis), swelling similar to after insect

stings (urticaria), increased growth of male type hair on a

woman’s body (hirsutism), thickening of skin tissue (skin

hypertrophy)

Decrease in the muscle mass (muscle atrophy), bone pain

Numbness and tingling in fingers and palm of the hand

due to squeezed nerve at hand wrist (carpal tunnel

syndrome) in children

Involuntary loss of urine (urinary incontinence), blood in

the urine (haematuria), passing more urine than normal

(polyuria, pollakiuria), abnormal urine

Genital discharge

Enlargement of the male breast gland (gynaecomastia) in

adults

Injection site reactions like thinning of skin tissue, a

copious discharge of blood from the blood vessels,

thickening

Weakness in children

Rare

Sugar disease (diabetes mellitus)

Nerve disorder outside the brain and spinal cord

(neuropathy), increased pressure in the skull (intracranial

pressure increased)

High blood pressure in the skull (benign intracranial

hypertension)

Abnormal sensation of the skin, such as pricking, tingling

and itchiness (paresthesia) in children

Increased blood pressure (hypertension) in children

Diarrhoea

Abnormal results in kidney function tests

Very rare

Sleeplessness (insomnia) in children

Enlargement of the male breast gland (gynaecomastia) in

children

Frequency not known

Single case of acute allergic reaction involving itching and

swelling similar to insect stings and itching

Severe reduction of insulin effects (insulin resistance)

In patients with adult-onset growth hormone deficiency swelling, muscle pain, joint pain and disorders

have been reported early in therapy with somatropin but these effects tended to be transient (short-

lived).

Medicinal product no longer authorised

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please

tell your doctor or pharmacist.

5.

HOW TO STORE Valtropin

Keep out of the reach and sight of children.

Do not use Valtropin after the expiry date which is stated on the labels and the carton after EXP.

The expiry date refers to the last day of that month.

Storage conditions of the unopened medicine

Store in a refrigerator (2°C - 8°C). Do not freeze.

The non-reconstituted medicine can be kept at room temperature (not above 25°C) for one

single period of up to 4 weeks before use.

Shelf-life after reconstitution with solvent

After reconstitution with the solvent provided the medicine may be stored in the refrigerator

(2°C - 8°C) for a maximum of 21 days.

Shelf-life after reconstitution with water for injections (NOT tap water)

After reconstitution with water for injections the medicine must be used immediately and as a

single use vial.

Do not use Valtropin if you notice that the solvent or the reconstituted solution is cloudy or

discoloured or if contains particulate matters.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to

dispose of medicines that are no longer required. These measures will help to protect the environment.

6.

FURTHER INFORMATION

What Valtropin contains

Powder:

The active substance is somatropin. One vial of powder contains 5 mg somatropin

(corresponding to 15 IU). After reconstitution with 1.5 ml solvent, 1 ml contains 3.33 mg

somatropin (corresponding to 10 IU).

The other ingredients are glycine, mannitol, sodium phosphate monobasic, sodium phosphate

dibasic and for pH (acidity) adjustment sodium hydroxide and hydrochloric acid.

Solvent:

The pre-filled syringe contains water for injections and metacresol (see section 2, ‘Important

information about some of the ingredients of Valtropin’).

What Valtropin looks like and contents of the pack

Valtropin is presented as a powder and solvent for solution for injection.

One pack contains:

5 mg of white to almost white powder in a glass vial closed with a rubber stopper and a cap

1.5 ml of solvent in a pre-filled syringe closed with a tip cap, for reconstitution as a clear

solution.

Medicinal product no longer authorised

Marketing Authorisation Holder and Manufacturer

BioPartners GmbH

Kaiserpassage 11

D-72764 Reutlingen

Germany

Tel: +49 (0) 7121 948 7756

Fax: +49 (0) 7121 346 255

This leaflet was last approved in

{MM/YYYY}

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu

---------------------------------------------------------------------------------------------------------------------------

INFORMATION ON HOW TO SELF-INJECT Valtropin

Please read the following instructions carefully before using Valtropin.

Introduction

The following instructions explain how to inject Valtropin

yourself. Please read the instructions carefully

and follow them step by step. Your doctor or his/her assistant will instruct you how to self-inject Valtropin.

Do not attempt to inject yourself unless you are sure you understand the procedure and requirements of

self-injection.

General notes

For patients with a known allergy to metacresol, Valtropin should not be reconstituted with the

supplied solvent (see section 2, ‘Do not use Valtropin’). If allergy to the accompanying solvent occurs,

the vials should be reconstituted with water for injections: please fill a syringe with 1.5 ml of water for

injections and follow the same instructions as for the pre-filled syringe (see section 5 ‘How to store

Valtropin’). Do not use tap water.

Collect the necessary items before you begin. These are:

Supplied in the pack

the Valtropin

vial with powder for solution for injection

the pre-filled syringe with 1.5 ml solvent for solution for injection

NOT supplied in the pack

sterile injection syringe and needles

alcohol swabs

dry gauze or cotton pad

an adhesive plaster

disposal box for used syringes and needles.

Preparing the solution

Wash your hands thoroughly with soap and water before preparing the medicine.

Take the Valtropin carton out of the

refrigerator

and take the

powder vial

pre-filled syringe

with solvent out of the box. Check that the medicine is within the expiry date.

Medicinal product no longer authorised

Remove the protective plastic cap from the powder vial.

Clean the rubber stopper on the top of the powder vial with an alcohol swab. After cleaning do not

touch the top of the vial.

Vial containing the powder of your medicine

Take the

pre-filled syringe

with solvent

supplied in the pack to prepare your medicine. Remove the

rubber tip cap and firmly attach a needle to the syringe. Your doctor or his/her assistant will tell you

what size of needle to use.

Remove the needle guard without touching the needle.

Slowly insert the needle straight through the centre of the rubber stopper of the vial.

Medicinal product no longer authorised

Slowly inject all of the solvent (1.5 ml) into the powder vial aiming the stream of liquid against the

side of the vial.

DO NOT

aim it at the white powder at the bottom of the vial.

Before taking the syringe out of the vial, draw in the same amount of air (1.5 ml) as the solvent you

injected to reduce the pressure in the vial. Withdraw the syringe and replace the needle guard.

Swirl the vial

GENTLY

to completely dissolve the contents.

DO NOT SHAKE.

Dissolving up your medicine

The resulting solution should be clear, without particles.

Label the vial with the date on which you prepared the solution.

Preparing the injection

Clean the rubber stopper on the top of the vial with an alcohol swab again. After cleaning do not

touch the top of the vial.

Vial containing the solution of your medicine

Medicinal product no longer authorised

Take the

injection syringe

and the needle supplied by your pharmacy or hospital, to withdraw the

solution of medicine. Remove the injection syringe from its sterile packaging and attach the needle to

the syringe.

Fill the syringe with air by pulling the plunger back to the level that represents your dose as

prescribed by your doctor.

Remove the needle guard without touching the needle.

Slowly insert the needle straight through the centre of the rubber stopper of the vial.

Gently push the plunger to discharge the air in the syringe into the vial.

Medicinal product no longer authorised

Turn the vial upside down with the needle still in it and hold the vial in one hand. Hold the syringe

with the needle in the vial pointing up. Ensure that the tip of the needle is in the solution. Using your

other hand slowly pull back the plunger in a continuous motion to draw the correct dose into the

syringe ensuring that the needle tip remains in the solution.

Withdrawing the right volume of your medicine with the help of the syringe markings

Remove the syringe from the needle leaving the needle in the vial without touching the tip of the

syringe. Withdraw the needle, replace the needle guard and dispose in a closed container. For

handling the vial see ‘Injecting the solution’, step 32.

Take a new needle (one that is suitable for subcutaneous injection) and place it firmly onto the tip of

the syringe.

Syringe containing your medicine being attached to a new needle

Remove the needle guard from the syringe needle and check for air bubbles in the syringe.

If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing

up, until the bubbles disappear. Push the plunger slowly back up to the correct dose.

Replace the needle guard and place the syringe with the needle on a flat surface.

Medicinal product no longer authorised

Injecting the solution

Ensure the solution is at room temperature. If the solution is cold, warm the syringe between your

palms.

Inspect the solution prior to administration: if the solution is discoloured or if you can see any solid

particles in the liquid the solution

MUST NOT

be injected.

Select the injection site according to the recommendation of your doctor. It is very important that you

vary the injection site

each time you give the medicine.

Cleanse the injection site with an alcohol swab and wait for the area to dry.

Check that the correct dose of Valtropin solution is in the syringe. Hold the syringe in your hand as

you would hold a pencil.

Squeeze a big skin fold between your thumb and index finger. Insert the needle into the pinched skin

at a 45° to 90° angle with a quick, firm motion. This hurts less than pushing the needle in slowly.

Slowly (over a few seconds) inject the solution by gently depressing the plunger until the syringe is

empty.

Withdraw the needle quickly and apply pressure over the injection site with a dry gauze or cotton pad

for several seconds. If there is bleeding, cover the injection site with an adhesive plaster.

Dispose the used syringe in a closed container. Be sure to

return the vial to the refrigerator

. When

empty, discard the vial as well. For shelf-life after reconstitution see section 5 ‘How to store

Valtropin’.

If the powder is reconstituted with water for injections, then the vial is for single use only. Any

unused solution should be discarded.

Medicinal product no longer authorised