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Valtropin (somatropin) – Labelling - H01AC01

Updated on site: 10-Oct-2017

Medication nameValtropin
ATC CodeH01AC01
Substancesomatropin
ManufacturerBioPartners GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

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

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial of powder contains 5 mg (15 IU) somatropin (3.33 mg/ml somatropin after reconstitution with 1.5 ml solvent).

3. LIST OF EXCIPIENTS

Powder: glycine, mannitol, sodium phosphate monobasic, sodium phosphate dibasic.

pH adjustment: sodium hydroxide and hydrochloric acid.

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Solvent: metacresol (see leaflet for further information) and wat for injections.

 

 

4. PHARMACEUTICAL FORM AND CONTENTS

 

 

 

 

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Powder and solvent for solution for injection

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1 vial of 5 mg powder

 

 

 

 

 

 

 

1 pre-filled syringe of 1.5 ml solvent.

 

 

 

 

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5. METHOD AND ROUTE(S) OF ADMINISTRATION

6.SPECIALMedicinalWARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

After reconstitution with the solvent provided: can be stored for 21 days in a refrigerator. After reconstitution with water for injections: must be used immediately.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

BioPartners GmbH, Kaiserpassage 11, D-72764 Reutlingen, Germany

12.

MARKETING AUTHORISATION NUMBER(S)

 

EU/1/06/335/001

 

 

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13.

BATCH NUMBER

 

 

 

Lot

 

 

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GENERAL CLASSIFICATION FOR SUPPLY

 

 

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Medicinal product subject to medical pres ription.

 

 

15.

INSTRUCTIONS ON USE

 

 

 

 

 

 

 

 

16.

INFORMATION IN BRAILLE

 

 

 

 

Medicinal

 

 

 

Valtropin 5 mg/1.5 ml

 

 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL OF POWDER

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Valtropin 5 mg/1.5 ml powder for solution for injection somatropin

Subcutaneous use

2. METHOD OF ADMINISTRATION

 

Read the package leaflet before use.

 

 

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3.

EXPIRY DATE

 

 

 

 

 

EXP

 

 

 

 

 

 

 

 

 

 

 

 

 

4.

BATCH NUMBER

 

 

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Lot

 

 

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5.

 

 

 

 

 

CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

 

 

5 mg (15 IU)

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OTHER

 

 

 

 

 

 

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Store in a refrigerator. Do ot freeze.

 

 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE OF SOLVENT

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Solvent for Valtropin

Subcutaneous use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

 

 

 

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5.

 

 

 

CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1.5 ml (water for injections with metacresol)

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OTHER

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Store in a refrigerator. Do not freeze.

 

 

 

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B. PACKAGE

 

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LEAFLETlonger

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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:

 

1.

What Valtropin is and what it is used for

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2.

Before you use Valtropin

 

3.

How to use Valtropin

 

4.

Possible side effects

 

5.

How to store Valtropin

 

6.

Further information

 

1.

WHAT Valtropin IS AND WHAT IT IS USED FOR

 

 

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Your medicine is called Valtropin. It is a human growth hormon , 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 gr wth 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

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to treat adults with severeproductgrowth hormone deficiency who already had growth hormone

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to treat children (2 to 11 years old) and eenagers (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 l se their ability to perform their normal functions, such as the

 

removal of wastes and extra fluid from the body).

 

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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 consid r 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

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

-If you had cancer as a child. A higher risk for having a secondauthorisedtumour (benign and malignant) has been reported in patients that survived their cancer and were treated w omatropin. 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 c eck for ear infections

such as otitis media, because Turner syndrome patients have an increased risk of ear or other hearing disorders.-- tumour has not come back.

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.longer

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If the child begins to limp under treatme

nowith Valtropin, please ask your doctor for advice.

-If you are a child and you are treated wi h 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 (acromega y), high blood sugar (hyperglycaemia) and presence of sugar in the urine (glucosuria). Always use Valtropin as recommended by your doctor.

-If an allergic react on to solvent occurs, the vials should be reconstituted with water for injections w thout 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.Medicinalproduct

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.

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

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If you are breast-feeding or intend to breast-feed, please ask your doctor for adv ce 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 drivelongerand use machines.

Important information about some of the ingredients of Valtropin

The accompanying solvent of Valtropin contains metacres . 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

 

 

 

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

to store Valtropin’).

 

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

3.

HOW TO USE Valtropin

 

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

Dosage

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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).

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

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

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

tunnel syndrome (hand numbness and pain).

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

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

Administration

Valtropin is intended for subcutane us 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.

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 are injectingMedicinalth s medicine yourself you will be instructed how to prepare and give the injection. Do not inject Valtrop yourself unless you have received training.

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.

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:

 

 

 

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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

 

 

 

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(oedema) in adults

 

 

 

Development of proteins that bind other substances

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(antibody building)

 

 

 

Underactive thyroid gland (hypothyroidism)

 

 

Impaired ability to reduce sugar levels (glucose tolerance)

 

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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

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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)

 

 

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 (mu cle atrophy), bone pain

 

 

Numbness and tingling in finge and palm of the hand

 

 

due to squeezed nerve at

and wrist (carpal tunnel

 

 

syndrome) in children

 

 

 

Involuntary loss of urine (

rinary incontinence), blood in

 

 

the urine (haematu ia), passing more urine than normal

 

 

 

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(polyuria, pollakiuria), abnormal urine

 

 

Genital dischar

 

 

 

 

Enlargeme t of the male breast gland (gynaecomastia) in

 

 

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Injecti n site reactions like thinning of skin tissue, a

 

 

copious discharge of blood from the blood vessels,

 

 

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hickening

 

 

 

 

Weakness in children

 

Rare

 

Sugar disease (diabetes mellitus)

 

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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

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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).

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 frigerator

 

(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.

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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 h usehold waste. Ask your pharmacist how to

What Valtropin contains

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

 

 

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6. FURTHER INFORMATION

 

Powder:

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-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 (correspo ding to 10 IU).

-The other ingred ents are glycine, mannitol, sodium phosphate monobasic, sodium phosphate dibasic and for pH (acidity) adjustment sodium hydroxide and hydrochloric acid.Medicinal

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.

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

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

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INFORMATION ON HOW TO SELF-INJECT Valtropin

Please read the following instructions carefully before using V ltropin.

self-injection.

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Introduction

 

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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 assista t will instruct you how to self-inject Valtropin. Do not attempt to inject yourself unless you are sure y u understand the procedure and requirements of

General notes

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

supplied solvent (see section 2, ‘Do not se 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 inst ucti ns as for the pre-filled syringe (see section 5 ‘How to store

Valtropin’). Do not use tap water.

 

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Collect the necessary

tems 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

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

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

2.Take the Valtropin carton out of the refrigerator and take the powder vial and pre-filled syringe with solvent out of the box. Check that the medicine is within the expiry date.

3.Remove the protective plastic cap from the powder vial.

4.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

 

 

5.

Take the pre-filled syringe with solvent supplied in the pack to prepare y ur medicine. Remove the

 

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

 

what size of needle to use.

 

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6.Remove the needle guard without tou hing the needle.

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

8. 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.

9. Swirl the vial GENTLY to completely dissolve the contents. DO NOT SHAKE.

 

Dissolving up your medicine

 

 

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10.

The resulting solution should be clear, without particles.

 

 

 

 

11.

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

Preparing the injection

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

touch the top of the vial.

Vial contain ng the solution of your medicineproduct

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13. 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.

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

15.

Remove the needle guard without touching the needle.

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16.

 

 

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

 

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17.

 

 

 

 

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

18. 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

19.

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.

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

 

the syringe.

 

 

 

 

 

 

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Syringe containing your medicine being attached to a new needle

21.

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

22.

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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.

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

Injecting the solution

 

24.

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

 

palms.

 

25.

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.

 

26.

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.

 

27.

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

28.

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

 

you would hold a pencil.

 

29.

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.

30.

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

31.

empty.

authorised

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

 

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

32.

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 secti n 5 ‘How to store

 

Valtropin’.

 

 

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

 

unused solution should be discarded.

 

 

 

no

longer

 

product

 

Medicinal

 

 

 

 

 

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