GENOTROPIN MINIQUICK 1.6MG POWDER AND SOVENT FOR SOLUTION FOR INJECTION

Active substance: SOMATROPIN (RBE)

View full screen / Print PDF » Download PDF ⇩

Transcript
inks on file

Process structure
Black

PACKAGE LEAFLET: INFORMATION FOR THE USER

deficiency is confirmed, your doctor will propose continuation of Genotropin MiniQuick treatment.
You should only be given this medicine by a doctor who has experience with growth hormone
treatment and who has confirmed your diagnosis.

RECTO

0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg,
1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, 2.0 mg
powder and solvent for solution for injection
somatropin

2. Before You Use Genotropin Miniquick
8R3201
425

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 Genotropin MiniQuick is and what it is used for
2. Before you use Genotropin MiniQuick
3. How to use Genotropin MiniQuick
4. Possible side effects
5 How to store Genotropin MiniQuick
6. Further information

1. What Genotropin MiniQuick is and what it is used for
Genotropin MiniQuick is a recombinant human growth hormone (also called somatropin). It has the
same structure as natural human growth hormone which is needed for bones and muscles to grow. It
also helps your fat and muscle tissues to develop in the right amounts. It is recombinant meaning it is
not made from human or animal tissue.

Process Black

In children, Genotropin MiniQuick is used to treat growth disturbances:
• If you are not growing properly and you do not have enough of your own growth hormone.
• If you have Turner syndrome. Turner syndrome is a chromosomal error in girls that can affect
growth - your doctor will have told you if you have this.
• If you have chronic renal (kidney) insufficiency. As kidneys lose their ability to function normally,
this can affect growth.
• If you have Prader-Willi syndrome (a chromosomal disorder). Growth hormone will help you grow
taller if you are still growing, and will also improve your body composition. Your excessive fat will
decrease and your reduced muscle mass will improve.
• If you were small or too light at birth. Growth hormone can help you grow taller if you have not
been able to catch up or maintain normal growth by four years of age or later.
In adults, Genotropin MiniQuick is used to treat persons with pronounced growth hormone deficiency.
This can start during adult life, or it can continue from childhood.
If you have been treated with Genotropin MiniQuick for growth hormone deficiency during childhood,
your growth hormone status will be retested after completion of growth. If severe growth hormone

Do not use Genotropin MiniQuick and tell your doctor if
• You are allergic (hypersensitive) to somatropin or any of the other ingredients of Genotropin
MiniQuick.
• You have an active tumour (cancer). Tumours must be inactive and you must have finished your
anti-tumour treatment before you start your treatment with Genotropin MiniQuick.
• You are seriously ill (for example, complications following open heart surgery, abdominal surgery,
acute respiratory failure, accidental trauma or similar conditions). If you are about to have, or have
had, a major operation, or go into hospital for any reason, tell your doctor and remind the other
doctors you are seeing that you use growth hormone.
• Genotropin MiniQuick has been prescribed to stimulate growth but you have already stopped
growing (closed epiphyses).

• During treatment, your doctor will check you for signs of scoliosis, a type of spinal deformity.
• During treatment, if you develop a lung infection, tell your doctor so that he can treat the infection.
Children born small or too light at birth:
• If you were small or too light at birth and are aged between 9 and 12 years, ask your doctor for
specific advice relating to puberty and treatment with this product.
• Your doctor will check your blood sugar and insulin levels before the start of treatment and every
year during treatment.
• Treatment should be continued until you have stopped growing.
Using other medicines
Please tell your doctor or pharmacist if you are using or have recently used any other medicines,
including medicines obtained without a prescription.
You should tell your doctor if you are using:
• medicines to treat diabetes,
• thyroid hormones,
• synthetic adrenal hormones (corticosteroids),
• sex hormones (for example oestrogens),
• ciclosporin (a medicine that weakens the immune system after transplantation),
• medicines to control epilepsy (anticonvulsants).
Your doctor may need to adjust the dose of these medicines or the dose of Genotropin MiniQuick.

Take special care with Genotropin MiniQuick and tell your doctor if any of the following
statements apply to you
• If you are at risk of developing diabetes, your doctor will need to monitor your blood sugar level
during treatment with Genotropin MiniQuick.
• If you have diabetes, you should closely monitor your blood sugar level during treatment with
Genotropin MiniQuick and discuss the results with your doctor to determine whether you need to
change the dose of your medicines to treat diabetes.
• After starting Genotropin treatment some patients may need to start thyroid hormone
replacement.
• If you are receiving treatment with thyroid hormones it may be necessary to adjust your thyroid
hormone dose.
• If you are taking growth hormone to stimulate growth and walk with a limp or if you start to limp
during your growth hormone treatment due to pain in your hip, you should inform your doctor.
• If you develop raised intracranial pressure (with symptoms such as strong headache, visual
disturbances or vomiting) you should inform your doctor about it.
• If you are receiving Genotropin MiniQuick for growth hormone deficiency following a previous
tumour (cancer), you should be examined regularly for recurrence of the tumour.
• Experience in patients above 80 years of age is limited. Elderly persons may be more sensitive to
the action of Genotropin MiniQuick, and therefore may be more prone to develop side effects.

Recommended dosage
The dose depends on your size, the condition for which you are being treated and how well growth
hormone works for you. Everyone is different. Your doctor will advise you about your individualised dose
of Genotropin MiniQuick in milligrams (mg) from either your body weight in kilograms (kg) or your body
surface area calculated from your height and weight in square metres (m2), as well as your treatment
schedule. Do not change the dosage and treatment schedule without consulting your doctor.

Children with chronic renal (kidney) insufficiency:
• Your doctor should examine your kidney function and your growth rate before starting Genotropin
MiniQuick. Medical treatment for your kidney condition should be continued. Genotropin MiniQuick
treatment should be stopped at kidney transplantation.

Children with growth hormone deficiency:
0.025-0.035 mg/kg bodyweight per day or 0.7-1.0 mg/m2 body surface area per day. Higher doses
can be used. When growth hormone deficiency continues into adolescence, Genotropin MiniQuick
should be continued until completion of physical development.

Children with Prader-Willi syndrome:
• Your doctor will give you diet restrictions to follow to control your weight.
• Your doctor will assess you for signs of upper airway obstruction, sleep apnoea (where your
breathing is interrupted during sleep), or respiratory infection before you start treatment with
Genotropin MiniQuick.
• During treatment, if you show signs of upper airway obstruction (including starting to snore or
worsening of snoring), your doctor will need to examine you and may interrupt your treatment with
Genotropin MiniQuick.

Children with Turner syndrome:
0.045-0.050 mg/kg bodyweight per day or 1.4 mg/m2 body surface area per day.

Pregnancy and breast-feeding
You should not use Genotropin if you are pregnant, think you may be pregnant or are trying to
become pregnant.
Ask your doctor for advice before using this medicine while breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Important information about some of the ingredients of Genotropin MiniQuick
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

3. How To Use Genotropin Miniquick

Children with chronic renal (kidney) insufficiency:
0.045-0.050 mg/kg bodyweight per day or 1.4 mg/m2 body surface area per day. Higher doses may
be necessary if the rate of growth is too low. Dosage adjustment may be necessary after 6 months of
treatment.

Children with Prader-Willi syndrome:
0.035 mg/kg bodyweight per day or 1.0 mg/m2 body surface area per day. The daily dosage should
not exceed 2.7 mg. Treatment should not be used in children who have almost stopped growing after
puberty.
Children born smaller or lighter than expected and with growth disturbance:
0.035 mg/kg bodyweight per day or 1.0 mg/m2 body surface area per day. It is important to continue
treatment until final height is reached. Treatment should be discontinued after the first year if you are
not responding or if you have reached your final height and stopped growing.
Adults with growth hormone deficiency:
If you continue Genotropin MiniQuick after treatment during childhood you should start with
0.2-0.5 mg per day. This dosage should be gradually increased or decreased according to blood test
results as well as clinical response and side effects.
If your growth hormone deficiency starts during adult life you should start with 0.15-0.3 mg per day.
This dosage should be gradually increased according to blood test results as well as clinical response
and side effects. The daily maintenance dose seldom exceeds 1.0 mg per day. Women may require
higher doses than men. Dosage should be monitored every 6 months. Persons above 60 years
should start with a dose of 0.1-0.2 mg per day which should be slowly increased according to
individual requirements. The minimum effective dose should be used. The maintenance dose seldom
exceeds 0.5 mg per day. Follow the instructions given to you by your doctor.
Injecting Genotropin MiniQuick
Genotropin MiniQuick is intended for subcutaneous use. This means that it is injected through a short
injection needle into the fatty tissue just under your skin. Your doctor should have already shown you
how to use Genotropin MiniQuick. Always inject Genotropin MiniQuick exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are not sure.
Please see the “Instructions for Use” at the end of the package leaflet for advice on how to use your
Genotropin MiniQuick. If you cannot remember what to do, do not try to do your injection. Ask your
doctor to show you again.
You can take your growth hormone out of the refrigerator half an hour before your injection. This lets
it warm up slightly and can make your injections more comfortable.
Remember to wash your hands and clean your skin first.
Inject your growth hormone at about the same time every day. Bedtime is a good time because it is
easy to remember. It is also natural to have a higher level of growth hormone at night.
Most people do their injections into their thigh or their bottom. Do your injection in the place you have
been shown by your doctor. Fatty tissue of the skin can shrink at the site of injection. To avoid it, use
a slightly different place for your injection each time. This gives your skin and the area under your
skin time to recover from one injection before it gets another one in the same place.
If you use more Genotropin MiniQuick than you should
If you inject much more than you should, contact your doctor or pharmacist as soon as possible. Your
blood sugar level could fall too low and later rise too high. You might feel shaky, sweaty, sleepy or
“not yourself”, and you might faint.
If you forget to use Genotropin MiniQuick
Do not take a double dose to make up for a forgotten dose.
It is best to take your growth hormone regularly. If you forget to take a dose, have your next injection
at the usual time the next day. Keep a note of any missed injections and tell your doctor at your next
check-up.

If you stop using Genotropin MiniQuick
Ask for advice from your doctor before you stop taking Genotropin MiniQuick.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

VERSO

Like all medicines, Genotropin MiniQuick can cause side effects, although not everybody gets them.
Common side effects (likely to occur in fewer than 1 in 10 patients) include:
Formation of antibodies to the injected growth hormone but these do not seem to stop the growth
hormone from working.
In children:
• Temporary reddening, itchiness or pain at the injection site.
In adults:
• Numbness / tingling,
• Stiffness in the arms and legs, joint pain, muscle pain,
• Water retention (which shows as puffy fingers or swollen ankles. These symptoms may be seen
for a short time at the start of treatment, but they disappear spontaneously or when the dosage is
lowered.
These common side effects in adults may start within the first months of treatment and may either
stop spontaneously or if your dose is reduced.
Uncommon side effects (likely to occur in fewer than 1 in 100 patients) include:
In children:
• Numbness / tingling,
• Stiffness in the arms and legs, joint pain, muscle pain,
• Water retention (which shows as puffy fingers or swollen ankles, for a short time at the start of
treatment).
In adults:
• Pain or burning sensation in the hands or underarms(known as Carpal Tunnel Syndrome).
Rare side effects (likely to occur in fewer than 1 in 1,000 patients) include:
• Type 2 diabetes mellitus,
• Increased intracranial pressure (which causes symptoms such as strong headache, visual
disturbances or vomiting).
Very rare side effects (likely to occur in fewer than 1 in 10,000 patients) include:
• Leukemia.
The skin around the injection area can get uneven or lumpy, but this should not happen if you inject
in a different place each time.
There have been rare cases of sudden death in patients with Prader-Willi syndrome. However, no link
has been made between these cases and treatment with Genotropin MiniQuick.

Process Black

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 Genotropin Miniquick
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton as MM/YYYY. The expiry date
refers to the last day of that month.
Before reconstitution:
Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the syringe in the outer carton in order to
protect from light.
Before opening, the product may be taken out of the refrigerator, without being replaced, for a
maximum period of 6 months at a temperature not above 25°C. The date when the medicine is taken
out and the new expiry date should be written on the outer packaging. This new expiry date should
never exceed the one initially mentioned on the outer carton. If the medicine has not been used
before the new expiry date, it should be disposed of.
After reconstitution:
Use immediately or store in a refrigerator (2°C – 8°C) for up to 24 hours. Do not freeze. Keep the
syringe in the outer carton in order to protect from light.
Do not use this medicine if you notice particles or if the solution is not clear.
Never throw away needles or empty syringes with your ordinary rubbish. When you have finished with
a needle, you must discard it carefully so that no-one will be able to use it or prick themselves on it.
You can get a special ‘sharps’ bin from your hospital or growth clinic.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use.
These measures will help to protect the environment.

6. Further Information
What Genotropin MiniQuick contains
• The active substance is somatropin*.
• One cartridge contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, 1.2 mg, 1.4 mg, 1.6 mg,
1.8 mg, or 2.0 mg per 0.25 ml of somatropin* after reconstitution, corresponding to a
concentration of 0.8 mg, 1.6 mg, 2.4 mg, 3.2 mg, 4 mg, 4.8 mg, 5.6 mg, 6.4 mg, 7.2 mg and
8 mg per ml.
• The other ingredients in the powder are: glycine (E640), mannitol (E421), sodium dihydrogen
phosphate anhydrous (E339), and disodium phosphate anhydrous (E339).
• The ingredients in the solvent are: water for injections, and mannitol (E421)
* produced in Escherichia coli cells by recombinant DNA technology
What Genotropin MiniQuick looks like and contents of the pack
Powder and solvent for solution for injection, in a two-chamber cartridge containing the powder in
one section and the solvent in the other (0.2 mg/0.25 ml, 0.4 mg/0.25 ml, 0.6 mg/0.25 ml,
0.8 mg/0.2 ml, 1.0 mg/0.25 ml, 1.2 mg/0.25 ml, 1.4 mg/0.25 ml, 1.6 mg/0.25 ml, 1.8 mg/0.25 ml
or 2.0 mg/0.25 ml). The cartridge is contained in a syringe. Pack size of 4 or 7 or 28 syringes.
Not all strengths and pack sizes may be marketed.
The powder is white and the solvent is clear.

Marketing Authorisation Holder
UK PL Holder:
Pfizer Limited,
Ramsgate Road,
Sandwich, Kent,
CT13 9NJ, UK

Ireland PA Holder:
Pfizer Healthcare Ireland,
9 Riverwalk, National Digital Park
Citywest Business Campus
Dublin 24, Ireland

Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs
Belgium
This medicinal product is authorised in the Member States of the EEA under the following names:
Genotropin MiniQuick: Austria, Denmark, Germany, Greece, Ireland, Italy, Portugal, Sweden, United
Kingdom
Genotonorm MiniQuick: Belgium, France, Luxembourg, Spain
This leaflet was last approved in 09/2013
Ref No: GN27_0
Genotropin MiniQuick Instructions for Use
Genotropin MiniQuick is a syringe used to mix and administer a single dose of Genotropin (growth
hormone).
Each Genotropin MiniQuick comes preloaded with a cartridge with two sections and a needle. If you
need additional needles, ask for the same Becton Dickinson Micro-Fine needles provided with the
MiniQuick. The injection volume is always 0.25 ml.

1 Peel the paper
covering from the
injection needle.
Position the needle
squarely onto the end
of the rubber stopper. Screw the needle onto the
Genotropin MiniQuick by turning it clockwise
until it no longer can turn.
2 Hold the Genotropin
MiniQuick with the
needle pointing
upwards. Turn the
plunger rod
clockwise until it will go
no further.
DO NOT shake the solution. Mix it gently.
Shaking the solution could make your growth
hormone foam and damage the active
substance. Check the solution for clarity, and
only use clear solutions that are particle free.
3 Remove the outer and
inner protective caps of
the needle.

QUESTIONS AND ANSWERS
Question
Is it a problem if I see air bubbles in the syringe?

Answer
No. There is no need to remove the air from
Genotropin MiniQuick. The small amount of air
in the syringe has no consequence on the
injection.
The resistance could be because the needle
has been inserted at an angle into the rubber
stopper.
Carefully replace the outer protective cap (the
opaque white one) over the needle and unscrew
anti-clockwise to remove the needle. Hold the
MiniQuick syringe with the needle-end pointing
up and reposition the needle squarely on top of
the syringe. Screw the needle into the syringe.

The diagram below identifies the different components.

Outer
protective cap

Needle
thread

Needle

Two-chamber
cartridge

Rubber
stopper

Growth
hormone

Liquid

Finger grip

5 Push the plunger rod
as far as possible to
inject the entire
content of the
Genotropin MiniQuick.
Wait a few seconds
before withdrawing the
needle to ensure that all the growth hormone is
injected.
6 After injection, do not
attempt to replace the
protective caps on the
needle. Dispose of the
syringe with the,
needle, outer and inner protective caps in
accordance with standard guidelines or as
directed by your doctor or pharmacist.

What should I do if there is resistance when I turn
the plunger rod (step 2) or when I make the
injection (step 5)?

The Genotropin MiniQuick is disposable; after you have administered a dose, dispose of it as
described in step 6.

Inner
protective cap

4 Pinch a fold of skin at
the injection site firmly
and push the needle
into the skinfold.

Plunger rod

The cartridge of Genotropin MiniQuick contains the growth hormone powder in one section and a
liquid in the other. When you turn the plunger rod clockwise, the growth hormone powder and the
liquid mix and the powder dissolves.

What should I do if the needle is damaged or bent? Discard the needle and use a new needle with
the MiniQuick.

8R3201

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Questions about Atrial Fibrillation? Get answers from our expert. Watch Video

Close
Hide
(web3)