GHRH FERRING POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 50 MICROGRAMS - patient leaflet, side effects, dosage

5. How to store GHRH

• Keep out of the sight and reach of children.
• Do not use GHRH after the expiry date stated on the box and ampoule (glass bottle). The expiry date refers to the last day of that month.
• Do not store GHRH above 25°C.
• Medicines should not be disposed of via wastewater or household waste. Ask your doctor or pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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6. Further information

• What GHRH Ferring contains The active substance

is somatorelin acetate. Each ampoule contains 50 micrograms of somatorelin acetate.

• The diluent contains water for injection and sodium chloride.

What GHRH Ferring looks like and contents of the pack

GHRH Ferring is a sterile freeze-dried powder. It is supplied in boxes of 1 clear glass ampoule with 1 ampoule of diluent 1ml. The diluent is used to dissolve the powder before it is injected.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Ferring Pharmaceuticals Ltd Drayton Hall, Church Road, West Drayton, UB7 7PS

Manufactured by: Ferring GmbH, Wittland 11, D-24109 Kiel, Germany.

GHRH FERRING PL 03194/0050

Diluent PL 03194/0051

This leaflet was last revised in November 2018

FERRING

Read all of this leaflet carefully before you are given this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further ^-questions, ask your doctor, SLnurse or pharmacist.
• If any of the side effects become serious, or if you ^notice any side effects not 'T listed in this leaflet, please g^tell your doctor, nurse or SLpharmacist.

In this leaflet:

1. What GHRH is and what it is used for

2.Before GHRH is given to you 3.How GHRH is given to you 4.Possible side effects 5.How to store GHRH 6.Further information

1. what ghrh is and what it is used for

• The full name of your medicine is, GHRH Ferring powder and solvent for solution for injection 50mcg. It is called GHRH in this leaflet. GHRH contains an active substance called somatorelin acetate. It is a man-made form of the natural hormone somatorelin. Somatorelin is made by a part of the brain called the ^hypothalamus.
• When it is released, it causes the pituitary gland (just underneath the brain) to release growth hormone.
• GHRH is used when your doctor thinks that you may not have enough growth hormone (growth hormone deficiency). When it is injected, it shows whether the lack of this hormone is caused by a problem with either: the pituitary gland or the hypothalamus.

• 2. Before GHRH is given to you

You must not be given GHRH if:

• You are allergic to somatorelin or any of the other ingredients of GHRH Ferring (listed in Section 6).

You must not be given GHRH if the above applies to you. If you are not sure, talk to your doctor or nurse before you are given GHRH.

Take special care with GHRH if:

• You have recently been treated with growth hormone.

If the above applies to you (or you are not sure) talk to your doctor or nurse before you are given GHRH.

Taking other medicines Please tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because GHRH can affect the way some other medicines work. Also some other medicines can affect the way GHRH works.

In particular tell your doctor or nurse if you are taking any of the following medicines:

• Medicines for diabetes such as insulin.
• Medicines for high blood pressure such as clonidine or propranolol.
• Medicines for Parkinson’s disease such as levodopa.
• Medicines for thyroid problems.

If any of the above apply to you (or you are not sure), talk to your doctor or nurse before you are given GHRH.

Pregnancy and breastfeeding

You must not be given GHRH if you are pregnant or are breast-feeding.

3. How GHRH is given to you

GHRH will be given to you by a doctor. They will decide how much you need. The dose will depend on your weight.

GHRH will be given to you as an injection into a vein.

4. possible side effects

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

The following common side effects affect between 1 and 10 of every 100 patients treated:

• Feeling of warmth in the head, neck and upper part of the body (a ‘hot flush’).
• With the hot flush there is sometimes a slight change in blood pressure and a change in your heart rate.
• Changes to your sense of smell and taste.