Gonal F 900IU Injection(Pfs) 1's

Introduction About GONAL F 900IU INJECTION(PFS)

GONAL F 900IU INJECTION(PFS) contains Follitropin Alfa which belongs to the
group of medicines called Gonadotropins. It is used in the management of
infertility in men and women. It can promote ovulation (release of matured egg
from the ovaries) in women who do not produce eggs. It also helps in the growth
and development of several egg follicles in women undergoing fertility
managements. It can also be used to improve sperm production among infertile
men.

Prior to the management, your doctor may evaluate your and your partner’s
fertility status thoroughly as a precaution. During management with GONAL F
900IU INJECTION(PFS), your doctor will closely monitor your health condition
through several blood tests and ultrasounds to avoid the risk of side effects.

Before receiving GONAL F 900IU INJECTION(PFS) inform your doctor if you have any
unexplained vaginal bleeding, blood clot problems or any tumours in the brain,
breast, uterus or ovaries. You must also inform your doctor if you have any
damage in the fallopian tubes, as management with GONAL F 900IU INJECTION(PFS)
may cause ectopic pregnancy (pregnancy outside of the womb) in such cases.

GONAL F 900IU INJECTION(PFS) should not be used in pregnant women after
successful conce
and in children or adolescents (aged below 18 years) due to lack of safety data.

The most common side effects of receiving GONAL F 900IU INJECTION(PFS) are hot
flushes, stomach pain, headache and injection site reactions (such as pain,
redness, and swelling). Consult your doctor if they worsen.

Uses Of GONAL F 900IU INJECTION(PFS)

• Manage infertility in men and women
• Promotes ovulation and stimulate the growth of egg follicles among infertile women
• Improves sperm production among infertile men

How GONAL F 900IU INJECTION(PFS) Works

GONAL F 900IU INJECTION(PFS) is a hormonal medicine. In women, it stimulates the
body to secrete sufficient amount of a female sex hormone called estrogen that
is required for the normal growth and development of the ovarian (egg)
follicles. This action stimulates egg growth and maturation. It also promotes
the release of matured eggs from the ovaries (ovulation) in women facing
problems in becoming pregnant.

In men, it stimulates the release of a male sex hormone called testosterone that
is required for sperm production. This action improves sperm production among
infertile men.

How to use GONAL F 900IU INJECTION(PFS)

GONAL F 900IU INJECTION(PFS) will be given to you only by a doctor or a nurse
into the muscles (intramuscularly) or under the skin (subcutaneously). It can
also be self-administered by the patient if instructed by the doctor. Carefully
follow the instructions given by your doctor in case of self-administration.

Your doctor will decide the correct dose and duration of therapy depending upon
your age, body weight and disease condition.

Side Effects Of GONAL F 900IU INJECTION(PFS)

Common

• injection site reactions (pain, redness, itching or swelling)
• headache
• stomach pain, bloated stomach
• hot flushes
• nausea, vomiting, stomach discomfort, diarrhoea, constipation
• fluid filled cysts in ovaries
• breast enlargement in men
• acne
• weight gain

Rare

Contact your doctor immediately if you experience any of the following side
effects after receiving GONAL F 900IU INJECTION(PFS):

• signs of ovarian hyperstimulation syndrome (such as lower abdominal pain with sensation of nausea or vomiting, weight gain, difficulty in breathing, difficulty in passing urine, enlarged ovaries and fluid build-up in chest or abdomen)
• signs of allergic reactions (such as skin rash, itching, swelling of the eyes, face, lips, tongue or throat leading to difficulty in breathing or swallowing)
• skin blistering/peeling especially after sun exposure
• stomach pain, arm pain or leg pain
• signs of blood clots (such as chest pain, difficulty in breathing, heart attack, stroke)

How To Manage Side Effects

Injection site reactions:

Place an ice pack on the affected area. Do not frequently move the injection
site. Consult your doctor if the symptom did not improve.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or
machines completely while you are feeling dizzy. Do not consume excessive
alcohol, as it could aggravate your dizziness. Consult your doctor if your
dizziness worsens.

Constipation:

Taking GONAL F 900IU INJECTION(PFS) with meals may reduce the chances of
constipation. However, if you experience constipation, eat plenty of fiber rich
foods such as fresh fruits, vegetables and cereals. Drink plenty of fluids.
Exercise more regularly. Consult your doctor if this side effect bothers you.

Nausea and Vomiting

Take GONAL F 900IU INJECTION(PFS) with or just after meals. Stick to simple
meals. Avoid eating oil rich or spicy foods. Consult your doctor if your symptom
worsens.

Headache:

Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as
water or electrolytes. Applying a pain-relieving balm on your forehead can be
beneficial. Do not consume excessive alcohol, as it could aggravate your
headache. Consult your doctor if your headache worsens.

Warning & Precautions

!### Pregnancy

GONAL F 900IU INJECTION(PFS) is not recommended for use in pregnant women.
Therefore, consult your doctor before receiving it.

!### Breastfeeding

GONAL F 900IU INJECTION(PFS) is not recommended for use in breastfeeding women.
Therefore, consult your doctor before receiving it.

!### Driving and Using Machines

GONAL F 900IU INJECTION(PFS) does not affect your ability to drive or operate
machinery. However, do not drive or handle any heavy tools or machines if your
ability is affected by GONAL F 900IU INJECTION(PFS).

!### Alcohol

Avoid consum

!### Allergy

Talk to your doctor before receiving GONAL F 900IU INJECTION(PFS) if you are
allergic to Follitropin Alfa or to Follicle Stimulating Hormone (FSH).

Others

GONAL F 900IU INJECTION(PFS) is not recommended for use if you:

• have primary ovarian failure (ovaries that do not produce eggs)
• have any tumours in the pituitary gland or hypothalamus
• have breasts cancer, uterine cancer or ovarian cancer
• have polycystic ovarian disease or enlarged ovaries
• have any malformation of sex organs that hinders pregnancy
• had an early menopause
• are a man with damages testis

Before receiving GONAL F 900IU INJECTION(PFS), inform your doctor if you:

• have porphyria
• have overactive thyroid gland
• have hyperprolactinemia (high levels of a hormone called prolactin in blood)
• have undiagnosable vaginal bleeding
• have fibroids in the uterus
• have blood clots in the body or have a family history of blood clots
• have or had stroke
• are overweight

Use in pediatrics:

GONAL F 900IU INJECTION(PFS) is not recommended for use in children and
adolescents (aged below 18 years). Therefore, consult your doctor for advice.

Use in geriatrics:

GONAL F 900IU INJECTION(PFS) should be used with caution in elderly patients
(aged 65 years or older). Therefore, consult your doctor before receiving it.

Interactions

A. Drug-Drug interactions:

Before receiving GONAL F 900IU INJECTION(PFS), inform your doctor if you are
taking any of the following medicines such as:

• other medicine used in the management of female infertility (such as HCG, clomiphene citrate)
• medicines used to manage cancers of prostate, breast or ovaries (such as leuprolide, goserelin, triptorelin and histrelin)

Overdosage:

GONAL F 900IU INJECTION(PFS) will be administered to you only by a doctor or a
nurse in a hospital, and so it is unlikely to receive an overdose. However,
consult your doctor or nurse if you experience any unusual symptoms.

Synopsis

Drug	:	Follitropin Alfa
Pharmacological Category	:	Ovulation stimulators
Therapeutic Indication	:	Infertility
Dosage Forms	:	Injection, Pre-filled syringes (PFS), Cartridge

More Information

• Keep GONAL F 900IU INJECTION(PFS) out of reach of children
• Store GONAL F 900IU INJECTION(PFS) at room temperature

FAQs About GONAL F 900IU INJECTION(PFS)

What is the use of GONAL F 900IU INJECTION(PFS)?

GONAL F 900IU INJECTION(PFS) is used in the management of infertility in men and
women. It can promote ovulation (release of matured egg from the ovaries) in
women who do not produce eggs. It also helps in the growth and development of
several egg follicles in women undergoing fertility managements. It can also be
used to improve sperm production among infertile men.

How GONAL F 900IU INJECTION(PFS) works?

GONAL F 900IU INJECTION(PFS) is a hormonal medicine. In women, it stimulates the
body to secrete sufficient amount of a female sex hormone called estrogen that
is required for the normal growth and development of the ovarian (egg)
follicles. This action stimulates egg growth and maturation. It also promotes
the release of matured eggs from the ovaries (ovulation) in women facing
problems in becoming pregnant. In men, it stimulates the release of a male sex
hormone called testosterone that is required for sperm production. This action
improves sperm production among infertile men.

How GONAL F 900IU INJECTION(PFS) is administered?

GONAL F 900IU INJECTION(PFS) will be given to you only by a doctor or a nurse
into the muscle (intravenously) or under the skin (subcutaneously). It can also
be self-administered by the patients if advised by the physician. Carefully,
follow the instructions given by the doctor in case of self-administration.

What precautions must be followed while receiving GONAL F 900IU
INJECTION(PFS)?

Before receiving GONAL F 900IU INJECTION(PFS) inform your doctor if you have any
unexplained vaginal bleeding, blood clot problems or any tumours in the brain,
breast, uterus or ovaries. You must also inform your doctor if you have any
damage in the fallopian tubes, as management with GONAL F 900IU INJECTION(PFS)
may cause ectopic pregnancy (pregnancy outside of the womb) in such cases. GONAL
F 900IU INJECTION(PFS) should not be used in pregnant women after successful
conce
ultrasounds recommended by him/her without fail.

Is GONAL F 900IU INJECTION(PFS) safe?

GONAL F 900IU INJECTION(PFS) is considered safe at the doses administered by the
physician. However, consult your doctor if you experience any unusual side
effects

What are the common side effects of receiving GONAL F 900IU INJECTION(PFS)?

The most common side effects of receiving GONAL F 900IU INJECTION(PFS) are hot
flushes, stomach pain, headache and injection site reactions (such as pain,
redness, and swelling). Consult your doctor if they worsen.

Can I stop receiving GONAL F 900IU INJECTION(PFS) once my symptoms subside?

Do not stop receiving GONAL F 900IU INJECTION(PFS) without consulting your
doctor. You need to receive GONAL F 900IU INJECTION(PFS) for the duration
recommended by your doctor to achieve better results.

Can I use GONAL F 900IU INJECTION(PFS) during pregnancy?

GONAL F 900IU INJECTION(PFS) should not be used in pregnant women after
successful conce

Can GONAL F 900IU INJECTION(PFS) be used in children?

GONAL F 900IU INJECTION(PFS) is not recommended for use in children and
adolescents (aged below 18 years). Therefore, consult your doctor for advice.

Useful Diagnostic Tests

• Anti-Mullerian Hormone
• Glycosylated Haemoglobin
• Testosterone Total
• Thyroid Stimulating Hormone