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Introduction About BRAVELLE 75IU INJECTION
BRAVELLE 75IU INJECTION contains Urofollitropin which belongs to the group of medicines called Gonadotropins. It helps your body produce sufficient levels of female sex hormones (estrogen) that is required for conception.
Prior to the management, your doctor may evaluate your and your partner’s fertility status thoroughly as a precaution. During management with BRAVELLE 75IU INJECTION, your doctor will closely monitor your health condition through several blood tests and ultrasounds to avoid the risk of side effects.
Before receiving BRAVELLE 75IU INJECTION 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 BRAVELLE 75IU INJECTION may cause ectopic pregnancy (pregnancy outside of the womb) in such cases.
BRAVELLE 75IU INJECTION should not be used in pregnant women after successful conception. It is also not recommended for use in breastfeeding women and in children or adolescents (aged below 18 years) due to lack of safety data.
The most common side effects of receiving BRAVELLE 75IU INJECTION are hot flushes, stomach pain, headache and injection site reactions (such as pain, redness, and swelling). Consult your doctor if they worsen.
Uses Of BRAVELLE 75IU INJECTION
- Supports reproductive health in women
How BRAVELLE 75IU INJECTION Works
BRAVELLE 75IU INJECTION supplements your body with a sufficient levels of a female sex hormone called estrogen that is required to maintain proper functioning of female genital system.
How to use BRAVELLE 75IU INJECTION
BRAVELLE 75IU INJECTION 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 BRAVELLE 75IU INJECTION
Common
- injection site reactions (pain, redness, itching or swelling)
- headache
- stomach pain, bloated stomach
- urinary tract infection
- inflammation of throat and nasal passage
- hot flushes
- nausea, vomiting, stomach discomfort, diarrhoea, constipation
- skin rash
Uncommon
- overactive thyroid gland (hyperthyroidism)
- changes in mood
- feeling tired
- dizziness
- nose bleeds
- breast enlargement and pain
- vaginal bleeding or discharge
Contact your doctor immediately if you experience any of the following side effects after receiving BRAVELLE 75IU INJECTION:
- 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)
How To Manage Side Effects
Constipation
Taking BRAVELLE 75IU INJECTION 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.
Dizziness Or Drowsiness
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.
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.
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.
Nausea And Vomiting
Take BRAVELLE 75IU INJECTION with or just after meals. Stick to simple meals. Avoid eating oil rich or spicy foods. Consult your doctor if your symptom worsens.
Warning & Precautions
Pregnancy
ContraindicatedBRAVELLE 75IU INJECTION is not recommended for use in pregnant women. Therefore, consult your doctor before receiving it.
Breastfeeding
ContraindicatedBRAVELLE 75IU INJECTION is not recommended for use in breastfeeding women. Therefore, consult your doctor before receiving it.
Driving and Using Machines
Use with CautionBRAVELLE 75IU INJECTION 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 BRAVELLE 75IU INJECTION.
Alcohol
Consult your doctorAvoid consumption of alcohol before receiving BRAVELLE 75IU INJECTION.
Allergy
ContraindicatedTalk to your doctor before receiving BRAVELLE 75IU INJECTION if you are allergic to Urofollitropin.
Use In Pediatrics
Consult your doctorThe safety and effectiveness of BRAVELLE 75IU INJECTION have not been established in children and adolescents (aged below 18 years). Therefore, consult your doctor for advice.
Use In Geriatrics
Use with CautionBRAVELLE 75IU INJECTION should be used with caution in elderly patients (aged 65 years or older). Therefore, consult your doctor before receiving it.
Others
BRAVELLE 75IU INJECTION is not recommended for use if you:
- have primary ovarian failure (ovaries that do not produce eggs)
- have problems with thyroid, pituitary or adrenal glands
Before receiving BRAVELLE 75IU INJECTION, inform your doctor if you:
- have overactive thyroid gland
- have hyperprolactinemia (high levels of a hormone called prolactin in blood)
- have any tumours in the breasts, uterus, pituitary gland or hypothalamus
- have polycystic ovarian disease or enlarged ovaries
- have any malformation of sex organs that hinders pregnancy
- have undiagnosable vaginal bleeding
- have fibroids in the uterus
- had an early menopause
- have blood clots in the body or have a family history of blood clots
- are overweight
Interactions
A. Drug-Drug interactions:
Before receiving BRAVELLE 75IU INJECTION, inform your doctor if you are taking any of the following medicines:
- Clomiphene citrate (another medicine used in the management of female infertility)
Overdosage:
BRAVELLE 75IU INJECTION 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 | : | Urofollitropin |
| Pharmacological Category | : | Ovulation stimulators |
| Therapeutic Indication | : | Female Infertility |
| Dosage Forms | : | Injection, Pre-filled syringes (PFS), Cartridge |
More Information
Storage
- Keep BRAVELLE 75IU INJECTION out of reach of children
- Store BRAVELLE 75IU INJECTION at room temperature
FAQs About BRAVELLE 75IU INJECTION
Q. What is the use of BRAVELLE 75IU INJECTION?
A. BRAVELLE 75IU INJECTION supplements your body with a sufficient levels of a female sex hormone called estrogen that is required to maintain proper functioning of female genital system.
Q. How BRAVELLE 75IU INJECTION is administered?
A. BRAVELLE 75IU INJECTION will be given to you only by a doctor or a nurse into the vein (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.
Q. What precautions must be followed while receiving BRAVELLE 75IU INJECTION?
A. Before receiving BRAVELLE 75IU INJECTION 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 BRAVELLE 75IU INJECTION may cause ectopic pregnancy (pregnancy outside of the womb) in such cases. BRAVELLE 75IU INJECTION should not be used in pregnant women after successful conception. Regularly visit your doctor and perform all blood tests and ultrasounds recommended by him/her without fail.
Q. Is BRAVELLE 75IU INJECTION safe?
A. BRAVELLE 75IU INJECTION is considered safe at the doses administered by the physician. However, consult your doctor if you experience any unusual side effects.
Q. What are the common side effects of receiving BRAVELLE 75IU INJECTION?
A. The most common side effects of receiving BRAVELLE 75IU INJECTION are hot flushes, stomach pain, headache and injection site reactions (such as pain, redness, and swelling). Consult your doctor if they worsen.
Q. Can I stop receiving BRAVELLE 75IU INJECTION once my symptoms subside?
A. Do not stop taking BRAVELLE 75IU INJECTION without consulting your doctor. You need to receive BRAVELLE 75IU INJECTION for the duration recommended by your doctor to achieve better results.
Q. Can I use BRAVELLE 75IU INJECTION during pregnancy?
A. BRAVELLE 75IU INJECTION should not be used in pregnant women after successful conception. Therefore, consult your doctor for advice.
Q. Can BRAVELLE 75IU INJECTION be used in children?
A. The safety and effectiveness of BRAVELLE 75IU INJECTION have not been established in children and adolescents (aged below 18 years). Therefore, consult your doctor for advice.
References
1. KD. Tripathi. Anterior pituitary Hormones. Essentials of Medical Pharmacology. 7th Edition. 2013. Page-240-241.
2. Andrea Cocci, Gianmartin Cito and others. Effectiveness of highly purified urofollitropin treatment in patients with idiopathic azoospermia before testicular sperm extraction. Urologia Journals. SAGE Journals. [Revised in July 2017]. [Accessed on 7th November 2022] https://journals.sagepub.com/doi/10.5301/uj.5000253
3. Pharmasure Ltd. Revised in June 2016]. [Accessed on 7th November 2022] https://www.pharmasure.co.uk/uploads/uk-PIL-Fostimon-75-150-IU.pdf
4. Ferring Ireland Ltd. Health Products Regulatory Authority. [Revised in April 2016]. [Accessed on 7th November 2022] https://www.hpra.ie/img/uploaded/swedocuments/PIL-2178582-26072016122111-636051324724310000.pdf
5. Bharat Serums and Vaccines Ltd. Foligraf 75 I.U./150 I.U. [Accessed on 7th November 2022] https://bsvgroup.com/assets/pdf/products/Foligraf.pdf
6. Ferring Pharmaceuticals Inc. Bravelle (Urofollitropin for Injection). U.S. Food and Drug Administration. [Revised in February 2014]. [Accessed on 7th November 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021289s019lbl.pdf
7. Cipla Ltd. Newmon-R PFSTM injection (Recombinant Human Follicle Stimulating Hormone). [Revised in January 2018]. [Accessed on 7th November 2022] https://ciplamed.com/content/newmon-r-pfstm-injection
Useful Diagnostic Tests
- Anti-Mullerian Hormone
- Glycosylated Haemoglobin
- Testosterone Total
- Thyroid Stimulating Hormone
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