Monthly Archives: January 2013

Aliaxin-FL1

Aliaxin FL

Aliaxin FL –Lips- is a reabsorbable medicinal product (physiological, apyrogenoussterile gel) to be used as a filler for increasing the volume and contours of the lips.
The principlecomponent is cross-linked Hyaluronic Acid of non-animal origin, producedby bacterial fermentation.

COMPOSITION
Cross-linked hyaluronic acid………………………………….. 25 mg/g
Phosphate buffer, Water for injectable solutions…………..1 g

PACKAGE
Aliaxin FL –Lips- is available in a 2ml package. Each package contains:
• package insert leaflet
• 2 sealed blisters, each containing 1 sterile pre-filled mono-use syringe of 1 ml, tobe assembled with the backstop supplied;
• Adhesive labels to stick to the patient’s medical record for product traceability.
• 4 sterile needles (27 G Sterimedix CE 0120 – 30 G Sterimedix CE 0120).

MODALITY OF ACTION

Aliaxin FL –Lips- must be injected into the cutaneous and mucosal tissues for the supplementationof the extra-cellular root and the intra-cutaneous volumetric increase, that is, forthe treatment of cutaneous and/or mucosal depressions caused by wrinkles and scarring.

AREAS OF USE

Aliaxin FL –Lips- is an injectable medical device designed to restore physiologicalvolume and indicated for the treatment of imperfections in the following areas:
• Lips
• Vermillion border
• Oral commissures
• Perioral wrinkles
The outcome of the treatment depends on the type of skin and the nature of theImperfection: the less evident the imperfection, the better the result.

INSTRUCTIONS FOR USE
Before any form of intervention with Aliaxin FL – Lips-, the doctor must carry out anadequate case history and a comprehensive assessment of the conditions of thepatient, in order to guarantee the total absence of contraindications to the implant.
The areas to be treated must be identified and evaluated bearing in mind the criteriarelative to lines and symmetries to follow.
Local anesthetic may be used for treatment to the lips, in order to guarantee thenecessary comfort to the patient.
The doctor must inform the patient in advance of the modalities of the intervention,its nature, warnings, precautions and possible individual outcomes, potentialadverse responses, the expected duration of the implant and the eventuality of asupplementary intervention for the maintenance and/or definition in detail of theachieved result.
The area of intervention must be cleansed with antiseptic solution before proceedingto the implant.
Extract the syringe from the blister pack, unscrew the top and assemble theneedle together with the protection. The latter is only to be removed right beforethe intervention.
Aliaxin FL –Lips- is administered with a sterile needle (27G – 30 G) in compliancewith the Luer-Lock standards with normalized connections, which is included inthe pack.
The implantation must be carried out in correspondence to the medium/deepDermis the procedure is, however, at the discretion of the doctor and depends onthe correction desired and the method of implantation adopted.
At the end of the procedure it is advisable to carry out a delicate massage of thetreated area in order to allow for better distribution of the implant.

DOSAGE AND ADMINISTRATION
The volumetric grading printed on the syringe has an indicative value: it is left tothe doctor’s discretion to choose the dosage to be used for each individual case.
The intervals at which the treatment should be repeated depend on various factors,regarding both the physiology of the patient (type of skin, individual metabolism,anatomy, age) and their lifestyle. Another element to consider is relative to theimplant techniques used. For maintenance of the obtained results it is advisable to repeat the treatment periodically, every 6-12 months.

PRECAUTIONS
During the treatment the usual precautions in the case of percutaneous proceduresmust be adopted. The risks are the common ones of infection relative tothe type of treatment.
Aliaxin FL –Lips- must not be used on patients affected by:
• Infective or inflammatory processes near the area of intervention
• known hypersensitivity to cheloids
• Allergy to the components
• Immune system illnesses
• Serious pathological skin conditions
• Problems with coagulation or anti-coagulating therapies in progress.
Close to treatment the patient should avoid consumption of substances which acton blood fluidity (aspirin, NSAID, Vitamin E), in order to minimize the possibility ofbruising or bleeding of the injected areas.
Aliaxin FL –Lips- may not be implemented in areas where there are mammary tendons,bone or muscular implants present.
Following the treatment, and until the complete absorption of swelling and reddening,the implanted areas must not be exposed to excessive heat (sun, UV tanningsessions or laser) or intense cold.
After use, needles and syringes must be disposed of according to the proceduresindicated for hospital waste.

ADVERSE REACTIONS, WARNINGS AND CONTRAINDICATIONS
As with any percutaneous injection, there can be incidents of:
• Inflammatory reactions (reddening, edema, etc), sometimes associated with itchingand pain to the touch
• Hematoma
• Hardening or nodules at the point of injection
• Coloringor discoloring of the skin at the point of injection
These reactions usually disappear within a few days. If they persist for more thana week the patient should contact their doctor immediately.
Aliaxin FL –Lips- is an intra cutaneous injection and must not be injected intoblood vessels.
There are no reports of problems due to excessive doses or interaction withother medicines.
Do not use in pregnancy.
Aliaxin FL –Lips- is available in single dose sterile packages.
The product must not be reused for future applications or on other patients.
Once open the product must be used immediately.
Any remaining product must be disposed of.
Do not use the product if the packaging is damaged.
Do not mix with other injectable substances and do not carry out other implantstogether with Aliaxin FL –Lips-.
The implant must be carried out in an aseptic environment observing the appropriatetechniques.
Fill in the adhesive label contained in the box and stick it to the patient’s medicalrecords kept at the doctor’s surgery.
Keep out of the reach of children.

STORAGE
Aliaxin FL -Lips- must be stored at temperaturebetween 2°and 28°C.
Do not freeze. Do not expose to heat.

sino

Sinovial Mini

8 mg/1 ml hyaluronic acid sodium salt

Viscosuppletive device for small joints.

Sterile – disposable.

Sinovial ® Mini is made up of a buffered physiological solution of hyaluronic acid sodium salt with visco-elastic properties.

Sinovial ® Mini contains 0.8% of highly purified hyaluronic acid sodium salt with a molecular weight between 800 and 1,200 kDalton. The other components of the product are: sodium chloride, sodium phosphate and water for injectable preparations.

Hyaluronic acid sodium salt (hyaluronan*) is formed by repeated chains of disaccharide units of N-acetylglucosamine and sodium glucuronate. It is a fundamental component of the synovial fluid, to which it gives the particular visco-elastic properties.

The hyaluronic acid sodium salt of Sinovial Mini is obtained by fermentation and has not undergone any chemical modification processes.

Sinovial ® Mini is presented in a 1.25 ml glass syringe containing 1 ml of solution.

The content of the syringe is sterile and pyrogen-free.

Indications

A visco-suppletive treatment for small joints: all the joints of the wrist and hand, including the interphalangeal, intercarpal, metacarpal-phalangeal, carpo-metacarpal, distal radio-ulnar and the radio carpal joint, all the joints in the foot and the temporo-mandibular joint.

Sinovial® Mini substitutes the synovial fluid, which restores the physiological and rheological properties of arthrosic joints.

This therapeutic action is carried out by the special characteristics of the hyaluronic acid used.

The hyaluronic acid in Sinovial® Mini, obtained by fermentation and not chemically modified, shows excellent tolerability.

By restoring the visco-elastic properties of the synovial fluid, Sinovial® Mini reduces pain and re-establishes joint mobility.

Sinovial® Mini acts only at the joint level into which it is injected, without exercising any systemic action.

2-3 treatments a year are recommended, at an interval of 4-6 months, according to medical opinion.

Contraindications

Sinovial ® Mini must not be injected in the presence of an infected or seriously inflamed joint or if the patient has a cutaneous disease or an infection in the area of the injection site.

Side Effects

Extra-articular seepage of Sinovial ® Mini may cause undesired effects locally. During the use of Sinovial® Mini, symptoms such as pain, the sensation of heat, reddening or swelling may appear at the injection site. These secondary emergences can be relieved by applying ice to the treated joint. They generally disappear in a short space of time. Doctors must ensure that patients notify them of any undesired effects which occur after the treatment.

Warnings and Precautions

- The content of the pre-filled syringe is sterile. The syringe is packed in a sealed blister pack. The external surface of the syringe is not sterile.

- Do not use Sinovial® Mini after the expiry date shown on the pack.

- Do not use Sinovial ® Mini if the packaging is open or damaged.

- The injection site must be on healthy skin.

- Do not inject vascularly. Do not inject outside the joint cavity, into the synovial tissue or into the articular capsule.

- Do not administer Sinovial ® Mini in the presence of heavy intra-articular effusion.

- Do not sterilize again. The device was foreseen as a throwaway device only.

- Do not reuse to avoid any risk of contamination.

- Store at 0 °- 25°C away from heat sources. Do not freeze.

- Once opened, Sinovial ® Mini must be used immediately and discarded after use.

- Keep out of reach of children.

- After the intra-articular injection advise the patient to avoid any intense physical activity and to resume his or her normal activities only after several days.

- The presence of an air bubble does not alter in any way the quality of the product.

Precautions for use

Do not mix Sinovial Mini with disinfectants such as quaternary ammonium salts or chlorhexidine as a precipitate may be formed.

Drug Interactions

To date no interactions between Sinovial ® Mini and other medicinal products are known.

Packaging

Packs of 1 and 3 syringes.

Pre-filled syringe (8 mg hyaluronic acid sodium salt in 1 ml buffered physiological solution of sodium chloride).

Steam sterilized.

Instructions for use

- Aspirate any joint effusion before proceeding with the injection of Sinovial® Mini.

- Insert the grip support, included, pushing until it is perfectly in place in the flange of the syringe.

- Pull out the cap of the syringe, being particularly careful to avoid contact with the opening.

- Insert the needle, of 18-22 G diameter.

- Screw the needle tightly to the Luer type closure neck of the syringe to ensure an airtight seal and prevent leakage of liquid during the medication.

- Inject Sinovial® Mini at ambient temperature and under strict asepsis conditions. Inject Sinovial ®Mini only into the synovial space.

TO BE SOLD ON MEDICAL PRESCRIPTION ONLY.

THE INTRA-ARTICULAR INJECTION MAY ONLY BE ADMINISTERED BY A DOCTOR

VISCODERM


0.8%-8mg/1ml Hyaluronic acid sodium salt

1.6%-16mg/1ml Hyaluronic acid sodium salt

2.0%-20mg/1ml Hyaluronic acid sodium salt

TRIO-1.6% – 1.5ml Hyaluronic acid sodium salt

Pre-filled 1ml or 1.5ml syringe

Medical device for intra-dermal use

Sterile-Disposable

Description

Hyaluronic acid (HA) is a polysaccharide which is naturally present in the human body. Its main function consists of maintaining the correct moisturization of the tissues, thanks to its intrinsic capacity to bind a large amount of water. The sodium salt of Hyaluronic acid is formed of repeated chains of disaccharide units of N-acetylglucosamine and sodium glucuronate, and is a fundamentally important component of the extracellular matrix of the majority of tissues, including the skin. VISCODERM constitutes a buffered physiological solution of Hyaluronic acid. The hyaluronic acid used is obtained by fermentation and has not been subjected to chemical change processes. VISCODERM contains the sodium salt of hyaluronic acid, highly purified and with a molecular weight of around 1 million Daltons, which is very close to the natural molecular weight of endogenous hyaluronic acid. It is undoubtedly important to ensure an appropriate choice of molecular weight of the hyaluronic acid and to come close to the natural molecular wight of endogenous hyaluronic acid, as in this manner the product is rendered totally biocompatible.The other components of the product are: sodium chloride, sodium phosphate and water for injectable preparations.

Pharmaceutical Form

VISCODERM appears in the form of a 1.25ml or 2.25ml glass syringe containing 1ml or 1.5ml of solution respectively (VISCODERM TRIO)

The content of the syringe is sterile and pyrogen-free.

Indications

VISCODERM acting through a corrective/filling action of the natural and induced cutaneous hollows, intervenes:

  • In the physiological process of ageing of the skin, the effects of which include inspissation of the horny layer and changes in the elastic fibres of the dermis
  • In the dermal tissue repair process, in cases of scar results following superficial cutaneous trauma (.g. acne and chickenpox scars).

The viscoelastic and moisturizing properties of hyaluronic acid, combined with the possibility to maintain the hyaluronic acid at adequate levels in the cutaneous tissues, allows the moisturizing of the tissues and creation of the optimal condition for preventing and contrasting the skin ageing process, and favors remodeling of the tissue with a consequent corrective effect on scar results on the skin. Hyaluronic acid also has a role inside the extracellular matrix, creating the physiological conditions for the proliferation, migration and structure of the dermal cell component. Moreover, the intradermal administration of VISCODERM and therefore its action on the dermis rather than on the epidermis, allows an optimal quantity of hyaluronic acid to be brought directly into the tissue to be treated, to contrast the cytotoxic action of free radicals on the fibroblasts, ensuring the effectiveness of preventive and corrective esthetic medicine operations. The hyaluronic acid used in VISCODERM is produced through the biosynthesis of a natural substrate without further chemical transformation and VISCODERM therefore has excellent biocompatibility and its use in the dermis allows integration of the hyaluronic acid which has been reduced and modified due to the physiological ageing process of the skin or following superficial cutaneous trauma.

Concentration 0.8%-8mg/1ml Hyaluronic acid sodium salt: indicated for maintenance of the corrective effect of the treatment

Concentration 1.6%-16mg/1ml Hyaluronic acid sodium salt and 24mg/1.5ml Hyaluronic acid sodium salt: indicated for the initial course of treatment of large areas and thin, sensitive skin

Concentration 2.0%-20mg/1ml Hyaluronic acid sodium salt: indicated for the initial course of treatment mostly of the face

An initial course of three treatment sessions at one week intervals is recommended, followed if necessary by monthly maintenance sessions

Contraindications

VISCODERM must not be used with treatments such as laser resurfacing and medium deep skin-peeling

Side Effects

Extra-dermal infiltration of VISCODERM can cause undesired effects locally. During the use of VISCODERM, symptoms such a pain, the sensation of heat, reddening or swelling may appear at the injection site. These secondary emergences can be relieved by applying ice to the treated area. They generally disappear in a short space of time. Doctors must ensure that patients notify them of any undesired effects which occur after the treatment

Warnings and Precautions

Warnings

- The content of the pre-filled syringe is sterile. The syringe is packaged in asealed blister pack

- The external surface of the syringe is not sterile

- Do not use VISCODERM after the expiry date shown on the pack

- Do not use VISCODERM if the packaging is open or damaged

- The injection site must be on healthy skin

- Do not inject intravenously, into muscles, tendons or for mammary expansion

- Do not mix with other products

- Do not inject into areas where inflammation is present

- Do not sterilize again. The device was foreseen as a throwaway device only

- Do not reuse to avoid any risk of contamination

- Store at 0-250 C away from heat sources. Do not freeze

- Once opened, VISCODERM must be used immediately and discarded after use

- Keep out of reach of children

- After the injection and for the following 3-5 days, advise the patient to avoid exposing the treated area to UV rays and to protect it with total block sun-creams

- The presence of an air bubble does not alter in any way the quality of the product

Precautions

Do not concomitantly use disinfectants containing quaternary ammonium salts for skins preparation as hyaluronic acid can precipitate in their presence

Drug Interactions

None know at present

Instructions for use

sino

Sinovial 1.6%

32 mg/2 ml Hyaluronic acid sodium salt

Composition

Viscosuppletive joint device.

Sterile – disposable.

Sinovial® constitutes a buffered physiological solution of hyaluronic acid with viscoelastic properties.

Sinovial® contains 1.6% highly purified hyaluronic acid sodium salt with a molecular weight of 800 – 1200 kDaltons. The other components of the product are: sodium chloride, sodium phosphate and water for injectable preparations.

Hyaluronic acid sodium salt (hyaluronan[1][2]) is formed by repetitive chains of disaccharide units of N-acetylglucosamine and sodium glucuronate. It is a fundamental component of synovial fluid, to which it confers special viscoelastic properties. The hyaluronic acid sodium salt in Sinovial® is obtained by fermentation and has not undergone chemical change processes.

Sinovial® appears in the form of a 2.25 ml glass syringe containing 2 ml of solution.

The content of the syringe is sterile and pyrogen-free.

Indications

Pain or reduced mobility due to degenerative diseases, post-traumatic diseases or joint alterations.

Sinovial® is a substitute for synovial fluid, which allows the re-establishment of the physiological and rheological properties of joints affected by arthrosis.

This therapeutic action is rendered by the special characteristics of the hyaluronic acid used. The hyaluronic acid contained in Sinovial®, obtained by fermentation and not chemically modified, has excellent tolerability. By re-establishing the viscoelastic properties of the synovial fluid, Sinovial® reduces the pain and re-establishes joint mobility.

Sinovial® acts only at the level of the joint into which it is injected, without exercising any systemic action.

Inject Sinovial® at weekly intervals for a total of three weeks. If necessary, further injections may be administered. It is the doctor’s responsibility to evaluate the appropriateness of repeating the cycle of treatment and its frequency for each patient, taking into consideration the risk/benefit ratio of the treatment in each case.

Contraindications

Sinovial® must not be injected in the presence of an infected or seriously inflamed joint or if the patient has a cutaneous disease or an infection in the area of the injection site.

Side Effects

Extra-articular seepage of Sinovial® may cause undesired effects locally. During the use of Sinovial®, symptoms such as pain, the sensation of heat, reddening or swelling may appear at the injection site. These secondary emergences can be relieved by applying ice to the treated joint. They generally disappear in a short space of time. Doctors must ensure that patients notify them of any undesired effects which occur after the treatment.

Warnings and Precautions

  • The content of the pre-filled syringe is sterile. The syringe is packed in a sealed blister pack. The external surface of the syringe is not sterile.
  • Do not use Sinovial® after the expiry date shown on the pack.
  • Do not use Sinovial® if the packaging is open or damaged.
  • The injection site must be on healthy skin.
  • Do not inject intravenously. Do not inject outside the joint cavity, into the synovial tissue or into the articular capsule.
  • Do not administer Sinovial® in the presence of heavy intra-articular effusion.
  • Do not sterilise again. The device was foreseen as a throwaway device only.
  • Do not reuse to avoid any risk of contamination.
  • Store at 0 °- 25°C away from heat sources. Do not freeze.
  • Once opened, Sinovial® must be used immediately and discarded after use.
  • Keep out of reach and sight of children.
  • After the intra-articular injection advise the patient to avoid any intense physical activity and to resume his or her normal activities only after several days.
  • The presence of an air bubble does not alter in any way the quality of the product.

Precautions for use

Do not concomitantly use disinfectants containing quaternary ammonium salts or chlorhexidine for skin preparation as hyaluronic acid can precipitate in their presence.

Drug Interactioons

None known at present.

Packaging

Packs of 1, 3 and 5 syringes.

Pre-filled syringes (32.0 mg hyaluronic acid sodium salt in 2 ml buffered physiological solution of sodium chloride).

Steam sterilized.

Instructions for use

  • Aspirate any joint effusion before proceeding with the injection of Sinovial®.
  • Insert the grip support, included, pushing until it is perfectly in place in the flange of the syringe.
  • Pull out the cap of the syringe, being particularly careful to avoid contact with the opening.
  • Insert the needle, of 18-22 G diameter.
  • Screw the needle tightly to the Luer type closure neck of the syringe to ensure an airtight seal and prevent leakage of liquid during the medication.
  • Inject Sinovial® at ambient temperature and under strict asepsis conditions. Inject Sinovial ®only into the synovial space.

LAST PATIENT INFORMATION LEAFLET REVIEW:

APRIL 2010

TO BE SOLD ON MEDICAL PRESCRIPTION ONLY.

THE INTRA-ARTICULAR INJECTION MAY ONLY BE ADMINISTERED BY A DOCTOR.

sino

Sinovial 0.8%

Composition

 

16 mg/2 ml Hyaluronic acid sodium salt

Viscosuppletive joint device.

Sterile – disposable.

Sinovial® constitutes a buffered physiological solution of hyaluronic acid with viscoelastic properties.

Sinovial® contains 0.8% highly purified hyaluronic acid sodium salt with a molecular weight of 800 – 1200 kDaltons. The other components of the product are: sodium chloride, sodium phosphate and water for injectable preparations.

Hyaluronic acid sodium salt (hyaluronan*) is formed by repetitive chains of disaccharide units of N-acetylglucosamine and sodium glucuronate. It is a fundamental component of synovial fluid, to whichit confers special viscoelastic properties. The hyaluronic acid sodiumsalt in Sinovial® is obtained by fermentation and has not undergone chemical change processes.

Sinovial® appears in the form of a 2.25 ml glass syringe containing 2 ml of solution.

The content of the syringe is sterile and pyrogen-free.

 

Indications

Pain or reduced mobility due to degenerative diseases, post-traumatic diseases or joint alterations.

Sinovial® is a substitute for synovial fluid, which allows the re-establishment of the physiological and rheological properties of joints affected by arthrosis.

This therapeutic action is rendered by the special characteristics ofthe hyaluronic acid used. The hyaluronic acid contained in Sinovial®, obtained by fermentation and not chemically modified, has excellent tolerability. By re-establishing the viscoelastic properties of the synovial fluid, Sinovial® reduces the pain and re-establishes joint mobility.

Sinovial® acts only at the level of the joint into which it is injected, without exercising any systemic action.

Improvement is instant: after the first injection the WOMAC global index reduces and from the third injections onwards the reduction becomes statistically significant.

The results of a study confirm that 5 injections of Sinovial®, each administered one week apart, cause a reduction in pain and swelling in addition to an improvement in function, which can continue for up to 24 weeks.

 

Contraindications

Sinovial® must not be injected in the presence of an infected or seriously inflamed joint or if the patient has a cutaneous disease or an infection in the area of the injection site.

 

Side Effects

Extra-articular seepage of Sinovial® may cause undesired effects locally. During the use of Sinovial®, symptoms such as pain, the sensation of heat, reddening or swelling may appear at the injection site. These secondary emergences can be relieved by applying ice to the treated joint. They generally disappear in a short space of time. Doctors must ensure that patients notify them of any undesired effects

 

Warnings and Precautions

- The content of the pre-filled syringe is sterile. The syringe is packed in a sealed blister pack. The external surface of the syringe is not sterile.

– Do not use Sinovial® after the expiry date shown on the pack.

– Do not use Sinovial® if the packaging is open or damaged.

– The injection site must be on healthy skin.

– Do not inject intravenously. Do not inject outside the joint cavity, into the synovial tissue or into the articular capsule.

– Do not administer Sinovial® in the presence of heavy intra-articular effusion.

– Do not sterilize again. The device was foreseen as a throwaway device only.

– Do not reuse to avoid any risk of contamination.

– Store at 0 °- 25°C away from heat sources. Do not freeze.

– Once opened, Sinovial® must be used immediately and discarded after use.

– Keep out of reach of children.

– After the intra-articular injection advise the patient to avoid any intense physical activity and to resume his or her normal activities only after several days.

– The presence of an air bubble does not alter in any way the quality of the product.

 

Precautions for use

Do not concomitantly use disinfectants containing quaternary ammonium salts or chlorhexidine for skin preparation as hyaluronic acid can precipitate in their presence.

Drug Interactions

None known at present.

Packaging

Packs of 1, 3 and 5 syringes.

Pre-filled syringes (16.0 mg hyaluronic acid sodium salt in 2 ml buffered physiological solution of sodium chloride).

Steam sterilized.

which occur after the treatment.

Instructions for use

- Aspirate any joint effusion before proceeding with the injection of Sinovial®.

– Insert the grip support, included, pushing until it is perfectly in place in the flange of the syringe.

– Pull out the cap of the syringe, being particularly careful to avoid contact with the opening.

– Insert the needle, of 18-22 G diameter.

– Screw the needle tightly to the Luer type closure neck of the syringe to ensure an airtight seal and prevent leakage of liquid during the medication.

– Inject Sinovial® at ambient temperature and under strict asepsis conditions. Inject Sinovial® only into the synovial space.

*Alternative names are often used

merional

Merional

General

Highly Purified Human Menopausal Gonadotrophin (HMG) for intramuscular and subcutaneous injection

Composition

1 vial of active ingredient contains: Active ingredient: Human Follicle Stimulating Hormone (FSH) 75 or 150 I.U.;

Human Luteinizing Hormone (LH) 75 or 150 I.U.

Indications

Stimulation of follicle maturation in infertile women.

a) Simple follicular stimulation

Hypo-and normo-gonadotropic an ovulation either with or without menstrual disorders; luteal insufficiency. In patients partially or completely unresponsive to a treatment with clomiphene

b) Multiple follicular stimulation.

In patients participating in a medically assisted reproduction program (IVF-ET, GIFT).

Dosage Administration

Merional is administered by intramuscular or subcutaneous injection.

Induction of ovulation: induce ovulation with an injection of human chorionic gonadotrophin (HCG) to bring a single Graaf follicle to maturation

These two treatment schemes are followed:

Scheme 1: Daily administration: The first injection of 1 vial of Merional 75 I.U. i.m. or s.c. should be given on the 4th / 5th day following a spontaneous menstruation or an induced bleeding. The treatment at a daily dose of 1 vial of Merional 75 I.U. should last for 7 to 12 days maximum, or until an adequate follicular maturation is obtained. If the desired result is not obtained, the treatment can be discontinued or pursued at a dose of 2 vials/day (= 150 I.U. of Merional). If, on the contrary, oestrogen plasma levels increase too fast

(> 100% in 2-3 days), the dosage of Merional must be reduced. 24 to 48 hours after the last injection of Merional, a single dose of 5,000 to 10,000 I.U. of HCG i.m. can be administered.

Scheme 2:

Administration every 2 days. In this treatment protocol, Merional is administered every other day.