bhpardo/ema_en · Datasets at Hugging Face

english stringlengths 2 1.37k
3.
pre-filled pen (glass) (OptiSet)
16.
Following subcutaneous injection, serum levels of epoetin alfa are much lower than the levels achieved following intravenous injection, the levels increase slowly and reach a peak between 12 and
Actraphane 40 Penfill
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
6.3 Shelf-life
8.
Preparation of the 70 mg/ m2 infusion for paediatric patients > 3 months of age (using a 70-mg vial) 1.
16.
No specific information is available on the treatment of overdose with Aprovel.
117 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
6 ml
Excipients
If you have questions about how to inject, please ask your doctor, nurse or pharmacist for assistance.
480 soft capsules
BLISTER
The frequency of administration will depend on how well ADVATE is working for you.
Frequency of doses (hours)/duration of therapy (days)
CIALIS 10 mg film-coated tablets tadalafil
Therapy with AVAGLIM should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5X upper limit of normal) or with any other evidence of liver disease.
Uncommon - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
SANOFI SYNTHELABO LIMITED Edgefield Avenue - Fawdon Newcastle Upon Tyne, Tyne & Wear NE3 3TT - United Kingdom
Water or other liquid is not needed to swallow the dose.
7.
Actos 30mg tablets can be taken with or without food.
Moreover, in patients with a baseline haemoglobin of > 13 g/ dl, the possibility that epoetin alfa treatment may be associated with an increased risk of postoperative thrombotic/ vascular events cannot be excluded.
Correction Phase
Why has ATryn been approved?
NAME OF THE MEDICINAL PRODUCT
In addition, rosiglitazone preserved ß-cell function as shown by increased pancreatic islet mass and insulin content and prevented the development of overt hyperglycaemia in animal models of type 2 diabetes.
Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, severe aluminium toxicity, underlying haematologic diseases, or bone marrow fibrosis may also compromise the erythropoietic response.
PHARMACEUTICAL FORM AND CONTENTS
A special pack with the correct quantities of both strengths of tablets is available when initiating treatment.
The lack of carcinogenic potential was demonstrated in studies conducted with desloratadine and loratadine.
No interaction was observed when ibandronic acid was administered concomitantly with tamoxifen, or melphalan/ prednisolone.
L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from Trichoplusia ni.
If signs of toxicity are noted (e. g. pronounced adverse reactions - see section 4.8) the dose of Advagraf may need to be reduced.
The recommended oral dose in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).
Keep out of the reach and sight of children.
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
(NaH2PO4.2 H2O) and water for injections.
Patients receiving aripiprazole solution for injection should be observed for orthostatic hypotension.
Neuroleptic Malignant Syndrome (NMS):
ESAs are not indicated for use in this patient population.
4.
Due to its increased carbohydrate content darbepoetin alfa has a longer terminal half-life than r-HuEPO and consequently a greater
You may need to read it again.
8.
Do not freeze.
– The active substance is insulin human made by recombinant biotechnology.
In this situation, a reduced dose of atorvastatin should be considered.
Maintenance dose between 25 and 50 IU/ kg 2 times per week into 2 equal injections.
Activated Factor X converts prothrombin to thrombin.
LIST OF EXCIPIENTS
- hepatic impairment
NAME OF THE MARKETING AUTHORISATION HOLDER
Intramuscular use
Specific interaction studies with antidiabetic agents were not conducted.
medicine.
No data are available to recommend the use of CellCept in children who have received a heart transplant.
Many of these patients were also receiving chemotherapy and corticosteroids.
Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
The study lasted six months.
Aloxi should not be used in people who may be hypersensitive (allergic) to palonosetron or any of the other ingredients.
4.4 Special warnings and precautions for use
It has been shown in man that administration of an oral suspension of activated powdered charcoal or colestyramine leads to a rapid and significant increase in A771726 elimination rate and decline in plasma concentrations (see section 4.9).
Common:
The co-administration of tipranavir with vitamin E in the form of TPGS (d-alphatocopherol polyethylene glycol 1000 succinate) from 2,322 IU/ m² upwards in rats resulted in a significant increase in effects on coagulation parameters, bleeding events and death.
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
On rare occasions, injection site reactions may require discontinuation of Actraphane.
n
Pseudoephedrine sulphate carries the risk of abuse.
Gran Vía Carlos III, 94 E- 08028 Barcelona Tel.: +34 93 600 37 00
General disorders and administration site conditions
In the case of the following haemorrhagic events, the factor IX activity should not fall below the given plasma activity levels (in% of normal or in IU/ dl) in the corresponding period.
The other two studies involved a total of 1,159 patients with later stage disease, where AZILECT was added to the patients’ existing treatment including levodopa.
40 Injecting yourself
180 film-coated tablets
Retapamulin is a semi-synthetic derivative of the compound pleuromutilin, which is isolated through fermentation from Clitopilus passeckerianus (formerly Pleurotus passeckerianus).
Very rare:
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50% in order to ensure that the lowest approved dose of Aranesp is used to maintain haemoglobin at a level that controls the symptoms of anaemia.
The Committee recommended that Biograstim be given marketing authorisation.
Renal impairment: no dosage adjustment is necessary in patients with impaired renal function.
You should watch for a temperature of 37.8 °C or above, chills or other signs of infection, such as a rash, sore throat, diarrhoea, ear-ache, difficult or painful breathing or problems such as cough or wheezing.
2.
Tel: + 356 25600 500 Nederland Eli Lilly Nederland B. V.
AUC0-∞ (IU· h/ dl) t1/ 2 (h) Adjusted Recovery
Aspartate aminotransferase increased, ejection fraction decreased, blood creatinine increased, alanine aminotransferase increased
Film-coated tablets 11 x 0.5 mg and 14 x 1 mg
EU/ 1/ 07/ 410/ 016
The injections are given in the thighs or the anterior abdominal wall.
Ask your doctor, pharmacist or nurse for advice before taking any medicine.
15.4 (56.4)
- tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the
14 After removing Actraphane vial from the refrigerator it is recommended to allow the vial to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
POSSIBLE SIDE EFFECTS
General

3.

pre-filled pen (glass) (OptiSet)

16.

Following subcutaneous injection, serum levels of epoetin alfa are much lower than the levels achieved following intravenous injection, the levels increase slowly and reach a peak between 12 and

Actraphane 40 Penfill

NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

6.3 Shelf-life

8.

Preparation of the 70 mg/ m2 infusion for paediatric patients > 3 months of age (using a 70-mg vial) 1.

16.

No specific information is available on the treatment of overdose with Aprovel.

117 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

6 ml

Excipients

If you have questions about how to inject, please ask your doctor, nurse or pharmacist for assistance.

480 soft capsules

BLISTER

The frequency of administration will depend on how well ADVATE is working for you.

Frequency of doses (hours)/duration of therapy (days)

CIALIS 10 mg film-coated tablets tadalafil

Therapy with AVAGLIM should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5X upper limit of normal) or with any other evidence of liver disease.

Uncommon - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.

SANOFI SYNTHELABO LIMITED Edgefield Avenue - Fawdon Newcastle Upon Tyne, Tyne & Wear NE3 3TT - United Kingdom

Water or other liquid is not needed to swallow the dose.

7.

Actos 30mg tablets can be taken with or without food.

Moreover, in patients with a baseline haemoglobin of > 13 g/ dl, the possibility that epoetin alfa treatment may be associated with an increased risk of postoperative thrombotic/ vascular events cannot be excluded.

Correction Phase

Why has ATryn been approved?

NAME OF THE MEDICINAL PRODUCT

In addition, rosiglitazone preserved ß-cell function as shown by increased pancreatic islet mass and insulin content and prevented the development of overt hyperglycaemia in animal models of type 2 diabetes.

Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, severe aluminium toxicity, underlying haematologic diseases, or bone marrow fibrosis may also compromise the erythropoietic response.

PHARMACEUTICAL FORM AND CONTENTS

A special pack with the correct quantities of both strengths of tablets is available when initiating treatment.

The lack of carcinogenic potential was demonstrated in studies conducted with desloratadine and loratadine.

No interaction was observed when ibandronic acid was administered concomitantly with tamoxifen, or melphalan/ prednisolone.

L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from Trichoplusia ni.

If signs of toxicity are noted (e. g. pronounced adverse reactions - see section 4.8) the dose of Advagraf may need to be reduced.

The recommended oral dose in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).

Keep out of the reach and sight of children.

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

(NaH2PO4.2 H2O) and water for injections.

Patients receiving aripiprazole solution for injection should be observed for orthostatic hypotension.

Neuroleptic Malignant Syndrome (NMS):

ESAs are not indicated for use in this patient population.

4.

Due to its increased carbohydrate content darbepoetin alfa has a longer terminal half-life than r-HuEPO and consequently a greater

You may need to read it again.

8.

Do not freeze.

– The active substance is insulin human made by recombinant biotechnology.

In this situation, a reduced dose of atorvastatin should be considered.

Maintenance dose between 25 and 50 IU/ kg 2 times per week into 2 equal injections.

Activated Factor X converts prothrombin to thrombin.

LIST OF EXCIPIENTS

- hepatic impairment

NAME OF THE MARKETING AUTHORISATION HOLDER

Intramuscular use

Specific interaction studies with antidiabetic agents were not conducted.

medicine.

No data are available to recommend the use of CellCept in children who have received a heart transplant.

Many of these patients were also receiving chemotherapy and corticosteroids.

Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent relapse.

The study lasted six months.

Aloxi should not be used in people who may be hypersensitive (allergic) to palonosetron or any of the other ingredients.

4.4 Special warnings and precautions for use

It has been shown in man that administration of an oral suspension of activated powdered charcoal or colestyramine leads to a rapid and significant increase in A771726 elimination rate and decline in plasma concentrations (see section 4.9).

Common:

The co-administration of tipranavir with vitamin E in the form of TPGS (d-alphatocopherol polyethylene glycol 1000 succinate) from 2,322 IU/ m² upwards in rats resulted in a significant increase in effects on coagulation parameters, bleeding events and death.

NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

On rare occasions, injection site reactions may require discontinuation of Actraphane.

n

Pseudoephedrine sulphate carries the risk of abuse.

Gran Vía Carlos III, 94 E- 08028 Barcelona Tel.: +34 93 600 37 00

General disorders and administration site conditions

In the case of the following haemorrhagic events, the factor IX activity should not fall below the given plasma activity levels (in% of normal or in IU/ dl) in the corresponding period.

The other two studies involved a total of 1,159 patients with later stage disease, where AZILECT was added to the patients’ existing treatment including levodopa.

40 Injecting yourself

180 film-coated tablets

Retapamulin is a semi-synthetic derivative of the compound pleuromutilin, which is isolated through fermentation from Clitopilus passeckerianus (formerly Pleurotus passeckerianus).

Very rare:

Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50% in order to ensure that the lowest approved dose of Aranesp is used to maintain haemoglobin at a level that controls the symptoms of anaemia.

The Committee recommended that Biograstim be given marketing authorisation.

Renal impairment: no dosage adjustment is necessary in patients with impaired renal function.

You should watch for a temperature of 37.8 °C or above, chills or other signs of infection, such as a rash, sore throat, diarrhoea, ear-ache, difficult or painful breathing or problems such as cough or wheezing.

2.

Tel: + 356 25600 500 Nederland Eli Lilly Nederland B. V.

AUC0-∞ (IU· h/ dl) t1/ 2 (h) Adjusted Recovery

Aspartate aminotransferase increased, ejection fraction decreased, blood creatinine increased, alanine aminotransferase increased

Film-coated tablets 11 x 0.5 mg and 14 x 1 mg

EU/ 1/ 07/ 410/ 016

The injections are given in the thighs or the anterior abdominal wall.

Ask your doctor, pharmacist or nurse for advice before taking any medicine.

15.4 (56.4)

- tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the

14 After removing Actraphane vial from the refrigerator it is recommended to allow the vial to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.

POSSIBLE SIDE EFFECTS

General